WO2017063425A1 - Raccord osseux en métal de tantale poreux et application associée - Google Patents

Raccord osseux en métal de tantale poreux et application associée Download PDF

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Publication number
WO2017063425A1
WO2017063425A1 PCT/CN2016/091725 CN2016091725W WO2017063425A1 WO 2017063425 A1 WO2017063425 A1 WO 2017063425A1 CN 2016091725 W CN2016091725 W CN 2016091725W WO 2017063425 A1 WO2017063425 A1 WO 2017063425A1
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WIPO (PCT)
Prior art keywords
bone
bone connector
medullary
ruthenium
gas
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PCT/CN2016/091725
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English (en)
Chinese (zh)
Inventor
赵德伟
王本杰
谢辉
黄诗博
尉晓蔚
王威
Original Assignee
赵德伟
王本杰
谢辉
黄诗博
尉晓蔚
王威
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Publication date
Priority claimed from CN201510673087.3A external-priority patent/CN105380731A/zh
Priority claimed from CN201520808181.0U external-priority patent/CN205107979U/zh
Application filed by 赵德伟, 王本杰, 谢辉, 黄诗博, 尉晓蔚, 王威 filed Critical 赵德伟
Publication of WO2017063425A1 publication Critical patent/WO2017063425A1/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
    • A61F2/28—Bones

Definitions

  • the invention relates to a medical permanent implant, in particular to a medical implant porous enamel metal bone connector for treatment of non-heavy fractures of the extremities and nonunion, bone defects and the like.
  • Bone defects after bone tumor resection, nonunion and defect after long bone fracture of the extremities are common clinical diseases. How to repair large segmental bone and joint defects caused by bone tumor resection has always been a major problem in the orthopedics. Although the bone defect can be repaired in a variety of ways (such as bone graft fusion, artificial prosthesis, and traditional allogeneic bone joint transplantation), various methods have their advantages and disadvantages. At present, frozen allogeneic bone joint transplantation is often used in clinical practice, but the bone joint of large-scale allogeneic bone joint transplantation takes a long time to heal, and some patients do not heal, resulting in nonunion, delayed bone healing, allogeneic bone fracture, etc. complication.
  • Porous medical metal implant materials have important and special applications for treating bone tissue wounds and inducing bone tissue regeneration. Common materials such as porous stainless steel and porous titanium are common materials. As a porous implant material used for the treatment of bone tissue trauma and defect, the porosity should be 30-85%, and the pores are preferably all connected and evenly distributed, or the pores are connected and evenly distributed according to the need, so that it is both The growth of the bone tissue is consistent, and the weight of the material itself is reduced to be suitable for human implantation.
  • Metal ruthenium has no side effects on the human body, has good biocompatibility and mechanical properties, and its porous material is expected to replace the aforementioned traditional medical metal biomaterials, and become the main biological material in the field of bone defect damage treatment.
  • the demand for porous metal ruthenium materials for human body implantation has become more and more urgent, and the requirements for it have become higher and higher.
  • a porous medical implant metal crucible if it has a high uniform distribution of connected pores and physical and mechanical properties compatible with the human body, it is an important connecting member constituting material for ensuring the normal growth of new bone tissue.
  • U.S. Patent 5,282,861 discloses a porous tantalum material for use in cancellous bone implants, cells and tissue receptors and preparation thereof.
  • This porous crucible is made of pure commercial crucible
  • the carbon skeleton obtained by thermal degradation of the urethane precursor is a scaffold.
  • the carbon skeleton is a multiple dodecahedron with a grid-like structure, and the whole is distributed throughout the micropores, and the porosity can be as high as 98%.
  • a method of chemical vapor deposition and infiltration is combined on a carbon skeleton to form a porous metal microstructure, referred to as a chemical deposition method.
  • the porous tantalum material obtained by this method has a tantalum layer thickness of 40 to 60 ⁇ m; in the whole porous material, the specific gravity of the tantalum is about 99%, and the weight of the carbon skeleton is about 1%.
  • the literature further describes that the porous material has a compressive strength of 50 to 70 MPa, an elastic modulus of 2.5 to 3.5 GPa, a tensile strength of 63 MPa, and a plastic deformation amount of 15%.
  • the mechanical properties of the material such as ductility have obvious deficiencies, which will affect the subsequent processing of the porous tantalum material itself, such as cutting and drilling of molded parts.
  • the medical implant for the filling of the defect portion made of a material such as titanium metal for the treatment of nonunion and defect is a distal medullary stalk, a proximal medullary canal and 2 sets of connecting screws
  • the industry is accustomed to call it a "segmental artificial prosthesis", embedded in the clinical treatment, through the distal medullary stem, proximal medullary stem and 2 connecting screws Fixed; this result of “segmented artificial prosthesis” lacks effective biomechanical support and good osteoinductive production, and requires secondary surgery to remove more clinical drawbacks, so it can not be effectively and widely used in clinical treatment.
  • the bone connector is mainly applied to bone tumor resection and large bone defect; however, there are some problems such as complicated structure, high technical requirements, high probability of loosening of the joint, insufficient bone lengthening, and insufficient anti-rotation ability.
  • the bone connector has a simple structure, good mechanical strength, anti-rotation, anti-loose performance, high tissue compatibility and biomechanical properties, can induce bone tissue formation, and facilitate bone tissue ingrowth.
  • a bone connector includes a body, and two ends of the body are respectively provided with a medullary canal that can be inserted into the medullary cavity, the medullary canal is integrally formed with the body, and at least one screw hole is respectively disposed on the medullary cavity .
  • two screw holes are respectively disposed on the medullary cavity handles at both ends of the body.
  • the porous base metal connector further includes a connecting screw matched with the screw hole, and both ends of the connecting screw are provided with anti-rotation threads. Screw hole and chain connection screw Threaded connection.
  • the body is preferably cylindrical, and the medullary cavity handle is preferably conical, but the shape of the medullary canal and the body does not exclude other shapes, and any shape may be adopted according to characteristics of the implantation site or the like. shape.
  • the body of the present invention is cylindrical, the medullary cavity is conical, and the diameter of the medullary canal is tapered from the connecting portion to the end of the body, wherein the medullary cavity is connected to the body.
  • the ratio of the diameter of the shank to the diameter of its end is 10:4-7.
  • the diameter of the medullary canal is gradually tapered from the connecting portion to the end portion, and the diameter ratio of the diameter of the medullary canal to the end portion of the body connecting portion is preferably 10:4 to 7.
  • the ratio of the diameter of the medullary canal to the diameter of the body of the body connecting portion is preferably 4 to 7:10, more preferably 6:10.
  • the ratio of the length of the medullary canal to the length of the body is preferably 1:1 to 3, more preferably 1:2.
  • the medullary canal is preferably conical, and the body is preferably cylindrical, but the shape of the medullary canal and the body does not exclude other shapes, and other shapes may be adopted according to characteristics of the implantation site, etc. Appropriate shape.
  • the shape of the opening of the screw hole provided in the medullary canal may be circular or hexagonal.
  • the porous bismuth metal bone connector of the invention has a body of a cylinder, similar to the shape of the bone, and can fill the defect area of the bone, and the medullary cavity handles at both ends have a conical structure, which is favorable for inserting into the medullary cavity and providing screw holes for performing Fixing at both ends and preventing rotation and looseness of the bone connector; the length and diameter of the body and the ends of the medullary cavity are respectively proportional to the length and diameter of the body, so as to maximize the function of the body and the medullary canal at both ends The effect is more conducive to the implantation and fixation of the two ends of the medullary cavity, and is also beneficial to the crawling replacement growth of the bone tissue.
  • the porous bismuth metal bone connector of the invention adopts a structure in which the medullary canal and the body are integrally formed, and has better mechanical strength than the existing "segment type" artificial prosthesis, and effectively reduces the risk of prosthesis fracture. Conducive to patients getting out of bed early.
  • the present invention provides at least one or more screw holes in the medullary canal, and the connecting screws matched thereto can be selected for screwing and screwing.
  • the bone connector can be inserted into the medullary cavity, and after the two ends are respectively inserted into the medullary cavity, the connecting screw with the anti-rotation thread at both ends can be screwed in, which can strengthen the anti-rotation and pressure stability.
  • the shape of the bone connector is close to the physiological structure of the bone, which better satisfies the mechanical transmission of the lower limbs, and can effectively avoid the occurrence of re-fracture caused by stress shielding; the connecting screws are provided at both ends. Defense The thread is screwed to better pressurize and prevent the rotation of the bone connector.
  • the material used in the bone connector is prepared by reducing a base metal compound into a base metal powder by a chemical vapor deposition method, and uniformly depositing a surface of the graphite carbon skeleton to form a tantalum coating, wherein the base metal compound is five.
  • One of cerium chloride and cerium fluoride; the graphite carbon skeleton has a porosity of >70%, a pore diameter of 200 to 600 ⁇ m; and the cerium coating layer has a thickness of 40 to 60 ⁇ m.
  • the invention also provides a method for preparing the above porous tantalum metal bone connector, the preparation method comprising the following steps:
  • reaction gas and hydrogen are simultaneously introduced into the reaction chamber, and the reaction is carried out for 4-6 hours at 900-1050 ° C under a vacuum of 10 Pa; wherein the treatment gas contains a base metal compound and a carrier gas, and the base metal compound is placed.
  • the source tank is heated to 120-250 ° C, and an inert gas of 300 ° C is used as a carrier gas to the reaction chamber; the flow rate of the processing gas is 80-100 ml/min; and the flow rate of the hydrogen gas is 100-150 ml/min.
  • the inert gas is preferably a mixture of one or both of argon gas and helium gas, and most preferably argon gas.
  • porous tantalum metal bone connector of the present invention can be applied to medical implants for treatment of nonunion, bone defect, and tumor reconstruction after tumor resection.
  • the porous enamel metal bone connector of the invention adopts a structure in which the medullary canal and the body are integrally formed, and has better mechanical strength than the existing "segment type" artificial prosthesis, which is more in conformity with
  • the physiological structure of the bone can effectively transmit mechanical mechanics, effectively reduce the risk of prosthesis fracture, prevent re-fracture of the fracture site caused by stress shielding; and provide screw holes on the medullary canal, using matching matching screws
  • the bone connector and the corresponding bone tissue can be fixed, and the anti-rotation thread is arranged at both ends of the connecting screw, which can better exert the pressing effect and effectively reduce the existing "segment type” artificial fake
  • the body is easy to rotate and loose.
  • the porous tantalum metal bone connector of the invention is beneficial to the formation of new bone and the replacement of bone, especially in the treatment of nonunion and defect after tumor resection, and overcomes the existing "stage artificial leave". "Body" is not effective in clinical treatment.
  • the material of the porous tantalum metal bone connector of the present invention has a dodecahedral three-dimensional network structure, the structure of which is similar to that of cancellous bone trabeculae, has high tissue compatibility, can induce bone tissue formation, and is convenient.
  • the growth of bone tissue; and has strong biomechanical properties can provide certain mechanical support to achieve the purpose of inducing and replacing bone tissue.
  • the porous tantalum metal bone connector of the invention has simple preparation method and low cost, Conducive to implementation and clinical application, suitable for the needs of the majority of patients.
  • FIG. 1 is a schematic view showing the structure of a porous tantalum metal bone connector of the present invention.
  • FIG. 2 is a schematic view showing the structure of a connecting screw of the present invention, which is matched with the screw hole of the bone connector of the present invention.
  • a porous enamel metal bone connector includes a body 1 , and two ends of the body are respectively provided with a medullary stalk 2 , and the medullary stalk 2 is integrally formed with the body 1 , and the medulla of the body 1
  • Two screw holes 3 are respectively disposed on the shank 2;
  • the body 1 is a cylindrical solid structure, and the medullary shank 2 is a conical solid structure, and the diameter of the medullary shank 2 gradually changes from the connecting portion to the end portion of the body 1.
  • the ratio of the diameter of the medullary canal 2 to the end of the body 1 and its end is 2:1.
  • the ratio of the diameter of the medullary canal 2 to the diameter of the body 1 of the connection portion with the body 1 is 1:2
  • the ratio of the length of the medullary canal 2 to the length of the body 1 is 1:2.
  • the bone connector further includes a connecting screw 4 matched with the screw hole 3, and both ends of the connecting screw are provided with an anti-rotation thread 5, and the screw hole and the link screw are screwed.
  • the bone connector can be applied to a medical implant for treatment of nonunion, bone defect, and prosthetic reconstruction after tumor resection.
  • the fracture end and the medullary cavity are removed, and the necrotic bone tissue and the surrounding proliferating granulation tissue are removed.
  • select the appropriate size bone connector according to the test, first insert one end, adjust the angle and position and then insert the other end; probe the stability of the fracture and the bone connector, from the outside of the bone
  • the connecting screw is screwed in, the anti-rotation screw passes through the bone hole of the bone and the bone connector, and the bone connector and the corresponding bone tissue are fixed. After the screwing is completed, the anti-rotation thread at both ends of the connecting screw acts as a pressurizing effect, thereby effectively reducing the existing "" Segmental type "prosthesis is easy to rotate and loose.
  • the porous tantalum material used in the body 1 of the porous tantalum metal bone connector of Embodiment 1 utilizes chemical gas.
  • the phase deposition method comprises the steps of: reducing a ruthenium metal compound into a ruthenium metal powder, uniformly depositing a surface of the graphite carbon skeleton to form a ruthenium coating, wherein the ruthenium metal compound is ruthenium pentachloride; and the porosity of the graphite carbon skeleton is 85%.
  • the pore diameter is 500 ⁇ m; the thickness of the tantalum coating layer is 40 to 60 ⁇ m.
  • the porous tibial connector is prepared as follows:
  • the graphite carbon skeleton is etched with dilute hydrochloric acid for 10 min, washed successively with water and ethanol, dried with nitrogen, and placed in a reaction chamber;
  • the porous tibia connector body material prepared by the above method has a porosity of 85%, an elastic modulus of 10 GPa, and a maximum compressive strength of 35 MPa.
  • the porosity is according to the national standard GB/T 21650.1-2008, and the elastic modulus is It is tested according to the method described in the national standard GB/T 22315-2008.
  • the porous tantalum material has a dodecahedral network structure with three-dimensional connected pores, and has a structure similar to that of cancellous bone trabeculae, has high tissue compatibility, can induce bone tissue formation, and facilitates bone tissue growth. And has strong biomechanical properties, can provide a certain degree of mechanical support, to promote fracture healing and repair, filling bone defects.
  • the experimental methods used are all conventional methods, and the reagents and the like used can be purchased from a chemical reagent company.
  • the graphite carbon skeleton is a commercial product and is commercially available. Generally, asphalt is used as a substrate for high-temperature treatment, and a foaming agent is added in the process to obtain a uniform porous dodecahedral graphite carbon fiber skeleton.
  • the graphite carbon skeleton is first processed into the shape described in Fig. 1, and then the porous tibia connector of the present invention is obtained through the steps (1) to (2).

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un raccord osseux en métal de tantale poreux, pouvant s'appliquer au traitement d'une pseudarthrose d'un membre fracturé, d'une pseudarthrose osseuse, de défauts osseux et analogue. Le raccord osseux en métal de tantale poreux comprend un corps (1). Deux extrémités du corps (1) présentent une poignée à cavité médullaire (2). Les poignées à cavité médullaire (2) et le corps (1) sont formés d'un seul tenant. Au moins un trou de vis (3) est formé dans chaque poignée à cavité médullaire (2). Le raccord osseux en métal de tantale poreux comprend en outre des vis de raccord (4) correspondant aux trous de vis (3). Dans le raccord osseux en métal de tantale poreux, une structure, formée d'un seul tenant par les poignées à cavité médullaire (2) et le corps (1), est mise en œuvre, une meilleure résistance mécanique est obtenue, et le risque de rupture de prothèse est réduit efficacement ; les trous de vis (3) sont formés dans les poignées à cavité médullaire (2), de sorte que le raccord osseux et les tissus osseux correspondants puissent être fixés, réduisant ainsi efficacement les problèmes de rotation et de desserrement d'une prothèse artificielle se produisant fréquemment. Le raccord osseux en métal de tantale poreux présente un procédé de préparation simple, est peu coûteux, facilite la mise en place et l'application clinique, et satisfait aux exigences d'une majorité de patients.
PCT/CN2016/091725 2015-10-15 2016-07-26 Raccord osseux en métal de tantale poreux et application associée WO2017063425A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201510673087.3 2015-10-15
CN201510673087.3A CN105380731A (zh) 2015-10-15 2015-10-15 一种多孔钽金属骨连接器及其应用
CN201520808181.0 2015-10-15
CN201520808181.0U CN205107979U (zh) 2015-10-15 2015-10-15 一种多孔钽金属骨连接器

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WO2017063425A1 true WO2017063425A1 (fr) 2017-04-20

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110404118A (zh) * 2019-08-16 2019-11-05 上海交通大学医学院附属第九人民医院 骨缺损修复支架及构建方法、制备方法、计算机可读存储介质、设备
CN115487353A (zh) * 2022-09-16 2022-12-20 华东交通大学 抗菌促成骨掺氟氧化钽涂层及其制法和应用
CN115887069A (zh) * 2023-02-15 2023-04-04 吉林大学 一种股骨干多层复合仿生自固定假体

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5282861A (en) * 1992-03-11 1994-02-01 Ultramet Open cell tantalum structures for cancellous bone implants and cell and tissue receptors
CN2753300Y (zh) * 2004-10-26 2006-01-25 冀原 骨折内固定交锁髓内钉的改进
CN201303979Y (zh) * 2008-11-25 2009-09-09 陈福杨 锁定型髓内钉
CN102846410A (zh) * 2012-08-27 2013-01-02 上海晟实医疗器械科技有限公司 一种用于人体长骨骨干部位的节段性假体
CN202801866U (zh) * 2012-08-27 2013-03-20 上海晟实医疗器械科技有限公司 一种用于人体长骨骨干部位的节段性假体
CN103462730A (zh) * 2013-09-26 2013-12-25 赵德伟 一种多孔钽棒及其应用
CN103480043A (zh) * 2013-09-26 2014-01-01 赵德伟 一种医用多孔钽植入材料及其制备方法
CN203576698U (zh) * 2013-09-26 2014-05-07 赵德伟 一种多孔钽棒
CN105380731A (zh) * 2015-10-15 2016-03-09 赵德伟 一种多孔钽金属骨连接器及其应用
CN205107979U (zh) * 2015-10-15 2016-03-30 赵德伟 一种多孔钽金属骨连接器

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5282861A (en) * 1992-03-11 1994-02-01 Ultramet Open cell tantalum structures for cancellous bone implants and cell and tissue receptors
CN2753300Y (zh) * 2004-10-26 2006-01-25 冀原 骨折内固定交锁髓内钉的改进
CN201303979Y (zh) * 2008-11-25 2009-09-09 陈福杨 锁定型髓内钉
CN102846410A (zh) * 2012-08-27 2013-01-02 上海晟实医疗器械科技有限公司 一种用于人体长骨骨干部位的节段性假体
CN202801866U (zh) * 2012-08-27 2013-03-20 上海晟实医疗器械科技有限公司 一种用于人体长骨骨干部位的节段性假体
CN103462730A (zh) * 2013-09-26 2013-12-25 赵德伟 一种多孔钽棒及其应用
CN103480043A (zh) * 2013-09-26 2014-01-01 赵德伟 一种医用多孔钽植入材料及其制备方法
CN203576698U (zh) * 2013-09-26 2014-05-07 赵德伟 一种多孔钽棒
CN105380731A (zh) * 2015-10-15 2016-03-09 赵德伟 一种多孔钽金属骨连接器及其应用
CN205107979U (zh) * 2015-10-15 2016-03-30 赵德伟 一种多孔钽金属骨连接器

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110404118A (zh) * 2019-08-16 2019-11-05 上海交通大学医学院附属第九人民医院 骨缺损修复支架及构建方法、制备方法、计算机可读存储介质、设备
CN115487353A (zh) * 2022-09-16 2022-12-20 华东交通大学 抗菌促成骨掺氟氧化钽涂层及其制法和应用
CN115887069A (zh) * 2023-02-15 2023-04-04 吉林大学 一种股骨干多层复合仿生自固定假体
US11992407B1 (en) 2023-02-15 2024-05-28 Jilin University Multi-layered composite bionic self-retaining prosthesis for femoral shaft

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