Coatings on medical implants to guide soft tissue healing

• US 8,414,907 B2
• Filed: 04/28/2005
• Issued: 04/09/2013
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Molz, Fred, Felton, Sharonda
• Primary Examiner(s): GULLEDGE, BRIAN M
• Application Number:
  US11/116,414
• Publication Number:
  US 20060246105A1
• Time in Patent Office: 2,903 Days
• Field of Search: 424/423
• US Class Current: 424/423
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 27/34 Macromolecular 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
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

Embodiments include coatings or surface treatments for medical instruments, devices, and/or implants that promote soft tissue healing. More particularly, embodiments relate to treating portions of instruments, devices, and implants where tissue healing is desired with tissue healing promoting treatments.

Claims

1. A medical implement selected from the group consisting of trocars, cannulas, expandable cannulas, endoscopes, rongeurs, curettes, trephines, catheters, scalpels, clamps, sponges, rotary cutters, guide sleeves, vertebral body distractors, rescetors, retractors, guide wires, fusion cages, cervical and lumbar plates, rods, screws, hooks, anchors, fasteners, ligaments, nucleus replacement devices, intramedullary nails, clamps, facet arthroplasty devices, distraction balloons, facet spacers, intervertebral spacers, cautery devices, bovie, and swabs;

wherein the medical implement comprises a tissue healing promoting coating disposed on at least a portion of its surface, the tissue healing promoting coating comprising;

(a) at least one anti-adhesion agent,

(b) at least one beneficial additive selected from the group consisting of antibiotics, antiretroviral drugs, anti-inflammatory agents, analgesics, immunosuppressives, substances that enhance isotonicity and chemical stability, and mixtures thereof,

(c) a tissue attachment or growth promoting agent, and

(d) a collagen/cartilage stimulation agent,

wherein the anti-adhesion agent is encapsulated in a first polymer, the beneficial additive is encapsulated in a second polymer, the tissue attachment or growth promoting agent is encapsulated in a third polymer, and the collagen/cartilage stimulation agent is encapsulated in a fourth polymer,

wherein the first, second, third, and fourth polymers are capable of differential release of the anti-adhesion agent, beneficial additive, tissue attachment or growth promoting agent, and the collagen/cartilage stimulation agent, the fourth polymer being configured to release the collagen/cartilage stimulation agent after the at least one anti-adhesion agent is released from the first polymer; and

wherein at least a portion of the surface of the medical implement includes nano-scale surface features configured to promote tissue growth.

2. The medical implement of claim 1, wherein the tissue healing promoting coating further comprises an osteoinductive agent or an osteoconductive agent, the osteoinductive agent or osteoconductive agent being encapsulated in a fifth polymer configured to release the osteoconductive agent or osteoinductive agent after the collagen/cartilage stimulation agent is released from the fourth polymer.

3. The medical implement of claim 1, wherein the anti-adhesion agent comprises polyethylene glycol.

4. The medical implement of claim 1, wherein the anti-adhesion agent comprises glucosamine.

5. The medical implement of claim 1, wherein the anti-adhesion agent comprises an agent selected from the group consisting of alkyd polyesters, polyvinyl alcohol, polyhydroxyalkanoate polymers, polyethylene oxide (PEO), fluorocarbons, and mixtures thereof.

6. The medical implement of claim 1, wherein the anti-adhesion agent is selected from the group consisting of alginates, chitosan, collagen, fibrinogen, hyaluronic acid, lactides, phospholipids, polysaccharides, and mixtures thereof.

7. The medical implement of claim 2, wherein the osteoconductive or osteoinductive agent is selected from the group consisting of one or more isolated osteoinductive agents selected from the group consisting of one or more Bone Morphogenic Proteins (BMPs), one or more Vascular Endothelial Growth Factors (VEGFs), one or more Connective Tissue Growth Factors (CTGFs), one or more Growth Differentiation Factors (GDFs), one or more Cartilage Derived Morphogenic Proteins (CDMPs), one or more Lim Mineralization Proteins (LMPs), one or more Transforming Growth Factor-betas (TGF-Ps), and any combination thereof.

8. The medical implement of claim 7, wherein the one or more isolated osteoinductive agents are selected from the group consisting of:

a) BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-15, BMP-16, BMP-17, BMP-18, and any combination thereof;

b) CTGF-1, CTGF-2, CGTF-3, CTGF-4, and any combination thereof;

c) VEGF-A, VEGF-B, VEGF-C, VEGF-D, VEGF-E, and any combination thereof;

d) GDF-1, GDF-2, GDF-3, GDF-7, GDF-10, GDF-11, GDF-15, and any combination thereof;

e) CDMP-1, CDMP-2, LMP-1, LMP-2, LMP-3, and any combination thereof;

f) TGF-P-1, TGF-a-2, TGF-P-3, and any combination thereof; and

g) any combination of one or more members of these groups.

9. A method of performing a spinal surgery comprising:

making an incision in the skin of a patient;

accessing the surgical site using minimally invasive procedures;

preparing the surgical site;

optionally implanting a spinal implant at the surgical site; and

closing the incision, whereby one or more of the procedures is carried out using the medical implement as claimed in claim 1.

10. The method of claim 9, wherein use of the medical implement results in release of tissue healing promoting formulations to the tissue adjacent the surgical site.

11. The method of claim 9, wherein accessing the surgical site comprises:

placing a guide wire through the incision to the surgical site; and

serially dilating the patient'"'"'s tissue using a series of consecutively larger diameter cannulas to prepare a channel to the surgical site, the channel capable of accepting surgical instruments useful in the surgery.

12. The method of claim 11, wherein the guide wire and each consecutively larger diameter cannula comprises a tissue healing promoting treatment on at least a portion of its surface, the tissue healing promoting treatment comprising at least an anti-adhesion agent.

13. The method of claim 9, wherein preparing the surgical site comprises expanding an expandable member coated with a tissue healing promoting treatment on at least a portion of its surface, the tissue healing promoting treatment comprising at least an anti-adhesion agent.

14. A kit comprising the medical implement of claim 1.

15. The kit of claim 14, wherein the tissue healing promoting coating and the medical implement are packaged separately.

17. The medical implant of claim 1, wherein the anti-adhesion agent is selected from the group consisting of cellulose and fibrin.

18. The medical implement of claim 1 wherein the nano-scale surface features configured to promote tissue growth includes appropriately sized pores and/or surface roughening.

20. The medical implant of claim 1, wherein the third polymer is configured to release the tissue attachment or growth promoting agent after or coincident with the release of the at least one anti-adhesion agent from the first polymer.

16. A medical implement selected from the group consisting of trocars, cannulas, expandable cannulas, endoscopes, rongeurs, curettes, trephines, catheters, scalpels, clamps, sponges, rotary cutters, guide sleeves, vertebral body distractors, resectors, retractors, guide wires, fusion cages, cervical and lumbar plates, rods, screws, hooks, anchors, fasteners, ligaments, nucleus replacement devices, intramedullary nails, clamps, facet arthroplasty devices, distraction balloons, facet spacers, intervertebral spacers, cautery devices, bovie, and swabs;

wherein the medical implement comprises a surface, wherein at least a portion of the surface is impregnated with a tissue healing promoting agent comprising;

(a) at least an anti-adhesion agent,

(b) at least one beneficial additive selected from the group consisting of antibiotics, antiretroviral drugs, anti-inflammatory agents, analgesics, immunosuppressives, substances that enhance isotonicity and chemical stability, and mixtures thereof,

(c) a tissue attachment or growth promoting agent, and

(d) a collagen/cartilage stimulation agent,

wherein the anti-adhesion agent is encapsulated in a first polymer, the beneficial additive is encapsulated in a second polymer, the tissue attachment or growth promoting agent is encapsulated in a third polymer, and the collagen/cartilage stimulation agent is encapsulated in a fourth polymer,

wherein the first, second, third, and fourth polymers are capable of differential release of the anti-adhesion agent, beneficial additive, tissue attachment or growth promoting agent and collagen/cartilage stimulation agent, the fourth polymer being configured to release the collagen/cartilage stimulation agent after the anti-adhesion agent is released from the first polymer; and

wherein at least a portion of the surface of the medical implement includes nano-scale surface features configured to promote tissue growth.

19. The medical implement of claim 16 wherein the nano-scale surface features configured to promote tissue growth includes appropriately sized pores and/or surface roughening.

21. The medical implant of claim 16, wherein the third polymer is configured to release the tissue attachment or growth promoting agent after or coincident with the release of the anti-adhesion agent from the first polymer.