WO2023216509A1 - Prothèse implantaire - Google Patents

Prothèse implantaire Download PDF

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Publication number
WO2023216509A1
WO2023216509A1 PCT/CN2022/126264 CN2022126264W WO2023216509A1 WO 2023216509 A1 WO2023216509 A1 WO 2023216509A1 CN 2022126264 W CN2022126264 W CN 2022126264W WO 2023216509 A1 WO2023216509 A1 WO 2023216509A1
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WO
WIPO (PCT)
Prior art keywords
drug
medicine
arc surface
carrying
cavity
Prior art date
Application number
PCT/CN2022/126264
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English (en)
Chinese (zh)
Inventor
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
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Application filed by 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 filed Critical 北京理贝尔生物工程研究所有限公司
Publication of WO2023216509A1 publication Critical patent/WO2023216509A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3859—Femoral components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/389—Tibial components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the present invention relates to the field of medical devices, and specifically to an implanted prosthesis.
  • 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.
  • 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.
  • 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.
  • 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 External connectivity of the ontology.
  • the prosthesis body is a bone plate.
  • 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.
  • 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.
  • the mounting part is a mounting cavity
  • the medicine-carrying container is a first medicine-carrying ball
  • the first medicine-carrying ball is interference-connected to the mounting cavity.
  • the plurality of sustained-release holes are arranged at intervals on the first drug-loaded ball.
  • the mounting part is a spherical cavity
  • the drug-carrying container is a second drug-carrying ball
  • the second drug-carrying ball is interference-connected to the spherical cavity.
  • 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
  • the sustained-release hole is located at the third end of the tubular cavity. Two ends.
  • the drug-carrying tube has a polyhedral structure.
  • 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.
  • 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
  • the height of the drug-carrying tube is in the range of 1mm to 3mm.
  • the outer surface of the prosthesis body and the outer surface of the drug-containing container are covered with an anti-spill layer.
  • the plurality of installation parts are arranged in multiple layers at intervals around the prosthesis body.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • Figure 7 shows a schematic cross-sectional view of the bone plate with a drug-containing tube for implanting the prosthesis of Figure 4;
  • Figure 8 shows a schematic three-dimensional structural diagram of the first medicine-loaded ball of Figure 2;
  • Figure 9 shows a schematic three-dimensional structural diagram of the second medicine-loaded ball of Figure 3.
  • Figure 10 shows a schematic three-dimensional structural view of the drug-carrying tube of Figure 4.
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • Figure 17 shows a schematic cross-sectional view of the femoral stem with a drug-carrying tube implanted with the prosthesis of Figure 13;
  • 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;
  • 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;
  • 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;
  • 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;
  • Figure 22 shows a schematic three-dimensional structural diagram of an embodiment of a negative pressure drug-loading device according to the present application.
  • 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.
  • 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 .
  • 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. .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the prosthesis body 10 and the drug-containing container 20 of the first embodiment can be cast or 3D printed.
  • the prosthesis body 10 and the drug-containing container 20 are one-time molded structures, that is, they become one part.
  • the prosthesis body 10 is a bone plate 101.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the medicine-loaded container 20 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.
  • 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.
  • the mounting part is a mounting cavity
  • the medicine-carrying container 20 is a first medicine-carrying ball 21
  • 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.
  • 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.
  • 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.
  • the multiple sustained release holes 25 there are multiple sustained release holes 25 , and the multiple sustained release holes 25 are spaced apart on the first drug-loaded ball 21 .
  • 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.
  • the mounting part is a spherical cavity
  • the drug-carrying container 20 is a second drug-loaded ball 22
  • the second drug-loaded ball 22 is interference-connected to the spherical cavity.
  • at least half of the second medicine-loaded ball 22 sinks into the outer surface of the bone plate 101.
  • 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.
  • 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.
  • 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.
  • an overflow hole 24 and one slow-release hole 25 respectively.
  • 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.
  • 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.
  • 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
  • the overflow hole 24 is located in the tubular cavity.
  • 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.
  • 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.
  • 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.
  • the drug-carrying tube 23 has a polyhedral structure.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • the difference from the first embodiment of the implanted prosthesis lies in the type of the prosthesis body 10 .
  • the prosthesis body 10 in the second embodiment is a femoral stem 102.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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
  • 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 .
  • 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.
  • 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.
  • 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 .
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une prothèse implantaire comprenant : un corps prothétique (10), une partie de montage étant disposée sur ledit corps (10) ; un contenant de médicament (20) monté fixe sur la partie de montage, ledit contenant (20) comportant une cavité de réception pour recevoir un médicament, ainsi qu'un orifice de débordement (24) et un orifice de libération prolongée (25) en communication avec la cavité de réception formée sur le contenant (20), une cavité de régulation de médicament à volume variable (11) étant formée dans le corps prothétique (10), l'orifice de débordement (24) étant en communication avec la cavité de régulation de médicament (11), et l'orifice de libération prolongée (25) étant en communication avec l'extérieur du corps prothétique (10). La prothèse implantaire selon l'invention permet de résoudre le problème lié à la rupture de la plaque orthopédique ou au desserrage de la prothèse d'articulation de hanche artificielle en raison d'une cicatrisation osseuse prolongée, et le médicament dans la cavité de réception peut être un médicament anti-infectieux, un médicament pro-ostéogenèse, un médicament anti-ostéoporose ou un médicament antitumoral. Le médecin peut choisir en fonction de l'état réel du patient, de sorte que la prothèse implantaire facilite le traitement correspondant.
PCT/CN2022/126264 2022-05-12 2022-10-19 Prothèse implantaire WO2023216509A1 (fr)

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CN114601602B (zh) * 2022-05-12 2022-08-30 北京理贝尔生物工程研究所有限公司 植入假体
CN115444531B (zh) * 2022-08-10 2023-05-26 郭建利 胫骨近端后外侧解剖锁定装置

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