Device for the use of multiple intraluminal surgical clips

专利摘要:
A catheter delivery system (100) comprising an elongated body (11A, 132) and a catheter sheath (13, 136), and a plurality of independent self-expanding vascular prostheses (140), each independent self-expanding vascular prosthesis (140) having a plurality of struts (26 , 27, 28, 29) and a radiopaque marker (22). The catheter delivery system further comprises a proximal handle (11F) with an actuator (11G) which is coupled to a proximal end of the catheter sheath (13, 136), the actuator (11G) being movably configured to withdraw the catheter sheath and the plurality of independently self-expanding vascular prostheses (140).
公开号:AT16877U1
申请号:TGM50068/2018U
申请日:2011-07-08
公开日:2020-11-15
发明作者:
申请人:Intact Vascular Inc；
IPC主号:

专利说明:

description
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation in part of U.S. patent application serial number 13/153257, filed June 3, 2011, and a continuation in part of U.S. patent application serial number 13/118388, filed May 28, 2011 was submitted. The aforementioned patent applications are again both partial continuations of US patent application serial number 12 / 790,819, which was filed on May 29, 2010, which in turn is a partial continuation of US patent application serial number 12 / 483,193, which was filed on June 11th Filed in 2009 and which is a continuation in part of U.S. Patent Application Serial No. 11 / 955,331, filed December 12, 2007 and now U.S. Patent No. 11 / 955,331. 7,896,911. This application also claims priority over U.S. Provisional Patent Application No. 61 / 362,650, filed July 8, 2010. U.S. Patent Application Serial No. 13 / 118,388 claims the benefit of priority over U.S. Provisional Patent Application No. 61 / 349,836, filed May 28, 2010.
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
The present invention relates to the treatment of atherosclerotic occlusive disease by intravascular procedures in which plaque that has deposited on the blood vessel walls is pushed aside and held so as to reopen blood flow.
Atherosclerotic disease is the primary cause of stroke, heart attack, amputation, and death in the United States and the industrialized world. Artherosclerotic plaque forms a hard layer along the wall of an artery and is made up of calcium, cholesterol, and compacted debris from thrombus and cells. As the atherosclerotic disease progresses, the flow of blood that should pass a particular blood vessel is reduced or even prevented by the occlusion process. One of the most widely used methods of treating clinically significant atherosclerotic plaque is balloon angioplasty.
[0004] Balloon angioplasty is a recognized procedure for opening blocked or narrowed blood vessels in any vascular bed in the body. Balloon angioplasty is performed with a balloon angioplasty catheter. The balloon angioplasty catheter consists of a cigar-shaped cylindrical balloon attached to a catheter. The balloon angioplasty catheter is inserted into the artery from a remote access site created either percutaneously or through the open exposure of the artery. The catheter is advanced on the inside of the blood vessel over a wire that guides the catheter on its way. The portion of the catheter with the balloon attached is placed at the site of the atherosclerotic plaque that needs treatment. The balloon is inflated to a size that corresponds to the original diameter of the artery before the occlusive disease developed. When the balloon is inflated, the plaque is broken up. Fracture planes form within the plaque, which allows the plaque to expand in diameter with the expanding balloon. Often, one segment of the plaque is more resistant to dilation than the rest of the plaque. If so, the higher pressure pumped into the balloon will result in full dilation of the balloon to the intended size. The ballori is deflated and removed, and the artery segment is reexamined. The process of balloon angioplasty results in uncontrolled plaque disruption. The lumen of the blood vessel at the treatment site is usually somewhat larger, but not always and not reliable.
Some of the fracture planes generated by the fracture of the plaque in balloon angioplasty can form a dissection. A dissection occurs when part of the
Plaque is lifted from the artery, is not fully attached to the artery, and may be mobile or loose. The plaque interrupted by dissection emerges and protrudes into the blood flow. If the plaque is lifted completely in the direction of blood flow, it can impede blood flow or cause acute occlusion of the blood vessel. There is evidence that dissection after balloon angioplasty must be treated to prevent occlusion and correct residual stenosis. It has also been shown that under certain circumstances it is better to use a metal holding structure, such as a stent, to hold the artery open after angioplasty and to force the divided material back against the wall of the blood vessel create adequate lumen for blood flow.
[0006] The clinical treatment of a dissection after balloon angioplasty is currently essentially carried out by means of stents. As shown in FIG. 1, a stent 3 is a small tube with a diameter which is matched to the artery 7 in terms of size. A stent is inserted into the artery at the dissection site to force the dissection tab against the inner wall of the blood vessel. Stents are usually made from metal alloys. They have varying degrees of flexibility and visibility, as well as different placement techniques. Stents are inserted into every vascular bed in the body. With the development of stents, the approach to minimally invasive treatment of vascular diseases has changed significantly, making it safer and, in many cases, more durable. The occurrence of acute occlusion after balloon angioplasty has been significantly reduced thanks to stents.
However, stents also have significant disadvantages and a great deal of research and development is being carried out to address these problems. Stents introduce repeated narrowing of the treated blood vessel (recurrent stenosis). The recurrent stenosis is the "Archilles heel" of stent placement. Depending on the position and size of the artery, intimal hyperplastic tissue can grow into the vascular wall between the webs or through the openings in the stent and lead to failure of the vascular reconstruction due to narrowing or occlusion of the stent. This can happen at any time after a stent has been inserted. In many cases, the stent itself appears to produce a local reaction of the vessel wall causing stenosis, even in the segment of the stent that was placed over artery segments that were not particularly narrowed or diseased when the original stent was deployed. This reaction of the blood vessel to the presence of the stent is likely due to the scaffolding effect of the stent. This reaction of recurrent stenosis or ingrowing tissue into the blood vessel occurs in response to the stent. This activity shows that the extensive use of metal and vascular covering in the artery that occurs during stent delivery contribute to the narrowing. Recurrent stenosis is a problem because it causes stent failure and there is no effective treatment for it. Existing treatments that have been used against this problem include: a. repeated angioplasty, angioplasty with a cutting balloon, cryoplasty, atherectomy, and even repeated stenting. Neither of these procedures can demonstrate a high level of long-term success.
[0008] Stents can also break due to material stress. A stent fracture can occur with chronic material stress, as it is associated with the development of a recurrent stenosis at the stent fracture site. This is a relatively recent discovery and specific stent designs may be required for each application in each vascular bed. The structural integrity of stents remains a current problem in their use. Mobile arteries, such as the arteries of the lower extremities and the carotid arteries, are particularly problematic. The integrity of the entire stent is tested each time the vessel is flexed or compressed anywhere along the stented segment. One reason stent fractures may occur is because a longer segment of the artery than necessary was treated. The scaffolding effect of the stent affects the general mechanical behavior of the artery, making the artery less flexible. The materials available for
Stent deployments have limited flex cycles and are prone to repetitive and frequent flexing.
Stents are used in many arterial segments, even if they are not required. This exacerbates the disadvantages of stents. There are mutliple reasons for this. In many cases more than one stent must be deployed, and often several are required. Much of the length of the stent is often placed over artery segments that do not require a stent. They simply border on an area of dissection or disease. No stents tailored to the exact length of the lesion are available. When attempting to deploy multiple stents into the segments where stent deployment is most needed, the cost is prohibitive as each stent involves deployment and material costs. The time it takes to do this also adds to the costs and risks of the procedure. The longer the artery in which a stent is to be inserted that is not required, the stiffer the artery becomes and the greater the scaffolding effect that then occurs. This can also help trigger the arterial response in the stent that causes recurrent stenosis.
SUMMARY OF THE INVENTION
There is a constant need to develop new and improved devices to support the treatment of vascular diseases, such as u. a. atherosclerotic disease, for the purposes described above.
In one embodiment, a system for providing a vascular prosthesis is provided which includes an elongated body, a sheath, and a plurality of intravascular staples. The elongate body has a proximal end, a distal end, and a plurality of delivery platforms disposed adjacent the distal end. Each of these delivery platforms includes a recess which extends distally from an annular marker band. The sheath has a proximal end, a distal end, and an elongated body extending therebetween. The envelope can be moved from a first position into a second position in relation to the elongated body. In the first position, the distal end of the sheath is located distal from a distal-most distal delivery platform. In the second position, the distal end of the sheath is positioned proximal to at least one delivery platform. Each of the intravascular staples is positioned around a respective delivery platform.
In certain embodiments, the system is configured so that at least two staples are placed in a treatment zone at spaced apart locations. With such placement, a minimal gap can be provided in the treatment area between a distal end of a proximal staple and a proximal end of a distal staple. This minimal gap can advantageously be provided without having to move the elongate body or the delivery platforms.
The gap advantageously minimizes the likelihood that two staples will get caught in the vessel, or that other complaints will occur due to being too close.
A minimum spacing between adjacent distal surfaces of each annular marker band is provided to minimize movement of the elongate body so as to ensure a minimum gap between the provided staples. In certain embodiments, for example, there is essentially no change in the axial spacings of the staples provided in comparison to the spacings between the staples on the delivery platforms. As a result of this, the minimum distances between the distal surfaces can help to avoid an excessively tight delivery state of the adjacent staples.
One approach to maintaining a minimum gap, for example minimizing the change in the distances between the non-provided and the provided staples, consists in providing a holder for immobilizing the proximal end of the ab-
gabesystem, so that the movement of the system in the envelope is focused and little, if any, movement is allowed in the elongated body.
Another approach involves providing a stabilizing device that is disposed on an outer surface of the delivery system so as to minimize at least one of the axial or radial displacements of at least one of the delivery platforms.
In another embodiment, a method of placing an intravascular staple is provided. A catheter system is provided which includes an elongated body containing a plurality of spaced apart delivery platforms disposed adjacent a distal portion of the elongated body. The position of at least one of the delivery platforms is indicated by a marker tape. A plaque staple is placed on each platform. The distal portion of the elongated body is advanced through a patient's vasculature until the marker tape is proximal or distal to an area to be treated with dissected plaque. The marker tape is visualized to confirm the position of at least one of the delivery platforms in relation to the dissected plaque. The outer cover is withdrawn while maintaining the position of the elongated body, and thereafter at least two of the staples are provided to arrange the staples in a predetermined position and at predetermined intervals.
In various methods, a stabilizer can be provided before the staples are provided. The elongated body can be stabilized by the actuation of a stabilizer, which is arranged at the distal end of the catheter system, or by coupling the elongated body to a holder at the proximal end, so as to prevent undesired displacement in the vessel at the distal end of the elongated body in the vicinity to minimize the number of delivery platforms.
In another embodiment, a system for providing a vascular prosthesis is provided that includes an elongated body, an elongated package, and an enclosure. The elongate body comprising a distal end, a proximal end, and a plunger disposed adjacent the distal end. The elongated package has a variety of intravascular staples coupled to it. The staples are provided along the length of the elongated package. The sheath has a proximal end and a distal end, the sheath being movable in relation to the elongated body from a first position in which the distal end of the sheath is disposed distal to at least a portion of the elongated package, to a second position, in which the distal end of the sheath is positioned proximal to the elongated package. The elongated package is configured to maintain a minimum clearance between the adjacent staples during deployment and to allow expansion and separation from the elongated body. The elongated package is configured to release the staples to allow them to expand toward a vessel after deployment.
An endoluminal staple can include proximal and distal peripheral portions. The proximal peripheral portion can be provided at a proximal end of the endoluminal staple. The distal peripheral portion can be provided at a distal end of the endoluminal staple. In some embodiments, the distal peripheral portion is the most distal aspect of the endoluminal staple, and the proximal peripheral portion is the most proximal aspect of the endoluminal staple. The proximal and distal peripheral parts can be connected by bridge parts. The bridge portions may include one or more anchors configured to be fixed in the plaque and / or in the blood vessel wall. The anchors can have an increased material thickness in contrast to the rest of the staple, which increases the radiopacity of the anchoring and eliminates the need for a separate visibility marking.
BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects, and advantages are referred to below
Described on drawings of preferred embodiments, which are for purposes of illustration, but are not intended to limit the present invention in any way.
FIG. Figure 1 illustrates the use of a stent that is deployed after angioplasty, as is commonly traditional practice.
FIG. Figure 2 illustrates the use of plaque staples that are inserted after an endoluminal procedure and shows their advantages over the prior art.
FIG. 3A shows one embodiment of a plaque staple in end view, FIG. 3B shows this in side view, FIG. 3C shows the plaque staple in perspective view and FIG. 3D shows a portion of the plaque staple in a flat or rolled-out view.
FIG. Figure 4 is a schematic representation of a distal portion of a delivery device advanced to a treatment site that has been expanded in the blood vessel.
FIG. 4A illustrates the proximal end of one embodiment of a delivery device.
FIG. 4B is a top plan view of the distal portion of the FIG. 4 shown delivery device.
FIG. 4C is a cross-sectional view of the distal portion of FIG. 4B, in one
A variety of stapling devices prepared for implantation is shown.
FIG. Figure 4D shows the provision of two staplers after a wrapper has been retracted.
FIG. 5A and 5B show another embodiment of a plaque staple, each in a folded state and in an expanded condition.
was standing.
FIG. 5C shows a detailed view of a region of the plaque staple from FIG. 5A-B.
FIG. 5C1 shows a variation of the embodiment from FIG. 5A-5C with a larger anchorage.
FIG. 5D shows a variation of the embodiment from FIG. 5A-5C with an anchor located on a center line of the staple.
FIG. Figure 5E shows a variation with lands that are tapered from wider am
lateral edge of a staple too narrow in the middle region of the web, and / or from narrower in the central region of a web to wider adjacent to a medial position of the staple.
FIG. Figure 6A is a graph comparing the expansion forces of a plaque staple with those of a stent.
FIG. Figure 6B illustrates the application of multiple plaque staples spaced the length of a treatment site compared to that of a typical stent.
FIG. Figure 7A shows another embodiment of a plaque staple in the fully compressed state. FIG. 7D shows the plaque staple in a fully expanded state, and FIG. 7B and 7C show the plaque staple in states of expansion between the fully compressed and fully expanded states.
FIG. 8 is a schematic illustration of the focal elevation element of a plaque staple of FIGS. 7A-D.
FIG. Figure 9 is a schematic diagram illustrating the variables in calculating the increased staple surface area through the use of focal elevation elements in a plaque stapler.
FIG. Figure 10 illustrates the use of a plaque staple with focal elevators to hold plaque against a blood vessel wall.
FIG. 11 and 12 illustrate a variant application of the focal elevation elements on a plaque staple.
FIG. Figures 13 and 14 illustrate another variant of the application of the focal elevation elements to a plaque staple.
FIG. Figure 15 illustrates the use of focal elevation elements to reshape arterial walls into a desired cross-sectional shape.
FIG. 16-22 illustrate variations in the shaping and positioning of focal elevation elements on the struts of a plaque staple.
FIG. 23-29 illustrate a method of providing a plaque booklet
clamp in a blood vessel. FIG. Figures 30A-B show a focal elevation element affixed to plaque. FIG. 31A-B show anchors that are fixed to plaque.
FIG. 32A-32B show the proximal and distal views, respectively, of a system for providing a vascular prosthesis, with a distal end of an enclosure of the system disposed distal to one or more plaque staples.
FIG. 33A-33B each show the proximal and the distal view of the system from FIGS. 32A-32B, the distal end of the envelope being arranged proximal to one or more plaque staples.
FIG. Figure 34 shows a system for providing a vascular prosthesis.
FIG. Figure 35 shows an enclosure that can be used to constrain and provide one or more staples.
FIG. 36-36A illustrate an embodiment of an elongate body which, within the enclosure of FIG. 35, may have one or more plaque staples around it.
FIG. 37A-37B illustrate a variation of the delivery system in which an actively actuated portion is provided for anchoring the system near the treatment area.
FIG. Figure 38 illustrates a variation of the delivery system in which a linkage is provided for actively actuating a part positioned near the treatment area.
FIGS. 39-40 illustrate delivery systems with passively expanding members to stabilize a distal delivery area.
FIG. Figure 41 illustrates a delivery system with a friction isolating wrapper for stabilizing a distal delivery area.
FIG. 42 illustrates a delivery system that includes a deployable package for maintaining spacing between adjacent prostheses.
FIG. Figure 43 illustrates one embodiment of a deployment package adapted to maintain spacing between adjacent prostheses.
FIG. Figure 44 illustrates a delivery system that includes a deployable package for maintaining spacing between adjacent prostheses with a constraining member located in the staples.
FIG. Figure 45 illustrates a balloon optimized for providing a plaque staple to impart plaque-driving rotational motion into a plaque anchor.
FIG. Figure 45A shows a balloon for providing multiple staples.
FIG. 46-48D illustrates a portion of a delivery system that can be used with any of the delivery systems disclosed herein.
FIG. 49 shows a shuttle providing device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The disclosed subject matter of this application relates to the improvement of a plaque staple or stapler. The plaque staple or stapling device can be used for the treatment of atherosclerotic occlusive disease. The plaque staple can be used to hold loose plaque against a blood vessel wall. The plaque staple may include an annular member configured to apply an expansion force to the loose plaque.
I. OVERVIEW OF ENDOLUMINAL TREATMENT WITH STAPLES
FIG. Figure 2 shows an embodiment of a plaque staple or stapling device 5 which includes a thin, annular band or ring made of a durable, flexible material. The stapling device can be inserted into a blood vessel in a compressed state and installed in an expanded state using a catheter delivery mechanism at one or two specific loose plaque sites against the blood vessel wall. The plaque staple 5 can be provided after or during an angioplasty operation. The plaque staple 5 is adapted in such a way that it exerts an expansion force on the plaque in the blood vessel 7 in order to press the plaque against the blood vessel walls and keep it pressed. The stapling device can be expanded radially outward by spring actuation or some other expansion force. The fully expanded diameter of the staple 5 is preferably greater than the transverse size of the vessel to be treated. As set out below, the staple 5 can advantageously be provided in a surprisingly large range of blood vessel sizes.
The plaque staple 5 can include a plurality of plaque anchors 9 on its outer annular periphery. The plaque anchors 9 can be integrated into the plaque, or at least brought into physical contact with the plaque, in that they are expanded against the plaque. In certain embodiments, the plaque anchors 9 are adapted in such a way that they lift adjacent areas of the staple 5 in relation to the wall of the vessel. At least in this sense, the anchors 9 may have some of the advantages of focal elevation elements, which are discussed in more detail below in SECTION III. The anchors 9 exert a holding force on the plaque while minimizing the size of the material surface area that is in contact with the plaque or the blood vessel wall. As a further feature, the plaque staple 5 can only extend over a small area in the axial direction of the vessel wall in order to reduce the amount of the foreign structure which is in
the blood vessel is placed to minimize. For example, each plaque staple 5 may have an axial length L that is only a small fraction of the axial length of a typical stent.
The plaque stapling devices 10 of the present patent application are provided as a minimally invasive approach to attaching loose or dissected atherosclerotic plaque to the wall of the artery, as shown in FIG. 2 shown. The plaque staple must be used to treat either de novo atherosclerotic lesions or inadequate balloon angioplasty results. The plaque staple is designed to maintain an adequate lumen in a treated artery without the inherent disadvantages of vascular stents. The device can also be used to deliver medications, fluids, or other "eluting" treatments into the atherosclerotic plaque or wall of the blood vessel or into the bloodstream.
One or more plaque staples 5 can be provided precisely in positions along the length of a plaque accumulation site where certain holding forces are required to stabilize the site and / or to keep parts of the plaque out of the bloodstream.
FIG. 2 shows that, in various plaque staple treatments, a plurality of plaque staples 5 can be provided in order to treat sites that are axially spaced along the vessel 7. In this way, the targeted treatments can be provided to hold loose plaque to a vessel wall without causing an excessive scaffolding effect, as discussed below. The plaque staple 5 and the installation method can be designed in a number of ways that share a common methodology of utilizing the outward force of a spring-like annular band to allow the staple to be compressed, collapsed, or twisted so that it has a volume assumes a smaller diameter so that it can be moved on a sheath or a catheter into the appropriate position in the blood vessel, and then released, unfolded or rotated back into an expanded state within the blood vessel.
The plaque staple device can be placed into the blood vessel through an endovascular insertion. SECTION IV below describes a variety of delivery methodologies and devices that can be used to deliver plaque staples. The delivery device for the various embodiments may be the same or different, with features specifically designed to provide the particular staple. The plaque staple and method of installation may be designed in a number of ways that share a common methodology of utilizing an expansion force of the delivery mechanism (such as balloon expansion) and / or the expansion force of a compressible annular band to cause the staple to move into position can move in the blood vessel, and then released, unfolded, or rotated back into an expanded state within the blood vessel.
Il. FURTHER EMBODIMENTS OF ENDOLUMINAL STAPLES
Variations of the plaque staple 5 may have a mesh-like configuration and may be arranged with one or more peripheral portions formed with discrete struts, such as in open and closed cell designs, among other designs.
A. PLAQUE STAPLES WITH METAL FABRIC CONSTRUCTION
An embodiment of a plaque staple 10 in the form of a metal fabric structure is shown in FIGS. 3A-D shown. The plaque staple 10 is shown as having a closed cell structure with an annular band 10a composed of interlaced tissue and protrusions 10b extending radially outward. The plaque staple can be laser cut or etched from a metal tube shape, or made from a thin metal wire that is bent and woven into a fabric that is shaped into the desired mesh shape,
those shown in FIG. 3C-D is shown, welded, soldered, bent and / or linked together. The protrusions 10b can protrude from the annular band 10a. The projections 10b can be located on the outer surface of the staple and touch and / or be integrated into the wall of a blood vessel.
The annular band of plaque staple 10 may have a dimension in the axial direction of the vessel walls (sometimes referred to herein as length) that is approximately equal to or less than its enlarged diameter so as to facilitate placement of a foreign scaffold structure in the blood vessel minimize. Expanded diameter means final diameter with unhindered expansion. One or more staples can only be used in positions along the length of a plaque accumulation site where certain holding forces are required to stabilize the site and / or to keep parts of the plaque out of the bloodstream.
The mesh pattern can be designed so that the plaque staple 10 can be compressed radially inward to a smaller volume. This allows the plaque staple 10 to be loaded onto or into a catheter delivery device for insertion into the blood vessel. For example, the staple 10 may have a generally annular shape with bends, such as internal V-bends, that allow it to be folded in a zigzag pattern into a compressed, smaller volume shape so as to be loaded into a delivery catheter such as a delivery tube to be able to.
In the desired position in the blood vessel, the compressed plaque staple 10 is released from the supply catheter. The mesh in combination with an annular shape can allow the plaque staple 10 to spring back into its expanded shape. Alternatively, the staple 10 can be expanded by another device such as a balloon. FIG. 3C shows the plaque staple 10 at rest in its fully expanded state, and FIG. 3D shows a detail of a section of the metal mesh.
FIG. 4-4D show that one or more plaque staples 10 can be placed at the treatment site in the vascular system of a patient by a delivery device 11 with an outer covering 13 and then expanded. Improvements to the delivery device 11 are discussed below in SECTION IV. The staple 10 is expandable in any suitable manner, such as a self-expanding configuration or a balloon expansion configuration. In the embodiment shown, a plurality of self-expanding staples 10 (or of variants such as the staple 10 ′ or the staple 10 ″) are arranged in the casing 13. The provision device 11 includes an elongated body 11A which is at least partially arranged in the casing 13. The delivery device 11 also includes a dilatation structure 11B, which atraumatically removes the tissue and helps guide the delivery device 11 through the vascular system. The body 11A is configurable with a lumen 11C extending therethrough for receiving and advancing a guide wire 40 therein. In the embodiment shown, the sheath 13 and the dilation structure 11B meet in order to provide the supply device 11 with a smooth outer surface, for example by having the same outer diameter at the contact point. The body 11A can be configured to have a large number of annular recesses 11D, in which the staples 10, 10 'and 10 "can be arranged. The annular recesses 11D can be defined between one or more shoulders 11E which prevent proximal or distal slipping of the staples along the elongate body 11A. The recesses 11D could be eliminated by providing another structure for axially locating the staples 10, 10 ', 10 "along the elongated body 10A.
FIG. 4A and 4D show a proximal end of the device 11 and a method for providing the staples 10, 10 ', 10 ". In particular, the proximal end of the device 11 includes a handle 11F and an actuator 11G. The actuator 11G is coupled to a proximal end of the casing 13 so that the proximal and distal movements of the actuator
11G cause a proximal and distal movement of the sheath 13. FIG. 4A illustrates a distal positioning of the actuator 11G, which corresponds to a forward positioning of the casing 13 in relation to the elongate body 11A and the recesses 11D. In this position, the recesses 11D and the staples 10, 10 °, 10 "are covered by the envelope. Movement of the actuator 11G proximally in relation to the handle 11F causes the sheath 13 to move proximally, for example into the position of FIG. 4D moves. In this position, the two most distal staples 10, 10 ', 10 "are uncovered and can self-expand in the manner discussed herein.
Returning to FIGS. 3A-B, the protrusions 10b on the surface of the staple 10 can act as anchors or lifting members for implementing in or pressing against the plaque. A number of anchors or lifting members can be used to connect the annular band of the staple to the plaque mass or the blood vessel wall. The protrusions 10b can be made of a sufficiently rigid material to withstand a locking or fixing relationship with the blood vessel tissue and / or to penetrate or be fixed to the plaque and thus to maintain the locking or fixing relationship. The protrusions 10b can project at an angle of 90 degrees to the tangent of the annular band, or an acute angle can also be used.
The plaque staple can be made of a material such as a corrosion resistant metal, polymer, composite, or other durable, flexible material. A preferred material is a metal with a "shape memory" (like nitinol). In some embodiments, a staple can have an axial length of about 0.1 to 6 mm, an expanded diameter of about 1 to 10 mm, and an anchor height of 0.01 to 5 mm. The annular band of the plaque staple generally has a length in the axial direction of the vessel walls that is approximately equal to or less than its diameter so as to minimize the amount of foreign structure that is placed in the blood vessel. The annular band can have an axial length to diameter ratio of as little as 1: 100.
B. OPEN-CELL PLAQUE STAPLE
FIG. 5A-5C illustrate that a plaque staple 10 'can be configured with an open cell structure in certain embodiments. The plaque staple 10 'includes one or more peripheral portions that have undulating, such as sinusoidal, configurations and that are axially spaced. The perimeter portions may be coupled together at one or more circumferentially spaced locations by axially extending portions, sometimes referred to herein as bridge portions. These embodiments can be expanded over a wide range of diameters and, as explained below, they can be arranged in a large number of different vessels.
The plaque staple 10 ° may have features that are similar to those described above with respect to the plaque staple 10. The plaque staple 10 'can, for example, also be cut or etched from a metal tube shape by laser. Likewise, the plaque staple 10 'may be made from a material such as a corrosion-resistant metal (e.g., certain coated or uncoated stainless steel or cobalt chrome alloys), a polymer, a composite, or other durable, flexible material. A preferred material is a metal with a "shape memory" (like nitinol).
FIG. 5A-B show the general structure of the plaque staple 10 'with an open cell array. The plaque staple 10 'is shown with two peripheral portions 12 which may be rings formed from a plurality of zigzag struts connected by bridges 14 extending between the rings 12. The rings and bridges define a column of limited cells 16 along an exterior surface of the staple. The outer surface extends over an outer periphery, such as an outer periphery of the staple 10 '. The boundary of each cell 16 consists of a series of parts or struts. As shown, the second ring is a mirror image of the first ring, although the first and second rings can be peripheral members of different configurations. In addition
In Figure 6, the bridges 14 may be symmetrical about a transverse plane, extending through the axial center thereof, although other configurations are possible. The rings 12 can be viewed as coaxial, which term is broadly defined to include two spaced apart rings, or structures that have centers of rotation or masses disposed along a common axis, such as the central longitudinal axis of the staple 10 '.
Fig. 5C is a schematic flat representation of a portion of a staple 10 'showing a portion of the cell 16 and a portion of a boundary thereof. The portion shown to the right of centerline C is, in one embodiment, one half of cell 16. The other half can be a mirror image as shown in Figures 5A-B, an inverted mirror image, or some other configuration. The portion of ring 12 that is part of an individual cell 16 may define a portion that is repeated in a pattern along the ring. In some embodiments, the ring 12 may include parts that are repeated in a pattern that extends across cells, such as 1.5 cells, 2 cells, 3 cells, etc. The pattern of the rings 12 in combination with other features of the staple 10 'can enable this to be compressible in scope. The difference between the compressed and expanded states can be seen by comparing the compressed view shown in FIG. 5A and the expanded view shown in FIG. 5B.
The cells 16 of the staple 10 ° can be delimited by parts of two rings 12, which can be mirror images of one another. Thus, some embodiments can be fully described by reference to only one page of staple 10 'and cell 16. The ring 12, a portion of which is illustrated in Figure 5C, has an undulating, sinusoidal pattern. The undulating pattern can have one or more amplitudes, such as the illustrated dual amplitude configuration.
The rings 12 can have a large number of struts or structural elements 26, 27, 28, 29. The plurality of struts can be repeated around the circumference of ring 12. The struts can be of many different shapes and sizes. The struts can extend in a variety of different configurations. In some embodiments, the plurality of struts 26, 27, 28, 29 extend between inner 18, 19 and outer apices 24, 25.
In some embodiments, the outer apices 24, 25 extend axially for different distances from a central region or the center line C of the staple 10 °. In particular, apex 24 can be considered a high apex in this regard and apex 25 can be considered a low apex. The inner apices 18, 19 may be axially aligned, for example they are positioned at the same axial distance from the center line C. Thus, outer apex 24 is further from the bridge and inner apices than outer apex 25. In some embodiments, the axial length of staple 10 'becomes from the top of outer apex 24 on one side of cell 16 to the corresponding top of the outer one Apex 24 measured on the other side of the cell. In other words, the first outer apex 24 extends a first axial distance from the centerline C of the staple 10 ', and the second outer apex 25 extends a second axial distance from the central region C of the staple 10', the first distance being greater is called the second distance. Each side of cell 16, as shown, has a high outer apex 24 and a low outer apex 25.
The bridge 14 can be connected to one or more of the inner apices 18, 19. The bridge 14 can connect the two rings 12 to one another. The bridge 14 can have many different shapes and configurations. Some embodiments of staple 10 'have a proximal ring and a distal ring with the bridge interposed therebetween and connecting them. As previously mentioned, the bridge 14 can be positioned in the central area or on the centerline C of the staple 10 '. In Figure 5C, the term "proximal" refers to a location on the staple 10 'that is closer to the vascular access site than the portion labeled "distal". In the case of the staple 10 ', however, a medial part is also conceivable which corresponds to the center line C, as well as lateral parts which extend in both directions.
extend from it. Accordingly, the location labeled “proximal” is also a medial location, and the location labeled “distal” is also a lateral location. All of these terms can be used herein.
As shown, the bridge 14 is connected to each ring at the inner apex 18. In some embodiments, a bridge connects to each inner apex and forms a closed cell structure. In some embodiments, the bridge 14 is connected to every other inner apex, connected to every third inner apex, or more spaced than required, creating a variety of open cell configurations. The number of bridges 14 can be selected depending on the application. For example, six or fewer bridges 14 can be used between the two rings 12 if neointimal hyperplasia is to be restricted with them.
One method of optimizing the plaque holding ability of bridges 14 is to align plaque holding structures (such as barbs 9, tabs 10b, or the anchors discussed below) with a force application position or direction of ring 12. In some embodiments, at least a portion of the bridge 14 can be aligned with one of the struts of ring 12. For example, where the bridge 14 is connected to the ring 12, whether at an inner apex or on a strut, the connecting portion of the bridge can be extended therefrom in a manner that is partially or substantially aligned with a strut. FIG. 5C shows that the bridge 14 is connected to the inner apex 18 and that the connecting portion of the bridge is substantially aligned with the strut 26. FIG. In one method, a plaque holding structure of bridge 14 is arranged on a projection of a longitudinal axis La of strut 26. As discussed below, retainer clip 10 ′ has a plurality of anchors 20. Axis LA intersects a portion of an anchor 20 to maximize torque action from expanded strut 26 to anchor 20. In the arrangement of FIG. 5C, an anchor is located on an opposite side of centerline C on the board of axis LA, and the board of a longitudinal axis LA of a mirror image strut 26 intersects anchor 20 of the strut on the same side of centerline C as strut 26 shown in Fig. 5C. In another method, the board of strut 26 and its mirror image strut can be aligned with the center line C, which is rigidly coupled to the anchors 20. Bridge 14 is also aligned with a sinusoidal, high amplitude section of adhesive clip 10 '.
A number of unique design features can be incorporated into the staple 10 ‘for various purposes, as discussed in greater detail in the sections below. The staple 10 'can contain, among other features, one or more anchoring (s), markers and focal elevation elements. As discussed above, Figure 5C shows that the plaque staple 10 'can include a plurality of anchors 20 (e.g., two). The staple 10 ′ can also include a position marker 22 on each bridge 14. The position markers 22 may be fluoroscopically opaque and are generally flat in an arrangement. As used in this context, flat markers are arranged to have a planar outer surface which is tangential to a cylinder which extends through an outer surface of staple 10 'or which is concentric with the outer surface but radially within Outer surface is arranged. The anchors 20 may likewise be configured so that they are tangential to a cylinder that extends through an outer surface of the staple 10 '.
As another example, a number of unique design features can be incorporated into the staple 10 'so as to dynamically distribute stresses within the staple 10'. These design features can enable the uniform control of staple 10 'during compression, expansion, deployment and catheter release. These design features can also individually and / or collectively manage the loads that act on the set of staples, along the struts and at the interface of the staple and the blood vessel lumen. Better control of stress distribution within the staple has the benefit of reducing cellular response and staple fracture by limiting strut fatigue and associated micro-rubbing at the staple / blood vessel interface
to reduce. Micro-abrasion causes a variety of small harmful interactions between implants and patient tissue, such as abrasion or friction which occurs at the cellular or intercellular level between the staple and the blood vessel lumen.
It is believed that a reduction in cellular response is achieved in part by reducing surface area contact between the staple and blood vessel lumen and in part by maximizing the alignment of the points of contact or structures with the natural alignment of the blood vessel cells. This allows the staple to move with the blood vessel while reducing micro-rubbing. Other devices, such as stents, contact the blood vessel cells in ways that may differ. U. can extend over several cells - for example transversely to several cells - as a result of which the micro-rubbing at the stent / blood vessel interface increases.
1. CELL VERSION WITH ONE PILLAR
One feature of the staple embodiment 10 'of Figures 5A-C is that it comprises an open cell structure with a column held between two zigzag rings. This arrangement ensures minimal (if any) scaffolding effects on a vessel. In one respect, a ratio of the vessel contact area to the total treatment area of the plaque staple 10 'is small. In this context, the vessel contact area is the sum of the area of the outer parts of staple 10 'that may come into contact with the vessel wall. More specifically, the vascular contact area can be calculated as a sum for all struts of the length of each strut times the mean transverse dimension (width) of the radially outer surface of each strut. When the struts of the zigzag rings have been laser cut, the width of the radially outer surface of the strut may be less than that of the radially inner surface. The vessel contact surface can also include the radially outer surface of the bridges 14. The total treatment area of the plaque staple 10 ’can be defined in terms of a fully expanded configuration in a cylinder with an optimal fit. A best fit cylinder is one that has an inner circumference that is equal to the unconstrained circumference of the plaque staple 10 '. The overall treatment area has an area defined between the proximal and distal ends (or the lateral edges) of the plaque staple 10 '. The total treatment area can be calculated as the length between the proximal and distal ends (or the lateral margins) in the best fit cylinder times the inner circumference of the best fit cylinder. In the embodiment shown, the length for the purpose of determining the total footprint can be the distance in the same circumferential position between the high outer apices of the rings 12.
In various embodiments, the ratio of the vessel contact area to the total treatment area is less than 50%. In some embodiments, the ratio of the vessel contact area to the total treatment area is even less, for example 40% or less. The ratio of the vessel contact area to the total treatment area can be as little as 20% or less. In certain examples, the ratio of the vessel contact area to the total treatment area is 5% or even 2% or less. As discussed below, focal elevation elements can enhance this beneficial feature, and thus further reduce the ratio of the vessel contact area to the total treatment area by providing a separation between the vessel wall and at least a portion of the peripheral portions 12.
In certain procedures, a vessel can be treated by the implantation of a variety of structures, such as a plaque staple 10 '. The structures have a total contact area with the vessel wall. The total contact area can be the sum of the vessel contact areas of the individual structures. In the method, an overall treatment area area may be defined as the surface area between the proximal end of the most proximal structure and the distal end of the most distal structure. In one process, the total contact area is no more than about 55% of the total treatment area area. Typically, the total contact area is between about 10% and about 30% of the total
action area area. In certain examples, the total contact area is no more than 5-10% of the total treatment area area.
The staple 10 'can also be understood to provide a relatively large open area within its lateral edges compared to stents. Unlike conventional stents, the staple 10 'does not need to contain sufficient metal to provide a scaffolding function in order to keep a vessel open. In order to achieve many of the contemplated treatments, the staple 10 'can be configured so that its contact is limited to only a single point or to a plurality of discrete points, such as one or more axial locations. The discrete points can be widely spaced, such as points on a perimeter separated by spaces or, if employed, by vascular tissue.
In some embodiments, the open area bound by lateral edges of the staple 10 'dominates the entire footprint, as defined above. The open area of the staple 10 'can be defined as the sum of the areas of the cells 16 when the staple 10' is in the fully expanded configuration, as defined above. The open area should be calculated as the outer perimeter of staple 10 ', such as the area extending between the internal lateral edges of each of the struts. In this context, the internal lateral edges are those that form at least part of the boundary of cells 16. In various embodiments, the sum of the radially outwardly facing surface of the struts of staple 10 'can not be more than about 25% of the open area of staple 10'. More typically, the sum of the radially outwardly facing surface area of the struts of staple 10 'is between about 10% to about 20% of the open area of staple 10'. In other embodiments, the sum of the radially outwardly facing surface area of the struts of staple 10 'is less than about 2% of the open area of staple 10'.
A single column structure includes arrays in a plurality of staple cells circumferentially about a central axis of staple 10 '. The staple cells can have many configurations, but generally they include spaces surrounded by struts and are located in the wall surface of the staple. Open cell structures include arrangements in which at least some of a plurality of internally disposed struts of proximal and distal peripheral portions are not connected by bridges or axial connectors. FIG. 5C shows that the inner apex 19 is not connected to a corresponding inner apex on a mirror image ring 12. Therefore, a part of cell 16 that is located above inner apex 19 in FIG. 5C is open to another part of cell 16 that is located below inner apex 19. Compared to closed cell structures, in which each of the internally arranged struts of a proximal peripheral part is connected to a corresponding internal strut of an adjacent peripheral part, open cell structures offer more flexibility and expandability. The cell 16 would by connecting the inner apex 19 to a corresponding one inner apex at the mirror image ring 12 divided into two closed cells. As noted above, closed cell plaque staples may be useful for certain indications and may incorporate other features as described herein. As shown, the open cell structure with the individual column extends along the center line C of the bridge (and in this embodiment also along the circumference of staple 10 ').
In one embodiment, the cell 16 is identical to a plurality of further cells 16 which would be arranged on the circumference around a central axis of the staple 10 '. The number of cells may vary depending on factors such as the size of the vessel (s) for which the staple 10 'is configured, the preferred arrangements of the rings 12, the number of bridges 14 to be provided, and other factors .
As noted above, the staple 10 ‘can include proximal and distal rings 12 connected by bridges 14. The proximal ring 12 can be arranged at a proximal end of the staple 10 '. The distal ring can be attached to a distal end of the
Staple 10 'be arranged. In some embodiments, the distal ring is the most distal aspect of the staple 10 'and the proximal peripheral portion is the most proximal aspect of the staple 10'. The bridges 14 may divide an outer surface of the staple 10 'into cells 16 bounded by the bridges 14 as well as a portion of each of the proximal and distal rings 12. In the embodiment of Figures 5A-5C, the one-pillar -Structure provided by the provision of bridges in only one axial position as well as by the provision of only a pair of circumferential parts or rings 12. 5C includes the terms “distal” and “proximal” for reference in relation to this and other examples, so the illustrated ring 12 is the distal ring. In other embodiments, the illustrated ring 12 can be the proximal ring.
As set forth above, cells 16 can have one of many different shapes and configurations. 5B shows that cells 16 are oriented in a repeating pattern so that they form an open cell structure with a column along the perimeter of staple 10 °.
Conventional stent structures are generally relatively long (e.g. 4 cm and even up to 20 cm when used in the peripheral vascular structure), from their distal to their proximal ends. When arranged with cells arranged on the periphery, conventional stents have a large number of cell columns. These structures have repetitive weak points and can create stresses that are difficult to manage. When the device is subjected to stresses and strains, these conventional stents must seek areas of greater compliance within the strut matrix. These strut areas absorb the stress throughout the system and begin to fail in phases in which external forces act on them repeatedly, such as through metallurgical frictional loading.
The single column configuration of staple 10 'is not susceptible to repeated stresses at weak points due to the movement of remote stent parts because the staple does not need to be axially elongated to provide effective stapling treatment. Other advantages that arise from the brevity include less friction at the interface with the catheter sheath during deployment and with the blood vessel wall. As stated above, the stress at the blood vessel wall interface is reduced by the lack of pulling and tearing forces from one cell to the next, which in turn reduces the possibility of the staple pulling or tugging adjacent cells, which leads to increased cellular inflammation or a histological reaction along the lumen wall can occur. A single column or other axially short configuration also reduces the stress along each strut because the overall length of the single column or other axially short structures or configurations are less prone to anatomical movement (e.g., bending, twisting, and twisting). The reason for this is, at least in part, the displacement of the anatomy around short structures, while longer structures do not allow any displacement of the anatomy, whereby longer structures take up more forces, which leads to this anatomical movement.
Any movement between the surface of the staple and the blood vessel can result in chafing and friction. If the movement is very small it can be described as micro-scrubbing, as explained above. Even micro-rubbing negatively affects both the staple 10 'and the biological cells of the blood vessel. For example, friction occurs when one part of an implanted object moves while another part is stationary or only moves to a lesser extent. Different degrees of movement weaken the material over time, resulting in fracture from processes such as solidification. The biological cells are irritated by the friction and can react with an inflammatory reaction. Inflammation can cause a variety of undesirable histological reactions, such as neointimal hyperplasia and restenosis.
2. CONTROLLED STRUT ANGLE
FIG. 5C shows that the staple 10 'has two peripheral portions or rings 12, each having a plurality of internal angles including angles Winkel and 6. A first angle is defined at the first outer apex 24 between the struts 26, 27, and a second angle o is defined at the second outer apex 25 between the struts 28,29. In some embodiments, the first angle can be greater than the second angle. The first angle can for example be between 43 ° and 53 ° or between 45 ° and 51 °. The second angle o can be between 31 ° and 41 ° or between 33 ° and 39 °. In some embodiments, the first angle can be about 48 ° and the second angle can be about 36 °.
In a preferred embodiment, the staple 10 ° has an expanded outer diameter of 7.5 mm and the first angle α can be 47.65 ° and the second angle o can be 35.56 °. In such an embodiment, the plaque staple 10 'can be formed from a tube blank having an initial outer diameter of 4 mm. The pipe blank can be expanded to 7.5 mm and then heat-treated in this form. In some embodiments, the plaque staple 10 'can be made from a shape memory material, and the heat treating step can consist of engraving that particular shape into the “memory” of the material. The plaque staple 10 'can then be crimped or compressed and frozen in the compressed state in order to then be loaded onto a delivery device.
An advantageous feature of the staple 10 'is that the angle of the struts, when they meet at each apex, can be controlled in at least one of the states - expanded and contracted. The internal angles α, o of the outer apices 24, 25 can be controlled, for example, so that they are within + 5% of a selected nominal value. This control can be achieved, for example, in the expanded state during the heat treatment during the production of the plaque staple 10 '.
It has been found that controlling the angles advantageously counteracts deficiencies in the manufacturing process. In some cases, control of other dimensions can be relaxed if these angles are adequately controlled. Controlling these angles can improve the quality of the production runs. It was found that such a control enables the repeatable, uniform and balanced compressibility of staples 10 ’during the crimping cycle in manufacture. These factors improve the repeatability of the production runs and allow for easier mass production, which in turn leads to a reduction in the overall cost of the part.
In addition, the control of the apex angle enables the plaque staple 10 'to better distribute the loads along the peripheral parts or rings 12. The control of the apex angles can be used to control or distribute the loads within the ring 12, for example uniformly along the length of the struts or non-uniformly over an area which can react more robustly to loads. By distributing the load along the strut, the problematic local loads on the staple 10 ', such as on sensitive areas, can be avoided during the expansion and crimping processes during manufacture.
3. INVERSE, TAPERED STRUT
In some embodiments, as shown in FIGS. 5A-C, the width of one or more of the struts 26, 27, 28, 29 of the staple 10 'may be different at different locations, for example along the Strut vary. The struts can, for example, taper along their lengths. The taper can be the same or different along each strut or along each type of strut. For example, each peripheral portion or ring 12 may consist of a pattern of repeating struts, each type of strut having a particular taper.
[00111] FIG. 5C shows that the ring 12 has a first strut which is connected to a bridge 14
that is tapered such that a portion of the strut that is closer to centerline C (sometimes referred to herein as the medial portion or medial position) is narrower than a portion of the strut that is farther from centerline C. (sometimes referred to herein as the lateral part). A second strut is connected to the first strut at the lateral ends of the first and second struts. The second strut can have the same or a different taper. The second strut can also have a medial part that is narrower than a lateral part of the second strut. In addition, the second strut can overall be narrower than the first strut. A third strut may be connected to the second strut at the medial ends of the second and third struts. The third strut may have a medial part that is wider than a lateral part thereof. A fourth strut may be connected to the third strut at the lateral ends of the third and fourth struts. The fourth strut may have a medial part that is wider than a lateral part thereof. The fourth strut can have the same or a different taper as the third strut. The fourth strut can, for example, be wider overall than the third strut.
5C illustrates schematically the differences in the widths in one embodiment. In some embodiments, the long struts 26 and the long strut 27 have the same width in the same axial position, and the shorter struts 28 and the short strut 29 have the same width in the same axial position. The struts 26 and the strut 27 can have the same shape. The strut 28 and the strut 29 have the same shape in some embodiments. The shape of the struts 26, 27 can differ from the shape of the struts 28, 29. In some embodiments, long strut 26 and long strut 27 have different widths in the same axial position, and short strut 28 and short strut 29 also have different widths in the same axial position.
In a preferred embodiment, the long struts 26, 27 are arranged adjacent to one of the markers 22 in a first circumferential position of staples 10 °. In particular, the strut 26 has a medial end which is connected to one of the inner apices 18 or forms a part thereof, and a lateral end which is arranged away from the inner apex 18. The lateral end is coupled to the strut 27 at or adjacent to the outer apex 24. The strut 26 has a width W4 adjacent the medial end and a width W2 adjacent the lateral end. In this embodiment, the width of strut 26 increases along the length thereof from width W4 to width W2. The increase in width along strut 26 is preferably continuous along this length.
In addition, the sides of the struts 26 can drop in relation to a longitudinal axis LA of the strut 26. Example: A first side 48, which is arranged between the longitudinal axis of strut 26 and strut 27, can be arranged at an angle (for example not parallel) to the longitudinal axis of strut 26. In another embodiment, a second side 46 of strut 26 may be arranged at an angle (for example, not parallel) to the longitudinal axis of strut 26. In one embodiment, both the first and second sides 46, 48 of the strut can be arranged at angles to the longitudinal axis of the strut 26.
The strut 27 also preferably has different widths at different points along its length. In particular, strut 27 may be wider in a generally lateral direction adjacent to outer apex 24 than adjacent to inner apex 19. As discussed above in connection with strut 26, strut 27 may have side surfaces that are in relation to the longitudinal axis the strut 27 are angled. The strut 27 can taper between its ends; it can, for example, have a continuously decreasing width along its length, from a wider width adjacent to the outer apex 24 to a narrower width adjacent to the inner apex 19.
The strut 28 extends from the strut 27 or from the inner apex 19. The strut 28 can have a medial end that is wider than a lateral end of the strut 28, and can have different widths at different points along its length . The side surfaces can also be angled relative to the longitudinal axis of strut 28.
Finally, a strut 29 can be connected to the strut 28 or to the outer apex 25 at a lateral end of the strut 29. The strut 29 may have a medial part that is wider than the lateral part thereof. The strut 29 can have a taper which corresponds to that of the strut 28 or differs from it. The strut 29 can, for example, be wider overall than the third strut.
In one embodiment, the strut 26 can have a width W2 of about 0.12 mm at the lateral end near the outer apex 24 and a width Ws of about 0.095 mm at the medial end near the inner apex 18, and the strut 28 can have a width We of about 0.082 mm near the outer apex 25 and a width Ws of about 0.092 mm near the inner apex 19. More generally, the change in thickness between W4 / W2, expressed as a percentage, can be between about 70% and about 90%, more typically between about 75% and about 85%, and in some embodiments about 80%. The taper can also be inverted if, for example, the struts taper from the ends (for example the lateral edges) to the medial part.
FIG. Figure 5E illustrates another variation in which the width of one or more struts of the staple can be different at different positions so that they can vary, for example, along the struts. A strut 27 'can be provided, for example, which is the same as the strut 27, with the exception that the strut 27' is narrowest in a central region N. The strut 27 'can have a laterally wide part L, adjoining the outer apex 28, and a medially wide part M, adjoining the inner apex 18. The width of the strut 27 'decreases along the length thereof, from the laterally wide portion L to the medial portion M. In one embodiment, the strut 27' becomes continuously narrower along the length, from the lateral end of the strut 27 'to the centerline of the strut. The strut 27 'can narrow to such an extent that the ratio of the width at the center line to the width at the lateral end of the strut 27', expressed as a percentage, is between 20% and about 85%. In some embodiments, this percentage is between about 35% and about 75%. The taper can be such that this percentage is between about. 55% and about 70%. From the medially wide part, the strut 27 'can narrow along the length thereof. In one embodiment, the strut 27 'becomes continuously narrower along its length, from the medial end of the strut 27' to the centerline of the strut. The strut 27 'can narrow so far that the ratio of the width at the center line to the width at the medial end of the strut 27', expressed as a percentage, is between 20% and about 85%. In some embodiments, this percentage is between about 35% and about 75%. The taper can be such that this percentage is between about. 55% and about 70%. The embodiment of Fig. 5E provides a greater area for compression and expansion in smaller diameter configurations. Smaller diameter configurations can be used in smaller body lumens, such as in blood vessels. For example, a staple of this configuration can be formed from a tube having a diameter of 2.3 mm, whereas the embodiments of FIG. 5C are optimally formed from a tube having a diameter of 4.5 mm. The configuration of Fig. 5E can be used to make staples suitable for a 4 French size delivery device. Staples configured as in Figure 5E can have an unconstrained expanded size of about 4.5 mm and about 6.5 mm. In some embodiments, devices with the configuration of FIG. 5E can have an unconstrained expanded size between about 5 mm and about 6 mm, for example between about 5.5 mm and about 6.0 mm. One embodiment expands to about 5.7 mm when unconstrained.
A unique inverse taper or variation in width along the strut is achieved by inverting the orientation of the taper between the shorter struts 28,29 and the longer struts 26,27. The longer struts 26, 27 go from a narrow width near the inner apices 18, 19 to a wider width near the higher outer apex 24. In contrast, the shorter struts 28, 29 are the opposite, with a wider width near the inner apices 18, 19 to a narrower width near the lower outer apex 25.
By strategically selecting the width of the struts, as outlined above, the plaque staple can distribute the stresses observed during compression and post deployment. This feature can also help control stress by distributing the stress area more evenly along the length of the strut. In some embodiments, it may be desirable to unevenly distribute the stress in areas that can better handle the stress.
4. STRIVE WITH DUAL AMPLITUDE
As stated above, the ring 12, which is shown in FIGS. 5A-5C, has an undulating sinusoidal pattern. The axial extent of ring 12 can vary around the circumference of ring 12 and, for example, provide a variety of amplitudes as measured by the distance from an inner apex to an adjacent outer apex. The undulating pattern can have one or more amplitudes, such as the illustrated dual amplitude configuration. In the dual amplitude configuration, the majority of the struts 26, 27, 28, 29 extend between the inner apices 18, 19 and the outer apices 24, 25.
In some embodiments, the outer apices 24, 25 alternate between a high outer apex 24 and a low outer apex 25. In this context, “high” corresponds to a greater distance H1, such as from a central area or centerline C of the staple 10 'measured, and "low" corresponds to a smaller distance H2 as measured from the centerline C (FIG. 5C).
The varying amplitude of the long and short sinusoidal struts described above can provide further control over the function of the plaque staple. In particular, it can improve the compression of the staple 10 'so as to provide a greater change in scope from the fully expanded configuration to a compressed configuration during the crimping process in manufacture. Greater compressibility simplifies provision in smaller vessels and provides a larger area of indication that can be treated, since a delivery system with a smaller cross-sectional profile is made possible.
The height H +, H; of the apices is measured from the center line C to the upper part of the corresponding outer apices 24,25. The plaque staple 10 'having the sinusoidal pattern and dual amplitude, such as those shown in FIG. 5A-C allows for a wide variety of customizable diameters that are easily scalable to different outside diameter configurations. The open-cell, single-column structure enables a wide range of compression and expansion. Part of the reason for this is the length of the strut that is available for effective expansion. The ease of compression is arranged with the position of the apices H + and H; from the center of the staple, allowing these apices to compress in different positions rather than in the same lateral position. When H +: and H; of the apices are aligned (e.g., in the same axial position), they would press against each other during compression, thereby limiting the compression area.
The compression areas for the plaque staple 10 ‘were measured as 0.25 times the nominal tube size in combination with expansion areas up to 2 times the nominal tube size, although these are not the expected limits of the device. By combining these areas, the full compression area was measured to be 0.125 times the heat treated outside diameter. As stated in SECTION 11.3.2 above, in some embodiments the tube size is 4.5 mm and the tube is expanded to 7.5 mm in the manufacturing process. In some embodiments, the distance from the centerline C of the device to the apex of the longer struts H + is about 3.0 mm, whereas the distance H »to the apex of the shorter struts is about 2.6 mm.
Apart from the optimized compression area, the energy stored in the struts with the shorter amplitude provides additional control of the plaque staple 10 ‘
during the release phase of the provision in the blood vessel. As the catheter sheath is withdrawn, the longer struts are exposed first, followed by the shorter struts (FIG. 5C). This discrepancy provides greater retention forces to hold the plaque staple 10 'in the delivery catheter and thus provides greater control of the plaque staple as it is delivered.
5. CENTRALLY ARRANGED ANCHORING AND LIFTING STRUCTURE
[00128] FIGS. 5A-5C illustrate that the plaque staple 10 'can contain anchors 20 arranged centrally. Although the anchorages 20 are primarily used to fix loose plaque, as explained above, their placement and configuration optimize the control over the provision and the performance of the staples 10 'after they have been placed in the blood vessel.
As stated above, the plaque staple 10 'can be a self-expanding perimeter structure, and the anchors 20 can be arranged on an outer part of the staple. The anchors 20 are engageable with any part of the staple 10 'but are preferably positioned adjacent the centerline C of the bridges 14, as set out above. In one embodiment, the staple 10 'includes two anchors, each located on one side of the center line C, as shown in Fig. 5C. In one embodiment, a single anchorage on the centerline C may be provided. In another embodiment, at least three anchors 20 may be provided, such as one on the centerline and one on each side thereof, as shown in Figure 5C. The bridge 14 may have two anchors on one side and one anchorage on the other side connecting the other two anchors, as shown in Figure 5D. In Fig. 5D there is an anchor 20 'in the center of staple 10', along its axial direction. This embodiment provides at least one anchor 20 'located on either side of the centerline C. In addition, the anchorage 20 'can be located on an opposite side of the marker 22 from the anchorages 20. Accordingly, the plaque can be anchored from a plurality of directions, for example a plurality of circumferential directions. In another embodiment, the anchors 20 are absent and a single anchor 20 'is provided on the centerline C. The in FIG. The embodiment illustrated in Figures 5A-C could also be modified to include one or more anchors on each side of the marker 22, where anchors are currently only displayed on one side.
In one aspect, the plaque interaction of the staple 10 'is provided substantially by the anchors 20 and, to a lesser extent, the bridges 14. In some embodiments, the anchors can have a preferred penetration length into the plaque of 0.01 to 5 mm. In certain variations, the penetration length is within a range from about 0.03 mm to about 1 mm. In other variations, the penetration length is within a range from about 0.05 mm to about 0.5 mm. The bridges 14, which may be located at alternating inner apices as set forth above, may be configured to lie on a plane of tangency to a cylinder when the staple 10 'is fully expanded and not to be deformed by any external structure . The tangent configuration causes anchors 20 to protrude outwardly from the cylindrical surface of staple 10 '. In this outwardly protruding position, the anchors are adapted in such a way that they fix plaque or other vascular deposits through which the vessel varies from its unrestricted solid state and, for example, has an imbalance.
The tangential protrusion of the anchors and bridges also advantageously improves control over the staple 10 'during provision. One method of providing the staple 10 'includes positioning the staple in a hollow catheter body. When positioned in the catheter body, the staple 10 'is compressed into a compressed state. As explained above, the rings 12 are extremely supple due to their design. As a result, the rings nestle completely against the luminal inner
surface of the hollow catheter body. In contrast, the bridges 14 and 20 are more rigid and therefore less pliable, and as a result, they hook into the inner luminal surface of the catheter body. This creates a retention force in the catheter and unintentional movement of the staple 10 '- partially or completely - in the direction of a catheter supply area is limited.
In some embodiments, the retention force of the barbs 20 is maintained or increased after the partial provision of staples 10 '. A region of relatively high flexibility can be provided particularly at the connection of the bridges 14 and the rings 12. Although stent areas of high flexibility can also be problematic areas, this is not the case with the plaque staple 10 'for the reasons listed below. The flexible area can have any material property or structure to improve its flexibility at least compared to that of the bridges 14 so that when the ring 12 moves at the leading supply edge, the tangential configuration and tendency of the anchors 20 to become elongated in the hollow To get caught catheter body, is not decreased. This is the case even if the leading edge ring 12 may expand to at least half of its fully expanded size.
As shown, the bridge 14 is connected to each ring at the inner apex 18, where at least a portion of the bridge 14 may be partially or substantially aligned with one of the struts forming the ring 12, as previously described. For example, as already shown, the bridge 14 is aligned with a sinusoidal region with a high amplitude of the pattern. The area of relatively high flexibility can be located between the inner apex 18 and the bridge 14.
In certain embodiments, the expansion of the ring 12 may even cause the anchors 20 to rotate outward to increase the retention force in the catheter body. For example, the expansion of the strut 26 can lead to an inward deflection of the inner apex 18. As ring 12 expands, there may be slight rotation of the anchors 20, which can result in an outward torque deflection of the front anchor and a corresponding outward torque deflection of the rear anchor. Referring to Fig. 5C, when the illustrated ring 12 is expanded for the first time as it moves out of the hollow catheter body, anchor 20 to the right of centerline C can be deflected inward toward the central axis of the catheter body, while anchor 20 to the left is deflected outward to increase the retention force thereof. Thus, the plaque staple 10 ’can be retained in the catheter during such a partial expansion. Because of this function, the plaque staple 10 'can be placed evenly, as explained in more detail below in Section 11.B.8.
The nature of the bridges 14 and anchors 20 to be external to the cylinder also offers advantages for the condition provided. In particular, in some embodiments in an expanded state, the plaque anchors 20 are arranged radially outward from a cylindrical surface formed by the rings 12. The degree of "outside the cylinder" nature may vary depending on the application, but in general it is sufficient to space at least a portion of the cylindrical surface from the inner walls of the vessel stem in providing it. Thus, the anchors 20 or the anchors in combination with the rings 12 can be configured as focal elevation elements, which are explained in more detail below in SECTION III.
While the plaque staple 10 'expands in a blood vessel, the struts snap into the vessel wall and / or in the plaque. It is believed that in most situations, at least some of the struts will deform as a result of irregularities in the shape of the blood vessel. At the same time, the bridges 14 are less readily deformable and thus withstand such deformations while maintaining a circular configuration. The outwardly acting forces exerted by the strut parts are transferred to the areas that touch the blood vessel wall. In some cases, when the staple 10 'follows an irregularly shaped blood vessel lumen, the rigid central anchors will
gen to the area where the blood vessel will be contacted. The cumulative outward force of the struts in the rings 12 is applied through the bridges 14 to the anchors. The adjacent struts share their load with the contact area, pressing the blood vessel into an enlarged configuration, like a shaped circle.
This configuration can provide advantages such as helping the plaque staple 10 'to remain in place after deployment and allowing plaque staple 10' to respond dynamically to movement and pulsing Blood vessel itself. In addition, this configuration can have the benefit of reduced cell reaction and device fracture by limiting strut fatigue and associated micro-friction that builds up at the staple / blood vessel interface.
In some embodiments, bridge 14 can include one or more anchors. In some embodiments, the bridge can be formed entirely from anchors.
After the plaque staple 10 'has been provided, the surgeon has the option of placing an angioplasty balloon at the stapling site and inflating the balloon to place the anchor or anchorages 20 in the plaque and / or the wall of the blood vessel to press.
6. FLAT CENTERLINE MARKERS
As discussed above, the plaque staple 10 'has one or more markers 22. In one embodiment, a series of radiopaque markers 22 can be located on the staple 10'. In some embodiments, the radiopaque markers 22 are on the centerline C of the device. The radiopaque markers 22 can be arranged between the two circumferentially aligned sinusoidal parts or rings 12.
In some embodiments, the radiopaque markers 22 (for example made of platinum or tantalum) can be arranged adjacent to the plaque anchors 20. The radiopaque markers 22 can have any of many different shapes or configurations. In some embodiments, the radiopaque markers 22 have a planar or flat structure. As shown in Figure 5C, each marker 22 is coupled to an annular eyelet, such as by interference fit or rivets, thereby creating a flat, flush surface with the eyelet. The marker 22 provides clear visibility of the staple 10 'in the catheter delivery system and provides the clinician with guidance in the precise placement during the procedure.
Under certain delivery methods, the co-placement of the anchors 20 and the markers 22 on the bridges 14 between the sinusoidal rings 12, the markers 22 can provide the clinician with a visual indication of the point at which the device will be released becomes. After the markers 22 have located, for example, a marker strip at the tip of a delivery catheter sheath, the complete device can be provided.
At this point, with reference to FIG. 5C1, a schematic representation of a staple 10 'is shown. As shown, the anchor 20 has an increased material thickness compared to the rest of the staple. This has the result that the anchorage 20 also has an increased radiopacity compared to the rest of the staple, whereby the anchorage is effectively converted into a marker.
7. SIMULTANEOUS DEVICE PLACEMENT IN THE VESSEL
[00144] The plaque staple 10 'can be configured for simultaneous placement within a blood vessel. The simultaneous placement of the staple 10 ‘can be defined so that the complete plaque staple 10‘ is released from the delivery catheter before one of the distal apices of the plaque staple 10 ° touches the blood vessel lumen where it is to be placed. This event can occur when the anchorages 20 are fully
are constantly exposed by the catheter covering, so that the entire plaque staple 10 ’can expand against the lumen wall of the blood vessel. The struts 26, 27, 28, 29 can be freely floating, for example at a distance from the vessel wall, or they can exert a negligible force on the wall so that they do not touch the lumen wall before the simultaneous placement. The anchors 20 can have the effect of spacing some or substantially all of the struts 26, 27, 28, 29 from the vessel wall. Other forms of focal elevation elements that can be used to space the staple 10 'from the lumen wall are discussed below.
Simultaneous placement provides the clinician with the ability to control placement until the markers 22 and / or anchors 20 are exposed, which can result in a complete expansion event (struts adjacent the lumen wall or struts contacting the lumen wall). In some embodiments, the full expansion event does not occur until the anchors 20 have been exposed, largely due to the internal forces of the staple 10 'which force the anchors 20 to anchor the supply enclosure described above.
Another advantage of simultaneous placement is the reduction of any inadvertent pulling or pushing of the struts against or along the lumen surface during placement of the plaque staple 10 '. Due to the complexity and variation of the disease, the placement position, and the dissection morphology, the ability of the outer surface of the plaque staple 10 'to touch the lumen wall at the same time is dependent on the deployment circumstances. However, the ability of the 10 ° plaque staple to completely contact the lumen wall within fractions of a second upon release from the catheter sheath was observed.
8. LOW SLOPE FORCE CURVE
Another unique aspect of this plaque staple 10 'is that it can be configured with a force curve with an expanded area and a slight slope. A force curve like that shown in FIG. 6A, indicates the amount of expansive force exerted by a self-expanding plaque staple 10 or stent in moving from a compressed state to an expanded state. This expansion force of a device can be a factor in selecting the correct device for placement in a particular blood vessel.
[00148] With further reference to FIG. 6A, the force curves of a SMART stent (i.e., an S.M.A.R.T.® controlled transhepatic biliary stent from Cordis Corporation), another conventional stent, and another plaque stent with the one shown in FIG. Wall pattern shown in Figure 5A. The diagram shows the radial force in Newtons (N) on the y-axis and the outside diameter of the device in millimeters (mm) on the x-axis. As the device expands or moves from the compressed state to the expanded state, the outer diameter increases. Because the devices are self-expanding, they have a fixed amount of potential energy stored. When released, the potential energy is converted into kinetic energy as the internal forces attempt to return the device to its expanded form. The kinetic energy can then have an effect on the blood vessel when the device is implanted. If the plaque staple 10 'is not fully expanded, a generally constant force is applied to the vessel wall that matches the remaining potential energy stored in staple 10'.
6A shows a first dark line A1, which indicates the compression of a 7.5 mm plaque staple 10 'from about 7.5 mm to a compressed diameter of about 2 mm. After a gradual range of inclination between about 7.5 mm and about 6 mm, the inclination of the force is greatly reduced for each incremental decrease in diameter, requiring a narrow force band to fully wrap the staple 10 'from about 6 mm to about 2 mm to compress. This part of the force curve is very flat; H. the exercised
compression force does not increase significantly as the staple 10 'approaches its fully compressed state. The force curve of the plaque staples 10 'during expansion is shown by a dark line B1 which extends from a compressed diameter of 2 mm to an expanded diameter of about 7.5 mm. This part of the curve can be viewed as the working part in which the force on the y-axis is the force that the plaque staple 10 'would exert on a vessel wall during expansion. If the plaque staple 10 'were provided, for example, in a vessel lumen with a bore of approximately 5.0 mm, the outward force of the staple 10' on the wall would be well below 1.0 Newton (N). Over a range of approximately 2 mm, the range of the outward force is less than approximately 0.05 N +/- approximately 30%.
Fig. 6A shows in a paler line A2 the crimping performance of a SMART stent in a similar test. As discussed above in connection with other prior art stents, the SMART stent is a longer structure than the plaque staple 10 '. In particular, the S.M.A.R.T.® stent tested was 40 mm long with an unlimited outside diameter of 8 mm, whereas the staple tested was 6 mm long with an unlimited outside diameter of 7.5 mm. However, it is assumed that the comparison between the plaque staple 10 'and the SMART stent makes a difference clear, which would also be shown in a SMART stent design of a comparable length. As shown in the diagram, line A2 has a much higher crimp force ranging from a little over 8mm up to about 6.5mm. At about 6.5 mm, the crimp force incline decreases and the crimp force increases at a significantly slower rate. The outward force when fully crimped is much higher. Although the fully crimped state of the SMART stent corresponds to a smaller diameter, the crimping force for a comparable diameter is much higher for the SMART stent. Line B2 illustrates the working area of the tested SMART stent. Line B2 shows the outward force over the expansion range from approx. 2 mm to approx. 6 mm. It can be seen that the slope of the line B2 is very much greater at all points along its range between 2 mm and 6 mm. The practical effect of this higher inclination is that the SMART stent is much more sensitive to changes in the bore size of the vessel in which the expanded plaque staple 10 'is provided.
As shown in FIG. 6A, in some embodiments, a minor slope of the force curve may be substantially flat over an expansion region having an outside diameter of about 3 mm. In other embodiments, a low slope of the force curve can extend over a range of expansion with an outer diameter of 2.5 mm, with a force change of less than 1 N. The factors relating to the ability of the staple to cover a wide range, with the radial forces changing around change less than 1 N, may include a. the centerline anchors, dual amplitude struts, and the varying strut thicknesses as described above.
FIG. 6A illustrates another conventional stent with a compression curve A3 and an expansion curve B3. The SMART stent is a common stent pattern. The curves A3, B3 represent another conventional stent structure. Although the curves A3, B3 have a lower peak compression force on the left-hand side of the curve, the inclination is nevertheless significantly higher than the range of use than for the staple, as illustrated by the curve A1, B1.
The staple is radially self-expanding, over a range of at least about 2 mm, generally at least about 3 mm, and typically over a range of at least about 4 mm or 5 mm, while having a radial expansion force of no more than about 5N occurs at any point in the entire area. In some embodiments, the maximum radial expansion force over the entire expansion range is no more than about 4 N, and preferably no more than about 3 N. In one embodiment, the staple is expandable over a range of at least about 3 mm (e.g., from about 3 mm to at least about 6 mm) and the radial expansion force is less than about 3 N within this range. In general, the expansion force change is no more than about
3N, and preferably no more than about 2N within the expansion range. In one embodiment, the expansion force falls from no more than about 2N for a 3mm diameter to no more than about 1N for a 6mm diameter. The difference between the radial compression force and the radial expansion force at any diameter in the entire expansion range is usually no more than about 4N, generally no more than about 3N, preferably no more than about 2N, and in one embodiment no more than about 1 N. In one implementation, the staple is expandable over an entire range, which is 3 mm to about 6.5 mm, and the difference between the compression force and the expansion force at any point along the compression / expansion region differs by no more than about 2N, and preferably by no more than about 1N.
In general, the outward force of the plaque staple 10 ° is preferably as small as possible, while still providing sufficient force to force the plaque against the wall in a wide range of luminal diameters. If the force is increased, for example by twice or three times the sufficient holding force, side effects can occur. These can u. a. involve irritation of the cells of the vessel wall in contact with the device, which can lead to restenosis. Although a very low force device is preferred in typical treatment, higher force devices can be helpful when loose plaque is found in calcified lesions.
An advantage of a slow change in force during expansion of the device is the ability to predict the energy that the blood vessel will experience regardless of the lumen diameter. Another criterion would be the reduction of the necessary inventory for hospitals. For example, it was found that two partial sizes of the staple 10 ', as shown in FIG. 5A-C, can be used for plaque stapling treatments in blood vessels throughout the leg, from the hip to the ankle. It is assumed that this is largely due to the fact that the staple 10 'has a slope of less than -0.3 N / mm.
C. PLAQUE STAPLE STRUCTURE PARAMETERS
A purpose of the plaque staple described herein, which differs from conventional stent deployment, is to minimize the amount of foreign material implanted while still providing focal treatment of the blood vessel condition so as to minimize the response Blood vessel wall and adverse restenosis after treatment. The plaque staple is designed in such a way that there is essentially less metal covering and / or essentially less contact with the blood vessel surface, as a result of which less acute and chronic inflammations are caused (see FIG. 6B). A reduced area of contact of the implanted material with the blood vessel wall correlates with a lower incidence of intimal hyperplasia and better long-term patency. A substantially reduced length along the axial distance of the blood vessel allows a more targeted treatment, correlates with a less strong foreign body coverage of the blood vessel surface, avoids the coverage of parts of the surface that do not need coverage, and correlates with an early as well as a late improved patency of blood vessel reconstructions.
The plaque staple can only be provided where it is needed to staple plaque that has been loosened during balloon angioplasty or by other mechanisms. Instead of covering an entire treatment area, the plaque staple can be applied locally and selectively so that it does not, for example, extend to normal or less diseased arterial segments (see FIG. 6B). As a result, the blood vessel maintains its natural flexibility since there is minimal to no scaffolding effect when a flat staple is used locally, or even when multiple staples are placed over the treatment area. An even further reduction in the pressure profile can be achieved through the use of "points of contact" in order to increase the pressure
to create the focal points and lift the adjacent strut portion from the blood vessel wall, thereby relieving the general exposure of the outward pressure elsewhere on the staple strut structure.
One parameter for designing a plaque staple has a ratio of axial staple length to expanded diameter (L / D) of no more than about 2.0, often no more than about 1.5, and in some implementations no more than about 1. In some embodiments, the staple has an L / D ratio of about 0.8. This means that the length of the staple along the axis of the blood vessel corresponds approximately to the expanded staple diameter or it is smaller than the expanded staple diameter. The preferred plaque staple is thus shaped like an annular ring or band, whereas the typical stent is shaped like an elongated tube. The flat staple can thus be used locally for the targeted treatment of defective areas of the blood vessel surface with a minimum of foreign material coverage or contact. Tests show that a plaque staple with an axial length / diameter ratio of <1 compared to a conventional stent, where the axial length is greater than the diameter - and usually significantly greater - causes virtually no biological reaction or subsequent blood vessel narrowing. Tests show that a device L / D ratio of <1 leads to a reduction in the scaffolding effect to a level that is significantly lower than that of the typical stent and that it causes a less severe reaction of the arterial wall. For use on small dissection sites after balloon angioplasty, a plaque staple with a minimal profile, such as a single thin ring staple with an L / D ratio in the range of 1:10 to 1: 100, can be used.
Stent deployment studies have shown that the axial length of a stent correlates with a tendency to occlude in multiple vascular areas. The more axial length of the stent placed, the greater the likelihood that the reconstruction will fail. The axial length of a stent also correlates directly with the frequency and tendency of the stent to break when placed in the superficial femoral artery. The medical literature indicates that the superficial femoral artery behaves like a rubber band and that changes in the natural elongation and contraction of the superficial femoral artery are likely to play a significant role in the failure of superficial femoral artery stents. In contrast, the flat plaque staple can only be implanted in local areas where it is needed, so the blood vessel retains its natural flexibility to move and bend even after it has been stapled. Multiple staples can be implanted free of metal supports, separated by area, leaving the artery free to bend more naturally.
An outward radial pressure exerted on the blood vessel wall can also be significantly reduced by the flat staple structure, even if multiple staples are used in a spaced configuration. To minimize this outward force while still providing the necessary retention of the dissections to the arterial wall, a variety of anchoring barbs or focal elevation elements can be used. The presence of these features, which apply focal pressure to the wall of the artery, allows the remainder of the staple to exert minimal outward force on the artery wall. The points on which the force is applied can be very focal, this is where most of the force acts. The focal nature of the pressure applied by the staple also minimizes the structural impact of the device. Uniformly distributed anchors or focal elevation elements can provide a distribution of radial energy, thereby maximizing the tendency for a circular lumen to form.
Another essential parameter for generating a plaque staple is the ratio of the vessel cover area (C) to the total vessel surface area (TVS). In one definition, the value C is the length of the prosthesis (e.g. stent or staple) multiplied by the mean circumference of the vessel in which it is placed, and the TVS value can be the length of the lesion or area in need of treatment multiplied by the same
Nominal size. This can also be simplified as the ratio of the total length of the prosthesis, expanded to the nominal circumference, divided by the length of the lesion in the vessel. These concepts can be applied to a stapling device or in the case where multiple spaced apart stapling devices are placed along the length of a blood vessel treatment area. If multiple stents or staples are used, a simplified ratio can be the total non-overlapping length divided by the lesion length, or alternatively the sum of the length of the prosthesis divided by the sum of the length (s) of the lesion (s). For a plaque staple, the ratio of C: TVS is in the range of about 60% or less, whereas for a stent it can be 100% or more (when applied so that it overlaps the treatment area).
For a focal lesion, the conventional length of a vessel being treated is X + 10mm to 20mm, where X is the length of the lesion and the added length is adjacent to a normal or less diseased artery that extends proximal or distal to the lesion is located. With conventional stent deployment, the entire length of the treated vessel would be covered by a stent. With a lesion of 2 cm, the treated vessel length would be 3 to 4 cm (usually a single stent of this length would be selected), so that the ratio of C: TVS would be 150% -200%. In contrast, if a staple were placed, only about 1/2 of X would be covered and no part of the adjacent normal or less diseased artery would be treated. A 2 cm lesion would cover about 1 cm, so the C: TVS ratio would be about 60% or less. A beneficial aspect of this innovative approach is the placement of ligaments only in areas where there are dissections that require vascular stapling.
As previously described, in some embodiments, a staple device 10 'is formed with rings or net bands 12 which are connected by longitudinal bridge parts 14 (FIG. 5A). In the illustration, staple 10 'is shown, which is compressed for provision in a blood vessel. Upon expansion, the diameter of the staple device may be approximately equal to the axial length of the staple device.
FIG. Figure 6B illustrates the use of multiple staples spaced a length of blood vessel at a treatment site compared to that of a typical stent. The distances between the staple devices is preferably at least the axial length of the staple device. Note that spacing adjacent staple devices leaves an untreated vascular surface. A typical stent is shown in the upper part of the figure compared to the use of 6 spaced apart stapling devices in the lower part of the figure. In this non-limiting example, the total length of the treatment area is 6.6 cm (the same length as the stent) whereas each band is shown as 6 mm long and 6 mm apart. Therefore, the vessel cover area for the stent is equal to the total vessel surface (= 6.6 cm x 0.6x or 12.44 cm®), which gives a ratio of C: TVS of 100%. For the row of spaced apart staplers, C is 6 x 0.6 cm x 0.6x or 6.78 cm While TVS is 12.44 cm®, so the ratio of C: TVS is 54.5%.
When two or more stents are to be deployed over a longer length of the treatment site, it is conventional to overlap adjacent stents to avoid kinking between the stents. Due to the reinforced metal grid, the overlapping area becomes very rigid and uncomfortable. This inflexible doubly rigid area further restricts the natural flexibility of the artery and increases the tendency for restenosis. Stent fractures are more common in the superficial femoral artery when there are frequent bends, and they are common when multiple stents are deployed and overlapping. Stent fractures are associated with a higher risk of internal restenosis and reclosure. In contrast, the plaque staples are designed not to be applied in an overlapping manner in the local area. The optimal spacing for the staples is at least 1 axial staple length apart. This allows the artery to maintain its flexibility and only half or less of the treated length of the artery is covered with metal. It should be noted that in the case of restenosis after
When the staple is placed, the overlap of the entire treated length by a stent allows the stent to remain permeable. This is due to the repetitive pattern of the areas that are not stapled, which provides relaxation areas and allows the artery to flex.
The literature in the industry has found that important factors in the stent structure can be the ratio of relative metal surface area (RMS) and the number of longitudinal segments in the device structure, as set out, for example, by Mosseri M, Rozenman Y, Mereuta A, Hasin Y, Gotsman M., "New Indicator for Stent Covering Area", in Catheterization and Cardiovascular Diagnosis, 1998, v. 445, pp. 188-192. In particular, for the respective metal surface area, a larger number of longitudinal segments (each being thinner) can reduce the size of the gap between adjacent segments and thus reduce the prolapse tendency. As adapted from the RMS metric, an effective metal interface (EMI) equation can be used to compare the longitudinal bridge member embodiment of the staple device to a typical stent, as follows:
1 + n2C EMI IOC
X (Iw) s
s = 1 Where x is a number of the metal sections, | is an individual metal section length, w is an individual metal section width, C is the vessel cover area under the device (lumen surface), and n is the number of bridge portions connected longitudinally between the circumferentially aligned segments. The summation in the denominator can be interpreted as the total metal surface area. The embodiment of the stapling device with the longitudinal bridge parts has an EMI <= 10, whereas the EMI of a typical stent would be many times higher. This low EMI is due to the nature of the staple structure, which is small in area and has minimal longitudinal bridges, whereas a stent is typically large in area and would be multiples of that.
To further reduce EMI during the ingestion of the cusp lift-off features (such as anchors, barbs, or focal lifts), improved EMI; for the effective metal interface of the staple as provided with levitation elements (see FIG. 9). EMI can be defined as:
CA + (nn)
X
X (dw-Lrwr) s
s = 1 Where all variables are the same as in the EMI equation, with the addition of I5 as a single metal section length not in contact with the artery ("floats" away from the artery, and where w- is its width If there are no floating sections then n = 0 and I: w == 0, therefore EMI = EMI.
EMIr =
The inclusion of metal sections that are floating (floating length Ir, floating width W £ and number of floating bridges n5) further reduces EMI, which is mathematically recorded as addition with negative variables in the EMI equation.
The presence of vom-cusp lifting features on the plaque staple (such as anchors, barbs or focal lifting elements) minimizes the pressure of the overall structure on the blood vessel wall by transmitting regionally occurring, outward forces to focal pressure points, thereby causing the higher pressure is exerted on focal points. The presence of these features, which apply focal pressure to the wall of the artery, allows the remainder of the staple to exert minimal outward force on the artery wall. Wherever the cusp lift features are placed, the outward radial energy is maximized in that area, creating a slight outward bulging of the arterial wall. The outward bulge can be used for arterial shaping
For example, 5 or more evenly distributed focal points can be used to form a circular lumen. Circular lumens offer an additional benefit from the point of view of vascular wall interaction, regardless of the vascular injury.
In each of the embodiments described herein, the plaque staple device may be made of nitinol, a silicone composite (with or without an inert coating), polyglycolic acid, or other superelastic material, as well as stainless steel, tantalum, cobalt chrome alloy, bioabsorbable or bioabsorbable materials (including bioabsorbable / bioabsorbable metal) or a polymer. The strip of material can be ribbon, round or rectangular wire, or a sheet of material that can be made by photolithographic processing, laser or water cutting, chemical etching or mechanical removal of the final shape, or the use of bottom-up manufacturing, for example chemical vapor deposition processes or injection molding, hot rolling or the application of electroplating / chemical coating. It can be made of a metal, plastic, ceramic or composite material.
The plaque stapler is designed to be inherently self-aligning; H. their mechanical installation can compensate for minor misalignments. By reducing the load on the strut parts when gripping the arterial wall in the middle of the structure, the staple aligns itself automatically with the longitudinal axis of the artery. Structural functions that provide relief and an even distribution of the unfolding struts are u. a. close spacing of the anchors, inconsistently thick struts, and anchor heads that are angled to reduce the device from bouncing forward during deployment. As discussed above, circumferentially aligned anchors on each bridge portion provide grasping force with the catheter tip as well as inherent features of abutment against the arterial wall. These structural features serve to simplify the placement of the staples in specific locations within the diseased blood vessels.
Il. IMPROVEMENT OF THE FOCAL LIFT ELEMENTS
FIG. 7A-D show a plaque staple 10 ″ similar to that of FIG. 5A-C is similar except as detailed below. In particular, the plaque staple 10 "includes a feature that reduces the amount or nature of the interactions between the plaque staple 10" and the vascular stem when provided by lifting and lifting a portion of the plaque staple 10 "away from the vessel wall.
In particular, the tall outer apex 24 'formed by the struts 26 and 27 is curved or rotated upward or positioned radially outward to form a focal elevation element (FEE) 32. FIG. 8 shows a schematic view of the FEE 32. In this embodiment, the tall outer apex 24 'is bent to form an angle with the struts 26 and 27. FIG. In this way, the FEE 32 can help minimize the size of the area of the staple 10 "that comes into contact with the plaque and / or the vessel wall, while at the same time the forces are localized at a few points to prevent the plaque staple 10" safer to place. These and other advantages are discussed in more detail below.
A plaque stapling device can be provided with focal elevation elements on the annular periphery of the device. The focal elevation elements can be distinguished from the anchors and barbs in that they generally have a larger plaque or arterial wall penetration to anchor or stabilize the staple in the blood vessel.
The focal elevation elements penetrate or do not penetrate, but they still provide regional strut elevation and are preferably placed at the apices of the struts or at regular intervals along (e.g., perpendicular to) the strut lengths. For both anchors and focal elevation elements, the size of the interface between the staple and arterial wall is preferably equal to or shorter than the strut width in FIG
at least one direction. The focal elevation elements may be similar to the anchors, but either do not penetrate or penetrate the tissue only slightly, minimizing the size of the surface area of material that is in contact with the plaque and providing a series of relaxation sections for the outward pressure of the stapler adjacent to the focal elevation elements, thus minimizing the friction generated on the blood vessel wall.
The focal elevation elements can be shaped and configured on the annular periphery of the staple device in a manner similar to that described for the previous staple device embodiments and can additionally include the raised contact areas for anchors or prongs. The contact areas can provide improved tack in that they increase the contact forces in the contact areas by compressing the plaque in the contact areas and reduce the outward forces in the areas adjacent the focal elevation element. This leads to regional pressure relief in some areas as well as increased contact pressure on the bumps or spikes, which collectively offers a reduction in the trauma and cell response of the blood vessel wall.
Since the staple device is held in the desired position by the pressure it exerts on the surface of the blood vessel, it is prone to friction, including slight movement between the device and the surface of the vessel. With every movement of the organ (e.g. bending the leg), the artery moves. It can be concluded that as the artery moves, the working device located in the artery also moves, but not necessarily every contact point moves synchronously. Whenever there is a small discrepancy in movement between the artery and device, the artery and device rub against each other, promoting cellular response and device failure. Experiments have shown that this rubbing can irritate the endothelium and lead to an inflammatory reaction. In some embodiments, strategically placed focal elevation elements (FEEs) are implemented to reduce the general regional frictional load (believed to be a source of inflammation, cell proliferation and the healing responses leading to restenosis) in the area that is kept open.
As an example, it is assumed that a blood vessel, such as the hollow of the knee, which is shortened and lengthened cylindrically, has cell or tissue structures which lengthen and compress in a direction parallel to the vessel axis. The natural behavior of this cellular structure or tissue structure involves a significant degree of local movement along this axial direction. If an implant to be placed in such a vessel is designed in such a way that it contacts the vessel wall in a direction transverse to the axial direction, the natural behavior of these tissues or cells is significantly disrupted. The tissue is restricted, for example, and natural movement is significantly reduced. The edges of the transversely contacting structure can also rub, which can lead to friction and / or abrasion of the tissue and corresponding inflammation. FEEs, on the other hand, reduce the disruption of the natural behavior of tissue or cells. When implemented in a stapling device or other prosthesis, FEEs can focus contact in areas spaced along a direction transverse to the predominant direction of movement (e.g., the axial direction at the hollow of the knee or similar vessel). Between these areas of focused contact according to the FEEs, the interaction of the compressing and elongating tissue or the compressing or elongating cells with the structure of the implant is significantly reduced. In this intermediate region, the movement between the compressing and lengthening tissue or the compressing and lengthening cells can approximate the movement of the tissue or the cells prior to implantation of the prosthesis. Areas raised by the FEEs limit the histological response of the tissue and also limit device fatigue by limiting device-tissue contact.
Regardless of the general number of contacts and the number of FEEs, the staple devices smooth the lumen wall and allow for more natural vascular movement. The FEEs are very helpful in lengthening / lengthening or compressing / compressing their ability to reduce the amount of interaction between the tissue or cells that are moving, causing chafing or friction against that tissue or cells can arise. It is this highly localized movement or "micro-movement" that increases the cellular response of the blood vessel surface to the foreign device.
The focal elevation elements are designed to reduce the effective metal interface (EMI) by minimizing general material contact with the blood vessel surface. The focal elevation element (FEE) is preferably configured as a narrow raised feature of sufficient height to raise adjacent strut portions of the stapling device from contact with the arterial wall so as to reduce the surface area of foreign material in contact with the arterial wall. The reduction in contact load is particularly useful when the strut parts are circumferentially connected rings or circumferentially aligned strut strips. Strut sections aligned against the natural direction of cell movement, which are in contact with the blood vessel wall, can lead to microfriction if they move or rub against the blood vessel walls. By reducing the foreign material contact with the blood vessel wall, the tendency to generate microfriction contact is reduced.
[00183] Referring to FIG. Figure 9 schematically illustrates some of the structural assumptions regarding the use of focal elevation elements on a plaque stapler. In the figure, h refers to the height of the focal elevation element that is extended out of the blood vessel (note: the penetration depth of the focal elevation element, which is anchored in the artery or in the plaque body, was not taken into account in this calculation) w refers to the width of the focal elevation element (at the base) and refers to the surface of the adjacent strut that is lifted from the arterial wall (mathematically simplified as a straight line). The struts that adjoin the focal elevation element can be made of shape memory materials or designed as a compression shaft that compensates for the variations in lumen diameter. The forces of the struts adjoining the focal elevation elements create an outward bulging of the struts, created by the forces of the struts trying to expand until they are in contact with the blood vessel wall. I refers to the length of the arterial wall at which contact with any adjacent strut structure is prevented by the focal elevation element.
One or more of the features shown in FIG. 9 can be varied to provide advantageous FEE performance. h can vary, for example, in the size of the delivery catheter. For example, a 4FR provides an h of up to 150 µm. In certain embodiments, a staple with FEEs configured for delivery in a 4FR catheter can have an h of about 100 µm or less. An exemplary embodiment that can be provided with a 4FR delivery system has one or more FEEs with an h of about 75 µm. Larger staples with FEEs configured to be provided in a 6FR catheter, for example, can have an h of up to about 300 µm, and in some cases 225 µm or less. An exemplary embodiment that can be provided with a 6FR delivery system has one or more FEEs with an h of about 200 µm. Even larger staples with FEEs, configured for delivery through an 8FR catheter, for example, could have an h of up to 950 µm, while in some embodiments FEEs of up to 500 µm could be provided. An exemplary embodiment that can be provided with an 8FR delivery system has one or more FEEs with an h of about 400 µm.
Any of the previous dimensions of h can be combined with a variety of dimensions for W of the FEE. The dimension W would usually be the width of the strut, but could also be only 50% of the strut width and in the position of the FEE can be between about 50% and about 100% of the width of the struts. I; and la are a function of W, the radial force
of the system, the topography of the lumen, and the delivery device, for example, will vary when a balloon is used to force the device into the artery. If we only look at W (non-elastic system), then Ia can be roughly equal to the length of the strut. As the outward force increases (both in terms of the resilient nature of the metal and the balloon support), Ia may decrease and approach zero. However, in various embodiments, Ia is at least about 20 µm.
The focal elevation elements can be formed as cylindrical, rectangular, linear, spherical, conical, teardrop-shaped, pyramidal or inclined elements on the annular periphery of the stapler. They can be made by bending or punching an area of the staple structure, by an addition process (such as by welding or tempering on a peripheral surface), by a subtraction process (such as by grinding or etching away surrounding material so that the bump element is higher than the surrounding surface), or by changing small areas of the peripheral surface so that they are higher than the surrounding surface before or after sheet metal or pipe cutting. For example, one method is to modify small areas of a mesh staple structure by knotting, twisting, bending, or weaving small portions of the wire mesh to create raised features from the mesh surface which then interface with the arterial wall of the stapling devices.
Properly aligned and symmetrically positioned focal elevation elements can provide focus for the expansion force. As the device exerts outward forces and the artery exerts inward forces, the focal elevation elements can be placed in strategic positions that reduce the outward pressure of the strut sections that are adjacent to the focal elevation elements.
Both anchors and focal elevators can offer strategic advantages that include: reducing the pressure load across the staple struts by reducing the contact area and transferring the outward forces to the anchors and focal elevators, thereby minimizing surface contact what causes a reduction in the tendency of the frictional charge caused by the micromotion between the arterial wall and the staple strut, as well as stabilizing the anchorage of the staple where the anchorage and the focal elevation element penetrates the vessel wall is at a fraction of the height of the features.
Because the staple device is held in the desired position by its own outward force exerted on the surface of the blood vessel, it can be prone to friction, e.g. H. a slight movement between the device and the vessel surface. FIG. Figure 10 illustrates the forces acting between the focal elevation members of the staple and the arterial wall. Deadline is the circumferential force exerted by the stapling device against the force of the arterial wall, F. F ££ is an additive circumferential force on the focal elevation element that is generated by the choice of structure and material, and FF is the frictional force of the artery that arises when the artery changes its orientation or shape due to body forces. Every time a part of the body moves, the blood vessels move with it. The focal elevation elements can be strategically positioned to reduce the local frictional load that can cause inflammation, cell proliferation, or a body reaction that leads to restenosis.
The number and locations of the focal elevation elements can affect the general relative metal surface area (RMS), as discussed previously. The focal elevation elements can be positioned along the lengths of the stapler surfaces such that a minimal amount of metal surface area is in contact with the arterial wall. Focal elevation elements placed on bridges between circumferential brace rings or at the apices of the brace sections of the stapler can provide much of the relief of the arterial injury. When focal elevation elements are placed only at the apices and bridges, the RMS of the strut parts that make up the concentric changes
Ring is formed, only slightly, while the RMS of the bridges is significantly reduced due to the narrow length, whereby a relief of the relative movement of the strut rings aligned on the circumference is offered.
FIG. 11 and 12 illustrate the application of the focal elevation elements to a stapler of the type described above with reference to FIG. 5A-C with two or more concentric ring sections connected by bridges between them. FIG. 11 shows a cell made up of two adjacent ring sections 290a and 290b with strut sections 290c which are connected in the middle by bridges 290d. FIG. 12 shows the ring sections expanded under the expansion force and opposing rows of focal elevation members 290e provided at opposite ends of the two adjacent ring sections 290a and 290b. A detail shows the round raised element at a raised height from the strut surface.
FIG. Figures 13 and 14 illustrate a cell of another variant of focal elevation elements formed on a staple device having two or more concentric ring sections 300a, 300b connected by bridges 300d therebetween. In this cell variant, the focal elevation elements 300e are formed by bending the sections of the strut (shown as the strut apex) from the circumferential plane in varying degrees of inclination, such as position “a” or position “b”, up to a vertical orientation of 90 degrees, shown in FIG Position “c” to form the lifting element.
Inherent in the use of shape memory alloys for the staple devices is the ability to smoothly follow the shape of the blood vessel walls. Since the focal elevation elements can exert an expansion pressure on the blood vessel walls with minimal risk of injury, they can be designed to reshape the blood vessel walls into a desired shape. FIG. Figure 15 illustrates the Focal Elevation Elements (FEE) placed in diametrically opposed positions and shaped with an expanded height for reshaping the arterial walls into an elliptical cross-sectional shape that better accommodates the arterial cross-section (such as an arterial branch) or for expanding the lumen, so that it is more open in plaque-free areas.
FIG. Fig. 16 shows a side view of the FEEs positioned along a strut length having a small area that is lifted from the artery due to the height of the FEE raising a short distance from the adjacent strut length. Outward forces generated by the structure or material used allow only a small area on either side of the FEE to lift off the blood vessel wall.
FIG. Figure 17 illustrates a perspective view of a row of FEEs spaced along the length of a strut portion of a stapler. FIG. Figure 18 illustrates a detailed view of a cylindrically shaped FEE positioned at the apex of a strut portion of the stapler. FIG. 19 illustrates a perspective view of a FEE formed as a pyramidal element at the apex of a strut section. FIG. 20 illustrates a perspective view of a FEE formed as a coupling element at the apex of a strut section. FIG. Figure 21 illustrates a perspective view of a FEE formed by bending the apex of a strut portion upward. FIG. 22 illustrates a perspective view of a FEE formed by twisting a strut section (made of wire).
IV. METHODS AND DEVICES FOR THE PROVISION OF PLAQUE STAPLES AND FOR THE FORMATION OF INTRAVASCULAR STRUCTURES IN SITU
A variety of delivery methodologies and devices may be used for the delivery of plaque staples, some of which are described below. For example, a plaque staple can be provided through an endovascular insertion in the blood vessel. The provision devices for the various embodiments may be different or the same, and may have features that are specific to
Providing the special staple were designed. The plaque staple and method of installation may be designed in a number of ways that share a common methodology of utilizing an expansion force of the delivery mechanism (such as balloon expansion) and / or the expansion force of a compressible annular band to cause the staple to move into position can move in the blood vessel, and then released, unfolded, or rotated back into an expanded state within the blood vessel.
With reference back to FIG. 4-4D, a delivery device or catheter 11 with an outer sheath 13 is shown in a state prior to delivery. A plurality of plaque staples 10 can be compressed so that they can be loaded onto the surface of the delivery device 11. The outer cover 13 can then be advanced to cover the plaque staple 10 in preparation for deployment. In some embodiments, the plaque staples 10 are frozen in their compressed state to facilitate loading onto the delivery device. The staples can extend in an array which corresponds to 10 times a respective length of the supply device.
It can be seen that the plaque staple 10 can be positioned by the supply device 11 at the treatment site in the vascular trunk of a patient. The outer cover 13 retracts or retracts to expose and release the plaque staple 10. The staple 10 is then expandable in any suitable manner, such as, for example, through the self-expanding or balloon-expanding configuration as described herein.
With present reference to FIG. 23-31B, a method for providing one or more staples 10 "is described. As already mentioned, an angioplasty procedure or another type of procedure can be performed on a blood vessel 7. The angioplasty can be performed on a diseased or blocked part of blood vessel 7. As shown in FIG. 23, a guidewire 40 followed by an angioplasty balloon catheter carrying the balloon 42 is advanced into a blood vessel 7 to a position containing a plaque-formed blockage. The balloon 42 is inflated in the desired position to compact the plaque and expand the vessel 7 (FIG. 24). The balloon 42 can then be deflated and removed.
When the vessel 7 is expanded, a dissection 44 of the plaque can be brought about by angioplasty (FIG. 25). A plaque staple or clip 10 ″ can then be used to fix the plaque dissection 44 to the lumen wall 7.
A delivery catheter 11 ', which has been pre-loaded with one or more staples 10', can be advanced along the guide wire 40 to the treatment site (FIG. 26). An outer sheath 13 can be pulled back, thereby exposing a portion of the plaque staple 10 ". As previously discussed, the outer sheath 13 can be withdrawn to a set point, then the position of the catheter within the vessel can be adjusted as needed to ensure accurate placement of the plaque staple 10 "(FIG. 27). The set point for example, may be just prior to exposure of any of the staples, exposure of part or all of the ring, exposure of a ring and anchor, and so on.
[00202] The staple 10 ”can then be released in the desired position in the lumen. As previously stated, in some embodiments the plaque staple 10 "may be placed simultaneously upon release. Additional plaque staples 10" can then be placed as needed (FIG. 28). After the placement of the second staple 10 " an intravascular structure is formed in situ. In situ placement can be in any suitable vessel, such as in any peripheral artery. The structure need not be limited to just two staples 10 ". In fact, a plurality of at least three intravascular staples can be used 10 ”(or any of the other staples herein) in an intravascular structure that is formed in situ
Embodiment, each of the plurality of staples is no more than about 8 mm in length, for example about 6 mm in an uncompressed state. In one configuration, at least one of, for example, all of the staples is spaced from an adjacent staple by at least about 4 mm. While certain embodiments are 8 mm or less in length, other embodiments can be longer, for example up to 15 mm long. In addition, adjacent staples 10 ″ can be spaced as closely as 2 mm apart, particularly in vessels that are less susceptible to bending or other movements. In one embodiment, each of the staples has a relatively weak radial force, such as a radial expansion force of no more than about 4N, and in some cases about 1N or less. In some embodiments, the staples can be configured with as little radial force as 0.25N. In the various delivery devices described herein, the distances between the implanted staples can be controlled to obtain a desired or a minimum distance between each staple. It will be appreciated that the delivery devices and / or staples may incorporate features that help maintain the desired spacing between the staples. Maintaining proper spacing between the staples can help ensure that the staples are distributed over a desired length without contacting one another or without accumulating in a particular area of the vessel being treated. This can help avoid kinking the vessel in which they are arranged.
While a three-staple structure formed in situ may be appropriate for certain indications, an intravascular structure with at least 5 intravascular staples can be used to treat loose plaque, vascular valves, dissections, or other ailments that are significantly more elongated (non-focal) beneficial. For example, while most dissections are focal (e.g., axially short), a number of dissections can be viewed and treated as a more elongated condition.
In some cases, even staples with a shorter axial length can be used to treat even more spaced positions. For example, a variety of staples, each no more than about 7 mm in length, can be placed in a vessel to treat a staple disease. At least some of, for example, all of the staples may be spaced from an adjacent staple by at least about 5 mm. In some cases, gaps may preferably be provided between adjacent staples which can range from about 6 mm to about 10 mm.
Optionally, after the plaque staples 10 "have been set, the angioplasty balloon can return to the treatment site and be inflated so as to expand the plaque staples 10" into the desired state of expansion. FIG. 29 shows the plaque staples 10 "in their final implanted state.
With reference to FIG. 29, 30A and 30B it can be seen how the focal elevation elements 32 can both penetrate the plaque in the blood vessel wall and minimize the contact area of the plaque staple 10 ″ with the blood vessel wall. Likewise, FIGS. 29, 31A and 31B show the penetration of the anchors 20. It can also be seen that the position of the anchors 20 on the bridge 14 allows the anchors to protrude tangentially from the annular shape formed by the plaque staple 10 " Anchors 20 advantageously hook into the plaque or the vessel wall, and also minimizes the general amount of contact by the plaque staple 10 ″, similar to the focal elevation elements 32.
A. OTHER SYSTEMS AND METHODS OF DEPLOYING PLAQUE STAPLES
[00207] FIG. 32A-48D illustrate a system for providing a vascular prosthesis, such as any of the endovascular staples or plaque staples described above. FIG. 32A shows a system 100 for the controlled provision of a
self-expanding staple. Other systems, discussed below, can be used to improve the staple position as well as the staples that are at least partially expanded by an outward radial force.
The system 100 includes a catheter unit 104 and a fitting 108 to which the catheter unit 104 can be coupled. The armature 108 may be a small configuration for manual operation, but in some embodiments it is fixed to a larger object or otherwise configured to be immobilized. The catheter unit 104 can be received by the armature 108 and held therein in the desired position in order to limit or exclude undesired relative movement between the armature and at least one component of the catheter unit 104. For example, the armature 108 may include one or more caps 112 which may be configured to hold a portion of the catheter assembly 104. FIG. 32A shows that the armature 108 in one embodiment includes proximal and distal caps 112A, 112B, which will be discussed in greater detail below. The caps 112A, 112B are removable to allow the clinician to place the catheter assembly 104 in the fitting 108, or it is already attached to the catheter assembly upon delivery. The features of the armature 108 can be compared with those of the illustrations of FIG. 46-48D or add those describing further details of the delivery systems that may be located at the proximal end.
The catheter assembly 104 includes an elongated body 132, a sheath 136, and a plurality of intravascular staples 140. Although a staple 140 is shown in FIG. 32B and 33B, a variety of additional staples may be disposed within catheter assembly 104, as will be discussed below in connection with FIG. 36A explained.
FIG. 36-36A show that elongated body 132 has a proximal end 152, a distal end 156, and a plurality of delivery platforms 160 disposed adjacent the distal end. Each of the delivery platforms 160 includes a recess 164 that extends distally from an annular marker band 168 (FIG. 33B). The ring-shaped marker band 168 has a larger outer diameter compared to the recess 164. In some embodiments, the recess 164 may be defined as the smaller diameter area adjacent or between one or two annular marker bands 168 and / or another feature on the elongated body 132. The platforms 160 are shown schematically in FIGS. 32A33B and in greater detail in FIG. 36A. In embodiments having a plurality of staples 140, a plurality of corresponding delivery platforms 160 are provided. Any number of staples and platforms may be provided, such as four staples and platforms, two or more staples and platforms, between 3 and 20 staples and platforms, or other configurations. Each delivery platform 160 includes at least one marker tape 168. For example, a proximal marker tape 168A and a distal marker tape 168B can be provided to visualize the ends of the platform 160 using standard visualization methods. In the embodiment shown, the proximal marker band 168A of a first platform 160 is also the distal marker band of the platform that is positioned directly distally.
The annular marker bands 168 can take any suitable shape, such as including one or more of the materials tantalum, iridium, and platinum, for example. In a particular arrangement (see FIG. 36A), the most proximal marker ribbon 168A comprises tantalum, while the distal marker ribbon 168B comprises one or more of platinum and iridium. The use of different materials to achieve radiopacity can be based on cost or a preference for better visibility and / or a thinner structure. Platinum / Iridium offers better radiopacity than tantalum, which means that the distal marker bands can be thinner or more visible than the tantalum band.
The ability to increase the radiopacity, which enables the doctor to see under fluoroscopy, can be provided in various ways on the delivery device and the staple. An example is the inclusion of thicker material
al areas (either wider in circumference or radially thicker).
In addition, the annular marker bands 168 have a radial height, which is the radial distance to the top of the band from the base of the recess 164. The radial distance can vary, but is preferably just enough to prevent the staple 140 from catching between the elongated body 132 on the annular marker tape 168 and the envelope 136. In certain embodiments, the radial distance is approximately equal to at least the thickness of the staples 140 arranged in the catheter unit 104.
In another embodiment, the delivery platforms 160 are located distal from a proximal marker band 168A where the marker bands are frustoconical so that the proximal end of each marker band has a radius almost the radius of the elongated body 132 while the radius of the Marker tape at the distal end is a reduced radius. In some embodiments, the reduced radius can be the original radius, as set out above. In other words, the marker tape slopes up proximally, toward the closest proximal staple. This creates a wall at the proximal end of marker tape 168A. A distal end of a staple after it has been provided is positioned on the wall, in this way the marker tape can aid in the proper placement of the staple. In addition, the inclined surface can be helpful in facilitating the smooth withdrawal of the envelope from the elongate member before the staple is deployed. For example, the sloped surface may limit the ability of the staple to hook onto a marker tape after deployment while the wrapper is being withdrawn. In some cases, the staple may have a strut portion that is not completely opposite the wall; the inclined marker tape can limit the ability of the marker tape to capture this raised portion of the strut as the wrapper is withdrawn. In this arrangement, the distal portion of the staple rests in the delivery platform directly proximal to the inclined end of the proximal marker tape in the delivery system 100, as opposed to directly on the wall with the inclined marker tape.
In another embodiment, the marker bands can be frustoconical in the opposite direction, in which the radius near a distal end is greatest and then inclines proximally downwards. In this embodiment, the marker tape has a wall at the distal end. The sloped surface can be helpful in making it easier to smoothly retract the elongated portion after the staple has been deployed. For example, the inclined surface may limit the ability of the staple to hook onto a marker tape after deployment while the elongate member is withdrawn from the receptacle. In a variation, the delivery platform can be frustoconical in one or more directions.
The marker bands can be frustoconical in one or more directions. The frustoconical segment of the marker tape can be formed by adhesive, which can fix the marker tape to the elongated part. The adhesive can form a connecting layer between the marker tape and the elongated part. The connection layer can have a concave, substantially planar or a convex outer surface. In some embodiments, the marker tape can have tie layers on both sides and with different outer surfaces. The marker tape can, for example, have a concave connecting layer at the distal end and a connecting layer at the proximal end, which has a substantially planar outer surface, or an outer surface which is less concave than the distal connecting layer.
In some variations, the staples 140 are completely self-expanding. In other variations, at least one of the delivery platforms 160 includes an expandable member so as to expand a staple placed thereon. The expandable member may have a standard structure, such as for balloon angioplasty, or a special design, as shown in FIG. 45 shown include. The staples 140 can also be prepared using special balloons
that are drug-coated to minimize restenosis, inflammation, or other side effects of plaque staple treatment.
The elongated body 132 includes a distal tip 172 that is tapered so as to allow easy insertion and a lumen 176 that extends proximally therefrom to the proximal end 152. As already mentioned above in connection with FIGS. 4-4D and FIG. 23-31, the lumen 176 can be used to guide the distal end of the catheter assembly 104 into a treatment area. The proximal end 152 may have any suitable shape, but is preferably configured to snap-lock into the fitting 108. FIG. 36 shows, for example, that the proximal end 152 can include a Luer hub 178 with flanges that can be received in a similarly shaped recess in the fitting 108. For example, a recess which at least partially corresponds to the shape of hub 178 can be formed between a base 110 of the fitting 104 and the cap 112A. When the elongate body is received in the fitting 104, the hub 178 between the cap 112A and the base 110 can be received in this recess and locked by securely connecting the cap 112 to the base 110, thus preventing undesirable movement of the elongate body 132 in relation to the envelope 136 and movement in relation to a fixed frame of reference, such as the frame of reference of the armature 104, can be reduced or prevented.
The sheath 136 has a proximal end 192, a distal end 198, and an elongated body 200 extending therebetween. The envelope 136 is movable in relation to the elongated body 132 from a first position to a second position. The envelope can be formed from a hypotube, such as a metal or a plastic hypotube. The flexibility and stiffness of the envelope can be controlled with many features, such as the incline and frequency of a spiral cut along the length of the hypotube.
FIG. 32A-32B show a first position in which the distal end 198 of the sheath 136 is positioned distal from a most distal distal delivery platform 160. In FIG. 32B, the most distal platform is occupied by a staple 140. Another platform, directly proximal to the occupied platform, is shown without a staple for clarity, but may be occupied by another staple. Additional platforms and staples can be positioned further proximally. FIG. 33A-33B illustrate a second position in which the distal end 198 of the sheath 136 is positioned proximal to at least one delivery platform 160.
The sheath 136 may also include a crotch luer 204 having a main arm to receive the elongated body 132 and a side arm 206 disposed at the proximal end of the elongated body 200. The side arm 206 includes a purge port that is used to purge air as well as to increase the lubricity in the distance between the envelope and the elongated body 132. A Tuohy-Borst adapter 208 (or other sealing arrangement) can be provided proximal to the bifurcation luer 204 to receive the distal end of the elongated body 132 prior to use on a patient (e.g., during manufacture). In some embodiments, a strain relief sleeve 212 is provided between the crotch luer 204 and the elongated body 200 to make the connection more robust. The strain relief sleeve 212 can take any shape, for example it can be made of polyolefin or a similar material.
In one method of use, the distal end of the catheter assembly 104 is inserted into the patient and the proximal end is placed in the armature 108. The sheath 136 is in a distal position, for example with the bifurcation Luer 204 at the front, in the armature 108. During the method, the sheath 136 is progressively moved in the direction of the proximal position, for example up to a proximal part of the Tuohy-Borst adapter 208 a distal part of the cap 112 A of the armature 108 contacts. While the sheath 136 is moved proximally, the staples are provided, either one at a time, selectively
Then, the clinician will reposition elongate body 132 after each staging or staging line, or all at once without repositioning elongate body 132.
The armature 108 advantageously supports the placement of multiple staples 140 in a treatment area in spaced-apart positions, as shown in FIG. 29 shown. For example, armature 108 reduces inadvertent relative movement between envelope 136 and elongate body 132. When armature 108 is immobilized, the armature helps limit movement of elongate body 132 by internally frictional bonding with envelope 136 during the crotch -Luer 204 is moved proximally. This can result in a more controlled delivery than if the clinician had to hold both the proximal ends of the elongate body 132 and the sheath 136 directly. This helps ensure that a minimal gap is provided in the treatment area between the distal end of a proximal staple and a proximal end of a distal staple. The gap is shown in FIG. 29, which illustrates the provision of two staples 10 ". The gap advantageously minimizes the likelihood that two staples will get caught in the vessel, or that other complaints will occur due to being too close. The gap or distance between the staples can be controlled to be between 4 mm and about 20 mm in certain embodiments. In other embodiments, the distance between the staples can be controlled to be between 5 mm and about 14 mm. In other embodiments, the distance between the staples can be controlled to be between 6 mm and about 12 mm.
In addition, this arrangement enables two or more staples to be placed without having to move the delivery platforms 160 between the staples 140 deployments. Instead, the delivery platforms 160 may be positioned and held in the desired position prior to providing a first staple 140. After the first staple 140 is deployed, the dispensing platforms 160 can be held in one position and the enclosure 136 can be retracted to expose and deploy a second staple 140, a third staple 140, or more.
The system 100 offers the further advantage of precise placement of multiple vascular prostheses after the catheter assembly 104 is placed in the patient. In particular after placement, the catheter unit 104 does not have to be withdrawn and exchanged for other catheters or catheter systems in order to be able to carry out further treatments. In this regard, the system 100 can be used for endovascular clips or staples, as well as stents and other vascular devices that are spaced apart in different treatment areas in the patient's body.
1. MINIMIZING MOVEMENT WITH A DISTAL ANCHOR
With certain endovascular prostheses, precise placement at a treatment site or area is important, for example when the prosthesis is relatively short, such as when it has an axial length to transverse width (e.g. diameter) ratio of 1 or less or if the placement is through a tortuous path (such as an arterial bend). Stabilization at a proximal end, such as armature 108, can provide reliable placement, but stabilization closer to the prosthesis can provide even better accuracy with respect to axial position and minimize tilt of the device within the vessel. In this context, inclination includes any non-perpendicularity of a transverse aspect of the device to the lumen in which it is provided. For staple 10 ', a transverse aspect may be defined by a plane that intersects the tall outer apices 24. A tilt in the case of relatively short prostheses can reduce the stability thereof. Tilting the staple 10 'can rotate the anchors 20 out of optimal alignment to hold plaque in place, thereby reducing their effectiveness, for example.
A. MINIMIZE MOVEMENT WITH AN ACTIVE EXPANDABLE DISTAL ANCHOR
FIG. 37A and 37B illustrate a delivery system 100A that is a variation of the delivery device 100, but has a distal portion thereof that is configured to stabilize the system in the vasculature so as to allow more accurate placement of two or more staples . In particular, the system 100A includes a stabilization device 250 which is arranged on an outer surface of the system, for example on an outer surface of an elongate body 132A. The stabilization device 250 can be adapted so that it anchors directly in a body lumen. In some embodiments, the stabilization device 250 is adapted to anchor in a plurality of locations located around the lumen, e.g. B. at discrete points or on a continuous perimeter or on a contact surface. Such anchoring can advantageously minimize movement of elongate body 132A relative to the body lumen when relative movement is provided between sheath 136 and elongate body 132A. For example, the stabilization device 250 may maximize radial centering during movement of the sheath 136, thereby advantageously controlling a gap between adjacent staples provided by the system 100A.
The stabilization device 250 can maximize radial centering during movement of the sheath 136 so as to locate the center of the elongated body 132 on the most distal delivery platform 160 within about 50% of the radius of the vessel in which the platform is located, thereby advantageously controlling the inclination of each staple provided by system 100A. In certain embodiments, the stabilization device 250 maintains the center of the elongate body 132 on the most distal delivery platform 160 within about 40% of the radius of the vessel in which the delivery platform is located. In another embodiment, the stabilization device 250 maintains the center of the elongated body 132 at the most distal platform 160 within about 30%, about 20%, or about 15% of the radius of the vessel in which the delivery platform is located. The radial displacement can include transverse movement within a body lumen or angling within a vascular segment. For example, due to the tortuosity or curvature of a blood vessel, the distal portion of system 100A may be a varying distance from the vessel wall along its distal length. In the side view, the elongated body 200 of the envelope 136 forms an angle with the central longitudinal axis of the vessel. Thus, one side of the elongated body 132A is closer to the vessel wall than the other, and the distance varies along the length of the staple 140. This may cause either of the proximal or distal ends of the staple 140 to snap into the vessel first, thereby causing the staple falls over in the vessel. The stabilization device 250 can bring a distal segment of the system 100A closer to being coaxial with the longitudinal axis of the vessel. For example, the stabilization device may be configured to maintain the longitudinal axis of the elongated body 132A within 20 degrees of the longitudinal axis of the vessel through at least 4 delivery platforms. In some embodiments, the stabilization device 250 can be configured to maintain the longitudinal axis of the elongated body 132A for at least at least 10 mm within 10 degrees of the longitudinal axis of the vessel. In some embodiments, the stabilization device 250 can be configured such that a transverse aspect of the staple 140 is within 10 degrees perpendicular to the longitudinal axis of the blood vessel.
The stabilization device 250 can be configured so that the axial displacement is reduced or minimized. The device 250 may decrease or minimize the movement of one or more delivery platforms 160 along the lumen of a vessel in which the platform is located so as to improve control over the delivery. The stabilization device 250 can maintain the axial position of a distally facing surface of an annular marker band 168 to within about 15%, 20%, 30%, 40%, or 50% of a delivery platform length. The delivery platform length can be parallel to the longitudinal
axis of the elongated body 132 between a distally facing surface of a proximal marker tape 168A, arranged at the proximal end of the delivery platform, and a proximally facing surface of a distal marker band 168B, arranged at the distal end of the same delivery platform. In some applications, the axial displacement is reduced or minimized for at least the second and subsequent staple (s) provided, for example to help maintain the spacing between the staples, as discussed elsewhere herein. The stabilization device 250 may also be configured so that any offset in the position of a first or subsequent staple that is provided is reduced or minimized compared to a planned implantation site. The planned implant site is the absolute position in a vessel that a clinician desires to place the staple, this may be based on visualization techniques such as fluoroscopy or some other surgical planning method.
The stabilization device 250 can include an inflatable balloon 254, which can take any suitable shape. For example, the balloon 254 may be cylindrical as shown in FIG. 37A-37B, or conical. One advantage of a conical shaped balloon is that the dilation function provided by the conical tip 172 can be performed by the leading edge of the conical balloon, thus these structures can be combined in some embodiments. Or if the anatomy is not cylindrical, an appropriately shaped balloon, such as a conical balloon, could be contoured to the shape of the anatomy to provide better apposition.
In the embodiment shown, a cylindrical balloon 254 is arranged proximal to the distal tip 172. The stabilization device 250 may be disposed between the distal end of the elongated body 132A and at least one of the delivery platforms 160. The balloon 254 is configured to minimize at least one axial or radial displacement of at least one of the delivery platforms 160 along a longitudinal axis of a blood vessel in which staples or other vascular prostheses are to be deployed or away from it.
The balloon 254 can be inflated by any suitable means, such as by the flow of an inflating agent through a lumen in the elongated body 132 from the proximal end thereof to an inflation port in the balloon 254. The elongated body 132 for the system 100A can be dual Lumen extrusion, one lumen being used for the guidewire and the other lumen being used to inflate the balloon 254. The inflation lumen may be connectable to a syringe or other negative pressure source at the proximal end of the elongated body 132 so as to provide the inflation agent. The balloon 254 has a flat configuration prior to inflation which allows it to rest on the elongate body 132 without interfering with the provision of the distal portion of system 100A. For example, the balloon 254 may be disposed within the envelope 136 (e.g., between an inner surface of the envelope 136 and the lumen 176) before it is inflated. In another embodiment, the balloon is positioned longitudinally between the envelope 136 and the tip 172. In this embodiment, it may be advantageous for the balloon to act as a tip with the distal end tapered to allow navigation in the vessel while the proximal end of the balloon is the same width (e.g., radius) as the envelope 136, so as to provide a smooth transition between the two so as to avoid any protrusion at the interface between the balloon and the distal end of the sheath 136.
The use of balloon 254 provides the clinician with the ability to first place and inflate the balloon distal to the lesion. After the balloon is then anchored in the wall of the vessel, the sheath 136 is pulled back and exposes one or more staples 140, allowing the staples to be released in previously defined separate locations. The separate locations are predefined since they match the previously made separations of the staples in the delivery system 100A.
An advantage of balloon 254 is the additional function that the balloon can be used for post-dilatation
the staples can be used after placement. In this case, after the staples have been placed in the vessel, the balloon 254 can be repositioned and re-inflated within a provided staple 140, the staple being anchored by outward pressure from the expanding balloon to improve the placement of the staple in the vessel wall .
Figure 38 illustrates one of several embodiments where a proximal control is provided to actuate a linkage to move one or more distal components of a delivery system, causing radial expansion for locking into a vessel wall. In particular, the system 100B includes a stabilization device 250A that is configured to actively expand from a flat configuration to an expanded configuration. The flat configuration is such that it is suitable for advancement through the vascular structure. The flat configuration allows the sheath 136 to be advanced over the stabilization device 250A without the sheath 136 having to be expanded radially.
The stabilization device 250A includes a stabilization element 270 that is disposed adjacent the distal end of an elongated body 132A. The elongated body 132B has a plurality of delivery platforms 160 proximal to the stabilizing member 270 and is similar to the elongated body 132 except as described below. In the illustrated embodiment, the stabilizing element 270 includes a plurality of elongated, axially arranged strips 274 that are separated by slots 278. The strips are sufficiently flexible that they can expand radially when compressive forces are applied to the proximal and distal ends thereof. The radial expansion of the strips 274 causes the outer surfaces thereof to anchor at circumferentially spaced apart locations in the wall of the lumen.
The stabilization device 250A also includes a link 282 and an actuation mechanism configured to apply a compressive force to the stabilization element 270 (shown by the arrows in FIG. 38). The link 282 can be a wire that has a distal end coupled to the tip 172 and a proximal end coupled to the actuation mechanism. The actuation mechanism can be incorporated into the delivery system 500 of FIG. 46, as discussed in greater detail below, or with any of the other delivery systems or devices described herein.
The connection 282 can be eliminated by providing a balloon or other actively expandable member within the stabilizing member 270 so that the operator can actuate the balloon to expand the elongated, axially disposed strips 274 into an anchorage with the vessel wall. The strips 274 preferably define gaps therebetween through which at least some blood can flow downstream from the stabilizing element 270. This can avoid ischemia in one procedure compared to other anchors that are more occlusive.
An imaging device 286, such as a radiopaque tape, may be positioned proximal to the stabilizing member 270, for example between the stabilizing member 270 and the most distal delivery platform 160, to indicate to the clinician that the stabilizing member 270 is distal to the lesion or treatment area.
B. MINIMIZE MOVEMENT WITH A PASSIVE EXPANDABLE DISTAL ANCHOR
Passive anchors can be used in addition or as an alternative to actively operated anchors to provide stabilization of a delivery system. Passive anchors may be disposed on an exterior surface of the delivery system so as to minimize at least one of the axial or radial displacements of at least one of the delivery platforms.
The structure of FIG. 38 can also be used in a distal anchor assembly for passive deployment. The stabilization element 270 can comprise a shape memory material, for example. In one embodiment, elongate, axially aligned strips 274 are formed from a shape memory material and configured to be in a radially enlarged state in the absence of circumferential restriction. This variation is provided adjacent or in a location that is in a restricted condition distal to a lesion or treatment area, such as wrapping 136 over elongated, axially aligned strip 274. The relative movement between wrapping 136 and the elongated Portion 132B exposes elongated, axially aligned strips 274 and allows the strips to return to their radially expanded configuration. This embodiment advantageously eliminates the need for connection 282.
FIG. 39-40 illustrate two passively deployed anchors that can be used in a delivery system 100C. The delivery system 100C is the same as the delivery system 100 with the exception of certain modifications to the elongate body 132. In particular, an elongate body 132 is provided on which a self-expanding member 300 is disposed. 39, the self-expanding member 300 includes a braid structure 304 having proximal and distal ends 308A, 308B connected to a portion of the elongated body 132C between the most distal delivery platform 160 and the distal tip 172. The braid structure 304 may be located within the Sheath 136 and provided by the imparting of relative movement between the sheath 136 and the elongate body 132C. The mesh structure 304 has an expanded width, in the absence of any circumferential restriction, that is greater than the size of the vessel in which the system 100C is to be provided. As a result, the passive expansion or self-expansion of the braid structure 304 creates an anchor in the vessel wall. Thereafter, one or more staples 140 can be provided in a precise and controlled manner.
The braid structure 304 has the further advantage of allowing blood to flow therethrough in order to maintain at least some perfusion of tissues downstream of the anchorage site. With regard to other more or fully occlusive anchorages herein, lumens can be provided as an alternative way of maintaining perfusion. For example, if a balloon is used to anchor a delivery system, a lumen may be provided through the balloon to perfuse the tissues downstream. For rapid procedures, perfusion may not be required.
FIG. 40 illustrates the self-expanding member 300 as one that includes a plurality of axially extending arms 320. Each arm 320 has a proximal end 324 coupled to elongated body 132D and a distal end 328. The elongated body 132D is shown without the tip 172, but the tip may be provided as in any of the embodiments above. Each of the arms 320 is configured to be supported by the sheath 136 in a flat configuration in which the distal end 328 of the arms 320 is adjacent the elongated body 132D and to extend radially away from the elongated body 132D when sheath 136 is positioned proximal to arms 320. In the expanded position or configuration as shown in FIG. 40, the distal ends of the arms are positioned such that apposition of a body lumen occurs. Any number of arms can be provided. The arms 320 function like a tripod to stabilize and position (e.g., center) the elongate body 132D distal to the delivery platforms 160.
FIG. Figure 41 illustrates another form of passive anchoring that involves improving the isolation of the delivery system 100 from friction that may result from anchoring the system in the vasculature. This friction increases markedly when the catheter unit 104 crosses any turns in the vasculature. One method of isolating the system 100 from friction is to provide a frictional insulating cover 340 that is disposed between the cover 136 and the vasculature. The travel
Exercise-isolating envelope 340 may take any suitable form, but is preferably configured to prevent frictional forces along the outer surface of envelope 136 from causing undesirable movement of elongate body 132 during setting of staples 140.
One method of isolating the sheath 136 from friction due to the curl is to configure the frictional insulating sheath 340 with a length sufficient to extend from the vascular access site A, such as a femoral artery, to the treatment area. FIG. 41 illustrates that the treatment area Z can run across the pelvic bifurcation B and in or distal to the iliac artery of the leg through which the vascular access was not established. In other words, the distal end 344 of the friction insulation wrap 340 is located beyond the bifurcation B or another turn T. Other treatment areas can be achieved using the friction isolation wrap 340. The length could be sufficient to extend distal to any additional bend below the iliac artery into the leg with or without the access. In other words, the distal end 344 of the frictional insulating wrap 340 is positioned beyond the arch or other turn. In some approaches, the frictional insulating cover could be configured with improved lubricity on an inner surface thereof. The improved lubricity would reduce the frictional forces below a threshold so as to eliminate undesirable movement of the elongate body 132 due to that friction.
2. STRUCTURES AND METHODS TO MAINTAIN THE SPACING
Staples and other vascular devices that benefit from maintaining a predetermined minimum spacing can be provided with the system 100, as discussed above. Once stabilized, for example using one of the methods described herein, a minimum spacing can for example be provided by a plurality of structures. For example, the delivery platforms 160 can help manage device spacing as needed. In some embodiments, the proximal marker bands 168 each protrude radially away from the elongated body 132 by an amount sufficient to present a distally oriented shoulder that can abut a staple 140 disposed on the delivery platform 160. The shoulder can act like a plunger and provide a holding or compressive force against a proximal aspect of the staple 140. This holding or compressing force may prevent proximal migration of the staple 140 as the sheath 136 is moved proximally relative to the elongated body 132.
FIG. 42 illustrates other embodiments in which there is provided a delivery system 400 adapted for providing a vascular prosthesis that includes a variety of discrete devices. The system 400 includes an elongated body 404, an elongated package 408, and an enclosure 412. The elongated body 404 includes a distal end 414, a proximal end (not shown), and a plunger 416 disposed adjacent the distal end 414. The elongated package 408 has a plurality of intravascular staples 140 coupled thereto. The staples 140 are arranged along the length of the elongated package 408.
The sheath 412 has a proximal end (not shown) and a distal end 420 and can be positioned in a first position in which the distal end 420 of the sheath 412 is distal to at least a portion of the elongated package 408. The first position may be one in which the entirety of the package 408 is disposed inside the enclosure 412. The distal end 424 of the package 408 can be arranged, for example, in and on or proximal to the distal end of the sheath 412. The sheath 412 can be positioned in a second position in which the distal end 420 of the sheath 412 is positioned proximal to the elongated package 408. The second position can be reached from the first position by a proximal movement of the envelope 412 in relation to the piston 416, by a distal movement of the piston 416 in relation to the envelope 412 or by the simultaneous proximal movement of the envelope 420 and distal movement of the piston 416 The piston is moved
or held stationary by applying a force to the proximal end of the elongated body 404.
The elongated package 408 is configured to maintain a minimum spacing between adjacent staples during deployment, for example during any type of movement, of components of the system 400 such as those described above. The elongated package 408 is also configured to allow expansion from a compressed configuration in which the elongated package 408 is received in the enclosure 412. In an expanded state, the elongated package 408 can anchor itself in a vessel wall.
In various embodiments, the elongated package 408 can be configured to release the staples to allow them to expand toward a vessel after deployment. The package 408 can be configured with an elongated cuff 428 and a drawstring 432. The pull cord 432 is preferably coupled to the cuff 428 such that the separation of the pull cord 432 from the cuff 428 enables the staples 140 to expand toward a vessel wall. FIG. 43 illustrates one embodiment of the cuff 428 that includes a weave structure 436 that can have a large weave angle. For example, weaving angles of at least about 110 degrees can be used. In this embodiment, the pull cord 432 may be configured as a severing cord or a plurality of severing cords. The pull cord 432 can be actuated to release the retaining force of the cuff 428. For example, in the woven embodiments, the pull cord 432 causes the cuff to separate so that the staples 140 are released.
The pull cord 432 would preferably have a proximal part which is coupled to an actuator at the proximal end of the corresponding provision device. The pull cord 432 could pass through a lumen (e.g., a dedicated lumen) in the delivery system and actuatable separately from a sheath or piston, if provided. The clinician would use this actuator to apply a force to the pull cord 432, which would separate the weave structure or otherwise provide the staples 140.
Another embodiment can be provided in which the pull cord is eliminated. For example, cuff 428 may include structure that weakens when immersed in blood so that it passively releases staples 140 shortly after deployment. The cuff 428 could comprise a bioabsorbable material or a non-reactive polymer that is left between the staples 140 and the vasculature. The entire structure provided, including the staples 140 and the cuff 428, could be configured to be absorbed into the vasculature in some forms of use and so gradually disappear into the patient. In other embodiments, the elongated package 408 may be coated with a drug elution, such as the bioabsorbable agent of the drawstring 432 and cuff 428, which are left with the staples for elution. As the drawstring 432 is absorbed, the remaining package 408 is pressed against the vessel wall by the expanding staples and remains there. In this alternative, the pull cord 432 may simply be a portion of the (or one or a plurality of threads of the) woven structure 436 and not an otherwise distinctive structure of the structure 436.
In one embodiment of FIG. 44, the elongated package 408 includes a plurality of staples 140 and a portion 440 that extends axially through a central portion of each of the staples. The member 440 is connected to each of the staples 140 to retain the staples in a flat configuration in which the staple can be disposed in the envelope 136. FIG. 44 shows a plurality of staples 140 after they have been separated from elongated portion 440 and after they have expanded into anchoring to the wall of vessel V. The elongate member 440 may be connected to the staples 140 in any suitable manner, such as by inserting one or a plurality of radially extending member 448. The portions 448 are configured to restrain the expansion of the staples 140 while the staples are in this sleeve.
ment 136 are arranged, but break after they have been provided therefrom. The breaking of the radial portions 448 can be achieved by any active mechanism such as cutting, untying, or pulling a pull cord, or by a passive mechanism such as erosion in the vasculature. After the radial portion 448 is separated from the staples 140, the staples can move from the portion 448 into a radially expanded configuration, creating a gap between the portions 448 and the staples 140.
The portion 440 can then be moved out of the enclosure 136 by allowing relative movement between the portion 404 and the enclosure 136. In the illustrated embodiment, the distal end of elongated portion 404 is connected to the proximal end of portion 440 and acts as a piston to force package 408 out of envelope 136. In other embodiments, elongated portion 404 has a distal end that is small enough that it can be inserted through staples 140 when the staples are in the low profile configuration. Elongated portion 404 may be coupled to the distal end of portion 440 of elongated package 408. In this arrangement, elongate member 404 functions at the distal end of package 408 rather than the proximal end, as in the embodiments of FIG. 42-43 shown.
[00256] In each of the embodiments of FIG. 42-44, a predefined and essentially fixed axial spacing is maintained between adjacent staples. Thus, the elongated package provides a device spacer which is capable of providing precise separation between the staples during placement. This provides benefits such as minimizing kinking of the vessel, excess metal, and other problems associated with placing the staples 140 and other vascular prostheses too closely together.
3. BALLOON EXPANSION
A balloon can also be used to provide a plurality of staples in a controlled manner so that they are properly spaced therebetween. FIG. 45 illustrates a delivery system balloon 490 to which a staple 140 is crimped. The illustrated portion of the staple 140 is one of a plurality of repeating segments having mirror image counterparts as described above, with other segments eliminated for clarity. The balloon 490 is used to provide and expand the staple 140 and can be referred to as a carrier balloon. The balloon 490 may be shaped or may include more than one plasticity that enables controlled inflation. The staple 140 and balloon 490 are transported to the repair site within an enclosure (not shown, but analogous to those discussed above). During deployment, the balloon 490 is expanded during or after it exits the distal end of the envelope. Expansion of balloon 490 expands staple 140. In one embodiment of this system, the balloon is used to provide staple 140, which may be non-self-expanding or partially self-expanding. For example, the balloon 490 can be expanded to a limit at which it ruptures a containment structure disposed between the staple 140 and an envelope. The breaking of the retaining structure allows the staple 140 to expand. The balloon 490 can fully expand the staple 140 (and, using the protrusions in the balloon 494, as discussed in more detail below, can raise portions of the staple for more effective anchoring), release the staple 140 to self-expand, or provide a combination of balloon and self-expansion .
Another method of controlled placement of a staple 140 is to expand the staple under radially outward pressure, such as by expanding a balloon. FIG. Figure 45 illustrates the balloon 490 in an expanded condition with a plaque staple 140 placed thereon. Although a single balloon is shown, in one embodiment a balloon is in each of the delivery platforms 160 of the delivery system 100
implemented. Balloon 490 can take any suitable configuration, but is preferably configured to rotate the anchors of staple 140 into plaque or other vascular abnormality to hold it against a vessel wall. For example, balloon 490 may include a radial protrusion region 494 disposed in an expandable region thereof. The radial protrusion region 494 is preferably configured so that the anchor 20 of the staple 140 (see the anchors 20 in FIG. 5C) rotates outside of a cylindrical plane containing proximal and distal portions of the staple.
The protrusion region 494 can have any suitable configuration, such as a plurality of discrete protrusions circumferentially around the balloon 490. The protrusions can be positioned so that they are under the anchors 20 of the staples 140, but not extend completely under the markers 22. The protrusions can be configured so that as the balloon 490 expands, the protrusions expand more so that the staple 140 can be deformed from a generally cylindrical deployment shape to an arrangement in which the bridges 14 rotate about an axis, which connects the endpoints of the bridges. The rotation tilts the anchors 20 away from the center of the blood vessel and into the plaque to be adhered.
In other embodiments, the protrusion region 494 can be a substantially continuous perimeter structure, such as a ridge, that extends completely around the balloon. In this arrangement, there is preferably a greater radial protrusion of the balloon when expanded at the location radially between the anchors 20 and the longitudinal axis of the balloon.
The protrusion region 494 is preferably at least about 0.05 mm high. In other words, the protrusion region 494 has a radially outermost tip or portion that is at least about 0.05 mm from the average surface of the balloon 490 when the balloon is expanded to the diameter of the vessel, in which the staple is to be placed. Or, if a plurality of protrusions are provided, a cylinder which intersects the tips of all protrusions is preferably about 0.05 mm radially larger than the average radius of the balloon. In other embodiments, the protrusion region 494 is between about 0.05 mm and about 0.4 mm high. While in other embodiments the protrusion region 494 is between about 0.07 mm and about 0.4 mm high. In still other embodiments, the protrusion region 494 is between about 0.1 mm and about 0.2 mm high. The balloon 490 may advantageously be coupled to a staple that is not self-expanding. Standard deformable stent materials such as stainless steel can be used. In some cases it may be advantageous to combine a balloon expansion stage with a self-expanding device. Thus, the balloon 490 can also be used in combination with self-expanding staples. The additional height of the protrusion region 494 may advantageously activate a function of a staple 140 (such as an anchor 20 or a bridge 14) to prevent the staple from slipping along the axis of the balloon. In a typical balloon, a length that is not surrounded by a prosthesis expands more than a length that is surrounded by a prosthesis, creating a "dog-bone" shape as it expands. A dog bone shaped balloon could involve undesirable movement of the staples attached to it. The protrusion area 494 can prevent this movement by anchoring the staple as described above. The balloon 490 can be configured to elute a drug that is beneficial for treatment, such as one that will help minimize restenosis or an inflammatory response.
A balloon 490 may also include a number of restrictions, such as restraint straps 492, that restrict expansion of the balloon to certain areas of the balloon, as shown in Figure 45A. For example, balloon 490 can be used with a series of non-self-expanding staples 140 which are attached along the length of balloon 490.
are ordered. Figure 45A illustrates a portion of this balloon. Because balloons have a tendency to expand from one end, the restraint straps can limit this type of expansion and focus expansion in any region that contains a staple 140. Segments 494 of the balloon that do not include a staple or restraint tape can be used to ensure proper spacing between the staples, and they can provide a barrier between successive staples as the balloon expands to its fully expanded position.
4. DEPLOYMENT SYSTEMS
As above in connection with the FIG. 4A, 32A, and 33A, a variety of tools and components may be provided for the proximal end of the delivery system 100. FIG. 46-48D illustrate further details of these and other embodiments of a delivery system 500 for the delivery system 100. The delivery system 500 preferably includes a housing 504 that can be held by the user and that includes a triggering device 508. The housing 504 is connected to the proximal end of the catheter assembly 104, for example it is connected to the elongated body 132 and sheath 136 (see FIG. 34) to initiate relative movement between these two components. In certain embodiments, it is preferred that the elongate body 132 be stationary and that the enclosure 136 be withdrawn to provide relative movement. But in other circumstances this can be reversed so that the elongate body 132 is set in motion with the envelope 136 stationary.
In one embodiment, the housing and trigger 504, 508 comprise a single deployment ratchet handle assembly that is manually operated. In this arrangement, each time the trigger 508 is activated, relative proximal movement of the enclosure 136 exposes a prosthesis (e.g., prosthesis 140). The trigger 508 would preferably be spring actuated so that it would spring back to the original position after actuation.
A. ELECTRONICALLY ASSISTED DEPLOYMENT DEVICES
As explained above, a plurality of indications are preferably treated with a plurality of discrete prostheses. In some treatments, the treatment site is remote from where the delivery system enters the vascular trunk or the body lumen system. Either condition can increase the amount of force required to operate the trigger 508. For such conditions and also to facilitate provision, the provision system may include a mechanical energy source 516 to generate a force required to provide relative movement of the enclosure 136 in relation to the elongate body 132. The energy source 516 can be configured to generate approximately the same force at the distal end of the system 100 to provide a staple 140 or to provide a plurality of staples 140. The power source 516 may be configured to generate a force that is constant over a stroke length that is more than twice the axial length of the staples disposed in system 100. In some embodiments, energy source 516 is configured to maintain approximately the same rate of relative movement (e.g., sheath retraction) at the location of a distally positioned staple and a proximally positioned staple.
[00266] The energy source 516 can include a variety of components and can deliver energy or power to the system. In one embodiment, the energy source 516 comprises, for example, a gas cylinder that provides controlled retraction of the enclosure over the required distance. The power source 516 could be external to the housing 504 as shown in FIG. 47 and include, for example, a liquid channel connected to an external gas tank. In one embodiment, the gas in housing 504 is contained in a small container that provides the required energy. In these embodiments, the system is not pressurized until the gas source is activated.
To retract the sheath 136 in relation to the elongated body 132 and
to initiate marker 168, a proximal piston 520 is coupled to sheath 136. The piston 520 is also disposed within the housing 504 to form part of an enclosed system that is in fluid communication with the gas from the energy source 516. The delivery device 500 is configured such that when a gas bolus is delivered in this enclosed space, the piston 520 moves proximally in the housing 504. The proximal movement creates a corresponding proximal movement of the sheath 136.
The power source 516 need not be limited to a gas cylinder. In another embodiment, a compression spring is provided which is adapted to generate a substantially constant force. The spring is preferably arranged to exert sufficient force over a longitudinal length sufficient to expose as many prostheses, such as staples 140, as desired for treatment. The distance or the stroke length can be between approximately 10 mm and approximately 200 mm (for example for a system which carries up to 20 staples or is actuated to provide them). In certain embodiments, the stroke length is between approximately 8 mm and approximately 80 mm (for example for a system which carries up to 10 staples or is actuated to provide them). In other embodiments, the stroke length is between approximately 7 mm and approximately 10 mm (for example for a system which carries 1 staple or is actuated to provide it). In one embodiment, the spring is tensioned prior to retraction of the enclosure 136. In another embodiment, the spring is tensioned (e.g., at the factory) prior to use by the clinician.
As explained in more detail below, it may be desirable to be able to select the number of devices that are to be provided. In such circumstances, the delivery system 500 can be configured to apply only a portion of the stroke of the spring. In choosing the number of staples to be provided, the handle would normally actuate the correct length of the spring and thus provide the adequate measure of force. As discussed in SECTION IV (A) (4) (b) below, a selector may be included which allows the clinician to provide a series of staples 140, e.g., a subset of the full number of staples on the delivery system that will be used at a particular Deployment event should be deployed.
By compressing the gas, a spring-like force can also be generated. A structure analogous to the piston 520 could, for example, be pushed and held distally within the handle and only released when the provision is to take place. The compressed gas would cause the plunger to be displaced proximally, along the envelope. This effect can be seen as a kind of springback.
Another spring arrangement that could be employed includes a bellows spring, which could be advantageous in structures where prolonged movement is required to retract the enclosure. In this arrangement, the energy source 516 is adapted in such a way that it acts via two points on the bellows spring. The source of energy could include a gas or a liquid under pressure acting at one end of the bellows to initiate movement of the bellows. While the energy spring is allowed to rebound, the distance the bellows retracts is a multiple of the distance traveled by the energy source spring. This system converts the high force of a spring into the low force of controlled retraction over long distances.
Another option would be to use a rotation spring that drives a lead screw. The spring could be preloaded and connected to a lead screw. The enclosure 136 would then be connected to a driver that moves as the lead screw rotates. This would allow the rotational movement provided by the spring to be converted into a proximal (linear) movement of the sheath with adequate strength by the lead screw.
B. SELECTOR FOR THE PROVISION OF MULTIPLE PROSTHESES [00273] An elongated treatment area, for example plaque or an elongated skin
valve can be treated with a variety of staples 140. With certain procedures, visualization or another surgical planning tool makes it possible to know the number of staples or prostheses required in order to be able to provide an adequate treatment. For these methods, the delivery system 500 may include a selector 532 to determine the number of prostheses or staples to be provided. In one form, the selector 532 may include indicia 534 on one or more elongated bodies 132 and the envelope 136. These markings can provide a visual indication of how many staples have been provided to the clinician holding handle 11F, armature 108, or housing 504. FIG. 32A indicates the markings 534 disposed on a proximal portion of the elongated body 132. The proximal movement of the sheath 136 causes an adapter 208 to pass each of a plurality of markings 534. Each time the adapter 208 passes a marker 534, a staple 140 is exposed and can be provided. Thus, the user can know how many staples 140 are provided by observing the movement of the adapter 208 across the markings 534.
FIG. 4A shows that the markings can also be placed on the handle 11F. In particular the handle 11F is provided with a series of markings 534 which indicate how far the casing 13 has already moved. Each time the actuator 11G passes a marking 534, another staple 140 is moved out of the envelope 13 and can be provided.
In certain embodiments, it is preferred that the selector 532 be configured to prevent conditions that would allow more than a selected number of staples 140 to be provided. In these embodiments, the selector 532 also includes a limiter 536 that prevents the provision of more than a preselected number of staples. FIG. 48A shows that the limiter 536, in one embodiment, includes a slidable stop 538 that may be disposed around a proximal portion of the elongated portion 132. A locking device, such as a thumb screw, is provided to immobilize the limiter 536 on the elongated portion 132. A viewing window 540 in the limiter 536 provides an indication of how many staples will be deployed when the envelope 136 is moved proximally into contact with the stop 538, how many remain in the system, or other useful indicators of the deployment status. In this case, when the limiter 536 is disposed on a proximal part of the elongated body 132, “1” is displayed. This tells the clinician that when the enclosure 136 contacts the stop 538, a staple will be provided.
FIG. 48B illustrates another variation in which the relative rotation of a proximal portion of the cuff 136 and a selector 560 associated with the housing 504 can enable the user to determine the number of prostheses (e.g., staples 140) that are provided should be selected. In one embodiment, the selector 560 includes a rod 564 that extends into the lumen formed in the sheath 136. The rod includes a pin or other radial protrusion 568 that extends outwardly into one of a plurality of notches 572 located on the interior surface of the enclosure 136. The notches include proximally aligned surfaces 576. Each counterclockwise notch 572, as shown in the figure, is progressively further from the proximal end of the sheath 136. Each progressively more distant notch 572 allows one further increment of axial movement of sheath 136 relative to pin 568. Each increment of axial movement corresponding to the amount of movement required at the distal end to release a delivery platform 160 and a corresponding staple 140 . By rotating the sheath 136 in relation to the pin from the position shown as indicated by arrow A, a greater number of staples can be provided in a single stroke. Relative rotation can be provided by coupling the rod 564 to a dial and indicator disposed on the exterior of the housing 504.
In a variation of the embodiment of FIG. 48B, the selector 560 can be used as a
be configured cuff which is disposed around the sheath 136. The sheath 136 can be modified to include an outwardly protruding pin similar to the pin 568, and the collar can be modified to have notches. In this arrangement, the structure in FIG. 48B, labeled "564", is a wrap, and the structure, labeled "136" is the sleeve that is placed around the wrap.
FIG. 48C illustrates a delivery system 600 packaged in a housing similar to that of FIG. 46 shown, can be arranged. The system includes both a mechanical energy source and a selector for selecting the number of staples to be provided. The system includes an actuator 604 coupled to an energy storage device 612 by a cable 608. The actuator 604 is mounted on a rigid body 606 that is also coupled to the elongated body 132. The energy storage device 612 may include a rotary spring that drives a lead screw. More specifically, the cable 608 is wrapped around a drum 610 which can rotate about the axis of a base screw 614. A spring is coupled to the reel 610 such that as the reel unwinds the cable 608, the spring becomes tensioned, and after the tension on the cable is released, the spring causes the reel to rotate back in the opposite direction and the cable thus rewinds onto the drum. The length of the cable 608 wound on the drum is equal to or greater than the linear distance from the distal end of the most distal delivery platform 160 to the proximal end of the most proximal delivery platform 160. The selector includes a plurality of stops 620 located proximal to the sheath 136 are. The stops can be activated or deactivated. A first stop 620A is closest to the distal end of the sheath 136 and allows the sheath to be moved an amount sufficient to provide only one staple 140. After the first staple is provided, the first stop 620A can be deactivated by pushing it into the rigid body 606 and a second stop 620B can be activated. The second stop enables the path of the envelope 136, a length sufficient to expose the second most distal dispensing platform 160 and the staple 140. After the second staple is provided, the second stop 620B can be deactivated by pushing it into the rigid body 606 and a third stop 620C can be activated. The third stop enables the path of the envelope 136, a length sufficient to expose the third most distal dispensing platform 160 and the staple 140. After the third staple is provided, the third stop 620C can be deactivated by pushing it into the rigid body 606 and a fourth stop 620D can be activated. The fourth stop enables the path of the envelope 136, a length sufficient to expose the fourth most distal delivery platform 160 and the staple 140. If more than four staples and platforms are provided, additional stops 620 may be provided. The energy stored in the energy storage device 612 has the effect that the actuator 604 is automatically returned to the initial position for further triggering.
FIG. Figure 48D illustrated another concept that could be used for a delivery sequence in which only one staple is delivered at a time. This arrangement corresponds to a locking mechanism. The delivery system includes a selector device 660 having a plurality of prongs 664 axially spaced along a rigid body 666. The prongs 664 provide a rigid stop structure. A movable part 668 coupled to a proximal portion of the enclosure 136 may be disposed between adjacent prongs 664, for example distal to prong 664 “2”, between prongs “2” and “3”, etc. The movable part 668 could be in front of the Provide a staple 140 proximal to, but adjacent to, prong "2". An actuator driven by an energy source could be triggered, after which the casing 136 and the movable part 668 coupled thereto slide proximally. The moving part 668 slides into contact with tine “3”. This provides a hard stop and can be helpful when using a relatively powerful power source. To provide additional staples, the movable member 668 would be moved sequentially to tines "4", "5" and "6".
5. SHUTTLE DEPLOYMENT DEVICE
A shuttle provision device 700, as shown in FIG. 49, may have one or more delivery platforms 160. The delivery platform 160 may include a marker tape 168 at one or both ends thereof, as discussed above. A set of rails, fingers, or prongs 702 can extend from one end of each marker tape 168. In the illustrated embodiment, there are 4 rails 702, although a greater or lesser number can be used. The rails 702 may extend distally from a proximal marker tape 168A. In other embodiments, the rails 702 extend proximally from a distal marker tape 168B. The proximal and distal marker bands 168A, 168B are shown in FIG. 36A and may be proximal and distal portions of a single band or of separate bands that are axially spaced apart. Only one set of rails 702 is also shown. It will be appreciated, however, that a set of rails 702 may be provided for each delivery platform 160 in other embodiments. The rails 702 can be in a compressed position, such as when in the enclosure 136, and an expanded position in which they are unrestrained. In the expanded position, the rails may be curved, flared, angled, or otherwise configured so that the shuttle 700 has a reduced dimension transverse to the longitudinal axis of the elongate portion 132 proximally along its length.
As sheath 136 is withdrawn, the rails move outwardly toward the vessel wall to the expanded position, as shown. This allows the catheter to be centered and a kind of ramp or gradual increase in diameter can be established to guide the positioning and expansion of the staple 140. As the staple 140 expands, it can slide down the rails into the intended position in the vessel wall. The radial expansion of the staple 140 is thus controlled because the struts are constrained by the radial rails to the degree of expansion. The staples 140 can be crimped around the rails 702, or they can be crimped with some rails inside the staple 140 and some rails around the rails.
The shuttle device 700 may be disposed at the distal end of the elongated body 132. As shown, the shuttle 700 has a plurality of gaps between the plurality of rails 702. These gaps can be used to aid in the proper positioning of the staple 140. For example, anchors, markers and / or other features of the staple 140 may protrude radially through the gap such that part of the staple is radially between the rails and the longitudinal axis of the elongated part and another part is in a radial position on the circumference between ( or beyond) adjacent rails. In this position, at least a portion of the rail can be viewed as being radially between a portion of the rail and the longitudinal axis of the elongate portion 132.
There are many advantages to this configuration, such as avoiding rotation and providing additional control over the placement of the staple 140 in the vasculature. The gaps can also allow anchoring positions of the staple anchors 20 in which a connection to the vasculature at the distal end of the shuttle device 700 or the splint 702 is established.
In some embodiments, the rails 702 of the shuttle are adapted for the closed position. At the same time, the staple 140 can be a self-expanding staple 10 that is adapted to move into its expanded configuration. When the self-expanding staple is loaded into the shuttle, these two opposing influences create a stored energy within the shuttle after the envelope is in its intended position and both are constrained to the appropriate position. The influence on the staple can be greater than the influence on the rails, in such a way that the tendency to collapse is slightly less than the energy of the staple to expand. Hence, after
With the sheath withdrawn from the delivery platform 160, the opposing forces cause controlled expansion as the staples exit the distal end of the delivery catheter. This can advantageously reduce or eliminate too rapid expansion of the staple 140 that can lead to unpredictable placement.
USING THE PLAQUE STAPLE AFTER A DRUG-ELUTING BALLOON ANGIOPLASTY
The use of plaque staplers can be combined with the use of drug aluting balloon (DEB) angioplasty for post-angioplasty dissection management and to eliminate the need for stents. In DEB angioplasty, a drug-eluting balloon or drug-coated balloon is prepared in a conventional manner. The medicament can be a biological active ingredient - or a combination thereof - which are used for a multitude of functions, such as, for example, anti-thrombotic, anti-mitotic, anti-proliferative, anti-inflammatory, healing-stimulating or for other functions. The DEB is deployed on a guidewire over a blockage or narrowing area in a blood vessel system. The DEB is inflated to a specified pressure and for a period of time consistent with manufacturer guidelines for treatment purposes as appropriate for the drug coating and intended results, then the DEB is deflated and removed. In this phase, the medication was transferred from the DEB to the wall of the blood vessel. Intravascular ultrasound imaging is then used to assess the integrity of the artery and the smoothness of the blood vessel surface at the site where the balloon was inflated. The presence of damage along the surface can manifest as dissection, a lifting of plaque, tearing of the tissue, an irregularity of the surface. The plaque staple is used to staple the damaged, torn, dissected, or irregular blood vessel surface. This enables a “stent-free” environment to be created even if the blood vessel has been damaged as a result of balloon angioplasty.
In this phase, the medication was transferred from the DEB to the wall of the blood vessel. Contrast agent is administered into the blood vessel under fluoroscopy or another method, such as intravascular ultrasound, is used to assess the integrity of the artery and the smoothness of the blood vessel surface where the balloon was inflated. In some cases, one or more final studies will demonstrate the presence of damage along the surface at the site of balloon inflation. This damage can include dissection, lifting of the plaque, tearing of the tissue, an irregularity of the surface.
The plaque staple delivery catheter is equipped with several staples that are placed at will of the user and can be advanced over a guide wire to the location of the blood vessel at which the dissection or the tearing or the irregularity has occurred. The site is specific and carefully selected using angiography. The plaque staple (s) is (are) provided at the site (s) of the lesion. More than one staple can be used to staple a larger dissection. If more than one staple is set, it may only be placed in accordance with the guidelines for proper spacing of the staples. I.e. the staple should be at least an axial length of the staple away. Once the staple is in place, it can be further expanded into the wall of the blood vessel using a standard angioplasty balloon or a drug-eluting or drug-coated balloon (either as a stand-alone device or integrated into the delivery system). The purpose of the staple is generally not to hold the blood vessel lumen open, but rather to staple the non-smooth or dissected surface of the blood vessel. This "patching strategy" allows the damage caused by the drug-eluting or drug-coated balloon to be repaired without resorting to stent placement, thereby creating a "stent-free" environment.
can be maintained.
As a further measure, as described above, the plaque stapling device itself can be used to deliver the medication into the blood vessel. In addition to providing the medication through the anchors, the staple can be coated with medication prior to the placement of the staple. The purpose of this action is to allow the staple to elute the biological agent or agents that are beneficial to the blood vessel.
One or more of the staples provided in accordance with the present invention may have been coated with a drug or otherwise carry a drug which is eluted at the deployment site over time. Any of a variety of therapeutically useful agents can be used including, but not limited to, agents for inhibiting restenosis, for inhibiting platelet aggregation, or for promoting endothelialization, for example. Some of the suitable agents may include smooth muscle cell proliferation inhibitors such as rapamycin, angiopeptin and monoclonal antibodies which may block smooth muscle cell proliferation, anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, acetylsalicylic acid, and Lipoxygenase inhibitors; Calcium entry blockers such as verapamil, diltiazem, and nifedipine; antineoplastic / antiproliferative / anti-mitotic agents such as paclitaxel, 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, cyclosporine, cisplatin, vinblastine, vincristine, colchicine, epothilone, endostatin, angiostatin, squaline kinase inhibitor and thymidine kinase inhibitor; L-arginine; antimicrobial agents such as astriclosan, cephalosporin, aminoglycosides and nitorfuirantoin; Anesthetics such as lidocaine, bupivacaine, and ropivacaine; Nitric oxide (NO) donors, such as lisidomine, molsidomine, NO protein adducts, NO polysaccharide adducts, polymer or oligomer NO adducts or chemical complexes; Anticoagulants, such as D-Phe-Pro-Arg-chloromethyl ketone, a mixture containing RGDPeptide, heparin, antithrombin mixtures, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet repeptor antibodies, enoxaparin, hirudin, warafin sodium, dicumarol , prostaglandin inhibitors, platelet inhibitors, and thick platelet function inhibitors; Interleukins, interferons and free radical scavengers; Vascular cell growth promoters such as growth factors, growth factor receptor antagonists, transcriptional activators, and translational promoters; Inhibitors of vascular cell growth, such as growth factor inhibitors (e.g. PDGF inhibitor - Trapidil), growth factor receptor angagonists, transcription repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, b consisting of an antibody and a cytotoxin; Tyrosine kinase inhibitors, chymase inhibitors, e.g. B. Tranilast, ACE inhibitors, e.g. B. enalapril, MMP inhibitors (e.g. llomastat, metastat), GP Ilb / Illa inhibitors (e.g. intergrilin, abciximab), seratonin antagonist and 5-HT reuptake inhibitors; Cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms. Polynucleotide sequences can also function as anti-restenosis agents, such as p15, p16, p18, p19, p21, p27, p53, p57, Rb, nFkB and E2F bait, thymidine kinase ("TK"), and combinations thereof and other agents which are helpful to prevent cell proliferation. The selection of an active agent can be made considering the clinical outcome desired and the nature of the condition and contraindications of a particular patient. With or without inclusion of a drug, any of the staples disclosed herein can be made from a biodegradable material. Various polymer carriers, bonding systems or other coatings to enable a controlled release of the active ingredient from the staple or its coating are well known in the art of coronary stents and are not set out again herein.
In summary, the plaque staple can be used for plaque retention after balloon angioplasty treatment for atherosclerotic disease, avoiding problems with stent deployment due to the introduction of a large mass of foreign material into the body, while this contribution
can lead to injury, inflammation and / or create sites of restenosis. In contrast to stents, the plaque stapling device minimizes material structure while installing only in one or more plaque dissection sites that need attention. The focal elevation elements on the staple periphery minimize the contact surface area of the plaque staple with the blood vessel walls and reduce the risk of causing plaque dissection or injury to the blood vessel walls. This approach enables clinicians to perform minimally invasive postangioplasty treatment and achieve a stent-like result without the use of a stent.
Although this invention has been disclosed in terms of certain preferred embodiments and examples, it will be apparent to those skilled in the art that the present invention extends to other alternative embodiments and / or applications of the invention and obvious modifications and equivalents beyond the specifically disclosed embodiments of which extends. In addition, it is conceivable that various aspects and features of the described invention can be carried out separately, combined with one another or replaced by one another, and that a large number of combinations and subcombinations of the features and aspects can be created which still fall within the scope of the invention. Therefore, it is intended that the scope of the present invention disclosed herein not be limited by the particular forms of the invention described and disclosed herein, but rather that it be determined solely through an adequate interpretation of the claims.
FURTHER EMBODIMENTS ARE DESCRIBED IN THE FOLLOWING IN ORDER TO FACILITATE UNDERSTANDING OF THE INVENTION.
A system for providing a vascular prosthesis comprising:
an elongated body comprising a proximal end, a distal end, and a plurality of delivery platforms disposed adjacent the distal end, each of the delivery platforms including a recess extending distally from a radial protrusion; a sheath having a proximal end, a distal end and an elongated body extending therebetween, the sheath in relation to the elongated body from a first position in which the distal end of the sheath is located distal to a most distal distal delivery platform in FIG move a second position in which the distal end of the sheath is positioned proximal to at least one delivery platform.
a plurality of intravascular staples, each intravascular staple being disposed about a respective delivery platform;
wherein the system is configured so that at least two staples are placed in a treatment area, in spaced locations so that a minimum gap is provided in the treatment area, between the distal end of a proximal staple and a proximal end of a distal staple, without the need for the delivery plates have to be moved.
2. System according to embodiment 1, further comprising a stabilization device, arranged on an outer surface of the system, configured so that at least one displacement - axially or radially - of at least one delivery platform along or away from a longitudinal axis of a blood vessel in which the staples are provided is minimized.
3. System according to embodiment 1, wherein the stabilization device is arranged between the distal end of the elongate body and at least one of the delivery platforms, the stabilization device being adapted to anchor directly in a plurality of locations which surround a Body lumens are arranged to minimize movement of the elongate body relative to the body lumen when providing relative movement between the enclosure and the elongate body.
4. The system of Embodiment 2, wherein the stabilization device comprises an expandable balloon having a cylindrical configuration.
5. The system of embodiment 2, wherein the stabilizing device is located at the distal end of the elongated body and comprises a conical balloon.
6. System according to embodiment 2, wherein the stabilization device comprises a self-expanding part.
7. The system of embodiment 6, wherein the self-expanding member includes a plurality of axially extending arms, each arm having a proximal end coupled to the elongated body and a distal end, each of the arms configured so is that it is held by the sheath in a flat configuration in which the distal end of the arms is contiguous with the elongated body, and in which it extends radially away from the elongated body when the sheath is positioned proximal to the arms, that the distal ends of the arms are positioned so that there is apposition of a body lumen.
8. The system of embodiment 6 wherein the self-expandable member comprises a braid structure configured to be supported by the sheath in a flat configuration and extending radially away from the elongated body when the sheath is proximal of the braid structure is arranged.
9. The system of embodiment 2, wherein the stabilizing device is configured so that it can be actively enlarged from a flat configuration to an expanded configuration.
10. The system of embodiment 8, wherein the flat configuration allows the envelope to be advanced over the stabilizing device without the envelope having to be expanded radially.
11. System according to embodiment 8, wherein the stabilization device comprises a stabilization element which is adapted accordingly to expand radially when compressive forces are exerted on the proximal and distal ends thereof.
12. The system of embodiment 1, wherein the system includes between 3 and 20 staples, which are arranged on respective delivery platforms.
13. The system of embodiment 1, wherein at least one of the delivery platforms includes an expandable member so as to expand a staple placed thereon.
14. The system of embodiment 13, wherein the expandable member includes a radial protrusion region configured to rotate, at least in the expanded state, a staple anchor outside of a cylindrical plane containing proximal and distal portions of the staple.
15. The system of embodiment 13, wherein the expandable member comprises a drug-eluting balloon.
16. The system of embodiment 1, wherein the enclosure is a first enclosure, and further comprising:
a second enclosure disposed around the first enclosure, the second enclosure configured to prevent frictional forces along the outer surface of the first enclosure from preventing undesirable movement of the elongate body during placement of the staples.
17. The system of embodiment 16, wherein the second sheath has a length sufficient to extend from a femoral artery of one leg of a patient via the aortic fork into at least the iliac artery of the patient's other leg and distal to any further bends to extend below the iliac artery in the other leg.
18. The system of embodiment 17, wherein the system has a pre-deployment configuration in which the first enclosure is fully inserted into the second enclosure, and wherein, in the pre-deployment configuration, at least one intravascular
Staple is disposed distal to the distal end of the second envelope.
19. The system of embodiment 16, wherein the second enclosure has improved lubricity on an inner surface thereof to reduce the frictional forces below a threshold so as to eliminate undesirable movement of the elongate body due to that friction.
20. The system of embodiment 1, wherein the stabilization device is configured so that it holds the axial position of a distally facing surface of a first annular marker band to within 50% of a length of a delivery platform, wherein the length of the delivery platform is parallel to the longitudinal axis of the elongated body between a distally facing surface of an annular marker band, arranged at the proximal end of the delivery platform, and a proximally facing surface of an annular marker band, arranged at the distal end of the delivery platform is measured.
21. The system of embodiment 1, wherein the stabilizing device is configured to maintain the position of a central longitudinal axis of the elongated body to within 50% of the radius of the blood vessel in axial positions corresponding to delivery platforms.
22. The system of embodiment 1, further comprising a hand release device connected to the proximal end of at least one option of the elongated body and sheath to cause retraction of the distal end of the sheath relative to the elongated body so as to cause expose the delivery platforms to enable staple delivery.
23. The system of embodiment 22, wherein the manual trigger includes a selector to determine an increment of movement of the envelope corresponding to a number of staples to be provided.
24. The system of embodiment 22, wherein the manual trigger includes a source of mechanical energy to generate a constant force to move the enclosure in relation to the elongate body.
25. The system of embodiment 1, further comprising one or more of an ultrasound or optical imaging device, an atherectomy device, a balloon angioplasty device, or a cryoplasty device.
26. System according to embodiment 1, further comprising a shuttle device arranged at the distal end of the elongated body, the shuttle device having a distal end which is configured so that it is anchored directly in the vasculature, a A plurality of rails extending proximally to the distal end and a plurality of gaps disposed between the rails, the gaps being configured to allow anchor portions of the staple anchors to connect to the vasculature at the distal end of the shuttle device; wherein the shuttle device is configured so that the staples slide distally along the rails as they expand gradually as the staples separate from the delivery system.
27. The system of embodiment 26, wherein the rails of the shuttle with stored energy are arranged so that the tendency to collapse is slightly less than the energy of the staples to expand, resulting in a controlled expansion when the staples reach the distal end of the delivery catheter.
28. A method of placing a variety of intravascular staples comprising:
Providing a catheter system including an elongated body having a plurality of spaced apart platforms disposed adjacent a distal portion of the elongated body, the position of the at least one of such delivery platforms being indicated by a marker tape, each platform having a plaque staple thereon has arranged.
Advancing the distal portion of the elongated body through a patient's vasculature until the marker tape is proximal or distal to an area to be treated with dissected plaque.
Visualize the marker tape to confirm the position of at least one of the delivery platforms in relation to the dissected plaque.
Withdrawing the outer wrapping while maintaining the position of the elongated body and then providing at least two of the staples to place the staples in a predetermined position and at predetermined spacings.
29. The method according to embodiment 28, further comprising stabilizing the elongate body by actuating a stabilizer, which is arranged at the distal end of the catheter before the provision of the staple (s).
30. The method of embodiment 29, wherein the stabilization includes maintaining the central longitudinal axis of the elongate body to be within 50% of the radius of the unconstrained expanded staple.
31. The method of embodiment 29, wherein the stabilization includes maintaining the axial position of the marker tape to within 50% of the length of the delivery platforms.
32. The method of Embodiment 29, wherein the stabilizer comprises a vascular anchoring device disposed distal to the most distal delivery platform, and wherein the stabilization further comprises anchoring the vascular anchoring device in the vasculature prior to deployment.
33. The method according to embodiment 32, further comprising separating the vascular anchoring device from the vascular system; positioning the vascular anchoring device within a provided staple; and expanding the vessel anchoring device to improve blood flow through the staple.
34. The method of embodiment 29, wherein at least one of the delivery platforms includes a balloon, and further comprises expanding the balloon to enlarge the staple placed thereon and fix the plaque to the lumen wall.
35. The method of embodiment 32, wherein the system further comprises an envelope disposed over the balloon and further comprises retracting the envelope relative to the balloon prior to expansion of the balloon.
36. The method of embodiment 29, wherein providing the staples includes retracting a sheath in a single pass a distance greater than a distance from a distal end of a distal delivery platform to the proximal end of a proximal delivery platform, the single pass provides at least two staples.
37. The method of embodiment 28, wherein providing the staple comprises retracting an enclosure by increments greater than twice a compressed length of a staple.
38. The method of embodiment 28, further comprising selecting an increment that corresponds to a number of staples to be provided, and withdrawing the envelope by the selected increment.
39. The method of embodiment 28, further comprising operating a selector to limit the providing step to no more than a selected number of staples over a treatment area length.
40. The method of embodiment 28, further comprising providing a frictional isolation enclosure between the outer enclosure and the vasculature prior to retraction of the outer enclosure so as to reduce inadvertent movement of the delivery platforms.
41. A system for providing a vascular prosthesis, comprising:
an elongated body including a distal end, a proximal end, and a piston disposed adjacent the distal end;
an elongated package having a plurality of intravascular staples coupled therewith, the staples being disposed along the length of the elongated package;
a sheath having a proximal end and a distal end, the sheath being movable in relation to the elongated body from a first position in which the distal end of the sheath is located distal to at least a portion of the elongated package to a second position in which the distal end of the sheath is positioned proximal to the elongated package; and
wherein the elongated package is configured so that it maintains a minimum distance between the adjacent staples during deployment and that it allows expansion and separation from the elongate body, the elongated package is configured to release the staples to allow them after Provision can expand in the direction of a vessel.
42. The system of embodiment 41, wherein the elongate package includes a portion that extends axially through a central portion of the staples, the portion being coupled to each of the staples to constrain the staples in a flat configuration.
43. The system according to embodiment 41, wherein the elongated package comprises an elongated cuff and a pull cord, the pull cord being coupled to the cuff so that the staples can expand in the direction of a vessel wall by separating the pull cord from the cuff .
44. The system of embodiment 43, wherein the cuff comprises a woven structure.
45. The system of embodiment 43, wherein the elongate package comprises a bioabsorbable material or a non-reactive polymer that is left between the system and the vasculature, whereby the staples can be absorbed into the vasculature.
46. System according to embodiment 43, wherein the radial protrusion comprises an annular marker band.

权利要求:
Claims (1)
[1]
Expectations
A catheter delivery system comprising: an elongated body (11A, 132) and a catheter sheath (13, 136); a plurality of independent self-expanding vascular prostheses (140) disposed on the elongate body (11A, 132) and spaced apart by a plurality of shoulders, each independent self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) a plurality of struts (26, 27, 28, 29) and a radiopaque marker (22) which has a flat shape with a planar outer surface which is tangential to a cylinder which extends through an outer surface of the independently self-expanding vascular prosthesis (140) extends; a proximal handle (11F) having an actuator (11G) coupled to a proximal end of the catheter sheath (13, 136), the actuator (11G) being movably configured to retract the catheter sheath (13, 136) and the plurality independently to expose self-expanding vascular prostheses (140).
The catheter delivery system of claim 1, wherein at least a portion of each independently self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) has an inclined orientation relative to a longitudinal axis of the independently self-expanding vascular prosthesis (140).
3. The catheter delivery system of claim 1, wherein the radiopaque marker (22) is coupled to an eyelet.
The catheter delivery system of claim 1, wherein each independently self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) has an axial length and an expanded diameter, the expanded diameter being a final diameter in unconstrained expansion.
The catheter delivery system of claim 1, wherein the elongated body (11A, 132) further includes a plurality of recesses for storing the plurality of independently self-expanding vascular prostheses (140).
The catheter delivery system of claim 4, wherein each independently self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) has an axial length to expanded diameter ratio that is no greater than about 2.
7. Catheter delivery system, comprising:
an elongated body (11A, 132) and a catheter sheath (13, 136);
a plurality of independently self-expanding vascular prostheses (140) disposed on the elongate body (11A, 132) and spaced from one another by a plurality of shoulders, each independently self-expanding vascular prosthesis (140) being one of the plurality of independently self-expanding vascular prostheses (140) A plurality of struts (26, 27, 28, 29) and a radiopaque marker (22), each independently self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) having a ratio of one axial length to one expanded Has a diameter no greater than about 2 and at least a portion of each independently self-expanding vascular prosthesis (140) of the plurality of independently self-expanding vascular prostheses (140) has an inclined orientation relative to a longitudinal axis of the vascular prosthesis;
a proximal handle (11F) with an actuator (11G) coupled to a proximal end of the catheter sheath (13, 136), the actuator (11G) being configured to be movable around the
10.
11.
12.
13. 14. 15. 16.
17th
Austrian AT 16 877 U1 2020-11-15
withdrawing the theter wrapping (13, 136) and exposing the plurality of independently self-expanding vascular prostheses (140).
The catheter delivery system of claim 7, wherein the radiopaque marker (22) has a flat shape with a planar outer surface tangential to a cylinder extending through an outer surface of the independently self-expanding vascular prosthesis (140).
The catheter delivery system of claim 7, wherein the radiopaque marker (22) is coupled to an eyelet.
The catheter delivery system of claim 7, wherein the expanded diameter is a final diameter in unconstrained expansion.
The catheter delivery system of claim 7, wherein the elongated body (11A, 132) further includes a plurality of recesses for storing the plurality of independently self-expanding vascular prostheses (140).
A system for providing a vascular prosthesis, comprising:
an elongated body (11A, 132) having a proximal end (152), a distal end (156), and a plurality of delivery platforms (160) disposed adjacent the distal end, each delivery platform (160) being selected from the plurality of delivery platforms (160) is separated from each other of the plurality of delivery platforms (160) by a distance between 2mm and 20mm;
a sheath (13, 136) having a proximal end (192), a distal end (198) and an elongated sheath body (200) extending therebetween, the sheath (13, 136) being movable relative to the elongated body ( 11A, 132) from a first position in which the distal end of the sheath (13, 136) is located distal from a most distal delivery platform (160) to a second position in which the distal end of the sheath (13, 136) located proximally of at least one delivery platform (160);
a plurality of self-expanding vascular prostheses (140), each vascular prosthesis (140) of the plurality of self-expanding vascular prostheses (140) having a plurality of struts (26, 27, 28, 29) which form a plurality of cells and wherein each vascular prosthesis (140) from the plurality of self-expanding vascular prostheses (140) is arranged on a separate delivery platform (160), the system being configured around at least two vascular prostheses (140) from the plurality of self-expanding vascular prostheses (140) sequentially provided at a treatment zone, at spaced apart locations such that a gap is provided between the distal end of a proximal vascular prosthesis (140) and a proximal end of a distal vascular prosthesis (140), each self-expanding vascular prosthesis (140) from the plurality of self-expanding vascular prostheses (140) one eye and one x-ray tight marker (22) which is arranged in the eyelet.
The system of claim 12, wherein the radiopaque marker (22) in the eyelet is planar or flat in shape.
The system of any one of claims 12-13, wherein the radiopaque marker (22) is press-fit or riveted into the eyelet.
The system of any of claims 12-13, wherein the radiopaque marker (22) comprises platinum and / or tantalum.
The system of any of claims 12-15, wherein the eyelet is located on an edge of the self-expanding vascular prosthesis (140).
The system of any one of claims 12-16, wherein the loop is located on a centerline of the self-expanding vascular prosthesis (140).
The system of any one of claims 12-17, further comprising a handle (11F) and an actuator (11G), the actuator (11G) coupled to a proximal end of the enclosure (13, 136) and configured to that actuation of the actuator (11G) causes a proximal movement of the sheath (13, 136).
The system of claim 18, further comprising markings on the handle (11F) to indicate the number of self-expanding vascular prostheses (140) that have been deployed.
The system of any of claims 12-19, further comprising at least one annular marker band (168) configured to enable visualization and delivery of at least a portion of the system to a planned implant site.
The system of any one of claims 12-20, further comprising a marker tape (168) between each delivery platform (160) of the plurality of delivery platforms (160) and each other delivery platform (160) of the plurality of delivery platforms (160).
The system of any of claims 12-21, wherein each delivery platform (160) includes at least one marker tape (168), the at least one marker tape (168) being frusto-conical in both directions.
The system of any one of claims 12-22, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) is 15mm or less in length.
The system of claim 23, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) is spaced from the self-expanding vascular prosthesis (140) in the next delivery platform (160) by at least 2mm.
The system of claim 23, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) is spaced from the self-expanding vascular prosthesis (140) in the next delivery platform (160) by at least 4mm.
26. The system of any of claims 12-25, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) is 8mm or less in length and the self-expanding vascular prosthesis (140) in the next delivery platform (160) is spaced apart by at least 4mm.
27. The system of any of claims 12-26, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) has an expanded diameter of 1 to 10 mm.
The system of any one of claims 12-27, wherein each of the self-expanding vascular prostheses (140) of the plurality of self-expanding vascular prostheses (140) has an expanded diameter of 4.5 to 6.5 mm.
29. The system of any of claims 12-28, wherein the plurality of struts (26, 27, 28, 29) form a plurality of closed cells.
30. The system of any of claims 12-28, wherein the plurality of struts (26, 27, 28, 29) form a plurality of open cells.
The system of any one of claims 12-30, wherein each of the plurality of delivery platforms (160) has a recess in the elongate body (11A, 132) for each delivery platform (160).
32. The system of any one of claims 12-30, wherein each of the plurality of delivery platforms (160) is defined at a distal end by a distal shoulder and at a proximal end by a proximal shoulder.
33. The system of any of claims 12-31, wherein the system comprises at least one of a 4 French (Fr) device, a 6 French (Fr) device, and an 8 French (Fr) device.
34. The system of any of claims 12-33, wherein the plurality of self-expanding vascular prostheses (140) comprises between 2 and 20 self-expanding vascular prostheses (140).
The system of any of claims 12-34, wherein each delivery platform (160) of the plurality of delivery platforms (160) is separated from every other delivery platform (160) of the plurality of delivery platforms (160) by a distance of between 4mm-20mm .
The system of any of claims 12-35, wherein each delivery platform (160) of the plurality of delivery platforms (160) is separated from every other delivery platform (160) of the plurality of delivery platforms (160) by a distance of between 5mm-14mm .
The system of any of claims 12-36, wherein the enclosure (13, 136) further comprises a marker strip (168) configured to enable visualization of at least a portion of the system during use.
38. The system of claim 37, wherein the marker strip is arranged at the distal end of the sheath (13, 136).
39. The system of claim 37, wherein the marker strip is configured to be aligned with the radiopaque marker (22) of each self-expanding vascular prosthesis (140) of the plurality of self-expanding vascular prostheses (140) prior to placement of each self-expanding vascular prosthesis (140) of the plurality of self-expanding vascular prostheses (140).
For this purpose 47 sheets of drawings

类似技术:

---

公开号 | 公开日 | 专利标题

---

AT16877U1|2020-11-15|Device for the use of multiple intraluminal surgical clips

---

JP6966378B2|2021-11-17|Intracavitary device

---

US10660771B2|2020-05-26|Deployment device for placement of multiple intraluminal surgical staples

---

AU2019204664B2|2021-02-18|Deployment device for placement of multiple intraluminal surgical staples

---

US9603730B2|2017-03-28|Endoluminal device and method

---

US20190192319A1|2019-06-27|Endoluminal device and method

---

US10285831B2|2019-05-14|Endovascular implant

---

AU2014201067B2|2014-10-02|Deployment device for placement of multiple intraluminal surgical staples

---

AT15630U1|2018-03-15|Device for using multiple intraluminal surgical clips

同族专利:

---

公开号 | 公开日

---

AU2011274392B2|2013-11-28|

---

CN106473849A|2017-03-08|

---

EP2590602A4|2014-07-23|

---

ES2564938T3|2016-03-30|

---

AU2011274392A1|2013-02-07|

---

EP2590602A2|2013-05-15|

---

EP3058900B1|2018-12-12|

---

DE202011110818U1|2016-09-15|

---

HK1223257A1|2017-07-28|

---

CN106466205A|2017-03-01|

---

CN103313682A|2013-09-18|

---

EP3871638A1|2021-09-01|

---

EP2590602B1|2015-12-09|

---

WO2012006602A9|2012-05-18|

---

EP3015078A1|2016-05-04|

---

CN106466205B|2020-12-29|

---

EP3508177B1|2020-12-30|

---

CA3108227A1|2012-01-12|

---

ES2707987T3|2019-04-08|

---

CA2804621C|2020-03-24|

---

CA3069319C|2021-05-04|

---

WO2012006602A2|2012-01-12|

---

CN110934675A|2020-03-31|

---

ES2715531T3|2019-06-04|

---

CN106473849B|2020-01-03|

---

EP3508177A1|2019-07-10|

---

EP3015078B1|2018-10-24|

---

EP3058900A1|2016-08-24|

---

CA2804621A1|2012-01-12|

---

DE202011110714U1|2015-12-15|

---

WO2012006602A3|2012-04-05|

---

DK3058900T3|2019-03-25|

---

CN106473786A|2017-03-08|

---

CN103313682B|2016-08-31|

---

CA3069319A1|2012-01-12|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

EP0714640A1|1994-11-28|1996-06-05|Advanced Cardiovascular Systems, Inc.|System and method for delivering multiple stents|

---

WO1996037167A1|1995-05-25|1996-11-28|Raychem Corporation|Stent assembly|

---

US6129754A|1997-12-11|2000-10-10|Uni-Cath Inc.|Stent for vessel with branch|

---

US20050288763A1|2004-06-28|2005-12-29|Xtent, Inc.|Custom-length self-expanding stent delivery systems with stent bumpers|

---

US20080132989A1|2004-06-28|2008-06-05|Xtent, Inc.|Devices and methods for controlling expandable prostheses during deployment|

---

WO2006026371A1|2004-08-27|2006-03-09|Cook Incorporated|Placement of multiple intraluminal medical devices within a body vessel|

---

EP1894545A1|2006-08-28|2008-03-05|Cordis Corporation|Multiple in vivo implant delivery device|

---

US20100137966A1|2008-12-01|2010-06-03|Cook Incorporated|System and method for sequentially deploying two or more implantable medical devices|

---

AU739203B2|1991-10-25|2001-10-04|Cook Medical Technologies Llc|A device for grafting a prosthesis|

---

US5702419A|1994-09-21|1997-12-30|Wake Forest University|Expandable, intraluminal stents|

---

US6193745B1|1995-10-03|2001-02-27|Medtronic, Inc.|Modular intraluminal prosteheses construction and methods|

---

US5824037A|1995-10-03|1998-10-20|Medtronic, Inc.|Modular intraluminal prostheses construction and methods|

---

US7491232B2|1998-09-18|2009-02-17|Aptus Endosystems, Inc.|Catheter-based fastener implantation apparatus and methods with implantation force resolution|

---

US6245101B1|1999-05-03|2001-06-12|William J. Drasler|Intravascular hinge stent|

---

US6517573B1|2000-04-11|2003-02-11|Endovascular Technologies, Inc.|Hook for attaching to a corporeal lumen and method of manufacturing|

---

ES2365208T3|2000-07-24|2011-09-26|Jeffrey Grayzel|CATHETER WITH RIGIDIZED BALLOON FOR DILATATION AND IMPLEMENTATION OF ENDOVASCULAR PROSTHESIS.|

---

EP1258230A3|2001-03-29|2003-12-10|CardioSafe Ltd|Balloon catheter device|

---

US7309350B2|2001-12-03|2007-12-18|Xtent, Inc.|Apparatus and methods for deployment of vascular prostheses|

---

US20030135266A1|2001-12-03|2003-07-17|Xtent, Inc.|Apparatus and methods for delivery of multiple distributed stents|

---

US20080264102A1|2004-02-23|2008-10-30|Bolton Medical, Inc.|Sheath Capture Device for Stent Graft Delivery System and Method for Operating Same|

---

US20050246008A1|2004-04-30|2005-11-03|Novostent Corporation|Delivery system for vascular prostheses and methods of use|

---

US20060111769A1|2004-11-23|2006-05-25|Medtronic Vascular, Inc.|Bi-axial oriented sheath|

---

CN101102728B|2005-01-10|2011-06-22|曲利姆医疗股份有限公司|Stand with self-deployable portion|

---

US20070156223A1|2005-12-30|2007-07-05|Dennis Vaughan|Stent delivery system with improved delivery force distribution|

---

CA2646885A1|2006-03-20|2007-09-27|Xtent, Inc.|Apparatus and methods for deployment of linked prosthetic segments|

---

WO2007112064A2|2006-03-24|2007-10-04|Prescient Medical Inc|Conformable vascular prosthesis delivery system|

---

EP2037848A1|2006-07-07|2009-03-25|Boston Scientific Limited|Endoprosthesis delivery system with stent holder|

---

US20080255653A1|2007-04-13|2008-10-16|Medtronic Vascular, Inc.|Multiple Stent Delivery System and Method|

---

US8540760B2|2007-07-11|2013-09-24|Cook Medical Technologies Llc|Tubular devices having reversible components for deployment of endoluminal occluders and related methods and systems|

---

US7896911B2|2007-12-12|2011-03-01|Innovasc Llc|Device and method for tacking plaque to blood vessel wall|US8128677B2|2007-12-12|2012-03-06|Intact Vascular LLC|Device and method for tacking plaque to a blood vessel wall|

---

US9603730B2|2007-12-12|2017-03-28|Intact Vascular, Inc.|Endoluminal device and method|

---

US10166127B2|2007-12-12|2019-01-01|Intact Vascular, Inc.|Endoluminal device and method|

---

US9375327B2|2007-12-12|2016-06-28|Intact Vascular, Inc.|Endovascular implant|

---

US10390977B2|2011-06-03|2019-08-27|Intact Vascular, Inc.|Endovascular implant|

---

US10022250B2|2007-12-12|2018-07-17|Intact Vascular, Inc.|Deployment device for placement of multiple intraluminal surgical staples|

---

US7896911B2|2007-12-12|2011-03-01|Innovasc Llc|Device and method for tacking plaque to blood vessel wall|

---

CN107157632B|2012-01-25|2021-05-25|因特脉管有限公司|Endoluminal device and method|

---

US10993824B2|2016-01-01|2021-05-04|Intact Vascular, Inc.|Delivery device and method of delivery|

---

US9375336B1|2015-01-29|2016-06-28|Intact Vascular, Inc.|Delivery device and method of delivery|

---

US9433520B2|2015-01-29|2016-09-06|Intact Vascular, Inc.|Delivery device and method of delivery|

---

CN106446360B|2016-09-08|2019-07-09|天津大学|Defects with skull scaffold for vascular tissue engineering parameterization design method based on Micro-CT scanning measurement|

---

WO2018059219A1|2016-09-30|2018-04-05|苏州茵络医疗器械有限公司|Stent for implantation into blood vessel|

---

CN106618819B|2017-01-11|2021-07-30|南华大学|Blood vessel stent and stent component|

---

CN108763818A|2018-06-12|2018-11-06|大连大学|A kind of bone structure prediction technique suitable for period dynamic loading|

---

CN109215023B|2018-09-17|2021-11-05|青岛海信医疗设备股份有限公司|Method and device for determining contact area between organ and tumor|

---

EP3941392A1|2019-03-20|2022-01-26|Inqb8 Medical Technologies, LLC|Aortic dissection implant|

---

CN110464519A|2019-08-30|2019-11-19|乐普（北京）医疗器械股份有限公司|A kind of balloon-stent|

---

CN112603497A|2020-12-23|2021-04-06|蚌埠冠硕医疗科技有限公司|Be used for arteria femoralis antegrade to intervene puncture utensil|

法律状态:
2021-09-15| MK07| Expiry|Effective date: 20210731 |

优先权:

---

申请号 | 申请日 | 专利标题

---

US36265010P| true| 2010-07-08|2010-07-08|

---

US13/118,388|US20110230954A1|2009-06-11|2011-05-28|Stent device having focal elevating elements for minimal surface area contact with lumen walls|

---

US13/153,257|US9375327B2|2007-12-12|2011-06-03|Endovascular implant|

---