Tissue anchor and anchoring system

• US 10,695,046 B2
• Filed: 08/18/2017
• Issued: 06/30/2020
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Sugimoto, Hiroatsu, Call, Aaron M., Leinsing, Karl R.
• Primary Examiner(s): Anderson, Gregory A
• Application Number:
  US15/680,742
• Publication Number:
  US 20180028171A1
• Time in Patent Office: 1,047 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 17/0401 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures

Abstract

A tissue anchor includes an anchor member formed from a generally flexible material. An activation member, which may be a tensioning member, causes proximal and distal end portions of the anchor member to move toward each other into a shortened configuration suitable for anchoring against the tissue. The tissue anchor can optionally be deployed and activated using a catheter device.

Claims

1. An apparatus for use with tissue of an annulus of a heart valve of a subject, the apparatus comprising an annuloplasty implant that comprises:

an elongate fabric member configured to be anchored to the tissue, and to move between an elongate configuration and a shortened configuration, the fabric member having a first end portion, a second end portion, and a compressible intermediate portion between the first end portion and the second end portion; and

a tensioning member;

having a first tensioning-member end and a second tensioning-member end,

defining a first segment and a second segment by being turned back on itself at a turn such that (i) the first segment extends between the first tensioning-member end and the turn, (ii) the second segment extends between the turn and the second tensioning-member end, and (iii) the second segment is alongside the first segment, and

operatively connected to the fabric member by the first segment and the second segment being threaded, along the fabric member and alongside each other, between the first end portion and the second end portion, such that the fabric member can slide relative to the tensioning member,

wherein;

the turn of the tensioning member is disposed at the second end portion of the fabric member,

the operative coupling of the tensioning member to the fabric member is such that tensioning of the tensioning member causes the fabric member to move from the elongate configuration to the shortened configuration by the tensioning member (i) pulling both the first end portion and the second end portion toward the intermediate portion, and (ii) compressing the intermediate portion, and

the implant is configured to reshape the annulus of the heart valve.

2. The apparatus according to claim 1, wherein the fabric member is formed from a material selected from at least one of:

natural fibers, synthetic fibers, polymers, and metals.

3. The apparatus according to claim 2, wherein the tensioning member further comprises a suture.

4. The apparatus according to claim 1, wherein the tensioning member further comprises a suture.

5. The apparatus according to claim 1, wherein the tensioning member includes a stop member engageable with the fabric member.

6. The apparatus according to claim 5, wherein the stop member further comprises a knot in the tensioning member.

7. The apparatus according to claim 1, wherein the tensioning member extends through the fabric member at multiple locations between the first end portion and the second end portion.

8. The apparatus according to claim 1, wherein the fabric member and the tensioning member are configured such that the fabric member forms at least one fold upon pulling the first tensioning-member end.

9. The apparatus according to claim 1, further comprising a lock member engageable with the tensioning member to retain the fabric member in the shortened configuration.

10. The apparatus according to claim 1, further comprising at least one radiopaque marker on at least one of the fabric member and the tensioning member.

11. The apparatus according to claim 1, further comprising a first radiopaque marker located proximate the first end portion of the fabric member is in the shortened configuration and a second radiopaque marker located proximate the second end portion when the fabric member is in the shortened configuration.

12. The apparatus according to claim 1, wherein the implant comprises a tip at the second end portion, the tip being narrower and more rigid than the fabric member.

13. The apparatus according to claim 12, wherein the tip acts as a compressive force applying member against the second end portion of the fabric member when the fabric member is in the shortened configuration.

14. The apparatus according to claim 1, wherein the fabric member varies in width along its length when in the elongate configuration.

15. The apparatus according to claim 1, wherein the fabric member includes an edge portion that is more rigid than a central area of the fabric member.

16. The apparatus according to claim 1, wherein at least the first tensioning-member end is disposed at the first end portion of the fabric member.

17. The apparatus according to claim 1, further comprising a catheter device, wherein the annuloplasty implant is configured to be transluminally delivered to the heart valve through the catheter device, with the second end portion distal to the first end portion, such that deployment of the annuloplasty implant from the catheter device exposes the second end portion prior to the first end portion.

18. The apparatus according to claim 1, further comprising a catheter device configured to facilitate securing of the second end portion to the tissue, and to facilitate securing of the first end portion to the tissue subsequently to the securing of the second end portion to the tissue.

19. A system for use with tissue of an annulus of a heart valve of a subject, the system comprising:

an annuloplasty implant that comprises;

an elongate fabric member configured to be anchored to the tissue, and to move between an elongate configuration and a shortened configuration, the fabric member having a first end portion, a second end portion, and a compressible intermediate portion between the first end portion and the second end portion; and

a tensioning member having a first tensioning-member end and a second tensioning-member end, defining a first segment and a second segment by being turned back on itself at a turn such that (i) the first segment extends between the first tensioning-member end and the turn, (ii) the second segment extends between the turn and the second tensioning-member end, and (iii) the second segment is alongside the first segment, and operatively connected to the fabric member by the first segment and the second segment being threaded, along the fabric member and alongside each other, between the first end portion and the second end portion, such that the fabric member can slide relative to the tensioning member; and

a catheter device configured to facilitate securing of the second end portion to the tissue, and to facilitate securing of the first end portion to the tissue subsequently to the securing of the second end portion to the tissue;

wherein the turn of the tensioning member is disposed at the second end portion of the fabric member, the operative coupling of the tensioning member to the fabric member is such that tensioning of the tensioning member causes the fabric member to move from the elongate configuration to the shortened configuration by the tensioning member (i) pulling both the first end portion and the second end portion toward the intermediate portion, and (ii) compressing the intermediate portion, and the implant is configured to reshape the annulus of the heart valve.