Smart Bag Used in Sensing Physiological and/or Physical Parameters of Bags Containing Biological Substance

• US 20170239404A1
• Filed: 08/10/2015
• Published: 08/24/2017
• Est. Priority Date: 08/08/2014
• Status: Active Grant

• Current Assignee: FreMon Scientific, Inc.
• Original Assignee: FreMon Scientific, Inc.
• Inventors: Shavit, Menachem
• Granted Patent: US 10,576,190 B2
• Time in Patent Office: Days
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61J 2200/42 Heating means
• CPC Class Codes: A61J 2200/70 Device provided with specific sensor or indicating means
• CPC Class Codes: A61J 2200/72 for temperature
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61M 1/025 Means for agitating or shaking blood containers A61M1/0245 takes precedence; shaking in general B01F31/00
• CPC Class Codes: A61M 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/3633 thermally insulated
• CPC Class Codes: A61M 2205/3693 by mechanical waves, e.g. ultrasonic
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: B01F 2035/99 Heating
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 31/20 : Mixing the contents of independent containers, e.g. test tubes
• CPC Class Codes: B01F 31/86 : with vibration of the receptacle or part of it
• CPC Class Codes: B01F 35/92 : for heating the outside of the receptacle, e.g. heated jackets or burners
• CPC Class Codes: G01N 33/492 : Determining multiple analytes
• CPC Class Codes: H05B 1/025 : For medical applications
• CPC Class Codes: H05B 3/34 : flexible, e.g. heating nets or webs

Abstract

The present technology discloses a cost-effective, single use bag or container for storing biological substances that incorporates on its inner wall an electronic device that is configured to measure physiological and/or physical parameters of the enclosed biological substances, such as source history, identification, demographics, time stamping, temperature, pH, conductivity, glucose, O₂, CO₂ levels etc. The electronic device of the disclosed bag comprises a sensor configured to measure physiological and/or physical parameters of the biological substances enclosed within the bag, and a radio-frequency (RF) device communicably coupled to the sensor and configured to: (a) acquire from the sensor data associated with the measured parameters, (b) store the acquired sensor data in nonvolatile memory, and (c) communicate the stored data wirelessly to a RF reader.

Claims

1. An enclosure for storing biological substances comprising:

a bag including an inner and an outer wall, the inner wall being in contact with biological substances; and

an electronic device attached to the inner wall of the bag, including;

(i) a sensor configured to measure physiological and/or physical parameters of the biological substances enclosed within the bag; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to a RF reader.

2. The enclosure of claim 1, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

3. The enclosure of claim 1, wherein the physical parameters of the biological substances include identification, source history, demographic data and time stamping.

4. The enclosure of claim 1, wherein the physiological parameters of the biological substances include temperature, pH, conductivity, glucose, O₂, and CO₂ levels.

5. The enclosure of claim 1, wherein the RF device is a radio-frequency identification (RFID) tag.

6. The enclosure of claim 1, wherein the RF device includes a wireless antenna or coil configured to receive power from and communicate with the RF reader.

7. The enclosure of claim 1, wherein the RF device includes acquisition circuitry configured to acquire from the sensor data associated with the measured parameters.

8. The enclosure of claim 5, wherein the RFID tag is passive.

9. The enclosure of claim 1, wherein the sensor is a temperature sensor that measures the temperature of the biological substances enclosed within the bag.

10. The enclosure of claim 9, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

11. The enclosure of claim 9, wherein the temperature sensor is a thermistor.

12. The enclosure of claim 11, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

13. A method for detecting or monitoring physiological and/or physical parameters of biological substances enclosed within a bag during the thawing process, comprising:

(a) acquiring data associated with physical and/or physiological parameters of biological substances enclosed within a bag using a sensor;

(b) storing the acquired sensor data on a RFID tag; and

(c) communicating the stored data wirelessly to a RF reader.

14. The method of claim 13, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

15. The method of claim 13, wherein the physical parameters of the biological substances include identification, source history, demographic data and time stamping.

16. The method of claim 13, wherein the physiological parameters of the biological substances include temperature, pH, conductivity, glucose, O₂, and CO₂ levels.

17. The method of claim 13, wherein the sensor is a temperature sensor that measures the temperature of the biological substances enclosed within the bag.

18. The method of claim 17, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

19. The method of claim 17, wherein the temperature sensor is a thermistor.

20. The method of claim 19, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

21. The method of claim 13, wherein the RFID tag is composed of a printed circuit board, an IC chip, a wireless antenna or coil to receive power from and communicate with a RF reader, nonvolatile memory configured to store parameters associated with the biological substances enclosed within the bag, and acquisition circuitry.

22. The method of claim 13, wherein the RFID tag is passive.

23. A device attached to an outer wall of a bag containing biological substances and is configured to measure physiological and/or physical parameters of the bag, comprising:

(iii) a sensor configured to measure physiological and/or physical parameters of bags containing biological substances; and

(iv) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to a RF reader.

24. The device of claim 23, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

25. The device of claim 23, wherein the physical parameters of the bags containing biological substances include identification, source history, demographic data and time stamping.

26. The device of claim 23, wherein the physiological parameter of the bags containing biological substances includes temperature.

27. The device of claim 23, wherein the RF device is a radio-frequency identification (RFID) tag.

28. The device of claim 23, wherein the RF device includes a wireless antenna or coil configured to receive power from and communicate with the RF reader.

29. The device of claim 23, wherein the RF device includes acquisition circuitry configured to acquire from the sensor data associated with the measured parameters.

30. The device of claim 27, wherein the RFID tag is passive.

31. The device of claim 23, wherein the sensor is a temperature sensor that measures the temperature of the bags containing biological substances.

32. The device of claim 31, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

33. The device of claim 31, wherein the temperature sensor is a thermistor.

34. The device of claim 33, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

35. A method for detecting or monitoring physiological and/or physical parameters of bags containing biological substances during the thawing process, comprising:

(d) acquiring data associated with physical and/or physiological parameters of bags containing biological substances using a sensor;

(e) storing the acquired sensor data on a RFID tag; and

(f) communicating the stored data wirelessly to a RF reader.

36. The method of claim 35, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

37. The method of claim 35, wherein the physical parameters of the bags containing biological substances include identification, source history, demographic data and time stamping.

38. The method of claim 35, wherein the physiological parameter of the bags containing biological substances includes temperature.

39. The method of claim 35, wherein the sensor is a temperature sensor that measures the temperature of the bags containing biological substances.

40. The method of claim 39, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

41. The method of claim 39, wherein the temperature sensor is a thermistor.

42. The method of claim 41, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

43. The method of claim 35, wherein the RFID tag is composed of a printed circuit board, an IC chip, a wireless antenna or coil to receive power from and communicate with a RF reader, nonvolatile memory configured to store parameters associated with the bags containing biological substances, and acquisition circuitry.

44. The method of claim 35, wherein the RFID tag is passive.

45. An enclosure for thawing bags containing biological substances comprising:

an overwrap bag having high thermal conductivity including an inner and an outer wall; and

an electronic device attached to the inner wall of the overwrap bag, the electronic device configured to come into contact with an enclosed bag containing biological substances, including;

(i) a sensor configured to measure physiological and/or physical parameters of the enclosed bag containing biological substances; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to a RF reader.

46. The enclosure of claim 45, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

47. The enclosure of claim 45, wherein the physical parameters of the biological substances include identification, source history, demographic data and time stamping.

48. The enclosure of claim 45, wherein the physiological parameter of the biological substances includes temperature.

49. The enclosure of claim 45, wherein the RF device is a radio-frequency identification (RFID) tag.

50. The enclosure of claim 45, wherein the RF device includes a wireless antenna or coil configured to receive power from and communicate with the RF reader.

51. The enclosure of claim 45, wherein the RF device includes acquisition circuitry configured to acquire from the sensor data associated with the measured parameters.

52. The enclosure of claim 49, wherein the RFID tag is passive.

53. The enclosure of claim 45, wherein the sensor is a temperature sensor that measures the temperature of the enclosed bag containing biological substances.

54. The enclosure of claim 53, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

55. The enclosure of claim 53, wherein the temperature sensor is a thermistor.

56. The enclosure of claim 55, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

57. A method for detecting or monitoring physiological and/or physical parameters of an enclosed bag containing biological substances during the thawing process, comprising:

(i) acquiring data associated with physical and/or physiological parameters of an enclosed bag containing biological substances using a sensor;

(ii) storing the acquired sensor data on a RFID tag; and

(iii) communicating the stored data wirelessly to a RF reader.

58. The method of claim 57, wherein the biological substance is fresh, frozen, stored, or thawed and is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

59. The method of claim 57, wherein the physical parameters of the enclosed bag containing biological substances include identification, source history, demographic data and time stamping.

60. The method of claim 57, wherein the physiological parameter of the enclosed bag containing biological substances includes temperature.

61. The method of claim 57, wherein the sensor is a temperature sensor that measures the temperature of the enclosed bag containing biological substances.

62. The method of claim 61, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

63. The method of claim 61, wherein the temperature sensor is a thermistor.

64. The method of claim 63, wherein the thermistor is a negative temperature coefficient (NTC) thermistor.

65. The method of claim 57, wherein the RFID tag is composed of a printed circuit board, an IC chip, a wireless antenna/coil configured to receive power from and communicate with a RF reader, nonvolatile memory configured to store parameters associated with the enclosed bag containing biological substances, and acquisition circuitry.

66. The method of claim 57, wherein the RFID tag is passive.

67. An apparatus for dry thawing a bag containing biological substances, comprising:

a first cushion device and a second cushion device each including;

(i) a flexible heat conducting sheet configured to make contact with a bag containing biological substances;

(ii) a high density heating element configured to supply thermal energy to the flexible heat conducting sheet;

(iii) a temperature sensor configured to make contact with and measure temperature of the bag;

(iv) a sonic vibrator assembly configured to sonically agitate the bag; and

(v) a flexible non-heat conducting layer configured to promote unidirectional heat transfer towards the bag containing biological substances, and insulate the sonic vibrator assembly and the temperature sensor from the high density heating element; and

(vi) a heat insulation barrier configured to thermally isolate the temperature sensor from the flexible heat conducting sheet and the high density heating element

wherein the flexible heat conducting sheet of the first cushion device faces the flexible heat conducting sheet of the second cushion device.

68. The apparatus of claim 67, wherein the biological substance is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

69. The apparatus of claim 67, wherein the flexible heat conducting sheet is composed of silicon.

70. The apparatus of claim 67, wherein the high density heating element is configured to supply thermal energy to the flexible heat conducting sheet when powered with electrical current.

71. The apparatus of claim 67, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

72. The apparatus of claim 67, wherein the temperature sensor is a negative temperature coefficient (NTC) thermistor.

73. The apparatus of claim 67, wherein the flexible non-heat conducting layer is composed of material selected from the group consisting of:

polystyrene foam, starch-based foams, cellulose, paper, rubber, non-woven material, and plastic.

74. The apparatus of claim 67, further comprising an electronic connector configured to supply electrical current to the temperature sensor and the high density heating element.

75. The apparatus of claim 67, wherein the high density heating element is configured to supply thermal energy that is sufficient to heat a 250-500 ml bag of biological substances with a starting temperature of −

40°

C. to 36.6°

C. within 10 minutes.

76. The apparatus of claim 67, wherein the perimeter of the flexible heat conducting sheet is larger than the perimeter of the bag.

77. A method for dry thawing a bag containing biological substances, comprising:

(i) driving electrical current through a high density heating element via an electronic connector;

(ii) transferring thermal energy generated by the high density heating element to a flexible heat conducting sheet, the flexible heat conducting sheet configured to diffuse thermal energy to a bag containing biological substances;

(iii) agitating the bag to achieve homogenous thawing using low frequency sonic vibrations;

(iv) measuring temperature of the bag using a temperature sensor; and

(v) communicating the measurements via the electronic connector.

78. The method of claim 77, wherein the biological substance is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

79. The method of claim 77, wherein the flexible heat conducting sheet is composed of silicon.

80. The method of claim 77, wherein the temperature sensor is a traditional resistance temperature detector (RTD).

81. The method of claim 77, wherein the temperature sensor is a negative temperature coefficient (NTC) thermistor.

82. The method of claim 77, wherein the high density heating element is configured to supply thermal energy that is sufficient to heat a 250-500 ml bag of biological substances with a starting temperature of −

40°

C. to 36.6°

C. within 10 minutes.

83. The method of claim 77, wherein the low frequency sonic vibrations range between 10 Hz to 50 Hz.

84. A computer-controlled apparatus for dry thawing bags containing biological substances, comprising:

(i) a first thawing chamber including;

(a) a first cushion device and a second cushion device each including;

(1) a flexible heat conducting sheet configured to make contact with a bag containing biological substances;

(2) a high density heating element configured to supply thermal energy to the flexible heat conducting sheet;

(3) a temperature sensor configured to make contact with and measure temperature of the bag;

(4) a sonic vibrator assembly configured to sonically agitate the bag;

(5) a flexible non-heat conducting layer configured to promote unidirectional heat transfer towards the bag containing biological substances, and insulate the sonic vibrator assembly and the temperature sensor from the high density heating element; and

(6) a heat insulation barrier configured to thermally isolate the temperature sensor from the flexible heat conducting sheet and the high density heating element

wherein the flexible heat conducting sheet of the first cushion device faces the flexible heat conducting sheet of the second cushion device; and

(b) a radio frequency (RF) reader configured to wirelessly communicate with a radio-frequency identification device (RFID) tag on the bag;

(ii) a central controller configured to receive temperature data from the temperature sensor and RF reader data, and control the high density heating element based on the received temperature data; and

(iii) a power supply configured to supply electrical current to the high density heating element based on control signals received from the central controller.

85. The computer-controlled apparatus of claim 84, wherein the computer-controlled apparatus further includes a plurality of thawing chambers identical to the first thawing chamber, wherein the plurality of thawing chambers are communicably coupled to the central controller.

86. The computer-controlled apparatus of claim 84, wherein the central controller includes an expansion port configured to communicably couple with a plurality of auxiliary thawing chambers.

87. The computer-controlled apparatus of claim 86, wherein the number of auxiliary thawing chambers is two, four, six, eight, ten, or twelve.

88. The computer-controlled apparatus of claim 84, wherein the bag is an overwrap bag including:

an inner and an outer wall; and

an electronic device attached to the inner wall of the overwrap bag, the electronic device configured to come into contact with an enclosed bag containing biological substances.

89. The computer-controlled apparatus of claim 88, wherein the electronic device includes:

(i) a sensor configured to measure physiological and/or physical parameters of the enclosed bag containing biological substances; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to the RF reader.

90. The computer-controlled apparatus of claim 84, wherein the bag is a container including an inner and an outer wall, the inner wall being in contact with biological substances;

and an electronic device attached to the outer wall of the container, including;

(i) a sensor configured to measure physiological and/or physical parameters of the container enclosing the biological substances; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to the RF reader.

91. The computer-controlled apparatus of claim 89 or 90, wherein the biological substance is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

92. The computer-controlled apparatus of claim 89 or 90, wherein the physical parameters include identification, source history, demographic data and time stamping.

93. The computer-controlled apparatus of claim 89 or 90, wherein the physiological parameter includes temperature.

94. The computer-controlled apparatus of claim 89 or 90, wherein the RF device is a radio-frequency identification (RFID) tag.

95. A computer controlled process for dry thawing biological substances comprising:

(i) generating heat via a high density heating element;

(ii) diffusing heat generated by the high density heating element to a bag containing biological substances via a flexible heat conducting sheet;

(iii) agitating the bag to achieve homogenous thawing using low frequency sonic vibrations;

(iv) measuring temperature of the bag using a temperature sensor;

(v) transmitting data associated with the measured temperatures to a central controller via an electrical connector; and

(vi) receiving, in response to (v), control signals for regulating the generation of heat by the high density heating element.

96. The computer controlled process of claim 95, wherein the low frequency sonic vibrations range between 10 Hz to 50 Hz.

97. The computer controlled process of claim 95, further comprising:

(i) measuring temperature of the bag using a radio-frequency identification device (RFID) tag that is affixed to the bag;

(ii) receiving temperature data from a RF reader configured to wirelessly communicate with the RFID tag; and

(iii) receiving control signals from the central controller for regulating the high density heating element in response to (ii).

98. The computer controlled process of claim 95, wherein the biological substance is selected from the group consisting of:

medication, plasma, whole blood, glycerolized blood, and RBCs.

99. The computer controlled process of claim 97, wherein the bag is an overwrap bag including an inner and an outer wall;

and an electronic device attached to the inner wall of the overwrap bag, the electronic device configured to come into contact with an enclosed bag containing biological substances.

100. The computer controlled process of claim 99, wherein the electronic device includes:

(i) a sensor configured to measure physiological and/or physical parameters of the enclosed bag containing biological substances; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to the RF reader.

101. The computer controlled process of claim 97, wherein the bag is a container including an inner and an outer wall, the inner wall being in contact with biological substances;

and an electronic device attached to the outer wall of the container, including;

(i) a sensor configured to measure physiological and/or physical parameters of the container enclosing the biological substances; and

(ii) a radio-frequency (RF) device communicably coupled to the sensor and configured to;

(a) acquire from the sensor data associated with the measured parameters;

(b) store the acquired sensor data in nonvolatile memory; and

(c) communicate the stored data wirelessly to the RF reader.

102. The computer controlled process of claim 100 or 101, wherein the physical parameters include identification, source history, demographic data and time stamping.

103. The computer-controlled apparatus of claim 100 or 101, wherein the physiological parameter includes temperature.

104. The computer-controlled apparatus of claim 100 or 101, wherein the RF device is a radio-frequency identification (RFID) tag.