Off-center tissue anchors

• US 9,907,547 B2
• Filed: 12/02/2015
• Issued: 03/06/2018
• Est. Priority Date: 12/02/2014
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Gilmore, Michael, Denti, Paolo, Mullins, John, Murphy, Charlotte, Lynn, Kevin, Guidotti, Andrea, Vanermen, Hugo, Campbell, Thomas
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/104,467
• Publication Number:
  US 20170209137A1
• Time in Patent Office: 825 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/068 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 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2418 : Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• 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 2/2478 : Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A tissue anchor (200, 258, 300) includes a shaft (122), a tissue-coupling element (128), and a flexible elongate tension member (202). The tissue-coupling element (128) includes a wire (150), which is shaped as an open loop (154) having more than one turn when the tissue anchor (200, 258, 300) is unconstrained. The tension member (202) includes a distal portion (204) that is fixed to a site (206) on the open loop (154), a proximal portion (208), which has a longitudinal segment (209) that runs alongside at least a portion (210) of the shaft (122), and a crossing portion (212), which (i) is disposed between the distal and the proximal N portions (204, 208) along the tension member (202), and (ii) crosses at least a portion of the open loop (154) when the tissue anchor (200, 258, 300) is unconstrained. The tissue anchor (200, 258, 300) is configured to allow relative axial motion between the at least a portion (210) of the shaft (122) and the longitudinal segment (209) of the proximal portion (208) of the tension member (202) when the tissue anchor (200, 258, 300) is unconstrained.

Claims

1. Apparatus for delivery in a constrained state within a deployment tool, the apparatus comprising a tissue anchor, which comprises:

a shaft;

a tissue-coupling element, which comprises a wire, which is shaped as an open loop having more than one turn when the tissue anchor is unconstrained by the deployment tool; and

a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the open loop, (b) a proximal portion, which has a longitudinal segment that runs alongside at least a portion of the shaft, and (c) a crossing portion, which (i) is disposed between the distal and the proximal portions along the flexible elongate tension member, and (ii) crosses at least a portion of the open loop when the tissue anchor is unconstrained by the deployment tool,

wherein the tissue anchor is configured to allow relative axial motion between the at least a portion of the shaft and the longitudinal segment of the proximal portion of the flexible elongate tension member when the tissue anchor is unconstrained by the deployment tool,

wherein the longitudinal segment of the proximal portion of the flexible elongate tension member is coupled in sliding communication with the at least a portion of the shaft when the tissue anchor is unconstrained by the deployment tool, and

wherein the tissue anchor comprises one or more annular elements, which are disposed around the at least a portion of the shaft, and couple the flexible elongate tension member in the sliding communication with the at least a portion of the shaft when the tissue anchor is unconstrained by the deployment tool.

2. The apparatus according to claim 1, wherein the open loop is shaped as a spiral when the tissue anchor is unconstrained by the deployment tool.

3. The apparatus according to claim 2, wherein the spiral is shaped as an elliptical spiral when the tissue anchor is unconstrained by the deployment tool.

4. The apparatus according to claim 1, wherein the site is on an outermost turn of the open loop when the tissue anchor is unconstrained by the deployment tool.

5. The apparatus according to claim 1, wherein a radius of the flexible elongate tension member is less than a radius of the wire.

6. The apparatus according to claim 5, wherein the radius of the flexible elongate tension member is less than 50% of the radius of the wire.

7. The apparatus according to claim 1, wherein, when the tissue anchor is unconstrained by the deployment tool and the flexible elongate tension member is tensioned straight, if the tissue-coupling element and the flexible elongate tension member were to be projected onto a plane that is perpendicular to a central longitudinal axis of the shaft, an angle between (a) the flexible elongate tension member and (b) a tangent to the open loop at the site would be between 70 and 90 degrees.

8. The apparatus according to claim 1, wherein the shaft comprises a sealing element.

9. The apparatus according to claim 1, wherein the shaft has a central longitudinal axis that is straight when the tissue anchor is unconstrained by the deployment tool.

10. The apparatus according to claim 1, wherein the shaft and the tissue-coupling element are integral to one another.

11. The apparatus according to claim 1, wherein a cross-sectional area of the wire is at least 0.09 mm2 and no more than 2.9 mm2.

12. The apparatus according to claim 1, wherein the site on the open loop is a first site on the open loop, and wherein, when the tissue anchor is unconstrained by the deployment tool and the flexible elongate tension member is tensioned straight:

the open loop surrounds a center point,

the wire extends from a distal end of the shaft at a second site on the open loop, and

if the tissue-coupling element and the flexible elongate tension member were to be projected onto a plane that is perpendicular to a central longitudinal axis of the shaft, an angle between the first and the second sites, having a vertex at the center point, would be between 130 and 180 degrees.

13. The apparatus according to claim 12, wherein the angle is between 150 and 180 degrees.

14. The apparatus according to claim 12, the second site is at a radially-outer end of the open loop when the tissue anchor is unconstrained by the deployment tool.

15. The apparatus according to claim 1, wherein, when the tissue anchor is unconstrained by the deployment tool:

the open loop surrounds a center point, and

(a) a site distance between the site and a distal end of the shaft is greater than (b) a center-point distance between the center point and the distal end of the shaft, when the tissue anchor is unconstrained by the deployment tool.

16. The apparatus according to claim 1, wherein, when the tissue anchor is unconstrained by the deployment tool:

the open loop has a greatest lateral dimension, measured perpendicular to a central longitudinal axis of the shaft, and

the at least a portion of the open loop crossed by the crossing portion has a length that equals at least 50% of the greatest lateral dimension.

17. The apparatus according to claim 16, wherein the length of the at least a portion of the open loop crossed by the crossing portion equals at least 75% of the greatest lateral dimension when the tissue anchor is unconstrained by the deployment tool.

18. The apparatus according to claim 1, wherein the wire extends from a distal end of the shaft at a radially-outer end of the open loop when the tissue anchor is unconstrained by the deployment tool.

19. The apparatus according to claim 1, wherein a proximally-facing surface defined by the tissue-coupling element is concave when the tissue anchor is unconstrained by the deployment tool.

20. The apparatus according to claim 1, wherein a proximally-facing surface defined by the tissue-coupling element is convex when the tissue anchor is unconstrained by the deployment tool.

21. The apparatus according to claim 1, wherein the apparatus further comprises one or more tethers, which are fixed to the flexible elongate tension member.

22. The apparatus according to claim 1,

wherein the tissue anchor is a first tissue anchor, and

wherein the apparatus further comprises:

a second tissue anchor, which is separate and distinct from the first tissue anchor; and

one or more tethers, which are configured to couple (a) the flexible elongate tension member to (b) the second tissue anchor.

23. The apparatus according to claim 22, wherein the one or more tethers are fixed to (a) the flexible elongate tension member and (b) the second tissue anchor.

24. The apparatus according to claim 22, wherein the one or more tethers are (a) fixed to the second tissue anchor and (b) not fixed to the shaft of the first tissue anchor.

25. The apparatus according to claim 1,

wherein the tissue anchor is a first tissue anchor, and

wherein the apparatus further comprises a second tissue anchor, which is separate and distinct from the first tissue anchor, and

wherein the flexible elongate tension member is coupled to the second tissue anchor.

26. The apparatus according to claim 1,

wherein the tissue anchor comprises a head connected to a proximal portion of the shaft,

wherein the head is shaped so as to define a passage in which the proximal portion of the flexible elongate tension member is slidably disposed,

wherein the flexible elongate tension member comprises a locking stopper, which is axially fixed to the proximal or the crossing portion of the flexible elongate tension member, and

wherein the locking stopper and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the locking stopper past the passage.

27. The apparatus according to claim 1, wherein the tissue anchor is shaped so as to define a bend between the tissue-coupling element and the shaft.

28. Apparatus for delivery in a constrained state within a deployment tool, the apparatus comprising a tissue anchor, which comprises:

a shaft;

a tissue-coupling element, which comprises a wire, which is shaped as an open loop having more than one turn when the tissue anchor is unconstrained by the deployment tool; and

a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the open loop, (b) a proximal portion, which has a longitudinal segment that runs alongside at least a portion of the shaft, and (c) a crossing portion, which (i) is disposed between the distal and the proximal portions along the flexible elongate tension member, and (ii) crosses at least a portion of the open loop when the tissue anchor is unconstrained by the deployment tool,

wherein the tissue anchor is configured to allow relative axial motion between the at least a portion of the shaft and the longitudinal segment of the proximal portion of the flexible elongate tension member when the tissue anchor is unconstrained by the deployment tool,

wherein the tissue anchor comprises a head connected to a proximal portion of the shaft,

wherein the head is shaped so as to define a passage in which the proximal portion of the flexible elongate tension member is slidably disposed,

wherein the flexible elongate tension member comprises a locking stopper, which is axially fixed to the proximal or the crossing portion of the flexible elongate tension member, and

wherein the locking stopper and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the locking stopper past the passage.

29. The apparatus according to claim 28, wherein the locking stopper is axially fixed to the proximal or the crossing portion of the flexible elongate tension member at a distance of between 7 and 22 mm from the site on the open loop.

30. The apparatus according to claim 28, wherein, if the tissue-coupling element were straightened in an elongated configuration, the locking stopper would be a distance of between 7 and 12 mm from the passage.

31. The apparatus according to claim 28, wherein the site is on an outermost turn of the open loop when the tissue anchor is unconstrained by the deployment tool.

32. The apparatus according to claim 28, wherein the site on the open loop is a first site on the open loop, and wherein, when the tissue anchor is unconstrained by the deployment tool and the flexible elongate tension member is tensioned straight:

the open loop surrounds a center point,

the wire extends from a distal end of the shaft at a second site on the open loop, and

if the tissue-coupling element and the flexible elongate tension member were to be projected onto a plane that is perpendicular to a central longitudinal axis of the shaft, an angle between the first and the second sites, having a vertex at the center point, would be between 130 and 180 degrees.

33. The apparatus according to claim 28, wherein the wire extends from a distal end of the shaft at a radially-outer end of the open loop when the tissue anchor is unconstrained by the deployment tool.

34. The apparatus according to claim 28, wherein the longitudinal segment of the proximal portion of the flexible elongate tension member is coupled in sliding communication with the at least a portion of the shaft when the tissue anchor is unconstrained by the deployment tool.