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EP0259484A1 - Materiau moulable pour implant osseux - Google Patents

Materiau moulable pour implant osseux

Info

Publication number
EP0259484A1
EP0259484A1 EP87902254A EP87902254A EP0259484A1 EP 0259484 A1 EP0259484 A1 EP 0259484A1 EP 87902254 A EP87902254 A EP 87902254A EP 87902254 A EP87902254 A EP 87902254A EP 0259484 A1 EP0259484 A1 EP 0259484A1
Authority
EP
European Patent Office
Prior art keywords
bone
implant
binder
particles
hydroxylapatite
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP87902254A
Other languages
German (de)
English (en)
Inventor
John R. Parsons
Harold Alexander
Andrew B. Weiss
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rutgers State University of New Jersey
Rutgers Health
Original Assignee
University of Medicine and Dentistry of New Jersey
Rutgers State University of New Jersey
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Medicine and Dentistry of New Jersey, Rutgers State University of New Jersey filed Critical University of Medicine and Dentistry of New Jersey
Publication of EP0259484A1 publication Critical patent/EP0259484A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/427—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of other specific inorganic materials not covered by A61L27/422 or A61L27/425
    • 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
    • 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
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable

Definitions

  • the present invention relates to a moldable bone-implant material formed of hard bone graft filler particles bo u n d together into a moldable cohesive mass with a biodegradable substrate.
  • Bone implants are used for bone reconstructive surgery and repair where bone loss or traumatic damage has occurred. In addition to the usual function of strengthening and filling in a repaired bone area, implants can also act to transmit forces to the surrounding bone area, to preserve the vitality of the bone. As an example of the l a tte r function, bone implants are commonly placed in tooth-extraction sites by to help preserve the alveolar bone by providing for continued force on the bone during chewing.
  • hydroxyl apatite The most proven and accepted synthetic material for bo ne reconstruction and repair is hydroxyl apatite. This material has outstanding biocompatibility, due to its similarity in composition and crystalline structure to the inorganic component of bone. The most important property of hydroxylapatite is its ability to bond directly to bone tissue. Tissue ingrowth into the matrix of the particles acts to stabilize the implant in the surrounding bone and, where the implant is formed of hydroxyl apatite particles, forms a tissue matrix which helps maintain the integrity of the implant.
  • hydroxylapatite implant which has been used heretofore is a rigid implant which is intended to be machined by the surgeon or dentist to fit the implant site
  • the implant may be formed of a solid dense block or p oro u s block of hydroxylapatite or by binding hydroxylapatite particles with a permanent, rigidifying polymer material.
  • Implants of this type suffer from a number of disadvantages. The process of determining the shape of the bone s i te and fashioning the implant to fit the site is time consuming and complicates the surgery. The implant rarely is ideally shaped and therefore may work loose in the site before tissue ingrowth can occur.
  • Such implants require suturing soft tissue to hold them in place, and may require protecting the site against movement for an extended post-operative period. Also, the implant cannot be f as h i o ne d to take advantage of undercut surfaces at the bone site which otherwise might contribute to anchoring the implant. Up to 90% of such implants have been reported to work loose within the first year of implantation.
  • Implants formed of loose non-bonded hydroxylapatite particles are also well known in the prior art. I n preparing an implant of this type, the particles are wet with saline or the patient's blood to give the particles some cohesion and make them manageable during the implant procedure. The loose mass of particulate material is placed in the bone site, where it can adapt to the contours of the surrounding support tissue. After implantation, the particle mass is ingrown with hard or soft tissue which stabilizes the mass of particles, typically in a period of a few days to weeks. The implant can thus acquire a rigid contoured fit, and can also conform to undercut regions in the site to provide increased anchorage.
  • Loose particles are generally difficult to deliver to the site in a convenient manner, and paraphernalia, such as mixing dishes, applicator funnels, suction devices, and the like, may be required.
  • the particle mass has little cohesive strength and ve ry often loses its shape before the mass is stabilized by tissue ingrowth. For example, particles used for rebuilding the alveolar ridge often exhibit ridge flattening and hence a loss of ridge height before the implant particles can be stabilized by tissue ingrowth.
  • the loose cohesion of the particle mass also allows particles to migrate away from the implant site before tissue ingrowth is complete, and this can result in implant failure and exfoliation of particles into the patient's mouth in the case of oral implants.
  • a more specific object of the invention is to provide such material which overcomes the disadvantages of loose-particle implant placement, including loss of implant material and shape, while maintaining the contour-fit and exceptional bone-like and biological ingrowth characteristics of particulate hyroxylapatite.
  • a related object of the invention is to provide such a material which is readily molded to fit the contours and undercut regions of a bone implant site.
  • Still another object of the invention is to provide a method using such material for filling a bone site with a rigid, contour-fitting, hydroxylapatite implant.
  • the binders which can be used in the present moldable bone-implant materials comprise inorganic materials.
  • Inorganic materials can include those materials which when placed in a bone-implant environment (a) are compatible with that environment, (b) undergo biodegradation in that environment to release only biocompatible degradation products, and (c) undergo biodegradation at a rate which allows gradual binder replacement in the material by in situ tissue ingrowth over a several-day to several-week period.
  • inorganic cements are preferred, with special preference being given to calcium sulfate hemihydrate as it can consistently yield an implant material which will have the desired mo l d ab i l i ty properties while allowing gradual binder replacement in the material by in situ tissue ingrowth over a several-day to several-week period.
  • the binder preferably constitutes no more than about one-third of the total solid volume of the material. When the binder biodegrades, its space becomes a void in the material which can accommodate tissue ingrowth.
  • the minimum amount of binder is that necessary to give easy formability and provide sufficient particle cohesion and shape retention and implant strength during the period of tissue ingrowth.
  • this invention provides a storable dry bone-implant material which is made up of the filler particles in admixture with particulate inorganic cement in precure form.
  • this invention provides a method of filling a bone site with a contour-fitting rigid particle bone implant.
  • the bone-implant material comprises hard filler particles and a binder and is moldable at the conditions and time of implanting.
  • the site is filled with the moldable material to-from a contour-fitting implant in the site.
  • the binder undergoes gradual biodegradation and is replaced by ingrowth of surrounding tissue.
  • the moldable implant material may be dispensed from any convenient device or form such as syringe, tube-type dispenser, dish, or in soft block or roll form.
  • the mold-in-place implant substantially retains its contour-fitting shape during the several-day to several-week period when the binder is gradually degraded and replaced by tissue ingrowth from the surrounding bone site, to rigidify the implant.
  • the bone-implant material of the invention is prepared by mixing hard bone-graft filler particles with biocompatible biodegradable binder.
  • the resulting material is moldable, allowing the material to be applied to a bone site in a contour-fitting manner.
  • biocompatible and biodegradable as used herein have their normal art-accepted meanings, that is, “biocompatible” means that material is compatible with a living animal and in use does not give rise to untoward effects, reactions, toxicity or the like; and “biodegradable” means that a material undergoes an expected breakdown in its physical or chemical structure when exposed to a given biological environment of use.
  • biocompatible inorganic hard filler particles including autogenous bone chips, can be used in this invention.
  • hydroxylapatite is the preferred filler for its permanence and biological profile.
  • Tricalcium phosphate (TCP) and calcium phosphate glass granules may also be used alone or in combination with hydroxylapatite, particularly if some degree of resorption is desired in the filler.
  • Hydroxylapatite particles are preferably the type of dry free-flowing hydroxylapatite particles supplied for use in forming wetted, loose-mass implants, and can be obtained commercially from Orthomatrix Corporation (Dublin, CA) or Calcitek (San Diego, CA). Particle sizes of between about 250 and 5000 microns are generally suitable and particle sizes between 250 and 2000 microns are preferred, smaller particles showing increased difficulty in allowing tissue ingrowth and larger particles requiring increased quantities of binder for ease of application. As marketed by Orthomatrix Corporation, these particles are supplied as ranges of various sized particles, for example from 250-550 microns (HA-500), 500-1000 microns (HA-1000), and the like. Such mixtures are quite suitable.
  • the binder used in forming the bone graft material is selected for three important properties: (a) susceptibility to rapid biodegradation, to allow for gradual binder replacement by tissue during tissue ingrowth, without retarding ingrowth; (b) flowability or fluid-flow properties in combination with cohesiveness s o as to allow the material to be molded and formed during implantation and achieve a contour fit at the bone site; and (c) biocompatibility, that is, the binder should not provoke a serious inflammatory or other tissue-rejection response, at lease within the several-week period when tissue ingrowth replacement is occurring.
  • biodegradation may involve gradual dissolution of a moderately soluble inorganic salt, hydrolysis of bonds within an inorganic structure or ionization of weakly acidic or basic groups within the inorganic material.
  • Preferred binders are those which are degraded to metabolites which are normal to the body or for which the body has effective elimination routes.
  • preferred inorganic binders include the inorganic cements such as the gypsum-based plasters including calcium sulfate hemihydrate (Plaster of Paris), sodium based Mack's cement and the like.
  • inorganic materials are characterized by forming a cohesive plastic mass when mixed with an aqueous liquid such as water, sterile water, sterile saline, patient's blood or the like, and through hydration taking a "set".
  • aqueous liquid such as water, sterile water, sterile saline, patient's blood or the like
  • calcium sulfate hemihydrate is generally preferred because of its long acceptance. (See, for example, Peltier, Leonard. F, CLINICAL ORTHOPAEDICS, Vol. 21, Pages 1-31, 1961) as a safe restorative material, as well as its properties of being plastic and moldable for useable periods before it "sets up” and of being bioerodible at rates consistent with the biodegradability requirements of this invention.
  • the calcium sulfate hemihydrate can be in either the alpha or beta crystal form.
  • the moldable, plastic nature of the inorganic binders is advantageous in the present invention for several reasons.
  • the inorganic cement type binders provide implant materials that may be hand formed as a relatively low-viscosity mixture when initially mixed with the aqueous liquid and then shortly thereafter, e.g. in a matter of from 3 to 45 minutes, assume a relatively high viscosity, more rigid shape when the cement sets.
  • These binders allow a cohesive mass of implant material to be formed and used and shaped. This corrects the problems of particle migration which occur when simple suspensions of powders are employed.
  • materials using the inorganic cement binders provide plasticity and moldability only during the implantation procedure so that the material, once implanted in a bone site, retains a more rigid, shape-retaining condition.
  • the binder preferably ranges in fluid-flow properties (flowability) between a highly viscous fluid and a puttylike semi-solid, at the selected conditions of use. With too low a binder viscosity, the implant material suffers the same problems seen in loose-particle implants: poor shape retention, once molded, and poor cohesiveness, leading to exfoliation of particles before or during the tissue ingrowth period.
  • thermosetting polymers such as polymethylmethacrylate (PMMA).
  • PMMA polymethylmethacrylate
  • Thermosetting polymers generally require initiators to catalyze hardening and such reactions are exothermic. Where PMMA is used, it can generate enough heat to damage adjacent tissue. Accordingly, the binders employed in this invention are at most only mildly exothermic when they set up and do not damage adjacent tissue.
  • Thermoset polymers also contain residual unpolymerized monomer which, along with catalyst residue, give material of questionable and variable biocompatibility. Also, the moldability of thermoset binders is time dependent and not reversible, or reformable once hardened.
  • the implant materials of this invention have the following desirable characteristics: 1. Formability, moldability - and the ability to completely fill undercut cavities not possible with solid blocks or composites.
  • the binder is biocompatible and biodegradable.
  • the solid particle phase is discontinuous and the size and shape of the solid particles determines and presents a unique pore structure for tissue ingrowth.
  • the binder is the continuous phase.
  • the binder's function is temporary for ease of application of the implant and to hold the particles in place for a limited period after implantation until the binder is replaced by tissue.
  • the binder-containing implant materials are generally formed in two steps.
  • the filler particles are blended with a dry particulate form of the binder.
  • the dry mixture is mixed with a pharmaceutically acceptable aqueous liquid, most typically sterile water, sterile saline or the patient's blood to yield the desired cohesive, moldable, plastic mass.
  • a pharmaceutically acceptable aqueous liquid most typically sterile water, sterile saline or the patient's blood to yield the desired cohesive, moldable, plastic mass.
  • This material is then applied as the desired implant and allowed to stand for a few minutes, i.e. from about 1 to a bo u t 30 minutes, and preferably from about 5 to 30 minutes, during which time it sets or solidifies into a relatively rigid body.
  • the ratio of particles to binder, the amount of aqueous liquid added and the amount of mixing applied can each have an effect on the properties of the moldable plastic implant material and the final "set" product.
  • the proportions of dry filler particles to binder ranges from the largest proportion of filler that will give a moldable cohesive product, (generally about 85-90% by weight filler and 10-15% binder) down to the smallest proportion of filler that will give a product that will still deliver an adequate amount of s o l i d fi ller to the bone area being repaired to achieve the desired repair (generally about 30-40% filler and 60-70% by weight binde r ) .
  • hydroxylapatite makes up the filler particles, it is of special advantage to use a mixture that provides at least 2/3 of the mixture volume as filler, as this permits the defined level of voids between the filler particles to permit the fortuitous growth of bone tissue into the particle matrix, more preferably so that from 70% to 95% of the volume is hydroxylapatite.
  • preferred range of proportions of the mixture of hydroxylapatite and calcium sulfate hemihydrate comprises from 85-40% by weight of the former and from 15-60% by weight of the latter.
  • a more preferred set of proportions are hydroxylapatite 55-75% by weight and especially 60-70% by weight, and calcium sulfate 24-45% by weight and especially 30-40% by weight.
  • the amount of aqueous liquid added to form the plastic mass should be controlled. If the weight of aqueous liquid is substantially greater than about 25% of the weight of filler plus binder, a product will result which is syrup-like and difficult to apply. If the weight of water is as low as 5% or so, the resulting product wil l not be properly plastic and cohesive, although it may be useable for repairing minor bone defects or holes such as filling tooth extraction sites, or like defects, where it can be tightly packed into the defect and its lack of coherence will not be a critical failing. Preferred aqueous liquid levels are from about 10 to about 22% by weight based on the weight of the dry components, and preferred aqueous liquid levels range from about 15 to about 20%. The mixing time should also be monitored.
  • the material After application of the inorganic binder-containing materials to the bone-implant site, it is generally preferred to allow the material to set for a brief period, such as from about 5 minutes to about 30 minutes, so as to allow the binder to fully cure and form a strong rigid body.
  • the implant materials of this invention may contain other added materials such as markers or the like, if desired.
  • the bone-implant material may be presterilized by heat, gamma radiation, ethylene oxide, or other available methods.
  • the material can be supplied in a syringe or squeeze-bottle container, allowing direct application of the material into the bone site.
  • the material can be supplied in dish, or flexible roll or block form.
  • This invention includes a method for forming a rigid contour-fitting hard filler implant in a bone site.
  • the method is generally applicable to bone reconstruction or repair needs where a hydroxylapatite or other hard filler bone implant can strengthen a bone region and/or act to transmit stresses to surrounding bone area, to preserve the vitality of bone.
  • Typical applications include replacing damaged or resorbed bone regions, repairing bone fractures, and filling tooth-extraction sites to help preserve underlying a l veo l ar bone.
  • the method may be used in anchoring a joint-replacement prosthetic device within a suitable bone cavity.
  • the bone site which is to receive the implant is prepared by conventional surgical techniques. These usually involve exposing and cleaning the bone site, and may require surgical removal of parts of the bone, for example, to form undercuts at the bone site or to shape the site for more favorable implant seating or stress transmission.
  • the bone is prepared with a suitable stem-receiving cavity.
  • the space between the bone cavity and the prosthesis stem forms the bone site which is to be filled with the implant material.
  • a moldable hydroxylapatite containing bone-implant material of the type above inorganic binder-containing implant materials having a range of molding temperatures and conditions and varying rates of biodegradability can be provided, by adjusting the composition and amount of binder in the material. Naturally, it is desirable to use proportions of binder which will assure adequate strength and cohesiveness. Also as discussed above, the composition and amount of binder can be adjusted to allow for effective tissue ingrowth in the implant material. For example, if the binder is expected to be degraded only slowly at the bone site, due to lack of enzymes, body fluid flow or the like, it may be advantageous to provide increased void spaces in the material, by reducing the amount of binder.
  • the material is formed into its cohesive moldable form in a suitably sterile mixing zone.
  • the moldable implant material is applied to the bone site to fill the site in a preferably space-filling manner, producing a contour fit between the bone and implant.
  • the m a te r i a l is applied to the bone surface and pressed into or onto the site to force the material into any surface irregularities of the site, such as cracks, holes, and particularly undercut features.
  • the outer surface of the material is then fashioned to give the bone site the desired surface appearance. The latter process may require filling the site with additional material and /or cutting away originally applied material.
  • the molded material is applied to the outer surface of the prosthesis stem and/or to the inner surface of the bone cavity, in an amount calculated to fill the space between bone and cavity.
  • the stem is then forced into the cavity until the prosthesis is fully seated in the cavity and the implant material is forced substantially completely into the stem/bone space.
  • the method of the invention is effective to produce a rigid, contour-fitting implant at the bone site.
  • implant rigidity is produced by tissue ingrowth and replacement of binder, and the binder itself only provides initial cohesivenss and semi-rigidity.
  • the tissue ingrowth typically occurs over about a three day to six-week period, and can involve tissue ingrowth into the void spaces of the material as well as biodegradation of the binder.
  • the implant material is easily applied in moldable form to a bone site, to provide a contour-fitting implant.
  • the method of filling the bone implant with the moldable material avoids the problems of measuring and shaping a rigid-block implant, leads to a better fit than can be achieved with solid implants, and can take advantage of undercut surfaces within the bone site.
  • the material is sufficiently cohesive to resist particle exfoliation during the tissue ingrowth period, and can be made relatively rigid, after cooling, to maintain its contoured shape until it can be rigidified by tissue ingrowth.
  • hydroxylapatite Orthomatrix HA 500, 250-500 microns particle size
  • calcium sulfate hemihydrate Durobond Plaster of Paris
  • the material is loaded into a syringe using a vibrator.
  • the syringe is vibrated and its open nozzle is placed in the moldable material.
  • the plunger is withdrawn to draw material into the syringe.
  • the material can then be dispensed into a bone site in need of restoration.
  • the inorganic binder sets up into a somewhat r i g i d body.
  • the material can be molded and shaped into the desired contours.
  • the implanted material takes on additional rigidity to serve as a rigid bone implant.
  • This preparation is repeated numerous times varying the relative proportions of binder and filler, the nature of the binder and the filler, the mixing time, and the nature and amount of added aqueous fluid.
  • the materials so produced are tested to determine their physical properties and the effect of the varied parameters as follows:
  • a series of mixtures of hydroxylapatite (500-1000 micron size) with calcium sulfate hemihydrate (Durobond-Plaster of Paris) were prepared. The proportions of the two solids were varied from 20% calcium sulfate hemihydrate to 30%, to 35%, to 90%. These mixtures were prepared i n to moldable bone defect repair materials by adding water, a n d were c a s t into 1.25 cm diameter test cylinders for compression strength tests. It was seen that the 90% sample failed at a stress of 8.2 MPa, the 40% material had the same strength and the 35% was similar, at 7.4 MPa. The 20% material failed at less than 2 MPa.
  • Either water or saline may be used to wet the mixed calcium sulfate hemihydrate and hydroxylapatite powders without affecting the maximum attainable strength of the cured implant.
  • the difference between the two lies in the mixing/working time constraints.
  • a mixing time of no more than 30 seconds to give a working time of 4 to 10 minutes was typical of the results obtained when sterile saline (0.9%) was used to wet the composite.
  • the working time ranged from 20 to 30 minutes. The working time could be decreased by increasing the mixing time. Since, sterile saline is readily available, it is the preferred wetting agent. Water may be used where a delayed setting time is desired.
  • a 35% Baker Chemical calcium sulfate hemihydratehydroxylapatite composite was allowed to set hard and then the compressive strength of the composite was tested wet, following a soak of a specified number of days. Equally important as the strength was the surface erosion which occurred, the number of loose particles resulting form the erosion and the maintenance of the set shape.
  • a five gram sample of dry (65 wt % HA-500/35 wt % CaSO 4 ) was wetted with saline. It was placed into a centrifuge tube and vibrated to remove air bubbles. The f i ve gram mixture filled the centrifuge tube to a volume of 2.9 cc.
  • the bone was labeled with oxytetracycline before sacrifice at 2 and 4 weeks.
  • the undecalcified sections were photographed with fluorescent light using appropriate filters.
  • the HA-Composite accelerated trabecular bone bridging of the defect. This could not occur if the material were not biocompatible nor if the calcium sulfate were not easily resorbed and readily replaced by bone.
  • the HA/CaSO 4 paste hardened in place in 15-30 minutes.
  • the calcium sulfate gradually degraded in the body and concurrently the HA particles were invaded with tissue.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Composite Materials (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Matériau moulable pour implant osseux contenant entre environ 40% et 85% de particules dures de charge et entre 15% et 60% d'un liant inorganique biocompatible et biodégradable. Le liant comprend un hémihydrate de sulfate de calcium. La substance dure de charge et de l'hydroxyapatite. A l'utilisation, le matériau est appliqué dans des conditions permetttant le moulage et le site osseux est rempli de matériaux moulables, qui forment ensuite un implant semi-rigide épousant les contours. L'implant maintient son adhérence sur les contours et acquiert un état final rigide à mesure que le liant dans l'implant est biodégradé graduellement et remplacé par le tissu osseux se développant à partir du site osseux environnant.
EP87902254A 1986-03-11 1987-03-11 Materiau moulable pour implant osseux Withdrawn EP0259484A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US83853386A 1986-03-11 1986-03-11
US838533 1986-03-11

Publications (1)

Publication Number Publication Date
EP0259484A1 true EP0259484A1 (fr) 1988-03-16

Family

ID=25277342

Family Applications (1)

Application Number Title Priority Date Filing Date
EP87902254A Withdrawn EP0259484A1 (fr) 1986-03-11 1987-03-11 Materiau moulable pour implant osseux

Country Status (2)

Country Link
EP (1) EP0259484A1 (fr)
WO (1) WO1987005521A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2694372B2 (ja) * 1988-12-12 1997-12-24 ウロプラスティ，インコーポレイテッド 微小移植物質
US5147403A (en) * 1989-03-15 1992-09-15 United States Gypsum Company Prosthesis implantation method
US5366507A (en) * 1992-03-06 1994-11-22 Sottosanti John S Method for use in bone tissue regeneration
DE69318835T2 (de) * 1992-04-06 1998-11-05 Uroplasty, Inc., Minneapolis, Minn. Behandlung einer refluxstörung durch injektion von mikropartikeln
DE19953771C1 (de) * 1999-11-09 2001-06-13 Coripharm Medizinprodukte Gmbh Resorbierbares Knochen-Implantatmaterial sowie Verfahren zur Herstellung desselben
SE517168C2 (sv) 2000-07-17 2002-04-23 Bone Support Ab En komposition för ett injicerbart ersättningsmaterial för benmineral
EP1344538A1 (fr) 2002-03-14 2003-09-17 Degradable Solutions AG Matériau d'implantation poreux et biodégradable et son procédé de préparation
SE0302983D0 (sv) 2003-11-11 2003-11-11 Bone Support Ab Anordning för att förse spongiöst ben med benersättnings- och/eller benförstärkningsmaterial och förfarande i samband därmed
DE102004016883A1 (de) * 2004-04-06 2005-10-27 Coripharm Medizinprodukte Gmbh & Co. Kg. Verfahren zur Herstellung eines Knochen-Implantat-materials mit verbesserter mechanischer Beanspruchbarkeit auf der Basis von Formkörpern aus porösem Implantatmaterial sowie nach dem Verfahren hergestelltes Implantatmaterial
US8163030B2 (en) 2004-05-06 2012-04-24 Degradable Solutions Ag Biocompatible bone implant compositions and methods for repairing a bone defect
SE527528C2 (sv) 2004-06-22 2006-04-04 Bone Support Ab Anordning för framställning av härdbar massa samt användning av anordningen
EP2191787A1 (fr) * 2007-06-27 2010-06-02 Roland Dricot Forêt pour soulever la membrane osseuse
US9180137B2 (en) 2010-02-09 2015-11-10 Bone Support Ab Preparation of bone cement compositions
ES2399273B1 (es) * 2011-09-13 2014-01-28 Universidad Politécnica De Valencia Estuco para la conservación y restauración de materiales óseos.
PL221445B1 (pl) 2012-06-27 2016-04-29 Inst Wysokich Ciśnień Polskiej Akademii Nauk Sposób wytwarzania implantów kostnych
CN105120908B (zh) 2013-02-20 2018-04-27 骨支撑股份公司 可硬化的骨替代物的改进的凝固
JP7205876B2 (ja) * 2018-11-01 2023-01-17 学校法人明治大学 骨再生材料キット、ペースト状骨再生材料、骨再生材料及び骨接合材

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL8304129A (nl) * 1983-12-01 1985-07-01 Klaas De Groot Werkwijze voor het bereiden van een implantatie-materiaal; daarvoor geschikt tweecomponentenpakket.
US4619655A (en) * 1984-01-26 1986-10-28 University Of North Carolina Plaster of Paris as a bioresorbable scaffold in implants for bone repair
NL8401061A (nl) * 1984-04-04 1985-11-01 Stichting Biomaterials Science Werkwijze voor het bereiden van een implantatiemateriaal dat geneesmiddelen afgeeft in het lichaam.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8705521A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

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