Tissue anchors with hemostasis seal

• US 10,588,618 B2
• Filed: 09/17/2019
• Issued: 03/17/2020
• 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:
  US16/573,328
• Publication Number:
  US 20200022697A1
• Time in Patent Office: 182 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 is provided that includes a head connected to a shaft, and a tissue-coupling element extending from the shaft. When the tissue anchor is unconstrained, the head is coaxial with an axis of the shaft, and the tissue-coupling element is generally orthogonal to the axis and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the axis, (a) at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the axis, and (b) the area would partially overlap, at least 3 mm from the vertex, both rays of a second angle of between 45 and 180 degrees in the plane having the vertex at the axis. Other embodiments are also described.

Claims

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

a shaft, which comprises a seal;

a head connected to a proximal portion of the shaft; and

a tissue-coupling element, which extends from a distal end of the shaft,

wherein, when the tissue anchor is unconstrained by the deployment tool;

the shaft has a central longitudinal axis,

the head is coaxial with the central longitudinal axis, and

the tissue-coupling element is generally orthogonal to the central longitudinal axis of the shaft and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the central longitudinal axis, (a) at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the central longitudinal axis, and (b) the area would partially overlap, at least 3 mm from the vertex, both rays of a second angle of between 45 and 180 degrees in the plane having the vertex at the central longitudinal axis, wherein both the rays fall within the first angle.

2. The apparatus according to claim 1, wherein at least 95% of the area of the projection of the tissue-coupling element on the plane would fall within the first angle.

3. The apparatus according to claim 1, wherein at least 80% of the area of the projection of the tissue-coupling element on the plane would fall within a third angle of 150 degrees in the plane having the vertex at the central longitudinal axis.

4. The apparatus according to claim 1, wherein an outer portion of the area of the projection of the tissue-coupling element on the plane would fall within all angular positions of a fourth angle of 90 degrees in the plane having the vertex at the central longitudinal axis, which outer portion consists of all points of the area at least 3 mm from the vertex.

5. The apparatus according to claim 1, wherein the tissue-coupling element is non-helical when the tissue anchor is unconstrained by the deployment tool.

6. The apparatus according to claim 1, wherein the central longitudinal axis is straight when the tissue anchor is unconstrained by the deployment tool.

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

8. The apparatus according to claim 7, wherein the shaft and the tissue-coupling element comprise a wire.

9. The apparatus according to claim 1, wherein the tissue-coupling element comprises at least three tines that extend radially outward from the central longitudinal axis in respective directions that are fixed with respect to one another when the tissue anchor is unconstrained by the deployment tool.

10. The apparatus according to claim 9, wherein tines comprise at least four tines.

11. The apparatus according to claim 1, wherein the tissue-coupling element comprises a wire.

12. The apparatus according to claim 11, wherein the wire is shaped as an open shape.

13. The apparatus according to claim 11, wherein the wire is shaped as an open loop having more than one turn, when the tissue anchor is unconstrained by the deployment tool.

14. The apparatus according to claim 13, wherein the open loop is shaped as a spiral when the tissue anchor is unconstrained by the deployment tool.

15. The apparatus according to claim 13, 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 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.

16. The apparatus according to claim 15, wherein a radius of the flexible elongate tension member is less than a radius of the wire.

17. The apparatus according to claim 15, wherein the apparatus further comprises one or more tethers, which are fixed to the flexible elongate tension member.

18. The apparatus according to claim 15,

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.

19. The apparatus according to claim 18, wherein the second tissue anchor comprises a stent.

20. The apparatus according to claim 15, 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.

21. The apparatus according to claim 20, 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.

22. The apparatus according to claim 21, 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.

23. The apparatus according to claim 11, wherein, when the tissue anchor is unconstrained by the deployment tool:

the wire of the tissue-coupling element is shaped as an open loop having more than one turn around a center point, and

the wire extends from the distal end of the shaft at a radially-outer end of the open loop.

24. The apparatus according to claim 23, wherein the open loop is shaped as a spiral when the tissue anchor is unconstrained by the deployment tool.

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

one or more tethers, which are configured to couple (a) the head of the first tissue anchor to (b) the second tissue anchor.

26. The apparatus according to claim 25, wherein the second tissue anchor comprises a stent.

27. The apparatus according to Claim 1, wherein the apparatus further comprises one or more tethers, wherein one of the one or more tethers is fixed to the head.

29. The method according to claim 27, further comprising, after delivering the tissue-coupling element through the wall of the heart:

ascertaining whether the tissue-coupling element overlies a coronary blood vessel; and

if the tissue-coupling element overlies the coronary blood vessel, rotating the tissue anchor until the tissue-coupling element no longer overlies the coronary blood vessel.

28. A method comprising:

providing a tissue anchor that comprises (a) a shaft, (b) a head connected to a proximal portion of the shaft, which comprises a seal, and (c) a tissue-coupling element, which extends from a distal end of the shaft;

introducing, during a transcatheter procedure, the tissue anchor into a cardiac chamber of a heart of a subject, while the tissue-coupling element is constrained by a deployment tool;

delivering the tissue-coupling element through a wall of the heart; and

at least partially releasing the tissue anchor from the deployment tool such that (a) the tissue-coupling element is unconstrained by the deployment tool, (b) the head is coaxial with a central longitudinal axis of the shaft, and (c) the tissue-coupling element is generally orthogonal to the central longitudinal axis of the shaft and is shaped such that if the tissue-coupling element were to be projected onto a plane that is perpendicular to the central longitudinal axis, (i) at least 80% of an area of a projection of the tissue-coupling element on the plane would fall within a first angle of 180 degrees in the plane having a vertex at the central longitudinal axis, and (ii) the area would partially overlap, at least 3 mm from the vertex, both rays of a second angle of between 45 and 180 degrees in the plane having the vertex at the central longitudinal axis, wherein both the rays fall within the first angle.

30. The method according to claim 28, further comprising, after delivering the tissue-coupling element through the wall of the heart, rotating the tissue anchor and bringing the tissue-coupling element into contact with an external surface of the heart.

31. The method according to claim 30,

wherein introducing the tissue anchor into the cardiac chamber comprises introducing the tissue anchor into an atrium of the heart, and

wherein bringing the tissue-coupling element into contact with the external surface of the heart comprises bringing the tissue-coupling element into contact with an external surface of a ventricle of the heart.