Prosthetic heart valve delivery systems and methods

Patent metadata

Field	Value
Publication number	US-10925728-B2
Application number	US-201916282885-A
Country	US
Kind code	B2
Filing date	Feb 22, 2019
Priority date	Feb 22, 2018
Publication date	Feb 23, 2021
Grant date	Feb 23, 2021

Abstract

Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

First claim

What is claimed is:

1. A method of delivering a prosthetic heart valve comprising:
advancing a distal region of a guide member assembly into a heart;
docking the distal region to native anatomy of the heart;
advancing a delivery device over the docked guide member assembly, the delivery device carrying a collapsed prosthetic heart valve;
tensioning the docked guide member assembly simultaneously with the step of advancing the delivery device;
locating the collapsed prosthetic heart valve at an implantation site;
deploying the prosthetic heart valve from the delivery device;
removing the delivery device from the patient; and
removing at least a portion of the guide member assembly from the patient.

2. The method of claim 1 , wherein the native anatomy is a wall of the heart.

3. The method of claim 1 , wherein the native anatomy is at least one heart valve leaflet.

4. The method of claim 1 , wherein the native anatomy includes chordae.

5. The method of claim 1 , wherein the native anatomy is a papillary muscle.

6. The method of claim 1 , wherein the implantation site is a mitral valve.

7. The method of claim 1 , wherein the step of removing at least a portion of the guide member assembly includes:
undocking the distal region from the native anatomy; and
removing an entirety of the guide member assembly from the patient.

8. The method of claim 1 , wherein the guide member assembly includes an elongated member and a docking structure, the docking structure defining the distal region of the guide member assembly, and further wherein the step of removing at least a portion of the guide member assembly includes:
releasing the elongated member from the docking structure; and
removing the elongated member from the patient.

9. The method of claim 1 , wherein the distal region comprises a docking structure including at least one anchor member selected from the group consisting of a clip, a hook, a screw, a barb, and a pincer.

10. The method of claim 1 , wherein the distal region comprises a docking structure including first and second anchor arms, and further wherein the step of docking the distal region includes:
docking the first anchor arm to a first wall of the heart; and
docking the second anchor arm to a second wall of the heart opposite the first wall.

11. The method of claim 1 , wherein the guide member assembly includes an elongated member, a docking structure connected to a distal end of the elongated member, and an outer sheath, the elongated member and docking structure slidably disposed within the outer sheath, and further wherein the step of advancing the distal region includes arranging the docking structure in a collapsed condition within the outer sheath, and even further wherein the step of docking the distal region includes:
locating the docking structure distal the outer sheath such that the docking structure assumes a deployed condition; and
docking the docking structure in the deployed condition to the native anatomy.

12. The method of claim 11 , wherein the docking structure is configured to self-deploy from the collapsed condition to the deployed condition upon release from the outer sheath.

13. The method of claim 1 , wherein the distal region comprises a docking structure including at least one inflatable anchor member comprising a balloon.

14. The method of claim 13 , wherein the guide member assembly further includes a plurality of gripping members disposed on an exterior surface of the balloon, and further wherein the step of docking the distal region includes:
inflating the balloon to force the gripping members into engagement with the native anatomy.

15. The method of claim 13 , wherein the step of removing at least a portion of the guide member assembly includes:
deflating the balloon.

16. The method of claim 13 , wherein the deficient heart valve is a mitral valve and the native anatomy includes chordae.

17. The method of claim 1 , wherein following the step of docking the distal region, the method further comprising:
applying electrical stimulation to the heart via the guide member assembly.

18. The method of claim 1 , wherein the guide member assembly is provided as part of the delivery device, including the distal region of the guide member assembly configured to provide a nose cone of the delivery device in a delivery state.

19. The method of claim 1 , wherein the guide member assembly includes an elongated member selected from the group consisting of a wire and a suture.

20. The method of claim 1 , wherein the deficient valve is a mitral valve, and further wherein the step of advancing the distal region includes advancing the distal region to the native anatomy via a transseptal approach.

21. The method of claim 1 , wherein the deficient valve is a mitral valve, and further wherein the step of advancing the distal region includes advancing the distal region to the native anatomy via a retrograde approach.

22. The method of claim 1 , wherein the guide member assembly includes a steerable elongated member, and further wherein the steps of advancing the delivery device includes selectively deflecting the steerable elongated member.

23. The method of claim 1 , wherein the guide member assembly includes a plurality of elongated members slidably disposed within an outer sheath, and further wherein the step of docking the distal region includes sequentially docking a distal segment of each of the plurality of elongated members to spaced locations of the native anatomy.

Assignees

• Medtronic Vascular Inc

Inventors

• Anderson Marc A
• Carroll Grainne Teresa
• Devereux Paul
• Duffy Niall
• Fleming Matthew
• Hill Alexander J
• Howard Elliot J
• Keogh James R
• Lally Marian Patricia
• Lehmann Luke
• Madden Jeffrey
• Mauch Kevin M
• Mcguinness Ciaran
• Mchenry Brian T
• Olney Karl L
• Orth Geoffrey
• Sarnowski Edward
• Schotzko Elizabeth A
• Wong Benjamin

Classifications

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2210/0033

  electrically, e.g. heated by resistor · CPC title

• A61F2/2454

  Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title