Method and apparatus for tricuspid valve repair using tension

• US 8,961,596 B2
• Filed: 07/21/2011
• Issued: 02/24/2015
• Est. Priority Date: 01/22/2010
• Status: Expired due to Fees

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Maisano, Francesco, Perevalov, Valery, Hof, Rephael, Alfieri, Ottavio, Tobis, Idan, Vanerman, Hugo
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/188,175
• Publication Number:
  US 20120035712A1
• Time in Patent Office: 1,314 Days
• Field of Search: 623/1.36, 623 236- 237, 623/2.4
• US Class Current: 623/2.36
• 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 2/2454 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

Abstract

Apparatus is provided, including a radially-expandable percutaneous implant, a tissue anchor, and a connecting element shaped so as to provide an annular loop surrounding a proximal portion of the tissue anchor in a manner which enables rotation of the anchor about a central longitudinal axis thereof when surrounded by the annular loop. The apparatus also includes a flexible longitudinal member coupled at a first portion thereof to at least a portion of the percutaneous implant and at a second portion to the connecting element. The annular loop of the connecting element facilitates rotation of the tissue anchor about the central longitudinal axis such that the anchor can rotate about the central longitudinal axis with respect to the annular loop, the flexible longitudinal member, and the percutaneous implant. Other applications are also described.

Claims

1. Apparatus, comprising:

a tissue anchor having a central longitudinal axis;

an adapter head coupled to a proximal portion of the tissue anchor, the adapter head being shaped so as to define an annular element;

a connecting element coupled to the proximal portion of the tissue anchor via the adapter head, the connecting element being shaped so as to provide an annular loop surrounding a portion of the adapter head, the annular loop being centered around the central longitudinal axis, the annular loop defining an opening having a diameter that is smaller than an outer diameter of the annular element of the adapter head such that the annular loop is axially constrained between (1) the annular element of the adapter head and (2) a proximal end of the tissue anchor; and

a flexible longitudinal member coupled to the connecting element, the annular loop of the connecting element facilitating rotation of the tissue anchor about the central longitudinal axis such that the tissue anchor can rotate about the central longitudinal axis with respect to the annular loop and the flexible longitudinal member.

2. The apparatus according to claim 1, wherein the longitudinal member comprises a plurality of fibers.

3. The apparatus according to claim 2, wherein the plurality of fibers are arranged such that the longitudinal member has a length of between 20 mm and 80 mm, a width of between 1 and 4 mm, and a thickness of between 1 and 2 mm.

4. The apparatus according to claim 2, wherein the plurality of fibers are interwoven so as to form a fabric.

5. The apparatus according to claim 1, further comprising a radially-expandable percutaneous implant that is coupled to the tissue anchor via the flexible longitudinal member, wherein the annular loop of the connecting element facilitates rotation of the tissue anchor about the central longitudinal axis such that the tissue anchor can rotate about the central longitudinal axis with respect to the annular loop, the flexible longitudinal member, and radially-expandable percutaneous implant.

6. The apparatus according to claim 5, further comprising:

a tube, which is sized to pass through a lumen defined by the percutaneous implant, the tube having at least one tube lumen, and

a torque-delivering tool configured for slidable passage through the tube, the torque-delivering tool is configured to be removably coupled to the tissue anchor, such that rotation of the torque-delivering tool rotates the tissue anchor.

7. The apparatus according to claim 6, further comprising a sheath configured to surround the percutaneous implant such that the percutaneous implant is maintained in a crimped state when the sheath surrounds the implant, and wherein the sheath is slidable with respect to the tube in order to expose the implant from within the sheath.

8. The apparatus according to claim 6, further comprising a secondary tube through which a guidewire may be passed, the secondary tube being configured to be disposed alongside the tube surrounding the torque-delivering tool, the guidewire being configured to facilitate guiding of the apparatus through vasculature of a patient.

9. The apparatus according to claim 6, wherein:

the connecting element is shaped so as to define a flexible-longitudinal-member-coupler at a proximal portion thereof that is proximal to the annular loop,

the flexible-longitudinal-member-coupler is coupled to the portion of the flexible longitudinal member, and

the torque-delivering tool passes alongside the flexible longitudinal member in a manner which restricts entanglement of the flexible longitudinal member during rotation of the torque-delivering tool to rotate the tissue anchor.

10. The apparatus according to claim 9, further comprising an anti-entanglement device coupled to the tube at a distal portion thereof, wherein the anti-entanglement device is configured to restrict entanglement of the flexible longitudinal member during (1) rotation of the torque-delivering tool to rotate the tissue anchor, and (2) rotation of the tissue anchor with respect to the surrounding annular loop of the connecting element.

11. The apparatus according to claim 10, wherein the anti-entanglement device is configured to be disposed adjacently to the flexible-longitudinal-member-coupler in a manner which restricts entanglement of the flexible longitudinal member during rotation of the torque-delivering tool to rotate the tissue anchor.

12. The apparatus according to claim 6:

wherein the torque-delivering tool comprises a first coupling at a distal end thereof,

wherein the adapter head comprises a second coupling reversibly couplable to the first coupling in a manner which;

(1) couples the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member to the torque-delivering tool when the first and second couplings are coupled together, and

(2) decouples the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member from the torque-delivering tool when the first and second couplings are not coupled together,

wherein, when the distal end of the tool is surrounded by the tube, the first and second couplings are disposed within the tube and are engaged,

wherein the torque-delivering tool is slidable within the tube so as to expose the distal end of the tool and the first and second couplings from within the tube in order to facilitate disengaging of the couplings,

wherein the apparatus further comprises a proximal handle portion coupled to a proximal portion of the tube, the handle portion comprising;

a holder having a recess, the holder being coupled to a proximal portion of the tube, and

an anchor-deployment actuator comprising a proximal knob and a distal protrusion slidable within the recess of the holder,

wherein the anchor-deployment actuator is coupled to a proximal portion of the torque-delivering tool,

wherein the anchor-deployment actuator is rotatable to rotate the torque-delivering tool and the tissue anchor, and

wherein, during a pushed state of the anchor-deployment actuator, the protrusion slides distally within the recess of the holder, and responsively, the torque-delivering tool is pushed distally to expose the first and second couplings from within the tube and disengage the first and second couplings.

13. The apparatus according to claim 6, wherein:

the torque-delivering tool comprises a first coupling at a distal end thereof,

the adapter head comprises a second coupling reversibly couplable to the first coupling in a manner which;

(1) couples the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member to the torque-delivering tool when the first and second couplings are coupled together, and

(2) decouples the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member from the torque-delivering tool when the first and second couplings are not coupled together, and

the proximal portion of the tissue anchor is shaped so as to define (1) an opening at the proximal end of the tissue anchor and (2) a passage through the proximal portion of the tissue anchor, and wherein the adapter head is shaped so as to define a distal protrusion sized so as to fit within the passage, thereby coupling the adapter head to the tissue anchor.

14. The apparatus according to claim 13, wherein:

a portion of the adapter head that is between the distal protrusion and the second coupling is shaped so as to define a longest dimension at a first cross-sectional plane that is perpendicular to the central axis of the tissue anchor,

the annular loop of the connecting element is shaped so as to define a longest dimension at a second cross-sectional plane that is perpendicular to the central axis of the tissue anchor, and

the annular element of the adapter head is disposed coaxially proximally to the annular loop along the longitudinal axis in a manner which restricts decoupling of the connecting element from the tissue anchor.

15. The apparatus according to claim 13, wherein the torque-delivering tool advances the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member through the tube while the first and second couplings are coupled together and when torque-delivering tool is coupled to the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member.

16. The apparatus according to claim 5, wherein the percutaneous implant comprises an endoluminal implant comprising a stent.

17. The apparatus according to claim 16, 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.

18. The apparatus according to claim 17, 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.

19. The apparatus according to claim 18, 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 one of the plurality of interconnectors to a respective one of the plurality of valleys 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.

20. The apparatus according to claim 16, wherein the stent is shaped so as to define a first section configured, in a radially-expanded state of the stent, to exert a stronger radial force on surrounding tissue than a second section of the stent.

21. The apparatus according to claim 20, 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.

22. The apparatus according to claim 21, 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.

23. The apparatus according to claim 22, 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 one of the plurality of interconnectors to a respective one of the plurality of valleys 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.

24. The apparatus according to claim 22, wherein the second section comprises a plurality of vertical elements extending from the first portion.

25. The apparatus according to claim 24, wherein the vertical elements each have a length of between 10 and 80 mm.

26. The apparatus according to claim 1, wherein:

the adapter head is shaped so as to define a distal tissue-anchor coupling element which has an outer diameter that is equal to or less than a diameter of a lumen of the tissue anchor and the tissue-anchor coupling element is fixed within the lumen of the tissue anchor to couple the connecting element to the tissue anchor.

27. The apparatus according to claim 26, wherein the distal tissue-anchor coupling element is welded to the proximal portion of anchor in order to couple the adapter head and thereby the connecting element to the tissue anchor.

28. The apparatus according to claim 26, wherein:

the connecting element is shaped so as to define a flexible-longitudinal-member-coupler at a proximal portion of the connecting element,

the flexible-longitudinal-member-coupler is shaped so as to define an opening configured for coupling of the flexible longitudinal member to the connecting element, and

the flexible-longitudinal-member-coupler is disposed offset with respect to the central longitudinal axis.

29. The apparatus according to claim 12, wherein the torque-delivering tool delivers the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member through the tube while the first and second couplings are coupled together and when torque-delivering tool is coupled to the tissue anchor, the connecting element, the adapter head, and the flexible longitudinal member.

30. A method, comprising:

providing (a) a tissue anchor having a central longitudinal axis, (b) an adapter head coupled to a proximal portion of the tissue anchor, the adapter head being shaped so as to define an annular element, (c) a connecting element coupled to the proximal portion of the tissue anchor via the adapter head, the connecting element being shaped so as to provide an annular loop surrounding a portion of the adapter head, the annular loop being disposed coaxially with respect to the proximal portion of the tissue anchor and perpendicularly to the central longitudinal axis, the annular loop defining an opening having a diameter that is smaller than an outer diameter of the annular element of the adapter head such that the annular loop is axially constrained between (1) the annular element of the adapter head and (2) a proximal end of the tissue anchor, and (d) a flexible longitudinal member, which is coupled to the connecting element;

delivering into a heart of a patient the tissue anchor, the adapter head, the connecting element, and the flexible longitudinal member, while the adapter head and the connecting element are coupled to the tissue anchor, and the flexible longitudinal member is coupled to the connecting element; and

coupling the tissue anchor to tissue in a vicinity of the heart valve of the patient by rotating the tissue anchor with respect to the annular loop and the longitudinal member, the annular loop of the connecting element facilitating the rotating of the tissue anchor about the central longitudinal axis such that the tissue anchor can rotate about the central longitudinal axis with respect to the annular loop and the flexible longitudinal member.

31. The method according to claim 30, wherein providing comprises providing a radially-expandable percutaneous implant that is coupled to the tissue anchor via the flexible longitudinal member, and wherein rotating comprises rotating the tissue anchor with respect to the annular loop, the longitudinal member, and the radially-expandable percutaneous implant.

32. The method according to claim 31, further comprising:

positioning the radially-expandable percutaneous implant in a blood vessel of the patient; and

after coupling the tissue anchor to the tissue, deploying the radially-expandable percutaneous implant such that the implant expands and is implanted in the blood vessel at an implantation site.

33. The method according to claim 32, further comprising, after coupling the tissue anchor to the tissue and before deploying the percutaneous implant, pulling the tissue anchor toward the implantation site.

34. The method according to claim 32, wherein the blood vessel is selected from the group of blood vessels consisting of:

a superior vena cave, an inferior vena cave, a coronary sinus, and a hepatic vein.

35. A method, comprising:

providing (a) a tissue anchor having a central longitudinal axis, (b) an adapter head coupled to a proximal portion of the tissue anchor, the adapter head being shaped so as to define an annular element, (c) a connecting element coupled to the proximal portion of the tissue anchor via the adapter head, the connecting element being shaped so as to provide an annular loop surrounding a portion of the adapter head, the annular loop being disposed coaxially with respect to the proximal portion of the tissue anchor and perpendicularly to the central longitudinal axis, the annular loop defining an opening having a diameter that is smaller than an outer diameter of the annular element of the adapter head such that the annular loop is axially constrained between (1) the annular element of the adapter head and (2) a proximal end of the tissue anchor, and (d) a flexible longitudinal member, which is coupled to the connecting element;

delivering into a heart of a patient the tissue anchor, the adapter head, the connecting element, and the flexible longitudinal member, while the adapter head and the connecting element are coupled to the tissue anchor, and the flexible longitudinal member is coupled to the connecting element; and

rotating the tissue anchor with respect to the annular loop and the longitudinal member while restricting rotation of the flexible longitudinal member, the annular loop of the connecting element facilitating the rotating of the tissue anchor about the central longitudinal axis such that the tissue anchor can rotate about the central longitudinal axis with respect to the annular loop and the flexible longitudinal member.

36. The method according to claim 35, wherein providing comprises providing a radially-expandable percutaneous implant that is coupled to the tissue anchor via the flexible longitudinal member, and wherein rotating comprises rotating the tissue anchor with respect to the annular loop, the longitudinal member, and the radially-expandable percutaneous implant.