WO2006039733A2 - Element de remplacement osseux - Google Patents

Element de remplacement osseux Download PDF

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Publication number
WO2006039733A2
WO2006039733A2 PCT/AT2005/000405 AT2005000405W WO2006039733A2 WO 2006039733 A2 WO2006039733 A2 WO 2006039733A2 AT 2005000405 W AT2005000405 W AT 2005000405W WO 2006039733 A2 WO2006039733 A2 WO 2006039733A2
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WO
WIPO (PCT)
Prior art keywords
bone
replacement part
bone replacement
ceramic
matrix
Prior art date
Application number
PCT/AT2005/000405
Other languages
German (de)
English (en)
Other versions
WO2006039733A3 (fr
Inventor
Thomas Zischinsky
Original Assignee
Mediceram Chirurgische Implantate Gmbh
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 Mediceram Chirurgische Implantate Gmbh filed Critical Mediceram Chirurgische Implantate Gmbh
Publication of WO2006039733A2 publication Critical patent/WO2006039733A2/fr
Publication of WO2006039733A3 publication Critical patent/WO2006039733A3/fr

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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
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the attempt to stabilize or replace biological bones by means of surgical bone replacement materials made of different natural or synthetic materials is very old.
  • the reconstruction of bone defects after accidents, tumor resections, diseases or malformations as well as the stabilization of fractures are based on the respective function and medically justified.
  • the reconstruction of the bone should also serve to restore harmonious contours and thus aesthetic rehabilitation.
  • An ideal and long-term stable design is sought.
  • the stabilization of a bone fracture should enable and accelerate bone healing and functional rehabilitation.
  • bioactive and absorbable (biodegradable) materials are used as a bone substitute.
  • the biocompatibility of a material is achieved by the material is not recognized by the body as an impurity and fought or degraded by the immune system.
  • Bioactive materials have the property that they stimulate the cells responsible for the formation of new bone, the osteoblasts, and thus support ingrowth. Resorbable materials disintegrate into small components after implantation and are excreted naturally.
  • the prior art includes stainless steel (US 2003171820), cobalt chromium and titanium alloys, high performance ceramics, especially alumina (Al 2 O 3 ) and various polymers with and without bioactive coating to the biocompatible materials.
  • Hydroxylapatite US 5759376, US6689375
  • calcium phosphate CA 2354552, US 5766669, WO 03092760
  • calcium carbonate and glass ceramic US 5074916
  • Resorbable materials for bone replacement are various polymers (US Pat. No. 6,692,760), such as polylactide (PLA), polyclycolide (PGA) and collagen from foreign bone.
  • titanium alloys and high performance oxide monolithic ceramics have become established as a material with tolerability for load bearing surgical bone replacement.
  • custom-made plates made of titanium and monolithic glass or high-performance ceramics are used to supply bone defects, in particular in the area of the skull and face.
  • these are manufactured individually for each patient.
  • the shape and mounting holes of the implant can be planned and manufactured. This happens before the operation and thereby shortens the operation time.
  • porous materials having bone-like properties have been known. They consist of both biological bones (US 2004059422), as well as synthetic bioactive substances such as hydroxyapatite or tricalcium phosphate (US 2004057939). In monolithic form, they are not suitable for load-bearing indications.
  • organic and inorganic short fibers are added (US 2003075822). The aim is to achieve an optimal balance between long-term stability and the stimulus of rapid ingrowth of bone-forming cells.
  • These composites are usually available in defined forms as blocks or plates and can be individually processed during the operation.
  • the porosity allows for optimal healing, which can be actively assisted in the simultaneous choice of a bioactive material, such as hydroxyapatite. They are usually used to fill cysts of similar bone defects. For fixation, resorbable membranes placed over the defect site are used.
  • the use of a body's own bone or cartilage as a bone substitute is also known and used.
  • the body's own bone or Cartilage is usually removed from the rib or pelvis of the patient, prepared and implanted in the defect region.
  • composites are created. These can be composed of different material groups or of the same material group. Depending on the nature of the surface structure and density, compact, microporous and highly porous composites with short or long fiber reinforcement are known as surgical implants. As a medical bone replacement material long fiber reinforced composite materials are known in the art, which consist mainly of carbon fibers and a matrix of thermoplastics or thermosets.
  • composites are known as bone substitutes from combinations such as PLGA / HA, PHB / HA, lactide and glycolic acid composites with calcium and magnesium phosphate, PE / HA, PLLA / HA, and bioglass / HA.
  • the material properties of the known surgical bone substitute materials are very different, but have great deficits in certain areas.
  • the ideal material for stabilizing and reconstructing biological bone should meet the requirements of biocompatibility, corrosion resistance, high strength and stability over a longer period of time with simultaneous elasticity, porosity, formability, sterilization resistance, ease of fabrication and reprocessing in the operating room, damage tolerance and affordability.
  • CT computed tomography
  • MR magnetic resonance
  • Monolithic high-performance ceramics do not allow plastic deformation. Instead, local stress peaks cause defects to crack. This has the disadvantage that even minor mismatch between biological bone and bone replacement in the support area can not be bridged by tension of the bone substitute. As a result, the bone substitute is not uniform, it heals badly and can loosen over time.
  • Custom-made bone substitutes made of titanium or monolithic high-performance ceramics can no longer be reworked during operation with conventional medical tools and devices. If the bone substitute can not be adequately fixed due to an unforeseen defect situation with the prefabricated mounting holes, or if mechanical tensions occur and thus the fracture has failed due to the low ceramic damage tolerance, the operation has failed.
  • Porous materials can be used according to the current state of the art despite admixture of short fibers for reinforcement only conditionally for load-bearing indications. Their strength is far below that of compact materials or composites.
  • Formable grid and punched tape as a bone substitute on all sides have a sharp-edged surface structure. It is known that this can lead to immune reactions usually in the form of inflammation of the surrounding tissue.
  • resorbable implants of predominantly polymers currently used in practice have such disadvantages that they repeatedly lead to inflammations and fistulas or are not stable enough to heal complicated or larger bone defects. Furthermore, it has not yet been sufficiently researched which biological requirements resorbable implants have to satisfy during bone healing, and in particular which influence the absorbed substances have on the human organism.
  • bone substitutes made of long fiber reinforced composite materials which consist predominantly of carbon fibers and a matrix of thermoplastics or thermosets, can trigger inflammation of the surrounding biological tissue. This can be caused by released carbon fiber particles (fragmentation) and by mechanical irritation.
  • the issue of biocompatibility of carbon fiber composites as bone substitutes is therefore a hot topic.
  • the invention is based on the object to find a biocompatible bone substitute for surgical implants for the stabilization and reconstruction of biological bone, in particular high strength over a long period of time with simultaneous workability with conventional medical devices and elastic behavior, at the same time high damage tolerance and custom formability equally well met.
  • the bone replacement part consists essentially of ceramic composite material (CMC), consisting of a substantially ceramic, in particular oxide ceramic, matrix and embedded therein substantially ceramic, in particular oxide ceramic, continuous fibers.
  • Ceramic composites (CMC) have a quasi-plastic behavior. This property allows low fitting tolerances in the interface area between biological bone and bone replacement part by clamping the same by means of the surgical screws to bridge. This stable support of the bone replacement part is a prerequisite for a secure screw connection even over a long period of time. Furthermore, by ensuring a good contact between biological bone and bone replacement part, the healing is promoted. Ceramic composites (CMC) have an exceptionally high damage tolerance that eliminates the brittle fracture behavior that exists, especially with monolithic ceramics. This allows the surgeon to perform through holes for fixation elements (eg screws) or shape adjustments of the bone replacement part with common medical devices even during surgery. The high damage tolerance additionally reduces the risk of fracture if the bone replacement part is overloaded after implantation.
  • the main component of the ceramic composite material (CMC) alumina Al 2 O 3 ) is.
  • Monolithic high-performance ceramics based on high-purity alumina have proven to be particularly biocompatible material with high corrosion resistance in many medical applications.
  • Alumina Al 2 O 3
  • the oxide-ceramic continuous fibers in a thickness of 0.05 to 1 mm, preferably from 0.2 to 0.5 mm, as a two or three-dimensional fabric or as a braid or as adjacent loops in the matrix embedded in one or more layers in the same or different directions.
  • Ceramic composite materials possess embedded fibers despite porous matrix even at low wall thicknesses (eg 0.8mm) enormous strength. This strength is sufficiently high for many medical applications, especially in the skull and face area.
  • the small wall thickness has the advantage that after implantation aesthetic contours are not impaired and the bone replacement part according to the invention is barely palpable, in the area where this rests on the biological bone.
  • the thin-walled inventive bone replacement part a low weight. This has the advantage that micro-movements, caused by the inertia of the bone replacement part, are minimized. The minimization of these micro-movements in the interface area between bone replacement part and biological bone is a prerequisite for optimal healing.
  • the anisotropic quasi-plastic behavior of the bone replacement part according to the invention can be adjusted such that, based on the elasticity, bone-like properties result. This is particularly important in load bearing indications of great importance to ensure the physiological introduction of the loads in the bony implant bearing. This elastically bone-like behavior prevents fracture of the biological bone, especially during load changes in the implant bed.
  • the bone replacement part may comprise at least one healing-promoting interface area for better healing in the biological tissue.
  • the aspect of rapid functional rehabilitation is of great importance.
  • the patient should regain full mobility as soon as possible after implantation. Therefore, an accelerated osteointegration is sought.
  • This can be achieved by modifying the area of the surface of the bone replacement part according to the invention that is in contact with the biological bone (interface area) in a manner that promotes healing.
  • at least one of the at least one healing-promoting interface region has a porosity, pores having an average pore diameter of 50-500 ⁇ m, in particular 100-300 ⁇ m, the pores not being connected to one another or partially or wholly.
  • the bone replacement part according to the invention is made porous in the interface region in order to achieve Ostekonduktterrorism.
  • This guardrail effect facilitates the ingrowth of capillaries, perivascular tissue and bone cells.
  • the bone cells can grow through the interface region of the bone replacement part according to the invention.
  • At least at least one of the at least one healing-promoting interface region has at least one bioactive substance, in particular hydroxylapatite (Ca 5 [OH (PO 4 ) 3 ]) or tricalcium phosphate (Ca 3 (PO-O 2 )).
  • the interface region of the bone replacement part according to the invention is bioactively modified with bone-building substances.
  • the resulting osteostimulation stimulates bone metabolism by activating already differentiated bone cells.
  • FIG. 1 shows a cross section through a ceramic composite material (CMC)
  • Figure 2 shows a cross section through an implanted form of the bone replacement part according to the invention
  • FIG 3 shows a section of a healing-promoting interface region of the bone replacement part according to the invention located in the early stage of healing.
  • FIG. 1 shows the section of a ceramic composite material (CMC) with a single-layered fabric of continuous fibers 1 embedded in a matrix 2.
  • the continuous fibers may in this case be in a thickness of 0.05 to 1 mm, preferably of 0.2 to 0.5 mm, be embedded as two or three-dimensional fabric or as a braid or as adjacent loops in the matrix in one or more layers in the same or different directions.
  • the anisotropic deformation behavior can be changed and adapted to the biomechanical requirements.
  • the fibers inhibit the crack growth of the ceramic matrix and allow for high damage tolerance, which facilitates processing. This is particularly important for manual post-processing by the surgeon to reduce fit tolerances between a prefabricated bone replacement part and the biological bone.
  • fiber-reinforced ceramics are also the low density, high strength, high temperature resistance. Because of different requirement profiles exist a variety of material variants, which differ mainly by the type and amount of fibers, the nature and composition of the matrix materials, the structure of the fiber reinforcement and the applied manufacturing technology. According to the current state of the art, they are used in particular in the air and Aerospace, applied in engine technology, chemical apparatus construction and furnace construction.
  • the main component of the ceramic composite is preferably alumina (AbO 3 ). But other biocompatible ceramics could be used. In particular, partially stabilized zirconium oxide (ZrO 2 ) and bioglass ceramic should be mentioned here.
  • Alumina (Al 2 O 3 ) suitable for medical use is highly pure and has a content of more than 99.5% by weight. Under normal conditions, ie at temperatures below 1000 degrees Celsius, aluminum oxide does not give off any ions in any environment. A release of ions is a prerequisite for a chemical reaction with the environment or corrosion. Aluminum oxide is chemically inert, ie extremely resistant to corrosion and bioinert with respect to the human body.
  • the described materials can be used for the matrix, for the fibers or for matrix and fibers.
  • alumina (Al 2 O 3 ) can be used for the fibers and / or zirconium oxide (ZrO 2 ) for the matrix or the reverse material combination can be used.
  • alumina (Al 2 O 3 ) or zirconium oxide (ZrO 2 ) can be used for matrix and fiber.
  • Another variant for the choice of material is silicon oxide SiO 2 for fiber and / or matrix.
  • the matrix or else the fiber may consist of the two or three materials aluminum oxide (Al 2 O 3 ), zirconium oxide (ZrO 2 ) or silicon oxide SiO 2 .
  • FIG. 2 shows a cross-section through an implanted form of the ceramic composite material (CMC) 6 according to the invention with an interface region 5 which induces heat (bearing area between biological bone 3 and bone replacement part 6).
  • the bone replacement part 6 is executed in the form shown by means of different wall thicknesses as coverage with bone defect filling of the Os Parietale. Other forms may be overlaps without bone defect filling, for example in the region of the midface or sleeves for bridging tubular bones after, for example, tumor resections.
  • In the interface area 5 of the bone replacement part 6 with surgical screws 4 is firmly connected to the biological bone.
  • the ceramic composite material (CMC) 4 Due to the quasi-elastic behavior of the ceramic composite material (CMC) 4 tolerance tolerances in the interface area can be bridged by means of slight tensioning of the bone replacement part 6 with the surgical screws 4. This ensures contact with the biological bone.
  • a anisotropic elastic bone-like behavior of the bone replacement part 6 according to the invention can be adjusted. This is particularly important for load-bearing indications to ensure the physiological introduction of loads into the bony implant bed. This prevents a rupture of the biological bone 3 in the implant bed.
  • the bone replacement part 6 in the interface region 5 can be made thin-walled. As a result, he is barely touchable from the outside and harmonic contours justice.
  • the ceramic composite material (CMC) can be shaped specifically for the patient and thus fulfills an aesthetic rehabilitation.
  • FIG. 3 shows a schematic detail of a healing-promoting interface region of an implanted bone replacement part according to the invention located in the early stages of healing.
  • the healing-promoting interface region may comprise pores or be modified with bioactive substances.
  • the interconnective pores 7 can also be modified additionally with a bioactive substance, in particular hydroxyapatite (Ca 5 [OH (PO 4 .4) 2 ] or tricalcium phosphate (Ca 3 (PO 4 ) 2 )
  • hydroxyapatite Ca 5 [OH (PO 4 .4) 2
  • tricalcium phosphate Ca 3 (PO 4 ) 2
  • These substances belong to the group of calcium phosphate compounds All calcium phosphates are soluble depending on the pH value, in contrast to the bio-inert, insoluble aluminum oxide (AI 2 O 3 ), which interacts with the body.
  • the solubility or absorbability is linked to the acceptance in the body, base , the bioactivity that stimulates bone growth in the direction of hydroxyapatite (Ca 5 [OH

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  • 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)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un élément de remplacement osseux (6) et vise à en renforcer la solidité, tout en lui conférant simultanément une bonne aptitude à être travaillé avec des appareils médicaux classiques et un comportement élastique similaire à celui de l'os, ainsi que simultanément, une tolérance élevée aux dommages et une plasticité individuelle. A cet effet, il est prévu que ledit élément se compose sensiblement de matériau composite céramique (CMC), à base d'une matrice (2) essentiellement céramique, notamment de céramique oxydée et de fibres continues (1) sensiblement céramiques, notamment de céramique oxydée, noyées.
PCT/AT2005/000405 2004-10-12 2005-10-11 Element de remplacement osseux WO2006039733A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
AT16982004 2004-10-12
ATA1698/2004 2004-10-12
ATA1643/2005 2005-10-10
AT16432005 2005-10-10

Publications (2)

Publication Number Publication Date
WO2006039733A2 true WO2006039733A2 (fr) 2006-04-20
WO2006039733A3 WO2006039733A3 (fr) 2006-07-20

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013153185A1 (fr) * 2012-04-11 2013-10-17 Innotere Gmbh Implant en matériau composite renforcé par des fibres
ITMI20121359A1 (it) * 2012-08-01 2014-02-02 Bioloren S R L Semilavorato per impianti dentali
CN111925226A (zh) * 2020-01-19 2020-11-13 湖南碳康生物科技有限公司 一种碳纤维复合材料颅骨补片及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230455A (en) * 1976-06-07 1980-10-28 Asahi Kogaku Kogyo Kabushiki Kaisha Prosthetic teeth and bones
US5652056A (en) * 1995-08-25 1997-07-29 Pepin; John N. Hydroxyapatite filament
US20030167093A1 (en) * 2002-03-01 2003-09-04 American Dental Association Health Foundation Self-hardening calcium phosphate materials with high resistance to fracture, controlled strength histories and tailored macropore formation rates

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230455A (en) * 1976-06-07 1980-10-28 Asahi Kogaku Kogyo Kabushiki Kaisha Prosthetic teeth and bones
US5652056A (en) * 1995-08-25 1997-07-29 Pepin; John N. Hydroxyapatite filament
US20030167093A1 (en) * 2002-03-01 2003-09-04 American Dental Association Health Foundation Self-hardening calcium phosphate materials with high resistance to fracture, controlled strength histories and tailored macropore formation rates

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013153185A1 (fr) * 2012-04-11 2013-10-17 Innotere Gmbh Implant en matériau composite renforcé par des fibres
US9572668B2 (en) 2012-04-11 2017-02-21 Innotere Gmbh Implant made of a fiber composite material
ITMI20121359A1 (it) * 2012-08-01 2014-02-02 Bioloren S R L Semilavorato per impianti dentali
EP2692312A1 (fr) * 2012-08-01 2014-02-05 Bioloren S.R.L. Produit semi-fini destiné à des implants dentaires
CN111925226A (zh) * 2020-01-19 2020-11-13 湖南碳康生物科技有限公司 一种碳纤维复合材料颅骨补片及其制备方法
CN111925226B (zh) * 2020-01-19 2022-04-08 湖南碳康生物科技有限公司 一种碳纤维复合材料颅骨补片及其制备方法

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Publication number Publication date
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