WO2002015948A9 - Method of treating and dehydrating bone for implantation - Google Patents
Method of treating and dehydrating bone for implantationInfo
- Publication number
- WO2002015948A9 WO2002015948A9 PCT/US2001/026553 US0126553W WO0215948A9 WO 2002015948 A9 WO2002015948 A9 WO 2002015948A9 US 0126553 W US0126553 W US 0126553W WO 0215948 A9 WO0215948 A9 WO 0215948A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bone
- mechanical strength
- conserving
- agent
- conserving agent
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
-
- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
-
- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/3094—Designing or manufacturing processes
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/3011—Cross-sections or two-dimensional shapes
- A61F2002/30112—Rounded shapes, e.g. with rounded corners
- A61F2002/30131—Rounded shapes, e.g. with rounded corners horseshoe- or crescent- or C-shaped or U-shaped
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30879—Ribs
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30891—Plurality of protrusions
- A61F2002/30892—Plurality of protrusions parallel
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
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- A—HUMAN NECESSITIES
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- A61L2430/00—Materials or treatment for tissue regeneration
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Definitions
- Monolithic bone intended for implantation is treated in order to conserve its
- This treatment is useful when combined with a number of methods of
- dehydrating the bone e.g. dehydrating under ambient or near ambient conditions
- the invention as compared to untreated lyophilized bone.
- processing e.g., to preserve the graft for later use and to remove immunogenic cellular
- the porous matrix is typically
- pharmacological agents antioxidants, bone growth factors, etc.
- Some treatment processes such as
- Processing requirements can be
- Treatment processes also can have a deleterious effect on such important
- Lyophilization freeze-drying, i.e.,
- than 6% moisture can be stored at ambient temperatures for up to five years after
- compressive strength can be reduced by up to 30% with little or no change in stiffness
- bending strength can be reduced by as much as 40%, and torsional strength can be
- conserving agent is not acting as a cryopreservative (i.e., minimizing crystal growth
- implant containing a mechanical strength-conserving agent and, optionally, one or more medically/surgically useful substances, e.g., an osteogenic material such as bone morphogenic proteins (BMPs).
- a mechanical strength-conserving agent e.g., one or more medically/surgically useful substances, e.g., an osteogenic material such as bone morphogenic proteins (BMPs).
- BMPs bone morphogenic proteins
- the method comprises:
- a mechanical strength-conserving amount of at least one biocompatible mechanical strength-conserving agent said agent being a liquid organic material or solution, mixture, or suspension thereof, which is capable of penetrating and remaining in the bone during its dehydration, packaging and storage;
- the invention includes the dehydrated bone obtained by the foregoing method(s) and use of bone obtained by the invention herein.
- monolithic bone refers to relatively large pieces of human or animal bone, i.e., pieces of bone, autograft, allograft or xenograft, that
- the monolithic bone of this invention is to be distinguished from particles, filaments, threads, etc. as disclosed in U. S. Patent Nos. 5,073,373, 5,314,476 and 5,507,813, which, due to their relatively small dimensions, are incapable of sustaining significant mechanical loads, either individually
- the monolithic bone can be provided as a single integral piece of bone or as a piece of bone permanently assembled from a number of smaller bone elements, e.g., as
- monolithic bone can contain factors which are osteogenic, monolithic bone can also contain additional materials, e.g., as disclosed in
- bone which exhibits improvement in toughness would be more desirable than bone having less toughness.
- toughness is a measure of the energy absorbed by the osteoimplant prior to breakage and is expressed in units of Newton-meters (N-m).
- conserving agent shall demonstrate at least about 2% less decrease in length dimension as
- conserving agent shall demonstrate at least greater than about 19 percent increase in
- Figure 1 is a graphical representation of a standard freeze-drying process.
- Figure 2 is a graphical representation of an alternative freeze-drying process in which the tissue is subjected to some level of dehydration prior to freezing and sublimation of any remaining moisture.
- Figure 3 is a representation of a ramp-shaped implant.
- Figure 4 is a graphical representation of the dimension change of bone implant prepared as in Example 5.
- Figure 5 is a graphical representation of the treatment effects on dimensional change.
- Bone for implantation is obtained, e.g., aseptically in a morgue or an operating
- the bone is cleansed, e.g., using 70% ethanol and washed with
- the bone may be treated with antibiotics such as
- polymyxin B sulfate, bacitracin, and/or gentamicin may contain trace amounts of
- lyophilization, and stoppering may be functions are performed under conditions
- the bone employed in the invention is any material that is selected from the following industry standards for tissue handling.
- the bone employed in the invention is any material that is selected from the following industry standards for tissue handling.
- treated according to the method of the invention is generally a relatively large piece or
- the bone herein will possess
- the prepared bone Prior to dehydration, the prepared bone is contacted with a mechanical strength-
- biocompatible mechanical strength-conserving agent appropriate to the invention is a
- bone more preferably from about 5°C. to about 65°C, and which penetrates the small
- the conserving agent is
- Suitable conserving agent include, but are not limited to:
- glycol triethylene glycol, tetraethylene glycol, propylene glycol, dipropylene glycol;
- polysaccharides and their derivatives e.g., hyaluronic acid; polyoxyethylene-
- polyoxypropylene copolymer e.g., of the type known and commercially available under
- copolymer e.g., of the type known and commercially available under the trade name
- Poloxamer alkylphenolhydroxypolyoxyethylene, e.g., of the type known and
- Fatty alcohol for example primary alcohols, usually straight chain having from 6 to
- Fatty alcohol ester for example, ethyl hexyl palmitate, isodecyl neopentate,
- octadodecyl benzoate diethyl hexyl maleate, and the like.
- Fatty acid ester for example, polyoxyethylene-sorbitan-fatty acid esters; e.g., mono-
- polyoxyethylene stearic acid esters of the type known and commercially available
- propylene glycol dicaprylate propylene glycol dilaurate, propylene glycol hydroxy
- Miglyol mono-, di-, and mono/di-glycerides, such as the
- esterification products of caprylic or caproic acid with glycerol e.g., of the type known
- sorbitan-monolauryl -monopalmityl, -monostearyl, -tristearyl, -monooleyl and trioleylesters; monoglycerides, e.g., glycerol mono oleate, glycerol mono palmitate and
- glycerol mon ⁇ stearate for example as known and commercially available under the trade
- Myvacet isobutyl tallowate, n-butylstearate, n-butyl oleate, and n-propyl oleate.
- Liquid silicone for example, polyalkyl siloxanes such as polymethyl siloxane and
- poly(dimethyl siloxane) and polyalkyl arylsiloxane are examples of poly(dimethyl siloxane) and polyalkyl arylsiloxane.
- the suitable biocompatible mechanical strength-conserving agent As stated above, the suitable biocompatible mechanical strength-conserving agent
- solution can be aqueous or can be one utilizing a polar organic solvent or other volatile
- volatile solvent as utilized herein is intended to refer to any organic solvent
- solvents useful in the invention herein would include but not be limited to, water;
- alcohols typically a low molecular weight alcohol such as methanol, ethanol,
- solvent e.g., dimethylsulfoxide, small ketones, acetone; chloroform; methylene chloride and ethylene chloride; straight chain hydrocarbons, e.g., hexane, pentane and similar alkanes; low molecular weight alkenes; esters; ether, e.g., ethyl ether, tetrahydrofuran,
- dioxane ethylene glycol monoethyl ether, crown ethers, etc.
- aldehyde or solutions containing aldehydes e.g., formaldehyde, formalin, etc., at low temperatures such that cross-linking does not proceed
- super critical fluids e.g., carbon dioxide or hydrogen sulfide at supercritical pressures, mixtures of any of the above liquids, etc.
- volatile solvents when present prior to lyophilization or other method of dehydration, will
- biocompatible mechanical strength-conserving agent neat or solution
- strength-conserving agent is glycerol, more preferably a 50% aqueous or alcoholic solution of glycerol, most preferably a series of graded dehydrating alcohols and glycerol.
- the bone is contacted with a mechanical strength-conserving amount of the
- a suitable container e.g., a 120 ml or 500 ml
- the conserving agent can be applied by infusing, e.g., employing a pressurized system such as that described in U.S.
- the conserving agent can be contacted with the bone in
- the conserving agent can be contacted with
- HypercenterTM XP Enclosed Tissue Processor commercially available
- vacuum-positive pressure or alternating positive pressure can be determined through
- the tissue processor allows for the simultaneous contacting of
- Such simultaneous contacting/dehydrating may result in an implant
- the bone and agent can be advantageously subjected to sonication. It has been determined that contacting the bone with strength-conserving agent in an ultrasonic
- contacting the bone with the strength-conserving agent can be carried out by any combination of
- Such shaping can be accomplished by cutting, forming, machining
- the bone can be rough cut, processed with
- bottle containing bone and conserving agent is subjected to, e.g., processes including but
- sub-atmospheric pressures e.g., drying oven at temperatures from about 35°C. to about
- the monolithic bone treated in accordance with the invention i.e., dehydrating
- bone treated according to the invention herein shows at least greater than 19%
- bone can optionally be further shaped prior to packaging.
- the dehydrated bone can be any suitable material.
- the dehydrated bone can be any suitable material.
- the dehydrated bone can be any suitable material.
- solution can be introduced via hypodermic needle through the sealed rubber stopper.
- strength-conserving agent also acts as a wetting agent decreasing the time necessary to
- the rehydration solution can be any of a number of suitable agents such as sterile
- it can contain one or more wetting agents
- substances such as antiviral agents, particularly those effective against HIV and hepatitis;
- antimicrobials and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin
- inorganic elements inorganic elements, co-factors for protein synthesis; hormones; endocrine tissue or tissue
- BMPs bone morphogenic proteins
- TGF-beta transforming growth factor
- IGF-1 insulin-like growth factor
- IGF-2 growth factor two
- PDGF platelet derived growth factor
- a bone defect site e.g., one resulting from injury
- the bone suitably sized and shaped as required, can be utilized as a graft
- joint reconstruction such as arthrodesis, general
- tumor surgery e.g., deficit filling
- implant herein include the ethmoid, frontal, nasal, occipital, parietal, temporal, mandible,
- maxilla maxilla, zygomatic, cervical vertebra, thoracic vertebra, lumbar vertebra, sacrum, rib, sternum, clavicle, scapula, humerus, radius, ulna, carpal bones, metacarpal bones,
- phalanges ilium, ischium, pubis, femur, tibia, fibula, patella, calcaneus, tarsal and
- the specimen is removed from the solution, and is then placed in a vacuum oven at 30° Celsius and standard laboratory vacuum. The specimen remains in the oven for a period of time necessary to evaporate off the remaining solvent, to remove the remaining water from the tissue, and to allow adherent treatment solution to penetrate. This time is determined by standard assays of
- Human cortical bone specimens prepared by cutting on a band saw into strut allografts, are placed into the retort chamber of an automated tissue-processing machine,
- diaphyseal cross-sections are placed into a closed container with a 50%) ethanol/50%)
- Bovine cortical bone specimens 4mm x 4mm x 40mm (nominal) were prepared
- Glycerol application prior to lyophilization reduces brittleness in the bone
- Freeze-drying composed of a freezing step and a water-removal step
- glycerol and also contained 0.5%(w/v) methylene blue dye to allow assessment of
- specimens received each of four treatments: A.) treated for 3 days in an ultrasonic bath
- the threaded hole was also tested using a mating screw prior to the
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP01966222A EP1311309A2 (en) | 2000-08-24 | 2001-08-24 | Method of treating and dehydrating bone for implantation |
CA002420113A CA2420113A1 (en) | 2000-08-24 | 2001-08-24 | Method of treating and dehydrating bone for implantation |
AU2001286755A AU2001286755A1 (en) | 2000-08-24 | 2001-08-24 | Method of treating and dehydrating bone for implantation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US64452100A | 2000-08-24 | 2000-08-24 | |
US09/644,521 | 2000-08-24 |
Publications (3)
Publication Number | Publication Date |
---|---|
WO2002015948A2 WO2002015948A2 (en) | 2002-02-28 |
WO2002015948A3 WO2002015948A3 (en) | 2002-06-13 |
WO2002015948A9 true WO2002015948A9 (en) | 2003-04-03 |
Family
ID=24585261
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2001/026553 WO2002015948A2 (en) | 2000-08-24 | 2001-08-24 | Method of treating and dehydrating bone for implantation |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP1311309A2 (en) |
AU (1) | AU2001286755A1 (en) |
CA (1) | CA2420113A1 (en) |
WO (1) | WO2002015948A2 (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2077718B2 (en) * | 2006-10-27 | 2022-03-09 | Edwards Lifesciences Corporation | Biological tissue for surgical implantation |
NZ602706A (en) | 2010-03-23 | 2014-02-28 | Edwards Lifesciences Corp | Methods of conditioning sheet bioprosthetic tissue |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6045602B2 (en) * | 1978-09-28 | 1985-10-11 | 正隆 片桐 | Biological implants and their production methods |
US5513662A (en) * | 1991-12-31 | 1996-05-07 | Osteotech, Inc. | Preparation of bone for transplantation |
US5797871A (en) * | 1994-08-19 | 1998-08-25 | Lifenet Research Foundation | Ultrasonic cleaning of allograft bone |
WO1999051170A1 (en) * | 1998-04-02 | 1999-10-14 | Crosscart, Inc. | Bone xenografts |
US6630001B2 (en) * | 1998-06-24 | 2003-10-07 | International Heart Institute Of Montana Foundation | Compliant dehyrated tissue for implantation and process of making the same |
US6293970B1 (en) * | 1998-06-30 | 2001-09-25 | Lifenet | Plasticized bone and soft tissue grafts and methods of making and using same |
US6162258A (en) * | 1999-08-25 | 2000-12-19 | Osteotech, Inc. | Lyophilized monolithic bone implant and method for treating bone |
-
2001
- 2001-08-24 EP EP01966222A patent/EP1311309A2/en not_active Withdrawn
- 2001-08-24 AU AU2001286755A patent/AU2001286755A1/en not_active Abandoned
- 2001-08-24 WO PCT/US2001/026553 patent/WO2002015948A2/en not_active Application Discontinuation
- 2001-08-24 CA CA002420113A patent/CA2420113A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
WO2002015948A2 (en) | 2002-02-28 |
EP1311309A2 (en) | 2003-05-21 |
WO2002015948A3 (en) | 2002-06-13 |
AU2001286755A1 (en) | 2002-03-04 |
CA2420113A1 (en) | 2002-02-28 |
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