# US 8,569,726 B2 · Reduced temperature sterilization of stents

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- Number: US 8,569,726 B2
- Document ID: US8569726B2
- Status: Granted
- Kind: B2
- Application number: 13/662,214
- Filed: 2012-10-26
- Published: 2013-02-28
- Granted: 2013-10-29
- Earliest claimed: 2006-07-13
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Advanced Cardiovascular Systems, Inc.
- Inventors: Bin Huang; Abigail Freeman; Daniel Castro; David C. Gale
- Web page: https://patentgrep.com/patent/US8569726B2

## CPC

- A61L 2/08: Radiation
- A61L 2/081: Gamma radiation
- A61L 2/082: X-rays
- A61L 2/085: Infrared radiation
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61L 2/10: Ultraviolet [UV] radiation
- B65B 55/00: Preserving, protecting or purifying packages or package contents in association with packaging (by packaging under special atmospheric or gaseous conditions B65B31/00; devices for placing protecting sheets, plugs, or wads over contents B65B61/22)
- B65B 55/16: by irradiation
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- 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)
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

Methods and systems for reduced temperature radiation sterilization of stents are disclosed.

## Claims

### Claim 1

A system for sterilizing a stent-catheter assembly, the stent-catheter assembly including a stent, comprising:
a cooling source;
a barrier configured for scattering radiation to thereby produce a more uniform dose distribution; and
a radiation source;
wherein the system is arranged so that at least the stent is located adjacent the cooling source and the barrier is disposed between the stent and the radiation source.

### Claim 2 (depends on 1)

The system of claim 1 in combination with a stent-catheter assembly including a polymer stent located adjacent the cooling source.

### Claim 3 (depends on 1)

The system of claim 1 in combination with a stent-catheter assembly including a stent located adjacent the cooling source, wherein the stent comprises a coating including a drug.

### Claim 4 (depends on 1)

The system of claim 1, the cooling source further including a cooling medium disposed in a cavity of a cooling member, the surface of the cooling member having a plurality of holes in communication with the cavity, the holes for conveying a cooling fluid from the surface of the cooling member, the cooling fluid facilitating maintaining a temperature of the stent at or near a sterilization temperature.

### Claim 5 (depends on 1)

The system of claim 1, further including a storage container configured to hold the stent, the storage container being disposed within a cavity of a body of thermal insulating material;
wherein the cooling source is disposed adjacent to the storage container within the cavity.

### Claim 6 (depends on 5)

The system of claim 5, wherein the cooling source comprises a first cooling source and a second cooling source, the second cooling source positioned in the cavity adjacent to the stent and on a side opposite to the first cooling source.

### Claim 7 (depends on 5)

The system of claim 5, wherein the cooling source is selected from the group comprising ice, dry ice, and a freezable gel.

### Claim 8 (depends on 5)

The system of claim 5, wherein the thermal insulating material comprises foam insulation.

### Claim 9

A system for sterilizing a stent comprising:
a container for holding a stent-catheter assembly including a polymer stent, wherein the container is capable of being sealed along an edge thereof, the container including
on a first side thereof, a barrier configured to scatter radiation, and
on a second side thereof, a cavity;
wherein the system is configured for sterilizing the stent-catheter assembly at a sterilization temperature maintained by a cooling member received in the cavity, and
wherein when the stent is exposed to radiation the barrier is disposed between a radiation source and the stent so as to increase the uniformity of dose received by the stent.

### Claim 10 (depends on 9)

The system of claim 9, further comprising a radiation source adjacent the container for exposing the stent to radiation for sterilization of the stent.

### Claim 11 (depends on 9)

The system of claim 9, wherein the cavity comprises a thermoform pocket.

### Claim 12 (depends on 9)

The system of claim 9, wherein the cavity is formed by a sleeve attached to the container.

### Claim 13 (depends on 9)

The system of claim 9, wherein the cooling member is selected from the group consisting of ice, dry ice, and a freezable gel.
