# US 8,540,927 B2 · Method for retaining a vascular stent on a catheter

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- Number: US 8,540,927 B2
- Document ID: US8540927B2
- Status: Granted
- Kind: B2
- Application number: 13/493,260
- Filed: 2012-06-11
- Published: 2012-10-04
- Granted: 2013-09-24
- Earliest claimed: 2005-04-12
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Sean McNiven; Jonathan Durcan; Boyd V. Knott; Jeremy Stigall
- Inventors: Sean McNiven; Jonathan Durcan; Boyd V. Knott; Jeremy Stigall
- Web page: https://patentgrep.com/patent/US8540927B2

## CPC

- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- B29C 33/3807: {Resin-bonded materials, e.g. inorganic particles}
- B29C 33/3828: {Moulds made of at least two different materials having different thermal conductivities}
- B29C 2049/2017: {outside the article}
- B29C 2049/2412: {outside the article}
- B29C 2949/08: Preforms made of several individual parts, e.g. by welding or gluing parts together
- B29K 2105/258: {Tubular}
- B29L 2031/7542: {Catheters}
- Y10T 29/49913: by constricting outer annulus
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A method of securely mounting a stent on a balloon of a catheter. The method generally includes crimping a stent on a balloon of a catheter at least one time, and positioning the balloon with the stent thereon within a polished bore of a mold formed at least in part of a metallic material. The balloon is pressurized and heated within the mold, or within a sheath, in two stages as the stent is restrained from radially expanding. The method may include crimping the stent onto the balloon one or two times during processing. The method increases retention of the stent on the balloon catheter following sterilization.

## Claims

### Claim 1

A method of mounting a stent on a balloon catheter, comprising:
positioning a stent on a balloon of a balloon catheter to create an assembly, wherein the stent includes an open-walled body formed from struts with gaps therebetween;
placing a sheath over the stent and the balloon to restrain radial expansion of the stent and the balloon;
pressurizing the balloon up to 30 psi (21 Newtons per square cm);
heating the stent and balloon assembly in a constant temperature oven for a period of time; and
depressurizing the balloon, and;
providing a dislodgment value to the stent of no less than 1.3 lbf (5.8 Newtons) at a 95% confidence level.

### Claim 2 (depends on 1)

The method of claim 1, wherein an outside diameter of the stent before mounting on the balloon is no more than 0.037 inch (0.094 cm) and the outside diameter of the stent after the balloon is depressurized is no more than 0.0426 inch (1.0820 cm).

### Claim 3 (depends on 1)

The method of claim 1, wherein the constant temperature is 145° F. (63° C.).

### Claim 4 (depends on 1)

The method of claim 1, wherein the time period for pressurization and heating is approximately twenty-four hours.

### Claim 5 (depends on 1)

The method of claim 1, wherein the balloon and stent are sterilized in Eto and after the sterilization step, the dislodgement force is not significantly changed.

### Claim 6 (depends on 1)

The method of claim 1, wherein a drug coating is applied to the stent prior to mounting on the balloon.

### Claim 7 (depends on 6)

The method of claim 6, wherein the stent is crimped onto the balloon before the balloon is pressurized and before heat is applied.