Multiple anchoring-point tension system

• US 10,039,643 B2
• Filed: 10/28/2014
• Issued: 08/07/2018
• 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 TRUYEN
• Application Number:
  US15/031,069
• Publication Number:
  US 20160235533A1
• Time in Patent Office: 1,379 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• 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

Abstract

A method is provided that includes implanting (a) a first venous tissue anchor in a superior vena cava, an inferior vena cava, or a coronary sinus, (b) exactly two atrial tissue anchors, which consist of second and third atrial tissue anchors, at respective different atrial sites, each of which sites is selected from: an annulus of a tricuspid valve, and a wall of a right atrium of a heart above the annulus, and (c) a pulley system, which includes (i) a pulley, which is connected to the second atrial tissue anchor, and (ii) a tether, which (A) is connected to the first venous tissue anchor and the third atrial tissue anchor, (B) is moveable through the pulley, and (C) has a length, measured between the first venous and the third atrial tissue anchors, of at least 30 mm. A size of a tricuspid orifice is reduced by tensioning the tether.

Claims

1. A method comprising:

implanting;

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

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

exactly two atrial tissue anchors, which consist of second and third atrial tissue anchors, at respective different atrial sites, each of which sites is 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, and

a pulley system, which includes (a) a pulley, which is connected to the second atrial tissue anchor, and (b) a tether, which (i) is connected to the first venous tissue anchor and the third atrial tissue anchor, (ii) is moveable through the pulley, and (iii) has a length, measured between the first venous and the third atrial tissue anchors, of at least 30 mm; and

reducing a size of a tricuspid orifice by tensioning the tether.

2. The method according to claim 1, wherein the pulley includes a loop, and wherein tensioning the tether comprises sliding the tether through the loop.

3. The method according to claim 2, wherein the loop is a closed loop.

4. The method according to claim 1, wherein the pulley includes a ring, and wherein tensioning the tether comprises sliding the tether through the ring.

5. The method according to claim 1, wherein the pulley includes a wheel, and wherein tensioning the tether comprises rotating the wheel by moving the tether through the pulley.

6. The method according to claim 1, wherein the first venous tissue anchor includes an intraluminal stent, and wherein implanting the first venous tissue anchor comprises expanding the intraluminal stent in the selected vein.

7. The method according to claim 6, wherein the second and the third atrial tissue anchors include respective helical tissue-coupling elements, and wherein implanting the second and the third atrial tissue anchors comprises rotating the helical tissue-coupling elements into tissue at the sites, respectively.

8. The method according to claim 1, wherein implanting the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system comprises positioning the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system such that two longitudinal portions of the tether adjacent to and on opposite sides of the pulley define an angle therebetween of between 40 and 85 degrees.

9. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a septal leaflet of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

10. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

11. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava, and

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

12. The method according to claim 11, wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve.

13. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava, and

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

14. The method according to claim 13, wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a septal leaflet of the tricuspid valve.

15. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the coronary sinus,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve.

16. The method according to claim 1,

wherein the tether is a first tether, and the length is a first length,

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

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

17. The method according to claim 1,

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

wherein the pulley is connected to the head, and

wherein tensioning the tether comprises 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.

18. The method according to claim 17, wherein the head includes a tether interface that is rotatable with respect to the tissue-coupling element.

19. The method according to claim 1, wherein implanting the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system comprises positioning the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system such that two longitudinal portions of the tether adjacent to and on opposite sides of the pulley define an angle therebetween of at least 120 degrees.

20. The method according to claim 1, wherein implanting the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system comprises positioning the first venous tissue anchor, the second atrial tissue anchor, the third atrial tissue anchor, and the pulley system such that two longitudinal portions of the tether adjacent to and on opposite sides of the pulley define an angle there between of less than 90 degrees.

21. The method according to claim 20, wherein the angle is less than 60 degrees.

22. The method according to claim 1, wherein the second atrial tissue anchor includes (a) a tissue-coupling element, and (b) a head, which includes the pulley, and wherein implanting the second atrial tissue anchor comprises implanting the head.

23. The method according to claim 22, wherein the head includes an interface, which (a) includes the pulley and (b) is rotatable with respect to the tissue-coupling element.

24. The method according to claim 22, wherein the pulley includes an eyelet.

25. The method according to claim 22, wherein the pulley includes a roller.

26. The method according to claim 22, wherein the pulley includes a flexible longitudinal member that is connected to the head at two points along the flexible longitudinal member, so as to define a loop longitudinally between the two points.

27. The method according to claim 22,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a posterior leaflet of the tricuspid valve.

28. The method according to claim 22,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of an anterior leaflet of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a posterior leaflet of the tricuspid valve.

29. The method according to claim 22,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a posterior leaflet of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of an anterior leaflet of the tricuspid valve.

30. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a septal leaflet of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a posterior leaflet of the tricuspid valve.

31. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

32. The method according to claim 1,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a septal leaflet of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

33. A method comprising:

implanting;

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

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

exactly two atrial tissue anchors, which consist of second and third atrial tissue anchors, at respective different atrial sites, each of which sites is 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, and

a pulley system, which includes (a) a pulley, which is connected to the first venous tissue anchor, (b) a first tether, which (i) is connected to the second and the third atrial tissue anchors, (ii) is moveable through the pulley, and (iii) has a first length, measured between the second and the third atrial tissue anchors, of at least 10 mm, and (c) a second tether, which (i) is connected to the first venous tissue anchor and to the pulley, and (ii) has a second length, measured between the first venous tissue anchor and the pulley, of at least 30 mm; and

reducing a size of a tricuspid orifice by tensioning the second tether.

34. The method according to claim 33,

wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the inferior vena cava,

wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve, and

wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a circumferential middle of a septal leaflet of the tricuspid valve.

35. The method according to claim 33, wherein the pulley includes a loop, and wherein tensioning the first tether comprises sliding the first tether through the loop.

36. The method according to claim 33, wherein the pulley includes a ring, and wherein tensioning the first tether comprises sliding the first tether through the ring.

37. The method according to claim 33, wherein implanting the first venous tissue anchor comprises implanting the first venous tissue anchor in the superior vena cava.

38. The method according to claim 37, wherein implanting the third atrial tissue anchor comprises implanting the third atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to an anteroposterior commissure of the tricuspid valve.

39. The method according to claim 38, wherein implanting the second atrial tissue anchor comprises implanting the second atrial tissue anchor within 1 cm of a site on the annulus that circumferentially corresponds to a septoanterior commissure of the tricuspid valve.