Transcatheter device for scoring calcification and cutting valve tissue

Abstract

The transcatheter device (10) includes a first jaw member (12), a second jaw member (14), and a linkage (16) coupled to the first and second jaw members (12, 14) for varying the distance between the first and second jaw members (12, 14). At least one of the first and second jaw members (12, 14) includes a scoring structure (20) capable of scoring calcifications or tissue or other anatomical structures along a jaw closure axis (25) extending between respective opposing faces (22, 24) of the first and second jaw members (12, 14), the direction of the scoring force being along the jaw closure axis (25) extending between respective opposing faces (22, 24) of the first and second jaw members (12, 14). The first jaw member (12) includes a cutting element (18) configured to cut in a cutting direction (27) transverse to the jaw closure axis (25).

Description

[Technical Field]

[0001] The present invention relates generally to devices and methods for transcatheter ablation of heart valve calcification and heart valve tissue. [Background technology]

[0002] PCT patent application PCT / IB2020 / 054729 describes a transcatheter valve dehiscence device and method. The present invention is a method and device that can be used to perform BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction). This device is a cutting device designed to prevent damage to adjacent tissue. This device can be used in other cardiac procedures, such as tricuspid valve dehiscence (transforming a bicuspid valve into a tricuspid valve by dehiscence or dividing one of the valve leaflets) or tricuspid valve dehiscence (transforming a quadricuspid valve into a tricuspid valve by dehiscence of one of the valve leaflets), thereby preparing the patient for safe transcatheter aortic valve replacement (TAVR) or other procedures involving the dehiscence of cardiac tissue. Summary of the Invention

[0003] The present invention provides a transcatheter device that can be used to score cardiac valve calcifications and also serve as a dehiscence device for cutting or slicing (these terms are used interchangeably) cardiac tissue. Thus, the device of the present invention can be used to perform BASILICA and other ablation procedures while simultaneously scoring calcifications at the ablation site. The term "scoring" refers to reducing size or changing shape or morphology, including, but not limited to, scoring, cutting, crushing, pulverizing, breaking, grinding, and chopping. This device can be used to treat aortic valves, mitral valves, and other cardiac tissues. This device can be introduced via transfemoral, transaortic, transclavicular, transscapular, transsternal, or other percutaneous approaches. For example, for transsternal access, the device can be placed retrograde on a device delivery system.

[0004] According to a non-limiting embodiment of the present invention, a transcatheter valve dehiscence device includes a cutting element attached to a guide structure. The cutting element is expandable and retractable relative to the guide structure. The guide structure can be delivered to a heart valve, and the cutting element is expanded and moved toward the valve leaflets (in a direction different from the direction of expansion) to cut them. A support structure can be provided opposite the leaflets to act as an "anvil" for the cutting force of the cutting element and to protect tissue that should not be cut from the cutting element. [Brief explanation of the drawings]

[0005] The present invention will be more fully understood from the following detailed description when read in conjunction with the drawings. [Figure 1] FIG. 1 is a simplified illustration of a transcatheter device constructed and operative in accordance with a non-limiting embodiment of the present invention, in a stowed (retracted) orientation for deployment over a guidewire to a surgical site. [Figure 2] FIG. 2 is a simplified diagram of the distal end of the transcatheter device contacting the valve tissue at the surgical site. [Figure 3]FIG. 3 is a simplified diagram illustrating how a first jaw member (including the cutting portion of the transcatheter device) is deployed radially outward from a second jaw member (which functions as a positioning member for the transcatheter device and / or anvil or scoring member). [Figure 4] FIG. 4 is a simplified schematic diagram illustrating the first and second jaw members advanced distally relative to the valve tissue. [Figure 5] FIG. 5 is a simplified diagram of the first and second jaw members being closed. [Figure 6] FIG. 6 is an enlarged view of FIG. [Figure 6A] FIG. 6A illustrates a scoring structure on one or both of the first and second jaw members. [Figure 7] FIG. 7 is a simplified schematic diagram illustrating the cutting element of the first jaw member moved proximally from the valve tissue prior to slicing the valve tissue. [Figure 8] FIG. 8 is a simplified schematic diagram showing the cutting element of the first jaw member moved distally to slice the valve tissue. [Figure 9] FIG. 9 is a cross-sectional view of FIG. [Figure 10] FIG. 10 is an enlarged view of FIG. [Figure 11] Figures 11-25 are simplified diagrams showing the components of the transcatheter device and their assembly with one another: Figure 11 shows a cutter mover coupled at its distal end to a cutting element. [Figure 12] FIG. 12 shows a cutter mover coupled to a cutting element. [Figure 13] FIG. 13 is another view of the cutter mover coupled to the cutting element, showing the interior portion of the cutting element. [Figure 14] FIG. 14 is a view of the distal end of the first jaw member. [Figure 15] FIG. 15 is a side view of the first jaw member. [Figure 16] FIG. 16 shows an assembly of the cutter mover and cutting element mounted on the first jaw member. [Figure 17] FIG. 17 illustrates a pivot member coupled to the first jaw member. [Figure 18] FIG. 18 illustrates a pivot member coupled to the first jaw member. [Figure 19] FIG. 19 shows a linkage mechanism coupled to the first and second jaw members for varying the distance between the first and second jaw members, which in the illustrated non-limiting embodiment is a foldable hinged parallelogram mechanism. [Figure 20] FIG. 20 shows a linkage connected to the pivot member of the first jaw member. [Figure 21] FIG. 21 shows the link mechanism deployed outward from the first jaw member. [Figure 22] FIG. 22 is a view showing the link mechanism deployed outward from the first jaw member from another angle. [Figure 23] FIG. 23 illustrates an actuator interface member configured to move one or more stabilizing arms of a transcatheter device. [Figure 24] FIG. 24 illustrates one or more stabilizing arms coupled to an actuator interface member. [Figure 25] FIG. 25 illustrates one or more stabilizing arms and an actuator interface member coupled to a first jaw member of a transcatheter device. [Figure 26] FIG. 26 illustrates an alternative linkage coupled to the first and second jaw members for varying the distance between the first and second jaw members. DETAILED DESCRIPTION OF THE INVENTION

[0006] 1-6, there is shown a transcatheter device 10 constructed and operative in accordance with a non-limiting embodiment of the present invention.

[0007] A general description of the major subassemblies of the device will be given first, followed by a more specific description of each component.

[0008] The device 10 has three main subassemblies (all three are shown in FIG. 3): a first jaw member 12, a second jaw member 14, and a linkage 16 coupled to the first and second jaw members 12, 14 for varying the distance between the first and second jaw members 12, 14. The first jaw member 12 comprises the cutting portion of the transcatheter device 10 and thus includes a cutting element 18. The second jaw member 14 functions as a positioning member for the transcatheter device 10.

[0009] The device 10 may be coupled to or part of a catheter 11 for delivery over a guidewire 13, as is well known in the art.

[0010] 1 shows a transcatheter device 10 in a stowed (contracted) state being deployed to a surgical site over a guidewire 13. In the illustrated embodiment, the distal end 19 of the transcatheter device 10, which is the distal end of the second jaw member 14, may be tapered and blunt to facilitate entry and prevent harm to tissue.

[0011] FIG. 2 shows the distal end 19 of the transcatheter device contacting valve tissue 15 at the surgical site.

[0012] 3 illustrates the first jaw member 12 deployed radially outward from the second jaw member 14. The second jaw member 14 functions as a positioning member for the transcatheter device 10 by ensuring that the transcatheter device 10 is properly positioned relative to the valve 15, e.g., centered relative to the valve.

[0013] FIG. 4 illustrates first and second jaw members 12 and 14 advanced distally into valve tissue 15.

[0014] 5 and 6 illustrate the use of linkage 16 to reduce the distance between first jaw member 12 and second jaw member 14. FIG.

[0015] 6A. The first and second jaw members 12 and 14 may also have the ability to score calcifications (or score tissue or other anatomical structures), such that one of the first and second jaw members 12 and 14 includes a scoring structure 20, while the other of the first and second jaw members 12 and 14 functions as an anvil against which tissue or other anatomical structure rests to provide a counterforce to the scoring force. Alternatively, both the first and second jaw members 12 and 14 may include a scoring structure 20, such that the anvil also has a scoring structure.

[0016] Scoring structure 20 is disposed on one or both of opposing faces 22 and 24 of each of first and second jaw members 12 and 14. The direction of the scoring force is along an imaginary axis, referred to as the jaw closure axis 25, that extends between faces 22 and 24.

[0017] The scoring structures 20 may include sharp protrusions, blunt protrusions, or any combination thereof, as shown. The scoring structures may face each other on both jaw members, as seen in Figure 6A, or only one jaw member may have a scoring structure, with the opposing jaw member having a smooth surface opposite the scoring structure.

[0018] Referring now to Figure 7, the cutting element 18 of the first jaw member 12 has been moved proximally away from the valve tissue 15 prior to slicing the valve tissue 15. In Figure 8, the cutting element 18 of the first jaw member 12 is moved distally to slice the valve tissue 15. The slicing (also called cutting) action of the cutting element 18 occurs in a slicing (also called cutting) direction 27 transverse to the jaw closure axis 25. This slicing direction is along the distal-proximal axis of the device and may, but is not necessarily, perpendicular to the jaw closure axis 25.

[0019] 9 and 10 are close-up views of the cutting element 18. The cutting element 18 has a sharpened edge 28 that may be sufficient alone to cut tissue, but which is enhanced by sliding past a sharpened edge 30 of the first jaw member 12 to create a slicing or scissoring effect. The sharpened edge 28 of the cutting element 18 may be at the distal end of the cutting element 18 and / or along its longitudinal length. Similarly, the sharpened edge 30 of the first jaw member 12 may be at its distal end and / or along its longitudinal length. In the illustrated embodiment, the cutting element 18 moves in a translational manner. Alternatively or additionally, the cutting element 18 may be a rotary or vibratory cutting element.

[0020] In the illustrated embodiment, the cutting element 18 is tubular with a longitudinal cutout. In such a configuration, an inner circumferential portion 33 (FIG. 10) at the distal end of the cutting element 18 can be coupled to a crosspiece 32, which provides rigidity to the cutting tube and facilitates assembly to the first jaw member 12. Alternatively, the cutting element 18 can have other shapes, such as a straight knife edge.

[0021] Reference is now made to Figures 11-25, which illustrate the components of the transcatheter device and their assembly with respect to one another.

[0022] 11 illustrates a cutter mover 34 coupled to the distal end of a cutting element 18 (not shown here). In the non-limiting illustrated embodiment, the cutter mover 34 comprises an elongated shaft 35 (e.g., a pair of elongated bars) having one or more distal fastening members 36 and a proximal interface member 37. The proximal interface member 37 can be coupled to an actuator (not shown) for moving the cutter mover 34 distally and proximally (or alternatively or additionally, in a linear as well as rotational or oscillatory manner).

[0023] 12 and 13 illustrate a cutter mover 34 coupled to a cutting element 18. One or more distal fastening members 36 are received in one or more slots 38 formed in the cutting element 18 and may be coupled thereto by welding, crimping, swaging, adhesive, or the like. The cutting element 18 may be formed with an open window 40 in which the surface 22 is disposed. The sharp edge 28 of the cutting element 18 is clearly visible in FIGS. 12 and 13. A portion of the scoring structure 20 is shown in dashed lines.

[0024] 14 and 15, the distal end of first jaw member 12 may have a notched window 42 formed therein that defines sharp edge 30 (FIG. 14) of first jaw member 12. The distal end of first jaw member 12 may have a distal stop 44 (FIG. 14) for limiting the travel of the cutting element.

[0025] FIG. 16 illustrates the assembly of the cutter mover 34 and cutting element 18 assembled to the first jaw member 12.

[0026] 17, there is shown a pivot member 46 coupled to the first jaw member and part of the linkage. The pivot member 46 has an axle 48 to which two spaced apart discs 50 may be mounted, each disc 50 having an arcuate groove 52 formed therein. A hub 54 is disposed adjacent to and on the outside of each disc 50.

[0027] Figure 18 shows pivot member 46 coupled to first jaw member 12. Hub 54 is journaled in bearing hole 56 (also seen in Figures 15 and 16) formed in first jaw member 12.

[0028] 19 illustrates a linkage 16 coupled to the first and second jaw members for varying the distance between them. In the illustrated non-limiting embodiment, linkage 16 is a foldable hinged parallelogram mechanism including a first bar 58, a second bar 60, a third bar 62, and a fourth bar 64. During operation, first bar 58 remains parallel to fourth bar 64, and second bar 60 remains parallel to third bar 62. Second bar 60 and third bar 62 are pivotally attached to first bar 58 at pivot 59 and to fourth bar 64 at pivot 61. Second bar 60 and third bar 62 may have recesses 63 and 65 formed therein, respectively, to allow second bar 60 and third bar 62 to nest within one another in the fully collapsed position.

[0029] The second bar 60 and the third bar 62 may be configured as a spaced apart pair of bars such that the first bar 58 and the fourth bar 64 fit into the gap between the spaced apart bars in the fully collapsed position. The first bar 58 may have gaps 67 and 69 formed therein to receive the pins 55 and 57 of the second bar 60 and the third bar 62, respectively, in the fully collapsed position.

[0030] First bar 58 has a portion 51 which, in its fully nested position, extends beyond the ends of second bar 60 and fourth bar 64. This portion 51 has an opening 53 formed therein.

[0031] FIG. 20 shows linkage 16 pivotally connected to first jaw member 12 by pivot member 46 which fits into opening 53 in first bar 58. As shown in FIG.

[0032] 21 and 22 show linkage 16 deployed outward from first jaw member 12. FIG.

[0033] Referring again to Figures 8, 9, and 10, one or more wires 70 (elongated wrappable elements, such as wires, cords, etc.) are wound around the pivot member 46. The distal ends of the one or more wires 70 are coupled to the second jaw member 14, and the proximal ends are coupled to an actuator (not shown) for pulling the wires 70. Note that the fourth bar 64 is coupled to the second jaw member 14. Proximal movement of the one or more wires 70 moves the bars of the linkage 16 to a fully nested position. Thus, proximal movement of the wires 70 reduces the distance between the first jaw member 12 and the second jaw member 14. This proximal movement of the one or more wires 70 acts to close the jaws of the mammal.

[0034] The radial outward deployment of the first jaw member 12 and the second jaw member 14 may be solely due to gravity, with the second jaw member 14 moving away from the first jaw member 12 due to its own weight in the absence of a counter force applied by the one or more wires 70. Alternatively, an actuator may be used to move the bar to deploy it outward without relying on the weight of the second jaw member 14.

[0035] 23, which illustrates an actuator interface member 72. The actuator interface member 72 may include a pivoting connector member 74. As seen in FIG. 24, one or more stabilizing arms 76 may be coupled to the actuator interface member 72, such as the pivoting connector member 74.

[0036] 25 illustrates one or more stabilizing arms 76 and actuator interface member 72 coupled to first jaw member 12 of a transcatheter device. Movement of pivot connector member 74 can deploy the stabilizing arms 76 to the radially outward position shown in FIG. 25 or to the retracted (radially inward) position shown in FIGS. 6, 7, and 8.

[0037] 26, there is shown another linkage 80 coupled to first and second jaw members 12, 14 to vary the distance therebetween. Linkage 80 is similar to linkage 16 in that it is a foldable hinged quadrilateral mechanism (which may or may not be kite-shaped) and includes a first bar 81 (coupled to first jaw member 12), a second bar 82, a third bar 83, and a fourth bar 84 (coupled to second jaw member 14). Linkage 80 differs from linkage 16 in that it is actuated by an actuator 86 that may slide or otherwise move linearly, such as by means of a slot 87 that slides relative to a pin 88. Actuator 86 may be pivotally connected to third bar 83 by a link 89.

Claims

1. A transcatheter device (10), comprising: a first jaw member (12), a second jaw member (14), and a linkage (16) coupled to the first and second jaw members (12, 14) for varying the distance between the first and second jaw members (12, 14); at least one of the first and second jaw members (12, 14) includes a scoring structure (20) capable of scoring calcifications or tissue or other anatomical structures, the scoring force applied by the scoring structure (20) being directed along a jaw closure axis (25) extending between opposing surfaces (22, 24) of each of the first and second jaw members (12, 14); and A transcatheter device (10), wherein the first jaw member (12) comprises a cutting element (18) configured to cut in a cutting direction (27) transverse to the jaw closure axis (25).

2. 2. The transcatheter device of claim 1, wherein the link mechanism comprises one or more wires wound around a pivot member coupled to the first jaw member, the distal ends of the one or more wires being coupled to the second jaw member, and wherein moving the proximal ends of the one or more wires in a proximal direction reduces the distance between the first and second jaw members.

3. The transcatheter device (10) of claim 1, wherein the cutting direction (27) is along a distal-proximal axis of the device (10).

4. The transcatheter device (10) of claim 1, wherein the cutting direction (27) is perpendicular to the jaw closure axis (25).

5. The transcatheter device of claim 1 , wherein the scoring structures include sharp or blunt protrusions, or any combination thereof.

6. The transcatheter device (10) of claim 1, wherein the cutting element (18) comprises a sharpened edge (28) movable beyond a sharpened edge (30) of the first jaw member (12).

7. The transcatheter device (10) of claim 1, wherein the cutting element (18) is a rotary cutting element.

8. The transcatheter device (10) of claim 1, wherein the cutting element (18) is a vibratory cutting element.

9. The transcatheter device (10) of claim 1, wherein the cutting element (18) is formed as a tube having a longitudinally cut-out portion.

10. The transcatheter device (10) of claim 1, further comprising a cutter mover (34) coupled to the cutting element (18).

11. 2. The transcatheter device (10) of claim 1, wherein the distal end of the first jaw member (12) is formed with a cutout window (42) that defines a sharp edge (30) of the first jaw member (12).

12. The transcatheter device (10) of claim 1, wherein a distal end of the first jaw member (12) includes a distal stop (44) for limiting travel of the cutting element (18).

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