MEDICAL ASSEMBLY TO MINIMALLY INVASIVELY IMPLEMENT AN ATRIAL SEALING SKIRT IN THE HEART

专利摘要:
a medical set that implants an atrial seal skirt into the heart at an atrial seal skirt placement site and related methods of implantation and delivery. an anchor is introduced endovascularly into the heart and implanted into a heart wall with an anchor delivery system and delivery cable. a second delivery system introduces a tether that attaches to the implanted anchor and an atrial seal skirt. the atrial seal skirt includes a top edge that is positioned to conform to the atrial floor at the placement site. the sealing skirt can be integrated into a valve or serve as a receptacle.
公开号:BR112019020864B1
申请号:R112019020864-0
申请日:2018-04-04
公开日:2021-09-08
发明作者:Vivek Rajagopal；Jaime Eduardo Sarabia；Yenchin Liao
申请人:Opus Medical Therapies, LLC；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[001] The present invention generally relates to medical devices and systems that are minimally invasively implanted in the heart and methods of implanting such devices and systems. More specifically, the invention relates to medical devices and systems that are minimally invasively implanted into any wall of the heart, using one or more anchors that tie transcatheter valves or other cardiac devices within the heart. The invention also relates to an atrial shroud that seals transcatheter valves to reduce paravalvular regurgitation, with or without the presence of intracardiac leads. BACKGROUND OF THE INVENTION
[002] Transcatheter valves are proven to be safe and effective for replacing native heart valves. These valves have been extensively tested for replacement of aortic, mitral and pulmonary valves, but replacement of tricuspid valves remains a challenge given the complex and delicate anatomy to which the prostheses must connect. Anchoring of transcatheter valves in general, or transcatheter tricuspid valves in particular, remains difficult due to the fact that, in the in situ position of heart valves, or in other body lumens, this requires interaction with a wide variety of shapes and heart valve ring sizes or other lumens. In this sense, the ability to tie the transcatheter valves with one or more anchors affixed to the intracardiac wall(s) would provide greater security and flexibility for the transcatheter prosthesis, reducing the need for fixation in the exact location of the prosthesis. This would be particularly advantageous for anchoring a transcatheter tricuspid valve prosthesis.
[003] Several groups have described intracardiac tethers and anchors, but these systems have limitations in their applications. For example, Vidlund (1) and Lutter (2) describe a prosthetic valve anchorage system using a single sling that connects the distal end valves to an "epicardial sling attachment device" (Vidlund's patent), which could be also described as an anchor. Because the fixation device is located outside the apex of the heart (epicardial), this system requires access to the apex of the heart through the chest wall. The need to access the heart through the chest may increase the risk of the procedure in patients with an impaired pumping function (ejection fraction), or in patients with fragile tissue, particularly in applications involving the tricuspid valve.
[004] In contrast, Rowe and colleagues (3) describe a coaptation device for tricuspid regurgitation that is anchored to the right ventricular apex using an endovascular approach without the need to access the heart through the chest wall. Rowe states: "A flexible anchor rail connects to the anchor and a coaptation element in a catheter passes over the anchor rail. Finally, there is a proximal anchor feature to secure the proximal end of the coaptation catheter subcutaneously adjacent to the vein subclavian." The first limitation of this application is the inability to retrieve and reposition the anchor in case of a wrong location or sub-optimal implementation. The next limitation is that the anchor rail is fixed to the anchor. In return for this, it should be advantageous to be able to deploy the anchor first, followed by the delivery of a rope or hawser of varying diameter or material that locks onto the anchor. By making the lanyard independent of the anchor, multiple permutations of lanyard/anchor elements can be easily implemented, maximizing the ability to customize the application depending on the specific clinical need. Finally, this application describes a fixed connection between the anchor, distal anchor rail, coaptation device and proximal anchor rail, which requires a large amount of anchor rail to remain in the superior vena cava and innominate/subclavian veins. The proximal anchor rail is connected to a subcutaneous pocket, all of which carry risks from permanent venous loads, specifically thrombosis, infection, and venous stenosis.
[005] Solem and his collaborators (4) circumvent some of these limitations with their application, which describes the possibility of a two-stage process, whereby the anchor can be implemented first, followed by the connection of an "elongated body portion" to the anchor, with the elongated body portion connecting to the tethers and the blood flow control device. Having a two-stage process can be useful "for situations where a user wants to replace a bonnet or other portion of the device...if...the expandable valve portion is not the ideal size or is not at an optimal distance from the device. anchor". The anchor can consist of "arms or hooks that expand outward as the anchor portion...is exposed". The elongated body can connect to the anchor through multiple mechanisms, including "quick-connect or push-on type connections". In one embodiment, the elongated body may have a "ring-like structure...configured to advance around...the generally tubular anchor projection". To facilitate connection, the "proximal end anchor...includes a coupling member...in the form of a generally tubular projection...which has outwardly extending locking clips...that can be bent inwardly in response to the inward pressure...but it will pop out once the inward pressure is released".
[006] Despite some of the advantages of applying Solem, this application also suffers from limitations. First, the preferred method of anchor delivery is to advance the anchor delivery catheter through a chest wall incision, then into an incision through one of the heart's chambers. It would be even more desirable to be able to deliver the anchor via a true endovascular approach (eg, via the femoral and internal jugular veins) without the need for cardiac cavity and thoracic incisions. Next, the anchor consists of expandable hooks or arms that dig into the heart wall, then flex backwards, analogous to hooks. Solem states that the expandable anchor hooks can be retrieved: "As the anchor portion...is pulled back into the distal end sheath...pressure into the tongues...from the sheath of distal end... will cause the tongues... of the anchor portion... to collapse inwards... thereby causing the anchor portion... to return to its delivery condition (this is, pre-implemented)..." However, it is doubtful the fact that the back-folding tabs that wrap around the fabric can be easily retrieved so that it does not damage the fabric in the process and a more securely retrievable anchor is desired. Also, the tabs can be secured in one location in the heart, but can cause damage (ie, puncture) if they need to be moved to a different location, due to the fact that the arm length is not adjustable. Therefore, the ability to change anchor tissue depth (eg, the interventricular septum can tolerate greater depth compared to the free ventricular wall) is desirable. Next, the connection of the elongated member to the anchor, even if through a separate step, is fixed so that the elongated member can rotate about the geometric axis of the anchor. When fitting a transcatheter valve in the elongated limb, it may be necessary to rotate the valve to fit the native cardiac ring, and Solem's elongated limb, once attached to the anchor, cannot rotate. Finally, the Solem application requires the lanyards to be connected to the anchor through the elongated member. It would be particularly advantageous to be able to connect the lanyards directly to the anchor, with the ability for the lanyards to rotate around the geometric axis of the anchor, due to the fact that this could more closely mimic the function of tendinous cords (the natural cords of the heart) , which connect directly from the heart walls to the heart valves.
[007] Furthermore, the limitation of paravalvular regurgitation of tricuspid valves and mitral transcatheter is challenging due to the fact that the mitral and tricuspid rings are complex saddle-shaped structures that are highly dynamic during the cardiac cycle. The composition of this difficulty for the tricuspid valve is the frequent presence of intracardiac leads in patients with significant tricuspid regurgitation (TR). As the ventricular cables traverse the ring from the right atrium to the right ventricle, a transcatheter tricuspid valve must seal around both the ring and the cable to limit regurgitation in these patients.
[008] In patients receiving transcatheter aortic valve replacements (TAVR), investigators have developed technologies to mimic paravalvular regurgitation, but these approaches have limitations, especially in the presence of intracardiac leads. In particular, self-expandable, mechanically-expandable, balloon-expandable TAVRs have incorporated sealing membranes around their stent structures at the annular level to decrease paravalvular regurgitation. Sealing membranes consist of polyethylene terephthalate, known as PET or Dacron, or a porcine pericardial tissue wrap. These sealing membranes work by filling the interstices between the outside of the TAVR and the aortic ring, but this requires direct apposition of the valve against the ring. For transcatheter tricuspid valves, direct apposition of the valve structure to the tricuspid annulus should not be desirable or feasible due to the fact that, unlike the aortic annulus, the tricuspid annulus is distensible, with minimal external support, and prone to injury. Additionally, sealing an intracardiac conductor by trapping it between the valve structure and the ring would increase the risk of injury to the cable, which is undesirable.
[009] Most transcatheter mitral valve replacements (TMVR) already use a similar mechanism to limit paravalvular regurgitation by trapping the base of the mitral leaflets between the valve and ring structure. Thus, similar to the TAVR approach, the TMVR approach to decrease paravalvular regurgitation can damage the fragile tricuspid annulus, or damage the intracardiac leads by trapping them between the valve structure and the annulus. For example, Medtronic Intrepid and NSCI Navigate valves anchor by radial force against the ring (Intrepid) or through "fins" or annular hooks (Navigate). CardiAQ-Edwards' TMVR interacts directly with the ring using a subannular prehension mechanism, while the Neovasc Tiara valve indirectly interacts through the fibrous trigones and also utilizes native leaflet engagement (both mechanisms can pinch and injure the cables). Three TMVR devices — Caisson, HighLife, and MValve — use an annular anchor as a mooring system for the TMVR device, which would compress, and likely damage, any intracardiac conductor between the anchor and the TMVR device.
[010] Damage to intracardiac conduits is not the only concern about the way in which TMVR devices mimic paravalvular regurgitation. Because most TMVR devices reduce regurgitation by sealing the mitral annulus through direct anchorage to the annulus, these devices restrict, to varying degrees, the freedom of mitral annular movement. Restricting this freedom can contribute to left ventricular dysfunction. For example, a study comparing the transcatheter mitral valve (using the Abbott Vascular's MitraClip device) with open heart surgery showed that mitral annular motion was significantly less with open heart surgery, which the authors suggested to be a factor in ejection fraction left ventricle (LVEF) after open heart surgery compared with transcatheter repair. Similarly, a study comparing flexible to rigid mitral annuloplasty rings found a significantly lower LVEF with rigid rings, which restrict mitral annular motion more than flexible rings. Thus, in order to limit paravalvular regurgitation, current TMVR devices must anchor and restrict the mitral annulus, and this can have detrimental effects on left ventricular function.
[011] To limit paravalvular regurgitation while avoiding mitral annular restriction, the TMVR atrial skirts alone can decrease paravalvular regurgitation and seal around the intracardiac conduits; for example, Medtronic Intrepid, Neovasc Tiara, and Highlifs TMVR devices have atrial vents that decrease paravalvular regurgitation, and can facilitate sealing around intracardiac conduits; however, without mitral annular anchorage used by these TMVR devices, all such skirts suffer from important limitations. The atrial skirt of Neovasc Tiara suffers the greatest of limitations as it is asymmetrical to conform to the "D-shaped" mitral annulus and the aorto-mitral curtain. This asymmetry is incompatible with the right atrial floor and the tricuspid annulus. The skirts of the other TMVRs are symmetrical and are potentially compatible with the right atrial floor and the tricuspid ring, but these skirts lack the downward force and flexibility (along the perpendicular geometric axis of the ring) that are required for reducing paravalvular regurgitation or for sealing of intracardiac conductors. Although the Abbott Vascular Tendyne valve avoids annular anchorage using an epicardial valve brace, its skirt also lacks the strength and flexibility to seal around an intracardiac conduit. The Tendyne valve skirt, similar to the skirts of other TMVR devices, consists of flexible interconnected wire loops covered with PET, and all of these skirts are funnel-shaped with the wide top in the atrium and the narrow bottom in the ring. valve. These funnel-shaped skirts flex easily inward and have no mechanism to differentially increase the downward and upward force of the atrial skirt. For example, a mechanism to increase these forces on the skirt where the skirt interacts with the cable allows the skirt to control and constrain the cable. The aforementioned atrial skirts have no such mechanism; therefore, a cable running through the right atrium into the ventricle would not be constricted by the upper part of the skirt; instead, the cable would likely curve the skirt inward, creating a discontinuity of the skirt on the atrial floor, allowing for paravalvular regurgitation.
[012] Finally, another limitation of current atrial shrouds is their attachment to their associated TMVR devices. It would be advantageous to have the ability to decouple from the valve; that is, being able to place an atrial valance first, followed by the implementation of a transcatheter valve in the mitral or tricuspid space. Accomplishing this would allow for many combinations of atrial valances and valves, which can maximize the ability to customize transcatheter valve seal and placement depending on atrial, annular, and ventricular variations in anatomy.
[013] Therefore, it is highly desirable to create a transcatheter valve skirt with several distinct features. First, its effectiveness must be independent of mitral or tricuspid annular anchorage to avoid damage to the annular anatomy or impairment of ventricular function. Second, the skirt must be able to bend downward with differential flexibility and strength to conform to the local topography of the atrial floor, and to conform and seal around the intracardiac conduits. Finally, it would be advantageous to develop an atrial skirt that could be placed as an integrated part of the transcatheter valve or independently of the transcatheter valve to facilitate docking and sealing of pre-existing transcatheter valves to the tricuspid or mitral annulus. Creating a skirt that can be independently placed and used as a docking system significantly expands the possibilities for treating patients suffering from mitral or tricuspid disease.
[014] Serial No. US 15/943,792 depositors disclose Methods, Systems and Devices of Mooring and Anchoring Transcatheter Implantation including an anchor delivery system for introducing a tether attached to the anchor and a valve delivery system for delivery , positioning and sealing the valve. In accordance with the disclosure described below, the anchor delivery system comprises an anchor that is deployed and not initially attached to a tether. SUMMARY OF THE INVENTION
[015] In the present invention are presented medical devices and systems that are implanted in a minimally invasive way for the implantation of one or more anchors in cardiac walls for the purpose of connecting the tethers from the anchor to intracardiac devices, in particular, transcatheter valves . Additionally, medical devices and systems are presented that are minimally invasively implanted for sealing transcatheter valves to reduce paravalvular regurgitation, with or without the presence of intracardiac leads. In one aspect, the anchor is delivered completely endovascularly, using an anchor delivery catheter, without the need for thoracic or cardiac incisions.
[016] In one aspect, the system comprises an anchor introducer sheath, an anchor delivery catheter, and an anchor screw attached to an anchor cap configured to accept a tether. The brace is configured to secure the one or more cords, and the brace attaches to the intracardiac device through the cords, such as a transcatheter valve and the like.
[017] According to various aspects, the anchor screw can be a plane including wrapped around a nail-like head, or the anchor screw can be any helical device, such as an Archimedes type screw, and can be "right-handed" or "left-handed". The anchor bolt is composed of any metallic alloy, such as, but not limited to, nitinol, stainless steel, titanium or cobalt-chromium.
[018] The anchor cap, can also be composed of any metallic alloy, and is coupled to a proximal portion of the anchor screw. A proximal end of the anchor plug defines an internal "female" thread, which accepts "male" threads from a distal end of a delivery cable. In one aspect, the delivery cable remains attached to the anchor plug during attachment of the anchor plug to the cardiac wall, which occurs by rotation of the anchor plug, thereby driving the anchor screw into the cardiac wall. In another aspect, after attaching the anchor to the wall, the delivery cable is used to guide the hawser until the mooring ring of the hawser engages with the anchor. Finally, the delivery cable can be unscrewed from the anchor cap and removed.
[019] In one aspect, the hawser has a mooring ring attached to at least one mooring ring arm with an eyelet defined at the proximal end of the mooring ring arm. Each eyelet attaches to a distal end of a tie rod that attaches to the eyelet via a hook. The tie rod is composed of any metallic alloy, and a proximal end of the tie rod is attached to a rope. In one aspect, the tether mooring ring is advanced over the anchor cap, lowering the locking arms projecting from the anchor cap. In another aspect, the mooring ring reaches the end of the anchor cap, allowing the lock arms to be pushed, thereby locking the mooring ring, and therefore the hawser, in place. In another aspect, even after being locked in place, the lanyard is free to rotate around the longitudinal axis of the anchor cap without affecting the position of the anchor cap or anchor bolt. For recovery, the anchor delivery catheter reverses over the lock arms, thereby lowering the lock arms, and allowing the tether mooring ring to be retracted. According to one aspect, the atrial sealing skirt is integrated into a transcatheter valve, and is delivered completely endovascularly, without the need for thoracic or cardiac incisions. Alternatively, the atrial sealing skirt is independent of the transcatheter valve and is delivered completely endovascularly, without the need for thoracic or cardiac incisions. By being placed independently of the transcatheter valve, the atrial skirt serves as a docking system for any transcatheter valve.
[020] In one aspect, regardless of whether the atrial skirt is integrated into the valve or not, the system comprises an atrial sealing skirt configured to secure to the atrial floor and at least one tether configured to couple and/or secure the sealing skirt to any intracardiac wall through the interaction of the tether with an anchor.
[021] In one aspect, the atrial seal skirt is self-expanding and composed of nitinol and covered with synthetic materials such as, but not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET), or biological membranes such as, but without limitation, bovine or porcine pericardial tissue.
[022] In one aspect, the membrane covering the atrial skirt has a larger diameter than the annulus at the apposition site so that in use the membrane substantially covers the mitral or tricuspid annulus.
[023] The atrial skirt frame begins as a cylindrical shape, with the bottom of the cylinder at or below the annular level of the valve, and with the top of the cylinder extending into the atrium. From the top of the cylinder extends a top edge, composed of one or more lengths of wire, made of laser cut or formed nitinol. These extents are customized as shapes such as, but not limited to, lines, arcs, hooks, circles, ellipses, sinusoidal curves, or polygon curves of three or more sides. Top edge extensions, such as the skirt body, are covered and/or connected to synthetic or biological membranes. The upper edge is perpendicular to the atrial skirt body, or it may flex toward the atrial floor as a convex or concave curve. To facilitate sealing as the top edge flexes towards the atrial floor, the overlay fabric consists of a braided or mesh fabric, which allows for "stretchability", enhancing the ability to conform to the topography of the atrial floor and wrap in around any intracardiac conductors.
[024] In one aspect, adjacent to the upper edge, running longitudinally along the interior or exterior of the skirt body, are one or more ducts, which adopt the shape of a cylinder whose cross section is any portion of a circle, ellipse, parabola or hyperbola, or adopt the shape of a polyhedron with a flat base and top that takes the shape of a polygon with three or more sides. These conduits are constructed from the membrane that covers the skirt, or may be made of, but not limited to, stainless steel, nitinol or other metal alloys. The one or more conduits are hollow and accommodate at least one rope attached to at least one tether, and each conduit is secured to a detachable latch proximate the atrial surface of the skirt.
[025] The at least one anchoring system comprises an anchor bolt configured to be screwed into or otherwise securely attached to any intracardiac wall. In one aspect, a tether is coupled to the anchor bolt through the anchor cap, and at least one rope extends from the tether through the at least one duct of the skirt body. Thus, the sealing skirt is threaded over the rope through the conduit so that the sealing skirt, independently or integrated with a valve, slides in interaction with the rope. In another aspect, the proximal end of the cord is attached to a suture, which extends outside the heart to be accessible by a user.
[026] The system further comprises at least one atrial positioning rod whose proximal end is fixed to the delivery system, and whose distal end is reversibly coupled to a detachable latch, which is fixed to the proximal end of the atrial skirt conduit. Through the internal lumen of the positioning rod runs the suture and/or cord so that the positioning rod pushes or pulls the atrial skirt, thereby applying differential force and flexion to the associated upper edge, allowing apposition to the atrial floor and/or conformation around an intracardiac conductor. In another aspect, rotation of the positioning rod and/or pushing or pulling internal elements of the positioning rod causes the detachable latch to engage the rope and/or suture, secure the rope and/or suture to the atrial skirt, maintain the force and flexion of the atrial skirt to the atrial floor and/or intracardiac conductor.
[027] Related operation methods are also provided. Other apparatus, methods, systems, features, and advantages of medical devices and systems that are minimally invasively implanted in the heart will or will become apparent to a person skilled in the art upon examination of the figures and detailed description below. All such apparatus, methods, systems, features and advantages included in this description are intended to be within the scope of medical devices and systems that are minimally invasively implanted in the heart, and to be protected by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[028] Figure 1 is a sectional perspective view of a heart showing the transcatheter atrial seal skirt system positioned through the tricuspid valve in the heart;
[029] Figure 2 is a sectional perspective view of a heart showing the transcatheter atrial seal skirt system positioned through the mitral valve in the heart;
[030] Figure 3 is a perspective view of the delivery cable of an anchor delivery device for anchoring a tether to a cardiac wall;
[031] Figure 4 is a perspective view of an anchor for anchoring a tether to a cardiac wall;
[032] Figure 5 is a perspective view of a tether for anchoring the atrial sealing skirt to the anchor;
[033] Figure 6 is a perspective view of the anchor assembly, comprised of the tether, to connect the atrial sealing skirt to the anchor, coupled to the anchor, for anchoring the tether to a cardiac wall;
[034] Figures 7A to 7C are perspective views of an anchor according to an alternative aspect with a divider anchor bolt;
[035] Figure 8A is a side elevation view of the anchor delivery device;
[036] Figure 8B is a side view of the anchor delivery device shown within the delivery sheath;
[037] Figure 8C is an end view of the anchor delivery device;
[038] Figure 9A is a perspective view of the anchor delivery device being positioned in the right ventricle;
[039] Figure 9B is a perspective view of the anchor that is implanted in the intracardiac wall;
[040] Figures 10A and 10B illustrate the anchor delivery being removed;
[041] Figure 11A is a perspective view of the tether delivery assembly on the deployed anchor;
[042] Figures 11B and 11C are a perspective view of the hawser delivery assembly being removed;
[043] Figure 11D is an enlarged view of the fusion of the cord with the suture;
[044] Figure 12A is a perspective view of the seal skirt delivery device wherein the atrial seal skirt delivery system is positioned in the right ventricle;
[045] Figure 12B is a perspective view of the atrial seal skirt delivery device in which the delivery guide is partially withdrawn and the seal skirt is expanded;
[046] Figure 12C is an end view of the atrial seal skirt;
[047] Figure 13A is a perspective view of the atrial seal skirt being positioned on the right atrial floor by the atrial positioning rods;
[048] Figure 13B is a perspective view of the atrial seal skirt locked into position on the tricuspid ring by atrial locks with the mates rod partially withdrawn;
[049] Figures 14A and 14B are side elevation views and top perspective views of the atrial sealing skirt;
[050] Figure 15A is a sectional perspective view of the heart showing the atrial seal skirt being positioned;
[051] Figure 15B is a sectional perspective view of the heart showing the atrial seal skirt positioned over and conforming to the atrial floor;
[052] Figure 16A is a sectional perspective view of the heart showing the atrial sealing skirt conforming to the atrial floor and sealing around an intracardiac conduit;
[053] Figure 16B is an enlarged perspective view of the atrial skirt conforming and sealing around an intracardiac lead;
[054] Figure 17A is an enlarged side elevation view of the atrial seal skirt coupled to atrial positioning rods and cords;
[055] Figure 17B is an enlarged side elevation view of the locking system;
[056] Figure 18A is a perspective view of the locking system;
[057] Figure 18B is a sectional view in perspective of the locking system;
[058] Figure 19A is a cross-sectional side view of the atrial seal skirt locking system positioning itself in an unlocked position;
[059] Figure 19B is a cross-sectional side view of the locking system for the atrial seal skirt positioning itself in a locked position;
[060] Figure 20A is a partially cut away view of the locking system in the locked position;
[061] Figure 20B is a perspective view of the locking system;
[062] Figure 21A is a cut-away view of a heart with the atrial skirt positioned within the heart and all delivery devices removed; and
[063] Figure 21B is a cut-away view of a heart with the atrial skirt positioned within the heart and illustrating the suture cutter;
[064] Figure 22 is a side elevation view of the sealing skirt with a margin that transitions from a concave to convex configuration;
[065] Figures 23A and 23B are top plan views and perspective of the atrial sealing skirt with a valve, composed of valve leaflets, integrated in the skirt;
[066] Figures 24A and 24B are views in perspective and upper planes of the atrial sealing skirt for receiving a valve; and
[067] Figures 25A to 25F are perspective views of an anchor that has an anchor bolt and anchor cap configured to receive a connecting ring and a tether system illustrated in sequential steps. DETAILED DESCRIPTION OF THE INVENTION
[068] The present invention may be more readily understood by reference to the following detailed description, examples and claims, and the preceding and following description thereof. Before the present system, devices, and/or methods are disclosed and described, it is understood that this invention is not limited to the specific systems, devices, and/or methods disclosed unless otherwise specified, as such may, of course, vary. It is also understood that the terminology used in the present invention is for the purpose of describing particular aspects only and is not intended to be limiting.
[069] The following description of the invention is provided as an enabling teaching of the invention in its currently known best aspect. Those skilled in the art will recognize that many changes can be made to the aspects described while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Consequently, those working in the art will recognize that many modifications and adaptations to the present invention are possible and may still be desirable under certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not as a limitation thereof.
[070] As used in the present invention, the singular forms "a," "an" and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, the reference to a "string" includes features that have two or more strings unless the context clearly indicates otherwise.
[071] Ranges may be expressed in the present invention as "about" a particular value and/or "about" another particular value. When such a range is expressed, another aspect includes from a particular value and/or to the other particular value. Similarly, when values are expressed as approximations, using the background "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the lanes are significant both in relation to the other endpoint and independently of the other endpoint.
[072] As used herein, the terms "optionally" or "optionally" mean that the event or circumstance subsequently described may or may not occur, and that the description includes cases where said event or circumstance occurs and cases where it does not occurs. As used in the present invention "fluid" refers to any substance that is free-flowing and includes liquids, gases and plasma. "Fluid communication" as used in the present invention refers to any connection or relative positioning that allows substances to flow freely between the relevant components.
[073] The application relates to medical devices and systems to be minimally invasively implanted in the heart and methods of implanting these devices and systems. More specifically, the application relates to devices, methods and systems for endovascularly introducing and anchoring an anchor 75 to a heart wall and implanting a valve 100 (see Figures 23 and 14A and 14B) in the heart tethered to the anchor 75 to replace the native valve. Also, a tether assembly cooperates with anchor 75 connecting valve 100 to anchor 75. Additionally, valve 100 includes a sealing skirt 46 to cooperate with valve 100 to conform to the respective atrial floor to prevent prosthesis paravalvular regurgitation. . Depositor's Order under serial number. US 15/943,792 refers to an atrial seal skirt and anchor that are tied together and fully implanted. According to the disclosure in the present invention, the anchor is deployed independent of the tether and atrial seal skirt. It should be noted, however, that the components of this disclosure and the disclosure previously deposited by the Depositor are interchangeable. For example, the anchor of the Depositor's previous disclosure can be deployed without having a tether attached during delivery of the anchor. Preferably, the tether systems described in the present invention can also be used in conjunction with the anchors disclosed in the present invention. The Anchor Set
[074] The components of the anchor assembly 101 shown in Figures 3 to 6 include an anchor 75 that has an anchor bolt 17, an anchor cap 16 and a delivery cable 12 that allow delivery of a hawser 18. The cap anchor screw 16 is coupled to anchor screw 17. Delivery cable 12 is detachably connected to anchor plug 16. Anchor screw 17, as shown, is sized and configured as a helical screw for securing to an intracardiac wall . Optionally, however, anchor screw 17 can be differentially sized (longer or shorter depending on the heart wall to which it is attached) and configured as an inclined plane, nail-like head, or any other type of screw that is known by those elements well versed in the art. In one aspect, the screw is composed of any known metallic alloy, including, but not limited to, nitinol, titanium or cobalt-chrome. In another aspect, the metal alloy of screw 17 can be coated with biological tissue, such as bovine, ovine, porcine or equine pericardium, or with any combination of anti-inflammatory drugs that can promote healing and limit inflammation. A tip 76 of anchor screw 17 is optionally constructed of and/or coated with the same or different materials as anchor screw 17, and can be customized as a blunt or sharpened tip.
[075] In use, anchor 75 is secured to the cardiac wall by rotating the anchor screw 17 until the tip 76 is at a desired depth in the cardiac wall. The depth to which the anchor screw 17 is screwed is adjustable according to the location within the heart. For example, the anchor screw 17 can be implanted deeper into the interventricular septum for greater fixation, as opposed to the ventricular free wall, i.e. epicardial wall, where a shallower implantation is safer. By reversing the rotation of anchor screw 17, anchor 75 is securely removed from the cardiac wall, to be repositioned or to be removed entirely.
[076] Anchor cap 16 comprises at least one locking arm 78 that extends radially outward from anchor cap 16. Locking arm 78 is sized and configured to releasably secure a portion of tether 18 ( described below) in the anchor plug 16. The at least one locking arm 78 moves between a first locked position, in which the locking member 78 extends a first distance away from the body of the anchor plug 16, and a second an unlocked position in which the locking member 78 extends a second distance away from the anchor plug 16 which is less than the first distance. Anchor plug 16 comprises at least one guide member (not shown), such as a spring, configured to urge each lock arm 78 into the first locked position. As shown, a plurality of lock arms 78 are provided and are equally spaced around the circumference of anchor plug 16, although it is contemplated that the lock arms 78 need not be evenly spaced.
[077] Referring now to Figure 3, delivery cable 12 includes a flexible delivery wire 13 having a threaded distal end portion 14 positioned on or formed at the distal end of delivery wire 13. The delivery wire is constructed. of, but not limited to, stainless steel, nitinol or other metallic alloys, with or without hydrophilic coatings, or with or without a polymeric coating such as polytetrafluoroethylene (PTFE). The threaded distal end portion 14 must be sized and configured to selectively engage complementary threads formed in a cavity defined in a proximal end 77 of the anchor plug 16. See Figures 4 and 6. In use, the threaded distal end portion 14 advances , for example, screws, through the proximal end 77 of the anchor plug 16 to couple the anchor plug 16 to the distal end of the flexible wire 13. As described more fully below, the threaded distal end portion 14 is unscrewed from the end. proximal from anchor 75, detaching flexible wire 13 from anchor 75.
[078] According to another aspect of the present invention, an expansion anchor assembly 102 is shown in Figures 7A to 7C. As shown, anchor assembly 102 is an interventricular anchor as through the interventricular septum. Anchor assembly 102 includes an anchor cap 16 and locking arm 78 as described above to cooperate with tether 18. Anchor assembly 102 also includes an anchor shaft 105 that has a distal tip 107 configured to penetrate an intracardiac wall . Anchor shaft 105 and anchor bolt 17 are comprised of at least two, and as shown three, sectors of anchor 108 and shaft. The sectors 108 are secured during implantation and penetration of the intracardiac wall by an internal tensioning means such as tensioning line 109 which divides into at least two, or three lines 109 shown that terminate at the distal end 107 of each section 108. One since the distal end 107 of the anchor shaft 105 enters an intracardiac wall, such as the interventricular septum, the internal tension line 109 is released and relaxed, allowing the shaft sectors 108 to separate by the action of the internal guiding members ( not shown), such as, but not limited to, one or more springs located along one or more inner walls of axis sectors 108.
[079] In accordance with another aspect of the disclosure, as shown in Figures 25A to 25F, an anchor assembly 103 is illustrated. Anchor 103 includes an anchor shaft 112 and an anchor bolt 114. As shown, the anchor bolt 114 has a helical configuration and extends distally from an anchor bolt base 115. The anchor bolt base 115 defines at least one, or a plurality as shown, of anchor flanges 116 and recessed areas 117 therebetween. Anchor shaft 112 includes at least one or, as shown, a plurality of locking members 118 shown in Figure 25B. The locking members 118 are oriented, as by a spring (not shown), radially outwardly from the anchor shaft 112. An anchor connector 120 and connector stem 121 cooperate with the anchor shaft 112 to rotate the anchor bolt. anchor 114. Anchor connector 120 defines at least one or, as shown, a plurality of apertures 122 configured to receive anchor flanges 116. Accordingly, anchor connector 120 and connector stem 121 are correspondingly connected to the shaft. of anchor 112, thus urging the locking members 118 inwardly. The cooperation of apertures 122 and flanges 116 integrate anchor connector 112 and anchor bolt base 115. Rotation of connector stem 121 thereby rotates anchor bolt 114 for interventricular or epicardial implantation into a wall intracardiac.
[080] After the anchor bolt 114 has been deployed, a tie ring 125 is applied over the connector stem 121 and the anchor connector 120 and abuts the proximal end of the anchor bolt 114. The tie ring 125 includes a generally cylindrical first distal portion 126 and a second proximal portion 127 that has a greater diameter than the first portion 126. The second portion 127 defines at least one or, as shown, a plurality of apertures 129 configured for receiving rods. 130 as shown in Figures 25E and 25F. As shown in Figure 25D, the anchor connector 120 and connector stem 121 are removed. The locking members 18 are urged radially outward for the purpose of engaging the second portion 127 of the tie ring 125 to lock the tie ring 125 to the anchor bolt base 115. The tie rods 130 are operative as described above for cooperate with an atrial seal skirt 46. The Mooring Set
[081] When the flexible wire 13 is coupled to the anchor 75, the flexible wire serves as a guide rail for the advancement of the tether 18 to the anchor 75. The tether 18 includes one or more tie rods 19 pivotally connected to a mooring ring 20. The mooring rods 19 are connected to an eyelet 70 defined by mooring ring arms 71 as shown in Figure 5. The hawser 18 is advanced by the flexible wire 13 of the delivery cable 12, and the mooring ring mooring 20 of tether 18 lowers the at least one locking arm 78 of anchor cap 16 to the second unlocked position. With locking arm 78 in the second position, tether 18 advances through locking arm 78 on anchor plug 16 until mooring ring 20 is adjacent and/or adjacent to a distal end 79 of anchor plug 16. At that point, the anchor cap guiding member 16 urges the at least one locking arm 78 into the first locked position, thereby releasably engaging the mooring ring 20, and thus the rest of the hawser. 18, to anchor 75.
[082] In one aspect, when coupled to anchor 75, lanyard 18 rotates around a longitudinal axis of the anchor for a full 360 degrees. Optionally, in another aspect, tether 18 may be constrained to lesser degrees of rotation by the interaction of a portion of tether 18 with the at least one locking arm 78.
[083] As shown in Figure 6, in one aspect, the hawser 18 comprises at least one mooring ring arm 71 coupled to the mooring ring 20, and at least one mooring rod 19 coupled to a mooring ring arm 71 As shown, a distal end of the docking ring arm 71 is securely coupled to or monolithically formed with the docking ring 20. As shown, the at least one docking ring arm comprises a plurality of docking ring arms 71 As shown, the plurality of mooring ring arms 78 are equally spaced around the circumference of the mooring ring, although it is contemplated that the mooring ring arms 71 need not be equally spaced. An eyelet 70 is defined by the mooring ring arm 71. The mooring rod 19 includes a mooring rod hook 72 configured to cooperate with the eyelet 70.
[084] A proximal end of each mooring ring arm 71 is swivelably coupled to a distal end of a respective mooring rod 19. A mooring rod hook 72 is defined by mooring rod 19 as shown and is coupled a or monolithically formed with the distal end of each tie rod 19. In another aspect, the eyelet 70 and the tie rod hook 72 are sized and configured so that the tie rod hook 72 is inserted into the eyelet 70 to securely and swivelly attach tie rod 19 to tie ring 20. In use, each tie rod hook 72 pivots around the circumference of eyelet 70. As shown in Figure 5, the proximal end of each tie rod The lashing rod is attached to a cord 21. The lashing rod 19 and the lashing rod hook 72 can be composed of any metal alloy.
[085] The tether 18 is configured to cooperate with any intracardiac anchor including, but not limited to, the interventricular and epicardial anchors disclosed in the present invention and the interventricular and epicardial anchors of the Depositor's previous disclosure incorporated in the present invention by way of reference. The Anchor Delivery Device
[086] Referring now to Figures 8A to 8C and 9A to 9B, the anchor delivery device 23 for positioning and implementing the anchor plug 16 in the desired position is illustrated and refers to the anchor assembly components 101 shown in Figures 3 to 6 and the anchor assembly 102 shown in Figures 7A to 7C. The delivery device 23 comprises an anchor delivery guide 25 and an anchor delivery rod 29. The anchor delivery guide has a distal end 28 and an inner guide lumen sized and configured so that at least a portion of the anchor delivery rod 29 extends through it. At least one anchor delivery guide portion 25 is flexible so that the distal end 28 of the anchor delivery guide 25 is positioned on or adjacent to an intracardiac wall 7.
[087] Anchor delivery rod 29 is configured to securely secure anchor screw 17 to intracardiac wall 7. Anchor delivery rod 29 has a distal end 31, an opposite proximal swivel handle 30, and a rod lumen that extends between them. The inner stem lumen is sized and configured so that at least a portion of the delivery cable 12 extends therethrough. At least a portion of the anchor delivery rod 29 is flexible so that a rod tip 31 at the distal end of the anchor delivery rod 29 can be positioned on or adjacent to the intracardiac wall 7.
[088] A portion of anchor plug 16 (as shown, the portion proximal to the distal end of anchor plug 79) is received by and extends into anchor stem tip 31. anchor 16 includes a first surface configuration and the inner wall configuration of said anchor rod distal portion 29 has a second configuration wherein the first and second configurations are matched. Thus, when anchor plug 16 is positioned and engaged with anchor rod tip 31, rotation of anchor delivery rod 29 rotates anchor plug 16. In this position, anchor bolt 17 extends distally from the Anchor delivery rod 29 as illustrated in Figure 8B and delivery cable 12 extends through the inner rod lumen of anchor delivery rod 29.
[089] The anchor delivery device 23 also includes a guide handle 26 which has a deflection boss 27 coupled to the anchor delivery guide 25. The guide loop 26 and the deflection boss 27 are configured and used to assist guiding the distal end 28 of the anchor delivery guide 25 to the intracardiac wall 7. A stem loop 30 is coupled to the anchor delivery stem 29 wherein rotation of the stem loop rotates the stem tip 31 and the plug. of anchor 16 when the anchor plug is positioned on the tip of anchor rod 31.
[090] As shown, in Figure 8A a sheath 24 is configured to receive the anchor delivery guide 25. The sheath 24 is in fluid communication with the anchor delivery guide so that fluids such as heparinized saline and the like surround the anchor delivery guide through sheath 24. A central sheath channel 33 (Figure 9B) is defined in sheath 24 to provide communication with the inner guide lumen of the anchor delivery guide 25 to the anchor delivery rod 29 and other system components to extend through the central sheath channel 33. The Anchor Implant Method
[091] As shown in Figure 9A, in the tricuspid ring, for example, a J wire 34 is endovascularly guided by the user to the intracardiac wall 7. The anchor delivery device 23 is then guided by the J wire until the distal end 28 of the anchor delivery guide 25 is positioned on or adjacent to the intracardiac wall 7. Figures 9 to 11 illustrate the anchor assembly 101 of Figures 3 to 6 implanted in an intracardiac wall which is an epicardial wall. Anchor assembly 101 can also be implanted into an interventricular wall. J wire is, for example, and without limitation, a J wire of 0.64 mm (0.025 in.) or 0.089 mm (0.035 in.). Obviously, J-shaped wires having other diameters are contemplated. The anchor plug 16 is coupled to the distal end 31 of the anchor delivery rod 29. The anchor delivery rod 29 must then be inserted through the inner guide lumen of the anchor delivery guide 25 until the anchor is inserted. anchor 16 and the distally extending anchor screw 17 are positioned on or adjacent to the intracardiac wall 7.
[092] The anchor set 102 of Figures 7A to 7C can also be deployed and guided by the J wire 34 as in the interventricular wall like the intracardiac wall 7 shown. The anchor assembly 103 of Figures 25A through 25F can also be implanted and guided by the J wire 34 into an intracardiac wall 7, such as an interventricular wall or an epicardial wall.
[093] With the anchor screw 17 of anchor systems 101, 102 or 103 positioned adjacent to the intracardiac wall 7, the swivel handle 30 of the anchor delivery rod 29 or 121 is rotated to cause corresponding rotation of the anchor plug 16 as illustrated in Figure 9B. For example, the swivel handle 30 is rotated in a first direction to cause corresponding rotation of the anchor plug 16. The anchor screw 17 coupled to the anchor plug 16 also rotates and screws into a portion of the intracardiac wall until the plug anchor 16 is adjacent to the apex wall. It is noted that in this position, the anchor screw 17 may or may not extend completely through any intracardiac wall, but transapical access is not required. Upon placement of the anchor plug 16 in the desired position, the anchor delivery rod 29 and anchor delivery guide 25 are retracted from the heart 2 as illustrated in Figure 10A. As shown in Figure 10B, after placement of the anchor plug 16, the flexible wire 13 of the delivery cable 12 extends from the anchor plug 16, through the tricuspid ring, and through the right atrium 3. The Atrial Seal Skirt
[094] As shown in Figures 14A, 14B, 23A, 23B, 24A and 24B the system 1 comprises a heart valve 100 having an atrial seal skirt 46 with an upper skirt edge 47 extending circumferentially along the upper end of valve 100. Atrial seal skirt 46 includes an atrial skirt body 48, shown substantially cylindrical, and atrial skirt top edge 47 which is configured to conform to an atrial floor 4, such as the right atrial floor as shown. Atrial seal skirt 46 is coupled to anchor 75 by tether 18 as described in the present invention. Lanyard 21, cast or otherwise coupled to tie rod 19 of lanyard 18, connects valve 100 to anchor 75 when anchor 75 is secured to an intracardiac wall 7.
[095] The transcatheter atrial seal skirt 46 is sized and configured to rest the tricuspid valve (in the example shown) between the right atrium 3 and the right ventricle 6 as shown in Figure 1. The seal skirt 46 can be pre-assembled with valve leaflets 110 such as an integral valve 100 (Figure 23A, 23B) or the seal skirt 46 can be constructed without valve leaflets and serve as a docking system for a separate transcatheter valve (Figure 24A, 24B). This is given by way of example. Optionally, however, with slight variations, the valve is sized and configured to be positioned in the mitral annulus between the left atrium 8 and the left ventricle 11 as illustrated in Figure 2. Consequently, then, with slight variations, these devices, systems and methods are used for the tricuspid or mitral valves and can be placed endovascularly through a venous structure including, but not limited to, the internal jugular vein, subclavian vein, or other femoral vein.
[096] The atrial seal skirt 46 is self-expanding (ie, the skirt is compressible so that it fits through a system catheter 1) and composed of nitinol, but may also contain elements made of, but not limited to, steel stainless, nitinol or other metallic alloys. In another aspect, the atrial seal skirt has a smaller diameter that is less than or approximately equal to the ring in deployment at location 5 (tricuspid ring) or deployment site 10 (mitral ring), thereby preventing or reducing, apposition to the fragile tricuspid annulus, and preventing or reducing constriction of the mitral annulus.
[097] At least one conduit 53 is defined in the outer wall of the atrial seal skirt 46 as illustrated in Figures 12C, 14A and 14B, 23A and 23B and 24A and 24B. Each conduit is sized and shaped so that a portion of cord 21 (attached at the proximal end to suture 45, as illustrated in Figures 12A and 12B) extends through conduit 53, thus connecting tether 18 to atrial sealing skirt 46, allowing free movement until skirt 46 is locked in place. In a further aspect, the atrial seal skirt 46 has anchoring elements (not shown) positioned along its outer diameter. These anchors allow attachment to the tricuspid or mitral annulus and/or leaflets, but are not necessarily used in a primary attachment mechanism.
[098] The at least one strand 21 is attached to the tie rod 19 of the lanyard 18, and the proximal portion of strand 21 is attached to the suture 45. In one aspect, the strand can be a flexible but strong cord as per example, and without limitation, a rope of expanded polytetrafluoroethylene (ePTFE) or ultra high molecular weight polyethylene (UHMWPE, UHMW). In use, described more fully below, a central portion of cord 21 (between the distal end and the proximal end) extends through and/or is coupled to the atrial sealing skirt 46 to maintain the skirt in the desired position relative to the ring. tricuspid or to the mitral annulus.
[099] Figures 23A and 23B also illustrate the atrial seal skirt 46. The seal skirt 46 is an integral valve 100, composed of leaflets 110 extending radially inward from the seal skirt body 48. The leaflets 110 are composed of bovine, equine or swine pericardial leaflets. The atrial seal skirt 46 can be used as a docking system for any conventional valve, or it may be pre-assembled to include valve 100 composed of leaflets 110. If the atrial seal skirt 46 contains valve 100 composed of leaflets 110 sewn into the seal skirt body 48, this configuration will function like any conventional valve, with the leaflets 110 opening during diastole (heart relaxation) allowing blood to enter from the right atrium 3 to the right ventricle 6, or from the left atrium 8 to the left ventricle 11, and closing during systole (contraction of the heart), preventing blood from regurgitating from the left or right ventricle back to the right or left atrium, respectively.
[0100] As shown in Figures 14A and 14B, 23A and 23B, and 24A and 24B, the atrial sealing skirt 46, defined by the atrial skirt body 48 and atrial skirt upper edge 47, includes a membrane-like material and the sealing skirt 46 has a larger diameter than the ring at the implementation site. For example, the atrial sealing skirt 46 may have a skirt diameter greater than the diameter of the tricuspid or mitral annulus. In another aspect, the atrial skirt is formed from, but not limited to, synthetic materials from the classes consisting of polycarbonate, polyurethane, polyester, expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate (PET), silicone, natural or synthetic rubbers, or a combination of them. The atrial skirt 46 can also be covered with adult or juvenile bovine, ovine, equine or porcine pericardium. Optionally, at least a portion of the atrial seal skirt 46 can be formed from alternative materials, such as, for example, and without limitation, polyurethane foam or other polymers.
[0101] In another aspect, at least a portion of the atrial seal skirt 46 has one or more attachment members (not shown) along its length, allowing for additional anchoring to the right atrial floor and/or other portions on the atrial side of the tricuspid annulus, preventing migration of the atrial sealing skirt 46 to the proximal right atrium 3, thereby preventing instability (eg, agitation) and paravalvular regurgitation of the prosthesis. Optionally, with slight modifications, these fixation members allow additional anchoring of the atrial sealing skirt 46 to the left atrial floor and/or portions on the atrial side of the mitral annulus, preventing migration of the atrial sealing skirt 46 into the proximal left atrium 8, also preventing instability (eg, agitation) and prosthesis paravalvular regurgitation.
[0102] The atrial seal skirt 46 comprises at least one atrial skirt body 48 and an atrial skirt upper edge 47. As shown, the atrial skirt body 48 is a cylinder and is of variable length and diameter. It is selectively composed of laser cut or molded nitinol, but it can also contain elements of any other metallic alloy, and it can be covered along any portion of its circumference or length with biological membranes or synthetic materials mentioned above. As shown, the top edge 47 extends radially outward from the skirt body 48 and downward, forming a substantially concave top edge with the concavity facing the right atrial floor 4 or left atrial floor 10. The edge 47 extends circumferentially around the upper end of the skirt body 48.
[0103] At least one, or as shown a plurality of, flexible extension members 49 are provided and which may, for example, be composed of, but not limited to, laser cut or molded nitinol attached to the top of the skirt body by extension member base 50 and terminating at extension member tip 51. Between one or more extension members 49 is an elastic sealing membrane 52 which extends perpendicular to adjacent extension members 49. As shown in Figures 14A and 14B, the extension member 49 may extend radially outwardly and substantially linearly, but this is exemplary. As shown in Figures 23A, 23B, 24A and 24B, the extension members may be non-linear and generally U-shaped. As shown, the sealing membrane 52 extends circumferentially around the skirt edge 47. It may extend only a portion of the circumference as well. The sealing skirt body 48 includes a plurality of supports 114 which like the extension members 49 of the top edge 47, may, for example, be composed of, but not limited to, laser cut or molded nitinol. As shown, brackets 114 form a truss-like configuration, but other configurations are contemplated including, but not limited to, brackets that extend vertically.
[0104] The sealing member 52 is composed of biological tissues or synthetic tissues as mentioned above. In one aspect, the synthetic fabric is braided or meshed, allowing for the "stretchability" required to conform to the topography of the atrial floor, including the ability to cover and seal intracardiac leads such as permanent pacemaker cables 66 as shown in Figures 16A and 16B. As shown in Figure 16a, the upper edge of the atrial skirt 47 conforms to the right atrial floor 4 and seals around the intracardiac lead 66, according to one aspect. In Figure 16B, the extension member 49 is secured to the atrial skirt body 48 through the extension member base 50, and the extension member tip 51 is flexing downward, allowing the elastic sealing membrane 52 to engage. around the top of the intracardiac lead 66, and thereby preventing regurgitation around the cable. This conformation requires downward force applied through one or more atrial positioning rods 44, secured to one or more conduits 53, and locked in place through one or more detachable latches 56 (Figure 17B) integrated into the atrial end of conduits 53 as described in the present invention. The Atrial Seal Mooring and Skirt Sets
[0105] According to the method described above, the anchor 75 is introduced by the anchor delivery device 23 and secured to an intracardiac wall and the anchor 75 comprising the anchor screw 17 has been implanted into an intracardiac wall. Anchor plug 16 and delivery cable 13 remain within the heart and are ready to receive tether 18 described above.
[0106] Referring now to Figures 11A, 11B, 11C and 11D and as described above, tether 18 is advanced by flexible wire 13 of delivery cable 12 through the atrial skirt delivery system shown in the form of delivery sheath 137 The lanyard 18 locks over the anchor cap 16 by coupling the mooring ring 20 to the anchor cap 16. Coupled to at least one tie rod 19 is at least one lanyard 21 extending from the tie rod 19. The at least one strand 21 is proximally connected to at least one suture 45, which extends out of the body through the central lumen 33 of the delivery sheath 137. Once the tether is locked into the anchor plug 16, the sheath 137 is retracted as shown in Figure 11C, leaving the implanted anchor 16, tether 18, strands 21 and suture extending from the implantation site. In the aspect shown in Figure 11C, a hawser delivery sheath 137 is provided as a second delivery guide and is a different sheath than the sealing skirt delivery guide sheath 38, which is the third delivery guide, described below. Therefore, tether sheath 137 is removed and the sealing skirt delivery guide sheath 38 is applied. This can be achieved in a single step, however, as shown in Figures 12A through 12B where the same sheath 38 releases both tether 18 and atrial seal skirt 46 with the same sheath and constitutes the second delivery step.
[0107] Referring now to Figures 12A and 12B, the atrial seal skirt delivery system 37 for positioning and deploying the atrial seal skirt 46 at desired deployment locations 5 or 10 is illustrated. The atrial seal skirt delivery system 37 comprises a seal skirt delivery guide 38, a conical tip 43, an atrial seal skirt implementing boss 39, and at least one atrial positioning rod 44. The delivery guide The seal skirt 38 has a distal end 41, an opposite proximal protrusion of the atrial seal skirt implementing 39, and an inner guide lumen 40 extending therebetween. The inner guide lumen 40 is sized and configured so that the atrial seal skirt 46 and other system components are selectively and removably inserted therethrough. At least a portion of the sealing skirt delivery guide 38 is flexible so that a tip 41 at the distal end of the anchor delivery guide 25 is positioned beyond the deployment site 5 and into the right ventricle 6. Alternatively, the distal tip 41 is positioned beyond the deployment site 10 and into the left ventricle 11.
[0108] The atrial seal skirt implementing boss 39 is coupled to the proximal end of the seal skirt delivery guide 38. The atrial seal skirt implementing knob defines a central channel 60 that is in Fluid Communication with the lumen of internal guide 40. Consequently, the atrial positioning rod 44, guide wire 13 and/or the at least one suture 45 can extend through the central channel 60 and into the internal guide lumen 40. As shown, the atrial seal skirt implementation 39 is swivel and configured so that rotation of protrusion 39 in a first direction causes the distal end 41 of the seal skirt delivery guide 38 around the atrial seal skirt 46 to be retracted, allowing the atrial seal skirt 46 to expand. The tapered tip 43 may be any conventional tapered tip coupled to the seal skirt delivery guide 38 and configured to guide the atrial seal skirt 46 to the deployment site 5. The Locking System
[0109] Referring to Figures 13A and 13B, the at least one atrial positioning stem 44 has a distal end 54, a proximal end 61 and an inner stem lumen 62 extending therebetween, the inner stem lumen being sized and configured so that a portion of a suture 45 and/or a cord 21 is inserted therethrough. At least a portion of the atrial positioning rod 44 is flexible so that the distal end 54 of the atrial positioning rod can be positioned at or adjacent to deployment site 5.
[0110] The at least one positioning rod 44 is coupled to conduit 53. As shown in Figures 13A and 13B, each conduit 53 contains a detachable latch 56 (Figures 17A and 17B), which is configured to securely attach at least one cord 21. Thus, the cord 21 is securely attached to the tie rod 19 of the tether 18, which is coupled to the anchor cap 16, secured to the intracardiac wall 7 through the anchor screw 17, and the detachable latch 56 securely secures the cord 21. in the right atrium, for example.
[0111] Referring to Figures 17A, 17B, 18A, 18B, 19A and 19B, the locking system 55 consists of a detachable lock 56, integrated inside the conduit 53, fixed to the first door hypotube 57 and to the second door hypotube retraction 58. Within the detachable latch 56 is a locking tab 59. Referring now to Figure 21B, system 1 further comprises a suture cutter 65 sized and configured to traverse delivery sheath 24 to cut the at least one suture 45 (as shown in Figure 21B). The Implant Method. Atrial Skirt Positioning and Locking
[0112] In use, system 1 deploys the atrial seal skirt 46 (with an integrated valve) using a transcatheter approach by placing a right or left ventricular anchor 75 and attaching a tether 18 to the anchor 75. As shown in Figure 12A, the atrial seal skirt delivery system 37 is inserted by flexible wire 13 of the delivery cable 12 and into a portion of the heart 2. As per the seal skirt delivery guide 38, with the atrial seal skirt 46 and the valve integrated 100 preloaded into the distal end 41, is inserted into the heart, at least a portion of the suture 45 is threaded through the at least one conduit 53 defined in the wall of the atrial seal skirt 46, illustrated in Figures 12B and 12C, and as per the sealing skirt delivery guide 38 advances, at least a suture portion 45 and the strand 21 extends along and proximally beyond the inner guide lumen 40 of the sealing skirt delivery guide 38. a portion of at least one strand 21 s and extends through and beyond the distal end 41 of the seal skirt delivery guide 38, and a portion of the at least one suture 45 extends through and beyond the seal skirt delivery guide 38. seal 38 is positioned so that the distal end 41 of the seal skirt delivery guide 38, with the atrial seal skirt 46 and valve 100 preloaded at the distal end 41, is passed through the deployment site 5 and into the inside the right ventricle 6.
[0113] The atrial seal skirt 46 and valve 100 are preloaded at the distal end 41 of the seal skirt delivery guide 38 for positioning at the deployment site 5. As shown, the suture 45 is pre-assembled with the valve 100 such that each suture 45 is threaded through the at least one conduit 53 defined in the wall of the atrial seal skirt 46 illustrated in Figures 12B and 12C. As the atrial seal skirt 46 and the distal end 41 of the seal skirt delivery guide 38 advance as a unit and approach the deployment site, the end of suture 45 and a portion of strand 21 become threaded through the conduit. 53 defined in the atrial seal skirt 46. As such, the atrial seal skirt 46 is movable along the length of the at least one chord until the desired deployment location 5 has been reached. That is, the atrial seal skirt is free to float on cord 21 until it is locked in place by the detachable latch 56.
[0114] When the atrial seal skirt 46 is at the desired deployment location 5, the atrial seal skirt deploying protrusion 39 is used to at least partially withdraw the delivery guide 38 around the atrial seal skirt 46. With guide 38 frees from sealing skirt 46, skirt 46 expands to its unrestricted full size. Optionally, due to the fact that the position of the atrial seal skirt is adjustable, the atrial seal skirt deployment button 39 is used to expand the atrial seal skirt 46 close to the desired deployment location.
[0115] An atrial positioning rod 44 must then be inserted over each suture 45 so that a portion of each suture 45 extends within the inner rod lumen 62 and a portion of each suture extends beyond the proximal end 61 of the positioning rod 44. Referring to Figures 13A and 13B, the positioning rod 44 is then inserted through the atrial seal skirt guide 38 and a portion of the cord 21 is received by the inner rod lumen 62 of the rod 44 and the distal end 54 of the positioning rod (with the detachable latch 56 secured thereto) is adjacent to the atrial seal skirt 46. The positioning rods 44 are pushed down by the user until the seal skirt is in a desired position. in relation to the tricuspid ring.
[0116] The position of the atrial seal skirt 46 does not require the pulling of a tether 18 through the ventricular apex of the heart 2, due to the fact that the atrial seal skirt 46 moves freely by the tether 18 until the desired position of the exit 46 is reached. After the desired valve position is reached, the at least one atrial positioning rod 44 urges the atrial seal skirt 46 into position and is locked in place by a detachable latch 56 nested within each conduit 53 and connected to the end of each rod of positioning 44. The atrial sealing skirt 46 can be repositioned or retrieved until the release of the sutures 45 that extend through each atrial positioning rod 44
[0117] As shown in Figures 15A and 15B, the positioning of the atrial seal skirt 46 within the right atrium 3 so that the upper edge of the atrial skirt 47 conforms to the topography of the right atrial floor 4 is shown. Through the atrial end sealing skirt delivery system 41, the physician advances one or more atrial positioning rods 44 so that the atrial sealing skirt 46 translates by one or more strands 21, which extend through one or more conduits. 53, defined by the atrial skirt body 48. As shown in Figure 15B, as the atrial seal skirt 46 advances toward the right ventricle 6, the upper edge of the atrial skirt 47 contacts the atrial floor 4, and the or more extension members 49 flex differentially according to local anatomy. Due to the fact that each atrial positioning rod 44 is pushed with differential force, precise amounts of tension are achievable and therefore more or less flexion of the extension members 49 to facilitate the conformation of the upper edge of atrial skirt 47 around the entire the perimeter of the atrial floor 4 to limit regurgitation through the tricuspid valve orifice.
[0118] Figure 22 illustrates the conversion of the upper edge of atrial skirt 47 from concave to convex. As the valve is pushed down to the atrial floor 4 by the atrial positioning rod 44 (Figures 15A and 15B), which is attached to the extension member base 50 of the extension member 49, the extension member tip 51 flexes upward, conforming to the convex atrial floor anatomy. Further distal movement of valve 100 (shown from left to right in Figure 22) further modifies the shape of seal skirt 46 as it conforms to the atrial floor and as extension member base 50 is urged downward by the positioning rod atrial 44 (Figures 13A, 15A and 15B). By way of example only, the description of the positioning and conformation of the atrial seal skirt 46, as described above, refers to the positioning of the atrial seal skirt 46 on the left atrial floor 9, thus limiting regurgitation through the mitral valve orifice 10.
[0119] Now referring to Figures 19A and 19B, the pulling of the retraction hypotube 58 causes the retraction of the locking tab 59, which pushes the locking tabs 63, engaging the cord 21. More specifically, the second hypotube 58 is retracted and due to its connection to the locking tab 59, it also retracts the locking tab 59. The locking tab 59, upon retraction, contacts the contact points 64 of the first door hypotube 57, disconnecting the tab 59 allowing it to the second hypotube 58 is removed. Once the retraction hypotube 58 is pulled, the inner portal hypotube arms 57 are pushed inward, allowing the portal hypotube to be removed. The first port hypotube 57 is beneficial as the cord 21 is locked while the second hypotube 58 is being retracted. Port hypotube 57 is then removed, leaving tab 59 within conduit 53 of atrial seal skirt 46. Figure 20A shows a cut away view of a fully engaged latch. According to one aspect, the positioning rod 44 can be integrated with the door hypotube or detachably connected thereto. Figure 20B shows an intact view of a fully engaged latch. It should be noted that the Depositor's Order locking system under the serial number. US 15/943,792 can be employed in place of the locking system described in the present invention. Locking systems can be employed in each system without departing from the spirit and scope of the present invention.
[0120] As illustrated in Figures 21A and 21B, with the atrial sealing skirt securely conforming to the atrial floor 4, the suture cutter 65 is advanced through the sutures 45 and to the upper edge of the atrial skirt 47. The suture cutter 65 cuts and releases the distal end of each suture 45 above the detachable latch 56. The sutures 45 and suture cutter 65 must then be removed from the heart 2
[0121] In one aspect, prior to cutting the sutures 45, the atrial sealing skirt 46 can be retrieved or repositioned. For example, if it is determined that the atrial seal skirt must be removed or repositioned, an atrial positioning rod 44 is positioned over each suture so that a portion of the suture is in the inner rod lumen 62. When distal end 54 of the positioning rod is adjacent to or in contact with detachable latch 56, the advancement of port hypotube 57 and retraction hypotube 58 secures the detachable latch to the distal end of the positioning rod, thereby unlocking the lanyard latch 21. With each rope unlocked, the valve can be removed from and/or repositioned at the implementation site 5.
[0122] In another aspect, the atrial seal skirt 46 can be repositioned and/or removed days to weeks after valve implementation. In this regard, the sutures are not cut but wrapped around a spool or other surrounding device. This device is then attached to the valve at the upper edge of the atrial skirt 47. Days after valve implementation and procedure completion, the spool/wraparound device can be recaptured, allowing the unwinding and retrieval of the sutures. An atrial positioning rod 44 is then positioned over each suture so that a portion of the suture is in the inner rod lumen 62. When the distal end 54 of the positioning rod is adjacent to or in contact with the releasable latch 56, the advancement of port hypotube 57 and retraction hypotube 58 secures the detachable latch to the distal end of the positioning rod, thereby unlocking the cord latch 21. With each cord unlocked, the valve is removed from and/or repositioned at the implementation site 5.
[0123] Although several aspects of the invention have been disclosed in the foregoing descriptive report, it is understood by those skilled in the art that many modifications and other aspects of the invention will occur to which the invention relates, taking the benefit of the teaching presented in the foregoing description and in the associated drawings. It is understood that the invention is not limited to the specific aspects disclosed in the present invention above, and that many modifications and other aspects are intended to be included within the scope of the appended claims. Furthermore, although specific terms are used in the present invention, as well as in the following claims, they are used only in a generic and descriptive sense, and not for purposes of limiting the described invention.

权利要求:
Claims (28)
[0001]
1. Medical kit for minimally invasively implanting an atrial seal skirt (46) in the heart (2) at an atrial seal skirt deployment site (5, 10), comprising: an atrial seal skirt (46) configured to receiving a valve and for endovascular introduction and implantation at an implementation site (5,10) and configured and sized to replace a native heart valve, said atrial seal skirt (46) having a portion being configured to fit a floor atrial (4, 9) adjacent to the valve deployment site (5, 10); an anchor assembly (101, 102) configured and sized for endovascular delivery to deploy an anchor (75) in an intracardiac wall (7) in a deployment site and comprising a delivery cable (12); a tether (18) advanced over said delivery cable (12) and includes at least one cord (21) connected to said anchor (75) and said sealing skirt atrial (46) to connect operationally said atrial seal skirt (46) and said anchor (75); characterized in that the medical kit further comprises: a removable anchor delivery system for introducing said anchor (75) endovascularly; and a removable atrial seal skirt delivery system (37) for positioning and sealing the atrial seal skirt (46).
[0002]
2. Medical set according to claim 1, characterized in that said anchor set (101, 102) comprises: an anchor cap (16) having a proximal and distal end; an anchor screw (17) extending from the distal end of the anchor plug (16) and configured for penetration a predetermined distance into the intracardiac wall (7) at the site of implantation; and at least one latch in said anchor plug (16) to lock said tether (18), said latch being selectively moved from a first locked position to a second unlocked position.
[0003]
3. Medical set according to claim 2, characterized in that said at least one latch is a locking arm (78) extending radially outward from said anchor cap (16).
[0004]
4. Medical set according to claim 2, characterized in that said anchor (75) comprises at least two of said latches.
[0005]
5. Medical set according to claim 1, characterized in that said anchor set (101, 102) further comprises: an anchor cap (16) having a proximal and distal end wherein said proximal end (77 ) includes a first surface configuration; an anchor screw (17) extending from the distal end of the anchor plug (16) and configured for penetration a predetermined distance into the intracardiac wall (7) at the implantation site; and said delivery cable (12) comprises a distal end (14) having a second surface configuration configured to mate with said proximal end surface configuration (77) of anchor plug (16).
[0006]
6. Medical set according to claim 5, characterized in that said delivery cable (12) comprises a flexible wire (13).
[0007]
7. The medical set of claim 5, characterized in that said first anchor plug surface configuration (16) is defined by a cavity having threaded side walls and said second configuration of said distal end (14 The delivery cable (12) is an outer surface configuration that is threaded to engage and engage said anchor cap (16), wherein said anchor delivery cap rotates said anchor cap (16) when forced. rotations are applied to it.
[0008]
8. Medical set according to claim 5, characterized in that said tether (18) comprises: a mooring ring (20) defining a central opening for receiving at least a portion of the delivery cable (12); and at least one tether rod (19) movably connected to said mooring ring (20).
[0009]
9. Medical set according to claim 8, characterized in that said anchor cap (16) comprises at least one latch, said latch being selectively moved from a first locked position to a second unlocked position and said mooring ring (20) of tether (18) cooperates with said at least one anchor cap latch (16) to secure the tether (18) to the anchor cap (16) when said latch is in said first position.
[0010]
10. Medical set according to claim 9, characterized in that said at least one tether rod (19) is rotatably connected to said mooring ring (20) and is rigid.
[0011]
11. Medical set according to claim 10, characterized in that a distal end of said tie rod (19) defines a hook (72) and said mooring ring (20) includes an eyelet (70) configured to receive said hook (72).
[0012]
12. Medical set according to claim 8, characterized in that said tether (18) additionally includes at least one suture (45) extending from a proximal end (77) of said at least tether rod (19).
[0013]
13. Medical set according to claim 12, characterized in that said tether (18) comprises at least two of said tether rods (19) and each of said at least two of said sutures (45) extending from a respective one of said tie rods (19).
[0014]
14. Medical set according to claim 2, characterized in that said anchor delivery set comprises: an anchor delivery guide (25) defining a longitudinally extending lumen and having a proximal and distal end; anchor delivery rod (29, 121) defining a longitudinally extending lumen and having a proximal and distal end and having a distal portion wherein the side walls of said delivery rod lumen have a second configuration and wherein a proximal portion of said anchor plug (16) includes a first configuration to cooperate with said second delivery rod lumen configuration to selectively engage therewith for implantation of said anchor bolt (17, 114) at the implantation site.
[0015]
15. The medical kit of claim 14, wherein said anchor delivery assembly further comprises a sheath (24) defining a longitudinally extending lumen to receive a portion of said anchor delivery guide (25 ), said sheath (24) having a length less than the length of said anchor delivery guide (25) defined between said proximal and distal ends.
[0016]
16. The medical set of claim 15, further comprising a guide loop (26) for receiving a proximal portion of said anchor delivery sheath.
[0017]
17. Medical set according to claim 1, characterized in that it further comprises a J wire (34) configured for endovascular insertion to guide said anchor delivery system.
[0018]
18. The medical set of claim 14, characterized in that said anchor delivery system further comprises a rotatable loop (30) at a proximal end of said delivery rod (29, 121) to facilitate rotation of the said delivery rod (29, 121) for rotating said anchor (75).
[0019]
19. Medical set according to claim 1, characterized in that said tether (18) further comprises at least one suture (45) extending from a proximal end of said at least one cord (21).
[0020]
20. The medical set of claim 1, further comprising a tether delivery assembly (137) comprising a removable tether delivery sheath defining a longitudinally extending lumen configured to receive said tether (18 ).
[0021]
21. Medical set according to claim 1, characterized in that said atrial skirt delivery system comprises: an atrial seal skirt delivery guide (38) having proximal and distal ends and defining an extension lumen guide wire (40) therebetween wherein a delivery sheath is removable and positioned along said delivery cable (12) and wherein said sheath includes said atrial sealing skirt (46) operatively connected to said cord (21) which extends within a lumen of said sheath.
[0022]
22. Medical set according to claim 21, characterized in that said tether (18) comprises a mooring ring (20) defining a central opening for receiving the flexible wire (13) of the delivery cable (12) and at least one tether rod (19) movably connected to said mooring ring (20) and said delivery guide also includes said tether (18) within said lumen, wherein said atrial sealing skirt ( 46) is connected to said tether (18) within said lumen.
[0023]
23. The medical set of claim 22, characterized in that said atrial skirt delivery system further comprises an atrial seal skirt implementation button (39) having a central channel for receiving a proximal portion of said atrial seal skirt delivery guide (38) and wherein said atrial seal skirt delivery guide (38) is retractable within said atrial seal skirt implementation button (39) when retracted.
[0024]
24. The medical set of claim 23, characterized in that said atrial skirt delivery system further comprises at least one positioning rod (44) having a central lumen to be inserted over said at least one cord (21) of said tether (18) and wherein said at least one positioning rod (44) is of sufficient length to extend proximal to said implementation knob (39) and into the heart (2), so contacting said atrial sealing skirt (46).
[0025]
25. Medical set according to claim 1, characterized in that it further comprises a locking system (55) to lock said atrial sealing skirt (46) positioned on the atrial floor (4, 9) and in which the said atrial skirt delivery system further comprises at least one positioning rod (44) having a central lumen to be inserted over said at least one strand (21) of said tether (18), said atrial sealing skirt (46). ) comprising an atrial upper edge (47), and said locking system (55) comprises at least one conduit (53) extending below said upper edge (47) and wherein said upper edge (47) defines at least an opening of said conduit (53) and said locking system (55) further comprises a detachable lock (56) positioned within said conduit (53) configured to cooperate with said at least one positioning rod (44) for locking. var said upper edge (47) on the atrial floor (4, 9).
[0026]
26. Medical set according to claim 25, characterized in that said detachable lock (56) defines a central lumen and said cord (21) of said tether (18) is received within said lock lumen.
[0027]
27. Medical set according to claim 26, characterized in that said locking system (55) further comprises a first access hypotube (57) defining a central lumen and configured to receive by said detachable locking lumen and configured to cooperate with said detachable latch (56) to secure said at least one strand (21).
[0028]
28. The medical kit of claim 1, wherein said atrial sealing skirt (46) defines a valve receptacle and said medical kit comprises a valve within said valve receptacle.

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法律状态:
2021-03-23| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-07-20| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-09-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/04/2018, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201762481846P| true| 2017-04-05|2017-04-05|

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US62/481,846|2017-04-05|

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US201762509587P| true| 2017-05-22|2017-05-22|

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US62/509,587|2017-05-22|

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US201762558315P| true| 2017-09-13|2017-09-13|

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US62/558,315|2017-09-13|

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US15/943,792|US10820991B2|2017-04-05|2018-04-03|Transcatheter atrial sealing skirt, anchor, and tether and methods of implantation|

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US15/943,792|2018-04-03|

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PCT/US2018/026118|WO2018187495A1|2017-04-05|2018-04-04|Transcatherer atrial sealing skirt, anchor, and tether and methods of implantation|

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