Method and apparatus for replacing a prosthetic valve

• US 9,095,434 B2
• Filed: 01/07/2011
• Issued: 08/04/2015
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US12/986,780
• Publication Number:
  US 20110166636A1
• Time in Patent Office: 1,670 Days
• Field of Search: 623/2.11, 623/2.14, 623/2.17, 623/2.18, 623/1.24, 128/898
• US Class Current: 1/1
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0075 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

In one aspect, the present disclosure concerns a percutaneously delivered adapter stent that is deployed within a previously implanted prosthetic valve and serves as an anchor or platform for implanting a percutaneously delivered replacement valve within the previously implanted valve. The adapter stent can be delivered to the implantation site via the patient'"'"'s vasculature and positioned within the previously implanted valve. The stent can then be deployed to cause the stent to expand and become anchored to the inner surface of the previously implanted valve. Subsequently, the replacement valve can be positioned within the adapter stent and deployed to cause the replacement valve to expand and become anchored to the adapter stent. The adapter stent and the replacement valve can be mounted on the same catheter for delivery to the implantation site.

Claims

1. A method of implanting a replacement prosthetic heart valve within a defective previously implanted prosthetic heart valve that comprises leaflets configured to articulate between a functionally closed position and a functionally open position, the method comprising:

advancing an adapter stent and a replacement prosthetic heart valve through a port between ribs of a patient'"'"'s thorax and through an apex of a left ventricle;

positioning the adapter stent within the defective previously implanted prosthetic heart valve, the previously implanted prosthetic heart valve having been implanted in an aortic annulus via open heart surgery, the adapter stent comprising an expandable tubular frame having an outer surface for contacting an interior region of the previously implanted prosthetic heart valve, the adapter stent further comprising a flexible annular sealing member disposed along an inner surface of the tubular frame;

radially expanding the adapter stent to cause the outer surface of the expandable tubular frame to become anchored within and to the interior region of the previously implanted prosthetic heart valve such that the adapter stent extends over an entire inner surface area of the previously implanted prosthetic heart valve;

after radially expanding the adapter stent within the previously implanted prosthetic heart valve, positioning the replacement prosthetic heart valve within the expanded adapter stent, the replacement prosthetic heart valve comprising a collapsible and expandable annular frame and a collapsible and expandable valve member mounted within the annular frame, the valve member comprising a tricuspid valve configuration formed with pericardial tissue and configured for allowing blood flow in only one direction when in an expanded condition; and

radially expanding the replacement prosthetic heart valve within the adapter stent and the previously implanted prosthetic heart valve such that the replacement prosthetic heart valve extends beyond an inflow end of the adapter stent and extends beyond an outflow end of the adapter stent, and such that the adapter stent provides a stable platform for anchoring the replacement prosthetic heart valve by increasing frictional forces on the replacement prosthetic heart valve and the previously implanted prosthetic heart valve, and wherein, when the adapter stent and the replacement prosthetic heart valve are radially expanded within the previously implanted prosthetic heart valve, the flexible annular sealing member provides a seal between the previously implanted prosthetic heart valve and the replacement prosthetic heart valve, and wherein the flexible annular sealing member comprises an elastomeric material such that an outer surface of the replacement prosthetic heart valve conforms to an inner surface portion of the adapter stent.

2. The method of claim 1 wherein the adapter stent and the replacement prosthetic heart valve are mounted on a common delivery catheter, which is used to position the adapter stent and the replacement prosthetic heart valve at respective deployment positions.

3. The method of claim 2 wherein:

the adapter stent is mounted on a first balloon of the catheter and the replacement prosthetic heart valve is mounted on a second balloon of the catheter;

radially expanding the adapter stent comprises inflating the first balloon to cause the adapter stent to expand and engage the previously implanted prosthetic heart valve; and

radially expanding the replacement prosthetic heart valve comprises inflating the second balloon to cause the replacement prosthetic heart valve to engage the flexible annular sealing member.

4. The method of claim 2, wherein:

the adapter stent is self-expandable and is retained in a radially compressed state on the catheter by a sheath; and

radially expanding the adapter stent comprises withdrawing the sheath from the stent to allow the adapter stent to expand and engage the previously implanted prosthetic heart valve.

5. The method of claim 4, wherein:

the replacement prosthetic heart valve is self-expandable and is retained in a radially compressed state on the catheter by the sheath; and

radially expanding the replacement prosthetic heart valve comprises withdrawing the sheath from the replacement prosthetic heart valve to allow it to expand and engage the flexible annular sealing member.

6. The method of claim 1, wherein:

the adapter stent has a length that is greater than a length of the previously implanted prosthetic heart valve and wherein the adapter stent has a generally cylindrical intermediate portion and enlarged opposite end portions that are greater in diameter than the intermediate portion of the adapter stent when the adapter stent is radially expanded; and

when the adapter stent is radially expanded, the enlarged opposite end portions of the adapter stent are positioned outside of the previously implanted prosthetic heart valve to assist in retaining the adapter stent in place within the previously implanted prosthetic heart valve.

7. The method of claim 1, wherein the flexible annular sealing member comprises sponge rubber.

8. The method of claim 1, wherein the flexible annular sealing member extends along both the inner surface and an outer surface of the adapter stent.

9. The method of claim 1, wherein the tubular frame of the adapter stent has a length of at least about 10 mm.

10. The method of claim 1, wherein the replacement prosthetic heart valve has an outer diameter in an expanded condition which is approximately equal to an inner diameter of the adapter stent in an expanded condition.

11. The method of claim 1, wherein the tubular frame of the adapter stent further comprises attachment elements along an outer surface for enhancing the ability of the adapter stent to anchor to the previously implanted prosthetic heart valve.

12. A method of implanting a replacement prosthetic heart valve within a defective surgically implanted prosthetic heart valve, the method comprising:

advancing a catheter carrying an adapter stent through a port between a patient'"'"'s ribs and through an apex of the left ventricle to position the adapter stent within the surgically implanted prosthetic heart valve, the surgically implanted prosthetic heart valve having been previously implanted in an aortic annulus via open heart surgery, the catheter also carrying the replacement prosthetic heart valve;

deploying the adapter stent to cause the adapter stent to become anchored to an interior region of the defective surgically implanted prosthetic heart valve, the adapter stent comprising a generally tubular frame having an inner surface and an outer surface and a compressible sealing member disposed along both the inner surface and the outer surface of the generally tubular frame, wherein the adapter stent comprises a substantially cylindrical portion that has a substantially constant diameter extending along the length of the adapter stent where the adapter stent overlies the interior region of the defective surgically implanted prosthetic heart valve;

re-positioning the catheter, after deploying the adapter stent, to position the replacement prosthetic heart valve within the deployed and expanded adapter stent; and

deploying the replacement prosthetic heart valve to cause the replacement prosthetic heart valve to expand and contact the compressible sealing member on the inner surface of the adapter stent such that the replacement prosthetic heart valve extends beyond an inflow end of the adapter stent and extends beyond an outflow end of the adapter stent, wherein the compressible sealing member of the adapter stent comprises an elastomeric material such that an outer surface of the replacement prosthetic heart valve conforms to an inner surface portion of the adapter stent to form a seal between the surgically implanted prosthetic heart valve and the replacement prosthetic heart valve after expansion of the replacement prosthetic heart valve, and wherein the adapter stent provides a stable platform for anchoring the replacement prosthetic heart valve by increasing frictional forces on the replacement prosthetic heart valve and the surgically implanted prosthetic heart valve.

13. The method of claim 12 wherein:

the adapter stent is mounted on a first balloon of the catheter and the replacement prosthetic heart valve is mounted on a second balloon of the catheter;

deploying the adapter stent comprises inflating the first balloon to cause the adapter stent to expand and engage the surgically implanted prosthetic heart valve; and

deploying the replacement prosthetic heart valve comprises inflating the second balloon to cause the replacement prosthetic heart valve to contact the compressible sealing member of the adapter stent.

14. The method of claim 12, wherein when the adapter stent is deployed, opposite end portions of the adapter stent extend outside opposite ends of the defective surgically implanted prosthetic heart valve and flare radially outwardly with respect to the opposite ends of the defective surgically implanted prosthetic heart valve.

15. A method of implanting a replacement prosthetic heart valve within a previously implanted prosthetic heart valve, the method comprising:

positioning an adapter stent within a previously implanted prosthetic heart valve, the previously implanted prosthetic heart valve having been implanted in an aortic annulus via open heart surgery, the adapter stent comprising an expandable tubular frame having an outer surface for contacting an interior region of the previously implanted prosthetic heart valve, the adapter stent further comprising a flexible annular sealing member comprising an elastomeric material and disposed on the expandable tubular frame;

radially expanding the adapter stent to cause the outer surface of the expandable tubular frame to become anchored to the interior region of the previously implanted prosthetic heart valve, such that the adapter stent extends over an entire inner surface area of the previously implanted prosthetic heart valve and an outflow end of the adapter stent flares radially outwardly past an outflow end of the previously implanted prosthetic heart valve and an inflow end of the adapter stent flares radially outwardly past an inflow end of the previously implanted prosthetic heart valve;

after radially expanding the adapter stent within the previously implanted prosthetic heart valve, positioning a replacement prosthetic heart valve within the expanded adapter stent; and

radially expanding the replacement prosthetic heart valve to expand within the adapter stent and the previously implanted prosthetic heart valve such that the replacement prosthetic heart valve extends axially beyond the inflow end of the adapter stent and extends axially beyond the outflow end of the adapter stent, such that the adapter stent provides a stable platform for anchoring the replacement prosthetic heart valve;

wherein, when the adapter stent and the replacement prosthetic heart valve are radially expanded within the previously implanted prosthetic heart valve, the flexible annular sealing member allows an outer surface of the replacement prosthetic heart valve to conform to an inner surface portion of the adapter stent to provide a seal between the previously implanted prosthetic heart valve and the replacement prosthetic heart valve.