Devices and methods for passive patient monitoring

• US 7,666,151 B2
• Filed: 11/20/2002
• Issued: 02/23/2010
• Est. Priority Date: 11/20/2002
• Status: Expired due to Fees

• Current Assignee: Hoana Medical, Inc.
• Original Assignee: Hoana Medical, Inc.
• Inventors: Sullivan, Christopher J., Pernambuco-Wise, Paul, Christensen, Scott, Rosenman, Mike, Sullivan, Patrick K., Cheung, Ken C. K.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US10/301,524
• Publication Number:
  US 20040111045A1
• Time in Patent Office: 2,652 Days
• Field of Search: 600/484, 600/534, 600/587, 600/595, 340/573.1
• US Class Current: 600/587
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/225 Connectors or couplings
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1126 using a particular sensing technique
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/6887 mounted on external non-worn devices, e.g. non-medical devices
• CPC Class Codes: A61B 5/6891 Furniture
• CPC Class Codes: A61B 5/6892 Mats

Abstract

Devices, systems and methods provide passive patient monitoring of such parameters as body motion, body position, respiratory rate and/or heart rate. Passive monitoring generally involves a sensor device having at least two piezoelectric sensors, provided on a surface, such as a bed, chair, operating table or the like, so that a patient may be coupled with the device by simply allowing the patient to lie, sit, lean, stand on or wear the surface. In one embodiment, multiple patients in a general care area of a hospital may be continuously monitored via multiple passive monitoring devices. If a patient fails to meet one or more predefined threshold criteria or has a negative physiological trend, the system may activate an alarm.

Claims

1. A system for passively monitoring multiple patients, the system comprising:

a plurality of sensor devices, each sensor device comprising;

a surface for coupling with a patient; and

at least two piezoelectric sensors coupled with the surface for sensing at least one mechanical signal from the patient, each of the sensors comprising a piezoelectric film;

a plurality of processors, each processor coupled with one sensor device and being operative for converting the at least one mechanical signal into at least one digital signal and for analyzing the digital signals corresponding to each of the at least two piezoelectric sensors to select the sensors with the highest quality heart rate and respiration rate signals to use for deriving heart rate and respiration rate data pertaining to the patient; and

at least one connector coupled with each processor for connecting each processor with a common alarm system for providing an alarm based on heart rate and/or respiration rate criteria for each of the multiple patients to a user at a remote location.

2. A system as in claim 1, wherein each surface comprises a flat pad.

3. A system as in claim 2, wherein the flat pad comprises at least one layer of a resilient foam material.

4. A system as in claim 1, wherein the piezoelectric sensors are disposed along each surface in a pattern to facilitate monitoring of at least one of patient body position, patient movement, patient respiratory rate and patient heart rate.

5. A system as in claim 4, wherein the pattern comprises two or more adjacent, flat piezoelectric sensors.

6. A system as in claim 5, wherein the pattern comprises a grid pattern comprising at least two adjacent rows and at least two columns of piezoelectric sensors.

7. A system as in claim 1, wherein dimensions of each surface allow the surface to be positioned on at least one of a crib and a bed for monitoring an infant.

8. A system as in claim 1, wherein dimensions of each surface allow the surface to be positioned on a bed for monitoring a patient in a hospital, long-term care facility or nursing home.

9. A system as in claim 1, wherein dimensions of each surface allow the surface to be positioned on a chair for monitoring a patient undergoing a procedure under conscious sedation.

10. A system as in claim 1, wherein each sensor device further includes a sheath for containing at least a portion of the surface to provide a protective layer between the surface and the patient.

11. A system as in claim 10, wherein the sheath is water resistant.

12. A system as in claim 10, wherein the sheath is removable from the sensor device after being used to monitor one patient.

13. A system as in claim 1, wherein the piezoelectric sensors are selected from the group consisting of polyvinylidene fluoride film, polyvinylidene fluoride cable, piezoelectric ceramic discs and piezoelectric foam.

14. A system as in claim 1, wherein each surface is provided on a flat surface of a bed, and wherein the at least one mechanical signal of the patient may be monitored when the patient lies on the surface.

15. A system as in claim 1, wherein the at least one mechanical signal comprises at least one of a stress signal, a thermal signal and an acoustic signal.

16. A system as in claim 1, wherein each of the sensor devices is coupled with one of the processors via a wireless connection.

17. A system as in claim 1, wherein the at least one connector connects each of the processors to at least one of a common display device, at least one digital pager, at least one handheld wireless device, an Ethernet connection, an Internet connection and an intranet connection.

18. A system as in claim 1, wherein each of the sensor devices is coupled with one of the processors via a second connector comprising means for detecting at least one of a type of sensor device coupled with the processor and a number of times the sensor device has been used.

19. A system as in claim 18, wherein the second connector further comprises means for activating the sensor device.

20. A system for passively monitoring multiple patients, the system comprising:

a plurality of sensor devices, each sensor device comprising;

a surface for coupling with the patient; and

at least two piezoelectric sensors coupled with the surface for sensing at least one mechanical signal from a patient;

a plurality of processors, each processor coupled with one sensor device for converting the at least one mechanical signal into at least one digital signal and for comparing digital signals corresponding to each of the at least two piezoelectric sensors to provide data pertaining to the patient; and

at least one connector coupled with each processor for connecting each processor with a common apparatus for providing the patient data for the multiple patients to a user;

wherein each sensor device further includes a sheath for containing at least a portion of the surface to provide a protective layer between the surface and the patient, the sheath including at least one sheath-surface connector mounted on the sheath for providing a detachable connection between the sheath and the surface, and wherein the surface must be connected with the sheath via the sheath-surface connector in order to monitor the at least one mechanical signal of the patient.

21. Apparatus for passively monitoring multiple patients, comprising:

a plurality of sensor devices, each sensor device being disposed on a patient support and having a surface for coupling with a patient on the support for sensing at least one mechanical signal from the patient;

a plurality of processors, each processor coupled with one sensor device and being operative for converting the at least one mechanical signal into at least one digital signal and for analyzing the digital signal to extract vital signs and position data pertaining to the patient;

a plurality of displays, each display coupled with one processor and being housed with the processor in a common unit adjacent the support for displaying the vital signs data;

at least one connector coupled with each processor for connecting each processor with a common alarm system for providing an alarm for each of the multiple patients at a location remote from the patient;

wherein the processors are configured to provide an alarm activation signal for activating an alarm based on vital signs or position criteria pertaining to the particular patient.

22. Apparatus as in claim 21, wherein each sensor device is disposed on a different bed for coupling with a patient lying on the bed.

23. Apparatus as in claim 21, wherein each sensor device is disposed on a different chair for coupling with a patient sitting in the chair.

24. Apparatus as in claim 21, wherein each sensor device is configured to couple with the patient through at least one layer of clothing, bedding or other material.

25. Apparatus as in claim 21, wherein each sensor device is configured to couple with a patient in a general care area of a hospital, in a long-term care facility, or in a nursing home.

26. Apparatus as in claim 21, wherein each sensor device is configured to couple with a patient undergoing a surgical procedure under conscious sedation.

27. Apparatus as in claim 21, wherein each sensor device includes a plurality of sensors disposed in an array.

28. Apparatus as in claim 21, wherein each sensor device has at least two piezoelectric sensors.

29. Apparatus as in claim 28, wherein each of said sensors comprises a polarized polymer film with piezoelectric properties.

30. Apparatus as in claim 28, wherein the piezoelectric sensors are selected from the group consisting of polyvinylidene fluoride film, polyvinylidene cable, piezoelectric ceramic disks and piezoelectric foam.

31. Apparatus as in claim 21, wherein each sensor device has at least two piezoelectric sensors for sensing a first mechanical signal from the patient with the first piezoelectric sensor and a second mechanical signal from the patient with the second piezoelectric sensor.

32. Apparatus as in claim 31, wherein each processor is coupled with the piezoelectric sensors in a respective one of the sensor devices, and is configured for converting the first and second mechanical signals into first and second digital signals and for comparing the first and second digital signals to extract the patient vital signs data based on the comparison of the digital signals.

33. Apparatus as in claim 31, wherein each of the piezoelectric sensors comprises a thin rectangular strip of polarized polymer film with piezoelectric properties, the strips being arranged on the surface in a pattern that runs laterally across the surface.

34. Apparatus as in claim 32, wherein each processor extracts vital signs data in the form of heart rate based on the comparison of the digital signals.

35. Apparatus as in claim 32, wherein each processor extracts vital signs data in the form of respiration rate based on the comparison of the digital signals.

36. Apparatus as in claim 32, wherein each processor extracts vital signs data in the form of heart rate and respiration rate based on the comparison of the digital signals.

37. Apparatus as in claim 32, wherein each processor is further operative to extract information about patient movement based on the comparison of the digital signals, and to provide an alarm activation signal for activating said alarm if the digital signals suggest that the patient is not moving on the surface, the patient is not in contact with the surface, or the patient is moving excessively on the surface.

38. Apparatus as in claim 21, wherein the at least one mechanical signal comprises at least one of a stress signal, a thermal signal, and an acoustic signal.

39. Apparatus as in claim 21, wherein each display is configured to display said vital signs data in numerical form.

40. Apparatus as in claim 21, wherein each display is configured to display said vital signs data in graphical form.

41. Apparatus as in claim 21, wherein each sensor device is disposed on a different bed for coupling with a patient lying in the bed, and the display associated with the sensor device is placed in a bedside location.

42. Apparatus as in claim 21, wherein the at least one connector comprises a wireless transmitter.

43. Apparatus as in claim 21, wherein each processor activates the alarm associated with a particular patient if a respiration rate of the patient falls below a pre-defined minimum respiration rate or rises above a pre-defined maximum respiration rate.

44. Apparatus as in claim 21, wherein each processor activates the alarm associated with a particular patient if a heart rate of the patient falls below a pre-defined minimum heart rate or rises above a pre-defined maximum heart rate.

45. Apparatus as in claim 21, wherein each processor is further operative to compare the at least one digital signal to at least one earlier digital signal for recognizing a trend in the vital signs data based on the comparison of the digital signal to the earlier digital signal, and to provide an alarm activation signal when the trend in the vital signs data matches a pre-defined negative trend.

46. Apparatus as in claim 45, wherein each processor is operative to compare at least one heart beat signal to at least one earlier heart beat signal and at least one respiration signal to at least one earlier respiration signal and to provide an alarm activation signal when the negative trend comprises a combination of a negative heart beat trend and a negative respiration trend.

47. Apparatus as in claim 21, wherein each processor provides an alarm activation signal if a combination of at least two vital signs parameters do not meet pre-defined thresholds associated with those parameters.

48. Apparatus as in claim 21, wherein the at least one connector is configured for coupling the processor with a pre-existing alarm system in a hospital, long-term care facility or nursing home.

49. Apparatus as in claim 21, wherein the at least one connector is configured for coupling the processor with a nurse call system in a hospital.

50. Apparatus as in claim 49, wherein the nurse call system is configured to activate an alarm located outside a room in which the particular patient is located.

51. Apparatus as in claim 49, wherein the nurse call system is configured to activate an alarm at a nurse call station.

52. Apparatus as in claim 21, wherein each of the multiple patients is monitored simultaneously.

53. Apparatus as in claim 21, wherein each of the processors simultaneously provides vital signs data corresponding to the multiple patients to a user at a central location.

54. Apparatus as in claim 21, wherein each of the processors is coupled with a common display device disposed at a central location for displaying vital signs data corresponding to the multiple patients.

55. Apparatus as in claim 54, wherein the central location comprises a nursing station on the general care floor of a hospital.

56. Apparatus as in claim 21, wherein each display is configured to display patient data on a monitor in the form of the patient'"'"'s heart rate and respiration rate in both numerical and graphical form, and further including multiple local alarms, each local alarm coupled with one processor and disposed adjacent one patient to provide an alarm indication whenever at least one of the digital signals does not meet at least one pre-defined threshold.

57. Apparatus as in claim 21, wherein each of the processors operates continuously around the clock.

58. A system for passively monitoring multiple patients, the system comprising:

a plurality of sensor devices, each sensor device being adapted to be disposed on a patient support and comprising at least two sensors for sensing at least one mechanical signal from the patient;

a plurality of processors, each processor coupled with one sensor device and being operative for converting the at least one mechanical signal into at least one digital signal and for analyzing the digital signals to select the sensors with the highest quality heart rate and respiration rate signals to use for deriving heart rate and respiration rate data pertaining to the patient; and

at least one connector coupled with each processor for connecting each processor with a common alarm system for providing an alarm based on heart rate and/or respiration rate criteria for each of the multiple patients to a user at a remote location.

59. A system as in claim 58, wherein each sensor device comprises a flat pad adapted to be placed on a bed under one or more layers of bedding.

60. A system as in claim 59, wherein the flat pad comprises at least one layer of a resilient foam material.

61. A system as in claim 58, wherein each of the sensors comprises a piezoelectric sensor.

62. A system as in claim 58, wherein each sensor device further includes a removable sheath for containing at least a portion of the sensor device to provide a protective layer between the sensor device and the patient.

63. A system as in claim 58, wherein the at least one mechanical signal comprises at least one of a stress signal, a thermal signal and an acoustic signal.

64. A system as in claim 58, wherein each of the processors is further operative to provide data indicating the presence or absence of the patient on the patient support surface.

65. A system as in claim 58, wherein each processor is further operative to compare the at least one digital signal to at least one earlier digital signal for recognizing a trend in the heart rate or respiration rate data based on the comparison of the digital signal to the earlier digital signal, and to provide an alarm activation signal when the trend in the data matches a pre-defined negative trend.

66. A system as in claim 58, wherein each processor is further operative to extract information about patient movement, and to provide an alarm activation signal for activating said alarm if the digital signals suggest that the patient is not moving on the surface, the patient is not in contact with the surface, or the patient is moving excessively on the surface.

67. A system as in claim 58, wherein the at least one connector is configured for coupling the processor with a pre-existing alarm system in a hospital, long-term care facility or nursing home.

68. A system as in claim 58, wherein each of the processors is coupled with a common display device disposed at a central location for displaying the heart rate and respiration rate data corresponding to the multiple patients, the central location comprising a nursing station on the general care floor of a hospital.

69. A system as in claim 58, further comprising a plurality of displays, each display being coupled with an individual one of the processors and being located adjacent a patient, wherein each display is configured to display patient data on a monitor in the form of the patient'"'"'s heart rate and respiration rate in both numerical and graphical form.

70. A system for passively monitoring multiple patients, the system comprising:

a plurality of sensor devices, each sensor device being adapted to be disposed on a patient support and comprising at least two sensors for sensing at least one mechanical signal from the patient;

a plurality of processors, each processor coupled with one sensor device and being operative for converting the at least one mechanical signal into at least one digital signal and for comparing digital signals corresponding to each of the at least two sensors to each other to derive data pertaining to the patient in the form of heart rate and respiration rate; and

at least one connector coupled with each processor for connecting each processor with a common alarm system for providing an alarm based on heart rate and/or respiration rate criteria for each of the multiple patients to a user at a remote location.

71. A system as in claim 70, wherein each sensor device comprises a flat pad adapted to be placed on a bed under one or more layers of bedding.

72. A system as in claim 71, wherein the flat pad comprises at least one layer of a resilient foam material.

73. A system as in claim 70, wherein each of the sensors comprises a piezoelectric sensor.

74. A system as in claim 70, wherein each sensor device further includes a removable sheath for containing at least a portion of the sensor device to provide a protective layer between the sensor device and the patient.

75. A system as in claim 70, wherein the at least one mechanical signal comprises at least one of a stress signal, a thermal signal and an acoustic signal.

76. A system as in claim 70, wherein the sensor device has at least two sensors for sensing a first mechanical signal with the first sensor and a second mechanical signal with the second sensor;

and

wherein each of the processors is operative to compare the digital signals by comparing presence or absence of the first signal with presence or absence of the second signal.

77. A system as in claim 70, wherein each of the processors is further operative to provide data indicating the presence or absence of the patient on the patient support surface.

78. A system as in claim 70, wherein each processor is further operative to compare the at least one digital signal to at least one earlier digital signal for recognizing a trend in the heart rate and respiration rate data based on the comparison of the digital signal to the earlier digital signal, and to provide an alarm activation signal when the trend in the data matches a pre-defined negative trend.

79. A system as in claim 70, wherein each processor is further operative to extract information about patient movement based on the comparison of the digital signals, and to provide an alarm activation signal for activating said alarm if the digital signals suggest that the patient is not moving on the surface, the patient is not in contact with the surface, or the patient is moving excessively on the surface.

80. A system as in claim 70, wherein the at least one connector is configured for coupling the processor with a pre-existing alarm system in a hospital, long-term care facility or nursing home.

81. A system as in claim 70, wherein each of the processors is coupled with a common display device disposed at a central location for displaying heart rate and respiration rate data corresponding to the multiple patients, the central location comprises a nursing station on the general care floor of a hospital.

82. A system as in claim 70, further comprising a plurality of displays, each display being coupled with an individual one of the processors and being located adjacent a patient, wherein each display is configured to display patient data on a monitor in the form of the patient'"'"'s heart rate and respiration rate in both numerical and graphical form.