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1. WO2021038559 - POINTE DE CANAL D'ANCRAGE

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

CLAIMS

1. An apparatus, for use with a tissue anchor, the apparatus comprising:

an implant, dimensioned to be advanced into a body of a subject; and

an anchor-delivery tool comprising:

an anchor-delivery channel, shaped to define a lumen therethrough, the lumen having a diameter, and the channel being dimensioned to be moveable within a lumen of the implant; and

an implant-gripping element disposed at a distal end portion of the anchor- delivery channel, the implant-gripping element being configured to reversibly grip an inner wall of the implant during implantation of the tissue anchor via the anchor-delivery channel.

2. The apparatus according to claim 1, wherein the implant-gripping element comprises a radiopaque material.

3. The apparatus according to any one of claims 1-2, wherein the implant comprises a flexible material, and wherein the flexible material of the implant encases a distal portion of the channel.

4. The apparatus according to any one of claims 1-3, wherein the implant-gripping element comprises a plurality of teeth which increase friction between the implant and the anchor-delivery channel.

5. The apparatus according to claim 4, wherein the plurality of teeth are cut from a distal portion of a cylinder coupled to the distal end portion of the anchor-delivery channel.

6. The apparatus according to claim 4, wherein:

each one of the plurality of teeth comprises a respective elongate element that is aligned with a longitudinal axis of the distal end portion of the anchor-delivery channel,

a portion of the implant surrounds the plurality of elongate elements, and

the elongate elements are spaced apart from one another such that the plurality of elongate elements are configured to grip the portion of the implant.

7. The apparatus according to claim 4, wherein a respective distal portion of each of the plurality of teeth are configured to grip the implant.

8. The apparatus according to claim 7, wherein the implant comprises a braided fabric, and wherein the distal portions of the plurality of teeth are configured to reversibly ensnare the braided fabric.

9. The apparatus according to any one of claims 1-8, further comprising the tissue anchor, wherein the tissue anchor comprises:

an anchor head; and

a tissue-engaging member, coupled to the anchor head, extending distally away from the anchor head until a distal tip of the tissue-engaging member, and configured to anchor the anchor to the tissue.

10. The apparatus according to claim 9, wherein the tissue-engaging member comprises a helical tissue-engaging member, and wherein the implant-gripping element is configured to reversibly grip the implant and prevent twisting of the implant during corkscrewing of the helical tissue-engaging member with respect to the implant.

11. The apparatus according to claim 9, further comprising an anchor driver slidable through the lumen of the anchor-delivery channel, the anchor driver comprising:

a longitudinal shaft, having a flexible distal portion and a distal end; and

a deployment element coupled to the distal end of the shaft, and reversibly couplable to the anchor head.

12. The apparatus according to claim 9, wherein the implant-gripping element comprises at least one deformable element configured to change shape from a resting state to a gripping state in response to passage of the tissue anchor alongside the deformable element.

13. The apparatus according to claim 12, wherein the implant-gripping element comprises a plurality of deformable elements disposed circumferentially with respect to the distal end portion of the anchor-delivery channel.

14. The apparatus according to claim 12, wherein the deformable element is shaped so as to define an elongate tine having a straight portion and a curved portion in the resting state of the deformable element, and wherein in the gripping state of the deformable element, the anchor is configured to radially push against the curved portion so as to straighten the curved portion and responsively, longitudinally lengthen the deformable element.

15. The apparatus according to claim 14, wherein, in the gripping state, a distal end of the deformable element extends beyond a distal end of the anchor-delivery channel.

16. The apparatus according to claim 15, wherein the at least one deformable element comprises a plurality of elongate tines, and wherein the anchor is configured to radially push against the respective curved portions of the plurality of elongate tines.

17. The apparatus according to claim 16, wherein the distal ends of the plurality of elongate tines are configured to increase surface area contact with the inner wall of the implant in the gripping state of the deformable element.

18. The apparatus according to claim 12, wherein:

the deformable element is shaped so as to define a laterally-moveable lateral projection, in the resting state of the deformable element, a lateral-most portion of the projection is aligned with a lateral surface of the anchor-delivery channel, and

in the gripping state, the anchor is configured to radially push against the lateral projection so as to extend the lateral-most portion of the projection beyond the lateral surface of the anchor-delivery channel.

19. The apparatus according to claim 18, wherein the at least one deformable element comprises a plurality of lateral projections, and wherein the anchor is configured to radially push against the plurality of lateral projections.

20. The apparatus according to claim 19, wherein the plurality of lateral projections are configured to increase surface area contact with the inner wall of the implant in the gripping state of the deformable element.

21. A method, comprising:

positioning an implant along a simulation annulus of a simulation heart valve, the implant being dimensioned such that it can be advanced into a body of a subject;

advancing an anchor-delivery tool with respect to the implant, the anchor-delivering tool including:

an anchor-delivery channel, shaped to define a lumen therethrough, the lumen having a diameter, and the channel being dimensioned to be moveable within a lumen of the implant; and

an implant-gripping element disposed at a distal end portion of the anchor- delivery channel, the implant-gripping element being configured to reversibly grip an inner wall of the implant during implantation of a tissue anchor via the anchor-delivery channel;

gripping a first portion of the implant using the implant-gripping element; and during the gripping of the first portion, anchoring the first portion of the implant to the simulation annulus using the tissue anchor deliverable through the anchor-delivery channel.

22. The method according to claim 21, further comprising:

decoupling the implant-gripping element from the first portion of the implant subsequently to the anchoring of the first portion of the implant to the simulation annulus; moving the anchor-delivery channel to a second portion of the implant;

gripping the second portion of the implant using the implant-gripping element; and during the gripping of the second portion, anchoring the second portion of the implant to the simulation annulus using a second tissue anchor deliverable through the anchor-delivery channel.

23. The method according to any one of claims 21 -22, wherein the implant-gripping element includes a radiopaque material.

24. The method according to any one of claims 21-23, wherein the implant includes a flexible material, and wherein the flexible material of the implant encases a distal portion of the channel.

25. The method according to any one of claims 21 -24, wherein the implant-gripping element includes a plurality of teeth, and wherein gripping the first portion of the implant comprises increasing friction between the first portion of the implant and the anchor-delivery channel.

26. The method according to claim 25, wherein the plurality of teeth are cut from a distal portion of a cylinder coupled to the distal end portion of the anchor-delivery channel, and wherein gripping the first portion of the implant comprises sandwiching the first portion of the implant between respective distal ends of the plurality of teeth and the annulus.

27. The method according to claim 25, wherein:

each one of the plurality of teeth includes a respective elongate element that is aligned with a longitudinal axis of the distal end portion of the anchor-delivery channel,

a lateral portion of the implant surrounds the plurality of elongate elements, the elongate elements are spaced apart from one another, and

gripping the first portion of the implant comprises gripping the lateral portion of the implant by the elongate elements.

28. The method according to claim 25, wherein a respective distal portion of each of the plurality of teeth are configured to grip the implant, and wherein gripping the first portion of the implant comprises sandwiching the first portion of the implant between respective distal ends of the plurality of teeth and the annulus.

29. The method according to claim 28, wherein the implant includes a braided fabric, and wherein gripping the first portion of the implant comprises reversibly ensnaring the braided fabric by the plurality of teeth.

30. The method according to any one of claims 21-29, wherein:

the tissue anchor includes:

an anchor head; and

a tissue-engaging member, coupled to the anchor head, extending distally away from the anchor head until a distal tip of the tissue-engaging member, and configured to anchor the anchor to the tissue, and

anchoring the first portion of the implant to the simulation annulus comprises anchoring the first portion using the tissue anchor including the anchor head and the tissue-engaging member.

31. The method according to claim 30, wherein:

the tissue-engaging member includes a helical tissue-engaging member, anchoring the first portion of the implant comprises corkscrewing the helical tissue-engaging member with respect to the first portion of the implant and into the simulation annulus, and

gripping the first portion of the implant comprises using the implant-gripping element to reversibly grip the first portion of the implant and prevent twisting of the implant during the corkscrewing of the helical tissue-engaging member with respect to the first portion of the implant.

32. The method according to claim 30, further comprising sliding through the lumen of the anchor-delivery channel an anchor driver including:

a longitudinal shaft, having a flexible distal portion and a distal end; and

a deployment element coupled to the distal end of the shaft, and reversibly couplable to the anchor head.

33. The method according to claim 30, wherein the implant-gripping element includes at least one deformable element configured to change shape from a resting state to a gripping state in response to passage of the tissue anchor alongside the deformable element, and wherein the method further comprises changing the shape of the deformable element by passing the tissue anchor alongside the deformable element.

34. The method according to claim 33, wherein the implant-gripping element includes a plurality of deformable elements disposed circumferentially with respect to the distal end portion of the anchor-delivery channel.

35. The method according to claim 33, wherein the deformable element is shaped so as to define an elongate tine having a straight portion and a curved portion in the resting state of the deformable element, and wherein passing the tissue anchor alongside the deformable element

comprises radially pushing the anchor against the curved portion, and by the pushing, straightening the curved portion and responsively, longitudinally lengthening the deformable element such that the deformable element assumes the gripping state.

36. The method according to claim 35, wherein, in the gripping state, longitudinally lengthening the deformable element comprises extending a distal end of the deformable element beyond a distal end of the anchor-delivery channel.

37. The method according to claim 36, wherein the at least one deformable element comprises a plurality of elongate tines, and wherein radially pushing the anchor comprises radially pushing the anchor against the respective curved portions of the plurality of elongate tines.

38. The method according to claim 37, wherein gripping the first portion of the implant comprises increasing surface area contact with the inner wall of the implant in the gripping state of the deformable element using the distal ends of the plurality of elongate tines.

39. The method according to claim 33, wherein:

the deformable element is shaped so as to define a laterally-moveable lateral projection, in the resting state of the deformable element, a lateral-most portion of the projection is aligned with a lateral surface of the anchor-delivery channel,

in the gripping state, the anchor is configured to radially push against the lateral projection so as to extend the lateral-most portion of the projection beyond the lateral surface of the anchor-delivery channel,

passing the tissue anchor alongside the deformable element comprises radially pushing the anchor against the lateral projection, and by the pushing, extending the lateral-most portion of the projection beyond the lateral surface of the anchor-delivery channel.

40. The method according to claim 39, wherein the at least one deformable element includes a plurality of lateral projections, and wherein pushing the anchor against the lateral projection comprises radially pushing the anchor against the plurality of lateral projections.

41. The method according to claim 40, wherein radially pushing the anchor against the plurality of lateral projections comprises increasing surface area contact with the inner wall of the implant in the gripping state of the deformable element.