Methods for delivering a self-expanding valve

• US 9,295,550 B2
• Filed: 03/28/2014
• Issued: 03/29/2016
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Nguyen, Than, Seguin, Jacques, Komatsu, Stan, Nguyen, Hung, Boertlein, Georg
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US14/229,518
• Publication Number:
  US 20140214154A1
• Time in Patent Office: 732 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2433 using balloon catheter
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

Methods for delivering a prosthetic heart valve include advancing a delivery catheter containing the prosthetic heart valve to a deployment native heart valve, advancing an inner core movably coupled to a restraining sheath of the delivery catheter to expose a first end of the prosthetic heart valve, and advancing the inner core and the restraining to expose a second end of the prosthetic heart valve. The delivery catheter can include a distal flange located at a distal end of an outer core of the catheter body, configured to restrict distal longitudinal displacement of the prosthetic heart valve, and a retaining structure located proximally from the distal flange along the outer core of the catheter body, configured to restrict proximal longitudinal displacement of the prosthetic heart valve.

Claims

1. A method for delivering a self-expandable heart valve, comprising:

approaching an inflow side of a cardiac valve with a valve delivery catheter, wherein the delivery catheter comprises;

a catheter body having an exterior surface;

a distal flange located at a distal end of the catheter body and extending radially outward from the exterior surface of the catheter body;

a retaining structure located proximally from the distal flange and extending radially outward from the exterior surface of the catheter body,

wherein a receptacle is formed between the distal flange and the retaining structure;

a restraining sheath movably coupled to the distal end of the catheter body, the restraining sheath having a distal end with a tapered tip; and

an expandable heart valve having a proximal end and a distal end, collapsed into the restraining sheath and coupled to the retaining structure of the delivery catheter at the distal end of the expandable heart valve,

wherein the restraining sheath is configured to move relative to the catheter body between a proximal closed position that restrains the expandable heart valve and a distal exposed position that first exposes the proximal end of the expandable heart valve,

wherein the retaining structure is configured to restrict proximal longitudinal displacement of the expandable heart valve as the restraining sheath moves between the proximal closed position and the distal exposed position, and

wherein the distal flange is configured to restrict distal longitudinal displacement of the expandable heart valve;

positioning the expandable heart valve across the cardiac valve;

expanding the proximal end of the expandable heart valve against valve leaflets of the cardiac valve; and

expanding the distal end of the expandable heart valve after expanding the proximal end of the expandable heart valve.

2. The method for delivering a self-expandable heart valve as in claim 1, further comprising pushing the restraining sheath distally and exposing the proximal end of the prosthetic valve.

3. The method for delivering a self-expandable heart valve as in claim 2, further comprising pushing the catheter body through the expandable heart valve and contacting the restraining sheath.

4. The method for delivering a self-expandable heart valve as in claim 3, further comprising pulling the catheter body and the restraining sheath from the expandable heart valve while the catheter body and the restraining sheath remain contacted.

5. The method for delivering a self-expandable heart valve as in claim 1, wherein the proximal end of the expandable heart valve is an inflow end, and wherein the distal end of the expandable heart valve is an outflow end.

6. The method for delivering a self-expandable heart valve as in claim 1, wherein the delivery catheter further comprises a taper segment proximal to the restraining sheath.

7. The method for delivering a self-expandable heart valve as in claim 1, wherein the restraining sheath is configured to move to a release position that exposes the retaining structure.

8. The method for delivering a self-expandable heart valve as in claim 1, wherein the retaining structure includes at least one protrusion component that is complementary to a receptacle component on the expandable heart valve.

9. A method for delivering a prosthetic heart valve, comprising:

advancing a delivery catheter containing the prosthetic heart valve to a deployment location at a native heart valve, the delivery catheter comprising;

a catheter body comprising an inner core and an outer core;

a distal flange located at a distal end of the outer core, configured to restrict distal longitudinal displacement of the prosthetic heart valve;

a retaining structure located proximally from the distal flange along the outer core, configured to restrict proximal longitudinal displacement of the prosthetic heart valve; and

a restraining, sheath movably coupled to the outer core, the restraining sheath having a distal end with a tapered tip;

collapsing the prosthetic heart valve into the restraining sheath;

coupling the prosthetic heart valve to the distal flange and the retaining structure advancing the inner core and the restraining sheath relative to the outer core to expose a first end of the prosthetic heart valve; and

advancing the inner core and the restraining sheath relative to the outer core to expose a second end of the prosthetic heart valve.

10. The method for delivering a prosthetic heart valve of claim 9, wherein the first end of the prosthetic heart valve is an inflow end and the second end of the prosthetic heart valve is an outflow end.

11. The method for delivering a prosthetic heart valve of claim 9, wherein exposing the first end of the prosthetic heart valve deploys the first end of the prosthetic heart valve by self expansion.

12. The method for delivering a prosthetic heart valve of claim 9, wherein exposing the second end of the prosthetic heart valve deploys the second end of the prosthetic heart valve by self-expansion.

13. The method for delivering a prosthetic heart valve of claim 9, further comprising:

deploying the heart valve prosthesis; and

advancing the outer core of the catheter body through the deployed heart valve prosthesis such that a proximal end of the outer core contacts a proximal end of the restraining sheath.

14. The method for delivering a prosthetic heart valve of claim 13, further comprising:

retracting the delivery catheter proximally through the deployed heart valve prosthesis.

15. The method for delivering a prosthetic heart valve of claim 9, wherein advancing the delivery catheter to the deployment location comprises advancing the delivery catheter in an antegrade manner.

16. The method for delivering a prosthetic heart valve of claim 9, wherein advancing the delivery catheter to the deployment location comprises inserting the delivery catheter through a transapical access point.

17. The method for delivering a prosthetic heart valve of claim 9, wherein the retaining structure includes at least one protrusion component that is complementary to a receptacle component on the expandable heart valve.