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

• US 5,879,621 A
• Filed: 08/04/1997
• Issued: 03/09/1999
• 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 I. Jr., Heymann, Bruce R.
• Primary Examiner(s): JASTRZAB, KRISANNE MARIE
• Application Number:
  US08/905,345
• Time in Patent Office: 582 Days
• Field of Search: 422/3, 422/105, 422/117, 422/119, 422/40, 364/413.01, 364/507
• 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

Abstract

The presence of a drape on a thermal treatment system for ensuring sterility of a sterile medium contained within a thermal treatment system basin is determined by the use of a drape identifier and corresponding detector. When a drape containing the identifier is placed on the corresponding thermal treatment system, a detector senses and verifies the drape identifier to determine the presence of the drape on the thermal treatment system. A controller receives a signal from the detector indicating whether or not a drape is present on the thermal treatment system. If a drape is not present on the thermal treatment system, the controller prevents thermal treatment system operation. Various drape identifiers may be utilized to indicate the presence of the drape on the thermal treatment system, such as bar codes, mechanical and optical keys, light filter patches disposed on the drape passing various intensities or bands of light, reflective material segments disposed on the drape or reflective material used to construct the drape itself for reflecting light from a light source toward a light detector, and magnetic media in the form of magnetic strips disposed on the drape or a magnetic pigment or resin additive incorporated into the drape material.

Claims

1. An apparatus for ensuring sterility of a sterile medium contained within a thermal treatment system basin by detecting the presence of a sterile drape providing a sterile field above the basin for thermal treatment of the sterile medium, said apparatus comprising:

a thermal treatment system for thermally treating the sterile medium, said thermal treatment system 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 the sterile medium, said surgical drape including a surgical drape identifier for indicating the presence of said surgical drape on said thermal treatment system;

a detector to sense said surgical drape identifier and to determine the presence of said surgical drape on said thermal treatment system; and

a controller to enable said thermal treatment system to thermally treat the sterile medium in response to said detector indicating the presence of said surgical drape on said thermal treatment system.

2. The apparatus of claim 1 wherein said surgical drape identifier includes a tag containing a bar code, and said detector includes:

a bar code reader;

a memory to store bar codes read by said bar code reader wherein the bar codes identify non-sterile previously used drapes; and

a processor to determine the presence of a sterile surgical drape on said thermal treatment system by comparing the bar code of said surgical drape to bar codes stored in said memory;

wherein said controller enables said thermal treatment system in response to said processor determining that the bar code of said surgical drape does not match any of the bar codes identifying non-sterile previously used drapes stored in said memory.

3. The apparatus of claim 2 wherein said memory further includes information associated with surgical drapes that is stored based on drape bar codes, and said processor includes a drape manager to perform drape management tasks that utilize said information.

4. The apparatus of claim 1 wherein said surgical drape identifier includes a mechanical key.

5. The apparatus of claim 4 wherein said mechanical key includes an identification code defined by at least one indentation formed in said key, and said detector includes:

a tumbler to ascertain the identification code; and

a processor to verify the identification code against a predetermined code indicating valid keys to determine the presence of said surgical drape on said thermal treatment system.

6. The apparatus of claim 1 wherein said surgical drape identifier includes an optical key.

7. The apparatus of claim 6 wherein said optical key includes an identification code defined by at least one hole formed in said key in a particular pattern, and said detector includes:

an optical key reader to ascertain the particular pattern and identification code; and

a processor to verify the identification code against a predetermined code indicating valid keys in order to determine the presence of said surgical drape on said thermal treatment system.

8. The apparatus of claim 1 wherein said surgical drape identifier includes at least one light filter patch.

9. The apparatus of claim 8 wherein each said light filter patch passes at least one specific band of light, and said detector includes:

at least one light receiver to receive light from a corresponding light filter patch; and

at least one light band filter circuit for receiving light from a corresponding light receiver and verifying that the light received from said corresponding light receiver contains only each specific band of light passed by said corresponding light filter patch to determine the presence of said surgical drape on said thermal treatment system.

10. The apparatus of claim 8 wherein each said light filter patch passes light at an altered intensity, and said detector includes:

at least one light receiver to receive and measure intensity of light passed by a corresponding light filter patch and to compare the intensity of the received light to a predetermined light intensity threshold to determine the presence of said surgical drape on said thermal treatment system.

11. The apparatus of claim 8 wherein each said light filter patch prevents passage of light, and said detector includes:

at least one light receiver to detect the absence of light from a corresponding light filter patch to determine the presence of said surgical drape on said thermal treatment system.

12. The apparatus of claim 1 wherein said surgical drape identifier includes at least one reflective material segment.

13. The apparatus of claim 12 wherein said detector includes:

at least one light source for emitting a particular band of light; and

at least one light detector for detecting said particular band of light emitted from a corresponding light source and reflected by a corresponding reflective material segment to determine the presence of said surgical drape on said thermal treatment system.

14. The apparatus of claim 1 wherein said surgical drape identifier includes reflective material used for construction of said surgical drape.

15. The apparatus of claim 14 wherein said detector includes:

at least one light source for emitting a particular band of light; and

at least one light detector for detecting said particular band of light emitted from a corresponding light source and reflected by said drape to determine the presence of said surgical drape on said thermal treatment system.

16. The apparatus of claim 1 wherein said surgical drape identifier includes at least one magnetic medium.

17. The apparatus of claim 16 wherein said detector includes at least one magnetic detector for sensing a corresponding magnetic medium to determine the presence of said surgical drape on said thermal treatment system.

18. The apparatus of claim 1 wherein said surgical drape identifier includes a magnetic pigment or resin additive incorporated into material used for construction of said surgical drape.

19. The apparatus of claim 18 wherein said detector includes at least one magnetic detector for sensing said magnetic pigment or resin additive to determine the presence of said surgical drape on said thermal treatment system.

20. A device for use in a surgical apparatus to ensure sterility of liquid being temperature controlled, wherein said surgical apparatus includes at least one temperature controlled basin and a detector fixedly positioned relative to said surgical apparatus, and said device comprises a drape containing a drape identifier adapted and disposed to be sensed by said detector to determine the presence of said drape on said surgical apparatus when said drape is placed on said surgical apparatus with said drape identifier positioned to be detectable by said detector 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 drape identifier indicates the presence of said drape on said surgical apparatus, and said surgical apparatus includes a controller for enabling operation of said surgical apparatus in response to determining the presence of said drape on said surgical apparatus thereby preventing operation of said surgical apparatus without a drape container.

21. The device of claim 20 wherein said drape identifier includes a tag containing a bar code.

22. The device of claim 20 wherein said drape identifier includes a mechanical key.

23. The device of claim 20 wherein said drape identifier includes an optical key.

24. The device of claim 20 wherein said drape identifier includes at least one light filter patch.

25. The device of claim 20 wherein said drape identifier includes at least one reflective material segment.

26. The device of claim 20 wherein said drape identifier includes reflective material used for construction of said drape.

27. The device of claim 20 wherein said drape identifier includes at least one magnetic medium.

28. The device of claim 20 wherein said drape identifier includes a magnetic pigment or resin additive incorporated into material used for construction of said drape.

29. A method for ensuring sterility of a sterile medium contained within at least one thermal treatment system basin by detecting the presence of a sterile surgical drape disposed over a thermal treatment system wherein the sterile surgical drape provides a sterile field above the basin, said method comprising the steps of:

(a) physically placing a drape identifier on surgical drapes;

(b) determining the presence of a drape placed on the thermal treatment system by detecting in the thermal treatment system said drape identifier of said drape placed on the thermal treatment system; and

(c) enabling temperature control of each basin only in response to detection of said drape identifier.

30. The method of claim 29 wherein said drape identifier includes a tag containing a bar code, and step (b) further includes:

(b.1) detecting said bar code to determine the presence and sterility of said drape placed on the thermal treatment system; and

step (c) further includes;

(c.1) storing bar codes of previously used drapes in a memory wherein the bar codes identify non-sterile previously used drapes;

(c.2) determining the presence and sterility of said drape placed on the thermal treatment system by comparing the bar code of that drape to bar codes stored in said memory; and

(c.3) enabling said temperature control in response to determining that the bar code of said drape does not match any of the bar codes identifying non-sterile previously used drapes stored in said memory.

31. The method of claim 30 wherein step (c) further includes:

(c.4) storing information associated with surgical drapes in said memory based on the drape bar codes; and

(c.5) performing drape management tasks utilizing said stored information associated with surgical drapes.

32. The method of claim 29 wherein said drape identifier includes a mechanical key, and step (b) further includes:

(b.1) detecting and verifying in the thermal treatment system, via a tumbler, said mechanical key to determine the presence of said drape on the thermal treatment system.

33. The method of claim 29 wherein said drape identifier includes an optical key, and step (b) further includes:

(b.1) detecting and verifying in the thermal treatment system, via an optical key reader, said optical key to determine the presence of said drape on the thermal treatment system.

34. The method of claim 29 wherein said drape identifier includes at least one light filter patch that passes at least one specific band of light, and step (b) further includes:

(b.1) verifying in the thermal treatment system, via at least one light receiver and associated light band filter circuit, that light received by a corresponding light receiver contains only each said specific band of light passed by a corresponding light filter patch to determine the presence of said drape on the thermal treatment system.

35. The method of claim 29 wherein said drape identifier includes at least one light filter patch that passes light at an altered intensity, and step (b) further includes:

(b.1) receiving in the thermal treatment system, via at least one light receiver, light passed by a corresponding light filter patch;

(b.2) measuring, via said at least one light receiver, intensity of the received light; and

(b.3) comparing the intensity of the received light, via said at least one light receiver, to a predetermined intensity threshold to determine the presence of said surgical drape on the thermal treatment system.

36. The method of claim 29 wherein said drape identifier includes at least one light filter patch that prevents passage of light, and step (b) further includes:

(b.1) detecting in the thermal treatment system, via at least one light receiver, the absence of light from a corresponding light filter patch to determine the presence of said surgical drape on the thermal treatment system.

37. The method of claim 29 wherein said drape identifier includes at least one reflective material segment, wherein the thermal treatment system includes at least one light source for emitting a specific band of light and a corresponding light detector for detecting the specific band of light, and step (b) further includes:

(b.1) detecting in the thermal treatment system, via each said light detector, light emitted from a corresponding light source and reflected by a corresponding reflective material segment to determine the presence of said drape on the thermal treatment system.

38. The method of claim 29 wherein said drape identifier includes reflective material used for construction of said drape, wherein the thermal treatment system includes at least one light source for emitting a specific band of light and a corresponding light detector for detecting the specific band of light, and step (b) further includes:

(b.1) detecting in the thermal treatment system, via each said light detector, light emitted from a corresponding light source and reflected by said drape to determine the presence of said drape on the thermal treatment system.

39. The method of claim 29 wherein said drape identifier includes at least one magnetic medium, and step (b) further includes:

(b.1) detecting in the thermal treatment system, via at least one magnetic detector, a corresponding magnetic medium to determine the presence of said drape on the thermal treatment system.

40. The method of claim 29 wherein said drape identifier includes a magnetic pigment or resin additive incorporated into material used for construction of said drape, and step (b) further includes:

(b.1) detecting in the thermal treatment system, via at least one magnetic detector, said magnetic pigment or resin additive to determine the presence of said drape on the thermal treatment system.