System and method of detecting fluid and leaks in thermal treatment system basins

• US 7,959,860 B2
• Filed: 02/09/2006
• Issued: 06/14/2011
• Est. Priority Date: 10/22/2001
• Status: Active Grant

• Current Assignee: Microtek Medical Incorporated (Ecolab, Inc.)
• Original Assignee: Ecolab, Inc.
• Inventors: Faries, Durward I. Jr., Blankenship, Calvin, Heymann, Bruce R., Hendrix, David
• Primary Examiner(s): Sakelaris; Sally A
• Application Number:
  US11/350,363
• Publication Number:
  US 20060194324A1
• Time in Patent Office: 1,951 Days
• Field of Search: None
• US Class Current: 422/62
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation

Abstract

A drape including a sensing device according to the present invention is disposed over a top surface of a thermal treatment system having a basin recessed therein. A portion of the drape is pushed down into the basin to form a drape container for collecting a sterile medium. The thermal treatment system may be of the type that either heats or congeals the sterile medium. The sensing device includes electrodes that are typically disposed through the drape and sealed. The electrodes provide signals indicating the presence of liquid and/or leaks or other conditions within the drape container to the system to facilitate control of system operation. In addition, the sensing device includes a fuse to limit the drape to a single use. The system disables the fuse to indicate prior use and detects tampering to bypass the fuse, thereby preventing use of the drape for subsequent medical procedures.

Claims

1. A system for detecting conditions within containers formed by surgical drapes during surgical procedures and controlling thermal treatment of said containers in response to said detected conditions, said system comprising:

a thermal treatment unit to thermally treat a sterile medium and including a basin;

a surgical drape, covering and substantially conforming to said basin, to serve as a drape container for said sterile medium;

a sensing device to detect drape container conditions including sterility of said drape, wherein said sensing device includes a status device and a plurality of conductors responsive to contact with said sterile medium to indicate conditions of said drape container, and wherein said status device includes a plurality of states with the state of said status device indicating said sterility of said drape;

a controller to operate said thermal treatment unit to control a temperature of said basin; and

a detection unit to determine occurrence of said drape container conditions from signals from said sensing device to control said controller to operate said thermal treatment unit in accordance with said determined drape container conditions.

2. The system of claim 1, wherein

at least two of said conductors are disposed on a sterile drape surface within said drape container.

3. The system of claim 2, wherein said status device is coupled to at least one of said conductors.

4. The system of claim 1, wherein said status device includes a fuse.

5. The system of claim 2, wherein said sensing device includes a strip with said plurality of conductors disposed thereon and a connector to couple said sensing device to said detection unit.

6. The system of claim 5, wherein said connector includes said status device and at least a portion of said plurality of conductors.

7. The system of claim 5, wherein said strip includes a temperature sensor coupled to at least one of said conductors to measure temperature of said sterile medium.

8. The system of claim 5, wherein said sensing device detects a change in a sterile medium amount within said drape container and further includes at least one of a weight sensor to measure a change in weight of said basin indicating said change in said sterile medium amount, an optical sensor to detect an implement within said basin altering said sterile medium amount, a proximity sensor to detect said implement within said basin altering said sterile medium amount, a Hall effect sensor to detect said implement within said basin altering said sterile medium amount and an RFID reader to detect an RFID label disposed on said implement to detect said implement within said basin altering said sterile medium amount.

9. The system of claim 1, wherein said sensing device includes a connector with a processor to provide signals to said detection unit to indicate at least one of said state and said drape container conditions.

10. The system of claim 6 further including:

a receptacle to receive said connector and couple said sensing device to said detection unit.

11. The system of claim 10, wherein said receptacle includes at least one contact to engage a corresponding conductor of said connector.

12. The system of claim 11, wherein each contact includes a plurality of arms separated to receive and engage a corresponding conductor therebetween.

13. The system of claim 1, wherein a first state of said status device enables an electrical path and indicates a sterile drape, and a second state of said status device disables said electrical path and indicates prior use of that drape, and said detection unit includes:

a status module to provide a status signal on said electrical path and detect characteristics of said electrical path to determine said state of said status device and ascertain said sterility of said drape.

14. The system of claim 13, wherein said status module determines a random time interval and provides said status signal and determines said status device state in response to expiration of that time interval.

15. The system of claim 13, wherein said detection unit further includes:

an element module to disable said electrical path by controlling said status device to enter said second state to indicate use of said drape in response to detection of characteristics indicating an enabled electrical path.

16. The system of claim 15, wherein said detection unit further includes:

a verification module to provide said status signal on said electrical path to said status device and verify placement of the status device in said second state, wherein detection of said status device in said second state indicates a sterile drape and detection of said status device in said first state indicates a used drape utilizing a conductive member with said status device in said second state.

17. The system of claim 1 further including a plurality of indicators to indicate drape container conditions, wherein said indicators are actuable in response to control signals generated by said detection unit in accordance with said determined occurrence of said drape container conditions.

18. The system of claim 1, wherein said drape container conditions further include at least one of a leak and the presence of said sterile medium within said drape container and said detection unit disables said thermal treatment unit in response to determining at least one of the presence of a leak, the absence of said sterile medium within said drape container and said status indicating a non-sterile drape.

19. The system of claim 1, wherein said drape container conditions further include at least one of a leak and the presence of said sterile medium within said drape container and said detection unit enables said thermal treatment unit in response to determining the presence of said sterile medium and absence of a leak within said drape container.

20. The system of claim 1, wherein said thermal treatment unit is operative to do at least one of heat and cool said sterile medium in said drape container.

21. The system of claim 1, wherein said drape includes a pre-formed container portion to form said drape container within said basin.

22. The system of claim 1 further including a processor to collect information relating to a surgical procedure and to generate a report including said collected information.

23. The system of claim 22 further including:

at least one of a bar code scanner and an RFID reader to provide information to said processor.

24. The system of claim 22 further including a printer to print a hardcopy of said report.

25. The system of claim 24, wherein said printer is enabled after system power down for a predetermined time interval.

26. The system of claim 22 further including a communications module to establish communications and transfer information with another device, wherein said processor generates said report in electronic form and said communications module transmits said report to said other device.

27. The system of claim 1, wherein said drape is formed of an electrically conductive material.

28. The system of claim 1, wherein said drape is formed of an electrically non-conductive material.

29. The system of claim 2, wherein said detection unit includes at least one circuit path coupled to said at least two conductors to receive signals from said sensing device to determine said drape container conditions, and wherein said detection unit provides power signals to at least one conductor in an oscillating fashion to prevent said sterile medium from attaining a charge.

30. The system of claim 2, wherein said drape includes a pouch to house said at least two conductors.

31. The system of claim 30, wherein said pouch is attached to said drape via intermittent seams.

32. The system of claim 8, wherein said strip includes at least one of said optical sensor, said proximity sensor and said Hall effect sensor each coupled to at least one of said conductors.

33. A device for detecting conditions within a basin of a thermal treatment system during surgical procedures and facilitating control of thermal treatment of said basin and sterile medium contained therein in response to said detected conditions, said device comprising:

a surgical drape to cover and substantially conform to said basin to serve as a drape container for said sterile medium; and

a sensing device to detect drape container conditions including sterility of said drape, wherein said sensing device includes a status device and a plurality of conductors responsive to contact with said sterile medium to indicate conditions of said drape container, and wherein said status device includes a plurality of states with the state of said status device indicating said sterility of said drape.

34. The device of claim 33, wherein at least two conductors are disposed on a sterile drape surface within said drape container.

35. The device of claim 34, wherein said status device is coupled to at least one of said conductors.

36. The device of claim 33, wherein said status device includes a fuse.

37. The device of claim 33, wherein said sensing device includes a strip with said plurality of conductors disposed thereon and a connector to couple said sensing device to said thermal treatment system.

38. The device of claim 37, wherein said connector includes said status device and at least a portion of said plurality of conductors.

39. The device of claim 37, wherein said strip includes a temperature sensor coupled to at least one of said conductors to measure temperature of said sterile medium.

40. The device of claim 37, wherein said sensing device detects a change in a sterile medium amount within said drape container and said strip includes at least one of an optical sensor to detect an implement within said basin altering said sterile medium amount, a proximity sensor to detect said implement within said basin altering said sterile medium amount, and a Hall effect sensor to detect said implement within said basin altering said sterile medium amount, each coupled to at least one of said conductors.

41. The device of claim 33, wherein said sensing device includes a connector with a processor to provide signals to said thermal treatment system to indicate at least one of said state and said drape container conditions.

42. The device of claim 33, wherein said drape includes a pre-formed container portion to form said drape container within said basin.

43. The device of claim 33, wherein said sensing device detects drape container conditions further including at least one of the presence of said sterile medium in said drape container and a leak within said drape container.

44. The device of claim 33, wherein said drape is formed of an electrically conductive material.

45. The device of claim 33, wherein said drape is formed of an electrically non-conductive material.

46. The device of claim 34, wherein said drape includes a pouch to house said at least two conductors.

47. The device of claim 46, wherein said pouch is attached to said drape via intermittent seams.

48. A system for detecting conditions within containers formed by surgical drapes during surgical procedures and controlling thermal treatment of said containers in response to said detected conditions, said system comprising:

a thermal treatment unit to thermally treat a sterile medium and including a basin;

a surgical drape, covering and substantially conforming to said basin, to serve as a drape container for said sterile medium;

a sensing device including a plurality of conductors with at least two of said conductors disposed on a sterile drape surface within said drape container and responsive to contact with said sterile medium to indicate conditions of said drape container;

a controller to operate said thermal treatment unit to control a temperature of said basin; and

a detection unit to determine occurrence of said drape container conditions from signals from said sensing device to control said controller to operate said thermal treatment unit in accordance with said determined drape container conditions, wherein said detection unit includes at least one circuit path coupled to said at least two conductors to receive signals from said sensing device to determine said drape container conditions, and wherein said detection unit provides power signals to at least one conductor in an oscillating fashion to prevent said sterile medium from attaining a charge.

49. A device for detecting conditions within a basin of a thermal treatment system during surgical procedures and facilitating control of thermal treatment of said basin and sterile medium contained therein in response to said detected conditions, said device comprising:

a surgical drape to cover and substantially conform to said basin to serve as a drape container for said sterile medium; and

a sensing device including a plurality of conductors with at least two of said conductors disposed on a sterile drape surface within said drape container and responsive to contact with said sterile medium to indicate conditions of said drape container, wherein said drape includes a pouch to house said at least two conductors.

50. The device of claim 49, wherein said pouch is attached to said drape via intermittent seams.

51. A method of detecting conditions during surgical procedures within a container formed within a thermal treatment system basin by a surgical drape to contain sterile medium and controlling thermal treatment of said drape container in response to said detected conditions, said method comprising:

(a) receiving said surgical drape over said thermal treatment system to cover and substantially conform to said basin to serve as a drape container for said sterile medium, wherein said drape includes a sensing device to detect drape container conditions including sterility of said drape, wherein said sensing device includes a status device and a plurality of conductors responsive to contact with said sterile medium to indicate conditions of said drape container, and wherein said status device includes a plurality of states with the state of said status device indicating said sterility of said drape;

(b) determining occurrence of said drape container conditions from signals from said sensing device and controlling said thermal treatment system to thermally treat said basin in accordance with said determined drape container conditions.

52. The method of claim 51, wherein at least two conductors are disposed on a sterile drape surface and step (b) further includes:

(b.1) determining occurrence of drape container conditions from signals from said plurality of conductors.

53. The method of claim 52, wherein said status device is coupled to at least one of said conductors, and step (b) further includes:

(b.2) determining occurrence of said drape container conditions based on the state of said status device indicating sterility of said drape.

54. The method of claim 51, wherein said status device includes a fuse.

55. The method of claim 52, wherein said sensing device includes a strip with said plurality of conductors disposed thereon and a connector, and step (a) further includes:

(a.1) coupling said drape to said thermal treatment system via said connector.

56. The method of claim 55, wherein said connector includes said status device and at least a portion of said plurality of conductors.

57. The method of claim 55, wherein said strip includes a temperature sensor coupled to at least one of said conductors, and step (b.1) further includes:

(b.1.1) measuring temperature of said sterile medium.

58. The method of claim 51, wherein step (b) further includes:

(b.1) detecting a change in a sterile medium amount within said drape container, wherein said sensing device includes at least one of a weight sensor to measure a change in weight of said basin indicating said change in said sterile medium amount, an optical sensor to detect an implement within said basin altering said sterile medium amount, a proximity sensor to detect said implement within said basin altering said sterile medium amount, a Hall effect sensor to detect said implement within said basin altering said sterile medium amount and an RFID reader to detect an RFID label disposed on said implement to detect said implement within said basin altering said sterile medium amount.

59. The method of claim 51, wherein said sensing device includes a connector with a processor, and step (b) further includes:

(b.1) providing signals from said processor to said thermal treatment system to indicate at least one of said status and said drape container conditions.

60. The method of claim 56, wherein said thermal treatment system includes a receptacle and step (a.1) further includes:

(a.1.1) receiving said connector in said receptacle to couple said drape to said thermal treatment system.

61. The method of claim 51, wherein a first state of said status device enables an electrical path and indicates a sterile drape, and a second state of said status device disables said electrical path and indicates prior use of that drape, and step (b) further includes:

(b.1) providing a status signal on said electrical path and detecting characteristics of said electrical path to determine said state of said status device and ascertain said sterility of said drape.

62. The method of claim 61, wherein step (b.1) further includes:

(b.1.1) determining a random time interval and providing said status signal and determining said status device state in response to expiration of that time interval.

63. The method of claim 61, wherein step (b) further includes:

(b.2) disabling said electrical path by controlling said status device to enter said second state to indicate use of said drape in response to detection of characteristics indicating an enabled electrical path.

64. The method of claim 63, wherein step (b) further includes:

(b.3) providing said status signal on said electrical path to said status device and verifying placement of the status device in said second state, wherein detection of said status device in said second state indicates a sterile drape and detection of said status device in said first state indicates a used drape utilizing a conductive member with said status device in said second state.

65. The method of claim 51, wherein step (b) further includes:

(b.1) actuating at least one of a visual and an audio indicator to indicate said determined occurrence of said drape container conditions.

66. The method of claim 51, wherein said drape container conditions further include at least one of a leak and the presence of said sterile medium within said drape container, and step (b) further includes:

(b.1) disabling said thermal treatment system in response to determining at least one of the presence of a leak, absence of said sterile medium within said drape container and said status indicating a non-sterile drape.

67. The method of claim 51 further including:

(c) collecting information relating to a surgical procedure and generating a report including said collected information.

68. The method of claim 67, wherein step (c) further includes:

(c.1) providing information for said report via at least one of a bar code scanner and an RFID reader.

69. The method of claim 67 further including:

(d) printing a hardcopy of said report.

70. The method of claim 69, wherein step (d) further includes:

(d.1) enabling printing of said report after system power down for a predetermined interval.

71. The method of claim 67 further including:

(d) establishing communications and transferring information with another device.

72. The method of claim 71, wherein step (d) further includes:

(d.1) generating said report in electronic form and transmitting said report to said other devise.

73. The method of claim 51, wherein said drape container conditions further include at least one of a leak and the presence of said sterile medium within said drape container, and step (b) further includes:

(b.1) enabling said thermal treatment system in response to determining the presence of said sterile medium and absence of a leak within said drape container.

74. The method of claim 52, wherein at least one circuit path is coupled to said at least two conductors to receive signals from said sensing device to determine said drape container conditions, and step (b.1) further includes:

(b.1.1) providing power signals to at least one conductor in an oscillating fashion to prevent said sterile medium from attaining a charge.

75. The method of claim 52, wherein said drape includes a pouch to house said at least two conductors.

76. The method of claim 75, wherein said pouch is attached to said drape via intermittent seams.