METHOD FOR IMPLANTING A CARDIOVASCULAR VALVE

• US 20120095551A1
• Filed: 12/23/2011
• Published: 04/19/2012
• Est. Priority Date: 01/19/2007
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose Luis, Chen, Ji-Feng
• Application Number:
  US13/336,974
• Publication Number:
  US 20120095551A1
• Time in Patent Office: Days
• US Class Current: 623/2.14
• 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 method for preparing a cardiac valve replacement comprising a tissue component securely attached to a root component to form a substantially dehydrated bioprosthetic valve, wherein at least the tissue component is chemically treated with a dimensional stabilizer, the method comprising the steps of:

securing the substantially dehydrated bioprosthetic valve to an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends

so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member; and

crimping the expandable support member and the attached substantially dehydrated bioprosthetic valve into a compressed configuration.

2. The method of claim 1 further comprising the step of:

storing the crimped expandable support member and the attached substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

3. The method of claim 1 further comprising the step of sterilizing the substantially dehydrated bioprosthetic valve by exposure to one of ethylene oxide gas or ionizing radiation either before or after placement in the container.

4. The method of claim 1, wherein said step of crimping the expandable support member further comprises the step of mechanically crimping the substantially dehydrated bioprosthetic valve by tactile means.

5. The method of claim 1 further comprising the step of placing the substantially dehydrated bioprosthetic value in a delivery catheter.

6. The method of claim 1 wherein both the tissue component and the root component are chemically treated with a dimensional stabilizer.

7. The method of claim 6 wherein the tissue component and the root component are chemically treated after secure attachment to one another.

10. A method for implanting a cardiac valve comprising:

removing a substantially dehydrated bioprosthetic valve from a sterile container, wherein the container is essentially free of liquid and wherein the substantially dehydrated bioprosthetic valve is attached to an expandable support member that is crimped into a compressed configuration;

loading the substantially dehydrated bioprosthetic valve in the compressed configuration in a delivery catheter;

obtaining minimally invasive access to a patient'"'"'s cardiovascular system;

delivering the compressed substantially dehydrated bioprosthetic valve to a target cardiac valve annulus; and

expanding the compressed bioprosthetic valve to engage the target valve annulus.

11. The method of claim 10, wherein the step of attaching the substantially dehydrated bioprosthetic valve to the expandable support member further includes attaching the substantially dehydrated bioprosthetic valve to a main body portion of the expandable support member that extends between first and second ends.

12. The method of claim 11 further comprising the step of expanding the compressed substantially dehydrated bioprosthetic valve by progressively removing the substantially dehydrated bioprosthetic valve from the delivery catheter to position the substantially dehydrated bioprosthetic valve in a valve annulus.

13. The method of claim 11 wherein a first end of the expandable support member engages a superior aspect of the valve annulus and a second end displaces existing valve leaflets.