Catheter reprocessing and sterilizing system

• US 5,310,524 A
• Filed: 02/11/1992
• Issued: 05/10/1994
• Est. Priority Date: 02/11/1992
• Status: Expired due to Fees

• Current Assignee: Minntech Corporation
• Original Assignee: Minntech Corporation
• Inventors: Cosentino, Louis C., Campbell, James L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Trembley, T. A.
• Application Number:
  US07/835,729
• Time in Patent Office: 819 Days
• Field of Search: 422/28, 422/33, 422/292, 422/295, 134/22.12, 134/22.18, 134/166 R, 134/170, 134/166 C
• US Class Current: 422/33
• CPC Class Codes: A61B 2090/701 for flexible tubular instruments, e.g. endoscopes
• CPC Class Codes: A61L 2/00 Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for contact lenses A61L12/00; atomisers for disinfecting agents A61M; sterilisation of packages or package contents in association with packaging B65B55/00; treatment of water, waste water, sewage or sludge C02F; disinfecting paper D21H21/36; disinfecting devices for water closets E03D; articles having provision for disinfection, see the relevant subclasses for these articles, e.g. H04R1/12
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: B08B 9/0325 Control mechanisms therefor

Abstract

A system for reprocessing and sterilizing a previously used catheter having at least one lumen is disclosed. The catheter is provided with a housing and enclosed within the housing. Heated sterilant is provided to the housing and the catheter. The lumen is tested during the reprocessing and sterilizing cycle for blockages and integrity. If the catheter is of a type having a balloon tip, the balloon is also tested for integrity by inflating and deflating it a plurality of times. The housing is pressurized to a level above the ambient pressure and maintained at such pressure whereby the sterility of the catheter is maintained for up to one week. Further disclosed is an apparatus for selectively coupling used catheters to a source of sterilant. The apparatus includes a housing having a tray for holding the catheter in place during reprocessing, a door for enclosing and locking the catheter within the housing, and a plurality of valves for coupling the housing to a source of sterilant. In addition, the apparatus includes a cap for maintaining the sterility of the catheter during storage.

Claims

1. A method for reprocessing and sterilizing a previously used catheter comprising the steps of:

(a) providing a catheter receiving housing and a catheter, having at least one lumen and a balloon member;

(b) enclosing said catheter within said catheter receiving housing;

(c) heating an external source of a sterilant to a temperature of about 53°

C.;

(d) introducing said sterilant into said catheter receiving housing;

(e) causing said sterilant to circulate throughout said catheter receiving housing and around and within said catheter, said at least one lumen and said balloon member while constantly maintaining said temperature of about 53°

C.;

(f) draining said sterilant from said catheter receiving housing;

(g) pressurizing said catheter receiving housing to a pressure level above said ambient pressure;

(h) maintaining said pressure level within said catheter receiving housing whereby the sterility of said catheter is maintained in a dry, sterile environment for at least one week by retaining said catheter in said pressurized catheter receiving housing.

2. The method as received in claim 1 wherein introducing sterilant into said catheter receiving housing further includes the step of:

(a) providing an anti-corrosive sterilant within said catheter receiving housing and within said catheter, said anti-corrosive sterilant comprising a mixture of hydrogen peroxide, peracetic acid, acetic acid, an anticorrosive agent and water.

3. The method as received in claim 1 wherein circulating said heated sterilant throughout said catheter receiving housing, said at least one lumen, and said balloon member further includes the step of:

(a) testing said at least one lumen for blockages by pressurizing said at least one lumen and monitoring said at least one lumen for a drop in pressure.

4. The method as recited in claim 3 wherein the step of testing said at least one lumen is repeated a plurality of times.

5. The method as received in claim 1 wherein the step of maintaining the pressure within said catheter receiving housing further includes the step of:

(a) providing a sterility maintaining cap means to said catheter receiving housing for ensuring that the sterility of said catheter having at least one lumen and a balloon member is maintained during storage.

6. The method as received in claim 1 wherein causing said sterilant to circulate within said catheter receiving housing, said at least one lumen and said balloon member further includes the step of:

(a) testing the integrity of said balloon member by inflating said balloon member with said sterilant under pressure and monitoring said balloon member for a drop in pressure; and

(b) sterilizing said balloon member within about 30 minutes by inflating and deflating said balloon member with said sterilant.

7. The method as recited in claim 1 further including the step of sterilizing said catheter in less than about one hour.

8. An apparatus for selectively coupling a previously used catheter to a source of sterilant for reprocessing and sterilizing said catheter, and for storing said catheter in a sterile environment for at least one week, said apparatus comprising:

(a) housing means for receiving a catheter, said housing means including sidewalls defining a catheter receiving chamber having a mouth portion, said mouth portion having an outer perimeter for permitting access to said catheter receiving chamber, and latch means coupled to said sidewalls;

(b) removable door means detachably coupled to said housing means for selectively enclosing a catheter having at least one lumen within said catheter receiving chamber;

(c) a plurality of valves operably carried by said removable door means for selectively coupling said housing means to a source of sterilant;

(d) sealing means operably engageable with said removable door means and said plurality of valves for selectively maintaining pressure within said housing means for at least one week when said housing means is removed from said source of sterilant; and

(e) a sterility maintaining cap detachably engageable with said plurality of valves and said door means, said sterility maintaining cap defining a plurality of interior valve receiving pockets and an interior channel extending substantially the length of said sterility maintaining cap, said interior channel being in fluid communication with each of said plurality of interior valve receiving pockets.

9. The apparatus as recited in claim 8, wherein said removable door means comprises:

(a) a door; and

(b) locking means operably coupled to said door.

10. The apparatus as recited in claim 9, wherein said locking means comprises:

(a) an overcenter cam mechanism, said overcenter cam mechanism including at least two journals coupled to said door, said at least two journals each defining a peg receiving aperture;

(b) a cam shaft including at least two pegs, said at least two pegs rotatably received within said at least two journals, and said cam shaft shiftable between a locked and an unlocked position; and

(c) a finger operable lever assembly coupled to said cam shaft for shifting said cam shaft between said locked and unlocked positions.

11. The apparatus as recited in claim 8, wherein said sealing means comprises latch means operably coupled to said housing means for detachably sealing said removable door means to said housing means;

and an O-ring, said O-ring detachably received within a groove defined by the perimeter of said mouth portion.

12. The apparatus as recited in claim 11 wherein said latch means includes a plurality of latches, each latch having an arm defining at least one recessed notch.

13. The apparatus as recited in claim 8, wherein said housing means includes sterility monitoring means for monitoring the sterility of the reprocessed catheter during said storage.

14. The apparatus as recited in claim 8, wherein said sterility maintaining cap further includes a plurality of purge-in and purge-out ports operably connected to said plurality of interior valve receiving pockets, said plurality of purge-in and purge-out ports being in fluid communication with said plurality of interior valve receiving pockets and said interior channel.