# US 12,318,291 B2 · Method for implanting a cardiovascular valve

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- Number: US 12,318,291 B2
- Document ID: US12318291B2
- Status: Granted
- Kind: B2
- Application number: 18/078,769
- Filed: 2022-12-09
- Published: 2023-09-07
- Granted: 2025-06-03
- Earliest claimed: 2022-12-09
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Jose Luis Navia; Ji-Feng Chen
- Web page: https://patentgrep.com/patent/US12318291B2

## 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 to implant a prosthetic heart valve stored in a liquid free package comprising:
removing the prosthetic valve from a sealed package essentially free of liquid;
implanting the prosthetic valve within a native annulus;
wherein the prosthetic valve in the liquid free package comprises an annular expandable support member having a compressed and an expanded configuration and at least two strut members spaced apart from each other, each of the at least two strut members affixed at a commissural section of a valve component such that at least two commissural sections are attached to one of the at least two strut members, wherein the annular expandable support member is comprised of a stent comprised of a shape memory metal and oppositely disposed first and second ends and a main body portion extending therebetween secured to the valve component at the at least two strut members, a layer of synthetic biocompatible material wrapped around an inner and an outer circumference of the annular expandable support member, and wherein the valve component is animal tissue having a surface comprised of interstices comprised of at least one dimensional stabilizer,
and wherein the implanting step comprises expanding the annular expandable support member to engage the native annulus.

### Claim 2 (depends on 1)

The method of claim 1, wherein the packaged device further comprises a delivery catheter and the implanting step comprises manipulating the delivery catheter to place the prosthetic heart valve within the native annulus.

### Claim 3 (depends on 2)

The method of claim 2, wherein the prosthetic heart valve is crimped about the periphery of a distal end of the delivery catheter.

### Claim 4 (depends on 2)

The method of claim 2, wherein the prosthetic heart valve is operably disposed about an inflatable balloon oriented at the distal end of the delivery catheter in the implanting step is comprised of expanding the inflatable balloon.

### Claim 5 (depends on 4)

The method of claim 4, wherein the prosthetic heart valve is crimped around the inflatable balloon.

### Claim 6 (depends on 5)

The method of claim 5, wherein the synthetic biocompatible material is selected from the group consisting of: a polyester, woven velour, polyurethane, PTFE, ePTFE, and heparin-coated fabric.

### Claim 7 (depends on 5)

The method of claim 5, wherein the layer of biocompatible material comprises interrupted sections.

### Claim 8 (depends on 1)

The method device of claim 1, wherein the layer of synthetic biocompatible material is attached about an entire circumference of the expandable support member.

### Claim 9 (depends on 1)

The method of claim 1, wherein the animal tissue is selected from the group consisting of: bovine pericardium, equine pericardium, porcine pericardium, peritoneal tissue, and a cell-seeded tissue and combinations thereof.

### Claim 10 (depends on 1)

The method of claim 1, further comprising a radiographically opaque marking associated with the expandable support member.

### Claim 11 (depends on 1)

The method of claim 1, further comprising a therapeutic agent associated with the expandable support member.

### Claim 12 (depends on 1)

The method of claim 1, wherein the expandable support member is comprised of a continuous series of W-shaped segments.

### Claim 13 (depends on 1)

The method device of claim 1, wherein the commissural section is one of three commissural selections, the at least two strut members are three strut members, wherein three valve leaflets of the valve component are joined together at the three commissural sections that are spaced apart from each other and attached to the three strut members to prevent prolapse of the valve leaflets following the implantation step.