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(12) Patent Application Publication (10) Pub. No.: US 2009/0324683 A1 Evans Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2009/0324683 A1 Evans Et Al US 20090324683A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0324683 A1 Evans et al. (43) Pub. Date: Dec. 31, 2009 (54) CONTROLLED RELEASE TISSUE GRAFT Publication Classification COMBINATION BOMATERALS (51) Int. Cl. (76) Inventors: Bruce G. Evans, Sandy, UT (US); A6IR 9/00 (2006.01) David Christopher Evans, Sandy, BOSD 3/10 (2006.01) UT (US); Paul C. Hogrebe, Salt A6IP 43/00 (2006.01) Lake City, UT (US); David W. Grainger, Salt Lake City, UT (US); Amanda Elaine Brooks, Highland, (52) U.S. Cl. ........................................ 424/426; 427/2.26 UT (US) Correspondence Address: Ballard Spahr LLP (57) ABSTRACT SUITE 1000,999 PEACHTREE STREET In one aspect, the invention relates to tissuegraft combination ATLANTA, GA 30309-3915 (US) biomaterials capable of controlled release of bioactive agents or pharmaceutically active agents through a rate-controlling (21) Appl. No.: 12/409.261 polymer coating encapsulating the graft material, methods (22) Filed: Mar. 23, 2009 for preparing same, methods of controlled release using same, and methods for treating tissue defects. This abstract is Related U.S. Application Data intended as a scanning tool for purposes of searching in the (60) Provisional application No. 61/070,638, filed on Mar. particular art and is not intended to be limiting of the present 25, 2008. invention. Sentaricit osci 8. Microencapsulatec sentarnicit: Microecapsulated: fe : cated to Earrier micin loaded cors Patent Application Publication Dec. 31, 2009 Sheet 1 of 9 US 2009/0324683 A1 Patent Application Publication Dec. 31, 2009 Sheet 2 of 9 US 2009/0324683 A1 Attilitic : vs tie feeks 4. Scak 3:y as 8.3383 tefise is ::: *. 8 : 3.SS:3 8883xic::cast::tex: ::ig 33 °. 8:35s: : 8888; & 3: 3rg 383&gi 388 Pack as 83.33. 3 * 3 x3 3: 3 E. & . fire weeks FIGURE 2 Patent Application Publication Dec. 31, 2009 Sheet 3 of 9 US 2009/0324683 A1 Antiiotic ml. vs Time weeks & Saa & Os3y & 3 res rig : FC :38:cr: a caps: 83 tad Big 33 °C. &88; cfcs wit: riggs is £888 88% : s.E FIGURE 3 Patent Application Publication Dec. 31, 2009 Sheet 4 of 9 US 2009/0324683 A1 Antibiotic fig visite weeks aw: 's s t s x. & fase 3: g :: P: & 8:a::gerag::8:ei 3:::g 38 p. 88:cs ::: *g &ades 88: 88kk Patent Application Publication Dec. 31, 2009 Sheet 5 of 9 US 2009/0324683 A1 Zone of inhibition Against Escherichia coli DBM and PC loaded Bone. After 4 Weeks of Release FIGURE 5 Patent Application Publication Dec. 31, 2009 Sheet 6 of 9 US 2009/0324683 A1 34:3 & see ::" is : 83. Rs. 8.6278 88:38:38.333:8:8; 8.3: ...g.8? 83. 8 = 3,343 Yess 88: 3 w8: Exig 3382d 3883 axis & s3&888 c. a e 8: C Patent Application Publication Dec. 31, 2009 Sheet 7 of 9 US 2009/0324683 A1 Patent Application Publication Dec. 31, 2009 Sheet 8 of 9 US 2009/0324683 A1 s 4. line seeks) FIGURE 8 Patent Application Publication Dec. 31, 2009 Sheet 9 of 9 US 2009/0324683 A1 Tobramycin Release Profiles From PCiliatrices, Normalized to Polymer ass Applied 3: s US 2009/0324683 A1 Dec. 31, 2009 CONTROLLED RELEASE TISSUE GRAFT cal non-degrading or thermosetting cement-loaded matrices COMBINATION BOMATERALS intended to resolve wound and implant infections require two Surgical operations: one for placing the cement-drug matrix CROSS-REFERENCE TO RELATED into the wound site, and a second for removal of the cement APPLICATIONS after drug dose exhaustion. Presently, no commercially avail able permanently implanted bone fillers or synthetic or 0001. This application claims benefit of U.S. Provisional allografted bone Substitutes are able to incorporate an inte Application No. 61/070,638, filed Mar. 25, 2008, which is grated drug, growth factor, antibiotic or combination agent hereby incorporated herein by reference in its entirety. release scheme. 0005. Current techniques of delivering drugs, growth fac BACKGROUND tors, and antibiotics locally into an active implant or bone 0002 Currently, there are many types of bone fillers and infection site include the simple topical application of drug grafting biomaterials on the market approved for human Solutions, use of a drug-soaked collagen membrane or implant use. Commercial examples include tricalcium phos sponge, and use of polymer bone cement loaded with antibi phate, calcium sulfate, hydroxyapatite, and processed cadav otic drugs, usually as a soluble drug Solution or Solid drug eric allograft human bone grafts in large pieces, croutons and powder dispersion, directly to the wound site. Numerous morsels, particles and powderforms intended for implant and studies examining the drug leaching or elution properties of Surgical use. These products provide Surrogate structural Sup bone cement have demonstrated that the greatest concentra port in bone defect and musculoskeletal implant sites, and act tion of drug release occurs within the first 8-10 days (so as osteoconductive agents, or biomaterial scaffolds, to facili called burst effect) followed by a reduced dose, with tapering tate bone tissue regeneration, mechanical restoration of func release often too low to produce reliable therapy. Intravenous tion, healing and structural re-integration of existing tissues. antibiotics are delivered to patients with bone and implant A second category of bone regenerative materials are called infections for an average of 6 to 8 weeks. Therefore, it is osteoinductive agents, usually in the form of Small bioactive beneficial to have a local source of antibiotic release at these molecules and human purified recombinant growth factors sites above the microbial killing threshold (e.g., minimal (proteins) or extracted natural protein mixtures that stimulate inhibitory concentration) and within the infection site for a or induce endogenous bone formation. Examples include similar time of 6 weeks, to reliably clear such infections from Bone Morphogenetic Proteins (BMPs), statins, bioactive the implant and Surrounding tissue sources of re-seeded peptides (e.g., P15), and Demineralized Bone Matrix (DBM). infection. These osteoinductive agents can be combined with osteocon 0006 Another problem that occurs in both orthopedic and ductive biomaterials carriers in attempts to provide both ben dental Surgery, as well as trauma and implant placement, is efits to patients. the occurrence of infection when bone grafting is used to fill bone defects. Typically, the rate of infection is greater when a 0003 Current clinically approved bone filler materials are bone graft is used than when it is not used, and with implants problematic in patients because they are associated with sev compared to no implants. Bone graft Substitutes do not have eral clinical problems, including lack of effective healing and or rapidly encourage an active host blood Supply and cannot tissue regeneration, lack of vascularity, insufficient structural be adequately perfused by host defense components (cells and mechanical properties, and a high potential for develop and antibodies) and serum-circulating antibiotics. This “dead ing infections at the Surgical, trauma or implant site. Conse tissue Surrogate, while acting as a filler in the wound or quently, where bone loss is associated with an active infection defect site, can also serve as a perfect site for colonization, or chronic lack of healing, currently available bone fillers are allowing infection to occur and persist. not recommended. The potential risk of introducing bone 0007 Thus, needed are bone graft substitutes and fillers graft materials into an active infection, also at implant sites, with antimicrobial properties that can incorporate and release requires a two-stage Surgical procedure in which the infection multiple drug types in programmed ways to wound and Sur is first eradicated, often requiring implant retrieval and result gical sites: antimicrobial agents alone or in tandem with ant trauma, followed by implant replacement and Subsequent osteoinductive agents or other pharmacologically active Sub bone grafting with autologous, synthetic, or allogenic graft stances to produce effective tissue generation with osteoin materials. ducing agents plus microcidal antibiotic concentrations at the 0004 Active infection at implant sites in and around bones local site for extended time periods (6-8 weeks), affecting and joints, in musculoskeletal trauma sites with or without both opportunistic pathogens known to colonize wound and implants, and in reducing open and closed fractures with and implant sites, those already present, and those that persist without fixation tooling, all remain problematic due to the despite systemic therapy. prolonged systemic and/or local antibiotic treatments required for reliable resolution. Currently, when an infection SUMMARY is present, antibiotic is delivered to implant and trauma sites and bone defects through systemic drug infusions, through 0008 Disclosed are tissue graft combination biomaterials locally placed but temporary bone cement carriers, and direct comprising a biocompatible, osteoconductive, porous Sub topical use, all of which intend to deliver sufficient antibiotic strate; a degradable polymer coated on the Substrate surface; dosing to the wound site. Antibiotic bone cement carriers and one or more bioactive agents or pharmaceutically active placed locally into wound sites (e.g., cement beads containing agents encapsulated by polymer, wherein the polymer has a antibiotics) allow the antibiotics to leach from the cement structure and a molecular weight selected to biodegrade over over a period of weeks. Much of the loaded drug dose is a time period when implanted within a subject and thereby unable to leach from these solid, glassy matrices over release the agent over the time period. extended times due to the dense delivery matrix and lack of 0009. Also disclosed are methods for preparing a tissue ready drug transport within these carriers. Additionally, typi graft combination biomaterials comprising the steps of pro US 2009/0324683 A1 Dec. 31, 2009 viding a biocompatible, osteoconductive, porous Substrate; meaning derived from grammatical organization or punctua combining an effective amount of a bioactive agent or phar tion, or the number or type of aspects described in the speci maceutically active agent with the Substrate; and coating the fication.
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