CN1299654C - Whole coxa thighbone prosthesis and method for making same - Google Patents
Whole coxa thighbone prosthesis and method for making same Download PDFInfo
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- CN1299654C CN1299654C CNB2004100253923A CN200410025392A CN1299654C CN 1299654 C CN1299654 C CN 1299654C CN B2004100253923 A CNB2004100253923 A CN B2004100253923A CN 200410025392 A CN200410025392 A CN 200410025392A CN 1299654 C CN1299654 C CN 1299654C
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Abstract
The present invention relates to a total-hip thighbone prosthesis and a preparation method thereof, which are used for the technical field of biologic medical treatment. The prosthesis is composed of an inner layer and an outer layer, wherein the inner layer is a continuous carbon fiber reinforced composite material layer of polyether ether ketone; the outer layer is a chopped carbon fiber reinforced composite material of polyether ether ketone; the two composite material layers are in hot-pressing mould clamp through a core rod mould and a prosthesis mould. The preparation method comprises the following steps: polyether ether ketone resin is dissolved in dichloroethane to prepare glue solution; the glue solution is brushed on carbon fibers or carbon cloth; before brushing, the carbon fibers or the carbon cloth is weighted; after the glue solution is brushed, dissolvent is volatilized, and thus, the dissolvent is weighted to obtain glue content; the carbon fibers or the carbon cloth is clipped according to the shape of the core rod or the prosthesis to be bundled; after heated, a mould is opened, and the bundled composite material is quickly put in the cavity of the mould to be in mould clamp; the bundled composite material is in press molding on a hot press; through pressure maintaining and heat preservation, the polyether ether ketone resin thoroughly flows; after pressure relief, the polyether ether ketone resin is cooled, and then the mould is opened to take out the prosthesis. The present invention can be tightly bonded with a femoral bone to increase stress transfer at the near end of the femoral bone.
Description
Technical field
The present invention relates to a kind of full hip femoral head prosthesis and preparation method thereof, specifically is a kind of full hip femoral head prosthesis that forms with carbon fiber reinforced polyetheretherketonecomposite composite material and preparation method thereof.Be used for the biologic medical technical field.
Background technology
The most effective Therapeutic Method of hip joint disease in late period is a replacement of total hip, and its main purpose is releasing hip pain, keeps the joint to stablize, improve function of joint, adjusts two lower limb length.The complexity of joint replacement requires material must have excellent biological compatibility, corrosion resistance, high strength, high tenacity and good anti-circulation impact and performance such as wear-resistant.Commercialization at present also only is confined to the full hip femoral head prosthesis that this three metalloid material of rustless steel (ferrous alloy), cobalt-base alloys and titanium-base alloy is made in clinical a large amount of uses, wherein cobalt alloy intensity height, abrasion resistance properties are good, biocompatibility is good, is a present most widely used class alloy.Yet the metal of use and alloy material thereof are tens times even tens times of bone itself owing to the elastic modelling quantity height, and its combination mechanical property can't be mated, and can not create near the force environment that is subjected under the human body physiological state.Therefore, behind the prosthese implant into body, produce stress shielding, stress concentration, phenomenon that stress distribution is unbalance, destroyed the normal human joint biomechanics regularity of distribution, and then caused a series of complication such as postoperative bone resorption, osteanabrosis and even prosthetic loosening, for from now on reconstruction brings difficulty.Composite have low modulus, high strength, material property adjustable extent big, corrosion-resistant, be easy to machine-shaping, low cost and other advantages, demonstrate wide application prospect in the design of artificial joint prosthesis with in making, but also exist simultaneously because elastic modelling quantity is low combines relatively poor the generation with osseous tissue interface and become flexible, can not finish fixed phenomenon biology.
Find by literature search, Turner, " the Maintenance of proximalcortical bone with use of a less stiff femoral component inhemiarthroplasty of the hip without cement.An investigation in acanine model at six months and two years " that T.M delivers, (J.Bone and Joint Surg., 1997,79-A, 1381～1390) (" low rigidity is near the application of femur component in uncemented total hip prostheses of cortical bone.The dog analoglike research of six months and 2 years ", bone with is connected surgical magazine), this article has designed a kind of prosthese that contains composite, its structure is: the centre is a vitallium, outer is the polyether-ether-ketone of being with titanium silk big envelope.Although the design of these materials with the bone strong bonded, effectively reduce aspect such as near-end bone resorption and demonstrate certain advantage, but still keep away unavoidable metal material as the inherent defective of biomedical material, the advantage of polymer composites does not ideally embody.
Summary of the invention
The present invention is directed to above-mentioned deficiency and defective, provide a kind of low elastic modulus and high-intensity full hip femoral head prosthesis and preparation method thereof, make it more close with the human body bone structure, with osseous tissue mechanical compatibility is preferably arranged, thereby can combine closely, increase the near end of thighbone Stress Transfer with femur, can solve a series of complication such as the present bone resorption that now causes by stress shielding and stress concentration, osteanabrosis, further improve the late result of replacement of total hip with material.
The present invention is achieved by the following technical solutions, the present invention is complete, and the hip femoral head prosthesis is made of inside and outside double-layer structure, internal layer is a continuous carbon fibre reinforced polyether ether ketone composite layer, the outer chopped carbon fiber reinforced polyether ether ketone composite layer that adopts, by using plug mould and prosthese mould two kinds of composite layer hot pressing matched moulds, form the full hip femoral head prosthesis of carbon fiber reinforced polyether-ether-ketone, described carbon fiber reinforced polyetheretherketonecomposite composite material is to brush by the glue that polyether-ether-ketone resin is configured to prepare on carbon fiber or carbon fiber plain.
Internal layer adopts the enhanced polyether-ether-ketone composite material of continuous carbon fibre, and continuous carbon fibre reinforced polyether ether ketone composite to arrive the far-end of femoral stem more few more, guarantee that prosthese has enough strength and stiffness, can not rupture easily, improve safety coefficient greatly; The outer chopped carbon fiber reinforced polyether ether ketone composite that adopts, its modulus will be lower than the enhanced polyether-ether-ketone composite material of continuous carbon fibre, suitable with the modulus of compact bone, make the rigidity of whole prosthese maintain on the lower level in the material design, make the rigidity of itself and osseous tissue be unlikely to differ too big, thereby obtain better mechanical compatibility, effectively reduce a series of adverse consequencess such as bone resorption that stress shielding causes and osteanabrosis.
Full hip femoral head prosthesis needs to strengthen a shop layer density at area of stress concentration, carbon fiber can be unidirectional 0 ° vertically arrange and be and intersect arranged vertical with the carbon fiber that increases by 90 ° of directions so that increase antitorque, shear strength.
The preparation method of the full hip femoral head prosthesis of the present invention is dissolved in dichloroethanes with polyether-ether-ketone resin and is mixed with the glue of solid content at the 10-30% percentage by weight, and this glue is brushed on carbon fiber or carbon cloth.Before brushing carbon fiber or carbon cloth are carried out weighing, after the gluing solution, solvent is through volatilization, and its gel content is learnt in weighing again, can repeatedly brush, till reaching required gel content 50-80%.To reach the carbon fiber or the carbon cloth of design gel content, cut out by plug or prosthese shape, by required feeding quantity carbon fiber through cutting out or carbon cloth are tied up by a design shop layer direction, with after the mold heated to 400 ℃, die sinking, the composite that to tie up is put into the mold cavity matched moulds fast, press molding on hot press, pressure-maintaining and heat-preservation make polyether-ether-ketone resin fully mobile, and the release postcooling is to being lower than 150 ℃, the composite prosthese that has been shaped is taken out in die sinking.
The present invention has substantive distinguishing features and marked improvement, the present invention possesses following advantage and positive role: 1. the modulus of prosthese and human femur under loading are complementary, has the good mechanical compatibility, for the stable bond of osseous tissue and prosthese, promote fixedly to have created biology good biomechanics environment.2. have certain intensity and wearability.3. has excellent biological compatibility.4. can bear the load of human hip complexity, increase the Stress Transfer of near end of thighbone, reduce stress shielding, stress concentration, thereby can reduce complication such as bone resorption, osteanabrosis, prosthese fatigue fracture.
The specific embodiment
The present invention is complete, and the hip femoral head prosthesis is made of inside and outside double-layer structure, internal layer is a continuous carbon fibre reinforced polyether ether ketone composite layer, the outer chopped carbon fiber reinforced polyether ether ketone composite layer that adopts, by using plug mould and prosthese mould two kinds of composite layer hot pressing matched moulds, form the full hip femoral head prosthesis of carbon fiber reinforced polyether-ether-ketone, described carbon fiber reinforced polyetheretherketonecomposite composite material is to brush by the glue that polyether-ether-ketone resin is configured to prepare on carbon fiber or carbon fiber plain.
Full hip femoral head prosthesis needs to strengthen a shop layer density at area of stress concentration, and 0 ° of carbon fiber one-way is vertically arranged and is with the carbon fiber that increases by 90 ° of directions and intersects arranged vertical.
Below in conjunction with embodiment the present invention is described in detail.
Embodiment 1
Polyether-ether-ketone resin is dissolved in dichloroethanes is mixed with the glue that solid content is 10% (percentage by weight), this glue is brushed on carbon fiber or carbon cloth.Before brushing carbon fiber or carbon cloth are carried out weighing, after the gluing solution, solvent is through volatilization, and weighing again can be learnt its gel content, can repeatedly brush, till reaching required gel content.This borrowed structure inner layer material gel content 50%, cladding material gel content 80%.To reach the carbon fiber or the carbon cloth of design gel content, cut out by plug or prosthese shape, by required feeding quantity carbon fiber through cutting out or carbon cloth are tied up by a design shop layer direction, with after the mold heated to 400 ℃, die sinking, the composite that to tie up is put into the mold cavity matched moulds fast, press molding on hot press, pressure-maintaining and heat-preservation make polyether-ether-ketone resin fully mobile, and the release postcooling is to being lower than 150 ℃, the composite prosthese that has been shaped is taken out in die sinking.
Embodiment 2
Polyether-ether-ketone resin is dissolved in dichloroethanes is mixed with the glue that solid content is 20% (percentage by weight), this glue is brushed on carbon fiber or carbon cloth.Before brushing carbon fiber or carbon cloth are carried out weighing, after the gluing solution, solvent is through volatilization, and weighing again can be learnt its gel content, can repeatedly brush, till reaching required gel content.This borrowed structure inner layer material gel content 60%, cladding material gel content 75%.To reach the carbon fiber or the carbon cloth of design gel content, cut out by plug or prosthese shape, by required feeding quantity carbon fiber through cutting out or carbon cloth are tied up by a design shop layer direction, with after the mold heated to 400 ℃, die sinking, the composite that to tie up is put into the mold cavity matched moulds fast, press molding on hot press, pressure-maintaining and heat-preservation make polyether-ether-ketone resin fully mobile, and the release postcooling is to being lower than 150 ℃, the composite prosthese that has been shaped is taken out in die sinking.
Embodiment 3
Polyether-ether-ketone resin is dissolved in dichloroethanes is mixed with the glue that solid content is 30% (percentage by weight), this glue is brushed on carbon fiber or carbon cloth.Before brushing carbon fiber or carbon cloth are carried out weighing, after the gluing solution, solvent is through volatilization, and weighing again can be learnt its gel content, can repeatedly brush, till reaching required gel content.This borrowed structure inner layer material gel content 55%, cladding material gel content 80%.To reach the carbon fiber or the carbon cloth of design gel content, cut out by plug or prosthese shape, by required feeding quantity carbon fiber through cutting out or carbon cloth are tied up by a design shop layer direction, with after the mold heated to 400 ℃, die sinking, the composite that to tie up is put into the mold cavity matched moulds fast, press molding on hot press, pressure-maintaining and heat-preservation make polyether-ether-ketone resin fully mobile, and the release postcooling is to being lower than 150 ℃, the composite prosthese that has been shaped is taken out in die sinking.
Embodiment 1-3 effect is as follows:
Stress shielding experiment shows: when ambient stress changed behind the prosthetic replacement, carbon fiber reinforced polyether-ether-ketone prosthese stress shielding was well below vitallium, and both differ nearly 30%, have significant difference.Shear stress between femur and the prosthese interface and strain experiment show: carbon fiber/polyetheretherketonecomposite composite material prosthese group is starkly lower than the vitallium group, and both have significant difference; No matter interfacial shearing stress is the inboard or the outside of prosthese handle, and carbon fiber/polyetheretherketonecomposite composite material prosthese group is less than the vitallium group, and both differ nearly 70%, significant difference.Torsional rigidity, torsion angle and torsional strength experiment show: the torsion angle of carbon fiber/polyetheretherketonecomposite composite material prosthese group is littler by nearly 40% than vitallium group, torsional rigidity is bigger by nearly 40% than the latter, from the interfacial failure situation, the composite group is little less to the bone interface damage greatly with torsional rigidity because of torsion angle.Above-mentioned result of study shows between full hip femoral head prosthesis of carbon fiber/polyetheretherketonecomposite composite material prosthese and the osseous tissue the good mechanical compatibility, can bear the load of human hip complexity, the Stress Transfer that increases near end of thighbone and reduction stress shielding, stress concentration, thereby can reduce complication such as bone resorption, osteanabrosis, prosthese fatigue fracture, fix biology for stable bond, the promotion of osseous tissue and prosthese, created good biomechanics environment.
Claims (3)
1, a kind of full hip femoral head prosthesis, constitute by inside and outside double-layer structure, it is characterized in that, internal layer is a continuous carbon fibre reinforced polyether ether ketone composite layer, skin is a chopped carbon fiber reinforced polyether ether ketone composite layer, by using plug mould and prosthese mould two kinds of composite layer hot pressing matched moulds, form the full hip femoral head prosthesis of carbon fiber reinforced polyether-ether-ketone, described carbon fiber reinforced polyetheretherketonecomposite composite material is to brush by the glue that polyether-ether-ketone resin is configured to prepare on carbon fiber or carbon fiber plain.
2, full hip femoral head prosthesis according to claim 1, it is characterized in that, the far-end that internal layer continuous carbon fibre reinforced polyether ether ketone composite layer arrives femoral stem more is few more, outer chopped carbon fiber reinforced polyether ether ketone composite layer material modulus is lower than continuous carbon fibre reinforced polyether ether ketone composite, and is suitable with the modulus of compact bone.
3, full hip femoral head prosthesis according to claim 1 is characterized in that, at area of stress concentration, strengthens a shop layer density, and 0 ° of carbon fiber one-way is vertically arranged and is with the carbon fiber that increases by 90 ° of directions and intersects arranged vertical.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100253923A CN1299654C (en) | 2004-06-24 | 2004-06-24 | Whole coxa thighbone prosthesis and method for making same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100253923A CN1299654C (en) | 2004-06-24 | 2004-06-24 | Whole coxa thighbone prosthesis and method for making same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1593356A CN1593356A (en) | 2005-03-16 |
| CN1299654C true CN1299654C (en) | 2007-02-14 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2004100253923A Expired - Fee Related CN1299654C (en) | 2004-06-24 | 2004-06-24 | Whole coxa thighbone prosthesis and method for making same |
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Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2200672B1 (en) | 2007-09-11 | 2012-06-27 | Solvay Specialty Polymers USA, LLC. | Improved prosthetic devices |
| CN106687077B (en) | 2014-09-07 | 2021-07-27 | 奥西奥有限公司 | Anisotropic biocomposites, medical implants comprising anisotropic biocomposites, and methods of treatment |
| CN107106210B (en) | 2014-12-26 | 2021-05-04 | 奥西奥有限公司 | Continuous Fiber Reinforced Biocomposite Medical Implants |
| CN105030378B (en) * | 2015-05-15 | 2017-11-03 | 江苏奥康尼医疗科技发展有限公司 | A kind of high-molecular organic material semi-artificial hip joint prosthese |
| WO2017155956A1 (en) | 2016-03-07 | 2017-09-14 | Ossio Ltd | Surface treated biocomposite material, medical implants comprising same and methods of treatment thereof |
| CN109641081A (en) | 2016-06-27 | 2019-04-16 | 奥西西奥有限公司 | Fiber reinforcement Biocomposite material medical implant with high mineral content |
| CN106620895B (en) * | 2016-12-16 | 2019-12-31 | 厦门市豪尔新材料股份有限公司 | Carbon fiber and polyether-ether-ketone composite bone fracture plate and preparation method thereof |
| CN108125713B (en) * | 2017-12-28 | 2024-02-23 | 武汉康斯泰德科技有限公司 | Long-chain carbon fiber PEEK (polyether-ether-ketone) outer-wrapped thermal-forming bone fixing plate and forming method |
| CN109675116A (en) * | 2019-02-18 | 2019-04-26 | 永康市仁合五金制品有限公司 | A kind of preparation method of PEEK composite material joint prosthesis |
| CN110841114B (en) * | 2019-09-27 | 2021-12-14 | 长沙晟天新材料有限公司 | A kind of carbon fiber composite artificial bone and preparation method thereof |
| CN110613535A (en) * | 2019-10-25 | 2019-12-27 | 北京安颂科技有限公司 | Femoral stem prosthesis and method of making same |
| CN110940609A (en) * | 2019-10-31 | 2020-03-31 | 江南工业集团有限公司 | Method for measuring gum content of gum-dipped cloth |
| GB202014555D0 (en) * | 2020-09-16 | 2020-10-28 | Invibio Device Component Mfg Limited | Devices comprising composite materials |
| US20240001630A1 (en) * | 2020-11-30 | 2024-01-04 | Arctic Biomaterials Oy | Method for manufacturing fiber reinforced article and apparatus |
| IL294542B1 (en) | 2021-07-19 | 2026-02-01 | Ossio Ltd | Cannulated implant delivery device with adjustable insertion depth |
| CN116392641A (en) * | 2023-03-16 | 2023-07-07 | 北京市春立正达医疗器械股份有限公司 | A kind of monolithic compound structure artificial hip joint acetabular cup |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994015652A1 (en) * | 1993-01-15 | 1994-07-21 | University Of Southampton | Load bearing implantable prosthesis |
| US5443513A (en) * | 1992-03-23 | 1995-08-22 | Howmedica Inc. | Composite orthopedic implant |
-
2004
- 2004-06-24 CN CNB2004100253923A patent/CN1299654C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5443513A (en) * | 1992-03-23 | 1995-08-22 | Howmedica Inc. | Composite orthopedic implant |
| WO1994015652A1 (en) * | 1993-01-15 | 1994-07-21 | University Of Southampton | Load bearing implantable prosthesis |
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| CN1593356A (en) | 2005-03-16 |
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