Method and apparatus for tricuspid valve repair using tension

• US 9,241,702 B2
• Filed: 07/19/2012
• Issued: 01/26/2016
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Maisano, Francesco, Vanerman, Hugo, Perevalov, Valery, Hof, Rephael, Alfieri, Ottavio, Tobis, Idan
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/553,081
• Publication Number:
  US 20130018459A1
• Time in Patent Office: 1,286 Days
• Field of Search: 623/1.36, 623/2.1, 623/2.17, 623/2.18, 623/2.36, 623/2.37, 623/2.4
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2250/0007 : for adjusting length

Abstract

Apparatus is provided including a radially-expandable percutaneous implant shaped so as to define a tension-distributing element. A flexible longitudinal member is coupled at a first portion thereof to at least a portion of the percutaneous implant via the tension-distributing element. The tension-distributing element is configured to distribute tension applied by the flexible longitudinal member along a longitudinal length of the percutaneous implant.

Claims

1. Apparatus comprising:

a radially-expandable percutaneous implant comprising;

a plurality of struts, which, when the implant is radially expanded, are arranged so as to define a tubular stent; and

a tension-distributing element that is coupled to the plurality of struts, the tension-distributing element, when the implant is radially expanded;

having a tension-distributing-element longitudinal length that is at least 15% of a percutaneous-implant longitudinal length of the percutaneous implant, each of the tension-distributing-element longitudinal length and the percutaneous-implant longitudinal length being measured along a longitudinal axis of the percutaneous implant,

having a tension-distributing-element width that is greater than a widest-strut width of a widest strut of the plurality of struts, and

being flush with the tubular stent along the tension-distributing-element longitudinal length and along the tension-distributing-element width; and

a flexible longitudinal member coupled to the percutaneous implant via the tension-distributing element,

wherein the tension-distributing element is configured to distribute tension applied to the percutaneous implant by the flexible longitudinal member,

wherein the tension-distributing element is shaped so as to provide at least one coupling site for coupling a portion of the flexible longitudinal member to the percutaneous implant, and

wherein the portion of the flexible longitudinal member is coupled to the percutaneous implant via the at least one coupling site.

2. The apparatus according to claim 1, further comprising a tissue anchor coupled to the radially-expandable percutaneous implant via the flexible longitudinal member, the tissue anchor and the flexible longitudinal member being configured to apply tension to the tension-distributing element.

3. The apparatus according to claim 1, wherein the tension-distributing element and the percutaneous implant are fabricated from a single unit.

4. The apparatus according to claim 1, wherein the tension-distributing-element width is between 1 and 4 mm.

5. The apparatus according to claim 1, wherein the widest strut width is between 100 and 500 micron.

6. The apparatus according to claim 1, wherein the tension-distributing-element width is at least 13 times the widest-strut width.

7. The apparatus according to claim 1, wherein the percutaneous-implant longitudinal length of the percutaneous implant is between 20 and 120 mm, and the tension-distributing-element longitudinal length of the tension-distributing element is between 10 and 120 mm.

8. The apparatus according to claim 1, wherein a first section of the stent comprises two or more coaxial annular ring portions, each ring portion shaped so as to define a plurality of peaks and valleys, and wherein the first section comprises a plurality of interconnectors configured to connect the two or more annular ring portions.

9. The apparatus according to claim 8, wherein:

the two or more coaxial annular ring portions comprise first and second annular ring portions that are in phase, and

each one of the plurality of interconnectors is disposed vertically between a respective valley of the first and second ring portions.

10. The apparatus according to claim 9, wherein:

the stent is configured to assume a compressed state within a sheath and an expanded state when exposed from within the sheath by retracting the sheath in a distal-to-proximal direction,

each one of the valleys of the first annular ring portion is connected by a respective interconnector to a respective valley of the second annular ring portion, and

each one of the peaks in a distal portion of the stent points in a distal direction in a manner in which, following expansion of the first and second annular ring portions from within the sheath, the first and second annular ring portions are compressible and retrievable into the sheath when the sheath is advanced in a proximal-to-distal direction.

11. The apparatus according to claim 1, wherein the stent is shaped so as to define a first section configured to exert a stronger radial force on surrounding tissue than a second section of the stent.

12. The apparatus according to claim 11, wherein the first and second sections are each shaped so as to define respective wire structures, each wire structure comprising a respective plurality of wire segments, wherein each wire segment of the second section has a length greater than a length of a respective wire segment of the first section.

13. The apparatus according to claim 11, wherein the first and second sections are each shaped so as to define respective wire structures, each wire structure comprising a respective plurality of wire segments, wherein each wire segment of the first section has a thickness greater than a thickness of a respective wire segment of the second section.

14. The apparatus according to claim 13, wherein each wire segment of the first section has a thickness of between 100 and 1000 micron, and wherein each wire segment of the second section has a thickness of between 100 and 1000 microns.

15. The apparatus according to claim 11, wherein the first section comprises two or more coaxial annular ring portions, each ring portion shaped so as to define a plurality of peak and valleys, and wherein the first section comprises a plurality of interconnectors configured to connect the two or more annular ring portions.

16. The apparatus according to claim 15, wherein:

the two or more coaxial annular ring portions comprise first and second annular ring portions that are in phase, and

each one of the plurality of interconnectors is disposed vertically between a respective valley of the first and second ring portions.

17. The apparatus according to claim 16, wherein:

the stent is configured to assume a compressed state within a sheath and an expanded state when exposed from within the sheath by retracting the sheath in a distal-to-proximal direction,

each one of the valleys of the first annular ring portion is connected by a respective interconnector to a respective valley of the second annular ring portion, and

each one of the peaks in a distal portion of the stent points in a distal direction in a manner in which, following expansion of the first and second annular ring portions from within the sheath, the first and second annular ring portions are compressible and retrievable into the sheath when the sheath is advanced in a proximal-to-distal direction.

18. The apparatus according to claim 16, wherein the second section comprises a plurality of vertical elements extending from the first portion.

19. The apparatus according to claim 18, wherein the vertical elements each have a length of between 10 and 60 mm.

20. The apparatus according to claim 18, wherein the stent is shaped so as to define a third portion configured to exert a stronger radial force on surrounding tissue than the second section of the stent.

26. The apparatus according to claim 1, wherein the percutaneous implant comprises exactly one flexible longitudinal member that is coupled to the percutaneous implant via the tension-distributing element.

27. The apparatus according to claim 1, wherein the tension-distributing element is shaped so as to define at least one eyelet through which a portion of the flexible longitudinal member is threaded, and wherein the at least one eyelet defines the at least one coupling site.

28. The apparatus according to claim 1, wherein the tension-distributing-element longitudinal length is generally equal to the percutaneous-implant longitudinal length.

29. The apparatus according to claim 28, wherein the tension-distributing-element longitudinal length is between 20 and 120 mm, and wherein the percutaneous-implant longitudinal length is between 20 and 120 mm.

30. The apparatus according to claim 1, wherein the tension-distributing element extends in parallel to the longitudinal axis of the percutaneous implant.

31. The apparatus according to claim 1, wherein the plurality of struts and the tension-distributing element together form the tubular stent.

21. A method, comprising:

positioning, in a body of a patient;

a radially-expandable percutaneous implant including;

a plurality of struts which, when the implant is radially expanded, are arranged so as to define a tubular stent; and

a tension-distributing element that is coupled to the plurality of struts, the tension-distributing element, when the implant is radially expanded;

having a tension-distributing-element longitudinal length that is at least 15% of a percutaneous-implant longitudinal length of the percutaneous implant, each of the tension-distributing-element longitudinal length and the percutaneous-implant longitudinal length being measured along a longitudinal axis of the percutaneous implant,

having a tension-distributing-element width that is greater than a widest-strut width of a widest strut of the plurality of struts, and

being flush with the tubular stent along the tension-distributing-element longitudinal length and along the tension-distributing-element width; and

a flexible longitudinal member coupled to the percutaneous implant via the tension-distributing element; and

applying tension to the flexible longitudinal member coupled to the percutaneous implant via the tension-distributing element, such that the tension-distributing element distributes the applied to the percutaneous implant by the flexible longitudinal member,

wherein the tension-distributing element is shaped so as to provide at least one coupling site for coupling a portion of the flexible longitudinal member to the percutaneous implant, and

wherein the portion of the flexible longitudinal member is coupled to the percutaneous implant via the at least one coupling site.

22. The method according to claim 21, wherein a tissue anchor is coupled to the radially-expandable percutaneous implant via the flexible longitudinal member.

23. The method according to claim 21, wherein the tension-distributing element and the percutaneous implant are fabricated from a single unit.

24. The method according to claim 21, wherein the tension-distributing-element width is between 1 and 4 mm.

25. The method according to claim 21, wherein the tension-distributing-element width is at least 13 times the widest-strut width.