Smart bag used in sensing physiological and/or physical parameters of bags containing biological substance

• US 10,576,190 B2
• Filed: 08/10/2015
• Issued: 03/03/2020
• Est. Priority Date: 08/08/2014
• Status: Active Grant

• Current Assignee: FreMon Scientific, Inc.
• Original Assignee: FreMon Scientific, Inc.
• Inventors: Shavit, Menachem
• Primary Examiner(s): Warden, Jill A
• Assistant Examiner(s): Brazin, Jacqueline
• Application Number:
  US15/502,642
• Publication Number:
  US 20170239404A1
• Time in Patent Office: 1,667 Days
• Field of Search: 436 55
• 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. A device for thawing a biological substance, comprising:

a reversibly sealable housing defining a chamber, wherein the housing comprises a plurality of cushion devices and each of the plurality of cushion devices comprises;

a heating element configured to generate thermal energy, a flexible first layer in direct contact with the heating element; and

a temperature sensor.

2. The device of claim 1, wherein each of the plurality of cushion devices further comprises:

a sonic vibrator assembly configured to mechanically agitate a biological substance contained within an enclosure that is received within the chamber; and

a flexible second layer interposed between the sonic vibrator assembly and the heating element, wherein the second layer is configured to inhibit thermal communication between the sonic vibrator assembly and the heating element.

3. The device of claim 2, wherein the sonic vibrator assembly and the heating element are configured to simultaneously heat and mechanically agitate a biological substance contained within an enclosure that is received within the chamber.

4. The device of claim 1 further comprising a radio frequency (RF) reader configured to interrogate a radio frequency ID tag (RFID) positioned within the chamber.

5. The device of claim 1, wherein each temperature sensor comprises a cushion temperature sensor that is thermally insulated from thermal energy generated by the respective heating element in each of the plurality of cushion devices.

6. The device of claim 5, wherein each cushion temperature sensor is positioned to be adjacent to an exterior surface of an enclosure containing a biological substance that is received within the chamber.

7. The device of claim 1 further comprising an enclosure containing a biological substance positioned within the chamber, wherein the enclosure comprises an enclosure temperature sensor.

8. The device of claim 7, wherein the enclosure further comprises an RFID tag.

9. The device of claim 7, wherein the enclosure temperature sensor is in direct contact with the biological substance contained within the enclosure.

10. The device of claim 7, wherein the enclosure is a reversibly sealable overwrap bag enclosing a bag containing a biological substance, wherein the enclosure temperature sensor is configured to measure a temperature of the bag containing the biological substance.

11. The device of claim 1, wherein a first cushion device of the plurality of cushion devices and a second cushion device of the plurality of cushion devices are positioned opposite one another such that the first layer of the first cushion device faces the first layer of the second cushion device.

12. The device of claim 1, wherein the chamber further comprises a first side chamber dimensioned to receive a first cushion device of the plurality of cushion devices and a second side chamber configured to receive a second cushion device of the plurality of cushion devices, wherein a position of the second side chamber is adjustable with respect to the first side chamber.

13. The device of claim 1 further comprising a controller in communication with each heating element, wherein the controller comprises instructions to regulate thermal energy generated by each heating element based upon a measured temperature.

14. A device for thawing a biological substance, comprising;

a reversibly sealable housing defining a chamber configured to receive an enclosure containing a biological substance to be thawed, wherein the housing comprises a plurality of cushion devices and each of the plurality of cushion devices comprises;

a cushion;

a heating element coupled to the cushion and configured to generate thermal energy; and

a temperature sensor positioned to be adjacent to the enclosure containing the biological substance to be thawed when the enclosure is received within the chamber.

15. The device of claim 14 further comprising a radio frequency (RF) reader configured to interrogate a radio frequency ID tag (RFID) positioned within the chamber.

16. The device of claim 14, wherein each temperature sensor is thermally insulated from thermal energy generated by the respective heating element in each of the plurality of cushion devices.

17. The device of claim 14 further comprising the enclosure containing the biological substance to be thawed positioned within the chamber, wherein the enclosure comprises an enclosure temperature sensor.

18. The device of claim 17, wherein the enclosure further comprises an RFID tag.

19. The device of claim 17, wherein the enclosure temperature sensor is in direct contact with the biological substance contained within the enclosure.

20. The device of claim 17, wherein the enclosure is a reversibly sealable overwrap bag enclosing a bag containing the biological substance, wherein the enclosure temperature sensor configured to measure a temperature of the bag containing the biological substance.

21. The device of claim 14, wherein a first cushion device of the plurality of cushion devices and a second cushion device of the plurality of cushion devices are positioned opposite one another such that a first layer of the first cushion device faces a first layer of the second cushion device.

22. The device of claim 14, wherein the chamber further comprises a first side chamber dimensioned to receive the first cushion device and a second side chamber configured to receive the second cushion device, wherein a position of the second side chamber is adjustable with respect to the first side chamber.

23. The device of claim 14 further comprising a controller in communication with each heating element, wherein the controller comprises instructions to regulate thermal energy generated by each heating element based upon a measured temperature.