Method and apparatus for tracking usage of a respiratory measurement device

• US 6,824,520 B2
• Filed: 09/20/2002
• Issued: 11/30/2004
• Est. Priority Date: 09/21/2001
• Status: Expired due to Fees

• Current Assignee: KOKO It LLC
• Original Assignee: Pulmonary Data Services Incorporated
• Inventors: Orr, Joseph, Kofoed, Scott Allen
• Primary Examiner(s): Nasser, Robert L
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/251,286
• Publication Number:
  US 20030116159A1
• Time in Patent Office: 802 Days
• Field of Search: 600/529, 600/531, 600/532, 600/533, 600/538, 600/537, 128/204.23
• US Class Current: 600/529
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/087 Measuring breath flow

Abstract

The present invention is directed to a reusable respiratory measurement device having a discardable flow tube in which a counter is included in a detachable (discardable) memory unit that removably engages the respiratory measurement device body. The memory unit includes a counter that tracks usage of the respiratory measurement device and disables the respiratory measurement device when usage has reached certain predetermined thresholds. The memory unit is then replaced with a new memory unit which re-enables the respiratory measurement device for further measurements. The memory unit is typically sold as part of a batch or lot of disposable flow tubes in which case the counter value is commonly the same as the number of flow tubes in the batch or lot.

Claims

1. A respiratory device for measuring a pulmonary condition of a patient, comprising:

a processor in a respiratory measurement device operable to determine at least a first respiratory parameter based on at least a first measurement signal;

a monitoring unit comprising a memory operable to store calibration information to determine the at least a first respiratory parameter and a counter for tracking a number of respiratory measurements performed by the respiratory device; and

at least a first detachable component operable to receive a respiratory airflow of a user, wherein the monitoring unit is not part of the first detachable component and detachably engages the respiratory measurement device.

2. The respiratory device of claim 1, wherein the at least a first detachable component provides the at least a first measurement signal.

3. The respiratory device of claim 1, wherein the memory is operable to store a flag for determining if the at least a first detachable component has been used in taking a predetermined number of respiratory measurements.

4. The respiratory device of claim 1, wherein the processor and memory are contained in a body member, the at least a first detachable component is detachable from the body member, the at least a first detachable component is disposable, and the body member is reusable.

5. The respiratory device of claim 1, wherein the at least a first respiratory parameter is one or more of PEF, FEV1, FEV6, FEV1/FEV6, FVC, FEV1/FVC, and FEF25-75 and wherein the respiratory measurement is enabled when a current value of the counter is less than a selected number of respiratory measurements and disabled when the current value of the counter is equal to the selected number of respiratory measurements.

6. The respiratory device of claim 1, wherein the processor is contained in a body member, and wherein the monitoring unit is separate from the respiratory measurement device.

7. The respiratory device of claim 1, wherein the memory is one or more of ROM, PROM, EPROM, flash memory, non-volatile RAM, battery-backed-up RAM, EEPROM, a magnetic disk, and an optical disk and further comprising a second memory in the respiratory measurement device.

8. A monitoring device for detachable engagement with at least a portion of a respiratory measurement device, comprising:

a memory including calibration information for measurements of the respiratory device;

a counter that determines a number of measurements taken by the respiratory measurement device; and

a state indicator, wherein, when a current value of the counter is different from a selected number of measurements, the state indicator indicates that the respiratory measurement device is enabled and, when the current counter value is the same as the selected number of measurements, the state indicator indicates that the respiratory measurement device is disabled.

9. The monitoring device of claim 8, further comprising a flow tube, and a body member that removably engages the flow tube and wherein the state indicator is a usage flag.

10. The monitoring device of claim 9, wherein the flow tube is disposable and the body member is reusable.

11. The monitoring device of claim 9, wherein the measurements determine a respiratory parameter that is one or more of PEF, FEV1, FEV6, FEV1/FEV6, FVC, FEV1/FVC, and FEF25-75 and wherein the monitoring device is not part of the flow tube.

12. The monitoring device of claim 9, wherein the monitoring device is detachable from the respiratory measurement device and a processor is contained in the respiratory measurement device.

13. The monitoring device of claim 8, wherein the memory is one or more of ROM, PROM, EPROM, flash memory, non-volatile RAM, battery-backed-up RAM, EEPROM, a magnetic disk, and an optical disk and wherein the respiratory measurement device comprises memory different from the memory of the monitoring device.

14. A method for monitoring use of a respiratory measurement device, comprising:

(a) engaging a flow tube with at least a portion of the respiratory measurement device;

(b) engaging a monitoring unit with the at least a portion of the respiratory measurement device, the monitoring unit including a memory including calibration information associated with at least one of the respiratory measurement device and the flow tube and a counter for determining a number of measurements taken by the respiratory measurement device;

(c) performing a respiratory measurement with the respiratory measurement device; and

(d) at least one of decrementing and incrementing the counter in response to the performing step, wherein the monitoring unit is not part of the flow tube and detachably engages the respiratory measurement device.

15. The method of claim 14, further comprising, after step (d),

(e) removing the flow tube from the respiratory measurement device; and

(f) engaging a second flow tube with the respiratory measurement device.

16. The method of claim 15, further comprising, after step (f), repeating steps (c) and (d).

17. The method of claim 14, further comprising, after step (d),

(e) comparing the counter value with a predetermined value;

(f) when the counter value is the same as the predetermined value, disabling the respiratory measurement device; and

(g) when the counter value is different from the predetermined value, enabling the respiratory measurement device.

18. The method of claim 17, wherein the predetermined value is zero.

19. The method of claim 17, further comprising, when step (f) occurs,

(h) removing the monitoring unit from the respiratory measurement device;

(i) engaging a second monitoring unit with the respiratory measurement device; and

(j) enabling the respiratory measurement device in response to step (i).

20. The method of claim 19, wherein step (j) includes the steps of reading both a second memory and a second counter in the second monitoring unit.

21. A method for monitoring use of a respiratory measurement device, comprising:

(a) providing a monitoring unit in detachable engagement with at least a portion of the respiratory measurement device, the monitoring unit including a memory;

(b) performing a respiratory measurement with the respiratory measurement device;

(c) at least one of decrementing and incrementing a counter in response to the performing step to provide a counter value;

(d) comparing the counter value with a predetermined value;

(e) enabling the respiratory measurement device when the counter value is different from the predetermined value; and

(f) disabling the respiratory measurement device when the counter value is the same as the predetermined value.

22. The method of claim 21, wherein step (b) includes engaging at least part of a flow tube with the respiratory measurement device, and performing a respiratory measurement with the respiratory measurement device.

23. The method of claim 22, further comprising after step (c),

(d) removing the flow tube from the respiratory measurement device; and

(e) engaging a second flow tube with the respiratory measurement device.

24. The method of claim 23, further comprising after step (e), repeating steps (b) and (c).

25. The method of claim 22, wherein said memory contains information associated with the flow tube.

26. The method of claim 25, wherein the information includes calibration information for the flow tube and usage information for determining a number of measurements taken by the respiratory measurement device.

27. The method of claim 26, wherein the counter value indicates the number of measurements taken by the respiratory measurement device.

28. The method of claim 21, wherein the predetermined value is zero.

29. The method of claim 21, wherein the monitoring unit is detachable from the respiratory measurement device and further comprising, when step (f) occurs,

(g) removing the monitoring unit from the respiratory measurement device;

(h) engaging a second monitoring unit with the respiratory measurement device; and

(i) enabling the respiratory measurement device in response to step (h).

30. A monitoring device for detachable engagement with a respiratory device, comprising:

memory means including counting means for counting a number of measurements taken by the respiratory device, and state indicating means for indicating, when the memory means is engaged with the respiratory device and the number of measurements taken by the respiratory device is different from a selected number, that the respiratory device is enabled and, when the memory means is engaged with the respiratory device and the number of measurements taken by the respiratory device is equal to the selected number, that the respiratory device is disabled.

31. The monitoring device of claim 30, wherein the memory means also include calibration information associated with a measurement signal generated by sensing means for sensing a respiratory parameter.

32. The monitoring device of claim 30, further comprising:

measuring means for measuring a respiratory parameter, wherein the measuring means is at least one of a flow tube, a pneumotach, a respiratory filter and a mouthpiece and wherein the state indicating means is a usage flag.

33. The monitoring device of claim 32, further comprising:

processing means for processing a measurement signal output by the measuring means, the processing means being detachable from the measuring means.

34. The monitoring device of claim 33, wherein the memory means is detachable from the processing means.

35. The monitoring device of claim 33, wherein the respiratory parameter is at least one of PEF, FEV1, FEV6, FEV1/FEV6, FVC, FEV1/FVC, and FEF25-75 and wherein the monitoring device is not part of a flow tube engaged with the respiratory device.

36. A monitoring device for detachable engagement with a respiratory device, comprising:

memory for storing a number of measurements taken by the respiratory device; and

a processor operable, when the memory is engaged with the respiratory device and the number of measurements taken by the respiratory device is different from a selected number, to enable the respiratory device and, when the memory is engaged with the respiratory device and the number of measurements taken by the respiratory device is equal to the selected number, to disable the respiratory device.

37. The monitoring device of claim 36, wherein said memory also includes calibration information associated with a measurement signal generated by a sensor operable to sense a respiratory parameter and the respiratory device comprises memory different from the memory of the monitoring device.

38. The monitoring device of claim 36, further comprising:

a measurement unit operable to measure a respiratory parameter, wherein the measurement unit is at least one of a flow tube, a pneumotach, a respiratory filter and a mouthpiece and wherein the monitoring device is not part of the measurement unit.

39. The monitoring device of claim 37, wherein the processor is operable to process a measurement signal output by the measurement unit, the processor being detachable from the measurement unit.

40. The monitoring device of claim 39, wherein the memory is detachable from the processor.

41. The monitoring device of claim 40, wherein the respiratory parameter is at least one of PEF, FEV1, FEV6, FEV1/FEV6, FVC, FEV1/FVC, and FEF25-75 and wherein the memory comprises a counter for deriving the number of measurements.

42. A method for supplying a disposable component for a respiratory measurement device, comprising:

(a) manufacturing at least a first disposable component for a respiratory measurement device;

(b) providing first calibration information for the first disposable component;

(c) manufacturing a first enabling device, including a first memory storing at least one of the first calibration information and a first counter for counting a number of measurements performed by the respiratory measurement device; and

(d) packaging at least the first disposable component together with the corresponding first enabling device for use by a respiratory measurement device user;

(e) manufacturing at least a second disposable component;

(f) determining second calibration information for the second disposable component;

(g) manufacturing a second enabling device, including a second memory storing at least one of the second calibration information and a second counter for counting a number of measurements performed by a respiratory measurement device attached to at least the second disposable component; and

(h) packaging at least the second disposable component together with the corresponding second enabling device for use by a respiratory measurement device user, wherein the second disposable component and second enabling device are in a different package than the first disposable component and first enabling device.

43. The manufacturing method of claim 42, wherein step (a) includes manufacturing a first plurality of disposable components, and wherein step (b) includes determining first calibration information for the first plurality of disposable components.

44. The manufacturing method of claim 42, wherein step (a) includes manufacturing a first plurality of disposable components, wherein step (b) includes determining first calibration information for the first plurality of disposable components, wherein step (e) includes manufacturing a second plurality of disposable components, and wherein step (f) includes determining second calibration information for the second plurality of disposable components.

45. The manufacturing method of claim 43, wherein the disposable components are at least one of a flow tube, a pneumotach, a respiratory filter and a mouthpiece.

46. The manufacturing method of claim 42, wherein the first calibration information differs from the second calibration information.

47. The manufacturing method of claim 42, wherein the first counter has the same value as the second counter.

48. A method for monitoring use of a respiratory measurement device, comprising:

(a) engaging a flow tube with the respiratory measurement device;

(b) engaging a monitoring unit with the respiratory measurement device, the monitoring unit including a memory including calibration information associated with at least one of the respiratory measurement device and the flow tube and a counter for determining a number of measurements taken by the respiratory measurement device;

(c) performing a respiratory measurement with the respiratory measurement device; and

(d) at least one of decrementing and incrementing the counter in response to the performing step;

(e) comparing the counter value with a predetermined value;

(f) when the counter value is the same as the predetermined value, disabling the respiratory measurement device; and

(g) when the counter value is different from the predetermined value, enabling the respiratory measurement device.

50. The method of claim 48, further comprising, when step (f) occurs,

(h) removing the monitoring unit from the respiratory measurement device;

(i) engaging a second monitoring unit with the respiratory measurement device; and

(j) enabling the respiratory measurement device in response to step (i).

51. The method of claim 50, wherein step (j) includes the steps of reading both a second memory and a second counter in the second monitoring unit.

49. The method of claim 49, wherein the predetermined value is zero.

52. A method for supplying a disposable component for a respiratory measurement device, comprising:

(a) manufacturing at least a first disposable component for a respiratory measurement device;

(b) determining first calibration information for the first disposable component;

(c) manufacturing a first enabling device, including a first memory storing at least one of the first calibration information and a first counter for counting a number of measurements performed by the respiratory measurement device;

(d) packaging at least the first disposable component together with the corresponding first enabling device for use by a respiratory measurement device user;

(e) manufacturing at least a second disposable component;

(f) determining second calibration information for the second disposable component;

(g) manufacturing a second enabling device, including a second memory storing the second calibration information and a second counter for counting a number of measurements performed by a respiratory measurement device attached to at least the second disposable component; and

(h) packaging at least the second disposable component together with the corresponding second enabling device for use by a respiratory measurement device user wherein the first counter has the same value as the second counter.

53. The manufacturing method of claim 52, wherein step (a) includes manufacturing a first plurality of disposable components, and wherein step (b) includes determining first calibration information for the first plurality of disposable components.

54. The manufacturing method of claim 52, wherein the first memory stores the first calibration information and the second memory stores the second calibration information.

55. The manufacturing method of claim 52, wherein the first memory stores the first counter and the second memory stores the second counter.

56. A method for monitoring use of a respiratory measurement device, comprising:

(a) engaging a flow tube from a set of flow tubes with the respiratory measurement device;

(b) engaging a monitoring unit with a body member of the respiratory measurement device, the monitoring unit including a memory comprising usage information associated with the set of flow tubes;

(c) performing a respiratory measurement with the respiratory measurement device; and

(d) at least one of decrementing and incrementing a use counter in response to the performing step;

(e) comparing the use counter with a predetermined number of respiratory measurements;

(f) when the use counter is different from the predetermined number of respiratory measurements, enabling the respiratory measurement device; and

(g) when the use counter is the same as the predetermined number of respiratory measurements, disabling the respiratory measurement device.

57. The method of claim 56, wherein the usage information comprises the use counter.

58. The method of claim 56, wherein the usage information comprises a usage flag, the usage flag indicating in a first state that the set of flow tubes has been used the predetermined number of respiratory measurements and in a second state that the set of flow tubes has not been used the predetermined number of respiratory measurements.

59. The method of claim 56, wherein the usage information comprises a unique identifier associated with the set of flow tubes.

60. The method of claim 56, wherein the usage information comprises the number of flow tubes in the set of flow tubes.

61. The method of claim 56, wherein the monitoring unit is discrete from the set of flow tubes and the body member of the respiratory measurement device, wherein the monitoring unit detachably engages the respiratory measurement device, and wherein the body member comprises a memory different from the memory in the monitoring unit.

62. The method of claim 56, wherein the monitoring unit comprises calibration information associated with the set of flow tubes.

63. A respiratory measurement device, comprising:

(a) a detachable flow tube;

(b) a body member engaging the detachable flow tube;

(c) a processor; and

(d) a detachable monitoring unit engaging the body member, the monitoring unit including a memory comprising usage information associated with the detachable flow tube, wherein the processor is operable to (i) at least one of decrement and increment a use counter when a respiratory measurement is performed;

(ii) compare the use counter with a predetermined number of respiratory measurements;

(iii) when the use counter is different from the predetermined number of respiratory measurements, enable the respiratory measurement device; and

(iv) when the use counter is the same as the predetermined number of respiratory measurements, disable the respiratory measurement device.

64. The device of claim 63, wherein the usage information comprises the use counter.

65. The device of claim 63, wherein the usage information comprises a usage flag, the usage flag indicating in a first state that the detachable flow tube has been used the predetermined number of respiratory measurements and in a second state that the detachable flow tube has not been used the predetermined number of respiratory measurements.

66. The device of claim 63, wherein the flow tube is a member of a set of flow tubes and the usage information is a unique identifier associated with the set of flow tubes.

67. The device of claim 63, wherein the flow tube is a member of a set of flow tubes and the usage information comprises the number of flow tubes in the set of flow tubes.

68. The device of claim 63, wherein the monitoring unit is discrete from the flow tube and the body member, wherein the processor is in the body member, end wherein the body member comprises a memory different from the memory in the monitoring unit.

69. The device of claim 63, wherein the monitoring unit comprises calibration information associated with the flow tube.