Integrated leukocyte, oxygen and/or CO;depletion, and plasma separation filter device

• US 9,005,343 B2
• Filed: 08/10/2012
• Issued: 04/14/2015
• Est. Priority Date: 05/05/2010
• 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:
  US13/572,412
• Publication Number:
  US 20130047861A1
• Time in Patent Office: 977 Days
• Field of Search: 96/4, 96/6, 96/8, 961/08, 961/53, 961/54, 95/46, 95/51, 95/54, 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: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0213 with isolated sections of the tube used as additive reservoirs
• CPC Class Codes: A61M 1/0218 with filters
• 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 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2202/0429 Red blood cells; Erythrocytes
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes lymphocytes A61M2202/0407
• CPC Class Codes: B01D 19/0031 by filtration
• CPC Class Codes: B01D 61/147 Microfiltration

Abstract

A blood filter device comprising: a housing comprising an outer wall and a first inlet, a first outlet and a second outlet; a membrane which is capable of separating plasma from the blood, wherein the membrane forms an inner chamber; a leukocyte and oxygen and/or carbon dioxide depletion media disposed wherein the inner chamber, the leukocyte and oxygen and/or carbon dioxide depletion media is capable of depleting leukocytes and oxygen and/or carbon dioxide from the blood; an outer chamber disposed between the outer wall and the membrane, wherein the plasma which permeates through the membrane enters the outer chamber and exits the filter device via the first outlet; whereby the blood which has been depleted of oxygen and/or carbon dioxide, leukocytes and plasma exists and filter device via the second outlet.

Claims

1. A blood filter device comprising:

a housing comprising an outer wall, a first inlet, a first outlet and a second outlet;

a membrane which is capable of separating plasma from said blood, wherein said membrane forms at least one inner chamber within said housing and said blood enters said at least one inner chamber of said blood filter device through said first inlet;

a leukocyte and oxygen depletion media disposed within said at least one inner chamber, said leukocyte and oxygen depletion media is capable of depleting leukocytes and oxygen from said blood;

an outer chamber disposed between said outer wall and said membrane, wherein said plasma permeates through said membrane, enters said outer chamber and exits said housing via said first outlet;

whereby said blood which has been depleted of oxygen, leukocytes and plasma exits said housing via said second outlet as packed red blood cells (pRBC).

2. The blood filter device of claim 1, wherein said depletion media is also capable of depleting CO₂ from said blood.

3. The blood filter device of claim 1, wherein said depletion media is also capable of depleting platelets from said blood.

4. The blood filter device of claim 1, wherein said first outlet further comprises a seal.

5. The blood filter device of claim 1, wherein said seal comprises a rotating seal.

6. The blood filter device of claim 1, wherein said inner chamber rotates relative to said outer chamber.

7. The blood filter device of claim 6, wherein said rotation creates vortices in said at least one inner chamber.

8. The blood filter device of claim 7, wherein said vortices are Taylor vortices.

9. The blood filter device of claim 1, wherein said pRBC have an O₂ saturation of 3% or less.

10. The blood filter device of claim 2, wherein said pRBC has a pCO₂ of less than 30 mmHg.

11. The blood filter device of claim 1, wherein said pRBC have a hematocrit of greater than 35%.

12. The blood filter device according to claim 1, wherein said membrane is at least one membrane formed from at least one material selected from the group consisting of:

PVDF rendered hydrophilic, nylon, cellulose esters, polysulfone, polyethersulfone, polypropylene rendered hydrophilic, and polyacrylonitrile.

13. The blood filter device according to claim 1, wherein said membrane is 25 to 250 microns thick.

14. The blood filter device according to claim 13, wherein said membrane has a pore size of less than 2 microns.

15. The blood filter device according to claim 1, wherein said leukocyte and oxygen depletion media comprises a macroporous structure comprising an oxygen sorbent material and a leukoreduction material.

16. The blood filter device according to claim 15, wherein said macroporous structure further comprises a CO₂ sorbent material.

17. The blood filter device according to claim 16, wherein said O₂ sorbent material is a metal oxide or metal hydroxide.

18. The blood filter device according to claim 15, wherein said macroporous structure is an oxygen sorbent material coated with a biocompatible leukocyte binding surface chemistry.

19. The blood filter device according to claim 15, wherein said macroporous structure is formed from an organic or inorganic material.

20. The blood filter device according to claim 19, wherein said macroporous structure is selected from the group consisting of a fibrous material, a foam, and a microsphere.

21. The blood filter device according to claim 20, wherein said macroporous structure has a mean flow pore of between 10 and 30 microns.

22. The blood filter device according to claim 20, wherein said macroporous structure has a surface area of at least 5×

10³ cm²/gram media.

23. The blood filter device according to claim 15, wherein said macroporous structure comprises microspheres coated with a biocompatible leukocyte binding surface chemistry, wherein said microspheres are then incorporated into a leukoreduction filler material.

24. The blood filter device according to claim 23, wherein said macroporous structure comprises layers of microspheres.

25. The device according to claim 15, wherein said macroporous structure comprises one or more fibers.

26. The blood filter device according to claim 15, wherein said one or more fibers are formed into a filter structure.

27. The blood filter device according to claim 26, wherein said one or more fibers are modified before or after they are formed into a filter structure.

28. The blood filter device according to claim 25, wherein said one or more fibers are formed from at least one material selected from the group consisting of poly(ethylene methacrylate cyclohexenyl methylacrylate), a polyolefin, a polyamide, a polyester, ethylene/vinyl cyclohexene copolymer (EVCH), and combinations thereof.

29. The blood filter device according to claim 15, wherein said one or more fibers comprise a leukoreduction fiber and a oxygen sorbent fiber.

30. The blood filter device according to claim 25, wherein said one or more fibers comprise a combined leukoreduction binding material and a oxygen depletion material.

31. The blood filter device according to claim 25, wherein said one or more fibers further comprise a CO₂ depletion material.

32. The blood filter device according to claim 29, wherein said one or more fibers comprises one or more bundles of oxygen sorbent fibers surrounded by leukocyte binding fibers.

33. The blood filter device according to claim 32, wherein said leukocyte binding fibers are biocompatible.

34. The blood filter device according to claim 32, wherein said core of oxygen sorbent fibers further comprises a carbon dioxide sorbent fiber.

35. The blood filter device according to claim 1, further comprising a platelet depletion media.

36. The blood filter device according to claim 15, wherein said leukoreduction material is at least one polymer selected from the group consisting of:

polyolefins, polyamides, polyesters, and other polymers which may be blended with an oxygen scavenger the polymer form and then spun into fibers.

37. The blood filter device according to claim 1, wherein said filter has a flow rate of at least 3 ml/minute.

38. The blood filter device according to claim 1, wherein said housing comprises a first end cap having at least one inlet and second end cap having said first and said second outlet.