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CN111529135A - Acetabular cup and acetabular prosthesis system - Google Patents

Acetabular cup and acetabular prosthesis system Download PDF

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Publication number
CN111529135A
CN111529135A CN202010445961.9A CN202010445961A CN111529135A CN 111529135 A CN111529135 A CN 111529135A CN 202010445961 A CN202010445961 A CN 202010445961A CN 111529135 A CN111529135 A CN 111529135A
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porous layer
antibacterial
acetabular cup
drug
acetabular
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郭谦
聂永嘉
王东
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Beijing Keyi Bangen Medical Devices Technology Co ltd
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Beijing Keyi Bangen Medical Devices Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/34Acetabular cups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/306Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406Antibiotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41Anti-inflammatory agents, e.g. NSAIDs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • A61L2300/414Growth factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • A61L2300/608Coatings having two or more layers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/12Materials or treatment for tissue regeneration for dental implants or prostheses

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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  • Orthopedic Medicine & Surgery (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

本申请提供一种髋臼杯及髋臼假体系统,涉及医疗器械技术领域。髋臼杯包括第一基体和第一多孔层。第一多孔层具有多个均匀分布且相互连通的孔洞。第一多孔层负载有促进骨生长药物和抗菌消炎药物,其中促进骨生长药物填充于第一多孔层的内层,抗菌消炎药物填充于第一多孔层的外层。负载于第一多孔层中的缓释药物能够在髋臼杯植入到人体后,继续持续不断地给药,在植入初期填充于第一多孔层的外层的抗菌消炎药物缓慢释放实现抗菌消炎防止感染,在髋臼杯与人体骨组织初步结合后,填充于第一多孔层的内层的促进骨生长药物缓慢释放用于在较长时间内促进骨生长,使人体与移植的髋臼杯的融合度和融合效率提高。

Figure 202010445961

The application provides an acetabular cup and an acetabular prosthesis system, and relates to the technical field of medical devices. The acetabular cup includes a first matrix and a first porous layer. The first porous layer has a plurality of uniformly distributed and interconnected pores. The first porous layer is loaded with a bone growth promoting drug and an antibacterial and anti-inflammatory drug, wherein the bone growth promoting drug is filled in the inner layer of the first porous layer, and the antibacterial and anti-inflammatory drug is filled in the outer layer of the first porous layer. The sustained-release drug loaded in the first porous layer can be continuously administered after the acetabular cup is implanted into the human body, and the antibacterial and anti-inflammatory drugs filled in the outer layer of the first porous layer at the initial stage of implantation are slowly released To achieve antibacterial and anti-inflammatory to prevent infection, after the initial combination of the acetabular cup and human bone tissue, the bone growth-promoting drug filled in the inner layer of the first porous layer is slowly released to promote bone growth for a long time, so that the human body and the transplanted The fusion degree and fusion efficiency of the acetabular cup are improved.

Figure 202010445961

Description

一种髋臼杯及髋臼假体系统An acetabular cup and acetabular prosthesis system

技术领域technical field

本申请涉及医疗器械技术领域,具体而言,涉及一种髋臼杯及髋臼假体系统。The present application relates to the technical field of medical devices, and in particular, to an acetabular cup and an acetabular prosthesis system.

背景技术Background technique

当髋臼周围发生肿瘤,需要通过外科切除的治疗手段,从而使髋臼部位造成较大的骨缺失,进而使骨盆的连续性中断,并且损失周围的部分软组织,因此需要对缺失的骨盆进行重建。When a tumor occurs around the acetabulum, surgical resection is required, resulting in a large bone loss in the acetabulum, thereby interrupting the continuity of the pelvis and losing part of the surrounding soft tissue, so the missing pelvis needs to be reconstructed .

近年来,越来越多的髋臼杯假体被移植到缺失的骨盆中进行骨盆修复,但是人体对外来移植假体具有排斥性,导致融合效率低。并且,在移植过程中不可避免地会伴有感染。In recent years, more and more acetabular cup prostheses have been transplanted into the missing pelvis for pelvic repair, but the human body is resistant to foreign implants, resulting in low fusion efficiency. Also, infection is inevitable during the transplant process.

发明内容SUMMARY OF THE INVENTION

本申请实施例的目的在于提供一种髋臼杯及髋臼假体系统,其能够改善髋臼杯假体移植效率低以及感染率高的技术问题。The purpose of the embodiments of the present application is to provide an acetabular cup and an acetabular prosthesis system, which can improve the technical problems of low transplantation efficiency and high infection rate of the acetabular cup prosthesis.

第一方面,本申请实施例提供一种髋臼杯,其包括第一基体和第一多孔层,第一基体的部分表面或全部表面覆盖有第一多孔层。In a first aspect, embodiments of the present application provide an acetabular cup, which includes a first base body and a first porous layer, and part or all of the surface of the first base body is covered with the first porous layer.

第一多孔层具有多个均匀分布于且相互连通的孔洞。The first porous layer has a plurality of pores that are evenly distributed and communicated with each other.

第一多孔层负载有促进骨生长药物和抗菌消炎药物,其中促进骨生长药物填充于第一多孔层的内层,抗菌消炎药物填充于第一多孔层的外层。The first porous layer is loaded with a bone growth promoting drug and an antibacterial and anti-inflammatory drug, wherein the bone growth promoting drug is filled in the inner layer of the first porous layer, and the antibacterial and anti-inflammatory drug is filled in the outer layer of the first porous layer.

在上述实现过程中,本申请提供的髋臼杯包括设置于第一基体的表面的第一多孔层,第一多孔层能够负载缓释药物,负载于第一多孔层中的缓释药物能够在髋臼杯植入到人体后,继续持续不断地给药。In the above implementation process, the acetabular cup provided by the present application includes a first porous layer disposed on the surface of the first substrate, the first porous layer can be loaded with a sustained-release drug, and the sustained-release drug loaded in the first porous layer The drug can be administered continuously after the acetabular cup is implanted in the body.

在植入初期填充于第一多孔层的外层的抗菌消炎药物缓慢释放实现抗菌消炎防止感染,在髋臼杯与人体骨组织初步结合后,填充于第一多孔层的内层的促进骨生长药物缓慢释放用于在较长时间内促进骨生长,使人体与移植的髋臼杯的融合度和融合效率提高。In the initial stage of implantation, the antibacterial and anti-inflammatory drugs filled in the outer layer of the first porous layer are slowly released to achieve antibacterial and anti-inflammatory prevention to prevent infection. After the acetabular cup is initially combined with human bone tissue, the inner layer filled in the first porous layer promotes The slow release of bone growth drugs is used to promote bone growth over a longer period of time, resulting in improved fusion and fusion efficiency between the human body and the implanted acetabular cup.

在一种可能的实施方案中,第一多孔层的表面涂覆有抗菌消炎药物。In a possible embodiment, the surface of the first porous layer is coated with antibacterial and anti-inflammatory drugs.

在一种可能的实施方案中,促进骨生长药物包括骨形态发生蛋白BMP、成纤维细胞生长因子FGF或转化生长因子TGF-Β。In one possible embodiment, the bone growth promoting drug comprises bone morphogenetic protein BMP, fibroblast growth factor FGF or transforming growth factor TGF-B.

在上述实现过程中,骨形态发生蛋白BMP、成纤维细胞生长因子FGF或转化生长因子TGF-Β等促进骨生长药物能够填充于第一多孔层的内层,在髋臼杯移植后,上述药物能够缓慢释放并且在较长时间内促进骨生长。In the above realization process, bone growth promoting drugs such as bone morphogenetic protein BMP, fibroblast growth factor FGF or transforming growth factor TGF-β can be filled in the inner layer of the first porous layer. The drug is released slowly and promotes bone growth over an extended period of time.

在一种可能的实施方案中,抗菌消炎药物包括青霉素类、头孢霉素类或阿司匹林类药物。In a possible embodiment, the antibacterial and anti-inflammatory drugs include penicillin, cephalosporin or aspirin.

在上述实现过程中,青霉素类、头孢霉素类或阿司匹林类药物等抗菌消炎药物能够填充于第一多孔层的外层,在髋臼杯移植后,上述药物能够缓慢释放实现抗菌消炎防止感染。In the above implementation process, antibacterial and anti-inflammatory drugs such as penicillin, cephalosporin or aspirin can be filled in the outer layer of the first porous layer, and after the acetabular cup is transplanted, the above drugs can be slowly released to achieve antibacterial, anti-inflammatory and prevent infection .

在一种可能的实施方案中,第一多孔层的孔隙率为86~90%,孔洞的截面孔径为200~1200μm。In a possible embodiment, the porosity of the first porous layer is 86-90%, and the cross-sectional diameter of the holes is 200-1200 μm.

在上述实现过程中,孔隙率为86~90%的第一多孔层与宿主骨组织相似,能够提高髋臼杯与宿主骨组织界面的结合强度,使髋臼杯与宿主骨组织实现深度融合。In the above realization process, the first porous layer with a porosity of 86-90% is similar to the host bone tissue, which can improve the bonding strength of the interface between the acetabular cup and the host bone tissue, so that the acetabular cup and the host bone tissue can achieve deep fusion .

在一种可能的实施方案中,第一多孔层的材质为钛合金或钛单质,第一多孔层的表面粗糙度为2~9μm。In a possible embodiment, the material of the first porous layer is titanium alloy or simple titanium, and the surface roughness of the first porous layer is 2-9 μm.

在上述实现过程中,多孔钛是一种良好的仿生材料,其具有良好的生物相容性、生物力学优异,且弹性模量接近骨组织。In the above realization process, porous titanium is a good biomimetic material, which has good biocompatibility, excellent biomechanics, and elastic modulus close to bone tissue.

第二方面,本申请实施例提供一种髋臼假体系统,其包括增大构件和上述的髋臼杯,髋臼杯具有第一曲面,增大构件具有第二曲面,增大构件与髋臼杯通过第一曲面与第二曲面配合连接。In a second aspect, embodiments of the present application provide an acetabular prosthesis system, which includes an augmenting member and the above-mentioned acetabular cup, the acetabular cup has a first curved surface, the augmenting member has a second curved surface, and the augmenting member and the hip The cup is matched and connected with the second curved surface through the first curved surface.

在上述实现过程中,增大构件用于填充于被除去的受损或手术除掉的髋臼形成的空腔内。In the above implementation, the augmentation member is used to fill the cavity formed by the removed damaged or surgically removed acetabulum.

本申请通过髋臼杯和增大构件配合使髋臼杯假体系统与宿主骨组织的形状更加契合。并且髋臼杯假体系统通过髋臼杯的第一多孔层负载的缓释药物在植入到人体后持续不断地给药,防止髋臼杯假体系统植入后感染,并且提高人体与移植的髋臼杯假体系统的融合度和融合效率。The present application makes the acetabular cup prosthesis system better conform to the shape of the host bone tissue through the cooperation of the acetabular cup and the augmenting member. In addition, the sustained-release drug loaded by the acetabular cup prosthesis system through the first porous layer of the acetabular cup is continuously administered after being implanted into the human body, so as to prevent infection after the acetabular cup prosthesis system is implanted, and improve the relationship between the human body and the human body. Fusion and fusion efficiency of implanted acetabular cup prosthetic systems.

在一种可能的实施方案中,增大构件包括第二基体和第二多孔层,第二基体的部分表面或全部表面覆盖有第二多孔层,第二多孔层具有多个均匀分布且相互连通的孔洞。In a possible embodiment, the enlargement member includes a second base body and a second porous layer, a part or all of the surface of the second base body is covered with the second porous layer, and the second porous layer has a plurality of uniform distributions and interconnected pores.

在上述实现过程中,增大构件也具有第二多孔层,第二多孔层与宿主骨组织相似,能够提高增大构件与宿主骨组织界面的结合强度,使增大构件与宿主骨组织实现深度融合。In the above implementation process, the augmenting member also has a second porous layer. The second porous layer is similar to the host bone tissue, which can improve the bonding strength of the interface between the augmenting member and the host bone tissue. achieve deep integration.

在一种可能的实施方案中,第二多孔层负载有促进骨生长药物和抗菌消炎药物,其中促进骨生长药物填充于第二多孔层的内层,抗菌消炎药物填充于第二多孔层的外层。In a possible embodiment, the second porous layer is loaded with a bone growth-promoting drug and an antibacterial and anti-inflammatory drug, wherein the bone growth-promoting drug is filled in the inner layer of the second porous layer, and the antibacterial and anti-inflammatory drug is filled in the second porous layer. the outer layer of the layer.

在上述实现过程中,第二多孔层还能够作为载体,负载有促进骨生长药物和抗菌消炎药物,在植入初期填充于第二多孔层的外层的抗菌消炎药物缓慢释放实现抗菌消炎防止感染,在增大构件与人体骨组织初步结合后,填充于第二多孔层的内层的促进骨生长药物缓慢释放用于在较长时间内促进骨生长,使人体与移植的增大构件的融合度和融合效率提高。In the above implementation process, the second porous layer can also be used as a carrier, loaded with drugs for promoting bone growth and antibacterial and anti-inflammatory drugs, and the antibacterial and anti-inflammatory drugs filled in the outer layer of the second porous layer at the initial stage of implantation are slowly released to achieve antibacterial and anti-inflammatory drugs. To prevent infection, after the initial combination of the enlargement member and the human bone tissue, the bone growth-promoting drug filled in the inner layer of the second porous layer is slowly released to promote bone growth for a long time, so that the enlargement of the human body and the transplant can be achieved. The fusion degree and fusion efficiency of the components are improved.

在一种可能的实施方案中,第二多孔层的表面涂覆有抗菌消炎药物。In a possible embodiment, the surface of the second porous layer is coated with antibacterial and anti-inflammatory drugs.

附图说明Description of drawings

为了更清楚地说明本申请实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本申请的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。In order to illustrate the technical solutions of the embodiments of the present application more clearly, the following drawings will briefly introduce the drawings that need to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore do not It should be regarded as a limitation of the scope, and for those of ordinary skill in the art, other related drawings can also be obtained according to these drawings without any creative effort.

图1为本申请实施例的髋臼杯的结构示意图;Fig. 1 is the structural representation of the acetabular cup of the embodiment of the application;

图2为本申请实施例的髋臼杯的剖面图;Fig. 2 is the sectional view of the acetabular cup of the embodiment of the application;

图3为本申请实施例的第一多孔层中缓释药物的第一种填充结构示意图;3 is a schematic diagram of the first filling structure of the sustained-release drug in the first porous layer according to the embodiment of the application;

图4为本申请实施例的第一多孔层中缓释药物的第二种填充结构示意图;4 is a schematic diagram of the second filling structure of the sustained-release drug in the first porous layer according to the embodiment of the application;

图5为本申请实施例的第一多孔层中缓释药物的第三种填充结构示意图;5 is a schematic diagram of the third filling structure of the sustained-release drug in the first porous layer according to the embodiment of the application;

图6为本申请实施例的第一多孔层中缓释药物的第四种填充结构示意图;6 is a schematic diagram of the fourth filling structure of the sustained-release drug in the first porous layer according to the embodiment of the application;

图7为本申请实施例的第一多孔层中缓释药物的第五种填充结构示意图;7 is a schematic diagram of the fifth filling structure of the sustained-release drug in the first porous layer according to the embodiment of the application;

图8为本申请实施例的髋臼假体系统未连接的结构示意图;8 is a schematic structural diagram of an unconnected acetabular prosthesis system according to an embodiment of the application;

图9为本申请实施例的髋臼假体系统连接后的结构示意图;FIG. 9 is a schematic structural diagram of an acetabular prosthesis system according to an embodiment of the application after being connected;

图10为本申请实施例的增大构件的剖面图。FIG. 10 is a cross-sectional view of an enlarged member according to an embodiment of the application.

图标:10-髋臼假体系统;100-髋臼杯;101-第一曲面;102-连接孔;110-第一基体;120-第一多孔层;130-抗菌消炎药物;140-促进骨生长药物;200-增大构件;201-第二曲面;210-第二基体;220-第二多孔层;300-螺钉。Icon: 10-acetabular prosthesis system; 100-acetabular cup; 101-first curved surface; 102-connecting hole; 110-first matrix; 120-first porous layer; 130-antibacterial and anti-inflammatory drug; 140-promoting 200-enlargement member; 201-second curved surface; 210-second matrix; 220-second porous layer; 300-screw.

具体实施方式Detailed ways

为使本申请实施例的目的、技术方案和优点更加清楚,下面将结合本申请实施例中的附图,对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本申请一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本申请实施例的组件可以以各种不同的配置来布置和设计。In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments It is a part of the embodiments of the present application, but not all of the embodiments. The components of the embodiments of the present application generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

因此,以下对在附图中提供的本申请的实施例的详细描述并非旨在限制要求保护的本申请的范围,而是仅仅表示本申请的选定实施例。基于本申请中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。Thus, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the application as claimed, but is merely representative of selected embodiments of the application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步定义和解释。It should be noted that like numerals and letters refer to like items in the following figures, so once an item is defined in one figure, it does not require further definition and explanation in subsequent figures.

在本申请的描述中,需要说明的是,术语“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该申请产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。此外,术语“第一”、“第二”等仅用于区分描述,而不能理解为指示或暗示相对重要性。In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "inside", "outside", etc. is based on the orientation or positional relationship shown in the accompanying drawings, or is usually placed when the product of the application is used. The orientation or positional relationship is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the present application. Furthermore, the terms "first", "second", etc. are only used to differentiate the description and should not be construed to indicate or imply relative importance.

在本申请的描述中,还需要说明的是,除非另有明确的规定和限定,术语“设置”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本申请中的具体含义。In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "arrangement" and "connection" should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, or Integrally connected; either mechanical or electrical. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood in specific situations.

请参阅图1~2,本申请实施例提供一种髋臼杯100,其包括第一基体110和第一多孔层120,第一基体110的部分表面或全部表面覆盖有第一多孔层120。Referring to FIGS. 1-2 , an embodiment of the present application provides an acetabular cup 100 , which includes a first base body 110 and a first porous layer 120 , and part or all of the surface of the first base body 110 is covered with the first porous layer 120.

在如图1~2所示的实施例中,第一多孔层120完全包裹第一基体110,即第一基体110的全部表面都覆盖有第一多孔层120。在本申请的其他一些实施例中,还可以只在髋臼杯100与宿主骨组织结合的表面覆盖有第一多孔层120,而在第一基体110的边缘部分可以不覆盖有第一多孔层120。In the embodiment shown in FIGS. 1-2 , the first porous layer 120 completely wraps the first substrate 110 , that is, the entire surface of the first substrate 110 is covered with the first porous layer 120 . In some other embodiments of the present application, only the surface of the acetabular cup 100 combined with the host bone tissue may be covered with the first porous layer 120 , and the edge portion of the first base body 110 may not be covered with the first porous layer 120 . Aperture layer 120 .

第一多孔层120具有多个均匀分布于内部和表面的不规则形状的孔洞。分布于第一多孔层120内部和表面的不规则形状的孔洞相互连通形成仿生物运输通道。The first porous layer 120 has a plurality of irregular-shaped pores uniformly distributed in the interior and the surface. Irregular-shaped holes distributed in the interior and surface of the first porous layer 120 are connected with each other to form a biomimetic transport channel.

第一多孔层120的孔隙率为86~90%,孔洞的截面孔径为200~1200μm,孔洞的深度>1500μm。The porosity of the first porous layer 120 is 86-90%, the cross-sectional diameter of the holes is 200-1200 μm, and the depth of the holes is >1500 μm.

在如图1~2所示的实施例中,第一多孔层120的孔隙率为88%,孔洞的截面孔径为200~1200μm,孔洞的深度>1500μm。在本申请其他一些实施例中,第一多孔层120的孔隙率还可以为86%、87%、89%或90%,第一多孔层120的孔洞的截面孔径还可以为300~800μm、500~1000μm、700~900μm、400~700μm或700~1000μm,孔洞的深度还可以>1600μm、>1650μm或>1850μm。In the embodiment shown in FIGS. 1-2 , the porosity of the first porous layer 120 is 88%, the cross-sectional diameter of the holes is 200-1200 μm, and the depth of the holes is >1500 μm. In some other embodiments of the present application, the porosity of the first porous layer 120 may also be 86%, 87%, 89% or 90%, and the cross-sectional pore size of the holes in the first porous layer 120 may also be 300-800 μm , 500~1000μm, 700~900μm, 400~700μm or 700~1000μm, the depth of the hole can also be >1600μm, >1650μm or >1850μm.

第一多孔层120具有类骨小梁的结构,其多孔结构能够用于负载缓释药物,提高髋臼杯100的负载能力。同时,本申请通过调整第一多孔层120的孔洞结构,包括孔隙率、孔洞的截面孔径以及孔洞的深度,使第一多孔层120弹性模量接近骨组织,具有良好的生物相容性,能够提高髋臼杯100与宿主骨组织界面的结合强度,使髋臼杯100与宿主骨组织实现深度融合。The first porous layer 120 has a trabecular bone-like structure, and the porous structure can be used to load sustained-release drugs, thereby improving the load capacity of the acetabular cup 100 . At the same time, in the present application, by adjusting the pore structure of the first porous layer 120, including the porosity, the cross-sectional diameter of the pore, and the depth of the pore, the elastic modulus of the first porous layer 120 is close to the bone tissue, and has good biocompatibility. , the bonding strength of the interface between the acetabular cup 100 and the host bone tissue can be improved, so that the acetabular cup 100 and the host bone tissue can be deeply fused.

第一基体110由金属制成。The first base body 110 is made of metal.

在如图1~2所示的实施例中,第一基体110采用钛合金制成。在本申请其他一些实施例中,第一基体110还可以采用其他金属材料例如银单质、铁合金、钛单质等制成。In the embodiment shown in FIGS. 1-2 , the first base body 110 is made of titanium alloy. In some other embodiments of the present application, the first base body 110 may also be made of other metal materials, such as silver element, iron alloy, titanium element, and the like.

第一多孔层120由钛单质或钛合金制成,第一多孔层120的表面粗糙度为2~9μm。The first porous layer 120 is made of titanium element or titanium alloy, and the surface roughness of the first porous layer 120 is 2-9 μm.

在如图1~2所示的实施例中,第一多孔层120由钛粉末通过3D打印技术打印制得,其表面粗糙度为3~6μm。在本申请其他一些实施例中,第一多孔层120还可以通过能够制得多孔结构的技术制得,其表面粗糙度还可以为2~6μm、3~7μm、4~8μm、5~9μm、2~8μm或3~9μm。In the embodiments shown in FIGS. 1-2 , the first porous layer 120 is made of titanium powder by 3D printing technology, and its surface roughness is 3-6 μm. In some other embodiments of the present application, the first porous layer 120 can also be produced by a technology capable of producing a porous structure, and the surface roughness of the first porous layer 120 can also be 2-6 μm, 3-7 μm, 4-8 μm, 5-9 μm , 2~8μm or 3~9μm.

需要说明的是,本申请实施例中多孔钛表面层结构的浸润响应,有利于血液中成分进行仿骨组织的功能化合成。It should be noted that the infiltration response of the porous titanium surface layer structure in the examples of the present application is beneficial to the functional synthesis of the components in the blood to imitate bone tissue.

请参阅图3~7,第一多孔层120负载有促进骨生长药物140和抗菌消炎药物130,其中促进骨生长药物140填充于第一多孔层120的内层,抗菌消炎药物130填充于第一多孔层120的外层。Please refer to FIGS. 3 to 7 , the first porous layer 120 is loaded with the bone growth-promoting drug 140 and the antibacterial and anti-inflammatory drug 130 , wherein the bone growth-promoting drug 140 is filled in the inner layer of the first porous layer 120 , and the antibacterial and anti-inflammatory drug 130 is filled in the inner layer of the first porous layer 120 . The outer layer of the first porous layer 120 .

需要说明的是,本申请实施例中第一多孔层120的内层和外层是相对的,填充于第一多孔层120的外层中的药物能够在假体移植后相对较快释放出来,而填充于第一多孔层120的内层中的药物能够在假体移植后在较长时间段释放出来。It should be noted that the inner layer and the outer layer of the first porous layer 120 in the embodiment of the present application are opposite, and the drug filled in the outer layer of the first porous layer 120 can be released relatively quickly after the implantation of the prosthesis out, and the drug filled in the inner layer of the first porous layer 120 can be released for a longer period of time after implantation of the prosthesis.

因此,填充于第一多孔层120的外层中的抗菌消炎药物130能够在髋臼杯100移植后3~4周内释放出来,即抗菌消炎药物130能够在髋臼杯100移植后的炎症消除期持续不断的给药实现抗菌消炎防止感染,使髋臼杯100在移植后稳定的过度炎症消除期。填充于第一多孔层120的内层中的促进骨生长药物140能够在髋臼杯100移植后半年后释放出来,即促进骨生长药物140能够在髋臼杯100移植后的整体恢复期持续不断的给药实现促进骨生长,使人体与移植的髋臼杯100的融合度和融合效率提高。Therefore, the antibacterial and anti-inflammatory drugs 130 filled in the outer layer of the first porous layer 120 can be released within 3 to 4 weeks after the acetabular cup 100 is transplanted, that is, the antibacterial and anti-inflammatory drugs 130 can be used in the inflammation after the acetabular cup 100 is transplanted. The continuous administration during the elimination period achieves antibacterial and anti-inflammatory prevention of infection, so that the acetabular cup 100 is stable in the elimination period of excessive inflammation after transplantation. The bone growth-promoting drug 140 filled in the inner layer of the first porous layer 120 can be released half a year after the acetabular cup 100 is implanted, that is, the bone-growth-promoting drug 140 can last in the overall recovery period after the acetabular cup 100 is implanted The continuous administration achieves the promotion of bone growth, so that the fusion degree and fusion efficiency of the human body and the implanted acetabular cup 100 are improved.

本申请实施例中第一多孔层120中的抗菌消炎药物130和促进骨生长药物140的量根据其缓释周期和人体骨组织生长的填充速度相适配。例如,填充于第一多孔层120中的抗菌消炎药物130的量能够保证至少3~4周的缓释周期,填充于第一多孔层120中的促进骨生长药物140的量能够保证至少半年的缓释周期。In the embodiment of the present application, the amount of the antibacterial and anti-inflammatory drug 130 and the bone growth promoting drug 140 in the first porous layer 120 is adapted according to the slow release period and the filling speed of human bone tissue growth. For example, the amount of the antibacterial and anti-inflammatory drugs 130 filled in the first porous layer 120 can ensure a sustained release period of at least 3-4 weeks, and the amount of the bone growth promoting drugs 140 filled in the first porous layer 120 can be guaranteed to be at least 3-4 weeks. A six-month slow-release cycle.

第一多孔层120中的抗菌消炎药物130和促进骨生长药物140能够如以下结构填充:The antibacterial and anti-inflammatory drugs 130 and the bone growth promoting drugs 140 in the first porous layer 120 can be filled as follows:

在如图3所示的实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度可以相等,并且抗菌消炎药物130和促进骨生长药物140相互不重叠充满整个第一多孔层120的孔洞。In the embodiment shown in FIG. 3 , the thickness of the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 may be equal, and the antibacterial and anti-inflammatory drugs 130 and the bone-growth-promoting drugs 140 do not overlap each other and fill the entire The pores of the first porous layer 120 .

在如图4所示的实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度不相等,其中促进骨生长药物140填充的厚度大于抗菌消炎药物130填充的厚度,并且抗菌消炎药物130和促进骨生长药物140相互不重叠充满整个第一多孔层120的孔洞。In the embodiment shown in FIG. 4 , the thicknesses of the antibacterial and anti-inflammatory drugs 130 and the bone-growth-promoting drugs 140 in the first porous layer 120 are not equal, and the thickness of the bone-growth-promoting drugs 140 is greater than that of the antibacterial and anti-inflammatory drugs 130 . thickness, and the antibacterial and anti-inflammatory drug 130 and the bone growth-promoting drug 140 do not overlap each other and fill the entire hole of the first porous layer 120 .

在如图5所示的实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度不相等,其中抗菌消炎药物130填充的厚度大于促进骨生长药物140填充的厚度,并且抗菌消炎药物130和促进骨生长药物140相互不重叠充满整个第一多孔层120的孔洞。In the embodiment shown in FIG. 5 , the thicknesses of the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 are not equal, and the thickness of the antibacterial and anti-inflammatory drugs 130 is greater than that of the bone-growth-promoting drugs 140 . thickness, and the antibacterial and anti-inflammatory drug 130 and the bone growth-promoting drug 140 do not overlap each other and fill the entire hole of the first porous layer 120 .

在如图6所示的实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度可以相等,并且抗菌消炎药物130和促进骨生长药物140在中部相互重叠充满整个第一多孔层120的孔洞。In the embodiment shown in FIG. 6 , the thicknesses of the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 may be equal, and the antibacterial and anti-inflammatory drugs 130 and the bone-growth-promoting drugs 140 are overlapped and filled in the middle part. Holes throughout the first porous layer 120 .

在如图7所示的实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度可以相等,并且抗菌消炎药物130和促进骨生长药物140相互不重叠也不充满整个第一多孔层120的孔洞。In the embodiment shown in FIG. 7 , the thicknesses of the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 may be equal, and the antibacterial and anti-inflammatory drugs 130 and the bone-growth-promoting drugs 140 do not overlap with each other nor do they Filling the entire pores of the first porous layer 120 .

在本申请其他一些实施例中,第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度可以不相等,并且抗菌消炎药物130和促进骨生长药物140在中部相互重叠充满整个第一多孔层120的孔洞。或第一多孔层120中抗菌消炎药物130和促进骨生长药物140填充的厚度可以不相等,并且抗菌消炎药物130和促进骨生长药物140相互不重叠也不充满整个第一多孔层120的孔洞。In some other embodiments of the present application, the thicknesses of the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 may not be equal, and the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 overlap each other in the middle and fill the entire The pores of the first porous layer 120 . Or the antibacterial and anti-inflammatory drugs 130 and the bone growth-promoting drugs 140 in the first porous layer 120 may be filled with different thicknesses, and the antibacterial and anti-inflammatory drugs 130 and the bone-growth-promoting drugs 140 do not overlap each other nor fill the entire first porous layer 120 . holes.

需要说明的是,本申请并不限定抗菌消炎药物130和促进骨生长药物140的种类,只要其能够发挥抗菌消炎和促进骨生长,且对人体无害即可。It should be noted that the present application does not limit the types of antibacterial and anti-inflammatory drugs 130 and bone growth-promoting drugs 140, as long as they can exert antibacterial and anti-inflammatory effects and promote bone growth, and are harmless to the human body.

在本申请实施例中,抗菌消炎药物130包括青霉素类、头孢霉素类、四环素类、氯霉素类、大环内酯类、林可霉素、氟喹诺酮类、硝基咪唑类、多肽类及季铵盐类抗菌消炎药物130以及阿司匹林、对吲哚美辛、萘普生、双氯芬酸、布洛芬、尼美舒利、塞来昔布类抗菌消炎药物130;促进骨生长药物140包括骨形态发生蛋白BMP、成纤维细胞生长因子FGF、转化生长因子TGF-Β和胰岛素样生长因子IGF中的一种或多种。In the embodiments of the present application, the antibacterial and anti-inflammatory drugs 130 include penicillins, cephalosporins, tetracyclines, chloramphenicol, macrolides, lincomycin, fluoroquinolones, nitroimidazoles, polypeptides and quaternary ammonium antibacterial and anti-inflammatory drugs130 and aspirin, p-indomethacin, naproxen, diclofenac, ibuprofen, nimesulide, celecoxib antibacterial and anti-inflammatory drugs130; One or more of morphogenetic protein BMP, fibroblast growth factor FGF, transforming growth factor TGF-β and insulin-like growth factor IGF.

抗菌消炎药物130和促进骨生长药物140通过包埋或涂覆的方式填充于第一多孔层120的孔洞中。The antibacterial and anti-inflammatory drugs 130 and the bone growth promoting drugs 140 are filled in the holes of the first porous layer 120 by embedding or coating.

当采用涂覆的方式时,最后可以在第一多孔层120的表面最后涂覆部分抗菌消炎药物130,涂覆的抗菌消炎药物130部分由于重力作用沉入到第一多孔层120内部的孔洞中,其他的抗菌消炎药物130分布于第一多孔层120的表面。When the coating method is adopted, a part of the antibacterial and anti-inflammatory drug 130 may be finally coated on the surface of the first porous layer 120, and part of the coated antibacterial and anti-inflammatory drug 130 sinks into the inner surface of the first porous layer 120 due to the action of gravity. In the holes, other antibacterial and anti-inflammatory drugs 130 are distributed on the surface of the first porous layer 120 .

涂覆于第一多孔层120的表面的抗菌消炎药物130能够直接作用,快速起效,对于刚移植的髋臼杯100能够起到较好的抗菌消炎作用。The antibacterial and anti-inflammatory drug 130 coated on the surface of the first porous layer 120 can act directly and take effect quickly, and can play a better antibacterial and anti-inflammatory effect on the newly transplanted acetabular cup 100 .

请参阅图8~9,本申请提供一种髋臼假体系统10,其包括用于填充于被除去的受损或手术除掉的髋臼形成的空腔内的增大构件200和上述的髋臼杯100,髋臼杯100具有第一曲面101,增大构件200具有第二曲面201,增大构件200与髋臼杯100通过第一曲面101与第二曲面201配合连接。Referring to Figures 8-9, the present application provides an acetabular prosthesis system 10 comprising an augmenting member 200 for filling a cavity formed by a removed damaged or surgically removed acetabulum and the aforementioned In the acetabular cup 100 , the acetabular cup 100 has a first curved surface 101 , the augmenting member 200 has a second curved surface 201 , and the augmenting member 200 and the acetabular cup 100 are connected to each other through the first curved surface 101 and the second curved surface 201 .

在如图8~9所示的实施例中,髋臼假体系统10还包括螺钉300,髋臼杯100和增大构件200均具有贯通的且相互配合的连接孔102,螺钉300依次髋臼杯100的连接孔102和增大构件200的连接孔102,最后固定在人体骨组织上,从而使髋臼杯100和增大构件200稳定连接。In the embodiment shown in FIGS. 8-9 , the acetabular prosthesis system 10 further includes a screw 300 , the acetabular cup 100 and the augmenting member 200 both have connecting holes 102 that pass through and cooperate with each other, and the screw 300 is in turn of the acetabulum The connecting hole 102 of the cup 100 and the connecting hole 102 of the augmenting member 200 are finally fixed on the human bone tissue, so that the acetabular cup 100 and the augmenting member 200 are stably connected.

增大构件200包括第二基体210和第二多孔层220,第二基体210的部分表面或全部表面覆盖有第二多孔层220。The enlarged member 200 includes a second base body 210 and a second porous layer 220 , and a part or all of the surface of the second base body 210 is covered with the second porous layer 220 .

在如图8~10所示的实施例中,第二多孔层220完全包裹第二基体210,即第二基体210的全部表面都覆盖有第二多孔层220。在本申请的其他一些实施例中,还可以只在增大构件200与宿主骨组织结合的表面覆盖有第二多孔层220,而在第二基体210的边缘部分可以不覆盖有第二多孔层220。In the embodiments shown in FIGS. 8 to 10 , the second porous layer 220 completely wraps the second substrate 210 , that is, the entire surface of the second substrate 210 is covered with the second porous layer 220 . In some other embodiments of the present application, the second porous layer 220 may be covered only on the surface of the augmenting member 200 combined with the host bone tissue, and the edge portion of the second base 210 may not be covered with the second porous layer 220 . Aperture layer 220 .

第二多孔层220与第一多孔层120结构相似,也具有多个均匀分布于内部和表面的不规则形状的孔洞。分布于第二多孔层220内部和表面的不规则形状的孔洞相互连通形成仿生物运输通道。The second porous layer 220 is similar in structure to the first porous layer 120, and also has a plurality of irregular-shaped pores evenly distributed in the interior and the surface. The irregular-shaped holes distributed in the interior and surface of the second porous layer 220 are connected with each other to form a biomimetic transport channel.

第二多孔层220的孔隙率为86~90%,第二多孔层220的孔隙率为86~90%,孔洞的截面孔径为200~1200μm,孔洞的深度>1500μm。The porosity of the second porous layer 220 is 86-90%, and the porosity of the second porous layer 220 is 86-90%.

在如图10所示的实施例中,第二多孔层220的孔隙率为88%,孔洞的截面孔径为200~1200μm,孔洞的深度>1500μm。在本申请其他一些实施例中,第二多孔层220的孔隙率还可以为86%、87%、89%或90%,第二多孔层220的孔洞的截面孔径还可以为400~800μm、500~9000μm、200~900μm、200~700μm或300~1000μm,孔洞的深度还可以>1700μm、>1750μm或>1900μm。In the embodiment shown in FIG. 10 , the porosity of the second porous layer 220 is 88%, the cross-sectional diameter of the holes is 200-1200 μm, and the depth of the holes is >1500 μm. In some other embodiments of the present application, the porosity of the second porous layer 220 may also be 86%, 87%, 89% or 90%, and the cross-sectional pore size of the holes in the second porous layer 220 may also be 400-800 μm , 500~9000μm, 200~900μm, 200~700μm or 300~1000μm, the depth of the hole can also be >1700μm, >1750μm or >1900μm.

第二多孔层220具有类骨小梁的结构,其与宿主骨组织相似,能够提高增大构件200与宿主骨组织界面的结合强度,使增大构件200与宿主骨组织实现深度融合。并且第二多孔层220的多孔结构能够用于负载缓释药物,提高增大构件200的负载能力。The second porous layer 220 has a trabecular bone structure, which is similar to the host bone tissue, and can improve the bonding strength of the interface between the augmenting member 200 and the host bone tissue, so that the augmenting member 200 and the host bone tissue achieve deep fusion. In addition, the porous structure of the second porous layer 220 can be used to load the sustained-release drug, so as to improve the load capacity of the augmenting member 200 .

第二基体210由金属制成。The second base body 210 is made of metal.

在如图10所示的实施例中,第二基体210采用钛合金制成。在本申请其他一些实施例中,第二基体210还可以采用其他金属材料例如银单质、铁合金、钛单质等制成。In the embodiment shown in FIG. 10 , the second base body 210 is made of titanium alloy. In some other embodiments of the present application, the second base body 210 may also be made of other metal materials, such as silver element, iron alloy, titanium element, and the like.

第二多孔层220由钛单质或钛合金制成,第二多孔层220的表面粗糙度为2~9μm。The second porous layer 220 is made of titanium element or titanium alloy, and the surface roughness of the second porous layer 220 is 2-9 μm.

在如图8~10所示的实施例中,第二多孔层220由钛粉末通过3D打印技术打印制得,其表面粗糙度为3~6μm。在本申请其他一些实施例中,第二多孔层220还可以通过能够制得多孔结构的技术制得,其表面粗糙度还可以为2~5μm、3~5μm、4~7μm、4~9μm、3~8μm或5~9μm。In the embodiments shown in FIGS. 8-10 , the second porous layer 220 is made of titanium powder by 3D printing technology, and its surface roughness is 3-6 μm. In some other embodiments of the present application, the second porous layer 220 can also be produced by a technology capable of producing a porous structure, and the surface roughness of the second porous layer 220 can also be 2-5 μm, 3-5 μm, 4-7 μm, 4-9 μm , 3~8μm or 5~9μm.

同样的,第二多孔层220也可以负载有促进骨生长药物140和抗菌消炎药物130,其中促进骨生长药物140填充于第二多孔层220的内层,抗菌消炎药物130填充于第二多孔层220的外层。Similarly, the second porous layer 220 can also be loaded with the bone growth-promoting drug 140 and the antibacterial and anti-inflammatory drug 130, wherein the bone growth-promoting drug 140 is filled in the inner layer of the second porous layer 220, and the antibacterial and anti-inflammatory drug 130 is filled in the second porous layer 220. The outer layer of the porous layer 220 .

本申请实施例中第二多孔层220中的抗菌消炎药物130和促进骨生长药物140的量根据其缓释周期和人体骨组织生长的填充速度相适配。填充于第二多孔层220的外层中的抗菌消炎药物130能够在髋臼假体系统10移植后3~4周内释放出来,即抗菌消炎药物130能够在髋臼假体系统10移植后的炎症消除期持续不断的给药实现抗菌消炎防止感染,使髋臼假体系统10在移植后稳定的过度炎症消除期。填充于第二多孔层220的内层中的促进骨生长药物140能够在髋臼假体系统10移植后半年后释放出来,即促进骨生长药物140能够在髋臼假体系统10移植后的整体恢复期持续不断的给药实现促进骨生长,使人体与移植的髋臼假体系统10的融合度和融合效率提高。In the embodiment of the present application, the amount of the antibacterial and anti-inflammatory drug 130 and the bone growth promoting drug 140 in the second porous layer 220 is adapted according to the slow release period and the filling speed of human bone tissue growth. The antibacterial and anti-inflammatory drugs 130 filled in the outer layer of the second porous layer 220 can be released within 3 to 4 weeks after the acetabular prosthesis system 10 is implanted, that is, the antibacterial and anti-inflammatory drugs 130 can be released after the acetabular prosthesis system 10 is implanted. The continuous administration of the inflammatory elimination period achieves antibacterial and anti-inflammatory prevention to prevent infection, so that the acetabular prosthesis system 10 is stable in the excessive inflammation elimination period after transplantation. The bone growth-promoting drug 140 filled in the inner layer of the second porous layer 220 can be released half a year after the acetabular prosthesis system 10 is implanted, that is, the bone-growth-promoting drug 140 can be released after the acetabular prosthesis system 10 is implanted. The continuous administration during the overall recovery period achieves the promotion of bone growth and improves the fusion degree and fusion efficiency of the human body and the implanted acetabular prosthesis system 10 .

抗菌消炎药物130和促进骨生长药物140在第二多孔层220中的填充结构与其在第一多孔层120中的填充结构相似。The filling structure of the antibacterial and anti-inflammatory drug 130 and the bone growth promoting drug 140 in the second porous layer 220 is similar to that in the first porous layer 120 .

抗菌消炎药物130和促进骨生长药物140通过包埋或涂覆的方式填充于第二多孔层220的孔洞中。The antibacterial and anti-inflammatory drugs 130 and the bone growth promoting drugs 140 are filled in the holes of the second porous layer 220 by embedding or coating.

当采用涂覆的方式时,最后可以在第二多孔层220的表面最后涂覆部分抗菌消炎药物130,涂覆的抗菌消炎药物130部分由于重力作用沉入到第二多孔层220内部的孔洞中,其他的抗菌消炎药物130分布于第二多孔层220的表面。When the coating method is used, a part of the antibacterial and anti-inflammatory drug 130 may be finally coated on the surface of the second porous layer 220, and part of the coated antibacterial and anti-inflammatory drug 130 sinks into the inner surface of the second porous layer 220 due to gravity. In the holes, other antibacterial and anti-inflammatory drugs 130 are distributed on the surface of the second porous layer 220 .

填充于第二多孔层220的表面的抗菌消炎药物130能够直接作用,快速起效,对于刚移植的髋臼假体系统10能够起到较好的抗菌消炎作用。The antibacterial and anti-inflammatory drugs 130 filled on the surface of the second porous layer 220 can act directly and take effect quickly, and can play a better antibacterial and anti-inflammatory effect on the newly transplanted acetabular prosthesis system 10 .

综上所述,本申请实施例提供的一种髋臼杯及髋臼假体系统,髋臼杯100包括第一基体110和设置于第一基体110的表面的第一多孔层120,第一多孔层120能够负载缓释药物,负载于第一多孔层120中的缓释药物能够在髋臼杯100植入到人体后,继续持续不断地给药。髋臼假体系统10包括上述髋臼杯100和增大构件200,增大构件200包括第二基体210和设置于第二基体210的表面的第二多孔层220,第二多孔层220也能够负载缓释药物,负载于第二多孔层220中的缓释药物能够在增大构件200植入到人体后,继续持续不断地给药。并且,第一多孔层120和第二多孔层220中的抗菌消炎药物130和促进骨生长药物140的量根据其缓释周期和人体骨组织生长的填充速度相适配。其中,填充于第一多孔层120和第二多孔层220中的抗菌消炎药物130的量能够保证至少3~4周的缓释周期,填充于第一多孔层120和第二多孔层220中的促进骨生长药物140的量能够保证至少半年的缓释周期。To sum up, an acetabular cup and an acetabular prosthesis system provided by the embodiments of the present application, the acetabular cup 100 includes a first base body 110 and a first porous layer 120 disposed on the surface of the first base body 110 . A porous layer 120 can be loaded with sustained-release drugs, and the sustained-release drugs loaded in the first porous layer 120 can be continuously administered after the acetabular cup 100 is implanted into the human body. The acetabular prosthesis system 10 includes the above-mentioned acetabular cup 100 and an augmentation member 200 . The augmentation member 200 includes a second base body 210 and a second porous layer 220 disposed on the surface of the second base body 210 . The second porous layer 220 The sustained-release drug can also be loaded, and the sustained-release drug loaded in the second porous layer 220 can be continuously administered after the augmentation member 200 is implanted into the human body. In addition, the amount of the antibacterial and anti-inflammatory drug 130 and the bone growth promoting drug 140 in the first porous layer 120 and the second porous layer 220 is adapted according to the slow release period and the filling speed of human bone tissue growth. The amount of antibacterial and anti-inflammatory drugs 130 filled in the first porous layer 120 and the second porous layer 220 can ensure a sustained release period of at least 3 to 4 weeks, and the amount of the antibacterial and anti-inflammatory drugs 130 filled in the first porous layer 120 and the second porous layer 220 can ensure a sustained release period of at least 3 to 4 weeks. The amount of the bone growth promoting drug 140 in the layer 220 can ensure a sustained release period of at least half a year.

以上所述仅为本申请的优选实施例而已,并不用于限制本申请,对于本领域的技术人员来说,本申请可以有各种更改和变化。凡在本申请的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本申请的保护范围之内。The above descriptions are only preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of this application shall be included within the protection scope of this application.

Claims (10)

1.一种髋臼杯,其特征在于,所述髋臼杯包括第一基体和第一多孔层,所述第一基体的部分表面或全部表面覆盖有所述第一多孔层;1. An acetabular cup, characterized in that, the acetabular cup comprises a first substrate and a first porous layer, and a part of the surface or the entire surface of the first substrate is covered with the first porous layer; 第一多孔层具有多个均匀分布且相互连通的孔洞;The first porous layer has a plurality of evenly distributed and interconnected pores; 所述第一多孔层负载有促进骨生长药物和抗菌消炎药物,其中所述促进骨生长药物填充于所述第一多孔层的内层的孔洞中,所述抗菌消炎药物填充于所述第一多孔层的外层的孔洞中。The first porous layer is loaded with a drug for promoting bone growth and an antibacterial and anti-inflammatory drug, wherein the drug for promoting bone growth is filled in the holes of the inner layer of the first porous layer, and the antibacterial and anti-inflammatory drug is filled in the in the pores of the outer layer of the first porous layer. 2.根据权利要求1所述的髋臼杯,其特征在于,所述第一多孔层的表面涂覆有所述抗菌消炎药物。2 . The acetabular cup according to claim 1 , wherein the surface of the first porous layer is coated with the antibacterial and anti-inflammatory drug. 3 . 3.根据权利要求1所述的髋臼杯,其特征在于,所述促进骨生长药物包括骨形态发生蛋白BMP、成纤维细胞生长因子FGF或转化生长因子TGF-Β。3. acetabular cup according to claim 1, is characterized in that, described bone growth promoting drug comprises bone morphogenetic protein BMP, fibroblast growth factor FGF or transforming growth factor TGF-B. 4.根据权利要求1所述的髋臼杯,其特征在于,所述抗菌消炎药物包括青霉素类、头孢霉素类或阿司匹林类药物。4 . The acetabular cup according to claim 1 , wherein the antibacterial and anti-inflammatory drugs include penicillin, cephalosporin or aspirin. 5 . 5.根据权利要求1所述的髋臼杯,其特征在于,所述第一多孔层的孔隙率为86~90%,所述孔洞的截面孔径为200~1200μm。5 . The acetabular cup according to claim 1 , wherein the porosity of the first porous layer is 86-90%, and the cross-sectional diameter of the holes is 200-1200 μm. 6 . 6.根据权利要求1所述的髋臼杯,其特征在于,所述第一多孔层的材质为钛合金或钛单质,所述第一多孔层的表面粗糙度为2~9μm。6 . The acetabular cup according to claim 1 , wherein the material of the first porous layer is titanium alloy or simple titanium, and the surface roughness of the first porous layer is 2-9 μm. 7 . 7.一种髋臼假体系统,其特征在于,所述髋臼假体系统包括增大构件和权利要求1~6任一项所述的髋臼杯,所述髋臼杯具有第一曲面,所述增大构件具有第二曲面,所述增大构件与所述髋臼杯通过所述第一曲面与所述第二曲面配合连接。7. An acetabular prosthesis system, characterized in that the acetabular prosthesis system comprises an augmenting member and the acetabular cup according to any one of claims 1 to 6, the acetabular cup having a first curved surface , the enlargement member has a second curved surface, and the enlargement member and the acetabular cup are connected with the second curved surface through the first curved surface. 8.根据权利要求7所述的髋臼假体系统,其特征在于,所述增大构件包括第二基体和第二多孔层,所述第二基体的部分表面或全部表面覆盖有所述第二多孔层,第二多孔层具有多个均匀分布且相互连通的孔洞。8. The acetabular prosthesis system according to claim 7, wherein the augmenting member comprises a second base body and a second porous layer, and a part or all of the surface of the second base body is covered with the The second porous layer has a plurality of uniformly distributed and interconnected pores. 9.根据权利要求8所述的髋臼假体系统,其特征在于,所述第二多孔层负载有所述促进骨生长药物和所述抗菌消炎药物,其中所述促进骨生长药物填充于所述第二多孔层的内层,所述抗菌消炎药物填充于所述第二多孔层的外层。9. The acetabular prosthesis system of claim 8, wherein the second porous layer is loaded with the bone growth-promoting drug and the antibacterial and anti-inflammatory drug, wherein the bone-growth-promoting drug is filled in In the inner layer of the second porous layer, the antibacterial and anti-inflammatory drug is filled in the outer layer of the second porous layer. 10.根据权利要求9所述的髋臼假体系统,其特征在于,所述第二多孔层的表面涂覆有所述抗菌消炎药物。10. The acetabular prosthesis system according to claim 9, wherein the surface of the second porous layer is coated with the antibacterial and anti-inflammatory drug.
CN202010445961.9A 2020-05-22 2020-05-22 Acetabular cup and acetabular prosthesis system Pending CN111529135A (en)

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CN112998912A (en) * 2021-03-12 2021-06-22 浙江大学医学院附属第一医院 3D printing acetabular cup prosthesis for artificial hip joint replacement surgery
CN116898639A (en) * 2023-09-12 2023-10-20 北京爱康宜诚医疗器材有限公司 Acetabular prosthesis

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* Cited by examiner, † Cited by third party
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CN112998912A (en) * 2021-03-12 2021-06-22 浙江大学医学院附属第一医院 3D printing acetabular cup prosthesis for artificial hip joint replacement surgery
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CN116898639B (en) * 2023-09-12 2024-01-23 北京爱康宜诚医疗器材有限公司 Acetabular prosthesis

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Application publication date: 20200814