Surface treatments for promoting selective tissue attachment to medical impants

• US 9,119,901 B2
• Filed: 04/28/2005
• Issued: 09/01/2015
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H., Molz, Fred
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): HOBAN, MELISSA A
• Application Number:
  US11/116,378
• Publication Number:
  US 20060247793A1
• Time in Patent Office: 3,778 Days
• Field of Search: 623/23.72, 623/23.74, 623/23.76, 606/151, 606/155, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/30028 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61L 2300/414 Growth factors
• 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 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Embodiments include a method for promoting selective tissue attachment to medical implants. By treating implant surfaces where tissue attachment is desired with tissue attachment promoting treatments, and treating implant surfaces where tissue attachment is not desired with tissue attachment inhibiting treatments, selective tissue attachment to medical implants may be achieved. Also, embodiments include an implant with at least one tissue contacting surface and at least one secondary surface where tissue attachment is not desired, and appropriate tissue attachment promoting or inhibiting treatments on the surfaces.

Claims

1. A method for promoting selective endogenous tissue attachment to an osteoimplant, comprising:

providing an osteoimplant having at least one endogenous tissue contacting surface where endogenous tissue attachment is desired, and at least one endogeneous tissue contacting surface where endogenous tissue attachment is not desired;

treating surfaces of the osteoimplant where endogenous tissue attachment is desired with a tissue attachment promoting treatment; and

treating surfaces of the osteoimplant where endogenous tissue attachment is not desired with an endogenous tissue attachment inhibiting treatment

wherein the tissue attachment promoting treatment comprises a tissue attachment formulation comprising a series of growth factors in a time dependent release formulation, the formulation comprising at least two agents selected from the group consisting of vascular growth promoting agents or factors, collagen/cartilage stimulation agents, osteoconductive agents and/or osteoinductive agents, and mixtures thereof, the at least two agents being combined with a sustained release polymer or biodegradable polymer having variable release rates such that at least one agent is released prior to an at least second agent.

2. The method of claim 1, wherein the tissue attachment promoting treatment comprises administration of at least a vascular growth promoting formulation and a bone attachment promoting formulation to at least the implant surfaces where bone attachment is desired.

3. The method of claim 2, wherein the tissue attachment promoting formulation is applied by a process selected from the group consisting of soaking, dip-coating, spray-coating, solution coating, powder coating, and combinations thereof.

4. The method of claim 2, wherein the tissue attachment promoting formulation comprises at least one component selected from the group consisting of:

Bone Morphogenetic Proteins (BMPs), Osteoprotegerin, Connective Tissue Growth Factors (CTGFs), Vascular Endothelial Growth Factors (VEGFs), Transforming Growth Factor-betas (TGF-bs), Growth Differentiation Factors (GDFs), Cartilage Derived Morphogenic Proteins (CDMPs), Lim Mineralization Proteins (LMPs), hydroxyapatite (HA), tricalcium phosphate (TCP), collagen, fibronectin (FN), osteonectin (ON), endothelial cell growth factor (ECGF), cementum attachment extracts (CAE), ketanserin, human growth hormone (HGH), animal growth hormones, epidermal growth factor (EGF), human alpha thrombin, insulin-like growth factor (IGF), platelet derived growth factors (PDGF), fibroblast growth factors (FGF), and mixtures and combinations thereof.

5. The method of claim 1, wherein the endogenous tissue attachment inhibiting treatment comprises administration of a tissue attachment inhibiting formulation to at least the implant surfaces where endogenous tissue attachment is not desired.

6. The method of claim 5, wherein the tissue attachment inhibiting formulation comprises a component selected from the group consisting of chemotherapeutics, anti-adhesion agents, and mixtures and combinations thereof

7. The method of claim 5, wherein the tissue attachment inhibiting formulation is applied by a process selected from the group consisting of soaking, dip-coating, spray-coating, solution coating, powder coating, and combinations thereof.

8. The method of claim 1, wherein the endogenous tissue attachment inhibiting treatment comprises a physical transformation of at least the implant surfaces where endogenous tissue attachment is not desired.

9. The method of claim 8, wherein the physical transformation comprises the use of a process selected from the group consisting of:

polishing, buffing, polycrystalline diamond deposition, the application of smooth cladding, the application of bio-inert materials, the application of bio-resorbable materials, and combinations thereof.

17. The method of claim 1, wherein the tissue attachment formulation comprises vascular growth promoting agents or factors, collagen/cartilage stimulation agents, and osteoconductive and/or osteoinductive agents, each combined with a different sustained release polymer or biodegradable polymer having variable release rates.

18. The method of claim 17, wherein the tissue attachment formulation is configured to release the vascular growth promoting agents or factors first, the collagen/cartilage stimulation agents after the vascular growth promoting agents or factors, and the osteoconductive and/or osteoinductive agents last.

10. An osteoimplant comprising at least one endogenous tissue contacting surface, and at least one secondary endogenous tissue contacting surface where endogenous tissue attachment is not desirable, where the at least one endogenous tissue contacting surface comprises a tissue attachment promoting treatment, and the at least one secondary surface comprises an endogenous tissue attachment inhibiting treatment;

wherein the tissue attachment promoting treatment comprises a tissue attachment formulation comprising a series of growth factors in a time dependent release formulation, the formulation comprising at least two agents selected from the group consisting of vascular growth promoting agents or factors, collagen/cartilage stimulation agents, osteoconductive agents and/or osteoinductive agents, and mixtures thereof, the at least two agents being combined with a sustained release polymer or biodegradable polymer having variable release rates such that at least one agent is released prior to an at least second agent.

11. The osteoimplant of claim 10, wherein the tissue attachment promoting treatment comprises at least a vascular growth promoting formulation and a bone attachment promoting formulation on bone contacting surfaces of the implant.

12. The osteoimplant of claim 11, wherein the tissue attachment promoting formulation comprises a component selected from the group consisting of:

Bone Morphogenetic Proteins (BMPs), Osteoprotegerin, Connective Tissue Growth Factors (CTGFs), Vascular Endothelial Growth Factors (VEGFs), Transforming Growth Factor-betas (TGF-bs), Growth Differentiation Factors (GDFs), Cartilage Derived Morphogenic Proteins (CDMPs), Lim Mineralization Proteins (LMPs), hydroxyapatite (HA), tricalcium phosphate (TCP), collagen, fibronectin (FN), osteonectin (ON), endothelial cell growth factor (ECGF), cementum attachment extracts (CAE), ketanserin, human growth hormone (HGH), animal growth hormones, epidermal growth factor (EGF), human alpha thrombin, insulin-like growth factor (IGF), platelet derived growth factors (PDGF), fibroblast growth factors (FGF), and mixtures and combinations thereof.

13. The osteoimplant of claim 10, wherein the endogenous tissue attachment inhibiting treatment comprises a tissue attachment inhibiting formulation on at least one secondary surface.

14. The osteoimplant of claim 13, wherein the tissue attachment inhibiting formulation comprises a component selected from the group consisting of chemotherapeutics, anti-adhesion agents, and mixtures and combinations thereof

15. The osteoimplant of claim 10, wherein the endogenous tissue attachment inhibiting treatment comprises a physically transformed secondary surface.

16. The osteoimplant of claim 15, wherein the physically transformed secondary surface comprises a surface transformed by a process selected from the group consisting of:

polishing, buffing, polycrystalline diamond deposition, the application of smooth cladding, the application of bio-inert materials, the application of bio-resorbable materials, and combinations thereof

19. The osteoimplant of claim 10, wherein the tissue attachment formulation comprises vascular growth promoting agents or factors, collagen/cartilage stimulation agents, and osteoconductive and/or osteoinductive agents, each combined with a different sustained release polymer or biodegradable polymer having variable release rates.

20. The osteoimplant of claim 19, wherein the tissue attachment formulation is configured to release the vascular growth promoting agents or factors first, the collagen/cartilage stimulation agents after the vascular growth promoting agents or factors, and the osteoconductive and/or osteoinductive agents last.