Device for repeated registration of the number of thermal cycles to which a part for medical usage has been subjected

• US 6,295,330 B1
• Filed: 08/03/1999
• Issued: 09/25/2001
• Est. Priority Date: 08/05/1998
• Status: Expired due to Term

• Current Assignee: Maquet Critical Care AB (Getinge AB)
• Original Assignee: Siemens-Elema AB (Siemens AG)
• Inventors: Slettenmark, Bruno, Skog, Göran, Krahbichler, Erik
• Primary Examiner(s): RUBIN, MARGARET R
• Application Number:
  US09/365,899
• Time in Patent Office: 784 Days
• Field of Search: 377/16, 377/15
• US Class Current: 377/15
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• 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

A device for repeated registration of the number of thermal cycles to which a part for medical usage has been subjected has a temperature-sensitive element and/or a pressure-sensitive element arranged in conjunction with the part. This element reversibly changes its physical shape with temperature and/or pressure, variations in pressure being invariably associated with changes in temperature. A registration unit registers this change in shape when it exceeds a specific threshold value, as an indication of the part undergoing, or having undergone, a thermal cycle.

Claims

1. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive elements and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature changes;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value;

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle; and

a resetting unit in mechanical communication with said indicator element for automatically resetting said indicator element to said first indication position upon an occurrence of a predetermined condition.

2. A device as claimed in claim 1 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

3. A device as claimed in claim 1 wherein said part for medical use is a component of a ventilator, and wherein said ventilator comprises an expiration line cassette containing said part, and an expiratory valve in communication with said expiration line cassette, and wherein said resetting unit comprises a resetting unit which resets said indicator element to said first indication position upon a first opening of said expiratory valve.

4. A device as claimed in claim 1 wherein said temperature-responsive element is comprised of memory metal.

5. A device as claimed in claim 1 wherein said temperature-responsive element is a bimetallic element.

6. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive elements and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature changes;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value; and

, said indicator element performing an accumulating one-way movement in a single direction in a plurality of successive thermal cycles, with said second indication position in a succeeding thermal cycle corresponding to the first indication position in a thermal cycle preceding said succeeding thermal cycle; and

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle.

7. A device as claimed in claim 6 wherein said registration unit comprises a tube, and wherein said temperature-responsive element and said indicator element are coupled together to form a moving body disposed inside said tube, said moving body moving incrementally in said single direction inside said tube during respective thermal cycles in said successive thermal cycles.

8. A device as claimed in claim 7 wherein said tube has an interior surface with a plurality of notches respectively spaced from each other at predetermined distances along a length of said tube, and wherein said moving body comprises a set of radially-projecting flanges which engage said notches to form a ratchet pawl allowing said moving body to incrementally move only if a change in a length of said moving body during a thermal cycle exceeds said distance between two successive notches in said plurality of notches.

9. A device as claimed in claim 8 wherein said moving body comprises a threaded rod disposed inside said tube and two threaded wheels threadably engaging said threaded rod, each of said wheels carrying said flanges thereon, said wheels being spaced apart from each other on said rod and said threaded wheels rotating in only one direction on said threaded rod and advancing along said threaded rod in said increments each time a thermal cycle exceeds said threshold.

10. A device as claimed in claim 7 wherein said moving body comprises a hermetically sealed, gas-filled bellows which is elongated in said direction by expansion of the gas when temperature increases.

11. A device as claimed in claim 7 wherein said thermal cycle includes autoclaving said part under positive pressure, and wherein said moving body comprises a hermetically sealed bellows which is compressed by said positive pressure, and which subsequently elongates in said direction after autoclaving, causing incremental movement of said bellows in said direction.

12. A device as claimed in claim 6 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

13. A device as claimed in claim 6 wherein said temperature-responsive element is comprised of memory metal.

14. A device as claimed in claim 6 wherein said temperature-responsive element is a bimetallic element.

15. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature changes;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value;

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle; and

said registration unit comprising a rod and said indicator element comprising two disks, each having a hole therein, disposed spaced from each other on said rod with said rod extending through said holes and allowing said disks to slide along said rod, and said temperature-responsive element mechanically interconnecting said disks and normally pressing said disks against said rod in a locked position and causing said disks to advance in a single direction along said rod by elongation of said temperature-responsive element when said threshold value is exceeded.

16. A device as claimed in claim 15 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

17. A device as claimed in claim 15 wherein said temperature-responsive element is comprised of memory metal.

18. A device as claimed in claim 15 wherein said temperature-responsive element is a bimetallic element.

19. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive elements and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature changes;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value;

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle; and

said registration unit including a tube and said indicator element and said temperature-responsive element being coupled together to form a moving body which incrementally moves in said tube with an incremental movement caused by each thermal cycle, and said registration unit comprising an electrical circuit, having a variable electrical parameter, which changes dependent on said incremental movement of said moving body, said electrical parameter being selected from the group of electrical parameters consisting of resistance, inductance and capacitance.

20. A device as claimed in claim 19 wherein said parameter comprises resistance, and wherein said electrical circuit comprises two longitudinal conductive pathways disposed in an interior of said tube, said pathways being short-circuited by said moving body.

21. A device as claimed in claim 19 wherein said electrical parameter comprises inductance and wherein said electrical circuit includes a coil wound around at least a portion of said tube, and wherein said moving body comprises an appliance attached thereto consisting of an axially-oriented rod composed of magnetic material which is successively inserted into said coil as said moving body incrementally moves, said rod causing an incremental increase in said inductance as a result of each thermal cycle.

22. A device as claimed in claim 19 wherein said electrical parameter comprises inductance and wherein said electrical circuit includes a coil wound around at least a portion of said tube, and wherein said moving body comprises an appliance attached thereto consisting of an axially-oriented rod composed of non-magnetic material which is successively inserted into said coil as said moving body incrementally moves, said rod causing an incremental decrease in said inductance as a result of each thermal cycle.

23. A device as claimed in claim 19 wherein said electrical component comprises a coil wound around at least a part of said tube with coil turns that increase linearly per unit length from a first end of said coil to a second end of said coil, and wherein said moving body comprises an appliance consisting of unmagnetized, ferromagnetic material which is inserted an incremental distance into said coil as said moving body incrementally moves for each thermal cycle.

24. A device as claimed in claim 19 wherein said electrical parameter comprises capacitance, and wherein said electrical circuit comprises a conductive coating covering at least a portion of an interior and an exterior of said tube with a degree of surface-area coverage varying from a first end of said tube to a second end of said tube, and wherein said incremental movement of said moving body causes incremental capacitance changes between said coating and said moving body as said moving body incrementally moves in said tube during a thermal cycle.

25. A device as claimed in claim 19 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

26. A device as claimed in claim 19 wherein said temperature-responsive element is comprised of memory metal.

27. A device as claimed in claim 19 wherein said temperature-responsive element is a bimetallic element.

28. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive elements and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature changes;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value;

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle; and

said temperature-responsive element and said indicator element being coupled together to form a moving body, and said registration unit comprising a tube in which said moving body is disposed, said moving body having a tapering appliance attached thereto which moves along a length of said tube together with said moving body, and said registration unit further comprising a light transmitter which transmits light through said tube in a direction substantially perpendicular to said length and a light receiver which receives said light, said appliance increasingly blocking light between said transmitter and said receiver as said moving body incrementally moves in said tube during a thermal cycle.

29. A device as claimed in claim 28 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

30. A device as claimed in claim 28 wherein said temperature-responsive element is comprised of memory metal.

31. A device as claimed in claim 28 wherein said temperature-responsive element is a bimetallic element.

32. A device for repeated registration of a number of thermal cycles to which a part for medical usage is subjected, comprising:

at least one temperature-responsive element selected from the group of elements consisting of temperature-sensitive elements and pressure-sensitive elements associated with a part for which a number of thermal cycles to which said part has been subjected is to be identified;

said temperature-responsive element having a physical shape which reversibly changes dependent on at least one of temperature and pressure, with variations in pressure always occurring with temperature chances;

an indicator element which is normally disposed in a first indication position and which is disposed to interact with said at least one temperature-responsive element so as to move to a second indication position when the change in physical shape of said temperature-responsive element exceeds a predetermined threshold value, said indicator element comprising two wheels, each having an opening therein, and a rod extending through the respective openings in said two wheels, said wheels rotating in only one direction around said rod and being interconnected to each other by said temperature-responsive element, said wheels incrementally rotating in steps of a predetermined angle in said direction during each thermal cycle; and

a registration unit communicating with said indicator element to register movement of said indicator element from said first indication position to said second indication position as an identification of said part undergoing a thermal cycle.

33. A device as claimed in claim 32 wherein said registration unit comprises a memory for accumulatively storing a total number of movements of said indicator element from said first indication position to said second indication position.

34. A device as claimed in claim 32 wherein said temperature-responsive element is comprised of memory metal.

35. A device as claimed in claim 32 wherein said temperature-responsive element is a bimetallic element.