# US 8,739,384 B2 · Method for stent retention on a balloon catheter

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- Number: US 8,739,384 B2
- Document ID: US8739384B2
- Status: Granted
- Kind: B2
- Application number: 13/252,965
- Filed: 2011-10-04
- Published: 2012-01-26
- Granted: 2014-06-03
- Earliest claimed: 2007-09-28
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Yunbing Wang; Gregory Kilinski; Luis Vazquez
- Inventors: Yunbing Wang; Gregory Kilinski; Luis Vazquez
- Web page: https://patentgrep.com/patent/US8739384B2

## 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}
- B23P 11/005: {by expanding or crimping}
- Y10T 29/49865: by temperature differential [e.g., shrink fit]
- Y10T 29/49908: Joining by deforming
- Y10T 29/49911: by expanding inner annulus
- Y10T 29/49913: by constricting outer annulus
- Y10T 29/49925: Inward deformation of aperture or hollow body wall
- Y10T 29/49934: by axially applying force
- 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)
- B23P: METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS (arrangements for copying or controlling B23Q)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A balloon is inflated from a collapsed configuration, then deflated. A polymeric stent is then disposed over the deflated balloon and the stent crimped to the balloon.

## Claims

### Claim 1

A method of crimping a stent to a balloon, the balloon having pre-arranged folds when configured in a collapsed configuration, comprising:
heating a polymer stent to a temperature of between 25 and 100 degrees Celsius, wherein a polymer of the stent has a glass transition temperature between 40 and 60 degrees Celsius;
inflating the balloon a first time, then deflating the balloon such that the balloon forms a relaxed state wherein at least a portion of the pre-arranged folds are removed;
partially crimping the heated stent to the balloon, followed by inflating the balloon a second time; and
fully crimping the heated stent to the balloon.

### Claim 2 (depends on 1)

The method of claim 1, wherein the inflating the balloon a first time includes increasing the balloon diameter from an intermediate diameter to a crimping diameter.

### Claim 3 (depends on 1)

The method of claim 1, wherein when the balloon is inflated a second time the balloon is held at a pressure for a period of time prior to release of the pressure.

### Claim 4 (depends on 3)

The method of claim 3, wherein the balloon is inflated to a fully inflated diameter when the balloon is inflated a first time.

### Claim 5 (depends on 1)

The method of claim 1, wherein the polymer stent is crimped using an iris or collet type of crimp mechanism.

### Claim 6

A method of crimping a polymer stent to a balloon, the balloon having a shape memory including pre-arranged folds when configured in a collapsed configuration, comprising:
working out the shape memory in the balloon including inflating and deflating the balloon, whereupon at least a portion of the pre-arranged folds are removed; and
fully crimping the polymer stent to the deflated balloon, so that the polymer stent is crimped to the balloon when the balloon has the at least a portion of its pre-arranged folds removed.

### Claim 7 (depends on 6)

The method of claim 6, wherein the polymer stent is crimped using an iris or collet type of crimp mechanism.

### Claim 8 (depends on 6)

The method of claim 6, wherein the balloon has a fully inflated diameter and the balloon is inflated to the fully inflated diameter before being deflated.

### Claim 9 (depends on 6)

The method of claim 6, wherein the polymer stent comprises poly(L-lactide) and the polymer stent has a temperature of between 30-50 degrees Celsius during crimping.

### Claim 10 (depends on 1)

The method of claim 1, wherein the polymer stent comprises poly(L-lactide) and the polymer stent has a temperature of between 30-50 degrees Celsius during crimping.

### Claim 11

A method of making a medical device, comprising the steps of:
providing a balloon having pre-arranged folds;
providing a stent made from poly(L-lactide);
inflating the balloon, then deflating the balloon such that the balloon forms a relaxed state wherein at least a portion of the pre-arranged folds are removed; and
using an iris or collet-type of crimping mechanism, crimping the stent to the balloon including the steps of crimping the stent to the balloon while the stent has a temperature of between 30 and 50 degrees Celsius;
wherein the stent is crimped to the balloon while the balloon has the at least a portion of its pre-arranged folds removed.

### Claim 12 (depends on 11)

The method of claim 11, wherein the balloon has a fully inflated diameter and during the inflation the balloon is inflated to the fully inflated diameter, whereupon the pre-arranged folds are removed.

### Claim 13 (depends on 6)

The method of claim 6, wherein the balloon is a 3.0 mm balloon and the stent has a diameter of 3.5 mm before the stent is crimped to the balloon.
