Prosthetic heart valve delivery system with controlled expansion

• US 10,716,666 B2
• Filed: 12/05/2016
• Issued: 07/21/2020
• Est. Priority Date: 12/05/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Anderson, Marc, Griffin, Patrick
• Primary Examiner(s): Herbermann, Erich G
• Application Number:
  US15/369,154
• Publication Number:
  US 20180153691A1
• Time in Patent Office: 1,324 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A system for repairing a defective heart valve. The system includes a delivery device, a balloon and a prosthetic heart valve. The delivery device includes an inner shaft assembly and a delivery sheath assembly. The delivery sheath assembly provides a capsule terminating at a distal end. The prosthesis includes a stent carrying a prosthetic valve. In a delivery state, the capsule maintains the prosthesis in a collapsed condition over the inner shaft assembly, and the balloon is in a deflated arrangement radially between the prosthetic heart valve and the capsule. In a deployment state, at least a portion of the balloon and at least a portion of the prosthetic heart valve are distal the capsule. Further, the balloon is inflated and surrounds an exterior of at least a portion of the prosthetic heart valve. The balloon controls self-expansion of the prosthetic heart valve.

Claims

1. A method for repairing a heart valve of a patient, the method comprising:

manipulating a heart valve replacement system in a delivery state to deliver a prosthetic heart valve of the system to a target site, the system further including an inner shaft assembly, a delivery sheath assembly including a capsule terminating at a distal end, and a balloon, the delivery state including the capsule maintaining the prosthetic heart valve in a collapsed condition over the inner shaft assembly, and the balloon in a deflated arrangement radially between the prosthetic heart valve and the capsule;

exposing at least a portion of the balloon distal the distal end;

inflating the exposed portion of the balloon;

positioning at least a portion of the prosthetic heart valve distal the distal end, wherein the inflated balloon is disposed between the at least a portion of the prosthetic heart valve and anatomy of the target site, including the inflated balloon simultaneously in direct physical contact with both the prosthetic heart valve and the anatomy of the target site; and

deploying the prosthetic heart valve from the inner shaft assembly to the target site.

2. The method of claim 1, wherein inflating and positioning include incrementally retracting the capsule relative to the balloon and the prosthetic heart valve and simultaneously inflating the balloon.

3. The method of claim 2, wherein following incrementally retracting and simultaneously inflating, an entirety of the balloon is distal the distal end and in an inflated arrangement, and an entirety of the prosthetic heart valve is distal the distal end and retained in a collapsed condition by the balloon, the method further comprising:

deflating the balloon to permit the prosthetic heart valve to self-expand.

4. The method of claim 3, wherein following deflating the balloon, the method further comprising:

disconnecting the balloon from components of the delivery system; and

removing the inner shaft assembly and the capsule from the patient;

wherein deploying the prosthetic heart valve includes the balloon in the deflated arrangement permanently located between the deployed prosthetic heart valve and anatomy of the target site.

5. The method of claim 1, wherein following positioning, the method further comprising incrementally retracting the balloon and the capsule relative to the prosthetic heart valve.

6. The method of claim 5, wherein following incrementally retracting, the method further comprising deflating the balloon.

7. The method of claim 6, wherein following deflating, the method further comprising removing the balloon, the inner shaft assembly and the capsule from the patient.

8. The method of claim 1, wherein the anatomy of the target site is walls of a heart of the patient.

9. A method for repairing a heart valve of a patient, the method comprising:

manipulating a heart valve replacement system in a delivery state to deliver a prosthetic heart valve of the system to a target site, the system further including an inner shaft assembly, a delivery sheath assembly including a capsule terminating at a distal end, and a balloon, the delivery state including the capsule maintaining the prosthetic heart valve in a collapsed condition over the inner shaft assembly, and the balloon in a deflated arrangement radially between the prosthetic heart valve and the capsule;

exposing at least a portion of the balloon distal the distal end;

inflating the exposed portion of the balloon;

positioning at least a portion of the prosthetic heart valve distal the distal end, wherein the inflated balloon is disposed between the at least a portion of the prosthetic heart valve and anatomy of the target site;

wherein inflating and positioning include incrementally retracting the capsule relative to the balloon and the prosthetic heart valve and simultaneously inflating the balloon;

wherein following incrementally retracting and simultaneously inflating, an entirety of the balloon is distal the distal end and in an inflated arrangement, and an entirety of the prosthetic heart valve is distal the distal end and retained in a collapsed condition by the balloon; and

deploying the prosthetic heart valve from the inner shaft assembly to the target site, including;

disconnecting the balloon from components of the delivery system; and

removing the inner shaft assembly and the capsule from the patient;

wherein deploying the prosthetic heart valve includes the balloon in the deflated arrangement permanently located between the deployed prosthetic heart valve and anatomy of the target site.