Off-center tissue anchors

• US 10,463,358 B2
• Filed: 06/12/2017
• Issued: 11/05/2019
• 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): Severson, Ryan J.
• Application Number:
  US15/619,881
• Publication Number:
  US 20170273681A1
• Time in Patent Office: 876 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
• 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 is provided for delivery in a constrained state within a deployment tool. The tissue anchor includes a tissue-coupling element; a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the tissue-coupling element, and (b) a proximal portion, which is slidably disposed through a passage defined by the tissue anchor; and a load-limiting element, which is attached to the flexible elongate tension member. The load-limiting element and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the load-limiting element past the passage, such that the load-limiting element limits a total load that can be applied to the tissue-coupling element by the flexible elongate tension member.

Claims

1. A tissue anchor for delivery in a constrained state within a deployment tool, the tissue anchor comprising:

a shaft;

a tissue-coupling element, which (a) extends from a distal end of the shaft, (b) comprises a wire comprising a shape-memory alloy, and (c) is configured to automatically transition to a predetermined shape when unconstrained by the deployment tool upon being released from the constrained state within the deployment tool, wherein the predetermined shape of the tissue-coupling element is generally orthogonal to a central longitudinal axis of the shaft;

a head, which (a) is axially fixed to the shaft such that a distal end of the head is proximate the tissue-coupling element, and (b) is shaped so as to define a passage that extends to the distal end of the head;

a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the tissue-coupling element, and (b) a proximal portion, which is slidably disposed through the passage defined by the head of the tissue anchor; and

a load-limiting element, which is attached to the flexible elongate tension member,

wherein the load-limiting element and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the load-limiting element past the passage, such that the load-limiting element limits a total load that can be applied to the tissue-coupling element by the flexible elongate tension member.

2. The tissue anchor according to claim 1, wherein the head comprises one or more collars that are shaped so as to define the passage.

3. The tissue anchor according to claim 1, wherein the passage is a channel through a portion of the head of the tissue anchor.

4. The tissue anchor according to claim 1, wherein the passage is a groove.

5. The tissue anchor according to claim 1, wherein the load-limiting element is axially fixed to the flexible elongate tension member.

6. The tissue anchor according to claim 5, wherein the load-limiting element is manufactured as a separate element that is fixed to the flexible elongate tension member.

7. The tissue anchor according to claim 5, wherein the load-limiting element is integral to the flexible elongate tension member.

8. The tissue anchor according to claim 1, wherein the load-limiting element is shaped so as to define a base and a flange, which flange is too large to pass through the passage.

9. The tissue anchor according to claim 1, wherein the wire is shaped so as to define a channel therein.

10. The tissue anchor according to claim 1, wherein the tissue-coupling element has less than one turn when the tissue anchor is unconstrained by the deployment tool.

11. The tissue anchor according to claim 10, wherein the tissue-coupling element is shaped as a portion of a circle or a portion of an ellipse when the tissue anchor is unconstrained by the deployment tool.

12. The tissue anchor according to claim 1, wherein the flexible elongate tension member further includes 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 predetermined shape of the tissue-coupling element when the tissue anchor is unconstrained by the deployment tool.

13. The tissue anchor according to claim 1, wherein the tissue anchor comprises only a single load-limiting element.

14. An anchor system comprising the tissue anchor according to claim 1, wherein the anchor system further comprises a tether fixed to the flexible elongate tension member such that tension can be applied to the flexible elongate tension member via the tether.

15. The anchor system according to claim 14, wherein the tissue anchor is a first tissue anchor, wherein the anchor system further comprises a second tissue anchor, and wherein the tether couples the first tissue anchor to the second tissue anchor.

16. A method comprising:

delivering, to a cardiac chamber, a tissue-coupling element of a tissue anchor while the tissue anchor is in a constrained state within a deployment tool, wherein the tissue-coupling element extends from a distal end of a shaft of the tissue anchor and comprises a wire comprising a shape-memory alloy;

delivering the tissue-coupling element through a cardiac tissue wall from a first side of the cardiac tissue wall to a second side of the cardiac tissue wall;

deploying the tissue-coupling element from the deployment tool on the second side of the cardiac tissue wall, such that the tissue-coupling element expands and automatically transitions on the second side of the cardiac tissue wall to a predetermined shape that is generally orthogonal to a central longitudinal axis of the shaft, thereby anchoring the tissue-coupling element to the cardiac tissue wall, wherein the tissue anchor further comprises a flexible elongate tension member, which includes (a) a distal portion that is fixed to a site on the tissue-coupling element, and (b) a proximal portion, which is slidably disposed through a passage that is defined by a head of the tissue anchor and extends to a distal end of the head, wherein the head is axially fixed to the shaft such that a distal end of the head is proximate the tissue-coupling element;

partially compressing the tissue-coupling element by applying tension to the flexible elongate tension member, until the passage prevents proximal movement, past the passage, of a load-limiting element that is attached to the flexible elongate tension member, such that the load-limiting element limits a total load that can be applied to the tissue-coupling element by the flexible elongate tension member; and

after the passage prevents proximal movement of the load-limiting element past the passage, applying, to the flexible elongate tension member, additional tension that does not further compress the tissue-coupling element.

17. The method according to claim 16, wherein the head comprises one or more collars that are shaped so as to define the passage.

18. The method according to claim 16, wherein the passage is a channel through a portion of the head of the tissue anchor.

19. The method according to claim 16, wherein the passage is a groove.

20. The method according to claim 16, wherein the load-limiting element is axially fixed to the flexible elongate tension member.

21. The method according to claim 20, wherein the load-limiting element is manufactured as a separate element that is fixed to the flexible elongate tension member.

22. The method according to claim 20, wherein the load-limiting element is integral to the flexible elongate tension member.

23. The method according to claim 16, wherein the load-limiting element is shaped so as to define a base and a flange, which flange is too large to pass through the passage.

24. The method according to claim 16, wherein the wire is shaped so as to define a channel therein.

25. The method according to claim 16, wherein deploying the tissue-coupling element comprises deploying the tissue-coupling element such that the tissue-coupling element has less than one turn when the tissue-coupling element expands on the second side of the cardiac tissue wall.

26. The method according to claim 25, wherein deploying the tissue-coupling element comprises deploying the tissue-coupling element such that the tissue-coupling element is shaped as a portion of a circle or a portion of an ellipse when the tissue-coupling element expands on the second side of the cardiac tissue wall.

27. The method according to claim 16, wherein applying the tension to the flexible elongate tension member comprises applying the tension to a tether affixed to the elongate tension member.