Apparatus and method for thawing biological materials

• US 7,722,839 B2
• Filed: 10/10/2002
• Issued: 05/25/2010
• Est. Priority Date: 10/11/2001
• Status: Active Grant

• Current Assignee: Cytotherm LP
• Original Assignee: Cytotherm LP
• Inventors: Kuzyk, Roman
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Chorbaji; Monzer R
• Application Number:
  US10/268,610
• Publication Number:
  US 20030082069A1
• Time in Patent Office: 2,784 Days
• Field of Search: 422/255, 422/307, 422/40, 210176-178, 210/175, 435/303.1, 604/291, 604/113, 604/6.13, 392/470, 141/10, 128/203.28, 126/263.07, 100/269.04, 220/723, 220/721, 383/110
• US Class Current: 422/307
• CPC Class Codes: A01N 1/0242 Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
• CPC Class Codes: A01N 1/0284 Temperature processes, i.e. using a designated change in temperature over time

Abstract

An apparatus and method are provided to rapidly thaw and heat frozen bags of biological materials, such as plasma. The apparatus has a hollow bladder having a flexible wall that is placed in contact with the bag. A circulation system draws fluid from a reservoir and fills the bladder with the fluid. The circulation system also drains fluid from the bladder. A heater in the reservoir heats the fluid before the fluid enters the bladder. As heated fluid flows through the bladder, heat is transferred through the bladder wall to the plasma bag to thaw the biological material. The bladder wall expands against the plasma bag as the bladder fills with fluid, and contracts from the plasma bag as the bladder is drained. The expansion and contraction of the bladder wall agitates the plasma bag and biological material to accelerate the thawing process.

Claims

1. An apparatus for thawing and heating biological material contained in a bag, said apparatus comprising:

A. a multi-chambered bladder having a flexible wall for engagement with the bag;

B. a reservoir containing a fluid;

C. a circulation system operably communicating with the reservoir to fill the bladder with the fluid from the reservoir and expand the bladder wall and effect movement of the bag, and operable to withdraw the fluid from the bladder for circulating into the reservoir thereby causing the bladder wall to contract and effect movement of the bag, wherein said circulation system moves the fluid in such a manner that one chamber of the bladder may fill or empty fluid independently of another chamber; and

D. a heater operable to heat the fluid within the reservoir,

wherein the expansion and contraction of the bladder wall in response to operation of the circulation system agitates the bag and the biological material, and wherein the bladder wall is thermally conductive to transfer heat from the heated fluid in the bladder to the bag of the biological material.

2. The apparatus of claim 1, wherein the bladder comprises:

A. an outlet through which fluid exits the bladder; and

B. a hollow tube extending within the bladder, said hollow tube having a first open end communicating with the outlet and a second open end disposed within the bladder,

wherein, the communication between the outlet and the first open end of the tube is configured to permit a suction pressure to be formed at the first open end of the tube as fluid exits through the outlet, said suction pressure being operable to draw a quantity of gas from the interior of the bladder through the second open end of the tube and discharge said quantity of gas through the first open end of the tube and through the outlet.

3. The apparatus of claim 1, wherein the bladder comprises a first cell having an inlet and an outlet communicating with the circulation system, and a second cell having an inlet and an outlet communicating with the circulation system, said first and second cells being sealed from one another and configured to expand and contract in response to operation of the circulation system.

4. The apparatus of claim 3, wherein the circulation system comprises a first pump connected with the first cell, and a second pump connected with the second cell, said first pump and second pump being operable to expand the first and second cells respectively.

5. The apparatus of claim 4, comprising a controller configured to activate the first pump during a period of time that the second pump is deactivated and activate the second pump during a period of time that the first pump is deactivated.

6. The apparatus of claim 5, wherein the controller comprises a cycle adjuster to control the frequency of operation of the first pump and the second pump.

7. The apparatus of claim 5, comprising a timer that limits operation of the heater and circulation system to a time duration.

8. The apparatus of claim 1, comprising a thermostat operable to measure the temperature of the fluid in the reservoir and regulate the heater to maintain a desired temperature in the fluid.

9. The apparatus of claim 8 wherein the heater is responsive to the thermostat to maintain the desired temperature between 6°

C.-38°

C.

10. The apparatus of claim 1, wherein the fluid is water.

11. The apparatus of claim 1 comprising a rack to support the bag and a tank that houses the reservoir and at least a portion of the circulation system.

12. The apparatus of claim 11, wherein the rack comprises a sensor operable to detect a fluid leak from the bladder or bag.

13. An apparatus for thawing and heating biological material in a bag, said apparatus comprising:

A. a bladder having a flexible wall for engagement with the bag;

B. a reservoir containing a fluid;

C. a circulation system operably communicating with the reservoir to convey fluid from the reservoir to the bladder and withdraw the fluid from the bladder for circulation to the reservoir;

D. a first cell in the bladder having an inlet and an outlet communicating with the circulation system and configured to expand and contract in response to operation of the circulation system;

E. a second cell in the bladder having an inlet and an outlet communicating with the circulation system and configured to expand and contract in response to operation of the circulation system; and

F. a heater operable to heat the fluid within the reservoir,

wherein the inlets are configured to pass fluid from the reservoir into the bladder to expand the first and second cells, and the outlets are configured to pass fluid out of the bladder to the reservoir to contract the first and second cells, said expansion and contraction of the first and second cells being operable to agitate the bag, and wherein the passage of fluid through the bladder is operable to transfer heat to the bag of the biological material.

14. The apparatus of claim 13, wherein each cell comprises a hollow tube extending within the cell, said hollow tube having a first open end communicating with the outlet of the cell and a second open end disposed within the cell, wherein the communication between the outlet and the first open end of the tube is configured to permit a suction pressure to be formed at the first open end of the tube as fluid passes through the outlet, said suction pressure being operable to draw a quantity of gas formed in the interior of the bladder through the second open end of the tube and discharge said quantity of gas through the first open end of the tube and through the outlet.

15. The apparatus of claim 13, wherein the circulation system comprises:

A. a first pump connected with the inlet of the first cell; and

B. a second pump connected with the inlet of the second cell.

16. The apparatus of claim 15, comprising a controller configured to activate the first pump during a period of time that the second pump is deactivated and operate the second pump during a period of time that the first pump is deactivated.

17. The apparatus of claim 16, wherein the controller comprises a cycle adjuster to control the frequency of operation of the first pump and the second pump.

18. The apparatus of claim 13, comprising a timer that limits operation of the heater and circulation system to a time duration.

19. The apparatus of claim 13, comprising a thermostat operable to measure the temperature of the fluid in the reservoir and regulate the heater to maintain a desired temperature in the fluid.

20. The apparatus of claim 19 wherein the desired temperature is between 6°

C.-38°

C.

21. The apparatus of claim 13, wherein the fluid is water.

22. The apparatus of claim 13 comprising a tank having a lower section that houses the reservoir and circulation system, and an upper section that houses the bladder for engaging the bag.

23. The apparatus of claim 22, wherein the upper section comprises a sensor operable to detect a fluid leak from the bladder or the bag.

24. A method for thawing and heating a biological material in a bag, comprising the steps of:

A. heating a fluid to a desired temperature;

B. placing the bag containing the biological material in contact with a bladder having a flexible wall, and at least a first and second cell;

C. pumping the heated fluid into the bladder to expand the bladder wall to agitate the biological material;

D. maintaining the heated fluid in the bladder to transfer heat through the bladder wall to the bag; and

E. withdrawing the heated fluid from the bladder to contract the bladder wall and agitate the biological material.

25. The method of claim 24 wherein the steps of pumping the heated fluid to the bladder and withdrawing the fluid from the bladder comprise pumping fluid to the first cell to pressurize and expand the first cell while draining fluid from the second cell, and then pumping fluid to the second cell to pressurize and expand the second cell while draining fluid from the first cell.

26. The method of claim 24 wherein the step of heating a fluid to a desired temperature includes heating the fluid to a desired temperature of between 6°

C.-38°

C.

27. The method of claim 24 comprising the step of removing a quantity of gas formed in the interior of the bladder.

28. An apparatus for thawing and heating biological material contained in a bag, said apparatus comprising:

A. a bladder having a flexible wall for engagement with the bag;

B. a reservoir containing a fluid;

C. a circulation system operably communicating with the reservoir to fill the bladder with the fluid from the reservoir and expand the bladder wall and effect movement of the bag, and operable to withdraw the fluid from the bladder for circulating into the reservoir thereby causing the bladder wall to contract and effect movement of the bag;

D. a heater operable to heat the fluid within the reservoir; and

E. at least one flexible tube extending into the bladder to permit gas to flow through the tube,

wherein the expansion and contraction of the bladder wall in response to operation of the circulation system agitates the bag and the biological material, and wherein the bladder wall is thermally conductive to transfer heat from the heated fluid in the bladder to the bag of the biological material.

29. The apparatus of claim 28, wherein the bladder has an outlet and an interior and wherein the tube has one end communicating with the outlet from the bladder and the other end communicating with the interior of the bladder at a position relatively higher than the outlet to permit gas to flow through the tube.

30. The apparatus of claim 28, wherein the flexible tube extends from a port on the bladder within an interior of the bladder so that any pressure differential between the ends of the tube permits gas to flow through the tube in communication with the port.

31. The apparatus of claim 28, wherein the bladder comprises a multi-chamber bladder and wherein the flexible tube includes a tube for each chamber.

32. An apparatus for thawing and heating biological material contained in a bag, said apparatus comprising:

A. a bladder having a flexible wall for engagement with the bag and at least one inlet and multiple outlets;

B. a reservoir containing a fluid;

C. a circulation system operable to fill the bladder with the fluid from the reservoir through the inlet and expand the bladder wall and effect movement of the bag, and operable to withdraw the fluid from the bladder for circulation into the reservoir through the outlets thereby causing the bladder wall to contract and effect movement of the bag of biological material; and

D. a heater operable to heat the fluid within the reservoir, wherein the expansion and contraction of the bladder wall in response to operation of the circulation system agitates the bag and the biological material, and wherein the bladder wall is thermally conductive to transfer heat from the heated fluid in the bladder to the bag of the biological material.

33. The apparatus of claim 32 comprising multiple inlets.

34. An apparatus for thawing and heating biological material contained in a bag, said apparatus comprising:

A. a bladder having a flexible wall for engagement with the bag and multiple inlets and at least one outlet;

B. a reservoir containing a fluid;

C. a circulation system operable to fill the bladder with the fluid from the reservoir through the inlet and expand the bladder wall and effect movement of the bag, and operable to withdraw the fluid from the bladder for circulation into the reservoir through the outlets thereby causing the bladder wall to contract and effect movement of the bag of biological material; and

D. a heater operable to heat the fluid within the reservoir, wherein the expansion and contraction of the bladder wall in response to operation of the circulation system agitates the bag and the biological material, and wherein the bladder wall is thermally conductive to transfer heat from the heated fluid in the bladder to the bag of the biological material.

35. The apparatus of claim 34 comprising multiple outlets.