WO2001078799A1

WO2001078799A1 - Coated anchoring device

Info

Publication number: WO2001078799A1
Application number: PCT/US2001/012112
Authority: WO
Inventors: Jeffry B. Skiba
Original assignee: Orthopaedic Biosystems Ltd., Inc.
Priority date: 2000-04-14
Filing date: 2001-04-13
Publication date: 2001-10-25
Also published as: AU2001253461A1; WO2001078799A9

Abstract

A coated/impregnated anchoring device and/or suture to prevent infection, deliver site specific drugs, and deliver human growth factors to the surgical site. The coatings can include anti-microbial agents to prevent or fight infection en route to and at the surgical site. The coatings can also include site specific drugs and/or human growth factors to fight infection, anesthetize tissue and/or bone en route and at the site, promote tissue regeneration, promote bone regeneration, and/or other desired medical processes.

Description

COATED ANCHORING DEVICE

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention generally relates to an anchoring device and/or suture and methods for its use. More particularly, the present invention relates to a coated anchoring device and/or suture and methods for its use.

2. Background Art and Technical Problems

In many surgical procedures requiring tissue to tissue, tissue to bone, and bone to bone fixation, anchoring devices are used in conjunction with a suture to secure the fixation site. For example, the anchoring device could be a screw to join tissue and/or bone, and the suture could be a type of stitch to bind the tissue and/or bone. The anchoring device and/or suture are susceptible to bacteria at every stage of insertion, from external to the body to internal to the tissue and/or bone. Although sterile conditions are desired at each stage of insertion, in practice, that is not always possible. For example, bacteria may originate outside the body and then use the anchoring device and/or suture as a vehicle for invading the body. Alternatively, bacteria may already exist inside the body and the anchoring device and/or suture may carry such bacteria to other areas continuing the infection process.

Sutures are available as both monofilaments and braided filaments with the filaments being comprised of a variety of polymers. The most common suture is a braided polyester.

Wicking of bacteria in the suture can be a concern. Braided filaments possess interstices which are sites where bacteria can proliferate. As these bacterial colonies outgrow their P T/US01/12112

homes, they begin to migrate further into the suture causing wicking. Thus, wicking is the process of bacteria infecting the suture and/or surrounding areas.

Sutures may be comprised of a variety of materials including, but not limited to, cellulose (cotton), protein-cellulose (silk), processed collagen (catgut), nylon, polypropylene, Aramid, polyglycolic acid, polyesters, polytetraflourethylene, steel, copper, silver, aluminum, various alloys, Mersilene™, Ticron™, Ethilon™, Prolene™, Ethiflex™, Polyglactin 910™, polyglycolide-lactide polymer (e.g., Vicryl™), polydioxanone (e.g., PDS™), polyglecaprone 25 (e.g., Monocryl™), polyglyconate (e.g., Maxon™), and Ethibond™. In other areas of medicine, known methods for reducing the potential for site infection include coatings on catheters or external fixation pins. One common anti-microbial used in these applications is metallic silver. For example, catheters coated with silver have already shown a reduction in infections of the urinary tract where they are used. In addition, antibiotic-impregnated cement has been used for postoperative infections. Fish et al., 49 Amer Jour Hosp Pharm 2469 (Oct 1992). For implant infections, an antibiotic-impregnated silicone rubber coating has been used to cover the implant devices. Rushton et al., 52 Jour of Neurology, Neurosurgery, and Psychiatry 223 (1989). Also, recombinant human Transforming Growth Factor-Bl adsorbed onto ceramic implants has been shown to improve bone cell repair. Overgaard et al., 43rd Annual Meeting of the Orthopedic Research Society (San Francisco, California, February 9-13, 1997).

However, prior art devices and methods for reducing infection and expediting healing have mainly been directed to implants alone. Such devices and methods have failed to address other key elements introduced into the body during surgery, such as sutures and the problems associated with those elements, such as wicking. Accordingly, a method and apparatus which substantially reduce infection, expedite the healing process, and reduce the problems associated with wicking are needed.

SUMMARY OF THE INVENTION

The present invention includes a coated/impregnated anchoring device and/or suture which prevents infection, delivers site specific drugs, promotes tissue regeneration, and/or promotes bone regeneration in a variety of medical procedures. Coatings for the coated anchoring device and/or suture may include anti-microbial agents for fighting infection, site specific drugs for delivering drugs, or human growth factors for delivering growth factors.

Thus, the present invention substantially reduces infection, expedites the healing process, and provides easier drug delivery.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The subject invention will hereinafter be described in the context of the appended drawing figures, wherein like numerals denote like elements, and: Figure 1 illustrates a prior art anchoring device; Figure 2 illustrates a prior art suture and a prior art braided polyester suture;

Figure 3 illustrates a coated anchoring device of the present invention; Figure 4 illustrates an anchoring device and suture of the present invention inserted into a shoulder;

Figure 5 illustrates a suture of the present invention; and Figure 6 illustrates a method of coating/impregnating an anchoring device and/or a suture in accordance with the present invention.

DETAILED DESCRIPTION

As discussed above, surgical anchoring devices are used in conjunction with surgical sutures to secure the fixation site. Since infection at the operative site and beyond can be a concern, the present invention combines an anti-microbial coating with the anchor and/or suture system commonly used by the surgeon. The present invention adds such a coating to the anchor and/or suture to prevent and reduce infection. The present invention can be used with any ir plantable surgical device where infection is a potential problem.

Other embodiments disclosed are site specific drug delivery coatings and human growth factor coatings using the existing anchors and/or sutures. For example, anchors and/or sutures comprising certain polymers have the ability to bond to drugs or human growth factors and subsequently release those substances to influence the area into which they are implanted. Figure 1 illustrates a prior art anchoring device 101 including spiral screw edges 103, a suture hole 105, and a tip 107. As discussed above, anchoring device 101 can be used to attach tissue to tissue, tissue to bone, and/or bone to bone. In addition, anchoring device 101 may be used to attach prosthetic or other materials foreign to the body to tissue and/or bone in the body. The spiral screw edges 103 allow anchoring device 101 to be driven into the tissue and/or bone. In addition, tip 107 provides a sharp edge for the initial insertion or further penetration into the tissue and/or bone. Many metallic and polymeric anchors are available to the surgeon. For example, anchors can be made of any biocompatible material. Examples of biocompatible materials include at least one of stainless steel, titanium, animal bone, cadaveric bone, absorbables, polymers, and the like. Furthermore, examples of polymers include polyester, nylon, poly lactic acid (PLA), poly-L lactic acid (PLLA), poly glycolic acid (PGA), or other bioabsorbable polymer materials.

Figure 2 illustrates a first prior art suture 201 and a second prior art suture 203. First suture 201 shows a generic suture used to fix tissue and or bone to tissue and/or bone. First suture 201 loops through anchoring device 101 of Figure 1 through suture hole 105 to anchor the tissue and/or bone to tissue and/or bone. Likewise, first suture 201 can be used independently to join tissue and/or bone, as is commonly done in stitching.

First suture 201 and second suture 203 can be made of a variety of materials for a variety of uses. For example, second suture 203 is available as a plurality of monofilaments that are braided together where the monofilaments are comprised of a variety of polymers, the most common being braided polyester. The braided interstices 205 and 207 of a braided polyester second suture 203 show where bacteria can proliferate, as discussed above. Thus, wicking of bacteria in the suture can be a concern.

Figure 3 illustrates the present invention embodied in an anchoring device 301. A coating 303 covers anchoring device 301 either partially or completely depending on the desired use. As such, a predetermined portion of anchoring device 301 may be coated depending on the desired use. Additionally, anchoring device 301 may be impregnated by coating 303. Coating 303 can be at least one of an anti-microbial agent, a site specific drug, human growth factors, and the like. The anti-microbial agents prevent the anchoring device and/or a suture from carrying or transferring infection during insertion of the anchoring device into tissue and/or bone, or at subsequent levels of insertion. The anti-microbial agents create effective barriers to the proliferation of bacteria on or around the anchoring device and/or the suture. In addition, the present invention places effective barriers to the proliferation of bacteria within the suture itself using anti-microbial agents that can be coated, impregnated, and/or bonded to the suture. For example, suitable coatings include at least one of silver, Silicone Rubber Coating, Fibrin Glue, Polymethylmethacrylate (PMMA) Cement, Hydroxyapatite Cement, PMMA Beads, Antibiotic Spray, Biodegradable Collagens, Liposomes, Collagen scaffold, Poylactuc acid microcapsules, Poly-L-lactic Acid (PLLA) scaffold, Polyhydroxyethyl ^' methacrylate (pHEMA), Polyvinylalcohol and gum arabica blend matrix, Xerogel discs using a sol-gel process, and the like. Such suitable coatings may include one or more antimicrobial agents, such as gentamycin, benzethonium chloride, acid antibiotics, penicillin, high-heparin content polyquaternary polyurethane elastomers, cephlosporins, penicillanic acids, vancomycin, neomycin, erythromycin, streptomycin, cycloserine, tetracycline, aureomycin, terramycin (oxtetracycline) gentamycin, or polymyxin B, and the like.

Site specific drugs can, for example, enhance tissue or bone regeneration, treat local infection, anesthetize an area, and/or treat a variety of problems. The present invention provides a vehicle for transferring such site specific drugs to the necessary area, such as tissue and/or bone. Alternatively, or in conjunction with the anti-microbial, such site specific drugs may be needed at different levels of insertion of the anchoring device and/or the suture.

For example, site specific drugs include at least one of Tobramycin, Gentamicin, Cefazolin,

Vancomycin, Cephalothin, Oxacillin-nafcillin, Ceftriaxone, Cefuroxime, Unspecified cephalosporin, Bacitracin, Erythromycin-colistin, Polymyxin B, and the like. Human growth factors can also enhance tissue and/or bone regeneration or stimulate other desired processes in or around tissue and/or bone. Once again, the present invention provides a vehicle in which such human growth factors can be transferred to the necessary area. Alternatively, or in conjunction with the anti-microbial and/or the site specific drugs, such human growth factors may be needed at different levels of insertion of the anchoring device and/or the suture. For example, anchoring devices made of certain polymers have the capability to bond to drugs or human growth factors and subsequently release the drugs or factors into the necessary area. Examples of such human growth factors include at least one of human growth hormones, morphogenic proteins, Transforming Growth Factor 1, Recombinant Human TGF- 1 , Bone Morphogenetic Protein- 1 , Recombinant Human BMP -2, Osteogenic growth peptide, Recombinant Human Growth Hormone, Basic fibroblast Growth Factor, Hepatocyte Growth Factor, and the like.

Coating 303 may be placed on anchoring device 301 and/or a suture (not shown) using a number of different techniques. As discussed above in relation to anchoring device 301, a predetermined portion of the suture may be coated based on the desired use. Any technique that leaves an effective residual on the anchoring device 301 and/or the suture is adequate. For example, possible techniques for applying the suitable coating to anchoring device 301 and/or the suture include at least one of plasma deposition, dipping, wiping, and the like. As long as an effective residual coats the anchoring device and/or the suture, it will be adequate. If the accompanying suture is covered with a metal, then it may be necessary to cover that part of the suture which contacts anchoring device 301 with the suitable coating.

Covering the suture with the suitable coating would reduce the potential for galvanic reactions, electrolysis, reactions at the surface, or the like. A separate embodiment would be a suture which is only partially coated. In addition, anchoring device 301 and/or the suture may be impregnated by coating

303 by any suitable method. For example, anchoring device 301 and/or the suture may be impregnated by coating 303 by compounding, which entraps coating 303 into the biocompatible material that anchoring device 301 and/or the suture are made of. By way of illustration, if anchoring device 301 and the suture are made of a polymer, then mechanical compounding will entrap coating 303 between the interstices of the matrix of the polymer material. Another example of impregnating coating 303 into anchoring device 301 and/or the suture is by chemically bonding coating 303 into the biocompatible material of anchoring device 301 and/or the suture. Thus, mechanically entrapping coating 303 or chemically bonding coating 303 into anchoring device 301 and/or the suture are two examples of methods by which anchoring device 301 and/or the suture may be impregnated by coating 303. Of course, those skilled in the art will appreciate that various other methods of impregnation are available.

Figure 4 illustrates how an anchoring device 407 may need to travel through several stages of insertion into a shoulder 401. Shoulder 401 depicts anchoring device 407 with suture 405 traveling through surface tissue 402, muscle and/or ligament 403, and bone 409.

At each level of penetration, anchoring device 407 and suture 405 are susceptible to bacteria.

A coating on anchoring device 407 and/or suture 405, as discussed above, would prevent such bacteria from proliferating on surface tissue 402, muscle and/or ligament 403, and/or bone 409. Alternatively, or in conjunction with preventing proliferation of bacteria, each ^• level of penetration may require delivery of site specific drugs or human growth factors to the necessary area. The present invention which includes anchoring device 407 and/or suture 405 with a suitable coating could deliver such drugs or factors to the necessary area.

To further illustrate the present invention as applied to a suture 501, refer to Figure 5. Suture 501 includes a braided section 503, an interstice 505, and an individual fiber 507.

In between several braided sections 503, interstices 505 may become infected and cause wicking, as described above. Also, in between individual fibers 507, bacteria and infection can cause wicking. A coating 509, similar to coating 303 of Figure 3, applied to a predetermined portion of suture 501 may reduce infection, expedite the healing process, and provide easier drug delivery. Coating 509 may be applied to braided section 503, interstice 505, and/or individual fiber 507, and may either partially cover or entirely encapsulate braided section 503, interstice 505, and/or individual fiber 507. In addition, braided section 503, interstice 505, and/or individual fiber 507 may be impregnated with coating 509. Thus, Figure 5 illustrates one embodiment of the present invention as applied to suture 501. Referring now to Figure 6, flowchart 601 of the present invention illustrates one method of coating/impregnating an anchoring device and/or a suture. In step 603, an anchoring device and/or suture are coated with a suitable coating. Of course, as discussed above, step 603 may alternatively, or also involve impregnating the anchoring device and/or the suture with one or more of an anti-microbial, a site specific drug, or a human growth

- / 01 12112

factor. The suitable coating controls infection in step 605, delivers site specific drugs in step 607, and/or delivers human growth factors in step 609. As discussed above, controlling infection in step 605 may involve using at least one anti-microbial, delivering site specific drugs in step 607 may include at least one of enhancing tissue or bone regeneration, treating local infection, or anesthetizing an area, and delivering human growth factors in step 609 may enhance tissue or bone regeneration, or stimulate other desired processes.

Tissue and/or bone to tissue and/or bone fixation represents one use for the devices and methods embodied in the present invention. Risk of infection is one of the most critical elements in a surgical procedure. Addition of a barrier to infection and prophelactic methods adds an additional level of protection for the patient which can be effective at the implant site and is an improvement over related anchors and/or sutures. In addition, other embodiments of the present invention include coating (and/or impregnating) the anchoring device and/or suture with site specific drugs and/or human growth factors to promote tissue regeneration, bone regeneration, or other desired bodily processes. Although the invention has been described herein with reference to the appended drawing figures, it will be appreciated that the scope of the invention is not so limited. Various modifications in the design and implementation of various components and method steps discussed herein may be made without departing from the spirit and scope of the invention, as set forth in the appended claims.

Claims

2112CLAIMSWhat is claimed is:

1. A medical device comprising: a surgical anchoring device; and a coating covering a predetermined portion of said surgical anchoring device, wherein said coating includes at least one of an anti-microbial, a site specific drug, or a human growth factor.

2. The device of claim 1 wherein said surgical anchoring device is comprised of a biocompatible material.

3. The device of claim 2 wherein said biocompatible material includes at least one of a stainless steel, a titanium, a polymer, a bone, or an absorbable.

4. The device of claim 3 wherein said polymer includes at least one of a polyester, a nylon, a poly lactic acid (PLA), a poly-L lactic acid (PLLA), or a poly glycolic acid (PGA).

5. The device of claim 1 further comprising a surgical suture.

6. The device of claim 5 wherein said surgical suture is comprised of a biocompatible material including at least one of a polymer, a cellulose based (cotton), a protein-cellulose (silk), a processed collagen (catgut), a nylon, a polypropylene, an Aramid, a polyglycolic acid, a polyesters, a polytetraflourethylene, a steel, a copper, a silver, an aluminum, an alloy, a polyglycolide-lactide polymer, a polydioxanone, a polyglecaprone 25, or a polyglyconate.

7. The device of claim 5 wherein a predetermined portion of said surgical suture is coated with at least one of a bactericide, a site specific drug, or a human growth factor.

8. The device of claim 5 wherein said surgical suture is impregnated with at least one of an anti-microbial, a site specific drug, or a human growth factor.

9. The device of claim 1 wherein said coating includes at least one of: a silver, a Silicone Rubber Coating, a Fibrin Glue, a Polymethylmethacrylate (PMMA) Cement, a Hydroxyapatite Cement, a plurality of PMMA Beads, an Antibiotic Spray, a Biodegradable Collagen, a Liposomes, a Collagen scaffold, a Poylactuc acid microcapsule, a Poly-L-lactic Acid (PLLA) scaffold, a Polyhydroxyethyl methacrylate (pHEMA), a Polyvinylalcohol and a gum arabica blend matrix, or a plurality of Xerogel discs using a sol- gel process; and a gentamycin, a benzethonium chloride, an acid antibiotic, a penicillin, a high- heparin content polyquaternary polyurethane elastomer, a cephlosporin, a penicillanic acid, a vancomycin, a neomycin, an erythromycin, a streptomycin, a cycloserine, a tetracycline, an aureomycin, a terramycin (oxtetracycline) gentamycin, or a polymyxin B.

10. The device of claim 1 wherein said site specific drug includes at least one of a Tobramycin, a Gentamicin, a Cefazolin, a Vancomycin, a Cephalothin, an Oxacillin- nafcillin, a Ceftriaxone, a Cefuroxime, an Unspecified cephalosporin, a Bacitracin, an Erythromycin-colistin, or a Polymyxin B.

11. The device of claim 1 wherein said human growth factor includes at least one of a human growth hormone, a morphogenic protein, a Traiisforrning Growth Factor 1, a Recombinant Human TGF-1, a Bone Morphogenetic Protein- 1, a Recombinant Human BMP-2, an Osteogenic growth peptide, a Recombinant Human Growth Hormone, a Basic fibroblast Growth Factor, or a Hepatocyte Growth Factor.

12. The device of claim 1 wherein: said coating includes at least one of a silver, a Silicone Rubber Coating, a Fibrin Glue, a Polymethylmethacrylate (PMMA) Cement, a Hydroxyapatite Cement, a plurality of PMMA Beads, an Antibiotic Spray, a Biodegradable Collagen, a Liposomes, a Collagen scaffold, a Poylactuc acid microcapsule, a Poly-L-lactic Acid (PLLA) scaffold, a Polyhydroxyethyl methacrylate (pHEMA), a Polyvinylalcohol and a gum arabica blend matrix, or a plurality of Xerogel discs using a sol-gel process; said coating also includes at least one of a gentamycin, a benzethonium chloride, an acid antibiotic, a penicillin, a high-heparin content polyquatemary polyurethane elastomer, a cephlosporin, a penicillanic acid, a vancomycin, a neomycin, an erythromycin, a streptomycin, a cycloserine, a tetracycline, an aureomycin, a terramycin (oxtetracycline) gentamycin, or a polymyxin B; and a surgical suture comprised of a biocompatible material, and wherein said surgical suture is coated with said coating.

13. . The device of claim 12 wherein said coating further includes said site specific drug, and wherein: said site specific drug includes at least one of a Tobramycin, a Gentamicin, a Cefazolin, a Vancomycin, a Cephalothin, an Oxacillin-nafcillin, a Ceftriaxone, a Cefuroxime, an Unspecified cephalosporin, a Bacitracin, an Erythromycin-colistin, or a Polymyxin B.

14. The device of claim 13 wherein said coating is impregnated into at least one of said surgical anchoring device or said surgical suture.

15. The device of claim 13 wherein said coating further includes said anti- microbial agent, and wherein: said anti-microbial agent includes a gentamycin, a benzethonium chloride, an acid antibiotic, a penicillin, a high-heparin content polyquatemary polyurethane elastomer, a cephlosporin, a penicillanic acid, a vancomycin, a neomycin, an erythromycin, a streptomycin, a cycloserine, a tetracycline, an aureomycin, a terramycin (oxtetracycline) gentamycin, and a polymyxin B.

16. The device of claim 15 wherein said coating is impregnated into at least one of said surgical anchoring device or said surgical suture.

17. The device of claim 15 wherein said coating further includes said human growth factor, and wherein: said human growth factor includes at least one of a human growth hormone, a morphogenic protein, a Transforming Growth Factor 1, a Recombinant Human TGF-1, a Bone Morphogenetic Protein- 1, a Recombinant Human BMP -2, an Osteogenic growth peptide, a Recombinant Human Growth Hormone, a Basic fibroblast Growth Factor, or a Hepatocyte Growth Factor.

18. The device of claim 17 wherein said coating is impregnated into at least one of said surgical anchoring device or said surgical suture.

19. A method for coating an anchoring device comprising the steps of: coating said anchoring device with a suitable coating; and configuring said suitable coating to include at least one of controlling infection, delivering site specific drugs, or delivering human growth factors.

20. The method of claim 19 further comprising the step of coating a suture with said suitable coating.

21. The method of claim 20 wherein said suture is comprised of a biocompatible material including at least one of a polymer, a cellulose based (cotton), a protein-cellulose (silk), a processed collagen (catgut), a nylon, a polypropylene, an Aramid, a polyglycolic acid, a polyesters, a polytetraflourethylene, a steel, a copper, a silver, an aluminum, an alloy, a polyglycolide-lactide polymer, a polydioxanone, a polyglecaprone 25, or a polyglyconate.

22. The device of claim 20, wherein said suture is comprised of braided filaments having interstices and said suitable coating covers a predetermined portion of said interstices of said suture.

23. The device of claim 22 wherein said suitable coating is impregnated into said suture.

24. The method of claim 19 wherein said anchoring device is comprised of a

' ~ - - biocompatible material wherein said biocompatible material includes at least one of a stainless steel, a titanium, a polymer, a bone, or an absorbable.

25. The method of claim 24 wherein said polymer includes at least one of a polyester, a nylon, a poly lactic acid (PLA), a poly-L lactic acid (PLLA), or a poly galactic acid (PGA).

26. The method of claim 20 wherein said suitable coating comprises at least one of a silver, a Silicone Rubber Coating, a Fibrin Glue, a Polymethylmethacrylate (PMMA) Cement, a Hydroxyapatite Cement, a plurality of PMMA Beads, an Antibiotic Spray, a Biodegradable Collagen, a Liposomes, a Collagen scaffold, a Poylactuc acid microcapsule, • ^'' a Poly-L-lactic Acid (PLLA) scaffold, a Polyhydroxyethyl methacrylate (pHEMA), a Polyvinylalcohol and a gum arabica blend matrix, or a plurality of Xerogel discs using a sol- gel process; and a gentamycin, a benzethonium chloride, an acid antibiotic, a penicillin, a high- heparin content polyquatemary polyurethane elastomer, a cephlosporin, a penicillanic acid, a vancomycin, a neomycin, an erythromycin, a streptomycin, a cycloserine, a tetracycline, an aureomycin, a terramycin (oxtetracycline) gentamycin, or a polymyxin B.

27. The device of claim 26 wherein said suitable coating is impregnated into at least one of said anchoring device or said suture.

28. The method of claim 20 wherein said suitable coating comprises at least one site specific drug including a Tobramycin, a Gentamicin, a Cefazolin, a Vancomycin, a Cephalothin, an Oxacillin-nafcillin, a Ceftriaxone, a Cefuroxime, an Unspecified cephalosporin, a Bacitracin, an Erythromycin-colistin, or a Polymyxin B.

29. The device of claim 28 wherein said suitable coating is impregnated into at least one of said anchoring device or said suture.

30. The method of claim 20 wherein said suitable coating comprises at least one human growth factor including a human growth hormone, a morphogenic protein, a Transforming Growth Factor 1, a Recombinant Human TGF-1, a Bone Morphogenetic Protein- 1, a Recombinant Human BMP -2, an Osteogenic growth peptide, a Recombinant Human Growth Hormone, a Basic fibroblast Growth Factor, or a Hepatocyte Growth Factor.

31. The device of claim 30 wherein said suitable coating is impregnated into at least one of said anchoring device or said suture.

32. The method of claim 19 further comprising the step of coating a suture with said suitable coating, and wherein: said suture is comprised of braided filaments having interstices and said suitable coating covers a predetermined portion of said interstices of said suture; and said suitable coating is impregnated into at least one of said anchoring device or said suture.