Systems and methods for anchoring an implant

• US 10,251,635 B2
• Filed: 06/24/2015
• Issued: 04/09/2019
• Est. Priority Date: 06/24/2014
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Peak Medical, Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alexander K., Lesh, Michael D., Klenk, Alan R., Mar, Craig, Tene, Danielle, Tun, Zaya
• Primary Examiner(s): David, Shaun
• Application Number:
  US14/749,344
• Publication Number:
  US 20150366556A1
• Time in Patent Office: 1,385 Days
• Field of Search: None
• 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 17/0487 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 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0425 the anchor or the separate member comprising threads, e.g. a set screw in the anchor
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0429 the barbs being expanded by a mechanical mechanism which also locks them in the expanded state
• 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 2017/0443 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 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

The invention relates in some aspects to a device for use in anchoring an implant, including anchors, sutures, implants, clips, tools, lassos, and methods of anchoring among other methods. Anchors as disclosed herein could be utilized to secure a coaptation assistance device, an annuloplasty ring, an artificial valve, cardiac patch, sensor, pacemaker, or other implants. The implant could be a mitral valve ring or artificial mitral valve in some embodiments.

Claims

1. A system for anchoring an implantable medical device within tissue of a patient, comprising:

an anchor comprising a proximal end and a distal end, the distal end configured to engage tissue,

a suture coupled to the proximal end of the anchor,

an implantable medical device, wherein the suture is configured to pass through at least a portion of the implantable medical device,

a clip comprising a longitudinal axis and at least two strands twisted together, wherein the suture is configured to pass through the at least two strands in a direction transverse to the longitudinal axis as the clip slides toward the implantable medical device and the anchor.

2. The system of claim 1, further comprising a needle on an end of the suture.

3. The system of claim 1, wherein the at least two strands comprise nitinol.

4. The system of claim 1, wherein the at least two strands comprise a shape memory material.

5. The system of claim 1, wherein the clip is linear.

6. The system of claim 1, wherein the clip is non-linear.

7. The system of claim 1, wherein the anchor comprises a needle.

8. The system of claim 1, wherein the implantable medical device is a coaptation assistance device configured to improve leaflet coaptation of a cardiac valve.

9. The system of claim 1, further comprising a delivery tool comprising an outer sleeve, an inner shaft, and a lasso extending through the inner shaft, the lasso configured to engage the suture.

10. The system of claim 9, wherein the outer sleeve is configured to push the clip off the inner shaft.

11. A system for anchoring an implantable medical device within tissue of a patient, comprising:

an anchor comprising a proximal end and a distal end, the distal end configured to engage tissue,

a suture coupled to the anchor,

an implantable medical device, and

a clip comprising a longitudinal axis and at least two strands twisted together, wherein the suture is configured to pass through the at least two strands in a direction transverse to the longitudinal axis as the clip slides toward the implantable medical device and the anchor.

12. The system of claim 11, wherein the at least two strands comprise a shape memory material.

13. The system of claim 11, wherein the clip is linear.

14. The system of claim 11, wherein the anchor comprises a helical portion.

15. The system of claim 11, wherein the implantable medical device is a coaptation assistance device configured to improve leaflet coaptation of a cardiac valve.

16. The system of claim 11, further comprising a delivery tool comprising an outer sleeve, an inner shaft, and a lasso extending through the inner shaft, the lasso configured to engage the suture.

17. The system of claim 16, wherein the outer sleeve is configured to push the clip off the inner shaft.

18. The system of claim 11, wherein the anchor comprises a cross-pin in a hub.

19. The system of claim 18, wherein the suture is coupled to the cross-pin.

20. The system of claim 11, further comprising a torque shaft, wherein rotation of the torque shaft causes rotation of the anchor.