# US 5,344,017 A · Instrument pouch with in-pouch sterile processing indicator

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- Number: US 5,344,017 A
- Document ID: US5344017A
- Status: Granted
- Kind: A
- Application number: 08/106,213
- Filed: 1993-08-13
- Granted: 1994-09-06
- Earliest claimed: 1993-08-13
- Inventors: Paul M. Wittrock
- Web page: https://patentgrep.com/patent/US5344017A

## CPC

- B65D 79/02: Arrangements or devices for indicating incorrect storage or transport ({B65D79/005 takes precedence } ; measuring devices G01)
- 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 2/206: Ethylene oxide
- A61L 2/26: Accessories
- A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
- B65D 55/026: {initial opening or unauthorised access being indicated by a visual change using indicators other than tearable means, e.g. change of colour, pattern or opacity (B65D55/066 takes precedence)}
- A61B 2050/002: {having adhesive means, e.g. an adhesive strip}
- A61B 2050/0065: {Peelable cover}
- A61B 2050/314: {Flexible bags or pouches}
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A medical instrument sterilization processing pouch is provided having a sterile processing indicator protected between the walls forming the pouch to register sterilizing processing of the medical instruments.

## Claims

### Claim 1

Medical instrument sterilization processing pouch comprising first and second sheet material walls joined by a perimetrical seal to have a closed volume within which medial instruments are sealed and sterile-processed and stored for later use, said perimetrical seal being tapered at one end of said pouch to limit locally the area of seal between said sheet material walls for ease of separating said sheet material walls and opening said seal, and within said pouch closed volume a sterile-processing indicator having signal response to sterile processing conditions experienced by said instruments, said sterile processing indicator being enclosed within said closed volume by additional seal lines of relatively less width than said perimetrical seal and extending at right angles to the tapered portions of said perimetrical seal to form a diamond shaped enclosure for said sterile processing indicator to limit the increase in seal area forming said sterile processing indicator enclosure.

### Claim 2 (depends on 1)

Pouch according to claim 1, in which said sterile processing indicator comprises an ink having color-change response to exposure to sterilization processing to signal a history of sterile processing.

### Claim 3 (depends on 2)

Pouch according to claim 2, in which said ink is responsive to sterilizing steam or vapor.

### Claim 4 (depends on 2)

Pouch according to claim 2, in which said ink is responsive to exposure to a sterilizing gas, organic agent or radiation.

### Claim 5 (depends on 4)

Pouch according to claim 4, in which said sterilizing gas comprises ethylene oxide.

### Claim 6 (depends on 1)

Pouch according to claim 1, in which said sterile-processing indicator has separate portions separately responsive to sterilizing steam or vapor, sterilizing gas, organic agent or radiation.

### Claim 7 (depends on 1)

Pouch according to claim 1, including also a flap on one of said walls arranged to overlie the other of said walls in sealed relation to fully enclose said closed volume.

### Claim 8 (depends on 7)

Pouch according to claim 7, in which said sterile processing indicator is within said enclosed volume.

### Claim 9 (depends on 8)

Pouch according to claim 8, in which said sterile processing indicator is adjacent said perimetrical seal.

### Claim 10 (depends on 8)

Pouch according to claim 8, in which said diamond shaped enclosure blocks frictional contact between said sterile processing indicator and instruments within said closed volume.

### Claim 11 (depends on 10)

Pouch according to claim 10, in which said diamond shaped enclosure is partly formed by said tapered portions of said perimetrical seal.

### Claim 12 (depends on 1)

Pouch according to claim 1, in which said sterile processing indicator is beyond the tapered portion of said perimetrical seal and covered between said first and second sheet materials.