Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device

• US 10,065,134 B2
• Filed: 11/29/2016
• Issued: 09/04/2018
• 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:
  US15/363,687
• Publication Number:
  US 20170072339A1
• Time in Patent Office: 644 Days
• 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
• 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 method for processing blood, comprising:

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

an outer chamber disposed between said outer wall and said membrane, separating said plasma from said blood by permeating through said membrane, wherein said plasma enters said outer chamber and exits said housing via said first outlet; and

depleting oxygen, carbon dioxide, leukocytes and plasma from said blood, whereby oxygen, carbon dioxide, leukocytes and plasma depleted blood exits said housing via said second outlet as packed red blood cells (pRBCs), wherein said membrane has a pore size from 0.2 to 2 microns in diameter.

2. The method according to claim 1, further comprising depleting platelets from said blood, and wherein said depletion media is also capable of depleting platelets from said blood.

3. The method according to claim 1, further comprising rotating at least one inner chamber relative to said outer chamber.

4. The method according to claim 3, wherein said rotating creates vortices in said at least one inner chamber.

5. The method according to claim 1, wherein said pRBCs have an O₂ saturation of 20% or less.

6. The method according to claim 1, wherein said pRBCs have a pCO₂ of less than 30 mmHg.

7. The method according to claim 1, wherein said pRBCs have a hematocrit of greater than 35%.

8. The method 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, 9 polypropylene rendered hydrophilic, and polyacrylonitrile.

9. The method according to claim 1, wherein said membrane is 25 to 250 microns thick.

10. The method according to claim 1, wherein said membrane has a pore size from 0.5 to 2 microns.

11. The method according to claim 1, wherein said leukocyte and oxygen depletion media comprises a macroporous structure comprising an oxygen sorbent material and a leukoreduction material.

12. The method according to claim 11, wherein said macroporous structure further comprises a CO₂ sorbent material, and wherein said CO₂ sorbent material is a metal oxide or metal hydroxide.

13. The method according to claim 11, wherein said macroporous structure is an oxygen sorbent material coated with a biocompatible leukocyte binding surface chemistry.

14. The method according to claim 11, wherein said macroporous structure has a feature selected from the group consisting of a mean flow pore of between 10 and 30 microns, a surface area of at least 5×

10³ cm²/gram media, and a combination thereof.

15. The method according to claim 11, wherein said macroporous structure comprises a structure selected from the group consisting of:

a. microspheres coated with a biocompatible leukocyte binding surface chemistry, wherein said microspheres are then incorporated into a leukoreduction filler material;

b. layers of microspheres;

c. one or more fibers; and

d. one or more fibers formed into a filter structure.

16. The method according to claim 15, 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.

17. The method according to claim 15, wherein said one or more fibers comprise fibers

selected from the group consisting of:

a. a leukoreduction fiber and an oxygen sorbent fiber;

b. a combined leukoreduction binding and an oxygen depletion fiber;

c. a CO₂ depletion fiber;

d. an oxygen sorbent fiber surrounded by biocompatible leukocyte binding fibers; and

e. an oxygen sorbent fiber and a carbon dioxide sorbent fiber surrounded by biocompatible leukocyte binding fibers.

18. The method according to claim 11, 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.

19. The method according to claim 1, wherein said passing is performed at a flow rate of at least 3 ml/minute.

20. A method for processing blood for transfusion, comprising:

Adding Nitric oxide or nitric oxide precursors to stored red blood cells (RBC) wherein said stored RBC were depleted of oxygen and carbon dioxide prior to storage,

wherein said stored RBC have an O₂ saturation of 20% or less and a pCO₂ of less than 30 mmHg; and

re-oxygenating said stored red blood cells.