Method and apparatus for ensuring sterility of surgical drapes used with surgical equipment

• US 5,653,938 A
• Filed: 04/26/1995
• Issued: 08/05/1997
• Est. Priority Date: 04/26/1995
• Status: Expired due to Term

• Current Assignee: Microtek Medical Incorporated (Ecolab, Inc.)
• Original Assignee: Medical Company, Inc. (Ecolab, Inc.)
• Inventors: Faries, Durward Jr., Heymann, Bruce R.
• Primary Examiner(s): BHAT, NINA NMN
• Application Number:
  US08/427,938
• Time in Patent Office: 832 Days
• Field of Search: 422/3, 422/105, 422/117, 422/119, 422/40, 364/413.01, 364/807
• US Class Current: 422/3
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 90/96 using barcodes
• 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: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

The sterility of a drape for use on surgical equipment is ensured by the use of bar codes and a microprocessor. When a drape containing a bar code is placed on the corresponding surgical equipment, a bar code reader ascertains the bar code on the drape. A microprocessor receives the bar code and determines whether the bar code has been previously written to memory indicating the drapes prior use. If the bar code is not present, the current bar code of the drape is written into memory, and subsequent operation of the surgical equipment commences. If the bar code is present, the microprocessor prevents the surgical equipment from operating. The microprocessor conserves memory by deleting bar code numbers of drapes that surpass a user determined time period.

Claims

1. In a machine for thermally treating a sterile fluid medium in a drape container to permit use of fluid medium in a surgical procedure, a method for preventing re-use of non-sterile drapes comprising the steps of:

(a) permanently placing on each drape coded indicia uniquely identifying said each drape;

(b) positioning one of said drapes on said machine, prior to each thermal treatment of sterile fluid, to form said drape container and to place said coded indicia adjacent a reading device;

(c) reading said coded indicia from the positioned drape;

(d) detecting sterility of the positioned drape by comparing said coded indicia of the positioned drape to coded indicia stored in a memory, wherein said coded indicia stored in said memory identify non-sterile previously used drapes; and

(e) controlling power to a temperature controller of said machine based on said comparison such that said machine is disabled in response to detecting a non-sterile drape.

2. The method according to claim 1 further comprising the step of:

(f) deleting from said memory stored coded indicia that have been stored longer than a predetermined time period.

3. The method of claim 1 wherein said step (e) comprises disabling power to said temperature controller when said coded indicia of said positioned drape matches a coded indicia in said memory.

4. The method of claim 3 wherein said step (e) further comprises storing said coded indicia of said positioned drape in said memory and enabling power to said temperature controller when said coded indicia of said positioned drape does not match any coded indicia in said memory.

5. The method of claim 1 wherein said step (a) comprises permanently placing on each drape an optically sensed coded indicia uniquely identifying each said drape.

6. The method of claim 1 wherein said step (a) comprises permanently placing on each drape a bar code uniquely identifying each said drape.

7. A method for preventing use of unsuitable surgical drapes with a thermal treatment machine of the type having a basin into which a portion of a surgical drape is placed to conform to the basin and receive sterile liquid to be used during a surgical procedure and temperature controlled by controlling the temperature of the basin, said method comprising the steps of:

(a) physically placing an indicator on suitable drapes;

(b) detecting in said machine the presence of said indicator for a drape placed on said machine; and

(c) enabling temperature control of said basin only in response to detection of said indicator for said drape placed on said machine.

8. The method of claim 7 wherein step (a) includes disposing indicia on said suitable drapes;

and wherein step (b) includes detecting the presence of said indicia.

9. The method of claim 8 wherein the indicia are optically detectable.

10. The method of claim 8 wherein the indicia are magnetic and are magnetically detectable.

11. The method of claim 7 wherein step (a) includes disposing coded indicia on said suitable drapes to uniquely identify suitable drapes and to distinguish each suitable drape from all other suitable drapes, and wherein step (b) includes reading said coded indicia;

and further comprising the steps of;

(d) storing coded indicia that have been read from suitable drapes previously used with the system;

(e) comparing coded indicia being read in step (b) with all coded indicia stored in step (d) to determine match and non-match conditions between the coding indicia being read and each of the stored coded indicia; and

(f) inhibiting the enabling of temperature control in step (c) unless said non-match condition is detected.

12. An apparatus for detecting a sterility of a surgical drape comprising:

thermal treatment means for thermally treating a liquid, said means including at least one basin;

a surgical drape covering and substantially conforming to said at least one basin to serve as a drape container for said liquid, said surgical drape including an identification code;

reader means for reading said identification code of said surgical drape when said surgical drape is properly positioned on said thermal treatment means;

actuable means for operating said thermal treatment means to control a temperature of each said basin;

memory means for storing said identification codes read by said reader means, wherein said codes identify non-sterile previously used drapes;

comparing means for detecting the sterility of said surgical drape by comparing said identification code of said surgical drape to identification codes stored in said memory means; and

control means for controlling said thermal treatment means based on said comparison such that said thermal treatment means is disabled in response to said comparing means detecting a non-sterile drape.

13. The apparatus of claim 12 further comprising means for deleting from said memory means stored identification codes that have been stored for longer than predetermined time period.

14. The apparatus of claim 12 wherein said thermal treatment means further includes means for generating surgical slush in said drape container.

15. The apparatus of claim 14 wherein said surgical drape further comprises a movable plate for automatically removing surgical slush formed on said surgical drape.

16. The apparatus of claim 12 wherein said thermal treatment means includes means for generating a heated liquid in said drape container.

17. The apparatus of claim 12 wherein said thermal treatment means comprises at least two basins and further includes means for generating heated and cooled liquid simultaneously in separate basins.

18. The apparatus of claim 12 wherein said control means disables power to said thermal treatment means when said identification code of said surgical drape matches an identification code in said memory means.

19. The apparatus of claim 18 wherein:

said comparing means further includes means for storing said identification code of said surgical drape in said memory means; and

said control means further includes means for enabling power to said actuable means when said identification code of said surgical drape does not match any identification codes stored in said memory means.

20. The apparatus of claim 12 wherein said identification code of said surgical drape comprises an optically sensed identification code.

21. The apparatus of claim 12 wherein said identification code of said surgical drape comprises a bar code and said reader means comprises a bar code reader.

22. A device for use in a surgical apparatus to ensure sterility of liquid being temperature controlled, wherein said apparatus includes at least one temperature controlled basin and reader means fixedly positioned relative to said apparatus, and said device comprises a drape containing coded indicia adapted and disposed to be read by said reader means for automatic identification of said drape by said apparatus when said drape is placed on said apparatus such that said indicia are positioned over said reader means and a portion of said drape is disposed in said at least one basin to form a drape container in the basin for containing and maintaining said liquid, wherein said coded indicia indicate the sterility condition of said drape, and said apparatus includes means for disabling operation of said apparatus in response to identifying a non-sterile drape thereby preventing operation of said apparatus with a non-sterile drape container.

23. The device of claim 22 wherein said coded indicia comprises optically sensed coded indicia.

24. The device of claim 22 wherein said coded indicia comprises a bar code.

25. An apparatus for detecting a sterility, comprising:

thermal treatment means for thermally treating a liquid, said thermal treatment means including at least one basin;

a surgical drape covering and substantially conforming to said at least one basin to serve as a drape container for said liquid, said surgical drape including an identification code indicating sterility of said drape;

reader means for detecting sterility of said drape by sensing said identification code of said surgical drape when said surgical drape is properly positioned on said thermal treatment means;

actuable means for operating said thermal treatment means to control a temperature of each said basin; and

power control means for disabling power to said thermal treatment means when said reader means does not sense an identification code of said surgical drape.

26. Apparatus for preventing use of unsuitable surgical drapes with a thermal treatment machine of the type having a basin into which a portion of a surgical drape is placed to conform to the basin and receive sterile liquid that is to be used during a surgical procedure and temperature controlled by controlling the temperature of the basin, said apparatus comprising:

drape, indicator means for designating suitable drapes for use with said machine;

detector means fixedly positioned on said machine for detecting the presence of said indicator means for a drape placed on said machine; and

control means for enabling temperature control of said basin only in response to detection of indicator means for said drape placed on said machine.

27. The apparatus of claim 26 wherein said indicator means comprises coded indicia disposed on said suitable drapes, and wherein said detector means comprises means for detecting said coded indicia.

28. The apparatus of claim 26 wherein said drape indicator means comprises coding means uniquely identifying suitable drapes and distinguishing each suitable drape from all other suitable drapes with said coded indicia;

wherein said detector means comprises code reading means for reading said coded indicia;

and further comprising;

memory means for storing coded indicia previously read by said code reading means;

comparison means for comparing coded indicia being read by said code reading means with all coded indicia stored in said memory means to determine match and non-match conditions between the coded indicia being read and each of said stored coded indicia; and

means for inhibiting said control means from enabling temperature control of said basin in response to detection of a match condition by said comparison means.