Tricuspid valve repair using tension

• US 9,307,980 B2
• Filed: 12/30/2013
• Issued: 04/12/2016
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Tobis, Idan, Gilmore, Michael, Latib, Mohamed Azeem
• Primary Examiner(s): SWEET, THOMAS
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/143,355
• Publication Number:
  US 20140114390A1
• Time in Patent Office: 834 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 2017/00314 Separate linked members
• 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 2017/0441 the shaft being a rigid coil or spiral
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• 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 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 : the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• 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 that includes first and second tissue-engaging elements, and first and second flexible longitudinal members, coupled at respective first end portions thereof to the first and the second tissue-engaging elements, respectively. The apparatus further includes a first flexible-longitudinal-member-coupling element coupled to a second end portion of the first flexible longitudinal member, a second flexible-longitudinal-member-coupling element coupled to a second end portion of the second flexible longitudinal member, and a flexible longitudinal guide member reversibly coupled to the first flexible-longitudinal-member-coupling element. The first and second flexible-longitudinal-member-coupling elements are configured to be couplable together to couple together the first and the second flexible longitudinal elements. Other applications are also described.

Claims

1. Apparatus comprising:

first and second tissue-engaging elements;

first and second flexible longitudinal members, coupled at respective first end portions thereof to the first and the second tissue-engaging elements, respectively;

a first flexible-longitudinal-member-coupling element coupled to a second end portion of the first flexible longitudinal member, wherein the first and the second end portions of the first flexible longitudinal member are disposed at opposite longitudinal ends of the first flexible longitudinal member;

a second flexible-longitudinal-member-coupling element coupled to a second end portion of the second flexible longitudinal member, wherein the first and the second end portions of the second flexible longitudinal member are disposed at opposite longitudinal ends of the second flexible longitudinal member; and

a flexible longitudinal guide member reversibly coupled to the first flexible-longitudinal-member-coupling element,

wherein the first and second flexible-longitudinal-member-coupling elements are configured to be couplable together to couple together the first and the second flexible longitudinal elements.

2. The apparatus according to claim 1, wherein the second flexible-longitudinal-member-coupling element is shaped so as to define a lumen therethrough, and is configured to slide along the flexible longitudinal guide member when the flexible longitudinal guide member passes through the lumen.

3. The apparatus according to claim 1, wherein a proximal end of the first flexible-longitudinal-member-coupling element is shaped so as to define a threaded coupling, and wherein the flexible longitudinal guide member is shaped so as to define a screw that is reversibly coupled to the threaded coupling.

4. The apparatus according to claim 1, further comprising a snare couplable to the flexible longitudinal guide member so as to facilitate extraction of a portion of the flexible longitudinal guide member to outside a body of a patient.

5. The apparatus according to claim 1, further comprising:

a first delivery tool, which (a) comprises a first catheter tube, and (b) is configured to deliver the first tissue-engaging element, the first flexible longitudinal member, the first flexible-longitudinal-member-coupling element, and the flexible longitudinal guide member; and

a second delivery tool, which (a) comprises a second catheter tube, and (b) is configured to deliver the second flexible longitudinal member and the second flexible-longitudinal-member-coupling element, and to couple the second flexible-longitudinal-member-coupling element to the first flexible-longitudinal-member-coupling element.

6. The apparatus according to claim 5, wherein the second delivery tool is configured to deliver the second flexible longitudinal member and the second flexible-longitudinal-member-coupling element after deployment of the second tissue-engaging element.

7. The apparatus according to claim 5,

wherein the second tissue-engaging element comprises a radially-expandable stent configured to be implanted in a blood vessel selected from the group consisting of:

an inferior vena cava, and a superior vena cava, and

wherein the second delivery tool is configured and sized to pass through the stent when the stent is in a radially-expanded state.

8. The apparatus according to claim 5, wherein the second delivery tool further comprises an advancement tube, which is advanceable through a lumen of the second catheter tube, and is configured to couple the second flexible-longitudinal-member-coupling element to the first flexible-longitudinal-member-coupling element.

9. The apparatus according to claim 1,

wherein the first flexible-longitudinal-member-coupling element comprises a plurality of male couplings, disposed along the first flexible-longitudinal-member-coupling element at respective, different longitudinal sites, and

wherein the second flexible-longitudinal-member-coupling element comprises a female coupling configured to receive the male couplings, allow advancement of the male couplings through the female coupling in a first direction, and restrict advancement of the male couplings through the female coupling in a second direction opposite the first direction.

10. The apparatus according to claim 9, wherein the male couplings have respective conical features.

11. The apparatus according to claim 9,

wherein the female coupling (a) comprises a hollow cylinder configured to receive the male couplings, and (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder,

wherein the male couplings are shaped so as to define respective protrusions, and

wherein the protrusions and the one or more tabs are shaped and sized to allow the advancement of the first flexible-longitudinal-member-coupling element through the hollow cylinder in the first direction, and to restrict the advancement of the first flexible-longitudinal-member-coupling element in the second direction.

12. The apparatus according to claim 11, wherein each of the male couplings is shaped so as to define one or more internal ridges, which are configured to engage the one or more tabs when the tabs enter one of the male couplings.

13. The apparatus according to claim 11,

wherein the protrusions are shaped so as to define respective edges, and

wherein the one or more tabs are configured to flex toward the longitudinal axis after the advancement of the edges of the male couplings beyond the one or more edges, so as to restrict advancement of the male couplings with respect to the one or more tabs in the second direction.

14. The apparatus according to claim 9, wherein the first flexible-longitudinal-member-coupling element comprises a flexible cable to which the male couplings are fixed at the respective, different longitudinal sites.

15. The apparatus according to claim 14, wherein the male couplings have respective conical features.

16. The apparatus according to claim 9, wherein the first flexible-longitudinal-member-coupling element comprises a flexible chain of interconnected links, which are shaped so as to define the male couplings, respectively.

17. The apparatus according to claim 16, wherein the male couplings have respective conical features.

18. The apparatus according to claim 16, wherein the links are shaped so as to define respective spherical heads and spherical receptacles, which are shaped and sized so as to couplingly receive the spherical head of an adjacent one of the links.

19. The apparatus according to claim 1,

wherein the first flexible-longitudinal-member-coupling element comprises:

a cable, which is configured to be flexible and substantially not twistable; and

a wire, which is helically wound around and fixed to the cable, and

wherein the second flexible-longitudinal-member-coupling element comprises a female coupling, which (a) comprises a hollow cylinder configured to receive the first flexible-longitudinal-member-coupling element, and (b) is shaped so as to define an internal thread shaped and sized so as to correspond with the helically-wound wire.

20. The apparatus according to claim 19, wherein the wire is helically wound around the cable at an average pitch equal to between one and four times a diameter of the cable.

21. The apparatus according to claim 1,

wherein the first flexible-longitudinal-member-coupling element comprises a flexible cable,

wherein the second flexible-longitudinal-member-coupling element comprises a female coupling, which (a) comprises a hollow cylinder configured to receive the cable, and (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder, and

wherein the cable and the one or more tabs are shaped and sized to allow advancement of the first flexible-longitudinal-member-coupling element through the hollow cylinder in a first direction, and to restrict, by friction, advancement of the first flexible-longitudinal-member-coupling element in a second direction opposite the first direction.

22. The apparatus according to claim 1, wherein the first flexible-longitudinal-member-coupling element comprises a male coupling, and wherein the second flexible-longitudinal-member-coupling element comprises a female coupling configured to receive the male coupling.

23. The apparatus according to claim 22,

wherein the female coupling (a) comprises a hollow cylinder configured to receive the male coupling, and (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder,

wherein the male coupling is shaped so as to provide one or more protrusions, and

wherein the male coupling and the one or more tabs are sized and shaped to (a) allow advancement of the male coupling with respect to the one or more tabs in a first direction, by pushing the one or more tabs away from the longitudinal axis, and (b) restrict advancement of the male coupling with respect to the one or more tabs in a second direction opposite the first direction.

24. The apparatus according to claim 22, wherein the male coupling is shaped so as to define one or more internal ridges, which are configured to engage the one or more tabs when the tabs enter the male coupling.

25. A method comprising:

implanting, in tissue of an atrium of a patient, a first tissue-engaging element, to which a first end portion of a first flexible longitudinal member is coupled, while a flexible longitudinal guide member is reversibly coupled to a first flexible-longitudinal-member-coupling element that is coupled to a second end portion of the first flexible longitudinal element, wherein the first and the second end portions of the first flexible longitudinal member are disposed at opposite longitudinal ends of the first flexible longitudinal member;

advancing, over the flexible longitudinal guide member, toward the atrium, a second flexible-longitudinal-member-coupling element coupled to a second end portion of a second flexible longitudinal member, wherein a second tissue-engaging element is coupled to a first end portion of the second flexible longitudinal member, and the first and the second end portions of the second flexible longitudinal member are disposed at opposite longitudinal ends of the second flexible longitudinal member;

coupling together the first and the second flexible-longitudinal-member-coupling elements; and

implanting the second tissue-engaging element upstream of the atrium.

26. The method according to claim 25, wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises performing one or both of the group of actions consisting of:

pulling the flexible longitudinal guide member, and pushing the second flexible-longitudinal-member-coupling element.

27. The method according to claim 25, wherein implanting the first tissue-engaging element comprises implanting the first tissue-engaging element in tissue selected from the group consisting of:

tissue of an annulus of an atrioventricular valve, and tissue of a wall of the atrium adjacent the atrioventricular valve.

28. The method according to claim 25,

wherein the first tissue-engaging element includes a helical tissue anchor, and the second tissue-engaging element includes a radially-expandable stent,

wherein implanting the first tissue-engaging element comprises implanting the helical tissue anchor in tissue selected from the group consisting of:

tissue of an annulus of an atrioventricular valve, and tissue of a wall of the atrium adjacent the atrioventricular valve, and

wherein implanting the second tissue-engaging element comprising expanding the radially-expandable in a blood vessel of the patient selected from the group consisting of;

an inferior vena cava, a superior vena cava, and a coronary sinus.

29. The method according to claim 25, further comprising facilitating repair of an atrioventricular valve of the patient by applying tension to the second flexible longitudinal member.

30. The method according to claim 25, further comprising decoupling the flexible longitudinal guide member from the first flexible-longitudinal-member-coupling element, after coupling together the first and the second flexible-longitudinal-member-coupling elements.

31. The method according to claim 30,

wherein a proximal end of the first flexible-longitudinal-member-coupling element is shaped so as to define a threaded coupling,

wherein the flexible longitudinal guide member is shaped so as to define a screw that is reversibly coupled to the threaded coupling, and

wherein decoupling comprises unscrewing the flexible longitudinal guide member from the first flexible-longitudinal-member-coupling element.

32. The method according to claim 25, wherein implanting the second tissue-engaging element comprises implanting the second tissue-engaging element after coupling together the first and the second flexible-longitudinal-member-coupling elements.

33. The method according to claim 25, wherein implanting the second tissue-engaging element comprises implanting the second tissue-engaging element before coupling together the first and the second flexible-longitudinal-member-coupling elements.

34. The method according to claim 33,

wherein the first flexible-longitudinal-member-coupling element includes (a) a cable, which is configured to be flexible and substantially not twistable;

and (b) a wire, which is helically wound around and fixed to the cable,

wherein the second flexible-longitudinal-member-coupling element includes a female coupling, which (a) includes a cylinder configured to receive the first flexible-longitudinal-member-coupling element, and (b) is shaped so as to define an internal thread shaped and sized so as to correspond with the helically-wound wire, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by rotating the cable with respect to the female coupling.

35. The method according to claim 34, wherein the wire is helically wound around the cable at an average pitch equal to between one and four times a diameter of the cable.

36. The method according to claim 35, wherein rotating the cable with respect to the female coupling comprises rotating the flexible longitudinal guide member.

37. The method according to claim 35, wherein rotating the cable with respect to the female coupling comprises:

advancing a rotation-stabilization tube over the flexible longitudinal guide member;

reversibly engaging and rotationally locking the rotation-stabilization tube with the second flexible-longitudinal-member-coupling element; and

while holding the rotation-stabilization tube rotationally stationary, rotating the flexible longitudinal guide member.

38. The method according to claim 33,

wherein the first flexible-longitudinal-member-coupling element includes a flexible cable,

wherein the second flexible-longitudinal-member-coupling element includes a female coupling, which (a) includes a cylinder configured to receive the cable, and (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder,

wherein the cable and the one or more tabs are shaped and sized to allow advancement of the first flexible-longitudinal-member-coupling element through the cylinder in a first direction, and to restrict, by friction, advancement of the first flexible-longitudinal-member-coupling element in a second direction opposite the first direction, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by performing one or both of the group of actions consisting of:

pulling the flexible longitudinal guide member, and pushing the second flexible-longitudinal-member-coupling element.

39. The method according to claim 33,

wherein the second tissue-engaging element includes a radially-expandable stent,

wherein implanting the second tissue-engaging element comprising expanding the radially-expandable in a blood vessel of the patient selected from the group consisting of:

an inferior vena cava, and a superior vena cava, and

wherein advancing the second flexible-longitudinal-member-coupling element comprises advancing the second flexible-longitudinal-member-coupling element through the radially-expanded stent.

40. The method according to claim 33,

wherein the first flexible-longitudinal-member-coupling element includes a plurality of male couplings, disposed along the first flexible-longitudinal-member-coupling element at respective, different longitudinal sites,

wherein the second flexible-longitudinal-member-coupling element includes a female coupling configured to receive the male couplings, allow advancement of the male couplings through the female coupling in a first direction, and restrict advancement of the male couplings through the female coupling in a second direction opposite the first direction, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by pulling one or more of the male couplings into the female coupling, by performing one or both of the group of actions consisting of:

pulling the flexible longitudinal guide member, and pushing the second flexible-longitudinal-member-coupling element.

41. The method according to claim 40, wherein the first flexible-longitudinal-member-coupling element includes a flexible chain of interconnected links, which are shaped so as to define the male couplings, respectively.

42. The method according to claim 41, wherein the links are shaped so as to define respective spherical heads and spherical receptacles, which are shaped and sized so as to couplingly receive the spherical head of an adjacent one of the links.

43. The method according to claim 40, wherein the first flexible-longitudinal-member-coupling element includes a flexible cable to which the male couplings are fixed at the respective, different longitudinal sites.

44. The method according to claim 40,

wherein the female coupling (a) includes a hollow cylinder configured to receive the male couplings, and (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder,

wherein the male couplings are shaped so as to define respective protrusions,

wherein the protrusions and the one or more tabs are shaped and sized to allow the advancement of the first flexible-longitudinal-member-coupling element through the cylinder in the first direction, and to restrict the advancement of the first flexible-longitudinal-member-coupling element in the second direction, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by pulling one or more of the protrusions through the hollow cylinder, by performing one or both of the group of actions consisting of:

pulling the flexible longitudinal guide member, and pushing the second flexible-longitudinal-member-coupling element.

45. The method according to claim 25, wherein the second flexible-longitudinal-member-coupling element is shaped so as to define a lumen therethrough, and wherein advancing comprises sliding the second flexible-longitudinal-member-coupling element along the flexible longitudinal guide member while the flexible longitudinal guide member passes through the lumen.

46. The method according to claim 25, further comprising extracting of a portion of the flexible longitudinal guide member to outside a body of the patient by snaring the flexible longitudinal guide member,

wherein implanting the first tissue-engaging element comprises advancing the first tissue-engaging element, the first flexible longitudinal member, and the first flexible-longitudinal-member-coupling element into the atrium via a vein selected from the group of veins consisting of:

a superior vena cava, and an inferior vena cava,

wherein advancing the second tissue-engaging element comprises advancing the second tissue-engaging element, the second flexible longitudinal member, and the second flexible-longitudinal-member-coupling element into the atrium via the other vein of the group of veins, and

wherein extracting comprises extracting of the portion of the flexible longitudinal guide member to outside the body via the other vein of the group of veins.

47. The method according to claim 25, further comprising:

wherein implanting the first tissue-engaging element comprising using a first delivery tool, which includes a first catheter tube, to deliver the first tissue-engaging element, the first flexible longitudinal member, the first flexible-longitudinal-member-coupling element, and the flexible longitudinal guide member, and

wherein advancing the second flexible-longitudinal-member-coupling element and coupling together the first and the second flexible-longitudinal-member-coupling elements comprises using a second delivery tool, which includes a second catheter tube, to deliver the second flexible longitudinal member and the second flexible-longitudinal-member-coupling element, and to couple the second flexible-longitudinal-member-coupling element to the first flexible-longitudinal-member-coupling element.

48. The method according to claim 47,

wherein the second tissue-engaging element includes a radially-expandable stent,

wherein implanting the second tissue-engaging element comprising expanding the radially-expandable in a blood vessel of the patient selected from the group consisting of:

an inferior vena cava, and a superior vena cava, and

wherein using the second delivery tool comprises passing a portion of the second delivery tool through the radially-expanded stent.

49. The method according to claim 47, wherein the second delivery tool further includes an advancement tube, and wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises advancing the advancement tube through a lumen of the second catheter tube, and using the advancement tube to couple the second flexible-longitudinal-member-coupling element to the first flexible-longitudinal-member-coupling element.

50. The method according to claim 25,

wherein the first flexible-longitudinal-member-coupling element includes a male coupling,

wherein the second flexible-longitudinal-member-coupling element includes a female coupling configured to receive the male coupling, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises coupling the male and the female couplings together.

51. The method according to claim 50,

wherein the female coupling (a) includes a cylinder configured to receive the male coupling, (b) is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the cylinder,

wherein the male coupling is shaped so as to provide one or more protrusions, and

wherein the male coupling and the one or more tabs are sized and shaped to (a) allow advancement of the male coupling with respect to the one or more tabs in a first direction, by pushing the one or more tabs away from the longitudinal axis, and (b) restrict advancement of the male coupling with respect to the one or more tabs in a second direction opposite the first direction.