Container and system for decontaminating a medical device with a fog

• US 8,821,807 B2
• Filed: 12/03/2010
• Issued: 09/02/2014
• Est. Priority Date: 12/03/2009
• Status: Active Grant

• Current Assignee: Medivators, Inc. (Steris PLC)
• Original Assignee: Medivators, Inc. (Steris PLC)
• Inventors: Schwartz, Mason, Olson, Jonathan K., Marxer, John E., Petersen, Michael P., Gentle, Thomas M. Jr.
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US12/959,535
• Publication Number:
  US 20110135537A1
• Time in Patent Office: 1,369 Days
• Field of Search: 422/292, 206/438, 206/439
• US Class Current: 422/292
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: 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
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/22 Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

A pouch for retaining an endoscope during and after a decontamination process includes a first pouch side, a second pouch side attached to the first pouch side to form the pouch that is configured to retain the endoscope, and a port member coupled to the second pouch side. The second pouch side is securable to the first pouch side to seal the endoscope within the pouch. The second pouch side is configured to permit passage of a decontaminating substance. The port member is coupled to the second pouch side and includes an external interface configured to be connected to a device that provides the decontaminating substance for passage through the port member into an interior of the pouch.

Claims

1. A pouch for retaining an endoscope during and after a decontamination process, the pouch comprising:

a first pouch side;

a second pouch side attached to the first pouch side to form the pouch that is configured to retain the endoscope, the second pouch side further securable to the first pouch side to seal the endoscope within the pouch, and wherein the second pouch side is configured to permit passage of a decontaminating substance; and

a port member coupled to the second pouch side, the port member including an external interface configured to be connected to a device that provides the decontaminating substance through the port member and through the second pouch side by permeating the second pouch side to an interior of the pouch when said external interface is connected to a source of decontaminating substance.

2. The pouch of claim 1, wherein the port member further includes an internal interface configured to be connected to the endoscope, wherein the second pouch side forms a barrier separating the internal interface from the external interface, and wherein the decontaminating substance is provided through at least a portion of the endoscope via the port member.

3. The pouch of claim 1, wherein the port member comprises:

an interior port member attached to an interior surface of the second pouch side without extending through the second pouch side and configured to be connected to the endoscope; and

an exterior port member attached to an exterior surface of the second pouch side without extending through the second pouch side, aligned with the interior port member, and configured to be connected to the device that provides the decontaminating substance for passage through the exterior port member, second pouch side, interior port member, and at least a portion of the endoscope.

4. The pouch of claim 1, wherein the second pouch side comprises a non-woven sheet.

5. The pouch of claim 4, wherein the non-woven sheet includes a polyethylene spun-bonded material.

6. The pouch of claim 1, wherein the pouch remains sealed after the decontamination process until opened when the endoscope is to be used.

7. The pouch of claim 1, and further comprising an indicator that shows that the pouch has been through one or more decontamination cycles.

8. The pouch of claim 1, wherein the decontaminating substance can be passed through the second pouch side, the port member, and at least a portion of the endoscope as a fog.

9. A system for decontaminating a medical device, the system comprising:

a chemical chamber configured to receive a decontaminating substance from a chemical reservoir and disperse the decontaminating substance into the chemical chamber as a fog;

a decontamination chamber configured to retain the medical device and receive the fog from the chemical chamber to surround the medical device;

a pressure control assembly connected to the decontamination chamber and configured to control the pressure in the decontamination chamber to manage fluid flow between the chemical chamber and the decontamination chamber; and

an enclosure for retaining the medical device including a fog-permeable layer and an exterior port member coupled to the fog-permeable layer, the exterior port member configured to interface with the decontamination chamber such that when the port member is interfaced with the decontamination chamber the fog is transferable from the chemical chamber into the interior of the enclosure through the exterior port member and through the fog-permeable layer by permeating the fog-permeable layer.

10. The system of claim 9, wherein the chemical chamber includes an atomizing nozzle connected between the chemical reservoir and the chemical chamber that transforms the decontaminating substance into the fog.

11. The system of claim 9, wherein the decontaminating substance comprises hydrogen peroxide and/or peracetic acid.

12. The system of claim 9, wherein the pressure control assembly comprises:

a fluid control valve connected between the chemical chamber and the decontamination chamber and configured to control fluid flow between the chemical chamber and the decontamination chamber.

13. The system of claim 9, wherein the enclosure is a pouch comprising:

a first pouch side;

a second pouch side attached to the first pouch side to form the pouch that is configured to receive the medical device in its interior, the second pouch side further sealable to the first pouch side to enclose the medical device within the pouch, wherein the second pouch side has an interior surface and an exterior surface, and wherein the second pouch side is fog-permeable; and

the exterior port member attached to the exterior surface of the second pouch side and configured to be connected to the chemical chamber such that the pressure control assembly forces the fog through the exterior port member and second pouch side into an interior of the pouch.

14. The system of claim 13, wherein the second pouch side comprises a non-woven sheet.

15. The system of claim 14, wherein the non-woven sheet includes a polyethylene spun-bonded material.

16. The system of claim 13, wherein the pouch further comprises:

an interior port member attached to the interior surface of the second pouch side such that the second pouch side forms a barrier separating the internal interface from the external interface, aligned with the exterior port member, and configured to be connected to the medical device such that the pressure control assembly forces the fog through the exterior port member, second pouch side, interior port member, and at least a portion of the medical device.

17. The system of claim 16, wherein the decontamination chamber is further configured to receive fog from the chemical chamber to surround the exterior of the pouch.

18. The system of claim 16, wherein the pressure control assembly comprises:

a first fluid control valve connected between the chemical chamber and the decontamination chamber and configured to control fluid flow from the chemical chamber through the exterior port member into the interior of the pouch; and

a second fluid control valve connected between the chemical chamber and the decontamination chamber and configured to control fluid flow from the chemical chamber into the decontamination chamber exterior of the pouch.

19. The system of claim 16, wherein the pressure control assembly is further configured to force the fog from the at least a portion of the medical device to the interior of the pouch such that the fog surrounds an exterior of the medical device.

20. The system of claim 19, wherein the pressure control assembly is further configured to force the fog through the second pouch side and out of the decontamination chamber.

21. A system for decontaminating a medical device, the system comprising:

a chemical chamber configured to receive a decontaminating substance from a chemical reservoir as a fluid;

a decontamination chamber configured to retain the medical device and receive the fluid from the chemical chamber to surround the medical device;

a pressure control assembly connected to the decontamination chamber and configured to control the pressure in the decontamination chamber to manage fluid flow between the chemical chamber and the decontamination chamber; and

an enclosure for retaining the medical device including a fluid-permeable layer and a port member coupled to and abutting a surface of the fluid-permeable layer without extending through the fluid-permeable layer, the port member configured to connect to the chemical chamber such that when the port member is connected to the chemical chamber the fluid is transferable from the chemical chamber through the port member, through a barrier formed by the fluid-permeable layer, and into the interior of the enclosure.

22. The system of claim 21, wherein the port member comprises:

an exterior port member attached to an exterior surface of the fluid-permeable layer; and

an interior port member attached to an interior surface of the fluid-permeable layer and aligned with the exterior port member such that the fluid-permeable layer forms a barrier separating the interior port member from the exterior port member.

23. The system of claim 22, and further comprising:

a plurality of fluid conduits configured for coupling to a plurality of channels of the endoscope, wherein each of the plurality of fluid conduits is connected to corresponding one of a plurality of connection interfaces on the interior port member.

24. The system of claim 21, wherein the fluid permeable layer comprises a substantially continuous fibrous non-woven sheet of material through which the decontaminating substance permeates when the decontaminating substance flows through the port member.

25. The system of claim 21, wherein the pressure control assembly comprises:

a first fluid control valve connected between the chemical chamber and the decontamination chamber and configured to control fluid flow from the chemical chamber through the port member into the interior of the pouch; and

a second fluid control valve connected between the chemical chamber and the decontamination chamber and configured to control fluid flow from the chemical chamber into the decontamination chamber exterior of the pouch.

26. The system of claim 21, wherein the fluid is a fog comprising both small droplets and fog in its vapor phase.