Bi-phasic compressed porous reinforcement materials suitable for implant

• US 9,308,076 B2
• Filed: 03/05/2013
• Issued: 04/12/2016
• 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: Ringeisen, Timothy A., McDade, Robert L.
• Primary Examiner(s): ZEMEL, IRINA SOPHIA
• Application Number:
  US13/786,355
• Publication Number:
  US 20130282140A1
• Time in Patent Office: 1,134 Days
• US Class Current: 1/1
• 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 device suitable for implantation in a living being, said porous implantable device:

(a) being in the form of a flexible/bendable sheet that comprises;

(b) at least two porous sheets layered together, the layered sheets defining;

(i) a plurality of low density porous zones, and

(ii) at least one high density porous zone, wherein said plurality of low density porous zones are arranged within the at least one high density porous zone; and

(c) wherein said at least two porous sheets are bonded to each other at said at least one high density porous zone.

2. The 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, further comprising at least one additive component.

5. The biphasic porous implantable device of claim 4, 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

g) in a portion of said porous implantable device.

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

7. The biphasic porous implantable device of claim 4, wherein the additive is selected from at least one of:

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

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

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

10. The biphasic implantable device of claim 4 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.

19. The porous device of claim 1, wherein the two porous sheets define a plurality of containment spaces therebetween.

20. The porous device of claim 19, wherein the at least one high density porous zone defines a plane.

21. The porous device of claim 20, wherein said containment spaces are located above said plane.

22. The porous device of claim 20, wherein said containment spaces are located within said plane.

23. The porous device of claim 1, wherein said arrangement is random.

24. The porous device of claim 1, wherein said arrangement is organized.

11. 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

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

12. A porous device suitable for implantation in a living being, said porous device comprising:

(a) at least one non-porous sheet and at least one porous sheet layered together, the porous sheet layer comprising;

(i) a plurality of low density porous zones, and

(ii) at least one high density porous zone, wherein said plurality of low density porous zones are arranged within the at least one high density porous zone;

(b) wherein said at least two sheets are bonded to each other at said at least one high density porous zone;

(c) the non-porous sheet and the porous sheet defining a plurality of containment spaces therebetween;

(d) the non-porous sheet defining a surface of said porous device;

(e) the at least one high density porous zone defining a plane; and

(f) the containment spaces being located above said plane.

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

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

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

c) placing the porous polymeric sheet atop a non-porous sheet 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 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

f) 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.

14. A porous device suitable for implantation in a living being, said porous device:

(a) being in the form of a flexible/bendable sheet that comprises;

(b) at least one porous sheet and at least one non-porous sheet layered together, the layered sheets defining;

(i) a plurality of low density porous zones, and

(ii) at least one non-porous zone, wherein said plurality of low density porous zones are arranged within the at least one non-porous zone;

(c) wherein said at least two sheets are bonded to each other at said at least one non-porous zone.

15. The porous device of claim 14, wherein the non-porous sheet and the porous sheet define a plurality of containment spaces therebetween.

16. The porous device of claim 15, wherein the at least one non-porous zone defines a plane.

17. The porous device of claim 16, wherein said containment spaces are located above said plane.

18. The porous device of claim 16, wherein said containment spaces are located within said plane.