Mitral valve implants for the treatment of valvular regurgitation

• US 10,500,048 B2
• Filed: 06/17/2015
• Issued: 12/10/2019
• Est. Priority Date: 06/18/2014
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Polares Medical Inc. (Polares Medical SA)
• Inventors: Khairkhahan, Alexander K., Lesh, Michael D.
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US14/742,199
• Publication Number:
  US 20150366666A1
• Time in Patent Office: 1,637 Days
• 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 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.

Claims

1. An anchoring system comprising:

an implant comprising a hub and a plurality of struts extending circumferentially around the hub, wherein the implant comprises a proximal end and a distal end, wherein the hub is located proximally, wherein at least one strut of the plurality of struts extends from the hub to the distal end of the implant, wherein the implant comprises a wider proximal end than distal end; and

a helical tissue anchor comprising a proximal end and a sharpened distal tip, the proximal end of the helical tissue anchor located proximal to the annular hub, the hub dimensioned to receive the helical tissue anchor therethrough, wherein a portion of the helical tissue anchor is configured to be passed through a distal end of the hub and toward the distal end of the implant to drive the sharpened distal tip of the helical tissue anchor into tissue;

wherein the helical tissue anchor comprises a first engagement structure, the first engagement structure for releasable engagement of a torque shaft;

wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor;

wherein the torque shaft is configured to rotate the helical tissue anchor relative to the hub and into tissue, wherein the helical tissue anchor is configured to secure the implant to tissue.

2. The anchoring system of claim 1, wherein the helical tissue anchor comprises a shoulder, the shoulder comprising the first engagement structure.

3. The anchoring system of claim 1, wherein the first engagement structure is an aperture and the second engagement structure is a projection.

4. The anchoring system of claim 3, wherein the projection is laterally moveable into and out of the aperture.

5. The anchoring system of claim 3, wherein the projection is laterally moveable into and out of the aperture in response to axial movement of an elongate element within the torque shaft.

6. The anchoring system of claim 1, wherein the hub comprises a cross-pin, wherein the cross-pin is configured to provide a site about which a helical structure of the helical tissue anchor is configured to wrap around.

7. The anchoring system of claim 1, wherein the helical tissue anchor comprises fluoroscopic markers.

8. The anchoring system of claim 1, wherein the implant comprises a coaptation assistance body, wherein the coaptation assist body comprises a first coaptation surface and a second coaptation surface, opposed to the first coaptation surface, wherein the first coaptation surface and the second coaptation surface are bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge.

9. The anchoring system of claim 1, wherein the plurality of struts comprise a shape memory material.

10. The anchoring system of claim 1, wherein the implant comprises one or more passive hooks.

11. The anchoring system of claim 1, further comprising one or more helical commissure anchors.

12. The anchoring system of claim 1, further comprising a delivery catheter having multiple lumens, wherein the lumens are configured to early individual torque shafts.

13. The anchoring system of claim 1, further comprising a steerable catheter, wherein the implant is adapted to follow the path of the steerable catheter.

14. The anchoring system of claim 1, further comprising the torque shaft.

15. The anchoring system of claim 1, wherein the hub is configured to be positioned near an annulus of a heart valve, wherein the helical tissue anchor is configured to engage the annulus.

16. The anchoring system of claim 1, wherein the second engagement structure is configured to be deflected to engage the helical tissue anchor.

17. An anchoring system comprising:

an implant comprising an annular hub and a plurality of struts extending circumferentially around the annular hub, wherein the annular hub is located near a proximal end of the implant, wherein at least one strut of the plurality of struts extends from the annular hub to a distal end of the implant, wherein the implant generally tapers in width from the proximal end to the distal end;

a helical tissue anchor comprising a proximal end and a distal tip, wherein the proximal end of the helical tissue anchor is located proximal to the annular hub, wherein the helical tissue is configured to be rotated such that the distal tip extends distally from the annular hub toward the distal end of the implant to engage tissue located distal to the annular hub;

a first engagement structure on the helical tissue anchor, the first engagement structure for releasable engagement of a torque shaft;

wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor;

wherein the torque shaft is configured to rotate to drive the sharpened distal tip of the helical tissue anchor into tissue and secure the implant to tissue.

18. The anchoring system of claim 17, wherein the implant comprises a coaptation assistance body, wherein the coaptation assist body comprises a first coaptation surface and a second coaptation surface, opposed to the first coaptation surface, wherein the first coaptation surface and the second coaptation surface are bounded by a first lateral edge, a second lateral edge, an inferior edge, and a superior edge.

19. The anchoring system of claim 17, herein the plurality of struts comprise a shape memory material.

20. The anchoring system of claim 17, wherein the second engagement structure is configured to be deflected to engage the helical tissue anchor.

21. An anchoring system comprising:

an implant comprising a hub and a plurality of struts extending around the hub and integrally formed with the hub, wherein the hub is located proximally on the implant and the plurality of struts extend laterally and distally from the hub to than a frame of the implant, wherein the implant is bounded by a proximal edge, a distal edge, a first lateral edge, and a second lateral edge, wherein a length of the proximal edge greater than a length of the distal edge; and

a helical tissue anchor comprising a proximal end and a distal end, the proximal end of the helical tissue anchor located proximal to the hub, the hub dimensioned to receive a portion of the helical tissue anchor, wherein the distal end of the helical tissue anchor is configured to extend distally from the hub to engage tissue located distal to the hub;

wherein the helical tissue anchor comprises a first engagement structure, the first engagement structure for releasable engagement of a torque shaft;

wherein the torque shaft comprises a second engagement structure for engaging the helical tissue anchor;

wherein the torque shaft is configured to rotate the helical tissue anchor relative to the hub and into tissue, wherein the helical tissue anchor is configured to secure the implant to tissue.