Method for implanting a cardiovascular valve

• US 9,610,160 B2
• Filed: 04/23/2013
• Issued: 04/04/2017
• Est. Priority Date: 01/19/2007
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis, Chen, Ji-Feng
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US13/868,892
• Publication Number:
  US 20130238088A1
• Time in Patent Office: 1,442 Days
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0092 Means for cleaning prostheses
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall

Abstract

A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Claims

1. A packaged device comprising:

an expandable heart valve comprising an expandable support member coupled to a fixed tissue component, the fixed tissue component having interstices comprising an aqueous solution comprising at least one dimensional stabilizer, wherein the dimensional stabilizer is selected from the group consisting of;

glycerol and derivatives of glycerol and combinations thereof, and wherein the expandable support member is at least partially crimped; and

a sealed and sterilized package containing the expandable heart valve in an environment essentially free of liquid.

2. The packaged device of claim 1, wherein the package further comprises a catheter.

3. The packaged device of claim 2, wherein the expandable heart valve is crimped in the catheter.

4. The packaged device of claim 2, wherein the expandable heart valve is crimped about an inflatable balloon.

5. The packaged device of claim 2, wherein the expandable heart valve is crimped on the catheter.

6. The packaged device of claim 1, further comprising a layer of biocompatible material covering at least a portion of an inside surface of the expandable support member, an outside surface of the expandable support member or both.

7. The packaged device of claim 6, wherein the layer is attached around an entire circumference of the expandable support member.

8. The packaged device of claim 6, wherein the layer is attached around a circumference of the expandable support member in pieces or interrupted sections.

9. The packaged device of claim 6, wherein the biocompatible material is selected from the group consisting of:

a polyester, woven velour, polyurethane, PTFE, ePTFE, Gore-Tex®

, and heparin-coated fabric.

10. The packaged device of claim 6, wherein the biocompatible material is a biological material.

11. The packaged device of claim 10, wherein the biological material is selected from the group consisting of:

bovine pericardium, equine pericardium, porcine pericardium, peritoneal tissue, pleura, submucosal tissue, dura mater, an allograft, a homograft, a patient graft, and a cell-seeded tissue.

12. The packaged device of claim 1, further comprising at least one of a radiographically opaque marking or a therapeutic agent associated with the expandable support member.