Stent with tether interface

• US 9,907,681 B2
• Filed: 03/09/2014
• Issued: 03/06/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Tobis, Idan, Murphy, Charlotte, Gilmore, Michael
• Primary Examiner(s): Pellegrino, Brian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/773,640
• Publication Number:
  US 20160022448A1
• Time in Patent Office: 1,458 Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A radially-expandable stent (20) is shaped so as to define one or more tether interfaces (50), a lower-securement portion (56), and a higher-securement portion (64). The lower-securement portion (56) extends (a) along at least a contiguous lower-securement axial segment (58) of the stent (20) and (b) circumferentially around a contiguous lower-securement circumferential portion (60) of the stent (20), which lower-securement axial segment (58) and lower-securement circumferential portion (60) include the one or more tether interfaces (50). The higher-securement portion (64) extends (a) along at least a contiguous higher-securement axial segment (65) of the stent (20) and (b) circumferentially around between 215 and 330 degrees of a circumference (C), at all circumferential locations other than those of the lower-securement circumferential portion (60). The stent (20) is shaped so as to define a plurality of outward protrusions (70) at respective circumferential locations (72) around the higher-securement portion (64), and not around the lower-securement portion (56). One or more tethers (34) are coupled to the one or more tether interfaces (50), respectively, and to one or more tissue anchors (30), respectively.

Claims

1. Apparatus for use with one or more tissue anchors and one or more tethers, the apparatus comprising:

a radially-expandable stent, which, when unconstrained in a radially-expanded state, is generally tubular and shaped so as to define;

one or more tether interfaces at one or more tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around a portion of a circumference of the stent,

a lower-securement portion that extends (a) along at least a contiguous lower-securement axial segment of the stent and (b) circumferentially around a contiguous lower-securement circumferential portion of the stent, which lower-securement axial segment and lower-securement circumferential portion include the one or more tether interfaces,

a higher-securement portion that extends (a) along at least a contiguous higher-securement axial segment of the stent and (b) circumferentially around between 215 and 330 degrees of the circumference, at all circumferential locations other than those of the lower-securement circumferential portion, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portion, and not around the lower-securement portion,

wherein the lower-securement axial segment of the stent extends along at least 30% of an axial length of the stent, when the stent is unconstrained in the radially-expanded state.

2. The apparatus according to claim 1, wherein the one more tether interfaces comprise exactly one tether interface at exactly one tether circumferential location.

3. The apparatus according to claim 2, wherein the tether circumferential location is circumferentially centered in the lower-securement circumferential portion.

4. The apparatus according to claim 1, wherein the outward protrusions are rotationally-asymmetrically distributed around the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

5. The apparatus according to claim 1, wherein the outward protrusions are periodically distributed around the higher-securement portion, when the stent is unconstrained in the radially-expanded state.

6. The apparatus according to claim 1, wherein the outward protrusions are blunt, when the stent is unconstrained in the radially-expanded state.

7. The apparatus according to claim 1, wherein the outward protrusions are shaped so as to define respective barbs, when the stent is unconstrained in the radially-expanded state.

8. The apparatus according to claim 1, wherein the higher-securement portion extends circumferentially around at least 270 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

9. The apparatus according to claim 8, wherein the higher-securement portion extends circumferentially around at least 300 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

10. The apparatus according to claim 1, wherein the higher-securement portion extends circumferentially around no more than 300 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

11. The apparatus according to claim 1, wherein each of the tether interfaces extends circumferentially contiguously around less than 30 degrees of the circumference of the stent.

12. The apparatus according to claim 1, wherein the apparatus further comprises the one or more tissue anchors.

13. The apparatus according to claim 1, wherein the apparatus further comprises the one or more tethers, which have respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively.

14. The apparatus according to claim 13, wherein the apparatus further comprises the one or more tissue anchors, and wherein the one or more tethers have respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

15. The apparatus according to claim 13, wherein the stent is shaped so as to define one or more tension-distributing elements, which (a) extend along at least a tension-distribution axial segment of the stent at the one or more tether circumferential locations, respectively, (b) define the one or more tether interfaces, respectively, and (c) are configured to distribute tension applied by the one or more tethers, respectively, along the tension-distribution axial segment of the stent.

16. The apparatus according to claim 15, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

17. The apparatus according to claim 15, wherein the one or more tension-distributing elements and the stent are fabricated from a single unit.

18. The apparatus according to claim 15, wherein an axial length of each of the tension-distributing elements equals at least 15% of an axial length of the stent.

19. The apparatus according to claim 13, wherein the one or more tether interfaces are shaped so as to define one or more openings, respectively, through which the one or more tethers are respectively coupled.

20. Apparatus for use with one or more tissue anchors, the apparatus comprising:

a radially-expandable stent, which, when unconstrained in a radially-expanded state, is generally tubular and shaped so as to define;

one or more tether interfaces at one or more tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around a portion of a circumference of the stent,

a lower-securement portion that extends (a) along at least a contiguous lower-securement axial segment of the stent and (b) circumferentially around a contiguous lower-securement circumferential portion of the stent, which lower-securement axial segment and lower-securement circumferential portion include the one or more tether interfaces,

a higher-securement portion that extends (a) along at least a contiguous higher-securement axial segment of the stent and (b) circumferentially around between 215 and 330 degrees of the circumference, at all circumferential locations other than those of the lower-securement circumferential portion, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portion, and not around the lower-securement portion,

wherein the apparatus further comprises one or more tethers, which have respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively, and

wherein the stent is shaped so as to define one or more tension-distributing elements, which (a) extend along at least a tension-distribution axial segment of the stent at the one or more tether circumferential locations, respectively, (b) define the one or more tether interfaces, respectively, and (c) are configured to distribute tension applied by the one or more tethers, respectively, along the tension-distribution axial segment of the stent, and

wherein each of the one or more tension-distributing elements has a circumferential arc of between 1 and 15 degrees, when the stent is unconstrained in the radially-expanded state.

21. The apparatus according to claim 20, wherein the apparatus further comprises the one or more tissue anchors, and wherein the one or more tethers have respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

22. The apparatus according to claim 20, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

23. The apparatus according to claim 20, wherein the higher-securement portion extends circumferentially around at least 270 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

24. The apparatus according to claim 20, wherein each of the tether interfaces extends circumferentially contiguously around less than 30 degrees of the circumference of the stent.

25. Apparatus for use with one or more tissue anchors and one or more tethers, the apparatus comprising:

a radially-expandable stent, which, when unconstrained in a radially-expanded state, is generally tubular and shaped so as to define;

one or more tether interfaces at one or more tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around a portion of a circumference of the stent,

a lower-securement portion that extends (a) along at least a contiguous lower-securement axial segment of the stent and (b) circumferentially around a contiguous lower-securement circumferential portion of the stent, which lower-securement axial segment and lower-securement circumferential portion include the one or more tether interfaces,

a higher-securement portion that extends (a) along at least a contiguous higher-securement axial segment of the stent and (b) circumferentially around between 215 and 330 degrees of the circumference, at all circumferential locations other than those of the lower-securement circumferential portion, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portion, and not around the lower-securement portion,

wherein an interior of the stent defines a right circular cylindrical shape having a radius, and wherein the outward protrusions extend radially outward from the cylindrical shape by a distance equal to between 5% and 25% of the radius, when the stent is unconstrained in the radially-expanded state.

26. The apparatus according to claim 25, wherein the lower-securement axial segment of the stent extends along at least 30% of an axial length of the stent, when the stent is unconstrained in the radially-expanded state.

27. The apparatus according to claim 25, wherein the apparatus further comprises the one or more tethers, which have respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively.

28. The apparatus according to claim 27, wherein the apparatus further comprises the one or more tissue anchors, and wherein the one or more tethers have respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

29. The apparatus according to claim 27, wherein the stent is shaped so as to define one or more tension-distributing elements, which (a) extend along at least a tension-distribution axial segment of the stent at the one or more tether circumferential locations, respectively, (b) define the one or more tether interfaces, respectively, and (c) are configured to distribute tension applied by the one or more tethers, respectively, along the tension-distribution axial segment of the stent.

30. The apparatus according to claim 29, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

31. The apparatus according to claim 25, wherein the higher-securement portion extends circumferentially around at least 270 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

32. The apparatus according to claim 25, wherein each of the tether interfaces extends circumferentially contiguously around less than 30 degrees of the circumference of the stent.

33. Apparatus for use with one or more tissue anchors and one or more tethers, the apparatus comprising:

a radially-expandable stent, which, when unconstrained in a radially-expanded state, is generally tubular and shaped so as to define;

one or more tether interfaces at one or more tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around a portion of a circumference of the stent,

a lower-securement portion that extends (a) along at least a contiguous lower-securement axial segment of the stent and (b) circumferentially around a contiguous lower-securement circumferential portion of the stent, which lower-securement axial segment and lower-securement circumferential portion include the one or more tether interfaces,

a higher-securement portion that extends (a) along at least a contiguous higher-securement axial segment of the stent and (b) circumferentially around between 215 and 330 degrees of the circumference, at all circumferential locations other than those of the lower-securement circumferential portion, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portion, and not around the lower-securement portion,

wherein the lower-securement portion has a circumferential arc that equals at least 200% of an average of circumferential distances between circumferential midpoints of circumferentially-adjacent ones of the outward protrusions around the higher-securement portion, when the stent is unconstrained in the radially-expanded state.

34. The apparatus according to claim 33, wherein the apparatus further comprises the one or more tethers, which have respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively.

35. The apparatus according to claim 34, wherein the apparatus further comprises the one or more tissue anchors, and wherein the one or more tethers have respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

36. The apparatus according to claim 34, wherein the stent is shaped so as to define one or more tension-distributing elements, which (a) extend along at least a tension-distribution axial segment of the stent at the one or more tether circumferential locations, respectively, (b) define the one or more tether interfaces, respectively, and (c) are configured to distribute tension applied by the one or more tethers, respectively, along the tension-distribution axial segment of the stent.

37. The apparatus according to claim 36, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

38. The apparatus according to claim 33, wherein the higher-securement portion extends circumferentially around at least 270 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

39. The apparatus according to claim 33, wherein each of the tether interfaces extends circumferentially contiguously around less than 30 degrees of the circumference of the stent.

40. Apparatus for use with one or more tissue anchors and one or more tethers, the apparatus comprising:

a radially-expandable stent, which, when unconstrained in a radially-expanded state, is generally tubular and shaped so as to define;

one or more tether interfaces at one or more tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around a portion of a circumference of the stent,

a lower-securement portion that extends (a) along at least a contiguous lower-securement axial segment of the stent and (b) circumferentially around a contiguous lower-securement circumferential portion of the stent, which lower-securement axial segment and lower-securement circumferential portion include the one or more tether interfaces,

a higher-securement portion that extends (a) along at least a contiguous higher-securement axial segment of the stent and (b) circumferentially around between 215 and 330 degrees of the circumference, at all circumferential locations other than those of the lower-securement circumferential portion, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portion, and not around the lower-securement portion,

wherein the stent comprises a plurality of columnar struts and a plurality of circumferential stent meanders coupled to the columnar struts at respective axial locations, and

wherein one or more of the circumferential stent meanders are shaped so as to define the outward protrusions at the respective circumferential locations around the higher-securement portion, when the stent is unconstrained in the radially-expanded state.

41. The apparatus according to claim 40, wherein, when the stent is unconstrained in the radially-expanded state, at least one of the circumferential stent meanders is shaped so as to define (a) around the higher-securement portion, the outward protrusions, and (b) around the lower-securement portion, an arc of a circle if the circumferential stent meander is projected onto a plane perpendicular to a longitudinal axis of the stent.

42. The apparatus according to claim 40, wherein at least one of the circumferential stent meanders is shaped so as to define a plurality of apices, at least some of which are shaped so as to define the outward protrusions, when the stent is unconstrained in the radially-expanded state.

43. The apparatus according to claim 40, wherein the apparatus further comprises the one or more tethers, which have respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively.

44. The apparatus according to claim 43, wherein the apparatus further comprises the one or more tissue anchors, and wherein the one or more tethers have respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

45. The apparatus according to claim 43, wherein the stent is shaped so as to define one or more tension-distributing elements, which (a) extend along at least a tension-distribution axial segment of the stent at the one or more tether circumferential locations, respectively, (b) define the one or more tether interfaces, respectively, and (c) are configured to distribute tension applied by the one or more tethers, respectively, along the tension-distribution axial segment of the stent.

46. The apparatus according to claim 45, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

47. The apparatus according to claim 40, wherein the higher-securement portion extends circumferentially around at least 270 degrees of the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

48. The apparatus according to claim 40, wherein each of the tether interfaces extends circumferentially contiguously around less than 30 degrees of the circumference of the stent.