Off-center tissue anchors

Patent metadata

Field	Value
Publication number	US-12226093-B2
Application number	US-202218045952-A
Country	US
Kind code	B2
Filing date	Oct 12, 2022
Priority date	Dec 2, 2014
Publication date	Feb 18, 2025
Grant date	Feb 18, 2025

Abstract

A tissue anchor system is provided that includes a first tissue anchor, a second tissue anchor that is separate and distinct from the first tissue anchor, and one or more tethers, which are configured to couple the first tissue anchor to the second tissue anchor. When the first tissue anchor is unconstrained, a head thereof is coaxial with an axis of a shaft thereof, and a tissue-coupling element thereof extends from a distal end of the shaft, 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, 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. Other embodiments are also described.

First claim

The invention claimed is:

1. A tissue anchor system for use with a deployment tool, the tissue anchor system comprising:
(i) a first tissue anchor, which is configured to be delivered to a cardiac chamber in a constrained state within the deployment tool, and which comprises:
a shaft;
a head connected to a proximal portion of the shaft; and
a tissue-coupling element, which (a) extends from a distal end of the shaft, and (b) is configured to be advanced through a heart wall;

(ii) a second tissue anchor, which is separate and distinct from the first tissue anchor; and
(iii) one or more tethers, which are configured to couple the first tissue anchor to the second tissue anchor,
wherein, when the first 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 tissue anchor system according to claim 1 , wherein the second tissue anchor comprises a stent.

3. The tissue anchor system according to claim 1 , wherein the one or more tethers are configured to coupled (a) the head of the first tissue anchor to (b) the second tissue anchor.

4. The tissue anchor system 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.

5. The tissue anchor system 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.

6. The tissue anchor system 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.

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

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

9. The tissue anchor system according to claim 1 , wherein the shaft and the tissue-coupling element are integral to one another.

10. The tissue anchor system according to claim 9 , wherein the shaft and the tissue-coupling element comprise a wire.

11. The tissue anchor system 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 first tissue anchor is unconstrained by the deployment tool.

12. The tissue anchor system according to claim 1 , wherein the tissue-coupling element comprises a wire.

13. The tissue anchor system according to claim 12 , wherein the wire is shaped as an open shape.

14. The tissue anchor system according to claim 12 , wherein the wire is shaped as an open loop having more than one turn, when the first tissue anchor is unconstrained by the deployment tool.

15. The tissue anchor system according to claim 12 , wherein, when the first 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.

16. The tissue anchor system according to claim 1 , wherein the first 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, (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 tissue-coupling element when the first tissue anchor is unconstrained by the deployment tool.

17. The tissue anchor system according to claim 16 , wherein the one or more tethers are fixed to the flexible elongate tension member.

18. The tissue anchor system according to claim 1 , further comprising the deployment tool, wherein the deployment tool comprises a sharp distal piercing tip, which is configured to deliver the tissue-coupling element through tissue of the heart wall while the tissue-coupling element is constrained within the deployment tool.

19. A tissue anchor system comprising:
(i) a deployment tool, which comprises a sharp distal piercing tip; and
(ii) a tissue anchor, which is configured to be delivered to a cardiac chamber in a constrained state within the deployment tool, and which comprises:
a shaft;
a head connected to a proximal portion of the shaft; and
a tissue-coupling element, which (a) extends from a distal end of the shaft, and (b) is configured to be advanced through a heart wall,

wherein the sharp distal piercing tip of the deployment tool is configured to deliver the tissue-coupling element through tissue of the heart wall while the tissue-coupling element is constrained within the deployment tool,
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.

20. The tissue anchor system according to claim 19 , wherein the tissue anchor is a first tissue anchor, and wherein the tissue anchor system 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 the first tissue anchor to the second tissue anchor.

Assignees

• 4Tech Inc

Inventors

• Gilmore Michael
• Denti Paolo
• Mullins John
• Murphy Charlotte
• Lynn Kevin
• Guidotti Andrea
• Vanermen Hugo
• Campbell Thomas

Classifications

• A61F2/915

  with bands having a meander structure, adjacent bands being connected to each other · CPC title

• A61B17/0057

  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 title

• A61B17/00234

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61F2/2478

  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 title

• A61F2/2442

  Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve · CPC title