STENT WITH TETHER INTERFACE

• US 20160022448A1
• Filed: 03/09/2014
• Published: 01/28/2016
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: TOBIS, Idan, MURPHY, Charlotte, GILMORE, Michael
• Granted Patent: US 9,907,681 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 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 less than 30 degrees 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;

one or more tissue anchors; and

one or more tethers having respective first longitudinal portions that are coupled to the one or more tether interfaces, respectively, and respective second longitudinal portions, different from the respective first longitudinal portions, which are coupled to the one or more tissue anchors, respectively.

2. The apparatus according to claim 1, 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.

3. The apparatus according to claim 2, wherein the tension-distribution axial segment axially coincides with the lower-securement axial segment.

4. The apparatus according to claim 2, wherein the one or more tension-distributing elements and the stent are fabricated from a single unit.

5. The apparatus according to claim 2, 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.

6. The apparatus according to claim 2, wherein an axial length of each of the tension-distributing elements equals at least 15% of an axial length of the stent.

7. The apparatus according to claim 6, wherein the axial length of the stent is between 20 and 120 mm, and the axial length of each of the tension-distributing elements is between 10 and 120 mm, when the stent is unconstrained in the radially-expanded state.

8. The apparatus according to claim 1, 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.

10. The apparatus according to claim 1, 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.

11. The apparatus according to claim 1, 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.

16. The apparatus according to claim 1, wherein the one more tether interfaces comprise exactly one tether interface at exactly one tether circumferential location, and wherein the one or more tethers comprise exactly one tether having a first longitudinal portion that is coupled to the tether interface.

17. The apparatus according to claim 16, wherein the tether circumferential location is circumferentially centered in the lower-securement circumferential portion.

18. The apparatus according to claim 16, 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.

20. 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.

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

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

23. 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.

24. The apparatus according to claim 1, 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.

25. The apparatus according to claim 1,

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.

26. The apparatus according to claim 25, 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.

27. The apparatus according to claim 25, wherein at least one of the circumferential stent meanders is shaped so as to define the outward protrusions around the higher-securement portion circumferentially between one or more circumferentially-adjacent pairs of the columnar struts, when the stent is unconstrained in the radially-expanded state.

28. The apparatus according to claim 25, 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.

29. The apparatus according to claim 25, wherein respective radii of the columnar struts are measured between respective inner surfaces of the columnar struts and a central longitudinal axis of the stent, and wherein an average of respective distances between the central longitudinal axis and respective most-outward surfaces of the protrusions equals between 105% and 125% of an average of the radii, when the stent is unconstrained in the radially-expanded state.

30. 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.

31. The apparatus according to claim 30, 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.

32. 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.

9. (canceled)

12-15. -15. (canceled)

19. (canceled)

33. Apparatus comprising:

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

a plurality of tether interfaces at a plurality of tether circumferential locations, respectively, each of which tether interfaces extends circumferentially contiguously around less than 30 degrees of a circumference of the stent,

a plurality of lower-securement portions that extend (a) along at least respective contiguous lower-securement axial segments of the stent and (b) circumferentially around respective contiguous lower-securement circumferential portions of the stent, wherein (i) each of the lower-securement axial segments includes one or more of the tether interfaces, (ii) each of the lower-securement circumferential portions includes one or more of the tether interfaces, and (iii) the lower-securement circumferential portions have respective circumferential arcs, each of which is between 30 and 90 degrees,

a plurality of higher-securement portions that extend (a) along at least respective contiguous higher-securement axial segments of the stent and (b) circumferentially around respective higher-securement circumferential portions of the stent, collectively at all circumferential locations other than those of the lower-securement circumferential portions, wherein the lower- and the higher-securement portions alternate around the stent, and

a plurality of outward protrusions at respective circumferential locations around the higher-securement portions, and not around the lower-securement portions, such that each of the higher-securement portions includes one or more of the outward protrusions;

a plurality of tissue anchors; and

a plurality of tethers having respective first longitudinal portions that are coupled to the plurality of tether interfaces, respectively, and respective second longitudinal portions, different from the respective first longitudinal portions, that are coupled the plurality of tissue anchors, respectively.

34. The apparatus according to claim 33, wherein the circumferential arcs of the lower-securement circumferential portions are equal to one another.

35. The apparatus according to claim 33, wherein the higher-securement circumferential portions have respective circumferential arcs that are equal to one another.

36. The apparatus according to claim 33, wherein the circumferential arcs of the lower-securement circumferential portions are equal to one another, and wherein the higher-securement circumferential portions have respective circumferential arcs that are equal to one another.

37. The apparatus according to claim 33, wherein the stent is shaped so as to define a plurality of tension-distributing elements, which (a) extend along at least respective tension-distribution axial segments of the stent at the tether circumferential locations, respectively, (b) define the tether interfaces, respectively, and (c) are configured to distribute tension applied by the tethers, respectively, along the tension-distribution axial segments of the stent, respectively.

38. The apparatus according to claim 37, wherein the tension-distribution axial segments axially coincide with the lower-securement axial segments, respectively.

39. The apparatus according to claim 37, wherein the tension-distributing elements and the stent are fabricated from a single unit.

40. The apparatus according to claim 37, wherein each of the tension-distributing elements has a circumferential arc of between 1 and 15 degrees, when the stent is unconstrained in the radially-expanded state.

41. The apparatus according to claim 37, wherein an axial length of each of the tension-distributing elements equals at least 15% of an axial length of the stent.

42. The apparatus according to claim 41, wherein the axial length of the stent is between 20 and 120 mm, and the axial length of each of the tension-distributing elements is between 10 and 120 mm, when the stent is unconstrained in the radially-expanded state.

43. The apparatus according to claim 33, 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.

45. The apparatus according to claim 33, 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.

46. The apparatus according to claim 33, wherein the tether interfaces are shaped so as to define respective one or more openings through which the tethers are respectively coupled.

51. The apparatus according to claim 33, wherein the stent, when unconstrained in the radially-expanded state, is shaped so as to define a same number of the tether interfaces and the lower-securement portions.

52. The apparatus according to claim 51, wherein the tether circumferential locations are circumferentially centered in the lower-securement portions, respectively.

53. The apparatus according to claim 33, wherein the outward protrusions are rotationally-asymmetrically distributed around the circumference of the stent, when the stent is unconstrained in the radially-expanded state.

54. The apparatus according to claim 33, wherein the outward protrusions are periodically distributed around each of the higher-securement circumferential portions, when the stent is unconstrained in the radially-expanded state.

57. The apparatus according to claim 33, wherein each of the circumferential arcs of the lower-securement circumferential portions 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 portions, when the stent is unconstrained in the radially-expanded state.

58. The apparatus according to claim 33,

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 portions, when the stent is unconstrained in the radially-expanded state.

59. The apparatus according to claim 58, 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 portions, the outward protrusions, and (b) around the lower-securement portions, respective arcs of a circle if the circumferential stent meander is projected onto a plane perpendicular to a longitudinal axis of the stent.

60. The apparatus according to claim 58, wherein at least one of the circumferential stent meanders is shaped so as to define the outward protrusions around the higher-securement portions circumferentially between one or more circumferentially-adjacent pairs of the columnar struts, when the stent is unconstrained in the radially-expanded state.

61. The apparatus according to claim 58, 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.

62. The apparatus according to claim 58, wherein respective radii of the columnar struts are measured between respective inner surfaces of the columnar struts and a central longitudinal axis of the stent, and wherein an average of respective distances between the central longitudinal axis and respective most-outward surfaces of the protrusions equals between 105% and 125% of an average of the radii, when the stent is unconstrained in the radially-expanded state.

44. (canceled)

47-50. -50. (canceled)

55-56. -56. (canceled)