WO2017004742A1 - 一种骨缺损填充物 - Google Patents

一种骨缺损填充物 Download PDF

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Publication number
WO2017004742A1
WO2017004742A1 PCT/CN2015/000728 CN2015000728W WO2017004742A1 WO 2017004742 A1 WO2017004742 A1 WO 2017004742A1 CN 2015000728 W CN2015000728 W CN 2015000728W WO 2017004742 A1 WO2017004742 A1 WO 2017004742A1
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Prior art keywords
bone defect
filler
bone
hollow
defect filler
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PCT/CN2015/000728
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English (en)
French (fr)
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朱健
徐龙伟
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江苏奥康尼医疗科技发展有限公司
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Publication of WO2017004742A1 publication Critical patent/WO2017004742A1/zh

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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
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • 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
    • A61F2/38—Joints for elbows or knees
    • 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
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix

Definitions

  • the invention belongs to the technical field of medical technology, and more particularly to a bone defect filler composed of a biocompatible polymer material and a biocompatible metal or bioceramic material composite.
  • Bone defects are common in patients with severe osteoporosis and severe skeletal deformities, and are also prevalent in patients due to osteolysis after the first artificial joint replacement (Callaghan JJ, Liu SS, Phruetthiphat OA. The revision acetabulum-- Allograft and bone substitutes: vestigial organs for bone deficiency. Bone Joint J. 2014 Nov; 96-B (11 Supple A): 70-2. doi: 10.1302/0301-620X.96B11.34452). There are two methods for the repair of bone defects. First, natural bone is used as the filling bone (Chun CH, Kim JW, Kim SH, Kim BG, Chun KC, Kim KM.
  • an object of the present invention is to provide a bone defect filler composed of a biocompatible polymer material and a biocompatible metal or bioceramic material composite.
  • a bone defect filler comprising a first portion and a second portion, wherein the first portion is a primary bone filling portion; the second portion is a portion in direct contact with natural bone; the first portion is highly biocompatible Molecular material composition; the second portion is comprised of a biocompatible metal or bioceramic material; the first portion is combined with the second portion.
  • the biocompatible polymer material is one or more of polyetheretherketone and its derivatives, ultrahigh molecular weight polyethylene and its derivatives, and polytetrafluoroethylene and derivatives thereof;
  • the biocompatible metal material is one or more of a cobalt chromium molybdenum alloy, titanium or titanium alloy, tantalum or niobium alloy, magnesium or magnesium alloy, stainless steel and zirconium-niobium alloy; the bioceramic material is hydroxyapatite.
  • first portion and the second portion are combined by surface spraying or chemical deposition methods.
  • the second portion is composed of a biocompatible metal material, the second portion The part is formed by machining or 3D printing; the first part is combined with the second part by injection molding.
  • the outer surface of the second portion is a porous structure.
  • the bone defect filler is a filling of an acetabular fossa for a severe malformation or a bone defect, wherein the second portion is a convex surface portion of the acetabular fossa filler, and the first portion is a The remainder of the acetabular fossa filling.
  • the acetabular socket filler contains one or more screw holes.
  • the filler is a hollow vertebral body of a hip joint upper end or a knee joint femur or an upper end of a knee joint for a severe bone defect, wherein the second portion is an outer surface portion of the vertebral body, The first part is the remainder of the vertebral body.
  • the filler is a hollow gasket of a knee joint femoral condyle for severe bone defect, wherein the second portion is a largest planar portion of the hollow gasket, and the first portion is the hollow gasket The remaining portion; or the filler is a hollow gasket for the upper end of the tibia of the knee joint for a severe bone defect, wherein the second portion is a sub-large planar portion of the hollow spacer, the first portion being a The remainder of the hollow gasket.
  • the hollow gasket contains one or more screw holes.
  • the elastic modulus of the bone defect filler provided by the present invention matches the natural bone, and the stress occlusion problem is alleviated;
  • the main part of the inner plant part in the bone defect filling provided by the invention is composed of a polymer material, which reduces metal corrosion and allergy and toxicity problems which may be caused by metal;
  • FIG. 1 is an embodiment of a bone defect filler provided by the present invention, wherein the bone defect filler is a acetabular fossa filling with a severe deformity or a bone defect;
  • FIG. 2 is another embodiment of a bone defect filler provided by the present invention, wherein the bone defect filler is a hollow vertebral body at the upper end of the hip joint of a severe bone defect;
  • FIG. 3 is a further embodiment of a bone defect filler provided by the present invention, wherein the bone defect filler is a hollow vertebral body of a femoral condyle of a knee joint with severe bone defects;
  • bone defect filler is a hollow vertebral body at the upper end of the knee joint of a severe bone defect
  • FIG. 5 is a further embodiment of a bone defect filler provided by the present invention, wherein the bone defect filler is a hollow gasket of a femoral condyle of a knee joint with severe bone defects;
  • FIG. 6 is a further embodiment of a bone defect filler provided by the present invention, wherein the bone defect filler is a hollow spacer of the upper end of the knee joint of a severe bone defect.
  • the invention provides a bone defect filler, comprising a first part and a second part, wherein the first part is a main bone filling part; the second part is a part directly contacting the natural bone; and the first part is a biocompatible polymer material
  • the second part is composed of a biocompatible metal or bioceramic material; the first part is combined with the second part.
  • the biocompatible polymer material is polyetheretherketone (PEEK) and its derivatives, ultrahigh molecular weight polyethylene (UHMWPE) and its derivatives, and polytetrafluoroethylene (PTFE) and its derivatives.
  • PEEK polyetheretherketone
  • UHMWPE ultrahigh molecular weight polyethylene
  • PTFE polytetrafluoroethylene
  • the biocompatible metal material is one or more of cobalt chromium molybdenum alloy, titanium or titanium alloy, tantalum or niobium alloy, magnesium or magnesium alloy, stainless steel and zirconium-niobium alloy
  • bioceramic material It is hydroxyapatite.
  • the biocompatible polymer material is preferably polyetheretherketone (PEEK), and the biocompatible metal material is preferably titanium or a titanium alloy.
  • Polyetheretherketone (PEEK) is widely used as a high-strength and high-biocompatible polymer material in clinical applications of orthopedic implants, including spinal fusion cages and spinal fixation rods.
  • the elastic modulus of PEEK is between the cortical bone and the cancellous bone.
  • the built-in material made of PEEK has a much lower potential occlusion problem for natural bone than the metal material.
  • the built-in material composed of PEEK has no imaging interference problem for magnetic resonance imaging (MRI), and there is no corrosion, especially electrochemical corrosion, in the bond with the metal screw. Therefore, PEEK has most of the advantages of being an artificial bone filler.
  • MRI magnetic resonance imaging
  • PEEK has no advantage in promoting bone growth compared to bioceramics or metallic materials. Therefore, the present invention proposes that PEEK (Part 1) is combined with bioceramic or metallic materials (Part 2) to form a composite material as artificial bone filling. The concept of things.
  • the bonding between PEEK (first part) and bioceramic or metal material (second part) can be achieved by surface spraying, such as spraying hydroxyapatite to PEEK by plasma (Part 1)
  • the surface or chemical deposition method is deposited onto the surface of the PEEK (Part 1), or the metal material is sprayed onto the surface of the PEEK (Part 1) or chemically deposited onto the surface of the PEEK (Part 1).
  • the bond between the PEEK (first part) and the metal (the second part) can also be achieved by injection molding, such as by mechanical processing or 3D printing.
  • the metal portion (second portion) of the filler is then molded by injection molding to form the PEEK portion (first portion) and the metal portion (second portion).
  • the outer surface of the second portion is a porous structure.
  • PEEK polyetheretherketone
  • Fig. 1 shows an acetabular fossa with a severely deformed acetabular fossa or bone defect and a filler filled with PEEK and a bioceramic or metal material to be repaired.
  • the convex surface of the particular filler is composed of bioceramic or metallic material and the remainder consists of PEEK.
  • the specific filler contains one or more screw holes.
  • Fig. 2 shows the upper end of the femur of the severe bone defect and the filler hollow vertebral body which is composed of PEEK and bioceramic or metal material to be repaired.
  • the outer surface of the vertebral body is composed of bioceramic or metallic material, and the remainder is composed of PEEK.
  • Fig. 3 shows a femoral condyle of a knee with a severe bone defect and a filler hollow vertebral body composed of PEEK and a bioceramic or metal material to be repaired.
  • the outer surface of the vertebral body is composed of bioceramic or metallic material, and the remainder is composed of PEEK.
  • Fig. 4 shows the upper end of the tibia of the knee joint with severe bone defect and the filler hollow vertebral body which is composed of PEEK and bioceramic or metal material to be repaired.
  • the outer surface of the vertebral body is composed of bioceramic or metallic material, and the remainder is composed of PEEK.
  • Fig. 5 shows a femoral condyle of a knee with a severe bone defect and a filler hollow spacer composed of PEEK and a bioceramic or metal material to be repaired.
  • the largest planar portion of the hollow spacer is constructed of bioceramic or metallic material and the remainder is comprised of PEEK.
  • the hollow gasket contains one or more screw holes.
  • Fig. 6 shows the upper end of the tibia of the knee joint with severe bone defects and the filler hollow spacer composed of PEEK and bioceramic or metal material to be repaired.
  • the sub-planar portion of the hollow spacer is constructed of bioceramic or metallic material and the remainder is comprised of PEEK.
  • the hollow gasket contains one or more screw holes.
  • the elastic modulus of the PEEK in the bone defect filler provided by the present invention matches the natural bone, and the stress shielding problem is alleviated;
  • the main part of the inner plant part in the bone defect filling provided by the present invention is composed of a polymer material.
  • the composition reduces the metal corrosion and allergy and toxicity problems that may be caused by the metal; in the present invention, the inner plant component composed of the biocompatible polymer material does not interfere with the nuclear magnetic resonance imaging.

Abstract

一种骨缺损填充物，包括第一部分和第二部分，该第一部分为主要骨填充部分，由生物相容性高分子材料构成，该第二部分为与自然骨直接接触的部分，由生物相容性金属或生物陶瓷材料构成，第一部分与第二部分相结合。该骨缺损填充物的弹性模量与自然骨相匹配，减轻了应力遮挡问题，其内植物部件的主要部分由高分子材料组成，降低了金属腐蚀和金属可能引起的过敏、毒性问题，并且由生物相容性高分子材料组成的内植物部件对核磁共振成像不造成干扰。

Description

一种骨缺损填充物 技术领域
本发明属于医疗技术领域，更具体地，涉及一种由生物相容性高分子材料和生物相容性金属或生物陶瓷材料复合组成的骨缺损填充物。
背景技术
骨缺损在严重骨质疏松病人及严重骨骼畸形的病人中非常普遍，另外在首次人工关节置换术失效后病人中由于骨溶解也普遍存在(Callaghan JJ,Liu SS,Phruetthiphat OA.The revision acetabulum--allograft and bone substitutes:vestigial organs for bone deficiency.Bone Joint J.2014Nov；96-B(11Supple A):70-2.doi:10.1302/0301-620X.96B11.34452)。骨缺损的修复一般有两种方法，其一，自然骨作为填充骨(Chun CH,Kim JW,Kim SH,Kim BG,Chun KC,Kim KM.Clinical and radiological results of femoral head structural allograft for severe bone defects in revision TKA--a minimum 8-year follow-up.Knee.2014Mar；21(2):420-3.doi:10.1016/j.knee.2013.04.012)，其二，人工骨作为填充物。自然骨的来源比较困难，特别在中国同种异体骨的来源由于文化及法规的限制更加稀缺。人工骨一般由生物陶瓷或金属两种材料构成最为普遍。生物陶瓷一般由磷酸钙，羟基磷灰石等组成，虽然其骨诱导和生物相容性优异，但是其承载能力不佳，所以其临床应用局限于轻度骨缺损及非承载部位(Egawa H1,Ho H,Huynh C,Hopper RH Jr,Engh CA Jr,Engh CA.A three-dimensional method for evaluating changes in acetabular osteolytic lesions in response to treatment.Clin Orthop Relat Res.2010Feb；468(2):480-90.doi:10.1007/s11999-009-1050-0)。金属材料特别是钛或钛合金一般应用于严重骨缺损或需要承载的骨缺损部位，特别是关节置换术失效后需要翻修的情 况下，虽然金属材料的机械性能及承载力极佳，但是其弹性模量和刚度远高于自然骨，因此应力遮挡问题比较严重(Agarwal S,Azam A,Morgan-Jones R.Metal metaphyseal sleeves in revision total knee replacement.Bone Joint J.2013Dec；95-B(12):1640-4.doi:10.1302/0301-620X.95B12.31190.)。此外，金属填充物一般需要与金属螺钉结合已达到与自然骨的固定，金属对金属在产生微动的情况下会产生磨损及腐蚀，从而释放金属离子及金属颗粒，在过量的情况下会引起病人的不良反应(Magone K1,Luckenbill D,Goswami T.Arch Orthop Trauma Surg.2015May；135(5):683-95.doi:10.1007/s00402-015-2196-8.Epub 2015Mar 21.Metal ions as inflammatory initiators of osteolysis)。
发明内容
针对上述待解决的技术问题，本发明的目的是提供一种由生物相容性高分子材料和生物相容性金属或生物陶瓷材料复合组成的骨缺损填充物。
为了实现上述发明，本发明采用如下技术方案：
一种骨缺损填充物，包括第一部分和第二部分，其中所述第一部分为主要骨填充部分；所述第二部分为与自然骨直接接触的部分；所述第一部分由生物相容性高分子材料构成；所述第二部分由生物相容性金属或生物陶瓷材料构成；所述第一部分与所述第二部分相结合。
进一步地，所述生物相容性高分子材料为聚醚醚酮及其衍生物、超高分子量聚乙烯及其衍生物和聚四氟乙烯及其衍生物中的一种或多种；所述生物相容性金属材料为钴铬钼合金、钛或钛合金、钽或钽合金、镁或镁合金、不锈钢和锆铌合金的一种或多种；所述生物陶瓷材料为羟基磷灰石。
进一步地，所述第一部分与所述第二部分通过表面喷涂或化学沉积方法相结合。
进一步地，所述第二部分由生物相容性金属材料构成，所述第二部 分通过机械加工或3D打印成型；所述第一部分与所述第二部分通过注塑成型相结合。
进一步地，所述第二部分的外表面为多孔结构。
进一步地，所述骨缺损填充物为用于严重畸形或骨缺损的髋臼窝的填充物，其中所述第二部分为所述髋臼窝填充物的凸表面部分，所述第一部分为所述髋臼窝填充物的剩余部分。
进一步地，所述髋臼窝填充物含有一个或多个螺钉孔。
进一步地，所述填充物为用于严重骨缺损的髋关节股骨上端或膝关节股骨髁或膝关节胫骨上端的空心椎体，其中所述第二部分为所述椎体的外表面部分，所述第一部分为所述椎体的剩余部分。
进一步地，所述填充物为用于严重骨缺损的膝关节股骨髁的空心垫片，其中所述第二部分为所述空心垫片的最大平面部分，所述第一部分为所述空心垫片的剩余部分；或者，所述填充物为用于严重骨缺损的膝关节胫骨上端的空心垫片，其中所述第二部分为所述空心垫片的次大平面部分，所述第一部分为所述空心垫片的剩余部分。
进一步地，所述空心垫片含有一个或多个螺钉孔。
由于采用以上技术方案，本发明的有益效果为：
1)本发明提供的骨缺损填充物的弹性模量与自然骨相匹配，减轻了应力遮挡问题；
2)本发明提供的骨缺损填充物中的内植物部件的主要部分由高分子材料组成，降低了金属腐蚀和金属可能引起的过敏、毒性问题；
3)本发明中由生物相容性高分子材料组成的内植物部件对核磁共振成像不造成干扰。
附图说明
图1是本发明提供的骨缺损填充物的一实施例，其中骨缺损填充物为严重畸形或骨缺损的髋臼窝填充物；
图2是本发明提供的骨缺损填充物的另一实施例，其中骨缺损填充物为严重骨缺损的髋关节股骨上端的空心椎体；
图3是本发明提供的骨缺损填充物的又一实施例，其中骨缺损填充物为严重骨缺损的膝关节股骨髁的空心椎体；
图4是本发明提供的骨缺损填充物的又一实施例，其中骨缺损填充物为严重骨缺损的膝关节胫骨上端的空心椎体；
图5是本发明提供的骨缺损填充物的又一实施例，其中骨缺损填充物为严重骨缺损的膝关节股骨髁的空心垫片；
图6是本发明提供的骨缺损填充物的又一实施例，其中骨缺损填充物为严重骨缺损的膝关节胫骨上端的空心垫片。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合附图及实施例对本发明作进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明提供的一种骨缺损填充物，包括第一部分和第二部分，其中第一部分为主要骨填充部分；第二部分为与自然骨直接接触的部分；第一部分由生物相容性高分子材料构成；第二部分由生物相容性金属或生物陶瓷材料构成；第一部分与所述第二部分相结合。
在上述技术方案中，生物相容性高分子材料为聚醚醚酮(PEEK)及其衍生物、超高分子量聚乙烯(UHMWPE)及其衍生物和聚四氟乙烯(PTFE)及其衍生物中的一种或多种；生物相容性金属材料为钴铬钼合金、钛或钛合金、钽或钽合金、镁或镁合金、不锈钢和锆铌合金的一种或多种；生物陶瓷材料为羟基磷灰石。
在上述技术方案中，生物相容性高分子材料优选聚醚醚酮(PEEK)，生物相容性金属材料优选为钛或钛合金。
聚醚醚酮(PEEK)作为一种高强度及高生物相容性的高分子材料被广泛应用于骨科内置物临床应用中，包括脊柱融合器，脊柱固定棒等。 PEEK的弹性模量介于皮质骨与松质骨之间，相较于金属材料，由PEEK构成的内置物对自然骨的潜在应力遮挡问题远小于金属材料。此外，由PEEK构成的内置物对核磁共振成像(MRI)没有成像干扰问题，与金属螺钉之间的结合不存在腐蚀特别是电化学腐蚀问题。因此，PEEK具备作为人工骨填充物的大部分优点。但在促进骨增长方面，相较于生物陶瓷或金属材料，PEEK不具有优势，所以本发明提出PEEK(第一部分)与生物陶瓷或金属材料(第二部分)相结合组成复合材料作为人工骨填充物的概念。
在上述技术方案中，PEEK(第一部分)与生物陶瓷或金属材料(第二部分)之间的结合可以通过表面喷涂的方法来实现，比如将羟基磷灰石通过等离子喷涂到PEEK(第一部分)的表面或化学沉积的方法沉积到PEEK(第一部分)的表面，或者将金属材料喷涂到PEEK(第一部分)的表面或化学的方法沉积到PEEK(第一部分)的表面。另外，当第二部分由生物相容性金属构成时，PEEK(第一部分)与金属(第二部分)之间的结合也可以通过注塑的方法来实现，比如通过机械加工或3D打印先制造复合填充物的金属部分(第二部分)，然后通过注塑来实现PEEK部分(第一部分)的成型及与金属部分(第二部分)的结合。
在上述技术方案中，第二部分的外表面为多孔结构。
如图1-6所示，本发明提供的骨缺损填充物的具体实施例，其中第一部分优选由聚醚醚酮(PEEK)构成。
如图1所示，图1示出了严重畸形髋臼窝或骨缺损的髋臼窝及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物。在该实施例中，该具体填充物的凸表面由生物陶瓷或金属材料构成，其余部分由PEEK构成。此外，该具体填充物含有一个或多个螺钉孔。
如图2所示，图2示出了严重骨缺损的髋关节股骨上端及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物空心椎体。在该实施例中，该椎体的外表面由生物陶瓷或金属材料构成，其余部分由PEEK构成。
如图3所示，图3示出了严重骨缺损的膝关节股骨髁及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物空心椎体。在该实施例中，该椎体的外表面由生物陶瓷或金属材料构成，其余部分由PEEK构成。
如图4所示，图4示出了严重骨缺损的膝关节胫骨上端及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物空心椎体。在该实施例中，该椎体的外表面由生物陶瓷或金属材料构成，其余部分由PEEK构成。
如图5所示，图5示出了严重骨缺损的膝关节股骨髁及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物空心垫片。在该实施例中，该空心垫片的最大平面部分由生物陶瓷或金属材料构成，其余部分由PEEK构成。此外，该空心垫片含有一个或多个螺钉孔。
如图6所示，图6示出了严重骨缺损的膝关节胫骨上端及其所需要修复的由PEEK及生物陶瓷或金属材料复合而成的填充物空心垫片。在该实施例中，该空心垫片的次大平面部分由生物陶瓷或金属材料构成，其余部分由PEEK构成。此外，该空心垫片含有一个或多个螺钉孔。
由此可见，本发明提供的骨缺损填充物中的PEEK的弹性模量与自然骨相匹配，减轻了应力遮挡问题；本发明提供的骨缺损填充物中的内植物部件的主要部分由高分子材料组成，降低了金属腐蚀和金属可能引起的过敏、毒性问题；本发明中由生物相容性高分子材料组成的内植物部件对核磁共振成像不造成干扰。
以上所述仅为本发明的较佳实施例，并非用来限定本发明的实施范围；如果不脱离本发明的精神和范围，对本发明进行修改或者等同替换，均应涵盖在本发明权利要求的保护范围当中。

Claims (10)

  1. 一种骨缺损填充物，其特征在于，包括第一部分和第二部分，其中所述第一部分为主要骨填充部分；所述第二部分为与自然骨直接接触的部分；所述第一部分由生物相容性高分子材料构成；所述第二部分由生物相容性金属或生物陶瓷材料构成；所述第一部分与所述第二部分相结合。
  2. 根据权利要求1所述的骨缺损填充物，其特征在于，所述生物相容性高分子材料为聚醚醚酮及其衍生物、超高分子量聚乙烯及其衍生物和聚四氟乙烯及其衍生物中的一种或多种；所述生物相容性金属材料为钴铬钼合金、钛或钛合金、钽或钽合金、镁或镁合金、不锈钢和锆铌合金的一种或多种；所述生物陶瓷材料为羟基磷灰石。
  3. 根据权利要求1或2所述的骨缺损填充物，其特征在于，所述第一部分与所述第二部分通过表面喷涂或化学沉积方法相结合。
  4. 根据权利要求1所述的骨缺损填充物，其特征在于，所述第二部分由生物相容性金属材料构成，所述第二部分通过机械加工或3D打印成型；所述第一部分与所述第二部分通过注塑成型相结合。
  5. 根据权利要求1所述的骨缺损填充物，其特征在于，所述第二部分的外表面为多孔结构。
  6. 根据权利要求1或2所述的骨缺损填充物，其特征在于，所述骨缺损填充物为用于严重畸形或骨缺损的髋臼窝的填充物，其中所述第二部分为所述髋臼窝填充物的凸表面部分，所述第一部分为所述髋臼窝填充物的剩余部分。
  7. 根据权利要求6所述的骨缺损填充物，其特征在于，所述髋臼窝填充物含有一个或多个螺钉孔。
  8. 根据权利要求1或2所述的骨缺损填充物，其特征在于，所述填充物为用于严重骨缺损的髋关节股骨上端或膝关节股骨髁或膝关节胫骨上端的空心椎体，其中所述第二部分为所述椎体的外表面部分，所述第 一部分为所述椎体的剩余部分。
  9. 根据权利要求1或2所述的骨缺损填充物，其特征在于，所述填充物为用于严重骨缺损的膝关节股骨髁的空心垫片，其中所述第二部分为所述空心垫片的最大平面部分，所述第一部分为所述空心垫片的剩余部分；或者，所述填充物为用于严重骨缺损的膝关节胫骨上端的空心垫片，其中所述第二部分为所述空心垫片的次大平面部分，所述第一部分为所述空心垫片的剩余部分。
  10. 根据权利要求9所述的骨缺损填充物，其特征在于，所述空心垫片含有一个或多个螺钉孔。
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