# US 10,864,291 B2 · Process and apparatus for cleaning, disinfection, sterilization, or combinations thereof

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- Number: US 10,864,291 B2
- Document ID: US10864291B2
- Status: Granted
- Kind: B2
- Application number: 15/854,369
- Filed: 2017-12-26
- Published: 2019-06-27
- Granted: 2020-12-15
- Earliest claimed: 2017-12-26
- Assignees: Asp Global Manufacturing GmbH
- Applicants: Ethicon, Inc.
- Inventors: Morris Fuller Fox, III
- Web page: https://patentgrep.com/patent/US10864291B2

## CPC

- A61L 2/24: Apparatus using programmed or automatic operation
- A61B 90/70: Cleaning devices specially adapted for surgical instruments
- A61L 2/14: Plasma, i.e. ionised gases
- A61L 2/208: Hydrogen peroxide
- A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/122: Chambers for sterilisation
- A61L 2202/123: Connecting means
- A61L 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- 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

Apparatus and methods are provided for cleaning, disinfecting, and/or sterilizing a device. More specifically, a first treatment chamber can be configured to conduct a first treatment stage therein at a first pressure, a first temperature, and a first sterilant concentration. A first passage can be operatively connected to the first treatment chamber and a second treatment chamber can be operatively connected to the first passage and in communication with the first chamber via the first passage. The second chamber can be configured to conduct a second treatment stage therein at a second pressure, a second temperature, and a second sterilant concentration. An object can be treated in the first treatment chamber and moved to the second treatment chamber via the first passage to be treated in the second treatment chamber.

## Claims

### Claim 1

An apparatus for treatment of an object, comprising:
a first treatment chamber configured to conduct a first treatment stage therein comprising subjecting the object to a first pressure, a first temperature, and a first sterilant concentration;
a first passage operatively connected to the first treatment chamber;
a second treatment chamber operatively connected to the first passage and in communication with the first chamber via the first passage, the second chamber configured to conduct a second treatment stage therein comprising subjecting the object to a second pressure, a second temperature, and a second sterilant concentration;
a hydrogen peroxide source associated with at least one of the first treatment chamber and the second treatment chamber, wherein the first sterilant concentration and the second sterilant concentration each comprise a hydrogen peroxide concentration; and
a programmable hardware device in communication with the first chamber and the second chamber, the programmable hardware device configured to measure a first parameter selected from the group consisting of the first pressure, the first temperature, the first sterilant concentration, and a time the object spends in the first chamber; and, based on the measured first parameter, move the object to the second chamber, begin the second treatment stage, or a combination thereof.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein at least one of the first pressure, the first temperature, and the first sterilant concentration is different from the second pressure, the second temperature, and the second sterilant concentration, respectively.

### Claim 3 (depends on 1)

The apparatus of claim 1, further comprising:
a second passage, wherein the second chamber is operatively connected to the second passage; and
a third treatment chamber operatively connected to the second passage and in communication with the second chamber via the second passage, the third chamber configured to conduct a third treatment stage therein at a third pressure, a third temperature, and a third sterilant concentration.

### Claim 4 (depends on 3)

The apparatus of claim 3, wherein at least one of the second treatment stage and the third treatment stage remediates a portion of sterilant comprising hydrogen peroxide.

### Claim 5 (depends on 4)

The apparatus of claim 4, further comprising a radiation source operatively connected to at least one of the second chamber and the third chamber, the radiation source configured to generate a plasma therein, wherein the plasma is utilized for remediation of the portion of the sterilant.

### Claim 6 (depends on 3)

The apparatus of claim 3, further comprising:
a first opening in the first chamber, the first opening configured to receive the object into the first chamber;
the first passage configured to facilitate transport of the object between the first chamber and the second chamber;
the second passage configured to facilitate transport of the object between the second chamber and the third chamber; and
a second opening in the third chamber, the second opening configured to facilitate transport of the object out of the third chamber.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein the first treatment chamber comprises an airlock.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the programmable hardware device is configured to control a parameter in at least one of the first treatment stage and the second treatment stage.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein the parameter is selected from the group consisting of the first temperature, the first pressure, the first sterilant concentration, the second temperature, the second pressure, the second sterilant concentration, and combinations thereof.

### Claim 10 (depends on 1)

The apparatus of claim 1, wherein the programmable hardware device is configured to control a time the object spends in at least one of the first chamber and the second chamber.

### Claim 11 (depends on 1)

The apparatus of claim 1, further comprising:
a shuttle system in communication with the second chamber, the shuttle system configured to transport the object between the first chamber and the second chamber.

### Claim 12 (depends on 1)

The apparatus of claim 1, wherein the first passage has at least two states of communication, including a first state which enables the first and second chambers to exchange at least one of: a fluid, heat, and pressure and a second state which enables separation of the first and second chambers.

### Claim 13

An apparatus for treatment of a medical device, comprising:
a first treatment chamber configured to conduct a first treatment stage therein comprising subjecting the medical device to a first pressure, a first temperature, and a first sterilant concentration;
a second treatment chamber operatively connected to the first passage and in communication with the first chamber via the first passage, the second treatment chamber configured to conduct a second treatment stage therein comprising subjecting the medical device to a second pressure, a second temperature, and a second sterilant concentration that is different from at least one of the first pressure, the first temperature, and the first sterilant concentration, respectively;
a shuttle system in communication with the second chamber, the shuttle system configured to transport the medical device between the first chamber and the second chamber via the first passage;
a programmable hardware device configured to control a parameter in at least one of the first treatment stage and the second treatment stage, wherein the parameter is selected from the group consisting of the first pressure, the first temperature, the first sterilant concentration, the second pressure, the second temperature, the second sterilant concentration, a time the medical device spends in at least one of the first chamber and the second chamber, and combinations thereof, wherein the programmable hardware device is configured to, based on the parameter, move the object to the second chamber, begin the second treatment stage, or a combination thereof; and
a hydrogen peroxide source associated with at least one of the first treatment chamber and the second treatment chamber, wherein the first sterilant concentration and the second sterilant concentration each comprise a hydrogen peroxide concentration.

### Claim 14 (depends on 1)

The apparatus of claim 1, wherein the first passage is moveable along a path from a first location to a second location, wherein a movement of the object between the first chamber and the second chamber is not impeded by the first passage in the first location and is impeded by the first passage in the second location.

### Claim 15 (depends on 14)

The apparatus of claim 14, wherein the first passage is configured to create a seal between the first chamber and the second chamber in the second location.

### Claim 16 (depends on 1)

The apparatus of claim 1, further comprising a support member configured to physically support the object in at least one of the first chamber and the second chamber.

### Claim 17 (depends on 1)

The apparatus of claim 1, wherein the first chamber is configured to conduct the first treatment stage concurrently while the second chamber conducts the second treatment stage.

### Claim 18 (depends on 3)

The apparatus of claim 3, wherein the first chamber is configured to establish a treatment condition, the second chamber is configured to maintain and/or adjust the treatment condition, and the third chamber is configured to remove the treatment condition.

### Claim 19 (depends on 6)

The apparatus of claim 6, wherein at least one of the first opening and the second opening is a sealable opening.

### Claim 20 (depends on 1)

The apparatus of claim 1, wherein at least one of the first sterilant concentration and the second sterilant concentration comprise a hydrogen peroxide concentration greater than 1% hydrogen peroxide vapor by weight.

### Claim 21 (depends on 13)

The apparatus of claim 13, wherein at least one of the first sterilant concentration and the second sterilant concentration comprise a hydrogen peroxide concentration greater than 1% hydrogen peroxide vapor by weight.
