Multiple anchoring-point tension system

• US 10,052,095 B2
• Filed: 05/05/2016
• Issued: 08/21/2018
• Est. Priority Date: 10/30/2013
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Gilmore, Michael, Tobis, Idan, Murphy, Charlotte, Lynn, Kevin
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): Ton, Martin T
• Application Number:
  US15/147,599
• Publication Number:
  US 20160242762A1
• Time in Patent Office: 838 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 17/0466 Suture bridges
• 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 2017/0414 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members

Abstract

A method is provided that includes implanting (a) a venous first tissue anchor in a vein selected from the group of veins consisting of: a superior vena cava and an inferior vena cava, (b) an atrial second tissue anchor at an atrial site selected from the group of sites consisting of: an annulus of a tricuspid valve, and a wall of a right atrium of a heart above the annulus of the tricuspid valve, (c) a venous third tissue anchor in a coronary sinus, and (d) one or more tethers, which connect the venous first tissue anchor, the atrial second tissue anchor, and the venous third tissue anchor. A size of a tricuspid orifice is reduced by tensioning the one or more tethers. Other embodiments are also described.

Claims

1. A method comprising:

implanting;

a venous first tissue anchor in a vein selected from the group of veins consisting of;

a superior vena cava and an inferior vena cava,

an atrial second tissue anchor at an atrial site selected from the group of sites consisting of;

an annulus of a tricuspid valve, and a wall of a right atrium of a heart above the annulus of the tricuspid valve,

a venous third tissue anchor in a coronary sinus, and

one or more tethers, which connect the venous first tissue anchor, the atrial second tissue anchor, and the venous third tissue anchor; and

reducing a size of a tricuspid orifice by tensioning the one or more tethers.

2. The method according to claim 1,

wherein the venous first tissue anchor and the venous third tissue anchor include first and second intraluminal stents, respectively,

wherein implanting the venous first tissue anchor comprises expanding the first intraluminal stent in the selected vein, and

wherein implanting the venous third tissue anchor comprises expanding the second intraluminal stent in the coronary sinus.

3. The method according to claim 2, wherein a greatest outer diameter of the second intraluminal stent is no more than 80% of a greatest outer diameter of the first intraluminal stent, when the first and the second intraluminal stents are unconstrained and fully radially expanded.

4. The method according to claim 2, wherein the atrial second tissue anchor includes a helical tissue-coupling element, and wherein implanting the atrial second tissue anchor comprises rotating the helical tissue-coupling element into tissue at the site.

5. The method according to claim 1, wherein implanting the venous first tissue anchor comprises implanting the venous first tissue anchor in the inferior vena cava.

6. The method according to claim 5, wherein implanting the atrial second tissue anchor comprises implanting the atrial second tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

7. The method according to claim 1, wherein implanting the venous first tissue anchor comprises implanting the venous first tissue anchor in the superior vena cava.

8. The method according to claim 7, wherein implanting the atrial second tissue anchor comprises implanting the atrial second tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

9. The method according to claim 1, wherein the atrial second tissue anchor includes a helical tissue-coupling element and a head.

10. The method according to claim 1,

wherein implanting comprises implanting a pulley system, which (a) is connected to the venous first tissue anchor, the atrial second tissue anchor, and the venous third tissue anchor, and (b) includes a pulley, and

wherein reducing the size of the tricuspid orifice by tensioning the one or more tethers comprises using the pulley system to distribute and transfer forces between the venous first tissue anchor, the atrial second tissue anchor, and the venous third tissue anchor.

11. The method according to claim 1, wherein implanting comprises implanting a pulley system, which includes (a) a pulley, which is connected to the atrial second tissue anchor, and (b) a first tether of the one or more tethers, which first tether (i) is connected to the venous first tissue anchor and the venous third tissue anchor, (ii) is moveable through the pulley, and (iii) has a first length, measured between the venous first tissue anchor and the venous third tissue anchor, of at least 15 mm.

12. The method according to claim 11, wherein the pulley includes a loop, and wherein tensioning the first tether comprises sliding the first tether through the loop.

13. The method according to claim 12, wherein the loop is a closed loop.

14. The method according to claim 11, wherein the pulley includes a ring, and wherein tensioning the first tether comprises sliding the first tether through the ring.

15. The method according to claim 11, wherein the pulley includes a wheel, and wherein tensioning the first tether comprises rotating the wheel by moving the first tether through the pulley.

16. The method according to claim 11, wherein implanting the venous first tissue anchor, the atrial second tissue anchor, the venous third tissue anchor, and the pulley system comprises positioning the venous first tissue anchor, the atrial second tissue anchor, the venous third tissue anchor, and the pulley system such that two longitudinal portions of the first tether adjacent to and on opposite sides of the pulley define an angle therebetween of between 5 and 150 degrees.

17. The method according to claim 11,

wherein the pulley system further includes a second tether of the one or more tethers, which second tether (a) is connected to the pulley and the atrial second tissue anchor, so as to connect the pulley to the atrial second tissue anchor, and (b) has a second length, measured between the atrial second tissue anchor and the pulley, of at least 3 mm, and

wherein implanting the pulley system further comprises implanting the second tether.

18. The method according to claim 11,

wherein the atrial second tissue anchor includes (a) a tissue-coupling element, and (b) a head,

wherein the pulley is connected to the head, and

wherein tensioning the one or more tethers comprises tensioning the first tether by fully extending the pulley away from the head, such that a distance between (a) a site on the pulley farthest from the head and (b) a site on the head closest to the pulley, is at least 3 mm.

19. The method according to claim 18, wherein the head includes an interface that is rotatable with respect to the tissue-coupling element.

20. The method according to claim 11, wherein the atrial second tissue anchor includes (a) a tissue-coupling element, and (b) a head, which includes the pulley, and wherein implanting the atrial second tissue anchor comprises implanting the head.

21. The method according to claim 20, wherein the head includes an interface, which (a) includes the pulley and (b) is rotatable with respect to the tissue-coupling element.

22. The method according to claim 1, wherein implanting comprises implanting a pulley system, which includes (a) a pulley, which is connected to the venous third tissue anchor, and (b) a first tether of the one or more tethers, which first tether (i) is connected to the venous first tissue anchor and the atrial second tissue anchor, (ii) is moveable through the pulley, and (iii) has a first length, measured between the venous first tissue anchor and the atrial second tissue anchor, of at least 15 mm.

23. The method according to claim 22, wherein the pulley includes a loop, and wherein tensioning the one or more tethers comprises tensioning the first tether by sliding the first tether through the loop.

24. The method according to claim 23, wherein the loop is a closed loop.

25. The method according to claim 22, wherein the pulley includes a ring, and wherein tensioning the one or more tethers comprises tensioning the first tether by sliding the first tether through the ring.

26. The method according to claim 22, wherein the pulley includes a wheel, and wherein tensioning the one or more tethers comprises tensioning the first tether by rotating the wheel by moving the first tether through the pulley.

27. The method according to claim 22, wherein implanting the venous first tissue anchor, the atrial second tissue anchor, the venous third tissue anchor, and the pulley system comprises positioning the venous first tissue anchor, the atrial second tissue anchor, the venous third tissue anchor, and the pulley system such that two longitudinal portions of the first tether adjacent to and on opposite sides of the pulley define an angle therebetween of between 5 and 150 degrees.

28. The method according to claim 22,

wherein the pulley system further includes a second tether of the one or more tethers, which second tether (a) is connected to the pulley and the venous third tissue anchor, so as to connect the pulley to the venous third tissue anchor, and (b) has a second length, measured between the venous third tissue anchor and the pulley, of at least 3 mm, and

wherein implanting the pulley system further comprises implanting the second tether.