Transcatheter prosthetic heart valve delivery system and method

• US 10,368,986 B2
• Filed: 04/15/2015
• Issued: 08/06/2019
• Est. Priority Date: 04/15/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gosal, Devin, Deshmukh, Susheel, Haarstad, Philip, Racchini, Joel, Rinne, Finn, Rothstein, Paul, Sandstrom, Jeffrey
• Primary Examiner(s): Stransky, Katrina M
• Assistant Examiner(s): Mendoza, Michael G
• Application Number:
  US14/687,295
• Publication Number:
  US 20160302921A1
• Time in Patent Office: 1,574 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A system for percutaneous delivery of a stented prosthetic heart valve. The system includes a delivery device with a self-expanding prosthetic heart valve attached thereto and a delivery sheath with an opening on a distal end thereof. The delivery sheath includes a funnel on a proximal end thereof. The delivery device is inserted into the funnel of the delivery sheath. As the delivery device is advanced into the funnel, the expanded heart valve is compressed by the shape of the funnel into a crimped arrangement. The delivery device further advances the heart valve distally within the delivery sheath past the delivery sheath opening. The delivery device is advanced relative to the delivery sheath in transitioning the heart valve from a crimped arrangement to the expanded and deployed arrangement.

Claims

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

providing a delivery device having a distal deployment portion and a proximal control handle portion by which the distal deployment portion is effectively controlled, the distal deployment portion having a prosthetic heart valve coupled thereto, the prosthetic heart valve being radially self-expandable;

providing a delivery sheath defining a lumen, the delivery sheath having a distal portion defining an opening and a loading cone coupled to a proximal end of the delivery sheath, the loading cone defining an opening in fluid communication with the lumen;

establishing an access portal to a bodily lumen of the patient with an introducer device;

inserting the delivery sheath into the bodily lumen through the introducer device;

manipulating the delivery sheath through the patient'"'"'s vasculature and into the defective heart valve;

inserting the delivery device into the loading cone, wherein the prosthetic heart valve is compressed until the prosthetic heart valve is in a crimped arrangement,

advancing the delivery device distally through the delivery sheath toward the opening of the delivery sheath; and

advancing the delivery device past the opening of the delivery sheath by sliding the delivery device relative to the delivery sheath to release the prosthetic heart valve from the delivery sheath and permit the prosthetic heart valve to self-expand into engagement with the defective heart valve.

2. The method of claim 1, wherein the loading cone has a funnel portion and a collar extending therefrom, wherein the collar is coupled to the proximal end of the delivery sheath, and the lumen of the delivery sheath has a smaller diameter than the collar.

3. The method of claim 1, wherein the lumen of the delivery sheath has a decreasing diameter from the proximal end to the opening.

4. The method of claim 1, wherein the distal portion is deformable and configured in a preformed curve such that when manipulating the delivery sheath through the patient'"'"'s vasculature, the distal portion deforms when a distal tip thereof encounters resistance with the patient'"'"'s vasculature.

5. The method of claim 1, wherein advancing the delivery device with the prosthetic heart valve coupled thereto is characterized by the absence of frictional contact between the delivery sheath and the delivery device.

6. The method of claim 1, wherein advancing the delivery device with the prosthetic heart valve coupled thereto is characterized by the absence of a sliding force being transmitted from the delivery sheath onto the delivery device.