Blood storage bag system and depletion devices with oxygen and carbon dioxide depletion capabilities

• US 8,535,421 B2
• Filed: 10/08/2010
• Issued: 09/17/2013
• Est. Priority Date: 10/12/2009
• Status: Active Grant

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Yoshida, Tatsuro, Vernucci, Paul J.
• Primary Examiner(s): Greene, Jason M
• Application Number:
  US12/901,350
• Publication Number:
  US 20120024156A1
• Time in Patent Office: 1,075 Days
• Field of Search: 95/46, 95/51, 95/54, 96/4, 96/6, 96/8, 604/4.01, 604/5.01, 604/5.04, 604/6.01, 604/6.15, 435/2, 206/524.6
• US Class Current: 96/6
• CPC Class Codes: A01N 1/0221 Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• 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: A61K 35/18 Erythrocytes haemoglobin A61K38/42
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: B01D 19/0031 by filtration
• CPC Class Codes: B01D 53/22 by diffusion manufacturing semi-permeable membranes B01D67/00; form, structure or properties of semi-permeable membranes B01D69/00; material for semi-permeable membranes B01D71/00
• CPC Class Codes: C12N 5/0641 Erythrocytes

Abstract

A blood storage system. The system has a collection bag for red blood cells; an oxygen/carbon dioxide depletion device; a storage bag for red blood cells; and tubing connecting the collection bag to the depletion device and the depletion device to the storage bag. The depletion device includes a receptacle of a solid material having an inlet and an outlet adapted to receiving and expelling a flushing gas; a plurality of hollow fibers or gas-permeable films extending within the receptacle from an entrance to an exit thereof. The hollow fibers or gas-permeable films are adapted to receiving and conveying red blood cells.

Claims

1. A blood storage device for storing oxygen and carbon dioxide depleted blood comprising:

an outer receptacle substantially impermeable to carbon dioxide;

an inner receptacle situated within said outer receptacle;

an amount of a carbon dioxide scavenger situated within said outer receptacle wherein said blood storage device maintains the blood in a carbon dioxide depleted state.

2. The device of claim 1, wherein said carbon dioxide scavenger is situated between said outer receptacle and said inner receptacle.

3. The device of claim 1, wherein said carbon dioxide scavenger is situated within a sachet, patch, or coating formed of a carbon dioxide-permeable material different than said carbon dioxide scavenger.

4. The device of claim 3, wherein said sachet takes the shape of a comb.

5. The device of claim 3, wherein said carbon dioxide-permeable material is a polymer or combination of polymers.

6. The device of claim 1, wherein said carbon dioxide scavenger is selected from the group consisting of:

a metal oxide and a metal hydroxide.

7. The device of claim 1, wherein said inner receptacle and said outer receptacle are bags formed from polymers.

8. The device of claim 7, wherein said inner receptacle is formed from the polymer polyvinyl chloride and said outer receptacle is formed from the polymer nylon.

21. The blood storage device of claim 1, wherein said outer receptacle substantially impermeable to carbon dioxide is substantially impermeable to oxygen and further comprises an amount of a oxygen scavenger situated within said outer receptacle or said inner receptacle.

22. The device of claim 21, wherein said oxygen scavenger is situated between said outer receptacle and said inner receptacle.

23. The device of claim 21, wherein said carbon dioxide scavenger and said oxygen scavenger is situated within a sachet, patch, or coating formed of a carbon dioxide and oxygen permeable material different than said carbon dioxide scavenger and oxygen scavenger.

24. The device of claim 8, wherein said inner receptacle formed from the polymer polyvinyl chloride further comprises di(2-ethylhexyl)-phthalate (DEHP).

9. An oxygen and carbon dioxide depletion device comprising:

a cartridge;

a plurality of gas-permeable films or membranes extending within the cartridge from an entrance to an exit thereof, wherein said plurality of gas permeable films or membranes are formed of a material that is permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying red blood cells; and

an amount of both an oxygen scavenger and a carbon dioxide scavenger packed within said cartridge and contiguous to and in between said plurality of gas-permeable films or membranes.

10. The device of claim 9, wherein said plurality of gas-permeable films or membranes are substantially parallel and longitudinally disposed within said cartridge from said entrance to said exit.

11. An oxygen and carbon dioxide depletion device comprising:

a receptacle of a solid material having an inlet and an outlet adapted to receiving and expelling a flushing gas and

a plurality of gas-permeable films or membranes extending within said receptacle from an entrance to an exit thereof, wherein said plurality of gas-permeable films or membranes are formed of a material permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying red blood cells.

12. The device of claim 11, wherein said plurality of gas-permeable films or membranes are substantially parallel and longitudinally disposed within said receptacle from said entrance to said exit.

13. The device of claim 11, further including a source of said flushing gas in communication with said inlet of said receptacle.

14. A method for removing oxygen and carbon dioxide from red blood cells, comprising:

passing the red blood cells through an oxygen and carbon depletion device, wherein the device includes

a cartridge;

a plurality of gas-permeable films or membranes extending within said cartridge from an entrance to an exit thereof, wherein said plurality of gas-permeable films or membranes are formed of a material permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying said red blood cells; and

an amount of an oxygen scavenger and a carbon dioxide scavenger packed within said cartridge and contiguous to and in between said plurality of gas-permeable films or membranes.

15. A method for removing oxygen and carbon dioxide from red blood cells, comprising:

passing red blood cells through an oxygen and carbon dioxide depletion device, wherein said device comprises;

a receptacle of a solid material having an inlet and an outlet adapted to receiving and expelling a flushing gas; and

a plurality of gas-permeable films or membranes extending within said receptacle from an entrance to an exit thereof, wherein said plurality of gas-permeable films or membranes are formed of a material permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying said red blood cells.

16. A blood storage system comprising:

a collection bag for red blood cells;

an oxygen and carbon dioxide depletion device;

a storage bag for red blood cells; and

tubing connecting said collection bag to said oxygen and carbon dioxide depletion device and tubing connecting said oxygen and carbon dioxide depletion device to said storage bag,

wherein said oxygen and carbon dioxide depletion device includes

a cartridge;

a plurality of gas-permeable films or membranes extending within said cartridge from an entrance to an exit thereof, wherein said plurality of gas-permeable films or membranes are formed of a material permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying red blood cells; and

an amount of both an oxygen scavenger and a carbon dioxide scavenger packed within said cartridge and contiguous to and in between said plurality of gas-permeable films or membranes.

17. A blood storage system comprising:

a collection bag for red blood cells;

a oxygen and carbon dioxide depletion device;

a storage bag for red blood cells; and

tubing connecting said collection bag to said depletion device and tubing connecting said depletion device to said storage bag,

wherein said depletion device includes

a receptacle of a solid material having an inlet and an outlet adapted to receiving and expelling a flushing gas; and

a plurality of gas-permeable films or membranes extending within said receptacle from an entrance to an exit thereof, wherein said plurality of gas-permeable films or membranes are formed of a material permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying red blood cells.

18. A blood storage device comprising:

a receptacle adapted to retain and store red blood cells, said receptacle being formed from a laminate, said laminate including (a) an outer layer of a material substantially impermeable to both oxygen and carbon dioxide, (b) an inner layer of a material compatible with red blood cells, and (c) an interstitial layer between the outer layer and the inner layer wherein said interstitial layer is of a material having admixed therein an amount of both an oxygen scavenger and a carbon dioxide scavenger.

19. A blood storage system comprising:

a collection bag for red blood cells;

a unitary device for depleting oxygen and carbon dioxide and reducing leukocytes from red blood cells;

a storage bag for red blood cells; and

tubing connecting the collection bag to said unitary device and tubing connecting said unitary device to said storage bag.

20. The blood storage system of claim 19, wherein said unitary device further comprises platelet depletion.