# US 8,105,375 B2 · Method for implanting a cardiovascular valve

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- Number: US 8,105,375 B2
- Document ID: US8105375B2
- Status: Granted
- Kind: B2
- Application number: 12/016,168
- Filed: 2008-01-17
- Published: 2008-07-24
- Granted: 2012-01-31
- Earliest claimed: 2007-01-19
- Assignees: The Cleveland Clinic Foundation
- Inventors: Jose Luis Navia; Ji-Feng Chen
- Web page: https://patentgrep.com/patent/US8105375B2

## CPC

- A61F 2/2433: {using balloon catheter}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2/2415: {Manufacturing methods}
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2/9524: {Iris-type crimpers}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2230/0078: hyperboloidal
- A61F 2250/0092: Means for cleaning prostheses
- A61L 27/3625: {Vascular tissue, e.g. heart valves}
- A61L 27/3629: {Intestinal tissue, e.g. small intestinal submucosa}
- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- 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}
- Y10T 29/49925: Inward deformation of aperture or hollow body wall
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:
preparing a substantially dehydrated bioprosthetic valve comprising the steps of treating a tissue component with an aqueous dimensional stabilizer solution and then substantially dehydrating the tissue component;
providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;
attaching the substantially dehydrated bioprosthetic valve 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;
crimping the expandable support member into a compressed configuration; and
placing the expandable support member at a desired location within the cardiovascular system of the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:
loading the expandable support member into a delivery catheter;
obtaining access to the desired location;
delivering the expandable support member to the desired location; and
expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

### Claim 3 (depends on 1)

The method of claim 1, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:
storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

### Claim 4 (depends on 3)

The method of claim 3 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.

### Claim 5 (depends on 1)

The method of claim 1, wherein said step of crimping the expandable support member further comprises the step of exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid.

### Claim 6 (depends on 1)

The method of claim 1, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve before the expandable support member is placed at the desired location.

### Claim 7 (depends on 1)

The method of claim 1, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve after the expandable support member is placed at the desired location.

### Claim 8 (depends on 1)

The method of claim 1, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

### Claim 9 (depends on 1)

The method of claim 1, wherein said step of placing the expandable support member at a desired location within cardiovascular system of the subject is done via a minimally invasive, open surgical approach.

### Claim 10

A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:
preparing a substantially dehydrated bioprosthetic valve comprising the steps of treating a tissue component with an aqueous dimensional stabilizer solution and then substantially dehydrating the tissue component;
providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;
attaching the substantially dehydrated bioprosthetic valve 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;
crimping the expandable support member into a compressed configuration, followed by
exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid; and
placing the expandable support member at a desired location within the cardiovascular system of the subject.

### Claim 11 (depends on 10)

The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:
loading the expandable support member into a delivery catheter;
obtaining access to the desired location;
delivering the expandable support member to the desired location; and
expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

### Claim 12 (depends on 10)

The method of claim 10, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:
storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

### Claim 13 (depends on 12)

The method of claim 12 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.

### Claim 14 (depends on 10)

The method of claim 10, wherein said step of crimping the expandable support member further comprises the step of exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid.

### Claim 15 (depends on 10)

The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

### Claim 16 (depends on 10)

The method of claim 10, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done via a minimally invasive, open surgical approach.

### Claim 17

A method for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject, said method comprising the steps of:
preparing a substantially dehydrated bioprosthetic valve comprising the steps of treating a tissue component with an aqueous dimensional stabilizer solution and then substantially dehydrating the tissue component;
providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends;
attaching the substantially dehydrated bioprosthetic valve 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;
exposing the substantially dehydrated bioprosthetic valve to a re-hydrating fluid, followed by
crimping the expandable support member into a compressed configuration; and
placing the expandable support member at a desired location within the cardiovascular system of the subject.

### Claim 18 (depends on 17)

The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject further comprises the steps of:
loading the expandable support member into a delivery catheter;
obtaining access to the desired location;
delivering the expandable support member to the desired location; and
expanding the expandable support member into engagement with the cardiovascular tissue at the desired location.

### Claim 19 (depends on 17)

The method of claim 17, wherein said step of preparing a substantially dehydrated bioprosthetic valve further comprises the steps of:
storing the substantially dehydrated bioprosthetic valve in a container that is essentially free of liquid.

### Claim 20 (depends on 19)

The method of claim 19 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.

### Claim 21 (depends on 17)

The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done percutaneously via the delivery catheter.

### Claim 22 (depends on 17)

The method of claim 17, wherein said step of placing the expandable support member at a desired location within the cardiovascular system of the subject is done via a minimally invasive, open surgical approach.
