Adjustable heart valve implant

• US 9,848,880 B2
• Filed: 11/14/2014
• Issued: 12/26/2017
• Est. Priority Date: 11/20/2013
• Status: Active Grant

• Current Assignee: Christy Cummins, James E. Coleman
• Original Assignee: Christy Cummins, James E. Coleman
• Inventors: Coleman, James E., Cummins, Christy
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US14/541,601
• Publication Number:
  US 20150142101A1
• Time in Patent Office: 1,138 Days
• Field of Search: 623 211
• CPC Class Codes: A61B 17/0057 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 Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00389 Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0008 : for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 5/0079 : Pyloric or esophageal obstructions

Abstract

Systems and methods are provided for repairing a heart valve, such as a mitral, tricuspid or aortic valve, using an adjustable and removable implant that can be delivered to the heart through the apex in a simplified and non-invasive manner. The implant can include a prosthetic valve portion coupled to a proximal end of a shaft, and an anchor portion coupled to a distal end of the shaft. The prosthetic valve can be suspended within an opening of the heart valve while the anchor portion is affixed to the apex of the heart. When the implant is deployed, a distance between the prosthetic valve portion and the anchor portion can be adjusted, and/or the implant or a portion thereof can be rotated to thereby change the position of the prosthetic valve within the heart valve. This can allow correcting for post-implantation movements of the implant to mitigate potential complications.

Claims

1. A method of repairing a mitral valve, comprising:

advancing an outer shaft of an introducer assembly through an apex of a heart into a left atrium of the heart;

deploying a prosthetic valve portion of an implant from the outer shaft in the left atrium such that the prosthetic valve portion moves from an unexpanded configuration to an expanded configuration and at least one positioning member on the prosthetic valve portion is disposed on opposite sides of an opening of the mitral valve to suspend the prosthetic valve portion within the opening of the mitral valve;

retracting the outer shaft from the left atrium towards the apex of the heart such that an inner shaft of the implant and at least a portion of an anchor portion of the implant are exposed; and

deploying proximal and distal deployable wings on the anchor portion using an actuator removably coupled proximally to the anchor portion to engage tissue between the proximal and distal deployable wings to removably affix the anchor portion to the apex of the heart.

2. The method of claim 1, further comprising adjusting a distance between the prosthetic valve portion and the anchor portion of the implant.

3. The method of claim 2, further comprising accessing a proximal end of the anchor portion with an adjustment tool and employing the adjustment tool to adjust the distance.

4. The method of claim 2, wherein the distance is adjusted by retractably moving the inner shaft with respect to the anchor portion.

5. The method of claim 2, wherein the inner shaft comprises at least one tether, and the distance is adjusted by adjusting a length of the at least one tether.

6. The method of claim 3, wherein the proximal end of the anchor portion is accessed percutaneously.

7. The method of claim 1, further comprising rotating a portion of the prosthetic valve portion suspended within the opening of the mitral valve.

8. The method of claim 1, further comprising rotating the implant when the prosthetic valve portion is suspended within the opening of the mitral valve.

9. The method of claim 1, further comprising removing the outer shaft.

10. The method of claim 1, wherein deploying the prosthetic valve portion comprises deploying the prosthetic valve portion from the outer shaft in the left atrium, and subsequently retracting the outer shaft from the left atrium to engage the at least one positioning member with the mitral valve.

11. The method of claim 1, further comprising adjusting a length of the inner shaft prior to affixing the anchor portion within the apex of the heart.

12. The method of claim 1, wherein the prosthetic valve portion includes an expandable frame and the at least one positioning member comprises an expandable ring circumferentially disposed at an end of the expandable frame.

13. The method of claim 12, further comprising adjusting a diameter of the expandable frame after the prosthetic valve portion is deployed.

14. The method of claim 1, further comprising determining a position of the prosthetic valve portion using at least one radiopaque marker associated with the prosthetic valve portion.

15. The method of claim 1, wherein the proximal and distal deployable wings are deployed within tissue of the apex of the heart.

16. The method of claim 1, wherein the proximal and distal deployable wings are deployed at opposite sides of a wall of the apex of the heart.

17. The method of claim 1, wherein deploying the proximal and distal deployable wings comprises deploying the distal wings and, after the distal wings are deployed, retracting the outer shaft proximally away from the prosthetic valve body to deploy the proximal wings.

18. The method of claim 1, further comprising:

mating a proximal end of the anchor portion with an actuator tool;

deploying the actuator tool to move the proximal and distal wings from a deployed configuration to an undeployed configuration;

advancing the introducer assembly over the actuator tool towards the prosthetic valve portion;

deploying the actuator tool to move the prosthetic valve portion from the expanded configuration to the unexpanded configuration; and

removing the prosthetic valve portion in the unexpanded configuration from the left atrium through the introducer assembly.

19. The method of claim 18, further comprising:

retracting the introducer assembly towards the apex of the heart; and

deploying second proximal and distal wings of a closure device to engage tissue therebetween.

20. A method of repairing a heart valve, comprising:

delivering an outer shaft of an introducer assembly through an apex of a heart into an atrium of the heart;

deploying a prosthetic valve from the outer shaft in the atrium such that the prosthetic valve moves from an unexpanded configuration to an expanded configuration and at least one positioning member on the prosthetic valve is disposed above an opening of the heart valve to suspend a body of the prosthetic valve within the opening;

retracting the outer shaft from the atrium towards the apex of the heart such that an inner shaft coupled to and extending between the prosthetic valve and an anchor is exposed;

removably affixing the anchor having proximal and distal ends to the apex of the heart such that the distal end of the anchor is closer to the opening of the heart valve than the proximal end; and

releasably mating an adjustment tool with the proximal end of the anchor to adjust a distance between the prosthetic valve and the anchor.

21. The method of claim 20, further comprising removing the outer shaft through the apex of the heart.

22. The method of claim 20, wherein the distance is adjusted after the anchor is affixed to the apex of the heart.

23. The method of claim 20, wherein removably affixing the anchor to the apex of the heart comprises deploying proximal and distal deployable wings of the anchor to engage tissue therebetween.

24. The method of claim 20, further comprising rotating the body of the prosthetic valve body within the opening of the heart valve.

25. The method of claim 20, wherein the heart valve comprises a mitral valve and the atrium comprises a left atrium.

26. The method of claim 20, further comprising removing the prosthetic valve from the atrium through the outer shaft.