# US 2014/0193299 A1 · Systems and Methods for Sterilization

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- Number: US 2014/0193299 A1
- Document ID: US20140193299A1
- Status: Published application
- Kind: A1
- Application number: 14/206,793
- Filed: 2014-03-12
- Published: 2014-07-10
- Earliest claimed: 2009-11-05
- Assignees: LifeCell Corporation
- Applicants: LifeCell Corporation
- Inventors: Patrick Leamy; Qing-Qing Qiu; Michael S. Pohle; Jason Michael Pomerleau; James R. Connor
- Web page: https://patentgrep.com/patent/US20140193299A1

## CPC

- A61L 2/26: Accessories
- A61B 50/30: Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40)
- A61L 2/16: using chemical substances
- A61L 2/206: Ethylene oxide
- A61B 2050/3014: {waterproof}
- A61B 2050/316: {double- or multiple-walled}
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/181: Flexible packaging means, e.g. permeable membranes, paper
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems for sterilization of tissues, including acellular tissue matrices, comprising a package having a portion permeable to supercritical carbon dioxide and a portion impermeable to moisture are described. Methods of sterilizing acellular tissue matrices from soft tissues or demineralized bone are provided.

## Claims

### Claim at position 1

1-8. (canceled)

### Claim 9

A method of sterilization, comprising:
selecting a medical device for sterilization;
placing the medical device in a first outer package, wherein the outer package comprises a first portion that is permeable to SC—CO2 and a sterilant and second portion that is impermeable to moisture; and
treating the medical device with SC—CO2 and the sterilant.

### Claim 10 (depends on 9)

The method of claim 9, wherein the device comprises acellular tissue matrix.

### Claim 11 (depends on 9)

The method of claim 9, wherein the device comprises demineralized bone matrix.

### Claim 12 (depends on 9)

The method of claim 9, wherein the sterilant comprises peracetic acid (PAA).

### Claim 13 (depends on 9)

The method of claim 9, wherein the sterilant further comprises a peroxide.

### Claim 14 (depends on 9)

The method of claim 9, wherein the peroxide is H2O2.

### Claim 15 (depends on 9)

The method of claim 9, wherein the concentrations of PAA and H2O2 in the sterilant are 10-14% and 1-3%, respectively.

### Claim 16 (depends on 9)

The method of claim 9, wherein during the sterilization process, pressure and temperature are kept constant.

### Claim 17 (depends on 9)

The method of claim 9, further comprising packaging the device in an inner package that is permeable to the sterilant.

### Claim 18 (depends on 9)

The method of claim 9, further comprising sealing the second portion subsequent to sterilization.

### Claim 19 (depends on 9)

The method of claim 9, wherein the first portion comprises flash spun high density polyethylene.

### Claim 20 (depends on 9)

The method of claim 9, wherein the second portion comprises foil.

### Claim 21 (depends on 9)

The method of claim 9, further comprising positioning a structure inside the outer package to maintain a flow path within the outer package during sterilization.

### Claim 22 (depends on 21)

The method of claim 21, wherein the inner structure comprises a mesh cylinder.

### Claim 23 (depends on 22)

The method of claim 22, wherein the device is positioned inside the mesh cylinder.

### Claim at position 17

24-29. (canceled)