Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve

• US 10,687,941 B2
• Filed: 01/03/2018
• Issued: 06/23/2020
• Est. Priority Date: 10/01/2009
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Dahlgren, Jonathan, Goertzen, Douglas, Gelbart, Daniel, Watkinson, Kelly, To, Derrick
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/861,032
• Publication Number:
  US 20180125657A1
• Time in Patent Office: 902 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A device, kit and method may employ an implantable device (e.g., annuloplasty implant) and a tool to implant such. The implantable device is positionable in a cavity of a bodily organ (e.g., a heart) and operable to constrict a bodily orifice (e.g., a mitral valve). Tissue anchors are guided into precise position by an intravascularly deployed anchor guide frame and embedded in an annulus. Constriction of the orifice may be accomplished via a variety of structures, for example by cinching a flexible cable or anchored annuloplasty ring, the cable or ring attached to the tissue anchors. The annuloplasty ring may be delivered in a generally elongated configuration, and implanted in an anchored generally arch, arcuate or annular configuration. Such may move a posterior leaflet anteriorly and an anterior leaflet posteriorly, improving leaflet coaptation to eliminate mitral regurgitation.

Claims

1. An implant kit comprising:

a helical tissue anchor comprising a plurality of coils;

a percutaneous delivery system operable to at least partially embed the helical tissue anchor into a tissue insertion location in tissue within a body during an implant procedure, the percutaneous delivery system comprising a member comprising a lumen; and

a guide rail configured to provide the helical tissue anchor to the tissue insertion location, a portion of the guide rail located within at least some of the plurality of coils of the helical tissue anchor at least in a state in which the guide rail is at least partially located within the lumen of the member,

wherein the guide rail comprises a bend configured to facilitate the helical tissue anchor spiraling off of the guide rail into tissue at a particular location spaced from an end of the guide rail via the helical tissue anchor rotating with respect to the guide rail.

2. The implant kit of claim 1, wherein the portion of the guide rail and the at least some of the plurality of coils of the helical tissue anchor reside within the lumen of the member at least in one configuration of the percutaneous delivery system.

3. The implant kit of claim 1, wherein the bend forms at least a 90°

angle in the guide rail.

4. The implant kit of claim 1, wherein the bend is configured to be proximate or to contact the tissue insertion location during the implant procedure.

5. The implant kit of claim 1, wherein the guide rail comprises a first part and a second part joined to the first part via the bend in the guide rail, and wherein at least some of the first part of the guide rail is configured to be located within the lumen of the member at least in a state in which at least some of the second part of the guide rail contacts at least some of the tissue within the body.

6. The implant kit of claim 1, wherein the bend comprises a joint.

7. The implant kit of claim 6, wherein the joint comprises a hinge or a flexure.

8. The implant kit of claim 1, wherein the bend is configured to engage the helical tissue anchor at a particular region along the guide rail during relative translational movement between the helical tissue anchor and the guide rail, the bend configured to cause the helical tissue anchor to helically rotate in response to the engagement between the bend and the helical tissue anchor.

9. The implant kit of claim 1, wherein the member comprising the lumen is provided by a single lumen push tube.

10. The implant kit of claim 1, wherein the guide rail and the helical tissue anchor are configured to matingly engage to permit an anchor tip of the helical tissue anchor to move along the guide rail in a manner that protects the tissue within the body away from the tissue insertion location from contacting the anchor tip.

11. The implant kit of claim 1, further comprising a latch mechanism configured to retain the helical tissue anchor in a latched state and configured to release the helical tissue anchor in an unlatched state.

12. The implant kit of claim 1, wherein the member is physically coupled to the helical tissue anchor to cause the helical tissue anchor to helically rotate in response to rotation of the member.

13. The implant kit of claim 1, wherein the member is physically coupled to the helical tissue anchor to cause the helical tissue anchor to rotate in response to rotation of the member about a portion of the guide rail located within the lumen of the member.

14. The implant kit of claim 1, wherein the member is removably coupled to the helical tissue anchor to allow the member to decouple from the helical tissue anchor at least in a state after the helical tissue anchor has been embedded into the tissue insertion location in tissue within the body.

15. A method of operating a medical device, the method comprising:

delivering a helical tissue anchor of the medical device along a guide rail of the medical device through at least a portion of a lumen of a member of the medical device, the helical tissue anchor comprising a plurality of coils surrounding a portion of the guide rail during the delivering; and

releasing the helical tissue anchor from the guide rail at least in a state in which the guide rail is partially located outside of the lumen of the member and partially located inside the lumen of the member,

wherein the releasing includes a bend in the guide rail causing the helical tissue anchor to spiral off of the guide rail at a particular location spaced from an end of the guide rail in a manner configured to deliver the helical tissue anchor into tissue via the helical tissue anchor rotating with respect to the guide rail.

16. The method of claim 15, wherein the bend in the guide rail is located at least proximate the particular location where the helical tissue anchor spirals off of the guide rail.

17. The method of claim 16, wherein the bend forms at least a 90°

angle in the guide rail.

18. The method of claim 16, wherein the bend is configured to be proximate, or in contact with, tissue during the spiraling the helical tissue anchor off of the guide rail.

19. The method of claim 16, wherein the bend comprises a joint.

20. The method of claim 19, wherein the joint comprises a hinge or a flexure.

21. The method of claim 15, comprising:

causing relative translational movement between the helical tissue anchor and the guide rail to cause engagement between the bend and the helical tissue anchor at a particular region along the guide rail,

wherein the rotating of the helical tissue anchor with respect to the guide rail occurs at least in response to the engagement between the bend and the helical tissue anchor.

22. The method of claim 21, wherein the particular location at which the helical tissue anchor spirals off of the guide rail is the particular region of engagement between the bend and the helical tissue anchor.

23. The method of claim 21, wherein the bend forms at least a 90°

angle in the guide rail.

24. The method of claim 21, wherein the bend is configured to be proximate, or in contact with, tissue during the spiraling of the helical tissue anchor off of the guide rail.

25. The method of claim 21, wherein the guide rail comprises a first part and a second part joined to the first part via the bend in the guide rail, and wherein, during the spiraling of the helical tissue anchor off of the guide rail, at least some of the first part of the guide rail is located within the lumen of the member and at least some of the second part of the guide rail is located outside of the lumen of the member.

26. The method of claim 21, wherein the bend comprises a joint.

27. The method of claim 26, wherein the joint comprises a hinge or a flexure.

28. The method of claim 15, wherein the member comprising the lumen is provided by a single lumen push tube.

29. The method of claim 15, wherein the member is physically coupled to the helical tissue anchor to cause the helical tissue anchor to helically rotate in response to rotation of the member.

30. The method of claim 15, wherein the member is physically coupled to the helical tissue anchor to cause the helical tissue anchor to rotate in response to rotation of the member about a portion of the guide rail located within the lumen of the member.

31. The method of claim 15, wherein the helical tissue anchor is configured to be released from the guide rail at least in a state after the helical tissue anchor has been embedded into tissue.