Container and system for decontaminating a medical device with a fluid

• US 9,439,991 B2
• Filed: 08/29/2014
• Issued: 09/13/2016
• 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., Gentle, Thomas M. Jr., Marxer, John E., Petersen, Michael P.
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US14/473,368
• Publication Number:
  US 20140369887A1
• Time in Patent Office: 746 Days
• Field of Search: 422/292
• US Class Current: 1/1
• 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 method for decontaminating a medical device includes enclosing the medical device in an enclosure including a fog-permeable layer and an exterior port member coupled to the fog-permeable layer. The exterior port member of the enclosure is coupled to a chemical dispersing interface in a decontamination chamber. A pressure in the decontamination chamber is reduced to a sub-atmospheric pressure in a first evacuation step. A room temperature decontaminating fluid is introduced as a fog into the decontamination chamber. The fog is held in the decontamination chamber for a decontaminating time. The pressure in the decontamination chamber is reduced to a sub-atmospheric pressure in a second evacuation step. The decontamination chamber is vented to atmospheric pressure.

Claims

1. A method for decontaminating a medical device, the method comprising:

enclosing the medical device in an enclosure, the enclosure including a fog-permeable layer and an exterior port member and an interior port member coupled to the fog-permeable layer;

placing the enclosure within a decontamination chamber;

coupling the exterior port member of the enclosure to a chemical dispersing interface in the decontamination chamber;

reducing a pressure in the decontamination chamber to a sub-atmospheric pressure in a first evacuation step;

introducing a room temperature decontaminating fluid as a fog into the enclosure within the decontamination chamber by flowing the fog through the exterior port member, the fog-permeable layer, the interior port member, and at least a portion of the medical device;

holding the fog in the enclosure and the decontamination chamber for a decontaminating time;

reducing the pressure in the decontamination chamber to a sub-atmospheric pressure in a second evacuation step; and

venting the decontamination chamber to atmospheric pressure.

2. The method of claim 1, wherein the introducing step comprises forcing the decontaminating fluid through an atomizing nozzle to transform the decontaminating fluid into the fog.

3. The method of claim 1, wherein the introducing step comprises:

dispersing the fog into a chemical chamber;

developing a pressure differential between the decontamination chamber and the chemical chamber; and

opening a pressure control valve between the decontamination chamber and the chemical chamber.

4. The method of claim 1, wherein the enclosure is a pouch and wherein the enclosing step comprises placing the medical device in the pouch including a first pouch side, a second pouch side attached to the first pouch side to form the pouch that is configured to retain the medical device, and a port member coupled to the second pouch side, the second pouch side further securable to the first pouch side to seal 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, the port member including the exterior port member which is configured to be connected to the chemical chamber.

5. The method of claim 4, wherein the port member further includes an interior port member configured to be connected to the medical device, and wherein the introducing step comprises forcing the fog through the exterior port member, second pouch side, interior port member, and at least a portion of the medical device.

6. The method of claim 1, and further comprising holding the decontamination chamber at the reduced pressure for a period of time after the second reducing step.

7. The method of claim 1, wherein after the venting step, the method further comprises:

reducing the pressure in the decontamination chamber to a sub-atmospheric pressure in a third evacuation step; and

venting the decontamination chamber to atmospheric pressure.

8. The method of claim 1, wherein the enclosure comprises

a pouch having an internal side and an external side and comprising

a first material layer defining an area and

a second material layer defining an area, the first material layer and second material layer secured along a periphery of the first material layer area and the second material layer area;

an interior port member coupled to the first material layer on the internal side of the pouch; and

an external port member coupled to the first material layer on the external side of the pouch and in fluid communication with the interior port member,

wherein a portion of the first material layer area is located between the interior port member and the external port member.

9. The method of claim 8, wherein the first material layer comprises a fog-permeable layer and wherein the introducing step includes flowing the decontaminating fluid through the external port member, through the portion of the first material layer located between the interior port and the external port member, through the internal port member, and into the enclosure within the decontamination chamber.

10. The method of claim 1, further comprising removing the enclosure from the decontamination chamber and wherein the medical device is retained in the enclosure in a terminally decontaminated state after the enclosure is removed from the decontamination chamber.