MATERIAL REMOVAL DEVICE AND METHOD OF USE

专利摘要:
"Material removal device and method of use". It is a catheter having a tubular body and a swiveling rod 5 disposed within a lumen of the tubular body. a cutting element is coupled to the rotating rod, with the cutting element having a cutting edge, the cutting element and the rotating rod being longitudinally movable within the tubular body between a stored position in which the cutting element is parallel to a longitudinal geometrical axis of the tubular body 10 and a cutting position in which the cutting element is offset between the proximal and distal ends of the tubular body to extend and beyond an outer diameter of the tubular body. The cutting element is configured to cut material from a vessel wall at a treatment site as the catheter is pushed distally through the treatment site. The catheter includes a collection chamber positioned proximal to the sectioning window.
公开号:BR102013001253A2
申请号:R102013001253-0
申请日:2013-01-17
公开日:2018-03-20
发明作者:Kusleika Richard
申请人:Covidien Lp；
IPC主号:

专利说明:

(54) Title: MATERIAL REMOVAL AND METHOD OF USE (51) Int. Cl .: A61B 17/3207 (30) Unionist Priority: 17/01/2012 US 61 / 587,369 (73) Holder (s): COVIDIEN LP (72) Inventor (s): RICHARD KUSLEIKA (74) Attorney (s): DANNEMANN, SIEMSEN, BIGLER & IPANEMA MOREIRA (57) Summary: MATERIAL REMOVAL DEVICE AND METHOD OF USE. It is a catheter that has a tubular body and a rotating rod 5 disposed within a lumen of the tubular body. A cutting element is coupled to the rotating shaft, the cutting element having a cutting edge, the cutting element and the rotating shaft are longitudinally movable within the tubular body between a stored position in which the cutting element is parallel to a longitudinal geometric axis of the tubular body 10 and a cutting position in which the cutting element is offset between the proximal and distal ends of the tubular body to extend E, in addition to an outside diameter of the tubular body. The cutting element is configured to cut material from the wall of a vessel at a treatment site as the catheter is pushed distally through the treatment site. The catheter includes a collection chamber positioned proximal to the cutting window.
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Descriptive Report of the Invention Patent for MATERIAL REMOVAL DEVICE AND METHOD OF USE.
FIELD OF THE INVENTION
The present invention relates to catheters used to remove and collect material from a treatment site in a body lumen. More particularly, this invention relates to atectectomy catheters for the treatment of vascular disease.
BACKGROUND OF THE INVENTION
Atherosclerosis is a progressive disease of the vascular system by which atheroma is deposited on the inner walls of blood vessels. Atherosclerosis is a complex degenerative condition that results in the concentration of cholesterol, calcium and other obstructive materials, known as plaque, on the walls of arteries. The accumulation of plaque narrows the inner lumen of the arteries, which reduces blood flow.
Plaque occurs in arteries in several different ways and can be located in many different anatomies throughout the arterial system. The plaque varies in composition, with portions that are hard and fragile, referred to as calcified plaque and other portions that are greasy or fibrous. Over time, atheromatous deposits can become large enough to reduce or occlude blood flow through the vessels, which leads to symptoms of low blood flow such as lameness (pain in the legs when walking or at rest), skin ulcer, critical limb ischemia and other symptoms. To treat this disease and improve or resolve these symptoms, it is desirable to restore or improve blood flow through the vessel.
Various means are used to restore or improve blood flow through atheromatous vessels. Atheroma deposits can be displaced by diametrical vessel expansion by inflatable balloons, expansion stents and other methods. Deposits can be fragmented by using lasers and other methods. Atherectomy catheters can be used to remove atheromatous deposits from the blood vessel.
Many types of atherectomy catheter devices have been proposed that include catheters with rotating burrs, lasers for photodisol2 / 35 see tissue and cutting balloon catheters. The various catheter modalities described in this document incorporate improvements in relation to the structure of the catheters and the methods of use and production.
SUMMARY OF THE INVENTION
Various catheter modalities, optional features and methods of use and production are disclosed in this document. Distinct features that can be included in these catheter modalities and methods are described below in connection with specific modalities or methods. It is intended that the catheters and methods described in this document may include one or more of these resources, either individually or in combination, and it is not intended that this disclosure be limited to the specific combination of resources described in connection with the modalities or methods disclosed in the this document.
In one embodiment, a catheter for removing material from a body lumen generally comprises a tubular body that has proximal and distal ends, a longitudinal geometric axis, a lateral opening adjacent to the distal end of the tubular body and a lumen that extends along the axis longitudinal geometric body; a rotating rod disposed within the lumen of the tubular body and having proximal and distal ends and a longitudinal geometric axis extending between its proximal and distal ends; a ramp coupled to the tubular body adjacent to the distal end of the body and having an angular surface generally opposite to the lateral opening; and a flexible cutting element that has proximal and distal ends, a longitudinal geometric axis that extends between its proximal and distal ends, and a axis of rotation that extends between its proximal and distal ends, the proximal end of the cutting element is coupled to the rotating rod to provide rotation of the cutting element about its axis of rotation and the distal end of the cutting element which has a cutting edge adapted to cut material from the body lumen. The cutting element and the rotating rod are movable longitudinally within the tubular body between a stored position, in which the cutting element is received in the tubular body, and the cutting position, in the
3/35 which the cutting element engages the angular surface of the ramp and is deflected along its longitudinal geometric axis such that at least a portion of the longitudinal geometric axis of the cutting element is not parallel to the longitudinal geometric axis of the tubular body and by at least a portion of the cutting edge extends through the side opening.
The catheter may further include a tilt member coupled to the rotating shaft and configured to tilt the cutting element towards the stored position. The tilt member may include a lock coupled to the tubular rod proximal to the side opening and a retraction member attached to the lock and the distal end of the rotating rod. As the cutting element is extended longitudinally from the stored position to the cutting position, the retracting member is compressed, which creates a retracting force that retracts the cutting element from the cutting position to the stored position. The catheter lock can be a retraction ring and the retraction member can be a retraction spring.
The catheter may include that the rotating rod has a wall that defines a lumen and the catheter may also include a material collection chamber positioned within the tubular body at a location proximal to the lateral opening. The catheter may include an end cone distal to the lateral opening, the end cone housing an imaging transducer. The end cone may further include a luminal wall and at least one groove, and the imaging transducer may be capable of 360 ° imaging of the vascular lumen through the luminal wall and groove of the end cone. The catheter may further include a lumen guidewire that extends along an external surface of the tubular body.
The catheter may include a handle attached to a proximal portion of the tubular body, the handle includes a power supply, a motor coupled to the power supply, and a meat follower attached to the rotating rod, where the motor is configured to transmit rotation and distal movement towards the cam follower and the rotating rod when energized by the power supply to thereby move the cutting element from the stored position to the cutting position. The handle can also include
4/35 a cylindrical cam coupled to the motor, the cylindrical cam comprises a spiral groove configured to receive a projection from the cam follower, in which the rotation of the cylindrical cam by the motor extends longitudinally the projection of the cam follower within the spiral groove from the cylindrical cam from the initial position at the proximal end of the spiral groove to an extended position towards a distal end of the spiral shank, which in this way extends the rotating rod and cutting element longitudinally from the stored position to the position of cut.
The catheter may include a controller that has a body that defines a lumen sized to accept the tubular body, the controller even has opposing rod engagement elements within the body, a lever and an activating member where the lever is movable in one engaged position by which the rod engaging elements engage the tubular body and engage the activation member in communication with the power supply to energize the motor and the disengaged position by which the body is free to rotate and move axially on the elongated tubular rod and communication is interrupted to the power supply.
The catheter can include a rotating rod that is metallic and the portion of the rotating rod can be cut in a spiral. In another embodiment, a catheter generally comprises:
a tubular body having proximal and distal ends and a lateral opening positioned proximal to the distal end of the tubular body; a rotating rod disposed within the lumen of the tubular body, the rotating rod having proximal and distal ends; a cutting element coupled to the rotating rod, the cutting element having a cutting edge; a cam follower secured to the rotating rod adjacent to the proximal end of the rotating rod; and a handle attached to the tubular body adjacent to the proximal end of the tubular body, the handle which includes a motor and a cylindrical cam coupled to the motor and the cam follower. The cutting element and the rotating rod are movable longitudinally within the tubular body between the stored position in which the cutting element is received in the tubular body, and the cutting position in which at least one
5/35 portion of the cutting edge extends through the side opening. The motor is configured to transmit rotation to the cylindrical cam to both translate the cam follower and to move the cutting element from the stored position to the cutting position and to give rotation to the cam follower when the cutting element is in the cutting position to rotate the cutting element on its axis of rotation.
The cylindrical cam may have a spiral groove and the cam follower may have a projection and in which a rotation of the cylindrical cam by the motor extends the rotating rod in the body longitudinally by the movement of the cam follower projection within the spiral groove of the cam cylindrical from the initial position at the proximal end of the spiral groove to the extended position towards the distal end of the spiral groove which, in this way, extends the rotating rod longitudinally from the stored position to the cutting position. The catheter may also include a tilt member coupled to the cylindrical cam configured to tilt the cam follower in the initial position of the cylindrical cam which, thus, tilts the cutting element towards the stored position. The tilt member may have a lock attached to the rotating rod and a retraction member attached to the lock and the proximal end of the cylindrical cam. Compression of the retracting member creates a retracting force that returns the cam follower pin from the extension position within the spiral groove of the cylindrical cam to the initial position of the spiral groove of the cylindrical cam when the rotation of the cylindrical cam is stopped, in this way it returns the cutting element from the cutting position to the stored position. The retraction member can be a retraction spring and the lock can be a nut.
The handle can include a depth of cut controller coupled to the rotating rod to selectively control the distance at which the cutting edge extends beyond the outer diameter of the tubular body in the cutting position. The cutting depth controller may have a nut that has more than one notched distance marker and a cutting depth adjustment member that has a movable lever, in which the
6/35 the cutting depth adjustment member is coupled in an adjustable way to the nut, the movable lever is accepted in one of the notched distance markers. Each notched distance marker marks the distance that the cam follower will extend longitudinally, which in this way marks the distance that the rotating rod and cutting element will extend lõhgitüdinally. The catheter can be further configured in such a way that the cutting depth adjustment member is coupled in an adjustable way to the nut, the shorter the distance from the initial position of the cylindrical cam to the nut, the less the cam follower will extend longitudinally. which, in this way, marks the distance that the rotating rod and the cutting element will extend longitudinally.
The catheter may include a tilt member coupled to the cylindrical cam and the rotating rod and configured to tilt the cam follower in the initial position of the cylindrical cam which, therefore, tilts the cutting element towards the stored position. The catheter can be configured in such a way that the compression of the tilt member creates a retraction force and in which a retraction force returns the cam follower pin from the extension position within the spiral groove of the cylindrical cam to the initial position of the spiral groove of the cylindrical cam when rotation of the cylindrical cam is interrupted which, in this way, returns the cutting element from the cutting position to the stored position.
The catheter may include an end cone distal to the lateral opening, the end cone housing an imaging transducer. The end cone has a luminal wall and at least one groove, and the imaging transducer is capable of 360 ° imaging of the vascular lumen through the luminal wall and the groove of the end cone.
The catheter may include a controller that has a body that defines a lumen sized to accept the tubular body. The controller may also have opposing rod engagement elements within the body, a lever and an activating member. The controller can be configured so that the lever is movable in an engaged position whereby the rod coupling elements engage the tubular body and engage the activation member in communication with the power supply to energize the motor and a disengaged position by which the body is free to rotate and move axially on the elongated tubular rod and communication is interrupted with the power supply.
In yet another embodiment, a method of removing material from a treatment site within a body lumen generally comprises advancing a catheter within the body lumen to a treatment site in the body lumen. The catheter includes a tubular body that has proximal and distal ends, a longitudinal geometric axis, a lateral opening adjacent to the distal end of the tubular body and a lumen that extends along the longitudinal geometric axis of the body, a rotating rod arranged within the lumen of the tubular body and which has proximal and distal ends and a longitudinal geometric axis that extends between its proximal and distal ends, a ramp coupled to the tubular body adjacent to the distal end of the body and which has an angular surface generally opposite to the lateral opening , and a flexible cutting element having proximal and distal ends, a longitudinal geometric axis extending between its proximal and distal ends, and a axis of rotation extending between its proximal and distal ends, the proximal end of the cutting is coupled to the rotating shaft to give rotation to the cutting element on its axis of rotation, and the end apart from the cutting element which has a cutting edge adapted to cut material from the body lumen. The method further comprises moving the rotating rod and the cutting element into the tubular body longitudinally after said catheter advance to move the cutting element from the stored position in which the cutting element is received in the tubular body to the cutting position in the which the cutting element engages the angular surface of the ramp and is deflected along its longitudinal geometric axis in such a way that at least a portion of the longitudinal geometric axis of the cutting element is not parallel to the longitudinal geometric axis of the tubular body and by at least a portion of the cutting edge extends through the side opening. The catheter
8/35 advances distally along the body lumen with the cutting element in the cutting position to move the cutting edge of the cutting element along the treatment site to cut material from the treatment site.
In another embodiment, a method of removing material from a treatment site within a body lumen generally comprises advancing a catheter within the body lumen to a treatment site in the body lumen. The catheter includes a tubular body that has proximal and distal ends and a lateral opening positioned proximal to the distal end of the tubular body, a rotating rod disposed within the lumen of the tubular body, the rotating rod having proximal and distal ends, a cutting element coupled to the rotating rod, the cutting element having a cutting edge, a cam follower secured to the rotating rod adjacent to the proximal end of the rotating rod, and a handle attached to the tubular body adjacent to the proximal end of the tubular body, the handle includes a motor, and a cylindrical cam coupled to the motor and the cam follower. The motor is activated after said advance of the catheter to transmit rotation to the cylindrical cam to confer both i) translation to the cam follower to move the rod and the cutting element longitudinally from the stored position in which the cutting element is received in the tubular body for the cutting position in which at least a portion of the cutting edge extends through the side opening, ii) rotation to the cam follower to rotate the shank and the cutting element after moving the cutting element to the cutting position . The catheter is distally advanced through the body lumen with the cutting element in the cutting position to move the cutting edge of the cutting element along the treatment site to cut material from the treatment site.
The catheter according to any of the above methods can include a tilt mechanism coupled to the rotating rod and configured to tilt the cutting element towards the stored position. The method may include that the step of moving the cutting element from the position stored within the tubular body to an extended cutting position compresses the tilt mechanism and creates a retracting force. In that
9/35 method, the step of retracting the cutting element from the extended cutting position to the stored position can be performed by a retraction force created by the compression of the tilting mechanism in which as a retracting force of the tilting mechanism is released , the color element 5 is retracted longitudinally.
The catheter handle according to any of the above methods can be coupled to the proximal end of the tubular body, and can have a power supply, a motor, and a cylindrical cam coupled to the motor. The cylindrical cam may have a spiral groove and a ca10 m follower attached to the rotating rod. The cam follower may have a pin configured to be received within the spiral groove of the cylindrical cam.
The step of moving the cutting element from the position stored within the tubular body to an extended cutting position can be performed by rotating the cylindrical cam that moves the cam follower pin within the spiral groove of the cylindrical cam from the initial position at the end proximal of the spiral groove to an extended position towards the distal end of the spiral groove which, in this way, extends the rotating shaft longitudinally and extends the cutting element portion to an angular surface of the ramp opposite the lateral opening and extends the cutting edge through the side opening plus an outer diameter of the tubular body.
The catheter according to any of the above methods can include a depth of cut controller coupled to the rotating shaft. The method may include the step of selectively controlling a depth of cut in which the cutting edge extends beyond the outer diameter of the tubular body in the cutting position.
The depth-of-cut controller according to any of the above methods can include a depth-of-cut adapter with an adjustable lever attached to the nut that has at least one notched distance marker, the lever being configured to be received within the at least one notched distance marker, the at least one notched distance marker being configured to be of a specific cutting depth of the cutting element. O
The catheter of the method may further include a gap between the proximal end of the cylindrical meat and the distal end of the nut, the gap has a length and the tilting mechanism is coupled to the proximal end of the cylindrical meat and the distal end of the nut.
The step of selectively controlling the distance at which the cutting edge extends beyond the outer diameter of the tubular body in the cutting position also includes that the length of the gap is controlled by the adjustable coupling of a cutting depth adapter to the nut and receiving the lever on the notched distance marker and as the pin of the meat follower moves inside the spiral groove of the cylindrical meat from the initial position towards the extension position, the nut extends longitudinally towards the proximal end of the cylindrical meat and compresses the tilt mechanism. The step of selectively controlling the distance at which the cutting edge extends beyond the outer diameter of the tubular body in the cutting position also includes that the shorter the length of the gap, the less the cutting edge extends beyond the diameter of the tubular body in the cut position.
The step of moving the cutting element from the position stored within the tubular body to an extended cutting position further includes that the compression of the tilt mechanism creates a retracting force. The step of retracting the cutting element from the extended cutting position to the stored position can be performed by a retraction force created by the compression of the tilting mechanism in which, as the rotation of the cylindrical cam is interrupted, a retraction force of the mechanism of inclination is released, which retracts the pin of the meat follower from the extended end of the spiral groove to the initial end of the spiral groove.
These and other aspects of the invention will become apparent from the following description of preferred embodiments, drawings and claims. Details of one or more embodiments of the invention are presented in the attached drawings and in the description below. Other features, objectives and advantages of the invention will become apparent from the description and drawings and from the claims.
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DESCRIPTION OF THE DRAWINGS
Figure 1A is a schematic view of a fragmentary longitudinal sectional view of a distal end portion of an atherectomy catheter with a cutting element in the stored position;
Figure 1B is similar to Figure 1A, except with the cutting element in the cutting position;
Figure 1C is a schematic fragmentary cross-sectional view of a distal end portion of an alternative embodiment of the atherectomy catheter;
Figure 2A is a schematic fragmentary cross-sectional view of a cutter guide for the atherectomy catheter of Figures 1A and 1C with a cam follower in the initial position in relation to the cylindrical cam;
Figure 2B is similar to Figure 2A, except with the cam follower in an intermediate position in relation to the cylindrical cam;
Figure 3 is a schematic fragmentary top view of the cam follower and the cylindrical cam;
Figure 4 is a schematic view of a side view of a controller and the cutter guide of Figure 2A;
Figure 5A is a schematic longitudinal sectional view of the controller;
Figure 5B is a schematic cross-sectional view of the controller;
Figure 6 is a schematic fragmentary longitudinal sectional view of a distal end of a second embodiment of the atherectomy catheter;
Figure 7A is a schematic fragmentary longitudinal sectional view of a distal end of a third embodiment of the atherectomy catheter with a cutting element in the storage position;
Figure 7B is similar to Figure 7A, except with the cutting element in the cutting position;
Figure 8 is a schematic longitudinal sectional view of a
12/35 housing a cutter guide for the atherectomy catheter of Figure 7A with a depth of cut adjuster;
Figure 9 is a schematic fragmentary end view of a proximal end of the depth of cut adjuster;
Figure 10A is a circuit diagram of a first embodiment of a guiding circuit in a first configuration;
Figure 10B is similar to Figure 10A, except that the guiding circuit is in a second configuration;
Figure 11A is a circuit diagram of a second mode10 of a guiding circuit in a first configuration;
Figure 11B is similar to Figure 11 A, except that the guiding circuit is in a second configuration.
DETAILED DESCRIPTION
Apparatus in accordance with embodiments of the present invention will generally comprise catheters having catheter bodies adapted for intraluminal introduction to the target body lumen. The dimensions and other physical characteristics of the catheter bodies will vary significantly depending on the body lumen that must be accessed. In the exemplary case of atherectomy catheters intended for intravascular insertion, the distal portions of the catheter bodies will normally be quite flexible and suitable for introduction through a guide wire to a target site within the vasculature. In particular, catheters can be intended for introduction onto the wire when a guide wire channel extends fully through the catheter body or for the introduction of rapid exchange where the guide wire channel extends only through the distal portion of the catheter body. In other cases, it may be possible to provide a fixed or integrated coil tip or guide wire tip in the distal portion of the catheter or even to dispense the guide wire entirely. For the convenience of the illustrations, guide wires will not be shown in all modalities, but it must be noted that they can be incorporated in any of these modalities.
Catheter bodies intended for intravascular introduction
13/35 will normally have a length in the range of 50 cm to 200 cm and an outside diameter in the range of 1 French to 12 French (0.33 mm = 1 French), usually 3 French to 9 French. In the case of coronary catheters, the length is normally in the range of 125 cm to 200 cm, the diameter is preferably below 8 French, more preferably below 7 French, and most preferably in the range from 2 French to 7 French. Catheter bodies will normally be comprised of an organic polymer that is manufactured by conventional extrusion techniques. Suitable polymers include polyvinyl chloride, polyurethane, polyester, polytetrafluoroethylenes (PTFE), silicone rubbers, natural rubbers, and the like. Optionally, the catheter body can be reinforced with interlacing, helical threads, coils, axial filaments or the like, to increase rotational force, column strength, resistance, moment and the like and the like. Suitable catheter bodies can be formed by extrusion, with one or more lumens being supplied when desired. The catheter diameter can be modified by expansion by heat and decrease by the use of conventional techniques. The resulting catheters will therefore be suitable for introduction to the vascular system, which includes both coronary and peripheral arteries, by conventional techniques.
The side openings or cutting windows of the atherectomy catheters of the modalities of the present invention can have a length of approximately 2 to 6 mm. In other embodiments, however, the opening or cutting window may be larger or smaller, but it should be large enough to allow the cutter to be propelled to a predetermined distance that is sufficient to cut or reduce the volume of material from the body lumen in a treatment site.
Figures 1 to 5B show various portions or features of a 2A atherectomy catheter. As shown in Figures 1A and 1B, catheter 2A has an end cone 3a, a tubular body 8 and a side opening 6. Catheter 2A also includes a flexible cutting element, generally indicated at 4, coupled to a rotating rod flexible 20, which is used to cut material from a blood flow lumen such as a vessel
Blood 14/35. The flexible cutting element 4 is coupled to a distal end of the flexible rotating rod 20. Cutting element 4 can comprise a first tubular member and the rod 20 can comprise a second tubular member. The first tubular member has an outer diameter dimensioned to be received within the inner diameter of the second tubular member so that an outer surface of the first tubular member can be connected or otherwise fixed to the inner surface of the second tubular member. By manipulating the rod 20, the cutting element 4 is movable between the stored position (Figure 1A) and the cutting position (Figure 1B). In the stored position, the axis of rotation of the cutting element 4 is parallel to the longitudinal geometric axis LA of the tubular body 8 as seen in Figure 1A. In the cutting position, the axis of rotation of the cutting element 4 is offset between the proximal and distal ends of the cutting element and at least a portion of a distal tip 19 of the cutting element 4 extends through the side opening 6 beyond an outer diameter of the tubular body 8 as shown in Figure 1B. The distal tip 19 can comprise a cutting edge 22. The distal tip 19 can also comprise abrasive material, tooth, fins or other similar structures (not shown) that fragment tissue or material without cutting. As the axis of rotation of the cutting element 4 is offset from the longitudinal geometric axis l_A of the tubular body 8 towards the lateral opening 6, the distal tip portion 19 extends out of the tubular body 8 and through the lateral opening 6 in addition to an outer diameter of the tubular body.
As described above, the flexible cutting element 4 and the rotating rod 20 can be comprised of multiple parts or tubular members subsequently grouped by welding, blasting, brazing, adhesive bonding, mechanical interlocking or other means. Alternatively, the cutting element 4 and the rotating rod 20 can be formed of a continuous part which can be a single tubular member that has sufficient flexibility in its distal end portion.
The flexible cutting element 4 and the rotating rod 20 can be made of any suitable material that has sufficient flexibility, for example
15/35 example, interlaced wires, helically wound wires or a solid tube that can be cut in a spiral to give additional flexibility. The flexible cutting elements 4 and rotating rod 20 can be made of any polymer or metal or suitable combination thereof. In addition, the cutting element 4, the rotating rod 20 or both can be a solid tube made of a suitable metal or polymer that has been provided with spiral cuts to give the tube additional flexibility.
As shown in Figure 1C, the distal tip 19 can be a separate part or element made of a material different from the material used in other portions of the cutting element 4. For example, the distal tip 19 can be provided with a material that is rigid enough , such as tungsten carbide, which can be formed into and maintained at the cutting edge 22 or other tissue fragmentation structure in a sharp condition. It should be noted that both the stem orientation 20 and the cutting element 4 can be made of the same materials or with different materials depending on the application.
During use, the distal end of catheter 2A is positioned close to a vessel treatment site with the cutting element 4 in the stored position (Figure 1A). The cutting element 4 is moved to the cutting position shown in Figure 1B by advancing the rod 20 distally. Then, catheter 2A can be moved distally through the vessel with the cutting element 4 in the cutting or working position and, at the same time, rotating on its central geometric axis as described in further details below. As catheter 2A moves through the blood vessel with the cutting edge 22 rotating in the cutting or working position, any tissue, cell debris, plaque, blood or other material cut or fragmented by the cutting edge of the cutting element 4 is directed in an emptied lumen 4a of the cutting element 4, and in a tissue chamber 12 positioned proximal to the cutting element 4. Tissue chamber 12 can be the deflated luminal portion of the rotating rod 20. In this design, the end cone Catheter 3a need not be sized to accommodate the tissue collection and can therefore be reduced in size or be
16/35 designed to accommodate viewing equipment as described in connection with Figure 6. Since the tissue collection chamber 12 is not limited in size by the size of the end cone 3a, it can be made of any desired size up to the length of the catheter body 8 near the cutting element 4.
A vacuum source (not shown) can be added to a proximal end of the tubular body 8 and can further assist in the collection and transportation of any cut and collected material at the treatment site. The vacuum source can suck up debris at the treatment site 10 in the emptied lumen 4a of the cutting element 4 and in the tissue chamber 12 of the rotating rod 20. Additionally, the vacuum source can be configured to suck up debris at the site of treatment, in the emptied lumen 4a of the cutting element 4, in the tissue collection chamber 12 and out through the proximal end of the catheter 2A. The vacuum source can control the suction of material that is collected and transported through pinch valves or other means of control depending on the application. In this way, the tissue chamber 12 is not limited by any storage or size restrictions and can have any desired length of the catheter body 8.
To expose the distal tip 19 of the cutting element 4 through the side opening 6, the rotating rod 20 and the cutting element coupled thereto are moved distally to the stored position. As the distal movement progresses, the cutting element 4 travels along a ramp 16a attached to the tubular body 8. The interaction between the cutting element 4 and the ramp
16a deflects the cutting element 4 in the cutting position in which the axis of rotation is deflected between the proximal and distal ends of the cutting element and away from the longitudinal geometric axis l_A of the catheter. As seen in Figure 1B, when the cutting element 4 is in the cutting position, a proximal portion of the cutting element has a rotation axis that is generally aligned with the longitudinal geometric axis LA of the catheter 2A while the distal portion of the cutting element section (including distal tip 19) has a rotation axis that is offset from the longitudinal geometric axis A of the catheter by
17/35 an angle α. The angle α is selected to be steep enough to expose the cutting edge 22 through the side opening 6 to a desired cutting depth CD without requiring the opening to be undesirably long. For example, angle α can be in the range of 10 ° to 30 °. The dimensions of the cutting depth CD can vary depending on the material to be cut, the vessel being treated and the application of the 2A catheter. As described in more detail hereinafter, the cutting depth CD can be adjusted so that the cutting depth can be controlled as desired depending on the application for which the catheter is used.
In some embodiments, catheter 2A may have a pre-formed curvature of the distal portion of the tubular body 8 which can assist in propelling the cutting element 4 against the surface of the luminal vessel in such a way that advancing distally from the entire body of the catheter 8 can move the rotary cutter through the occlusive material of the luminal vessel. Because the cutting element 4 has a cutting depth CD which is the distance beyond the outside diameter of the tubular body 8 of the catheter outside the side opening 6, the user does not need to invaginate the tissue in the side opening. The preformed impulse of the catheter 2A also assists in the distal advancement of the catheter by the tortuous anatomy of the vessel luminals.
Catheter 2A can be configured as a catheter over the wire or as a quick-exchange catheter, also known as a monorail catheter. For example, as shown in Figures 1A and 1B, the tip of catheter 2A may include a lumen 13 that has a distal opening and a proximal opening that are sized to receive a guide wire that is approximately 0.035 cm in diameter, approximately 0.045 cm in diameter, approximately 0.088 cm or any other suitable diameter.
With continued reference to Figures 1A and 1B, the catheter 2A may have a tilt mechanism, generally indicated at 7a, coupled to the distal end of the rotating rod 20, proximal to the side opening 6. The tilt mechanism 7a is configured to tilt the cutting element 4 towards the stored position. The tilt mechanism 7a can also help to prevent the cutting element 4 from extending outward
18/35 of the side opening 6 more than the desired cutting depth CD. The tilting mechanism 7a may include a lock 9 such as a continuous or discontinuous ring or other suitable means and a retraction member 10a such as the spring (e.g., a compression spring) or other suitable resilient member. The block 9 may be coupled to the tubular rod 8 at a location proximal to the side opening 6. One end of ^_ · retraction member 10a may be adjacent the proximal side block 9 and the other end may be adjacent the distal end of the rotating shaft 20. The distal end of the rotating rod 20 can optionally include a locking flange 21 to help reinforce the distal end of the rotating rod against the retracting member 10a. The retracting member 10a is in a rested or uncompressed condition when the cutting element 4 is in the stored position and is in the compressed condition when the cutting element is in the cutting position. When a force is applied to the rotating rod 20 to move the cutting element 4 distally from the stored position to the cutting position, the rotating rod compresses (roughly, deforms) the retracting member 10a. The compression of the retraction member 10a creates a retraction force that is stored within the tilt mechanism. When a force that compresses the resilient retraction member 10a is no longer applied, a retraction force stored by compressing the retraction member 10a pushes the rotating rod 20 proximally to the return of the cutting element 4 to the stored position.
As shown in Figure 1B, the force supplied to move the rotating rod 20 and the cutting element 4 from the stored position distally compresses the retracting member 10a between the distal end of the rod 20 and the lock 9 and creates a retraction force stored within the retraction member 10a. The locking flange 21 can reinforce the distal end of the rotating rod 20 to prevent wear of the rotation of the rod 20 against the retracting member 10a and / or any structural fatigue that may occur from the forces of compression. Compression of the retraction member 10a can continue until maximum compression of the retraction mem19 / 35 bro occurs against block 9, which produces a maximum cutting depth CD of the cutting element 4 through side opening 6. It must be understood that maximum compression retraction member 10a is not necessary and that less than full compression of the retraction member can occur depending on the application which, in this way, allows variability in the cutting depth of the cutting element 4. When a force is no longer applied to the shank rotary 20, a retraction force stored by compressing the retracting member 10a acts against the lock 9 and pushes the distal end of the rotating rod 20 in the proximal direction, thereby moving the cutting element 4 to the stored position.
With reference to Figures 1A and 1B, the cutting element 4 can have an inclined surface 24 that directs the cut fabric by the cutting edge 22 to the tissue chamber 12. The cutting edge 22 (and / or abrasive material, tooth, fins or other structure for fragmenting tissue) may be on a radial outer edge of the cutting element 4. In some embodiments, the sloped surface 24 may be a smooth, continuous surface free of teeth, fins or other features that hinder the smooth nature of the surface. In other embodiments, the inclined surface 24 may have a limited amount of teeth, fins or other resources that work to fragment and / or cut tissue.
As shown in Figures 2A and 2B, the rotating rod 20 extends through a lumen 18 in catheter 2A to an exemplary cutter guide or handle 5A that is coupled to the proximal end of catheter 2A. The cutter guide 5A includes a motor 11, a power supply 15 (for example, one or more batteries), a micro switch (not shown), a housing 17, and a rotation construction 25 to provide translation and rotation to the rotating rod 20 of motor 11.0 cutter guide 5A can act as a handle for the user to handle catheter 2A. A lever, driver, or other suitable actuation means (not shown), when actuated, close the micro switch, which electrically connects the power supply 15 to the motor 11, and in this way, rotates the rotating rod 20 and the cutting element 4. The cutting element 4 is
20/35 rotated at approximately 1 to 160,000 rpm, but can be rotated at any suitable speed depending on the particular application.
In the illustrated embodiment, rotation construction 25 includes a cylindrical cam 27 connected to an output rod (not shown) of the motor
11 and a cam follower 26 connected to the rotating rod 20, as shown in Figures 2A, 2B and 3. The cam follower 26 can be fixedly attached to the rotating rod 20 by welding, brazing, brazing, adhesive or interlocking mechanics or other means and can be made of metal such as steel or other metals or artificial polymer such as polyester, liquid crystal polymer, nylon, or other polymers. The cam follower 26 has a substantially cylindrical shaped body as shown in Figures 2A and 2B or can be other shapes. The cam follower 26 includes a projection 32 (e.g., a pin or roller) that extends out of the body. Projection 32 can be a pin-shaped member although other shapes are suitable. The cam follower 26 and the projection 32 can be separate parts that are suitably connected or joined or can be a single integrated part. For example, the projection 32 can be molded, welded, softly welded, adhesive-bonded, mechanically interlocked or other suitable means to the cam follower 26.
As best seen in Figure 3, the cylindrical cam 27 has a spiral groove 31 that accepts the projection 32 of the cam follower 26. In the illustrated embodiment, the spiral groove 31 extends through the wall of the cylindrical cam 27, although the groove spiral may instead be an internal groove in the inner surface of the cylindrical cam. The spiral groove 31 of the cylindrical cam 27 can have the starting position X towards the proximal end of the cylindrical cam, and an extended position Z towards the distal end of the cylindrical cam where the direction of rotation can be counterclockwise. as shown by arrows 38 in Fig. 30. It should be understood, however, that the position of the spiral groove 31 within the cylindrical cam 27 is not limiting and that the starting point can be located towards the distal end and the extended position can be to be
21/35 located towards the proximal end of the cylindrical cam 27 depending on the direction of rotation and the application. It should also be understood that the starting position X and the extended position Z do not need to be located at the ends of the spiral groove 31 and both can be located at any desired location within the spiral groove. It should also be understood that 0 the spiral groove 31 angle relative to geométri- longitudinal axis ^_ co cylindrical cam 27 can be varied to suit specific design requirements anatomies.
As the rotation is supplied to the cylindrical cam 27 of the motor 11, 10 the cam follower 26 is moved (that is, it moves linearly) as it follows the cylindrical cam inside the groove 21, which, in this way, provides translation or linear movement to the rod 20. In particular, the rod 20 and the cutting element 4 move distally, as shown by the arrow 35 in Figure 3, from the stored position shown in Figure 1A to the cutting position shown in Figure 1B . As the rotating rod 20 moves distally, a retraction force in the proximal direction is created by compressing the retracting member 10a. When the projection 32 of the cam follower 26 has completely advanced to the extended position Z of the spiral groove 31, the cam follower rotates with the cylindrical cam 27, which, in this way, gives the rod 20. rotating movement. cam follower 26 and stem 20, the distal movement of the cam follower, stem and cutting element 4 is interrupted and compression is maintained for the retracting member 10a. The length of the spiral groove 31 from the starting position X to the extended position Z can determine the distance that the cutting element 4 extends distally from the stored position to the cutting position. It is to be understood that the distance that the projection 32 of the cam follower 26 travels within the spiral groove 31 of the cylindrical cam 27 is not limiting and that the spiral groove can be given various lengths corresponding to various depths of cut as desired.
When the rotation of the cylindrical cam 27 by the motor 11 is interrupted, the rotation of the cam follower 26 is also interrupted, as well
22/35 such as that of the rotating rod 20 and the cutting element 4. Additionally, when the rotational force is interrupted, a retraction force stored by the compression of the retracting member 10a acts against the rotating rod 20 and pushes / retracts the rotating rod 20 proximally to the cut position for the stored position. The projection 32 of the cam follower 26 also retracts into the spiral groove 31 of the cylindrical cam 27 from the extended position Z towards the starting position X.
It should also be understood that if the retracting member 10a reaches maximum compression before the projection 32 reaches the extended position of the spiral groove 31, the distal movement of the rotating rod 20 can be interrupted while the rotation of the cam follower 26 and the cylindrical cam 27 is maintained. Therefore, the compression length of the retraction member 10a and, depending on the application, the compression length of the retraction member against blockage, can also be used to control the cutting depth of the catheter 2A. It should also be understood that, in some applications, the retracting member 10a may not be used and battery power, anti-rotation of the motor or alternative means may be used to return the cutting element 4 from the cutting position to the stored position.
Figures 4, 5A and 5B illustrate an optional controller 50 that can be swiveled and / or slidable coupled to the tubular body 8 and can be configured for use with one hand by a catheter operator 2A. Controller 50 is attached to handle 5A by wires 67 as will be described in more detail hereinafter. Controller 50 functions as an optional secondary controller that allows an operator to activate engine 11 and / or pick up the stem or tubular body 8 at a remote location on handle 5A that is near or at least closer to the access site to the catheter in the patient's body. The controller 50 comprises a body 52 that can have left and right housing halves, a lumen 51 that accepts the torque rod or tubular body 8, a button 54 and a lever, generally indicated at 55. The lever portion 55 extends from the body 52 through an opening in the body. Button 54 includes a member of
23/35 button compression 56 (Figure 5B) such as a spring or the like and is housed at one end in the receiving cavity 57 of the button 54. The other end of the button compression member 56 is received in compartment 58 of the body 52 Button 54 also includes a groove 59 that accepts lever 55 when the groove is aligned with the lever as described in more detail hereinafter. Button 54 has an extended or resting position and a pressed position. The button compression member 56 holds the button 54 in the extended or resting position until the button 54 is pressed by an operator.
Referring to Figure 5A, lever 55 includes teeth 60, the pivot pin 61 and a limb compression lever 62. When lever 55 is pressed, the tubular body 8 is clamped or compressed between the teeth 60 of the lever and a anvil 63 having teeth 64. In the illustrated embodiment, teeth 60, 64 are large body engaging elements. Controller 50 also includes an activator switch 65 that has an activator button 66 in electrical communication with control wires 67. Control wires 67 electrically connected to activator switch 65, battery 15 and motor 11 of the cutter guide 5A. Body 52, lever 55, anvil 63, teeth 60 and 64 and buttons 54 may be made of poly20 carbonate, nylon, or other materials and may be injection molded or otherwise manufactured in the desired configuration. Lever 55, button compression member 56, pivot pin 61, anvil and teeth 60 and 64 can also be comprised of metal such as steel, spring steel, or other metals, or artificial polymer such as polyester, polymer liquid crystal, nylon, or other polymers. The body 52 can be molded in two halves and the halves connected together by ultrasound, mechanical fitting, adhesives or other means.
Lever 55 is configured in such a way that a first quantity can be pressed to a first position when the button
54 is in the extended or resting position and to a second position when the button is pressed. When lever 55 is pressed to the first position, teeth 60 move towards teeth 64, which
24/35 results in stem 8 being caught between teeth 60 and 64. Controller 50 can then be used to manipulate stem 8 in a rotational and axial manner when lever 55 is in the first position. The movement of lever 55 to the second position supplies power to the motor 11 to extend and rotate the cutting element 4. However, lever 55 cannot be moved from the first position to the second position unless button 54 is pressed by the operator. This prevents the operator from accidentally or inadvertently engaging engine 11 before the operator is ready to begin the tissue cutting or fragmentation procedure. During use, when the operator wants to start the cutting operation, button 54 is pressed to move groove 59 to the position that aligns with lever 55. In that aligned position, the exposed lever portion 55 can be pressed, which does that the lever portion 55 is received in the groove 59. Pressing the lever 55 causes the lever to pivot on the pin 61 so that the lever portion 55 also contacts and press the activator button 66 of the activator switch 65 The activating switch 65 is in communication with the battery 15 and the motor 11 of the cutter guide 5A through the control wires 67, which, in this way, electrically connects the power supply to the motor in order to engage and rotate the rotating rod 20 and which, depending on the application, causes distal movement of the rotating rod and the cutting element 4 to the cutting or working position.
In use, controller 50 is positioned at the desired location along the torque rod or tubular body 8 which must be mechanically manipulated (forward, retracted, torque). The user presses lever 55 to the first position, which causes teeth 60 and 64 to grasp the tubular body 8 and allow mechanical manipulation of the catheter body 8. When the catheter has been positioned in the desired location, the operator presses the button 54 which allows lever 55 to be pressed to the second position. Pressing lever 55 to the second position engages the activator button 66 which is in electrical communication with the motor 11 of the cutter guide 5A by control wires 67, activating remote manipulation of the rotation and distal movement of the rotating rod 20 and cutting element 4 with controller 50.
Figure 6 illustrates an alternative catheter modality generally indicated in reference number 2B. Catheter 2B is substantially similar to catheter 2A of Figures 1 to 5 except that it is provided with imaging capabilities. Catheter 2B has an extended end cone 3b that houses and protects a transducer 40 that has vessel imaging capabilities, located distal to the cutting element 4. Transducer 40 can be connected to a control with a different base than a catheter that uses a or more among wires, cables, connectors, wireless communication, or other means. Components of signal processing or signal conditioning, either based on a catheter or with a different catheter base, can be interspaced between the transducer and the control or can be integrated with the transducer, the controller or any combination thereof. Imaging transducers are catheter-based and can transduce ultrasonic energy, light energy, infrared energy, magnetic energy, X-ray energy, or combinations thereof. Some examples of known imaging modalities suitable for use in the catheters disclosed in this document include intravascular ultrasound (IVUS), optical coherence tomography (OCT), and magnetic resonance imaging (MRI). Although the remaining discussion is directed to IVUS, it will be appreciated that the catheters, systems and methods of the modalities described in this document can be understood from any of IVUS, OCT or MRI imaging.
Transducer 40 may be fragile and tend to break and crack as the catheter is advanced into the vessel or lumen. The end cone 3b can protect the transducer 40 by performing or translating the mechanical stresses and forces surrounding the transducer 40. The outer wall of the end cone 3b can comprise material that is thick or has properties that minimize acoustic attenuation by allowing better penetration of the acoustic ultrasound signal produced by the transducer through the outer wall of the end cone, which improves the image quality. To better preserve the structural integrity of the outer wall of the end cone 3b, structural support ribs (not shown) can be provided. The outer wall of the end cone 3b can be provided with one or more optional groove (s) 41 which are axially aligned to the transducer crystals of transducer 40, which allows ultrasonic sound pulses to travel between crystals transducer and the vessel wall in order to minimize attenuation or interference. Although transducer 40 produces a 360 ° image of the vessel through the outer wall of end cone 3b and the optional groove 41, the radially angled portion of the imaged 360 ° vessel obtained through the groove may be of higher quality than the rest the radially angled portion of the vessel imaged in 360 ° obtained through the outer wall of the end cone. Therefore, a larger groove 41 may be preferred, particularly in the direction that the cutter 4 projects through the window. Groove 41 can produce an imaged radial angle of the vessel in the range of 60 ° to 180 ° of the circumference of the vessel. To minimize any distortion effect and to minimize the amount or size of any artifact in the image, the edges of the groove opening 41 can be shaped or angled to match the radius of the catheter 4.
Groove 41 can be positioned directly distal to the side opening 6 so that the physician is able to see more clearly and precisely what will be cut or removed at a treatment site in a vessel or lumen as the catheter is distally advanced in the lumen with the cutting element 4 in the cutting position. Additionally, after the material has been cut, the 2B catheter can be retracted proximally to the vessel lumen until the groove 41 is aligned adjacent to the treatment site so that the doctor is able to see more clearly and precisely what has been cut or removed from the treatment site.
Catheter 2B was also provided with an extended ramp surface 16b extending from the side opening 6 into the luminal surface of the tubular body 8 opposite the side opening. It should be understood that the ramp surface 16b is not limiting and that the size, slope, width
27/35 and ramp surface length can be any dimension or angle as desired depending on the application.
Figures 7A, 7B, 8 and 9 show an alternative catheter modality, catheter 2C, which includes an alternative tilt mechanism and a cutting depth adjustment controller. Catheter 2C has properties and features similar to catheter 2A except as described below. Figure 7A illustrates a partial cross-sectional view of the distal end of catheter 2C with a flexible cutting element, generally indicated at 4 in the storage position. Figure 7B illustrates the partial cross-sectional view of the distal end of catheter 2C with the cutting element 4 in the cutting position. The 2C catheter is substantially similar to the 2A catheter and includes a tubular body 8 and a lateral opening
6. The flexible cutting element 4 is coupled to the distal end of the flexible rotating rod 20. By manipulating the rod 20, the cutting element 4 is movable between the stored position (Figure 7A) and the cutting position (Figure 7B). In the stored position, the axis of rotation of the cutting element 4 is parallel to the longitudinal geometric axis LA of the tubular body as seen in Figure 7A. In the cutting position, the axis of rotation of the cutting element 4 is offset between the proximal and distal ends of the cutting element and at least a portion of a cutting edge 22 of the cutting element extends through the side opening 6 in addition to an outer diameter of the tubular body 8 as shown in Figure 7B. The cutting edge portion 22 extends out of the tubular body 8 and through the side opening 6 beyond an outer diameter of the tubular body when the cutting element 4 is deflected.
To expose the cutting edge 22 of the cutting element 4 through the side opening 6, the rotating rod 20 and the cutting element coupled thereto are moved distally from the stored position to the cutting position. As the distal movement progresses, the cutting element 4 per30 runs the ramp 16c coupled to the tubular body 8 of the catheter 2C. The interaction between the cutting element 4 and the ramp 16c deflects the cutting element 4 in the cutting position in which the axis of rotation of the cutting element is deflected
28/35 between the proximal and distal ends of the 2C catheter and away from the longitudinal geometric axis LA of the catheter. At least a portion of the cutting edge 22 extends through the side opening 6 beyond an outer diameter of the tubular body 8 and towards the tissue to be cut at a treatment site. Catheter 2C may have optional lock 34 such as a continuous or discontinuous ring or other suitable means positioned proximal to the side opening 6. Lock 34 is positioned to engage the distal end of the stem 20 and still prevent distal movement of the stem. The lock 34 can help prevent over-extension of the cutting element 4 through the side window10a 6. The lock 34 also serves as a cushion for the cutting element 4, which eliminates an excessive annular gap between the cutting element and the body 8 and prevents wear of the body 8 due to contact with the cutting element 4 as the cutting element rotates.
As shown in Figure 8, the rotating rod 20 extends through the lumen 18 in the catheter 2C to the cutter guide 5B. The cutter guide 5B includes a motor 11, a power supply 15 (for example, one or more batteries), a micro switch (not shown), a housing 17, and a rotation construction 25 that includes a meat follower 26 and a cylindrical cam 27 to provide translation and rotation to a rotating rod 20 of the engine 11. Each of these components is similar or identical to the corresponding elements described above in relation to catheter 2A and, therefore, the description presented for catheter 2A applies to present 2C catheter.
Catheter 2C includes an alternative tilt mechanism, generally indicated at 7b. Where the tilt mechanism 7a of catheter 2A has been positioned at a distal location on the body of catheter 8, the tilt mechanism 7b of catheter 2C is generally positioned within handle 5B. The tilt mechanism 7b may include a lock 33 securely attached to the rod 20, and a retracting member 10b such as a spring or other suitable means. One end of the retracting member 10b can be adjacent to the distal side of the lock 33 and the other end can be adjacent to the proximal end of the cylindrical cam 27 or another
29/35 alternative fixed surface.
When rotation is supplied to the cylindrical cam 27, the projection 32 of the cam follower 26 follows the cam within the spiral groove 31. The rotation of the cylindrical cam 27 provides translation (that is, distal movement) to the rotating rod 20, to the cut 4, and lock 33, which compresses the retracting member 10b. The compression of the retraction member 10b creates a retraction force stored within the compressed retraction member. When the projection 32 advances distally to the extended position, the distal movement of the rod 20 is interrupted and the cam follower 26 rotates with the cylindrical cam 27, which rotates the rotating rod 20 and the cutting element 4 and supplies compression retraction member 10b. When the rotational force on the cylindrical cam 27 is interrupted, the rotation of the cam follower 26 and the rotating rod 20 is stopped and the compression is no longer supplied to the retracting member 10b. The cession of compression to the retraction member 10b releases the stored retraction force of the retraction member and proximally retracts the projection 32 of the cam follower 26 towards the initial position of the spiral groove 31 of the cylindrical cam 27, which, thus proximally retracts the rotating rod 20 and the cutting element 4 from the cutting position (Figure 7B) to the stored position (Figure 20A) parallel to the longitudinal geometric axis LA.
It should also be understood that the distal movement of the rotating rod 20 can be interrupted before the projection 32 of the cam follower 26 advances completely in the spiral groove 31 of the cylindrical cam 27 to the extended position if the retracting member 10b reaches maximum compression 25 before the projection reaches the extended position of the spiral groove. Therefore, the compression length of the retraction member 10b and, depending on the application, the compression length of the retraction member against the lock 33, can also be used to control the cutting depth CD of the cutting element 4.
As can be seen in Figures 8 and 9, catheter 2C includes a depth of cut controller, generally indicated at 30. The depth of cut controller 30 comprises an adjusting member
30/35 threaded cutting depth 35 which has an end rotationally coupled to the handle housing 17, such as by a mechanical fit, and an opposite end coupled in thread to the lock 33. An adjustment lever 36 is coupled to the member adjusting profundida5 35 by a pivot pin 37. the setting lever 36 is receptive of one of a plurality of circumferential grooves 34 in the block 33. Con- ^_ form described further below, the DC cutting depth can be adjusted by adjustment 35 rotation clockwise or counterclockwise to move the adjustment member distally or proximally to the cylindrical cam
27.
In some embodiments of catheter 2C, the depth of cut controller 30 controls the cutting depth CD of the cutting element 4 through the distal lateral opening 6 of the tubular body 8. In particular, the threaded adjustment member in the lock 33 (and, therefore, threaded on the rotating rod) is used to adjust the amount of translation of the rod 20 prior to rotation if conferred to the rod through the cylindrical cam 27. The proximal end portion of the lever 36 is angled towards the grooves 34 in the lock 33. The distal end portion of lever 36 can be pressed to pivot the proximal end of lever 36 away from grooves 34. When lever 36 is pressed, adjusting member 35 can be rotated both clockwise and counterclockwise in with respect to housing 17 and lock 33 to move the adjusting member towards or away from the cylindrical cam 27. The rotation of the adjusting member 35, the lever 36 with one of the grooves 3 4. Each of the grooves 34 corresponds to a different cutting depth CD, and indices (not shown) can be provided in the lock to indicate the ratio of cutting depths associated with each groove. When the adjusting member 35 has been threaded into the lock 33 in a position where lever 36 aligns with one of the grooves 34 at a desired cutting depth, the lever 30 is released so that the proximal portion of the lever end is received in the groove that corresponds to a desired cutting depth CD. Lever 36 locks the depth adjustment member of
31/35 cut 35 in place when the lever is received in the desired groove 34 to avoid any tightening or loosening of the cutting depth adjustment member on nut 33 during rotation and distal advance of the rotating rod 20.
In the present embodiment, the lock 33 coupled to the rotating rod 20 and the adjusting member 35 move distally towards the cylindrical cam 27 as the rotating rod 20 advances distally due to the rotation of the cylindrical cam. These components advance distally until the adjusting member 35 engages the cylindrical cam 27 (or another lock), whereby the rod 20 can no longer advance distally. By engaging the adjusting member 35 with the cylindrical cam 27 (or another lock), the rotation of the cylindrical cam gives rotation, instead of translation, to the cam follower 26 and rod 20. Accordingly, a length of an interval G between the adjusting member 35 and the cylindrical cam 27 (or other lock) determines (that is, directly relates to) the cutting depth CD of the cutting element 4. The length of the gap G is controlled by the cutting depth controller 30. In particular, the distance that the cutting depth adjustment member 35 is threadedly coupled to the lock 33 and locked in place by accepting the lever 36 in one of the grooves 34 determines the length of the gap G between the cylindrical cam 27 (or other lock), and the adjusting member 35. The greater the length of the G gap, the greater the length that the projection 32 of the meat follower 26 can advance into the spiral groove 31 of the cylindrical meat 27 before the adjustment member 3 5 engage the cylindrical meat (or other lock) and the longer the cutting element 4 will move distally, resulting in the greater length of the cutting depth CD of the cutting element 4. Alternatively, the less the cutting member cutting depth adjustment 35 is threaded coupled to nut 33 and locked in place by accepting lever 36 in one of the grooves 34, the smaller the distance gap G between the cylindrical cam 27 and the adjusting member. Therefore, a smaller gap G results in a smaller cutting depth CD.
32/35
When the rotation is no longer supplied to the cylindrical cam 27, and thus to the rotating rod 20, a retraction force stored by compressing the retracting member 10b pushes / retracts the rotating rod 20 to the stored position, which in this way , retracts the cutting element 4 from the cutting position by the ramp 16c and back to the stored position parallel to the longitudinal geometric axis LA of the tubular body 8 of the catheter. It should be understood that in some embodiments the retraction member (10a, 10b) can be omitted. In some embodiments, the cutting element 4 may not be tilted towards the stored position. For these applications, battery power or alternative means can be used to return the cutting element 4 from the cutting position to the stored position and are discussed in greater depth below.
During the use of the catheter, catheter 2A, 2B, 2C or any similar modality with the resources of catheters 2A to 2C is advanced through the vessel with the cutting element 4 in the stored position until the side opening 6 and is positioned adjacent or just proximal to the proximal end of a vessel treatment site. The illustrated controller 50 can assist in placing the 2A-2C catheter adjacent or proximal to the treatment site through the tortuous anatomy of the vessels through mechanical manipulation (advance, retraction and torque). The cutting element 4 coupled to the rotating rod 20 is then moved distally from the stored position to the cutting position. Controller 50 can power motor 11 to advance cutting element 4 to the cutting position. Alternatively, a driver in the cutter guide 5 can be used to power the motor 11. Once the cutting element 4 has been distally advanced into the catheter body 8 and deflected out through the side opening 6 of the tubular body 8 of the catheter at a desired cutting depth CD so that at least a portion of the cutting edge 22 (or teeth, fins, or other tissue fragmentation structure) of the cutting element extends beyond the outer diameter of the tubular body 8 of the catheter, the catheter is pushed distally through the vessel with the cutting element 4 in the cutting position. As the 2A-2C catheter moves through the blood vessel, with the
33/35 cutting element 4 in the cutting or working position, the fabric material is cut by the cutting edge 22 of the cutting element 4 (or is fragmented by teeth, fins or other tissue fragmentation structure of the tip portion distal from the cutting element) and is directed to the tissue collection chamber 12 (for example, a rotating rod lumen 20) positioned proximal to the cutting element. The tissue collection chamber 12 can extend the length of the catheter body 8.
In this embodiment and in the other catheter embodiments described in this document, a vacuum source (not shown) can be applied to a proximal end of the catheter body 8 to assist in collecting and transporting the cut material by the cutting element 4 through the rod swivel 20. As previously mentioned, any of the catheter bodies 8 described in this document can be provided with an opening in the side wall or another opening in a proximal location that can be connected by tubing to a suction source so that debris created by the rotating cutter element 4 can be aspirated through the annular space between the catheter body and the flexible rotating rod 20. The tissue collection chamber 12 can be as long as the length of the catheter that is proximal to the window. When the tissue material has been treated appropriately and appropriately at the treatment site by the cutting element 4, the power is interrupted for the motor 11 and the retracting member 10a, 10b retracts the cutting element back to the stored position and the catheter is retracted from the vessel.
Figures 10A and 10B are circuit diagrams of an orientation circuit, generally indicated at 70, which guides motor 11 in a forward direction by using battery power 15 during use of the catheter and subsequently guides the motor in one direction contrary to the use of capacitor power when the battery power to the motor is turned off. This orientation circuit 70 can be used in combination with catheter modalities 2A to 2C and can also be used in catheter modalities that do not use a tilt mechanism 7a, 7b for retraction of the cutting element 4. Therefore, capacitor power can
34/35 be used to retract the cutting element 4 only or in addition to the tilt mechanism 7a, 7b.
Guidance circuit 70 includes four switches: two single pole and single thrust (SPST) 72 switches and two single pole and double thrust (SPDT) switches 74. Figure 10A shows switches 72, 74 as they would be configured when the catheter 2A-2C is used to cut material from a vessel lumen. The SPST 72 switches are in the closed position, and the SPDT 74 switches are closed on the left side in relation to the central common pole and open on the right side, in such a way that the motor load X and the positive charge of a capacitor C are connected to the positive terminal of the battery 15 and both the motor 11 and the capacitor are also connected to the negative terminal of the battery. Figure 10B shows switches 72, 74 as they would be configured when power to motor 11 is turned off. In Figure 10B, the two SPST 72 switches are open and the two SPDT 74 switches are in an open position on the left side and in a closed position on the right side. In this configuration, battery 15 is disconnected from both motor 11 and capacitor C, the capacitor is connected to the motor, and the motor load X is connected to the negative terminal of the capacitor. Thus, capacitor C will supply power to motor 11 in the rotational direction opposite to the circuit of Figure 10A, until the capacitor charge is discharged to the point where it can no longer start the motor.
Figures 11A and 11B are circuit diagrams of the second modality of an orientation circuit, generally indicated at 80, which will orient motor 11 in a forward direction by using battery power 15 and will subsequently orient the motor in a reverse direction by using battery power. This circuit 80 can be used in combination with catheter modalities 2A to 2C and can also be used in catheter modalities that do not use the tilt mechanism for retracting the cutting element. Thus, battery power can be used for retraction of the cutting element 4 only or in addition to the tilt mechanism 7a, 7b.
Figures 11A and 11B show two SPDT 82 switches that
35/35 connect battery 15 to the motor 11. In Figure 11A both switches 82 are in the closed position on the right side in relation to the central common pole in such a way that the motor load X is connected to the positive terminal of the battery 15 and the motor 11 is also connected to the negative battery terminal. In Figure 11B, the two SPDT 82 switches are in an open position on the right side and in a closed position on the left side. In this configuration, the motor load X is connected to the negative terminal of battery 15. Thus, in the circuit configuration of Figure 11B, battery 15 will supply power to motor 11 in the rotational direction opposite to the circuit configuration of Figure 11 A. When the motor 11 is energized, such as by pressing the controller lever 55 of the modality described in relation to Figure 4, the motor must be activated through the circuit configuration shown in Figure 11A to advance the cutting element 4 out of the side opening 6. When controller lever 55 is allowed to return or retreat to the unpressed position, motor 11 is briefly activated via the circuit configuration shown in Figure 11B to retract cutting element 4 through side opening 6 and into the body 8.
The above description and drawings are provided for the purpose of describing modalities of the invention and are not intended to limit the scope of the invention in any way. It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit or scope of the invention. Thus, it is intended that the present invention covers the modifications and variations of this invention as long as they fall within the scope of the appended claims and their equivalents. In addition, although choices of materials and configurations may have been described above in relation to certain modalities, one skilled in the art will understand that the described materials and configurations apply to all modalities.
1/4

权利要求:
Claims (2)
[1]
1/9
2Α
2Α
Petition 870180002088, of 10/01/2018, p. 4/16
1. Catheter for the removal of material from a body lumen comprising:
a tubular body that has proximal and distal ends, a longitudinal geometric axis, a lateral opening adjacent to the distal end of the tubular body, and a lumen that extends along the longitudinal geometric axis of the body;
a rotating rod disposed within the lumen of the tubular body and having proximal and distal ends and a longitudinal geometric axis;
a ramp coupled to the tubular body adjacent to the distal end of the body and which has an angular surface in general opposite to the lateral opening;
a flexible cutting element that has proximal and distal ends, a longitudinal geometric axis and a rotation axis, the proximal end of the cutting element is coupled to the rotating shaft to give rotation to the cutting element around its axis of rotation and the distal end of the cutting element having a cutting edge adapted to cut material from the body lumen, in which the cutting element and the rotating rod are longitudinally movable within the tubular body between a stored position, in which the element cutting edge is received in the tubular body, and a cutting position, in which the cutting element engages the angular surface of the ramp and is deflected along its longitudinal geometric axis so that at least a portion of the longitudinal geometric axis of the cut is not parallel to the longitudinal geometric axis of the tubular body and at least a portion of the cutting edge extends through the lateral opening.
A catheter according to claim 1, wherein the flexible cutting element has a lumen that extends longitudinally through the proximal and distal ends of the cutting element to receive material cut by the distal end of the cutting element.
The catheter according to claim 2, wherein the rati gi2 / 4 rod has a lumen that extends longitudinally on the rod and in communication with the lumen of the cutting element to receive the cut material from the lumen of the cutting element.
4. The catheter according to claim 1, which further comprises a tilt mechanism configured to tilt the cutting element towards the stored position.
5. Catheter according to claim 4, wherein the tilt mechanism comprises a lock coupled to the tubular body at a location close to the lateral opening and a resilient retraction member intermediate to the lock and to the distal end of the rotating rod.
A catheter according to claim 1, which further comprises an end cone distal to the side opening and an imaging transducer housed within the end cone.
7. The catheter according to claim 1, which further comprises a meat follower securely attached to the rotating rod adjacent to the proximal end of the rotating rod and configured to couple with a cylindrical flesh of a handle for use with the catheter.
8. Catheter, according to claim 7, in combination with a handle fixable to a proximal portion of the catheter, the handle including a power supply, a motor connected to the power supply and a cylindrical meat configured to be coupled to the meat follower attached to the rotating rod, where the motor is configured to transmit rotation to the cylindrical meat, both to provide translation to the meat follower to move the cutting element from the stored position to the cutting position and to give rotation to the meat follower meat when the cutting element is in the cutting position to rotate the cutting element around its axis of rotation.
9. Catheter according to claim 8, which further comprises;
a controller that has a body that defines a lumen sized to accept the tubular body, and the controller also has opposite body engagement elements on the body for the handle of the tubular body
3/4 of the catheter, and a lever connected to at least one of the body engaging elements, where the lever is configured to move at least one of the body engaging elements from a disengaged position, in which the controller is free to move along at least the length of the tubular body, to an engaging position, in which the body engaging elements engage the tubular body to allow manipulation of the tubular body.
10. Catheter according to claim 9, in which the controller includes an activation member electrically connected to the manipulator's power supply to selectively supply power to the motor, in which the controller lever is configured to activate the control member activation to selectively deliver power to the engine.
11. Catheter for the removal of material from a body lumen comprising;
a tubular body having proximal and distal ends and a lateral opening positioned proximal to the distal end of the tubular body;
a rotating rod disposed within the lumen of the tubular body, the rotating rod having proximal and distal ends;
a cutting element coupled to the rotating rod, the cutting element having a cutting edge;
a meat follower attached to the rotating rod adjacent to the proximal end of the rotating rod; and a handle attached to the tubular body adjacent to the proximal end of the tubular body, the handle including a motor and a cylindrical cam attached to the motor and the cam follower, in which the cutting element and the rotating rod are longitudinally movable inside of the tubular body between a stored position, in which the cutting element is received in the tubular body, and a cutting position, in which at least a portion of the cutting edge extends through the side opening, in which the motor is configured to transmit rotation to the meat
4/4 cylindrical, both to give translation to the cam follower to move the cutting element from the stored position to the cutting position and to give rotation to the cam follower when the cutting element is in the cutting position to rotate the cut around its axis of
5 rotation.
12. Catheter according to claim 11, which further comprises a tilt mechanism attached to the handle and configured to tilt the rotating rod in a proximal position, thereby tilting the cutting element towards the stored position .
10
13. The catheter according to claim 12, wherein the tilt mechanism comprises a lock coupled to the rotating rod and a retraction member positioned between the lock and the proximal end of the cylindrical cam.
14. The catheter according to claim 11, wherein the jump handle further comprises a cutting depth controller coupled to the rotating rod and configured to selectively control a cutting depth of the cutting element, in which the cutting depth of the cutting element is a distance at which the cutting edge extends beyond an outer diameter of the tubular body in the cutting position.
15. The catheter according to claim 14, wherein the cutting depth controller comprises an adjustment member threaded on the rotating stem to adjust the amount of translation of the stem prior to the rotation that is provided to the stem through the cylindrical cam.
[2]
2/9
2Α

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法律状态:
2017-12-05| B150| Others concerning applications: publication cancelled|

---

2018-03-20| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

---

2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-01-28| B11B| Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements|

优先权:

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申请号 | 申请日 | 专利标题

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US201261587369P| true| 2012-01-17|2012-01-17|

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US61/587,369|2012-01-17|

---