WO2023216509A1

WO2023216509A1 - Implant prosthesis

Info

Publication number: WO2023216509A1
Application number: PCT/CN2022/126264
Authority: WO
Inventors: 张巍; 李健; 李建涛; 任晓萌; 李猛; 马睿; 唐佩福; 柴伟; 宋岳
Original assignee: 北京理贝尔生物工程研究所有限公司; 中国人民解放军总医院第四医学中心
Priority date: 2022-05-12
Filing date: 2022-10-19
Publication date: 2023-11-16
Also published as: CN114601602A; CN114601602B

Abstract

An implant prosthesis, comprising: a prosthetic body (10), a mounting part being provided on the prosthetic body (10); a drug carrying container (20), fixedly mounted on the mounting part, the drug carrying container (20) having an accommodating cavity for accommodating a drug, and an overflowing hole (24) and a sustained-release hole (25) in communication with the accommodating cavity being formed on the drug carrying container (20), wherein a volume-variable drug control cavity (11) is provided in the prosthetic body (10), the overflowing hole (24) is in communication with the drug control cavity (11), and the sustained-release hole (25) is in communication with the exterior of the prosthetic body (10). The implant prosthesis solves the problem that the orthopedic plate breaks or the artificial hip joint prosthesis loosens due to prolonged unhealing of the bone, and the drug in the accommodating cavity can be one of an anti-infection drug, a pro-osteogenesis drug, an anti-osteoporosis drug and an anti-tumor drug. A doctor can select according to the actual condition of the patient, so that the implant prosthesis can provide help for the corresponding treatment.

Description

植入假体Implantation of prosthesis

相关申请Related applications

本发明要求申请日为2022年5月12日，申请号为202210511913.4，发明名称为“植入假体”的中国发明专利申请的优先权。This invention requires the priority of a Chinese invention patent application with an application date of May 12, 2022, an application number of 202210511913.4, and an invention name of "Implantation Prosthesis".

技术领域Technical field

本发明涉及医疗器械领域，具体而言，涉及一种植入假体。The present invention relates to the field of medical devices, and specifically to an implanted prosthesis.

背景技术Background technique

接骨板是目前国内外治疗骨折最常用的一种内固定器械。迄今为止，使用接骨板治理骨折已有百余年的历史，其治疗原理为在骨折断端处切口放置接骨板，使得接骨板横跨骨折位置，再通过螺钉将接骨板固定于骨折远近两端，从而使骨折断端处的骨骼获得有效固定。因此，接骨板的结构均包括与骨骼表面形状相似的接骨板本体，本体上开设有用于螺钉固定的螺钉孔。Bone plate is currently the most commonly used internal fixation device for treating fractures at home and abroad. So far, bone plates have been used to treat fractures for more than a hundred years. The treatment principle is to place a bone plate through an incision at the fracture end so that the bone plate spans the fracture position, and then fix the bone plate to the far and near ends of the fracture through screws. , so that the bone at the fracture end can be effectively fixed. Therefore, the structure of the bone plate includes a bone plate body with a similar shape to the surface of the bone, and screw holes for screw fixation are provided on the body.

现有的接骨板均是作为物理固定器械，其功能均是为了实现骨折断端的桥接固定，让骨骼实现自体融合。但是目前数据统计，在日常开放性骨折手术后感染率达到3％至29％；在战时火器伤中，由于组织损伤和污染严重，在弹道周围0.5cm以内有大量细菌存在，即使清创后骨愈软组织的感染率仍然高达25％至40％，如果使用内固定则感染率再增加30％以上。因此，创伤型骨髓炎一直未得到很好的解决。Existing bone plates are used as physical fixation devices, and their function is to achieve bridging fixation of fracture ends and allow bones to achieve autogenous fusion. However, current statistics show that the infection rate after daily open fracture surgery reaches 3% to 29%; in wartime firearm injuries, due to serious tissue damage and contamination, there are a large number of bacteria within 0.5cm around the ballistic trajectory, even after debridement. The infection rate of bone healing soft tissue is still as high as 25% to 40%, and if internal fixation is used, the infection rate increases by more than 30%. Therefore, traumatic osteomyelitis has not been well resolved.

一般传统的治疗方法为先使用彻底清创或病灶清除等外科手段去除大部分细菌；在此基础上，使用外固定支架临时固定骨折断端；全身或局部应用大剂量抗生素消灭残留细菌；待伤口关闭。确实无感染后再行铜板等内固定方法固定骨折断端。而在开放性骨折和火器伤中钢板螺丝钉等内固定则被视为禁忌，这是因为细菌与植入物材料粘附以及形成完整的生物膜是固定物相关感染的主要病理基础，而金黄色葡萄球菌和表皮葡萄球菌占深部检出细菌的70％至90％，其中耐甲氧西林金葡菌约60％，近来甚至出现了耐万古霉素金葡菌，导致临床面临无抗生素可用的严峻局面。当使用钢板等内固定时，残留的致病菌会在固定物上粘附并大量繁殖，形成生物膜使其毒力大增，远远超出了抗生素传统应用方法的抗菌能力。即使在近年来提出的聚甲基丙烯酸甲酯(PMMA)的局部缓释抗生素的应用前提下，仍然存在诱导细菌耐药、作为异物必须取出和无固定骨折断端效力等缺点。The general traditional treatment method is to first use surgical methods such as thorough debridement or lesion removal to remove most of the bacteria; on this basis, use an external fixator to temporarily fix the fractured end; systemic or local application of large doses of antibiotics to eliminate residual bacteria; wait for the wound to be treated closure. After it is confirmed that there is no infection, internal fixation methods such as copper plates can be used to fix the broken ends. In open fractures and firearm injuries, internal fixation such as plates and screws is considered contraindicated. This is because the adhesion of bacteria to implant materials and the formation of complete biofilms are the main pathological basis of fixation-related infections, and golden yellow Staphylococcus aureus and Staphylococcus epidermidis account for 70% to 90% of the bacteria detected in deep areas, of which about 60% are methicillin-resistant Staphylococcus aureus. Recently, even vancomycin-resistant Staphylococcus aureus has appeared, leading to the serious clinical situation of no antibiotics available. situation. When internal fixation such as steel plates is used, residual pathogenic bacteria will adhere to the fixation and multiply in large numbers, forming a biofilm that greatly increases its virulence, far exceeding the antibacterial ability of traditional antibiotic application methods. Even under the premise of the application of local sustained-release antibiotics using polymethylmethacrylate (PMMA) proposed in recent years, there are still shortcomings such as inducing bacterial resistance, having to be removed as a foreign body, and having no effectiveness in fixing fracture ends.

由于感染的发生，会导致骨性愈合时间长甚至骨不愈合等问题。而现阶段，临床中会因骨折周围血运较差等情况而导致骨性不愈合的情况发生。由于长时间骨性不愈合，接骨板发生断板情况。Due to the occurrence of infection, problems such as long bone healing time or even non-healing may occur. At this stage, bony non-union may occur clinically due to poor blood supply around the fracture. Due to long-term bone non-union, the bone plate breaks.

发明内容Contents of the invention

本申请的主要目的在于提供一种植入假体，以解决相关技术中的由于长时间骨性不愈合，接骨板发生断板的问题，并根据载药容器内所载的药物的种类，对开放性创伤的疗效提供帮助。The main purpose of this application is to provide an implanted prosthesis to solve the problem in the related art that the bone plate is broken due to long-term bone non-union, and to open the prosthesis according to the type of medicine contained in the medicine-containing container. Help with sexual trauma healing.

为了实现上述目的，本申请提供了一种植入假体，包括：假体本体，假体本体上设置有安装部；载药容器，固定安装于安装部，载药容器具有容纳药物的容纳腔，载药容器上设置有与容纳腔连通的过流孔和缓释孔；其中，假体本体内设置有容积可变的控药腔，过流孔与控药腔连通，缓释孔与假体本体的外部连通。In order to achieve the above purpose, the present application provides an implanted prosthesis, which includes: a prosthesis body, which is provided with a mounting part; a medicine-carrying container, which is fixedly installed on the mounting part; the medicine-carrying container has a containing cavity for containing medicine, The drug-carrying container is provided with an overflow hole and a sustained-release hole that are connected to the containing cavity; wherein, a drug-control cavity with variable volume is provided in the prosthesis body, the over-flow hole is connected to the drug-control cavity, and the sustained-release hole is connected to the prosthesis. External connectivity of the ontology.

进一步地，假体本体为接骨板。Further, the prosthesis body is a bone plate.

进一步地，控药腔还包括第一弧面和第二弧面，第一弧面的开口朝向第二弧面，第二弧面的开口朝向第一弧面，在假体本体受力的情况下第一弧面和第二弧面之间的距离逐渐减小。Further, the drug control chamber also includes a first arc surface and a second arc surface. The opening of the first arc surface faces the second arc surface, and the opening of the second arc surface faces the first arc surface. When the prosthesis body is stressed, The distance between the lower first arc surface and the second arc surface gradually decreases.

进一步地，第一弧面的第一侧与第二弧面的第一侧连接，第一弧面的第二侧与第二弧面的第二侧之间形成开放口，过流孔位于开放口处。Further, the first side of the first arcuate surface is connected to the first side of the second arcuate surface, an open opening is formed between the second side of the first arcuate surface and the second side of the second arcuate surface, and the overflow hole is located in the opening. Mouth.

进一步地，安装部为安装凹腔，载药容器为第一载药球，第一载药球过盈连接于安装凹腔。Further, the mounting part is a mounting cavity, the medicine-carrying container is a first medicine-carrying ball, and the first medicine-carrying ball is interference-connected to the mounting cavity.

进一步地，缓释孔为多个，多个缓释孔间隔地设置于第一载药球。Furthermore, there are a plurality of sustained-release holes, and the plurality of sustained-release holes are arranged at intervals on the first drug-loaded ball.

进一步地，安装部为球缺形腔，载药容器为第二载药球，第二载药球过盈连接于球缺形腔。Further, the mounting part is a spherical cavity, the drug-carrying container is a second drug-carrying ball, and the second drug-carrying ball is interference-connected to the spherical cavity.

进一步地，过流孔和缓释孔各为一个。Further, there is one overflow hole and one slow-release hole.

进一步地，安装部为管形腔，载药容器为载药管，载药管过盈连接于管形腔，过流孔位于管形腔的第一端，缓释孔位于管形腔的第二端。Further, the installation part is a tubular cavity, the drug-carrying container is a drug-carrying tube, the drug-carrying tube is interference-connected to the tubular cavity, the overflow hole is located at the first end of the tubular cavity, and the sustained-release hole is located at the third end of the tubular cavity. Two ends.

进一步地，载药管为多面体结构。Further, the drug-carrying tube has a polyhedral structure.

进一步地，过流孔的直径和/或缓释孔的直径在100微米至800微米的范围内；载药容器为载药球时，载药球的外径在0.5mm至3mm的范围内，载药球的内径在0.3mm至2.5mm的范围内，载药容器为载药管时，载药管的内径在0.05mm至0.5mm的范围内，载药管的高度在1mm至3mm的范围内；假体本体的外表面和载药容器的外表面均覆盖有防溢层。Further, the diameter of the overflow hole and/or the diameter of the sustained-release hole is in the range of 100 microns to 800 microns; when the drug-carrying container is a drug-carrying ball, the outer diameter of the drug-carrying ball is in the range of 0.5mm to 3mm, The inner diameter of the drug-carrying ball is in the range of 0.3mm to 2.5mm. When the drug-carrying container is a drug-carrying tube, the inner diameter of the drug-carrying tube is in the range of 0.05mm to 0.5mm, and the height of the drug-carrying tube is in the range of 1mm to 3mm. Inside; the outer surface of the prosthesis body and the outer surface of the drug-containing container are covered with an anti-spill layer.

进一步地，安装部为多个，多个安装部围绕假体本体间隔地布置成多层，载药容器为多个，多个载药容器与多个安装部一一对应地设置，控药腔为多个，多个载药容器中位于同一层的载药容器与一个或者多个控药腔对应设置。Further, there are a plurality of installation parts, and the plurality of installation parts are arranged in multiple layers at intervals around the prosthesis body. There are a plurality of drug-containing containers, and the plurality of drug-containing containers are arranged in one-to-one correspondence with the plurality of installation parts. The drug control chamber There are a plurality of drug-carrying containers, and the drug-carrying containers located on the same layer among the plurality of drug-carrying containers are arranged correspondingly to one or more drug-control chambers.

进一步地，当多个载药容器中位于同一层的载药容器与一个控药腔对应设置时，控药腔包括第三弧面和第四弧面，第三弧面的开口朝向第四弧面，第四弧面的开口朝向第三弧面，第三弧面和第四弧面之间形成环形开放口，多个载药容器中位于同一层的载药容器的过流孔位于环形开放口处。Further, when the drug-containing containers located on the same layer among the plurality of drug-containing containers are arranged corresponding to one drug-control chamber, the drug-control chamber includes a third arc surface and a fourth arc surface, and the opening of the third arc surface faces the fourth arc surface. surface, the opening of the fourth arc surface faces the third arc surface, an annular opening is formed between the third arc surface and the fourth arc surface, and the overflow hole of the drug-containing container located on the same layer among the multiple drug-containing containers is located in the annular opening. Mouth.

应用本申请的技术方案，植入假体包括：假体本体和载药容器。假体本体上设置有安装部。载药容器固定安装于安装部，载药容器具有容纳药物的容纳腔，载药容器上设置有与容纳腔连通的过流孔和缓释孔。这样，载药容器的容纳腔单独载药，方便计算，以此来控制载药总量，同时也方便设计载药容器的大小，以适配不同形状及尺寸的假体本体。在本申请中，假体本体内设置有容积可变的控药腔，过流孔与控药腔连通，缓释孔与假体本体的外部连通。可以将植入假体植入至人体的骨折周围处，载药容器的容纳腔内载有药物，药物经缓释孔作用于骨折处，使骨折周围血运良好，缩短骨性愈合时间。进而降低了接骨板发生断板的可能性，并根据载药容器内所载的药物的种类，对开放性创伤的疗效提供帮助。因此，本申请的技术方案能够解决相关技术中的由于长时间骨性不愈合，接骨板发生断板的问题。并且，在骨性愈合的过程中，假体本体受力弯曲时，控药腔受到压缩，控药腔的容积由大变小，控药腔内的介质经过流孔溢向容纳腔内以推动药物，加速药物从缓释孔的释放，当骨折未愈合或者患者活动越多时，药物释放量越大，大大改善了骨折周围血运环境，能够有效地缩短骨性愈合时间，进而大大降低了接骨板发生断板的可能性。Using the technical solution of this application, the implanted prosthesis includes: a prosthesis body and a drug-carrying container. The prosthesis body is provided with a mounting portion. The medicine-carrying container is fixedly installed on the mounting part. The medicine-carrying container has a containing cavity for containing the medicine. The medicine-carrying container is provided with a flow hole and a sustained-release hole connected with the containing cavity. In this way, the receiving cavity of the drug-containing container is separately loaded with drugs, which facilitates calculation to control the total amount of drug loaded. It also facilitates the design of the size of the drug-containing container to adapt to prosthetic bodies of different shapes and sizes. In this application, a drug control cavity with variable volume is provided in the prosthesis body, the overflow hole is connected to the drug control cavity, and the sustained release hole is connected to the outside of the prosthesis body. The implanted prosthesis can be implanted around the fracture of the human body. The drug-carrying container contains the drug in the cavity. The drug acts on the fracture through the sustained-release hole, so that the blood supply around the fracture is good and the bone healing time is shortened. This further reduces the possibility of fracture of the bone plate and helps to improve the efficacy of open wounds according to the type of medicine contained in the medicine container. Therefore, the technical solution of the present application can solve the problem in the related art that the bone plate is broken due to long-term bone non-union. Moreover, during the process of bone healing, when the prosthesis body bends under force, the medicine control cavity is compressed, and the volume of the medicine control cavity changes from large to small. The medium in the medicine control cavity overflows into the accommodation cavity through the flow hole to push the medicine. The drug accelerates the release of the drug from the sustained-release hole. When the fracture is not healed or the patient moves more, the greater the drug release, which greatly improves the blood supply environment around the fracture and can effectively shorten the bone healing time, thus greatly reducing the cost of bone grafting. The possibility of board breakage.

附图说明Description of the drawings

构成本申请的一部分的说明书附图用来提供对本申请的进一步理解，本申请的示意性实施例及其说明用于解释本申请，并不构成对本申请的不当限定。在附图中：The description and drawings that constitute a part of this application are used to provide a further understanding of this application. The illustrative embodiments and their descriptions of this application are used to explain this application and do not constitute an improper limitation of this application. In the attached picture:

图1示出了根据本申请的植入假体的实施例一的接骨板植入至胫骨远端骨折周围处的立体结构示意图；Figure 1 shows a schematic three-dimensional structural diagram of a bone plate implanted around a distal tibial fracture according to Embodiment 1 of the implanted prosthesis of the present application;

图2示出了图1的植入假体的带有第一载药球的接骨板的立体结构示意图；Figure 2 shows a schematic three-dimensional structural view of the bone plate with the first drug-loaded ball implanted in the prosthesis of Figure 1;

图3示出了图1的植入假体的带有第二载药球的接骨板的立体结构示意图；Figure 3 shows a schematic three-dimensional structural view of the bone plate with a second drug-loaded ball implanted in the prosthesis of Figure 1;

图4示出了图1的植入假体的带有载药管的接骨板的立体结构示意图；Figure 4 shows a schematic three-dimensional structural view of the bone plate with a drug-loaded tube for implanting the prosthesis of Figure 1;

图5示出了图2的植入假体的带有第一载药球的接骨板的剖视示意图；Figure 5 shows a schematic cross-sectional view of the bone plate with the first drug-loaded ball implanted in the prosthesis of Figure 2;

图6示出了图3的植入假体的带有第二载药球的接骨板的剖视示意图；Figure 6 shows a schematic cross-sectional view of the bone plate with a second drug-loaded ball implanted in the prosthesis of Figure 3;

图7示出了图4的植入假体的带有载药管的接骨板的剖视示意图；Figure 7 shows a schematic cross-sectional view of the bone plate with a drug-containing tube for implanting the prosthesis of Figure 4;

图8示出了图2的第一载药球的立体结构示意图；Figure 8 shows a schematic three-dimensional structural diagram of the first medicine-loaded ball of Figure 2;

图9示出了图3的第二载药球的立体结构示意图；Figure 9 shows a schematic three-dimensional structural diagram of the second medicine-loaded ball of Figure 3;

图10示出了图4的载药管的立体结构示意图；Figure 10 shows a schematic three-dimensional structural view of the drug-carrying tube of Figure 4;

图11示出了图5的植入假体的带有第一载药球的接骨板未受力时的局部示意图；Figure 11 shows a partial schematic view of the bone plate with the first drug-loaded ball of the implanted prosthesis of Figure 5 when no force is applied;

图12示出了图5的植入假体的带有第一载药球的接骨板受力时的局部示意图；Figure 12 shows a partial schematic diagram of the bone plate with the first drug-loaded ball of the implanted prosthesis of Figure 5 when it is stressed;

图13示出了根据本申请的植入假体的实施例二的股骨柄植入至股骨颈骨折周围处的立体结构示意图；Figure 13 shows a schematic three-dimensional structural diagram of a femoral stem implanted around a femoral neck fracture according to Embodiment 2 of the implanted prosthesis of the present application;

图14示出了图13的植入假体的带有第一载药球的股骨柄的立体结构示意图；Figure 14 shows a schematic three-dimensional structural view of the femoral stem with the first drug-loaded ball implanted in the prosthesis of Figure 13;

图15示出了图14的植入假体的带有第一载药球的股骨柄的剖视示意图；Figure 15 shows a schematic cross-sectional view of the femoral stem with a first drug-loaded ball implanted with the prosthesis of Figure 14;

图16示出了图13的植入假体的带有第二载药球的股骨柄的剖视示意图；Figure 16 shows a schematic cross-sectional view of the femoral stem with a second drug-loaded ball implanted in the prosthesis of Figure 13;

图17示出了图13的植入假体的带有载药管的股骨柄的剖视示意图；Figure 17 shows a schematic cross-sectional view of the femoral stem with a drug-carrying tube implanted with the prosthesis of Figure 13;

图18示出了图16的植入假体的带有第二载药球的股骨柄未受力时的局部示意图；Figure 18 shows a partial schematic view of the femoral stem with the second drug-loaded ball implanted in the prosthesis of Figure 16 when no force is applied;

图19示出了图16的植入假体的带有第二载药球的股骨柄受力时的局部示意图；Figure 19 shows a partial schematic diagram of the femoral stem with the second drug-loaded ball implanted in the prosthesis of Figure 16 when it is stressed;

图20示出了图18的植入假体的带有第二载药球的股骨柄未受力时的局部放大示意图；Figure 20 shows a partial enlarged schematic view of the femoral stem with the second drug-loaded ball implanted in the prosthesis of Figure 18 when no force is applied;

图21示出了图19的植入假体的带有第二载药球的股骨柄受力时的局部放大示意图；Figure 21 shows a partial enlarged schematic view of the femoral stem with the second drug-loaded ball of the implanted prosthesis of Figure 19 when it is stressed;

图22示出了根据本申请的负压载药装置的实施例的立体结构示意图。Figure 22 shows a schematic three-dimensional structural diagram of an embodiment of a negative pressure drug-loading device according to the present application.

其中，上述附图包括以下附图标记：Among them, the above-mentioned drawings include the following reference signs:

1、胫骨；2、股骨；10、假体本体；101、接骨板；102、股骨柄；11、控药腔；111、第一弧面；112、第二弧面；113、第三弧面；114、第四弧面；20、载药容器；21、第一载药球；22、第二载药球；23、载药管；24、过流孔；25、缓释孔；30、真空泵；40、药物推杆件；51、箱体；52、箱盖；60、载药盒；80、加热管；F、力。1. Tibia; 2. Femur; 10. Prosthesis body; 101. Bone plate; 102. Femoral stem; 11. Drug control cavity; 111. First arc surface; 112. Second arc surface; 113. Third arc surface ; 114. The fourth arc surface; 20. Drug-carrying container; 21. The first drug-carrying ball; 22. The second drug-carrying ball; 23. Drug-carrying tube; 24. Overflow hole; 25. Sustained release hole; 30. Vacuum pump; 40. Drug push rod; 51. Box; 52. Box lid; 60. Medicine box; 80. Heating tube; F. Force.

具体实施方式Detailed ways

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，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。以下对至少一个示例性实施例的描述实际上仅仅是说明性的，决不作为对本申请及其应用或使用的任何限制。The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the application or its application or uses.

申请如图1至图12所示，实施例一的植入假体包括：假体本体10和载药容器20。假体本体10上设置有安装部。载药容器20固定安装于安装部，载药容器20具有容纳药物的容纳腔，载药容器20上设置有与容纳腔连通的过流孔24和缓释孔25。其中，假体本体10内设置有容积可变的控药腔11，过流孔24与控药腔11连通，缓释孔25与假体本体10的外部连通。As shown in FIGS. 1 to 12 , the implanted prosthesis in Embodiment 1 includes: a prosthesis body 10 and a drug-containing container 20 . The prosthesis body 10 is provided with a mounting portion. The medicine-carrying container 20 is fixedly installed on the mounting part. The medicine-carrying container 20 has a containing cavity for containing medicine. The medicine-carrying container 20 is provided with a flow hole 24 and a sustained-release hole 25 connected with the containing cavity. Among them, the prosthesis body 10 is provided with a drug control cavity 11 with variable volume, the overflow hole 24 is connected to the drug control cavity 11 , and the sustained release hole 25 is connected to the outside of the prosthesis body 10 .

应用实施例一的技术方案，载药容器20固定安装于安装部，载药容器20具有容纳药物的容纳腔，载药容器20上设置有与容纳腔连通的过流孔24和缓释孔25。这样，载药容器20的容纳腔单独载药，方便计算，以此来控制载药总量，同时也方便设计载药容器20的大小，以适配不同形状及尺寸的假体本体10。在实施例一中，假体本体10内设置有容积可变的控药腔11，过流孔24与控药腔11连通，缓释孔25与假体本体10的外部连通。可以将植入假体植入至人体的骨折周围处，载药容器20的容纳腔内载有药物，药物经缓释孔25作用于骨折处，使骨折周围血运良好，缩短骨性愈合时间。进而降低了接骨板发生断板的可能性，并根据载药容器内所载的药物的种类，对开放性创伤的疗效提供帮助。因此，实施例一的技术方案能够解决相关技术中的由于长时间骨性不愈合，接骨板发生断板的问题。并且，在骨性愈合的过程中，假体本体10受力F弯曲时，控药腔11受到压缩，控药腔11的容积由大变小，控药腔11内的介质经过流孔24溢向容纳腔内以推动药物，加速药物从缓释孔25的释放，当骨折未愈合或者患者活动越多时，药物释放量越大，大大改善了骨折周围血运环境，能够有效地缩短骨性愈合时间，进而大大降低了接骨板发生断板的可能性。这样，患者无需进行二次翻修手术，能够降低二次的伤害及消除大量临床费用的产生。Applying the technical solution of Embodiment 1, the medicine-carrying container 20 is fixedly installed on the installation part. The medicine-carrying container 20 has a containing cavity for containing the medicine. The medicine-carrying container 20 is provided with a flow hole 24 and a sustained-release hole 25 connected with the containing cavity. . In this way, the containing cavity of the drug-containing container 20 is separately loaded with drugs, which facilitates calculation to control the total amount of drug loaded, and also facilitates the design of the size of the drug-containing container 20 to adapt to prosthetic bodies 10 of different shapes and sizes. In the first embodiment, a drug control chamber 11 with variable volume is provided in the prosthesis body 10, the overflow hole 24 is connected to the drug control chamber 11, and the sustained release hole 25 is connected to the outside of the prosthesis body 10. The implanted prosthesis can be implanted around the fracture of the human body. The drug-containing container 20 contains medicine in the cavity. The medicine acts on the fracture through the slow-release hole 25, so that the blood supply around the fracture is good and the bone healing time is shortened. . This further reduces the possibility of fracture of the bone plate and helps to improve the efficacy of open wounds according to the type of medicine contained in the medicine container. Therefore, the technical solution of the first embodiment can solve the problem in the related art that the bone plate is broken due to long-term bone non-union. Moreover, during the process of bone healing, when the prosthesis body 10 bends under the force F, the medicine control cavity 11 is compressed, the volume of the medicine control cavity 11 changes from large to small, and the medium in the medicine control cavity 11 overflows through the flow hole 24 To push the drug into the accommodation cavity and accelerate the release of the drug from the sustained release hole 25. When the fracture is not healed or the patient moves more, the drug release amount is greater, which greatly improves the blood supply environment around the fracture and can effectively shorten the bone healing. time, thereby greatly reducing the possibility of bone plate breakage. In this way, the patient does not need to undergo a second revision surgery, which can reduce secondary injuries and eliminate a large amount of clinical expenses.

需要说明的是，上述的“容积可变”是指假体本体10受力后，随着作用力逐渐增大，控药腔11的容积能够由大变小，随着作用力逐渐减小，控药腔11的容积能够由小变大。上述的“控药腔11内的介质”可以是颗粒状的药物，还可以是粉末状的药物，也可以是液态的药物，其中，液态的药物如抗感染类药物、促成骨类药物、抗骨质疏松药物。具体地要根据载药容器20内的药物决定，即载药容器20内的药物与控药腔11内的介质为同一药物。It should be noted that the above-mentioned "volume variable" means that after the prosthesis body 10 is stressed, as the force gradually increases, the volume of the drug control chamber 11 can change from large to small. As the force gradually decreases, The volume of the medicine control chamber 11 can change from small to large. The above-mentioned "medium in the drug control chamber 11" can be granular drugs, powdered drugs, or liquid drugs, wherein liquid drugs such as anti-infective drugs, bone-promoting drugs, anti-inflammatory drugs, etc. Osteoporosis drugs. Specifically, it depends on the medicine in the medicine-carrying container 20 , that is, the medicine in the medicine-carrying container 20 and the medium in the medicine-control chamber 11 are the same medicine.

实施例一的假体本体10和载药容器20可以铸造成型或者3D打印成型。其中，假体本体10和载药容器20为一次成型结构，即成为一个零件。The prosthesis body 10 and the drug-containing container 20 of the first embodiment can be cast or 3D printed. Among them, the prosthesis body 10 and the drug-containing container 20 are one-time molded structures, that is, they become one part.

如图1至图7所示，假体本体10为接骨板101，这样，将接骨板101植入至胫骨1的远端骨折周围处，载药容器20的容纳腔内的药物经缓释孔25作用于骨折处，使骨折周围血运良好，缩短骨性愈合时间。上述的接骨板101采用医用金属制成，所用医用金属包括但不局限于钛及钛合金、钴合金、不锈钢以及钽金属、镁合金，此类金属材料在ISO-5830系列国际标准中均有规定，其生物相容性已经得到国内外多年骨科植入应用的实践证实。接骨板101还可以植入至股骨、肱骨、桡骨等四肢易发骨折的部位处。As shown in Figures 1 to 7, the prosthesis body 10 is a bone plate 101. In this way, the bone plate 101 is implanted around the distal fracture of the tibia 1, and the medicine in the receiving cavity of the medicine container 20 passes through the sustained release hole. 25 acts on the fracture site to improve blood circulation around the fracture and shorten the bone healing time. The above-mentioned bone plate 101 is made of medical metal. The medical metals used include but are not limited to titanium and titanium alloys, cobalt alloys, stainless steel, tantalum metal, and magnesium alloys. Such metal materials are specified in the ISO-5830 series of international standards. , its biocompatibility has been confirmed by years of practice in orthopedic implant applications at home and abroad. The bone plate 101 can also be implanted into the femur, humerus, radius and other parts of the limbs prone to fractures.

当人体骨折发生后，根据骨折位置，选择合适的接骨板101规格，根据解剖匹配位置关系，将接骨板101上的载药容器20靠近骨折线位置进行螺钉固定，确保载药容器20的缓释孔25进行药物释放时能直接作用于骨折部位，从而实现减小剂量、提高效率的目的。When a human body fracture occurs, the appropriate specifications of the bone plate 101 are selected according to the fracture position, and according to the anatomical matching position, the drug-containing container 20 on the bone plate 101 is screwed close to the fracture line to ensure the sustained release of the drug-containing container 20 The hole 25 can directly act on the fracture site when releasing the drug, thereby achieving the purpose of reducing the dose and improving efficiency.

如图11和图12所示，控药腔11还包括第一弧面111和第二弧面112，第一弧面111的开口朝向第二弧面112，第二弧面112的开口朝向第一弧面111，在假体本体10受力F的情况下第一弧面111和第二弧面112之间的距离逐渐减小。第一弧面111和第二弧面112的形状保证控药腔11具有一定的支撑力，在控药腔11受力变形时仍能够保证假体本体10的内部结构稳定。需要说明的是，上述的第一弧面111和第二弧面112均可以是拱桥形或者球缺形。As shown in Figures 11 and 12, the drug control chamber 11 also includes a first arc surface 111 and a second arc surface 112. The opening of the first arc surface 111 faces the second arc surface 112, and the opening of the second arc surface 112 faces the second arc surface 112. There is an arcuate surface 111. When the prosthesis body 10 is subjected to force F, the distance between the first arcuate surface 111 and the second arcuate surface 112 gradually decreases. The shapes of the first arcuate surface 111 and the second arcuate surface 112 ensure that the drug control chamber 11 has a certain supporting force, and can still ensure the stability of the internal structure of the prosthesis body 10 when the drug control chamber 11 is deformed by force. It should be noted that both the above-mentioned first arcuate surface 111 and the second arcuate surface 112 may be in the shape of an arch bridge or a spherical segment.

如图11和图12所示，假体本体10受力F弯曲时，控药腔11受到压缩，由于第一弧面111的第一侧与第二弧面112的第一侧连接，第一弧面111的第二侧与第二弧面112的第二侧之间形成开放口，过流孔24位于开放口处，使得第一弧面111的第一侧与第二弧面112的第一侧连接处封闭，控药腔11内的介质仅能够从开放口流出并进入过流孔24内，以使控药腔 11能够提供较大的推力，以加速药物的释放，当骨折未愈合或者患者活动越多时，容纳腔内的药物释放量也越大，反之容纳腔内的药物释放量也越小，这样能够根据患者实际情况动态控制药物释放情况。As shown in Figures 11 and 12, when the prosthesis body 10 bends under the force F, the medicine control chamber 11 is compressed. Since the first side of the first arc surface 111 is connected to the first side of the second arc surface 112, the first An opening is formed between the second side of the arcuate surface 111 and the second side of the second arcuate surface 112 , and the flow hole 24 is located at the opening, so that the first side of the first arcuate surface 111 and the second side of the second arcuate surface 112 are The connection on one side is closed, and the medium in the drug control chamber 11 can only flow out from the open port and enter the overflow hole 24, so that the drug control chamber 11 can provide a larger thrust to accelerate the release of the drug. When the fracture is not healed, Or when the patient moves more, the amount of drug released in the accommodation cavity will be greater, and conversely, the amount of drug released in the accommodation cavity will be smaller. This way, the drug release can be dynamically controlled according to the actual situation of the patient.

在实施例一中，载药容器20为载药球时，载药球的外径在0.5mm至3mm的范围内，载药球的内径在0.3mm至2.5mm的范围内，载药容器20为载药管时，载药管的内径在0.05mm至0.5mm的范围内，载药管的高度在1mm至3mm的范围内。In the first embodiment, when the medicine-loaded container 20 is a medicine-loaded ball, the outer diameter of the medicine-loaded ball is in the range of 0.5mm to 3mm, and the inner diameter of the medicine-loaded ball is in the range of 0.3mm to 2.5mm. The medicine-loaded container 20 When it is a drug-carrying tube, the inner diameter of the drug-carrying tube is in the range of 0.05mm to 0.5mm, and the height of the drug-carrying tube is in the range of 1mm to 3mm.

在实施例一中，上述的药物为抗感染药物、促成骨药物、抗骨质疏松药物以及抗肿瘤药物中的一种，医生可以根据患者的实际情况进行选择，这样植入假体也能够对相应的治疗提供帮助。In the first embodiment, the above-mentioned drugs are one of anti-infection drugs, bone-promoting drugs, anti-osteoporosis drugs and anti-tumor drugs. The doctor can choose according to the actual situation of the patient, so that the implanted prosthesis can also Appropriate treatment is provided to help.

如图2、图5和图8所示，安装部为安装凹腔，载药容器20为第一载药球21，第一载药球21过盈连接于安装凹腔。这样，第一载药球21的至少一半部分露在接骨板101的外表面外，当第一载药球21内载入抗感染药物时，第一载药球21内的抗感染药物经缓释孔25作用于骨折处，可实现抗感染，使骨折周围血运良好，能够有效地缩短骨性愈合时间。上述的抗感染药物包含但不限于庆大霉素、万古霉素、美罗培南、伏立康唑。上述的第一载药球21的外径在0.5mm至1.5mm的范围内。As shown in Figures 2, 5 and 8, the mounting part is a mounting cavity, the medicine-carrying container 20 is a first medicine-carrying ball 21, and the first medicine-carrying ball 21 is interference-connected to the mounting cavity. In this way, at least half of the first medicine-loaded ball 21 is exposed outside the outer surface of the bone plate 101. When the anti-infective medicine is loaded into the first medicine-loaded ball 21, the anti-infective medicine in the first medicine-loaded ball 21 is slowed down. The release hole 25 acts on the fracture to achieve anti-infection, improve blood circulation around the fracture, and effectively shorten the bone healing time. The above-mentioned anti-infective drugs include but are not limited to gentamicin, vancomycin, meropenem, and voriconazole. The outer diameter of the above-mentioned first drug-loaded ball 21 is in the range of 0.5 mm to 1.5 mm.

需要说明的是，第一载药球21的至少一半部分露在接骨板101的外表面外是指第一载药球21仅有一部分位于接骨板101内，第一载药球21的大部分伸出至接骨板101的外表面的外侧。It should be noted that the fact that at least half of the first medicine-loaded ball 21 is exposed outside the outer surface of the bone plate 101 means that only a part of the first medicine-loaded ball 21 is located in the bone plate 101 , and most of the first medicine-loaded ball 21 is located inside the bone plate 101 . Extending to the outside of the outer surface of the bone plate 101.

如图2、图5和图8所示，缓释孔25为多个，多个缓释孔25间隔地设置于第一载药球21。这样，多个缓释孔25使得第一载药球21内的抗感染药物释放速度较快，使得整个释放周期较短，有利于实现抗感染效果。As shown in FIGS. 2 , 5 and 8 , there are multiple sustained release holes 25 , and the multiple sustained release holes 25 are spaced apart on the first drug-loaded ball 21 . In this way, the multiple sustained release holes 25 enable the anti-infective drug in the first drug-loaded ball 21 to be released faster, making the entire release cycle shorter, which is beneficial to achieving the anti-infective effect.

如图3、图6和图9所示，安装部为球缺形腔，载药容器20为第二载药球22，第二载药球22过盈连接于球缺形腔。这样，第二载药球22的至少一半部分沉在接骨板101的外表面内，当第二载药球22的容纳腔内载入促成骨药物时，第二载药球22内的促成骨药物经缓释孔25作用于骨折处，使骨折周围血运良好，可实现较快地骨整合，能够缩短骨性愈合时间。上述的促成骨药物包含但不限于双膦酸盐、甲状旁激素、氟化物、生长激素。上述的第二载药球22的外径在1mm至3mm的范围内。当第二载药球22的容纳腔内载入抗骨质疏松药物时，第二载药球22内的抗骨质疏松药物经缓释孔25作用于骨质疏松处，使骨质疏松周围血运良好，可较快地治疗骨质疏松。上述的抗骨质疏松药物包含但不限于特立帕肽、鲑降钙素、雷洛昔芬、唑来膦酸。As shown in Figures 3, 6 and 9, the mounting part is a spherical cavity, and the drug-carrying container 20 is a second drug-loaded ball 22, and the second drug-loaded ball 22 is interference-connected to the spherical cavity. In this way, at least half of the second medicine-loaded ball 22 sinks into the outer surface of the bone plate 101. When the bone-promoting medicine is loaded into the receiving cavity of the second medicine-loaded ball 22, the bone-promoting medicine in the second medicine-loaded ball 22 will The drug acts on the fracture through the sustained-release hole 25, so that the blood supply around the fracture is good, enabling faster osseointegration and shortening the bone healing time. The above-mentioned bone-promoting drugs include but are not limited to bisphosphonates, parathyroid hormone, fluoride, and growth hormone. The outer diameter of the above-mentioned second drug-loaded ball 22 is in the range of 1 mm to 3 mm. When the anti-osteoporosis drug is loaded into the receiving cavity of the second drug-loaded ball 22, the anti-osteoporosis drug in the second drug-loaded ball 22 acts on the osteoporosis area through the sustained-release hole 25, so that the surrounding areas of the osteoporosis With good blood circulation, osteoporosis can be treated quickly. The above-mentioned anti-osteoporosis drugs include but are not limited to teriparatide, salmon calcitonin, raloxifene, and zoledronic acid.

需要说明的是，第二载药球22的至少一半部沉在接骨板101的外表面内是指第二载药球22整***于接骨板101内，或者第二载药球22的一部分伸出至接骨板101的外表面的外侧。It should be noted that the fact that at least half of the second medicine-loaded ball 22 is sunk into the outer surface of the bone plate 101 means that the entire second medicine-loaded ball 22 is located within the bone plate 101 , or that a part of the second medicine-loaded ball 22 extends out. to the outside of the outer surface of the bone plate 101.

如图3、图6和图9所示，过流孔24和缓释孔25各为一个。这样，一个过流孔24和一个缓释孔25使得第二载药球22内的促成骨药物释放速度较慢，使得整个释放周期较长，有利于实现促成骨效果，以实现较快地骨整合。As shown in Figures 3, 6 and 9, there is one overflow hole 24 and one slow-release hole 25 respectively. In this way, an overflow hole 24 and a sustained release hole 25 make the bone-promoting drug in the second drug-loaded ball 22 release at a slower rate, making the entire release cycle longer, which is beneficial to achieving the bone-promoting effect and achieving faster bone healing. Integrate.

上述的第一载药球21的容纳腔的直径和第二载药球22的容纳腔的直径均在0.3mm至2.5mm的范围内。The diameters of the accommodating cavity of the first drug-loaded ball 21 and the accommodating cavity of the second drug-carrying ball 22 are both in the range of 0.3 mm to 2.5 mm.

如图4、图7和图10所示，安装部为管形腔，载药容器20为载药管23，载药管23过盈连接于管形腔，过流孔24位于管形腔的第一端，缓释孔25位于管形腔的第二端。这样，载药管23的至少一半部分沉在接骨板101的外表面内，当载药管23的容纳腔内载入抗肿瘤药物时，具有较大容纳腔的载药管23能够承载更多的载药量，载药管23内的抗肿瘤药物经缓释孔25作用于肿瘤处，使肿瘤周围血运良好，较快地***。上述的抗肿瘤药物包含但不限于烷化剂和氮芥类、铂类化合物、丝裂霉素、二氢叶酸还原酶抑制剂、放线菌素D、紫杉醇、多西他赛。As shown in Figures 4, 7 and 10, the installation part is a tubular cavity, the medicine-carrying container 20 is a medicine-carrying tube 23, the medicine-carrying tube 23 is interference-connected to the tubular cavity, and the overflow hole 24 is located in the tubular cavity. At the first end, the slow-release hole 25 is located at the second end of the tubular cavity. In this way, at least half of the drug-carrying tube 23 sinks into the outer surface of the bone plate 101. When the anti-tumor drug is loaded into the receiving cavity of the drug-carrying tube 23, the drug-carrying tube 23 with a larger containing cavity can carry more The anti-tumor drug in the drug-loading tube 23 acts on the tumor through the sustained-release hole 25, so that the blood supply around the tumor is good and the tumor can be treated quickly. The above-mentioned anti-tumor drugs include but are not limited to alkylating agents, nitrogen mustards, platinum compounds, mitomycins, dihydrofolate reductase inhibitors, actinomycin D, paclitaxel, and docetaxel.

需要说明的是，载药管23的至少一半部分沉在接骨板101的外表面内是指载药管23整***于接骨板101内，或者载药管23的一部分伸出至接骨板101的外表面的外侧。It should be noted that the fact that at least half of the drug-carrying tube 23 is sunk into the outer surface of the bone plate 101 means that the entire drug-carrying tube 23 is located within the bone plate 101 , or that a part of the drug-carrying tube 23 extends to the outside of the bone plate 101 . outside of the surface.

如图4、图7和图10所示，载药管23为多面体结构。这样，管形腔也为多面体结构，多面体结构的载药管23内能够承载更多的载药量，同时使得缓释孔25较大，以提升载药管23的载药量和释放速度，使得整个释放周期较短，有利于实现抗肿瘤效果。上述的多面体结构优选为蜂窝状。蜂窝状的载药管23的内切圆的直径在0.05mm至0.5mm范围内，高度在1mm至3mm的范围内。As shown in Figures 4, 7 and 10, the drug-carrying tube 23 has a polyhedral structure. In this way, the tubular cavity also has a polyhedral structure. The polyhedral structure of the drug-loading tube 23 can carry more drug loading, and at the same time, the sustained-release hole 25 is made larger to increase the drug loading capacity and release speed of the drug-carrying tube 23. This makes the entire release cycle shorter, which is beneficial to achieving anti-tumor effects. The above-mentioned polyhedral structure is preferably honeycomb-shaped. The diameter of the inscribed circle of the honeycomb drug-carrying tube 23 is in the range of 0.05mm to 0.5mm, and the height is in the range of 1mm to 3mm.

如图5、图6、图8以及图9所示，过流孔24的直径和缓释孔25的直径在100微米至800微米的范围内，这样，缓释孔25能够作为载药容器20的药物缓释窗口，缓慢释放载药容器20的容纳腔内的抗感染药物或促成骨药物或抗骨质疏松药物或抗肿瘤药物。这样，在术中对假体本体10上的载药容器20所载药物进行合理调整与匹配，可实现抗感染或者促成骨或者治疗骨质疏松类或者抗肿瘤不同药物的选择，实现灵活应对骨折急诊的患者选择。As shown in Figure 5, Figure 6, Figure 8 and Figure 9, the diameter of the overflow hole 24 and the diameter of the sustained release hole 25 are in the range of 100 microns to 800 microns. In this way, the sustained release hole 25 can be used as the drug-carrying container 20 The drug sustained release window slowly releases the anti-infective drug, bone-promoting drug, anti-osteoporosis drug or anti-tumor drug in the containing cavity of the drug-loaded container 20 . In this way, during the operation, the drugs contained in the drug-containing container 20 on the prosthesis body 10 are reasonably adjusted and matched, which can realize the selection of different drugs for anti-infection, bone promotion, osteoporosis treatment or anti-tumor, and realize flexible response to fractures. Patient selection in the emergency department.

如图1至图4所示，在载药容器20的容纳腔载入液态的药物时，为了防止药物溢出，假体本体的外表面和载药容器的外表面均覆盖有防溢层。防溢层优选为生物凝胶。As shown in FIGS. 1 to 4 , when liquid medicine is loaded into the containing cavity of the medicine-loaded container 20 , in order to prevent the medicine from overflowing, the outer surfaces of the prosthesis body and the medicine-loaded container are covered with an anti-overflow layer. The anti-spill layer is preferably a biogel.

当然，在图中未示出的实施例中，过流孔的直径或者缓释孔的直径可以在100微米至800微米的范围内。Of course, in embodiments not shown in the figures, the diameter of the overflow hole or the diameter of the slow-release hole may be in the range of 100 microns to 800 microns.

实施例一的假体本体10还包括设置在假体本体10上的锁定螺钉孔和万向锁定孔，这样植入假体能够配合解剖形态设计实现解剖的稳定固定。The prosthesis body 10 of the first embodiment also includes a locking screw hole and a universal locking hole provided on the prosthesis body 10, so that the implanted prosthesis can cooperate with the anatomical shape design to achieve stable anatomical fixation.

在本申请的植入假体的实施例二中，与植入假体的实施例一的区别在于假体本体10的类型。如图13至图21所示，在实施例二的假体本体10为股骨柄102。这样，将股骨柄102植入至股骨2的颈骨折周围处，载药容器20的容纳腔内的药物经缓释孔25作用于骨折处，使骨折周围血运良好，缩短骨性愈合时间。In the second embodiment of the implanted prosthesis of the present application, the difference from the first embodiment of the implanted prosthesis lies in the type of the prosthesis body 10 . As shown in Figures 13 to 21, the prosthesis body 10 in the second embodiment is a femoral stem 102. In this way, the femoral stem 102 is implanted around the neck fracture of the femur 2, and the medicine in the receiving cavity of the medicine container 20 acts on the fracture through the slow-release hole 25, so that the blood supply around the fracture is good and the bone healing time is shortened.

如图18至图21所示，安装部为多个，多个安装部围绕假体本体10间隔地布置成多层，载药容器20为多个，多个载药容器20与多个安装部一一对应地设置，控药腔11为多个。假体本体10受力F弯曲时，控药腔11受到压缩，由于多个载药容器20中位于同一层的载药容器20与一个控药腔11对应设置。这样，一个控药腔11能够同时控制位于同一层的载药容器20内药物的释放量，在考虑股骨柄102的内部结构稳定性的同时，使得股骨柄102能够安装更多的载药容器20，增大了植入假体的载药量，以较快地实现骨折愈合。As shown in FIGS. 18 to 21 , there are multiple mounting parts, and the multiple mounting parts are arranged in multiple layers at intervals around the prosthesis body 10 . There are multiple medicated containers 20 , and the multiple medicated containers 20 are connected with the multiple mounting parts. They are arranged in one-to-one correspondence, and there are multiple drug control chambers 11 . When the prosthesis body 10 bends under the force F, the drug control chamber 11 is compressed, because among the plurality of drug-containing containers 20, the drug-containing containers 20 located on the same layer are arranged correspondingly to one drug-control chamber 11. In this way, one drug control chamber 11 can simultaneously control the release amount of drugs in the drug-containing containers 20 located on the same layer. While considering the internal structural stability of the femoral stem 102, the femoral stem 102 can be installed with more drug-containing containers 20. , increasing the drug loading of the implanted prosthesis to achieve faster fracture healing.

需要说明的是，上述的“位于同一层的载药容器20与一个控药腔11对应设置”是指水平方向上同一高度或者与水平方向成30度夹角范围内的高度的载药容器20与一个控药腔11对应设置。It should be noted that the above-mentioned "drug-containing containers 20 located on the same layer are arranged corresponding to one drug-control chamber 11" refers to the drug-containing containers 20 at the same height in the horizontal direction or within a height of 30 degrees with the horizontal direction. It is provided corresponding to one medicine control chamber 11.

如图18至图21所示，假体本体10受力F弯曲时，控药腔11受到压缩，由于控药腔11包括第三弧面113和第四弧面114。第三弧面113的开口朝向第四弧面114，第四弧面114的开口朝向第三弧面113。第三弧面113和第四弧面114之间形成环形开放口，多个载药容器20中位于同一层的载药容器20的过流孔24位于环形开放口处，控药腔11内的介质向四周扩散，能够从环形开放口流出并进入同一层的过流孔24内，以使控药腔11能够提供较大的推力，以加速药物的释放，当骨折未愈合或者患者活动越多时，容纳腔内的药物释放量也越大，反之容纳腔内的药物释放量也越小，这样能够根据患者实际情况动态控制药物释放情况。As shown in FIGS. 18 to 21 , when the prosthesis body 10 bends under force F, the medicine control cavity 11 is compressed because the medicine control cavity 11 includes a third arc surface 113 and a fourth arc surface 114 . The opening of the third arc surface 113 faces the fourth arc surface 114 , and the opening of the fourth arc surface 114 faces the third arc surface 113 . An annular opening is formed between the third arc surface 113 and the fourth arc surface 114 . Among the plurality of drug-containing containers 20 , the overflow hole 24 of the drug-containing container 20 on the same layer is located at the annular opening. The medium spreads around and can flow out from the annular opening and enter the overflow hole 24 on the same layer, so that the drug control chamber 11 can provide a larger thrust to accelerate the release of the drug. When the fracture is not healed or the patient moves more , the greater the drug release amount in the accommodation cavity, and conversely the smaller the drug release amount in the accommodation cavity, so that the drug release can be dynamically controlled according to the actual situation of the patient.

上述的第三弧面113和第四弧面114的形状保证控药腔11具有一定的支撑力，在控药腔11受力变形时仍能够保证假体本体10的内部结构稳定。需要说明的是，上述的第三弧面113和第四弧面114均可以是拱桥形或者球缺形。The shapes of the above-mentioned third arc surface 113 and the fourth arc surface 114 ensure that the drug control chamber 11 has a certain supporting force, and can still ensure the stability of the internal structure of the prosthesis body 10 when the drug control chamber 11 is deformed by force. It should be noted that both the above-mentioned third arc surface 113 and the fourth arc surface 114 may be in the shape of an arch bridge or a spherical gap.

当然，图18和图19中还示出了多个载药容器20中位于同一层的载药容器20与多个控药腔11对应设置。需要说明的是，上述的“多个载药容器20中位于同一层的载药容器20与多个控药腔11对应设置”是指水平方向上同一高度或者与水平方向成30度夹角范围内的高度的载药容器20与多个控药腔11一一对应地设置。Of course, FIGS. 18 and 19 also show that among the plurality of drug-carrying containers 20 , the drug-carrying containers 20 located on the same layer are correspondingly arranged with the plurality of drug-control chambers 11 . It should be noted that the above-mentioned "the drug-carrying containers 20 located on the same layer among the plurality of drug-carrying containers 20 are arranged correspondingly with the plurality of drug-control chambers 11" refers to the same height in the horizontal direction or the range of an angle of 30 degrees with the horizontal direction. The medicine-containing containers 20 with a height inside are arranged in one-to-one correspondence with the plurality of medicine-control chambers 11 .

本申请还提供了一种负压载药装置，如图22所示，负压载药装置用于对植入假体的多个载药容器20内载入药物。负压载药装置用包括：箱体51、载药盒60、真空泵30、药物推杆件40和箱盖52。载药盒60设置于箱体51内，植入假体可取出地放置在载药盒60内，载药盒60的顶部具有开口。真空泵30与箱体51的内腔连通。药物推杆件40设置于箱体51内并与载药盒60的内腔的连通。箱盖52可开闭地盖设于箱体51的箱口处，以与箱体51之间形成密闭腔体，进而能够形成无菌的环境。This application also provides a negative pressure drug loading device. As shown in Figure 22, the negative pressure drug loading device is used to load drugs into multiple drug loading containers 20 implanted in a prosthesis. The negative pressure medicine-carrying device includes: a box body 51, a medicine-carrying box 60, a vacuum pump 30, a medicine push rod 40 and a box cover 52. The medicine-carrying box 60 is arranged in the box 51 , and the implanted prosthesis is removably placed in the medicine-carrying box 60 . The top of the medicine-carrying box 60 has an opening. The vacuum pump 30 is connected with the inner cavity of the box 51 . The medicine pusher 40 is disposed in the box 51 and communicates with the inner cavity of the medicine box 60 . The box lid 52 is openably and closably disposed at the box opening of the box body 51 to form a sealed cavity with the box body 51, thereby forming a sterile environment.

上述的药物推杆件40内装有药物，药物推杆件40将药物的缓慢推注进载药盒60，使载药容器20的容纳腔内的药物在真空泵30负压吸力的作用下，将所需药物一次装载完成。这样可根据实际临床需求装载不同药物。具体地，药物装载通过真空泵30，将带有载药容器20的接骨板101或者带有载药容器20的股骨柄102放置于载药盒60内，抽至真空1×10 ^-1KPa，将药物推杆件40的阀门打开，将药物吸入载药盒60内。该负压载药装置可以放入手术室进行实时操作，可通过实际临床需求，选择第一载药球21、第二载药球22或者载药管23以载入相应种类的药物。当负压载药完成后，需在带有载药容器20的接骨板101或者带有载药容器20的股骨柄102的外表面上涂抹生物凝胶，防止载药容器20内的药物溢出。 The above-mentioned medicine push rod member 40 is filled with medicine. The medicine push member 40 slowly pushes the medicine into the medicine-containing box 60 , so that the medicine in the receiving cavity of the medicine-containing container 20 is pushed out under the action of the negative pressure suction of the vacuum pump 30 . The required medicines are loaded in one load. In this way, different drugs can be loaded according to actual clinical needs. Specifically, the medicine is loaded through the vacuum pump 30, the bone plate 101 with the medicine container 20 or the femoral stem 102 with the medicine container 20 is placed in the medicine box 60, and the vacuum is 1×10 ^-1 KPa. The valve of the medicine push rod 40 is opened, and the medicine is sucked into the medicine-carrying box 60 . The negative pressure drug-loading device can be placed in the operating room for real-time operation. According to actual clinical needs, the first drug-loaded ball 21, the second drug-loaded ball 22, or the drug-loaded tube 23 can be selected to load corresponding types of drugs. After the negative pressure drug loading is completed, biogel needs to be applied to the outer surface of the bone plate 101 with the drug container 20 or the femoral stem 102 with the drug container 20 to prevent the drug in the drug container 20 from overflowing.

如图22所示，为了对密闭腔体内进行高温高压消毒，负压载药装置还包括设置于箱体51内的加热管80，这样在真空泵30不工作的情况下，密闭腔体内的温度能够达到118℃至124℃的范围内，压力达到103KPa至115KPa的范围内，使得带有载药容器20的股骨柄102或者接骨板101可在无菌环境下进行高效载药。As shown in Figure 22, in order to carry out high-temperature and high-pressure sterilization in the sealed cavity, the negative pressure drug loading device also includes a heating tube 80 arranged in the box 51, so that when the vacuum pump 30 is not working, the temperature in the sealed cavity can be Reaching the range of 118°C to 124°C, and the pressure reaching the range of 103KPa to 115KPa, the femoral stem 102 or bone plate 101 with the drug-loading container 20 can be loaded with drugs efficiently in a sterile environment.

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 modifications, equivalent replacements, improvements, etc. made within the spirit and principles of this application shall be included in the protection scope of this application.

Claims

一种植入假体，其特征在于，包括：An implant prosthesis, characterized by including:

假体本体(10)，所述假体本体(10)上设置有安装部；The prosthesis body (10) is provided with a mounting portion;

载药容器(20)，固定安装于所述安装部，所述载药容器(20)具有容纳药物的容纳腔，所述载药容器(20)上设置有与所述容纳腔连通的过流孔(24)和缓释孔(25)；A medicine-carrying container (20) is fixedly installed on the mounting part. The medicine-carrying container (20) has a containing cavity for containing medicine. The medicine-carrying container (20) is provided with a flow passage communicating with the containing cavity. hole (24) and sustained release hole (25);

其中，所述假体本体(10)内设置有容积可变的控药腔(11)，所述过流孔(24)与所述控药腔(11)连通，所述缓释孔(25)与所述假体本体(10)的外部连通。Wherein, the prosthesis body (10) is provided with a drug control cavity (11) with variable volume, the overflow hole (24) is connected with the drug control cavity (11), and the sustained release hole (25 ) is connected to the outside of the prosthesis body (10).
根据权利要求1所述的植入假体，其特征在于，所述假体本体(10)为接骨板(101)。The implant prosthesis according to claim 1, characterized in that the prosthesis body (10) is a bone plate (101).
根据权利要求1所述的植入假体，其特征在于，所述控药腔(11)还包括第一弧面(111)和第二弧面(112)，所述第一弧面(111)的开口朝向所述第二弧面(112)，所述第二弧面(112)的开口朝向所述第一弧面(111)，在所述假体本体(10)受力的情况下所述第一弧面(111)和所述第二弧面(112)之间的距离逐渐减小。The implant prosthesis according to claim 1, characterized in that the drug control cavity (11) further includes a first arc surface (111) and a second arc surface (112), and the first arc surface (111) ) faces the second arc surface (112), and the opening of the second arc surface (112) faces the first arc surface (111). When the prosthesis body (10) is stressed The distance between the first arc surface (111) and the second arc surface (112) gradually decreases.
根据权利要求3所述的植入假体，其特征在于，所述第一弧面(111)的第一侧与所述第二弧面(112)的第一侧连接，所述第一弧面(111)的第二侧与所述第二弧面(112)的第二侧之间形成开放口，所述过流孔(24)位于所述开放口处。The implant prosthesis according to claim 3, characterized in that the first side of the first arc surface (111) is connected to the first side of the second arc surface (112), and the first arc surface (111) is connected to the first side of the second arc surface (112). An open opening is formed between the second side of the surface (111) and the second side of the second arc surface (112), and the overflow hole (24) is located at the open opening.
根据权利要求1所述的植入假体，其特征在于，所述安装部为安装凹腔，所述载药容器(20)为第一载药球(21)，所述第一载药球(21)过盈连接于所述安装凹腔。The implant prosthesis according to claim 1, characterized in that the mounting part is a mounting cavity, the medicine-loaded container (20) is a first medicine-loaded ball (21), and the first medicine-loaded ball (21) Interference connection to the installation cavity.
根据权利要求5所述的植入假体，其特征在于，所述缓释孔(25)为多个，多个所述缓释孔(25)间隔地设置于所述第一载药球(21)。The implant prosthesis according to claim 5, characterized in that there are a plurality of sustained-release holes (25), and the plurality of sustained-release holes (25) are arranged at intervals on the first drug-loaded ball (25). twenty one).
根据权利要求1所述的植入假体，其特征在于，所述安装部为球缺形腔，所述载药容器(20)为第二载药球(22)，所述第二载药球(22)过盈连接于所述球缺形腔。The implant prosthesis according to claim 1, characterized in that the mounting part is a spherical cavity, the drug-carrying container (20) is a second drug-carrying ball (22), and the second drug-carrying container (20) is a second drug-carrying ball (22). The ball (22) is interference-connected to the ball-shaped cavity.
根据权利要求7所述的植入假体，其特征在于，所述过流孔(24)和所述缓释孔(25)各为一个。The implant prosthesis according to claim 7, characterized in that there is one flow hole (24) and one slow-release hole (25).
根据权利要求1所述的植入假体，其特征在于，所述安装部为管形腔，所述载药容器(20)为载药管(23)，所述载药管(23)过盈连接于所述管形腔，所述过流孔(24)位于所述管形腔的第一端，所述缓释孔(25)位于所述管形腔的第二端。The implant prosthesis according to claim 1, characterized in that the mounting part is a tubular cavity, the medicine-carrying container (20) is a medicine-carrying tube (23), and the medicine-carrying tube (23) is The overflow hole (24) is located at the first end of the tubular cavity, and the slow-release hole (25) is located at the second end of the tubular cavity.
根据权利要求9所述的植入假体，其特征在于，所述载药管为多面体结构。The implant prosthesis according to claim 9, wherein the drug-carrying tube has a polyhedral structure.
根据权利要求1所述的植入假体，其特征在于，The implant prosthesis according to claim 1, characterized in that:

所述过流孔(24)的直径和/或所述缓释孔(25)的直径在100微米至800微米的范围内；The diameter of the overflow hole (24) and/or the diameter of the sustained release hole (25) is in the range of 100 microns to 800 microns;

所述载药容器(20)为载药球时，所述载药球的外径在0.5mm至3mm的范围内，所述载药球的内径在0.3mm至2.5mm的范围内，所述载药容器(20)为载药管时，所述载药管的内径在0.05mm至0.5mm的范围内，所述载药管的高度在1mm至3mm的范围内；When the medicine-loaded container (20) is a medicine-loaded ball, the outer diameter of the medicine-loaded ball is in the range of 0.5mm to 3mm, and the inner diameter of the medicine-loaded ball is in the range of 0.3mm to 2.5mm. When the drug-carrying container (20) is a drug-carrying tube, the inner diameter of the drug-carrying tube is in the range of 0.05mm to 0.5mm, and the height of the drug-carrying tube is in the range of 1mm to 3mm;

所述假体本体(10)的外表面和所述载药容器(20)的外表面均覆盖有防溢层。The outer surface of the prosthesis body (10) and the outer surface of the drug-containing container (20) are both covered with an anti-overflow layer.
根据权利要求1所述的植入假体，其特征在于，所述安装部为多个，多个所述安装部围绕所述假体本体(10)间隔地布置成多层，所述载药容器(20)为多个，多个所述载药容器(20)与多个所述安装部一一对应地设置，所述控药腔(11)为多个，多个所述载药容器(20)中位于同一层的所述载药容器(20)与一个或者多个所述控药腔(11)对应设置。The implant prosthesis according to claim 1, characterized in that there are multiple mounting parts, and the plurality of mounting parts are arranged in multiple layers at intervals around the prosthesis body (10), and the drug-loaded There are a plurality of containers (20), and the plurality of drug-carrying containers (20) are arranged in one-to-one correspondence with the plurality of mounting parts. There are a plurality of drug-control chambers (11), and the plurality of drug-carrying containers (20) are In (20), the drug-containing container (20) located on the same layer is provided correspondingly to one or more of the drug-control chambers (11).
根据权利要求12所述的植入假体，其特征在于，当多个所述载药容器(20)中位于同一层的所述载药容器(20)与一个所述控药腔(11)对应设置时，所述控药腔(11)包括第三弧面(113)和第四弧面(114)，所述第三弧面(113)的开口朝向所述第四弧面(114)，所述第四弧面(114)的开口朝向所述第三弧面(113)，所述第三弧面(113)和所述第四弧面(114)之间形成环形开放口，多个所述载药容器(20)中位于同一层的所述载药容器(20)的所述过流孔(24)位于所述环形开放口处。The implant prosthesis according to claim 12, characterized in that when the drug-containing container (20) of the plurality of drug-containing containers (20) located on the same layer and one of the drug-controlled chambers (11) When arranged accordingly, the drug control chamber (11) includes a third arc surface (113) and a fourth arc surface (114), and the opening of the third arc surface (113) faces the fourth arc surface (114). , the opening of the fourth arc surface (114) faces the third arc surface (113), and an annular opening is formed between the third arc surface (113) and the fourth arc surface (114). The overflow hole (24) of the medicine-loaded container (20) located on the same layer among the medicine-loaded containers (20) is located at the annular opening.