Porous spun polymeric structures and method of making same

• US 7,083,697 B2
• Filed: 12/30/2002
• Issued: 08/01/2006
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Dao, Kinh-Luan (Lenny) D., Chin, Yem, Zhong, Sheng-ping (Samuel), Mohan, Kshitij, Vu, Liem
• Primary Examiner(s): Kim, John
• Assistant Examiner(s): Menon, Krishnan S.
• Application Number:
  US10/331,213
• Publication Number:
  US 20040124146A1
• Time in Patent Office: 1,310 Days
• Field of Search: 156/167, 156/181, 156/578, 156/296, 156/244.11, 156/356, 156/350, 156/62.4, 118/200, 118/202, 427/206, 428/196, 264/239, 264/241
• US Class Current: 156/167
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: B01D 39/163 sintered or bonded
• CPC Class Codes: B01D 61/14 Ultrafiltration; Microfiltration
• CPC Class Codes: B01D 71/06 Organic material
• CPC Class Codes: D04H 3/05 in another pattern, e.g. zig-zag, sinusoidal D04H3/04 takes precedence
• CPC Class Codes: Y10T 156/1798 with liquid adhesive or adhesive activator applying means
• CPC Class Codes: Y10T 428/24 Structurally defined web or sheet [e.g., overall dimension, etc.]
• CPC Class Codes: Y10T 428/24479 including variation in thickness

Abstract

A non-woven polymeric matrix for separating leukocytes from a blood sample includes a non-woven three dimensional matrix formed from polymeric fibers having a predetermined pore volume fraction including a defined channel configuration, a predetermined pore size in the range of from about 10 μm to about 250 μm, and a plurality of connections between the plurality of fibers. The matrix is configured so as to remove at least about 98% of leukocytes from at least one unit of packed red blood cells. Methods of making and using the matrix are also provided.

Claims

1. A method of selectively generating a uniform or varied micro-architecture within a three-dimensional non-woven porous polymeric matrix comprising the steps of:

providing at least one liquid polymer capable of forming a fiber wherein said liquid polymer is formed by admixing a polymer and a solvent;

feeding said polymer through at least one applicator having at least one applicator opening to form at least one polymeric fiber;

applying said polymeric fiber in a plurality of layers onto a moveable table capable of motion in at least a first plane (x) and a second plane (y); and

controlling at least a motion of said table so as to form a three dimensional non-woven porous polymeric matrix comprised of interconnected fibers, such that a uniform or varied micro-architecture is formed within the matrix.

2. The method according to claim 1, wherein said matrix has a predetermined shape, a predetermined pore volume fraction including a defined channel configuration, a predetermined pore size, and a plurality of connections between said fibers.

3. The method according to claim 1, wherein said plurality of connections are formed from cross adherence of fiber contact points after removal of solvent by evaporation, applied vacuum, applied heat or a combination thereof.

4. The method according to claim 1, wherein said fiber is formed from one of a biodegradable polymer and a combination of a non-biodegradable and a biostable polymer.

5. The method according to claim 1, wherein said polymer is selected from the group consisting of an alginate, a hyaluronic acid, a cellulose, a dextran, a pullane, a polyhyaluronic acid, a chitin, a poly(3-hydroxyalkanoate), a poly(3-hydroxyoctanoate), a poly(3-hydroxyfatty acid), a collagen, a zein, a casein, a gelatin, a gluten, a serum albumen, a polyphosphazene, poly(vinyl alcohol), a polyamide, a polyester amide, a poly(amino acid), a polyanhydride, a polyester, a polycarbonate, a polyacrylate, a polyalkylene, a polyacrylamide, a polyalkylene glycol, a polyalkylene oxide, a polyalkylene terephthalate, a polyortho ester, a polyvinyl ether, a polyvinyl ester, a polyvinyl halide, a polyvinyl pyrrolidone, a polylactide, a polyglyxolide, a polysioxane, a polycaprolactone, a polyhydroxybutrate, a polyurethane, a poly α

-hydroxy acid, a poly L-lactic acid, a polyglycolic acid, a styrene isobutylstyrene block polymer and blends and copolymers thereof.

6. The method according to claim 1, further comprising the step of programming a computer to direct said table in relation to said applicator.

7. The method according to claim 1, wherein said controlling further comprises controlling a motion of said applicator.

8. The method according to claim 2, wherein said predetermined shape is selected from the group consisting of a sheet, a tube, a cylinder, a sphere, a semi-circle, a cube, a rectangle, a wedge, and an irregular shape.

9. The method according to claim 2, wherein said predetermined pore size is from about 0.5 micron to about 500 microns.

10. The method according to claim 2, wherein said predetermined pore volume fraction is from about 15% to about 98%.

11. A method of selectively generating a uniform or varied micro-architecture within a three dimensional non-woven matrix, comprising the steps of:

admixing at least one fiber forming polymer with a compatible solvent to form a flowable polymer mixture;

applying at least one fiber formed from said polymer mixture to a moveable table capable of motion in a first plane (x), a second plane (y) perpendicular to said first plane, and a third plane (z) perpendicular to said first plane (x) and said second plane (y); and

controlling movement of at least said table so as to form a three dimensional non-woven matrix of fibers having a predetermined pore volume fraction including a defined channel configuration, a predetermined pore size, and a plurality of connections between said fibers such that a uniform or varied micro-architecture is formed within the matrix.

12. The method according to claim 11, wherein said plurality of connections are formed from cross adherence of fiber contact points after removal of solvent by evaporation, applied vacuum, applied heat or a combination thereof.

13. The method according to claim 11, wherein said fiber is formed from one of a biodegradable polymer and a combination of biodegradable and biostable polymer.

14. The method according to claim 11, wherein said admixing step comprises admixing a polyurethane polymer and at least one further polymer.

15. The method according to claim 11, wherein said applying step includes feeding said flowable polymer mixture through at least one spinneret having a plurality of holes.

16. The method according to claim 15, wherein said admixing step includes forming two different flowable polymer mixtures consisting of a first flowable mixture and a second flowable mixture, said applying step includes feeding said first flowable polymer mixture through a first spinneret and feeding said second flowable mixture through a second spinneret.

17. The method according to claim 16, wherein said applying step comprises simultaneously applying said first flowable polymer and said second flowable polymer.

18. The method according to claim 16, wherein said applying step comprises alternating application of said first flowable polymer and said second flowable polymer.

19. The method according to claim 16, wherein said flowable polymer mixture comprises a plurality of flowable polymers, wherein said applying step includes one of sequential and simultaneous application of said plurality of flowable polymers.

20. The method according to claim 19, wherein a portion of said plurality of flowable polymers is applied simultaneously and a remainder of said plurality of flowable polymers is applied sequentially.

21. The method according to claim 11, wherein said applying step includes applying said flowable polymer in a plurality of fibers having an average diameter of from about 1 microns to about 40 microns.

22. The method according to claim 11, wherein said applying step comprises administering an electrostatic charge to said fibers, at least during an initial phase of application of said flowable polymer.

23. The method according to claim 11, wherein said controlling step comprises programming a computer attached to said moveable table to define movement of at least said table.

24. The method according to claim 23, wherein said computer is controlled using computer assisted design (CAD) software.

25. The method according to claim 11, wherein said controlling step forms a three dimensional non-woven matrix into one of a sheet, a tube, a cylinder, a sphere, a semi-circle, a cube, a rectangle, a wedge, and an irregular shape.

26. The method according to claim 11, wherein said controlling step forms a three dimensional non-woven matrix having a pore volume fraction of from about 15% to about 98%.

27. The method according to claim 11, wherein controlling step forms a three dimensional non-woven matrix having a pore size of from about 1 micron to about 40 microns.