BI-PHASIC COMPRESSED POROUS REINFORCEMENT MATERIALS SUITABLE FOR IMPLANT

• US 20100278891A1
• Filed: 10/09/2009
• Published: 11/04/2010
• Est. Priority Date: 12/04/2003
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Mcdade, Robert L., Ringeisen, Timothy A.
• Granted Patent: US 8,389,588 B2
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

A high strength porous biphasic polymeric reinforcement material manufactured by a compression and/or sintering process is disclosed. The material results in a network of interconnected collapsed pores, which forces thin overlapping walls and passages to be created. The network provides permeable access for fluid migration throughout the material. The strength and/or permeability are advantageous for medical devices and implants.

Claims

1. A biphasic porous implantable device suitable for implantation in a living being, said porous implantable device comprising a high density porous zone and a low density porous zone, wherein said high density porous zone is created through a compression process applied to at least one part of a resorbable porous material, wherein said compression process causes the sacrifice of at least some pores forming said high density porous zone, and wherein at least one part of said porous material is at least partially protected from compression thereby forming said low density porous zone.

2. The biphasic porous implantable device of claim 1, wherein said high density porous zone has further been subjected to a sintering or heating process, wherein said sintering or heating process causes pores of said high density porous zone to fuse together.

3. The biphasic porous implantable device of claim 1, wherein said high density porous zone and low density porous zone comprises at least one polymer material.

4. The biphasic porous implantable device of claim 1, wherein said sacrifice of said at least some pores creates laminar walls in said high-density porous zone.

5. The biphasic porous implantable device of claim 1, further comprising at least one additive component.

6. The biphasic porous implantable device of claim 5, wherein said at least one additive component is distributed in at least one manner selected from the group consisting of:

a. uniformly throughout the porous implantable device;

b. on the outside surfaces of said porous implantable device;

c. within said pores of said porous material of said porous implantable device;

d. between one or more of said porous material of said porous implantable device;

e. on the outside surfaces of the porous material of the porous implantable device; and

f. in a portion of said porous implantable device.

7. The biphasic porous implantable device of claim 5, wherein said at least one additive is selected from the groups consisting of:

a binder, a microstructure creating material, a reinforcing agent, a biologically active agent, a reinforcing material, and a tissue ingrowth promoting material.

8. The biphasic porous implantable device of claim 1, wherein said porous implant is arranged to be implanted as tissue reinforcement sheet.

9. The biphasic porous implantable device of claim 5, wherein the additive is selected from at least one of:

screens, mesh, fibers, threads, rods, ceramic particles, glass particles, polymer particles, and metal particles.

10. The biphasic implantable device of claim 1 wherein said porous material comprises a plurality of fibers.

11. The biphasic implantable device of claim 1, wherein said porous material is non-fibrous.

12. The biphasic implantable device of claim 5 wherein said at least one additive component provides a depot within the implantable device, said depot being arranged to deliver said additive component over a period of time.

13. The biphasic implantable device of claim 1 wherein sad resorbable porous material comprises a plurality of resorbable layers.

14. A biphasic porous implantable device suitable for implantation in a living being, said porous implantable device comprising a high density porous zone and a low density porous zone, wherein said high density porous zone is created through a compression process applied to at least one part of a multi-layered material, wherein said compression process causes the sacrifice of at least some pores and fusion of the layers at the points of compression thereby forming said high density porous zone, and wherein at least one part of said multi-layer material is at least partially protected from compression thereby forming said low density porous zone.

15. The porous implantable device of claim 14, wherein said high density porous zone has further been subjected to a sintering or heating process, wherein said sintering or heating process causes pores of said high density porous zone to fuse together.

16. The biphasic porous implantable device of claim 14, wherein said high density porous zone and low density porous zone comprises at least one polymer material.

17. The biphasic porous implantable device of claim 14, further comprising at least one additive component.

18. The biphasic porous implantable device of claim 17, wherein said at least one additive component is distributed in at least one manner selected from the group consisting of:

a. uniformly throughout the porous implantable device;

b. on the outside surfaces of said porous implantable device;

c. within said pores of said porous material of said porous implantable device;

d. between one or more of said porous material of said porous implantable device;

e. on the outside surfaces of the porous material of the porous implantable device;

f. in a contained space arranged between the layers within the low density porous zone; and

f. in a portion of said porous implantable device.

19. The biphasic porous implantable device of claim 14, wherein said porous implant is arranged to be implanted as tissue reinforcement sheet.

20. The biphasic porous implantable device of claim 17, wherein the additive is selected from at least one of:

screens, mesh, fibers, threads, rods, ceramic particles, glass particles, polymer particles, and metal particles.

21. The biphasic implantable device of claim 14 wherein said porous material comprises a plurality of fibers.

22. The biphasic implantable device of claim 14, wherein said porous material is non-fibrous.

23. The biphasic implantable device of claim 17 wherein said at least one additive component provides a depot within the implantable device, said depot being arranged to deliver said additive component over a period of time.

24. The biphasic implantable device of claim 14, wherein one of said layers comprises a non-porous material.

25. A method of producing a high density, high strength porous matrix sheet containing low-density zones comprising:

f) providing a high porosity polymeric matrix sheet;

g) inducing glass-transition within said porous polymeric matrix sheet;

h) applying a compressive force within one or more dimensions using a plate containing shaped cavities, wherein the shaped cavities allow for less compression than the areas of the plate surrounding the cavities to achieve a new size or shape;

i) holding the porous polymer matrix sheet above glass transition at the new size and shape for a period of time allowing the molecular chains within the matrix sheet that are under compression to rotate or move to a lower energy state; and

j) cooling the porous polymer to below the glass-transition wherein the polymer matrix sheet maintains the new size or shape.

26. A method of producing a high density, high strength porous matrix sheet containing low-density zones comprising:

a) creating at least two high porosity polymeric matrix sheets by methods known in the art;

b) inducing glass-transition within said porous polymeric matrix sheets;

c) placing the at least two sheets atop one another in a layered or laminated fashion;

d) applying a compressive force within one or more dimensions using a plate containing shaped cavities, wherein the shaped cavities allow for less compression than the areas of the plate surrounding the cavities to achieve a new size or shape;

e) holding the porous polymer matrix sheets above glass transition at the new size and shape for a period of time allowing the molecular chains within the matrix sheets that are under compression to rotate or move to a lower energy state; and

cooling the porous polymer to below the glass-transition wherein the polymer matrix sheets maintain the new size or shape.

27. A biphasic porous implantable device suitable for implantation in a living being, said porous implantable device comprising a non-porous zone, a high density porous zone and a low density porous zone, wherein said high density porous zone is created through a compression process applied to at least one part of a porous material that has been layered or laminated with a non-porous sheet, wherein said compression process causes the sacrifice of at least some pores forming said high density porous zone, and wherein at least one part of said porous material is at least partially protected from compression forming said low density porous zones, and further wherein at least said high density porous zone is fused with said non-porous sheet.

28. A method of producing a high density, high strength porous matrix sheet containing low-density zones comprising:

f) creating a high porosity polymeric matrix sheet by methods known in the art;

g) inducing glass-transition within said porous polymeric matrix sheet;

h) placing the porous polymeric sheet atop a non-porous sheet in a layered or laminated fashion;

i) applying a compressive force within one or more dimensions using a plate containing shaped cavities, wherein the shaped cavities allow for less compression than the areas of the plate surrounding the cavities to achieve a new size or shape;

j) holding the porous polymer matrix sheet above glass transition at the new size and shape for a period of time allowing the molecular chains within the matrix sheets that are under compression to rotate or move to a lower energy state; and

cooling the porous polymer to below the glass-transition wherein the polymer matrix sheets maintain the new size or shape and fuses with the non-porous sheet.