Delivery systems and methods of implantation for replacement prosthetic heart valves

• US 9,060,859 B2
• Filed: 07/13/2012
• Issued: 06/23/2015
• Est. Priority Date: 02/16/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/548,603
• Publication Number:
  US 20120277854A1
• Time in Patent Office: 1,075 Days
• Field of Search: 623/1.24, 623/1.26, 623 211- 219, 623/1.11, 623/1.12
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve including the steps of compressing a replacement prosthetic valve having an expandable stent within a sheath of a delivery system, wherein the delivery system comprises a proximal end, a distal end, and a centering structure positioned between the proximal and distal ends, advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve, deploying the centering structure to radially reposition the distal end of the delivery system, further advancing the delivery system toward the previously implanted prosthetic valve, and deploying the replacement prosthetic valve.

Claims

1. A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve, the method comprising:

compressing a replacement prosthetic valve comprising an expandable stent within a first sheath of a delivery system, wherein the delivery system comprises a proximal end and a distal end;

advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve;

partially retracting the first sheath of the delivery system toward the proximal end of the delivery system until a first distal portion of the expandable stent extends from a first end of the first sheath, wherein the extending first distal portion of the expandable stent extends radially relative to the first sheath;

further advancing the delivery system toward the previously implanted prosthetic valve and engaging the extending first distal portion of the expandable stent with the second side of the previously implanted prosthetic valve; and

retracting a second sheath of the delivery system toward the proximal end of the delivery system to expose the compressed stent and deploy the replacement prosthetic valve, wherein a second distal portion of the expandable stent radially extends to engage with a first side of the previously implanted prosthetic valve.

2. The method of claim 1, wherein the previously implanted prosthetic valve comprises an aortic valve and wherein the step of advancing the delivery system further comprises advancing the distal end of the delivery system through the aorta to the aortic valve.

3. The method of claim 2, wherein the second side of the previously implanted prosthetic valve comprises an outflow side of the aortic valve.

4. The method of claim 1, wherein the step of partially retracting the first sheath of the delivery system comprises engaging the extending first distal portion of the stent with a wall of the vessel and moving the distal end of the delivery system toward a central axis of the vessel.

5. A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve, the method comprising:

compressing a replacement prosthetic valve comprising an expandable stent within a sheath of a delivery system, wherein the delivery system comprises a proximal end, a distal end, and a centering structure positioned between the proximal and distal ends, and wherein the replacement prosthetic valve is positioned distal to the centering structure;

advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve;

deploying the centering structure to contact a wall of the vessel at a location away from the previously implanted prosthetic valve and radially reposition the distal end of the delivery system;

further advancing the delivery system toward the previously implanted prosthetic valve after deploying the centering structure; and

deploying the replacement prosthetic valve.

6. The method of claim 5, wherein the centering structure is inflatable.

7. The method of claim 6, wherein the step of deploying the centering structure comprises inflating a balloon of the delivery system, and further comprising the step of deflating the balloon after deployment of the replacement prosthetic valve.

8. The method of claim 5, wherein the centering structure comprises a porous mesh structure.