US2004138758A1PendingUtilityA1

Devices and methods for treating defects in the tissue of a living being

60
Priority: Jun 13, 2002Filed: Nov 5, 2003Published: Jul 15, 2004
Est. expiryJun 13, 2022(expired)· nominal 20-yr term from priority
A61P 43/00A61P 19/08A61P 19/02A61F 2002/30235A61F 2002/2835A61F 2002/4681A61F 2210/0061A61K 38/39A61F 2250/0023A61K 33/06A61L 2300/406A61B 17/00491A61B 17/064A61F 2002/30032A61B 2017/0647A61L 31/16A61F 2002/4662A61F 2/28A61F 2002/30293A61B 2090/062A61F 2002/2817A61B 17/32A61F 2002/30583A61F 2002/30677A61F 2230/0069A61L 27/56A61B 2034/108A61F 2002/2825A61F 2002/30004A61L 27/38A61F 2002/30224A61F 2310/00293A61F 2/3859A61F 2250/0014A61F 2002/4627A61F 2002/30062A61F 2/4601A61L 27/58A61F 2002/4635A61F 2002/3021A61F 2002/30822A61L 27/54A61B 17/32053A61F 2/4618A61F 2002/30075A61F 2002/30827A61F 2002/30891A61F 2310/00365A61L 27/44A61F 2210/0004A61F 2250/0018A61F 2002/30014A61F 2002/30772A61F 2/30756A61L 2300/414A61L 31/044A61F 2210/0085A61B 17/3468A61F 2002/4677A61K 33/42A61L 27/24A61F 2310/00179A61F 2002/30011A61F 2002/30233A61F 2250/003A61F 2002/30881A61L 27/12A61L 31/042A61F 2230/0067A61F 2230/0091A61B 17/06166A61L 31/146A61F 2310/00383
60
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Claims

Abstract

An implantable material for deployment in select locations or select tissue for tissue regeneration is disclosed. The implant comprises collagen, ceramics, and or other bio-resorbable materials or additives, where the implant may also be used for therapy delivery. Additionally, the implant may be “matched” to provide the implant with similar physical and/or chemical properties as the host tissue.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A flowable implant for the repair or regeneration of tissue, said implant comprising an osteoconductive matrix, wherein at least a first portion of said matrix comprises a ceramic granule and at least a second portion comprises a non-porous material.  
     
     
         2 . The implant of  claim 1 , wherein said ceramic granule is a porous ceramic.  
     
     
         3 . The implant of  claim 2 , wherein said porous ceramic is at least one of calcium phosphate and calcium sulfate.  
     
     
         4 . The implant of  claim 3 , wherein said porous ceramic is at least one of tricalcium phosphate and hydroxyapatite.  
     
     
         5 . The implant of  claim 3 , wherein said porous ceramic comprises from about ten to about ninety percent of the weight of the implant.  
     
     
         6 . The implant of  claim 1 , wherein said non-porous material comprises a gel.  
     
     
         7 . The implant of  claim 6 , wherein said gel comprises soluble collagen.  
     
     
         8 . The implant of  claim 1 , wherein said non-porous material comprises collagen.  
     
     
         9 . The implant of  claim 8 , wherein said collagen comprises soluble collagen.  
     
     
         10 . The implant of  claim 1 , wherein said matrix additionally comprises additives.  
     
     
         11 . The implant of  claim 10 , wherein said additives comprise at least one of ceramics, biologically active agents, drugs, and therapies.  
     
     
         12 . The implant of  claim 11 , wherein said additives are dispersed throughout the implant.  
     
     
         13 . The implant of  claim 11 , wherein said biologically active agent comprises at least one of bone marrow, autologous blood, and bone morphogenic protein.  
     
     
         14 . The implant of  claim 10 , wherein said additive is added to the implant at, or immediately prior to, placement of said implant into said tissue.  
     
     
         15 . The implant of  claim 14 , wherein said osteoconductive matrix is dry and said additive is liquid, such that said additive hydrates said matrix upon the addition thereof.  
     
     
         16 . The implant of  claim 3 , wherein said matrix is arranged to be compressed.  
     
     
         17 . The implant of  claim 16 , wherein said compression occurs during the implant procedure.  
     
     
         18 . The implant of  claim 17 , wherein said compression causes said implant to conform to the shape of the defect being treated.  
     
     
         19 . The implant of  claim 16 , wherein said compression occurs prior to the implant procedure.  
     
     
         20 . The implant of  claim 19 , wherein elastic recovery from said compression occurs following release into defect site.  
     
     
         21 . The implant of  claim 20 , wherein said elastic recovery causes said implant to conform to the shape of the defect being treated.  
     
     
         22 . A multi-stage composite implant for the repair or regeneration of tissue, with said implant comprising at least a first and a second material, wherein at least said first material is comprised of soluble collagen and is resorbable, with said second material comprising porous ceramic, and wherein at least a first material resorbs at a faster rate than said second material.  
     
     
         23 . The implant of  claim 22 , wherein said soluble collagen serves to provide structural integrity to the implant.  
     
     
         24 . The implant of  claim 22 , wherein at least one of said materials is osteoconductive.  
     
     
         25 . The implant of  claim 22 , wherein said resorption of said first material causes said first material to act as a delayed porosifying agent.  
     
     
         26 . The implant of  claim 22 , wherein said ceramic comprises calcium salt.  
     
     
         27 . The implant of  claim 26 , wherein said calcium salt comprises at least one of calcium phosphate and calcium sulfate.  
     
     
         28 . The implant of  claim 27 , wherein said calcium phosphate comprises at least one of tricalcium phosphate and hydroxyapatite.  
     
     
         29 . The implant of  claim 28 , wherein said calcium phosphate comprises from about ten to about ninety percent of the weight of the implant.  
     
     
         30 . The implant of  claim 22 , wherein said implant additionally comprises an additive comprising at least one of biologically active agents, drugs, and therapies.  
     
     
         31 . The implant of  claim 30 , wherein said additive is dispersed throughout the implant.  
     
     
         32 . The implant of  claim 30 , wherein said biologically active agent comprises at least one of bone marrow, autologus blood, and bone morphogenic protein.  
     
     
         33 . The implant of  claim 30 , wherein said biologically active agent is added to the implant at the time of the procedure.  
     
     
         34 . A flowable multi-phasic implant for the repair and regeneration of tissue, said implant comprising an osteoconductive matrix wherein at least a first phase of said matrix comprises an insoluble material and at least a second phase comprises a non-porous material.  
     
     
         35 . The implant of  claim 34 , wherein the second non-porous phase is a hydrated flowable material.  
     
     
         36 . The implant of  claim 35 , wherein the hydrated flowable material comprises at least one of soluble collagen paste and gel.  
     
     
         37 . The implant of  claim 34 , wherein the second non-porous phase degrades faster than the first porous phase.  
     
     
         38 . The implant of  claim 37 , wherein the second non-porous phase serves as a delayed porosifying agent.  
     
     
         39 . The implant of  claim 34 , wherein the first phase comprises insoluble fibers.  
     
     
         40 . The implant of  claim 39 , wherein the insoluble fibers are collagen fibers.  
     
     
         41 . The implant of  claim 40 , wherein the collagen fibers are composed of natural insoluble collagen.  
     
     
         42 . The implant of  claim 34 , wherein the first phase comprises insoluble granules.  
     
     
         43 . The implant of  claim 42 , wherein the granules are in the form of spheres.  
     
     
         44 . The implant of  claim 43 , wherein the granules are in the form of micro spheres.  
     
     
         45 . The implant of  claim 42 , wherein the granules are composed of ceramic.  
     
     
         46 . The implant of  claim 45 , wherein the ceramic is a tricalcium phosphate.  
     
     
         47 . The implant of  claim 46 , wherein the tricalcium phosphate is porous.  
     
     
         48 . The implant of  claim 34 , wherein the matrix further comprises a biologically active or pharmaceutical agent.  
     
     
         49 . The implant of  claim 48 , wherein the agent is added to the implant at, or immediately prior to placement of said implant into said tissue.  
     
     
         50 . The implant of  claim 49 , wherein the agent comprises one or more of the biologically active agents, pharmaceuticals, or active ingredients.  
     
     
         51 . The implant of  claim 49 , wherein said biologically active agent comprises cells.  
     
     
         52 . The implant of  claim 51 , wherein the cells are in blood or bone marrow.  
     
     
         53 . The implant of  claim 34 , wherein the first phase is in the form of a depot surrounded by the second phase.  
     
     
         54 . The implant of  claim 53 , wherein the first phase is homogeneous within the second phase.  
     
     
         55 . The implant of  claim 34 , wherein the first phase in the form of a granule, chip or fiber.  
     
     
         56 . The implant of  claim 55 , wherein the first phase is composed of a synthetic polymer material.  
     
     
         57 . The implant of  claim 55 , wherein the second phase provides some level of structural integrity to the first phase.  
     
     
         58 . The implant of  claim 55 , wherein the chip comprises bone.  
     
     
         59 . The implant of  claim 58 , wherein the bone has been demineralized.  
     
     
         60 . The implant of  claim 34 , wherein the first phase is between 10 percent and 90 percent of the construct by weight.  
     
     
         61 . The implant of  claim 34 , wherein the first phase is between 70 percent and 90 percent of the construct by weight.  
     
     
         62 . The implant of  claim 34 , wherein the first phase is between 75 percent and 85 percent of the construct by weight.  
     
     
         63 . The implant of  claim 34 , wherein the flowable implant is arranged for storage and delivery in a tube.  
     
     
         64 . The implant of  claim 34  wherein the flowable implant is arranged for storage and delivery in a syringe.  
     
     
         65 . The implant of  claim 34 , wherein the flowable implant is arranged for storage and delivery in a syringe-like cylindrical housing.  
     
     
         66 . A flowable multi-phasic implant for the repair and regeneration of tissue, said implant composed of components that resorb in stages wherein: 
 a. At least a first component is an insoluble ceramic granule; and    b. At least a second component is a non-porous collagen gel;    wherein the non-porous collagen gel suspends the granules, providing a level of structural integrity to the implant.    
     
     
         67 . The implant of  claim 66 , wherein the implant initially comprises ceramic granules which are in the form of a depot surrounded by lyophilized soluble collagen prior to implantation, wherein the lyophilized soluble collagen collapses into said non-porous gel upon hydration.  
     
     
         68 . The implant of  claim 67 , wherein said hydration occurs following implantation.  
     
     
         69 . The implant of  claim 67 , wherein said hydration occurs prior to implantation.  
     
     
         70 . A flowable multi-phasic implant for the repair and regeneration of tissue, said implant comprising a plurality of components that resorb in stages wherein: 
 a. At least a first component is an insoluble ceramic granule;    b. At least a second component is an insoluble collagen fiber: and    c. At least a third component is a non-porous collagen gel;    wherein the non-porous collagen gel suspends the Granules and fiber, providing a level of structural integrity to the implant.

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