Implantable medical devices having microporous surface layers and method for reducing foreign body response to the same

• US 8,647,393 B2
• Filed: 12/18/2012
• Issued: 02/11/2014
• Est. Priority Date: 11/25/2009
• Status: Active Grant

• Current Assignee: Healionics Corporation
• Original Assignee: Healionics Corporation
• Inventors: Marshall, Andrew J., Alvarez, Michel, Maginness, Max
• Primary Examiner(s): FISHER, ABIGAIL L
• Application Number:
  US13/718,847
• Publication Number:
  US 20130236502A1
• Time in Patent Office: 420 Days
• Field of Search: 424/422, 424/400, 424/423, 623/23.74
• US Class Current: 623/23.74
• 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 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: Y10T 428/12479 Porous [e.g., foamed, spongy, cracked, etc.]
• CPC Class Codes: Y10T 428/24355 Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]
• CPC Class Codes: Y10T 428/249979 Specified thickness of void-containing component [absolute or relative] or numerical cell dimension

Abstract

This disclosure provides implantable devices coated with microporous surface layers with macrotopographic features that improve bio-integration at the interface of the implantable devices and the surrounding tissue.

Claims

1. A microporous biomaterial comprising macrotopographic surface features and a plurality of pores, wherein substantially all the pores are each interconnected to at least 2 other pores, a mean diameter of the pores is between about 5 and about 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between about 5 micrometers and about 50 micrometers, and wherein the macrotopography is defined by a plurality of peaks and valleys, wherein each peak is microporous and has a height of between about 100 micrometers and about 2000 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured, wherein the microporous biomaterial comprises an open-cell structure throughout.

2. The microporous biomaterial of claim 1, wherein the surface of the floor of the valleys between the peaks is microporous.

3. The microporous biomaterial of claim 1, wherein the biomaterial is permeable to fluids or electrolytes.

4. The microporous biomaterial of claim 1, wherein the mean pore diameter is between about 20 and about 40 micrometers.

5. The microporous biomaterial of claim 1, wherein the height of each peak is between about 100 micrometers and about 500 micrometers.

6. The microporous biomaterial of claim 1, wherein the biomaterial is a hydrogel, silicone rubber, expanded fluoropolymer, a polymer or a metal.

7. The biomaterial of claim 1, wherein the biomaterial has a thickness of at least 40 micrometers excluding the height of the peaks.

8. An implantable device comprising:

a device body; and

the microporous biomaterial of claim 1 overlying the device body.

9. The implantable device of claim 8, further comprising an intermediate layer interposed between the device body and the microporous surface layer.

10. The implantable device of claim 9, wherein the intermediate layer is an adhesive layer.

11. The implantable device of claim 9, wherein the intermediate layer is a conformal sheath that covers a part of or an entire native surface of the device body.

19. A method for reducing implantable device-related foreign body response comprising:

implanting an implantable device comprising;

a device body; and

the microporous biomaterial of claim 1.

20. A method for reducing risk of implantable device-related infection comprising:

implanting an implantable device comprising;

a device body; and

the microporous biomaterial of claim 1.

22. A method for promoting angiogenesis comprising:

implanting an implantable device comprising;

a device body; and

the microporous biomaterial of claim 1.

12. An implantable device comprising:

a device body; and

a textured surface layer overlying the device body, wherein the textured surface layer comprises one or more granules of a microporous biomaterial, the granules forming a surface macrotopography that includes a plurality of peaks and valleys, each peak having a height of between about 100 micrometers and about 2000 micrometers, and wherein each granule comprises a plurality of interconnecting pores having a mean pore diameter of between about 5 and 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between 5 and 50 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.

13. The implantable device of claim 12 wherein the mean pore diameter is between about 20 and about 40 micrometers.

14. The implantable device of claim 12, wherein the height of each peak is between about 200 micrometers and about 1000 micrometers.

15. The implantable device of claim 12, further comprising an intermediate layer interposed between the device body and the textured surface layer.

16. The implantable device of claim 15, wherein the intermediate layer is an adhesive layer.

17. The implantable device of claim 15, wherein the intermediate layer is a conformal sheath that covers a part of or an entire native surface of the device body.

18. The implantable device of claim 12 , wherein the textured surface layer covers more than 80%, or more than 90% of a total area of a native surface of the device body.

21. A method for reducing risk of implantable device-related infection comprising:

implanting the implantable device of claim 12.

23. A method for promoting angiogenesis comprising:

implanting the implantable device of claim 12.

24. A method for reducing implantable device-related foreign body response comprising:

implanting the implantable device of claim 12.

25. The implantable device of claim 15 wherein the floor of the valley is an exposed portion of the surface of the underlying device body or an exposed portion of the intermediate layer.