WO2021180076A1 - 用于骨骼固定的螺钉组件及骨骼固定装置 - Google Patents

用于骨骼固定的螺钉组件及骨骼固定装置 Download PDF

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Publication number
WO2021180076A1
WO2021180076A1 PCT/CN2021/079771 CN2021079771W WO2021180076A1 WO 2021180076 A1 WO2021180076 A1 WO 2021180076A1 CN 2021079771 W CN2021079771 W CN 2021079771W WO 2021180076 A1 WO2021180076 A1 WO 2021180076A1
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Prior art keywords
degradable
nut
screw
bone
bone fixation
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PCT/CN2021/079771
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English (en)
French (fr)
Inventor
秦岭
周泳豪
廖志雄
周昊翘
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昶盛(物料应用制品)有限公司
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Priority to EP21767457.1A priority Critical patent/EP4119078A4/en
Publication of WO2021180076A1 publication Critical patent/WO2021180076A1/zh

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    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • 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
    • A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
    • A61B17/8057—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded the interlocking form comprising a thread
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8685—Pins or screws or threaded wires; nuts therefor comprising multiple separate parts
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive

Definitions

  • the invention relates to the field of medical equipment, and in particular to a screw assembly and a bone fixing device for bone fixation.
  • Implants made of traditional medical metal materials have good mechanical properties, can achieve early rigid fixation, and are especially suitable for fractures of load-bearing bones (such as femurs and tibias).
  • the mechanical properties (such as density and elastic modulus) of traditional medical metals do not match with human bones, and the mechanical properties of the entire fixation system cannot dynamically change with the bone healing process, leading to the "stress shielding effect" encountered in orthopedics. This can lead to osteoporosis or bone disuse degeneration and affect the strength of bone after healing.
  • the density and elastic modulus of pure magnesium (Mg) or magnesium alloy are similar and matched with human bone, which can reduce or avoid the "stress shielding effect". They also have the characteristics of biodegradable absorption, and magnesium is an essential trace element for the human body.
  • implants made of biodegradable and absorbed pure magnesium and magnesium alloys can also stimulate bone regeneration in the early stage of fracture healing and a stable biomechanical environment. It has great potential in the treatment of osteoporotic fractures, osteonecrosis and tendon healing.
  • the mechanical properties of implants made of biodegradable absorbent materials are still insufficient. Because magnesium has a lower modulus of elasticity than traditional medical metals, it is more prone to deformation and fracture. It is difficult to replace traditional metal implants for specific medical purposes (such as load-bearing bone fractures).
  • a screw assembly for bone fixation comprising a non-degradable nut and a degradable and absorbing screw body, the nut is detachably connected to one end of the screw body, and the outer peripheral surface of the screw body has an external thread .
  • the screw assembly for bone fixation further includes a connecting piece, and the nut and the screw body are detachably connected through the connecting piece.
  • the connecting piece is integrally connected with the nut, the connecting piece has an external thread, and the end surface of the screw body mating with the nut has a matching groove with an internal thread, the The connecting piece is threadedly connected with the matching groove;
  • the connecting piece is integrally connected with the screw body, the connecting piece has an external thread, the end surface of the nut mating with the screw body has a matching groove with an internal thread, and the connecting piece is connected to the screw body. Threaded connection with matching groove.
  • the connecting piece when the connecting piece is integrally connected with the nut, the connecting piece is non-degradable; when the connecting piece is integrally connected with the screw body, the connecting piece is Degradable and absorbable.
  • the pointed end of the screw body away from the nut has a smooth curved surface structure.
  • the end surface of the nut away from the screw body has a screwing groove or a convex post
  • the screwing groove is a non-circular groove
  • the convex post has a non-circular column structure.
  • the head of the nut at one end away from the main body of the screw is cylindrical, spherical, conical or spherical.
  • the outer surface of the nut has a degradable or non-degradable film or coating
  • the outer surface of the screw body has a degradable film or coating.
  • the outer surface of the connecting piece has a degradable or non-degradable film or coating.
  • the connecting piece is degradable and absorbing, the outer surface of the connecting piece has a degradable film or coating.
  • a bone fixation device comprising a bone plate and the screw assembly for bone fixation.
  • the bone plate is penetrated with a plurality of fixing through holes along its thickness direction, and the screw body of the screw assembly communicates with the fixation. After the holes are fitted, the end of the screw body away from the nut protrudes from the bone plate.
  • the fixing through hole has an internal thread
  • the outer peripheral surface of the end of the nut close to the screw body has an external thread
  • the external thread of the nut is threadedly engaged with the fixing through hole.
  • the fixing through hole is a countersunk hole
  • the nut is adapted to the fixing through hole
  • the nut and the fixing through hole are matched with the nut and the bone
  • the board is flush or the nut is located in the fixing through hole.
  • the bone fixing device further includes a non-degradable screw, and the non-degradable screw is used to cooperate with the fixing through hole.
  • the non-degradable screw is made of a non-degradable, biocompatible material.
  • the pointed end of the non-degradable screw has a smooth curved surface structure.
  • the surface of the bone plate for mating with the bone has a plurality of recessed relief grooves, and the fixed through holes and the relief grooves are distributed in a staggered manner.
  • the outer surface of the bone plate and the outer surface of the nut have a degradable or non-degradable film or coating
  • the outer surface of the screw body has a degradable film or coating
  • the connecting piece is not degradable, the outer surface of the connecting piece has a degradable or non-degradable film or coating.
  • the connecting piece is degradable and absorbing, the outer surface of the connecting piece has a degradable Film or coating.
  • the screw assembly used for bone fixation of the present invention can be used for bone fixation with stable mechanical properties and low cost.
  • the screw assembly is used to cooperate with the bone plate to achieve bone fixation and help the healing of broken bones.
  • the degradation products released after the degradation of the degradable and absorbable screw body will stimulate the surrounding bones and tissues and promote the formation of new bones.
  • the rigidity of the fracture fixation structure will gradually decrease, which can achieve dynamic fracture fixation, or can avoid or reduce the "stress shielding effect" caused by the traditional rigid "screw-plate” system. Therefore, the load on the bones near the fracture site will gradually increase, which can stimulate fracture healing and accelerate bone regeneration, while avoiding delayed union or nonunion of fractures, and achieving better bone healing and remodeling effects.
  • the nut of the screw assembly used for bone fixation of the present invention is made of non-degradable biocompatible materials with strong mechanical properties such as stainless steel, titanium alloy, etc., which can ensure the strength of the entire screw assembly, so that the nut can withstand greater Torsion without wear and slippage, in order to achieve the required fixed stability.
  • the main body of the screw is a magnesium or magnesium alloy screw, which degrades and releases magnesium ions in the vicinity of the fracture and raises the local pH value to be alkaline, which is conducive to the growth of new bone near the fracture site and fracture healing. As the screw body degrades, new bone tissue will be formed at the position of the original screw body after degradation, and fill up the gap in this position, which can reduce the risk of fracture again during and after the implant removal operation in the future.
  • the nut of the screw assembly used for bone fixation of the present invention uses non-circular grooves such as quincunx grooves, star-shaped grooves, hexagonal grooves, etc., or a convex column arranged in a non-circular columnar structure, so that the nut can bear Large torque without wear and slippage.
  • the bone fixing device of the present invention has stable mechanical properties, can realize bone fixation, and helps the fracture position to be repaired and healed quickly.
  • the external thread of the nut of the bone fixing device of the present invention matches the internal thread of the fixing through hole of the bone plate, and the two can be locked to each other to produce a more rigid and stable structure.
  • the bone fixing device of the present invention has a plurality of recessed relief grooves on the surface of the bone fixing device for mating with the bone.
  • the fixing through holes and the relief grooves are distributed in a misaligned manner. It fits and does not need to be pressed against the bone, which can reduce the damage of the bone plate to the blood supply of the periosteum and hinder the formation of callus.
  • the fixing through hole of the bone fixing device of the present invention is a countersunk hole, and the nut is fitted with the fixing through hole. After the nut is matched with the fixing through hole, the nut is flush with the bone plate or the nut is located In the through hole, the nut will not protrude and stimulate the soft tissue around the bone, avoiding the discomfort and pain of the surgeon after the implantation operation.
  • the bone fixation device of the present invention also uses non-degradable screws.
  • the non-degradable screws are used in combination with screw components.
  • the two fix the bone plate to the bone to achieve the required fracture fixation stability.
  • the screw components are used near the fracture site.
  • the outer peripheral surface of the nut of the bone fixing device of the present invention near the end of the screw body has an external thread, and the external thread of the nut is matched with the fixing through the thread.
  • Fig. 1 is a schematic cross-sectional view of a screw assembly for bone fixation according to embodiment 1 of the present invention
  • Fig. 2 is a schematic top view of the screw assembly for bone fixation shown in Fig. 1;
  • FIG. 3 is a schematic cross-sectional view of the screw assembly for bone fixation according to Embodiment 1 of the present invention
  • FIG. 4 is a schematic cross-sectional view of the bone fixation device according to Embodiment 2 of the present invention.
  • FIG. 5 is a schematic cross-sectional view of the bone fixation device according to Embodiment 2 of the present invention.
  • Fig. 6 is a schematic top view of the bone plate according to embodiment 2 of the present invention.
  • FIG. 7 is a schematic cross-sectional view of the bone plate according to the second embodiment of the present invention.
  • FIG. 8 is a schematic diagram of the bone fixation device and bone fixation shown in FIG. 5;
  • Fig. 9 is a schematic diagram of the bone fixation device and the screw body shown in Fig. 8 after degradation.
  • Bone fixation device 100: screw assembly; 110: nut; 111: screw groove; 120: screw body; 130: connecting piece; 200: bone plate; 210: fixing through hole; 220: giving way; 300 : Non-degradable screw; 20: bone.
  • an element when an element is referred to as being “fixed to” another element, it can be directly fixed on the other element or a central element may also be present.
  • an element When an element is considered to be “connected” to another element, it can be directly connected to the other element or an intermediate element may be present at the same time.
  • an element When an element is considered to be “mounted on” another element, it can be directly mounted on the other element or there may be a centered element at the same time.
  • an element When an element is considered to be “installed on” another element, it can be directly provided on the other element or a central element may exist at the same time.
  • the screw assembly 100 for bone fixation includes a non-degradable nut 110 and a degradable and absorbable screw main body 120.
  • the screw cap 110 is detachably connected to one end of the screw main body 120, and the outer peripheral surface of the screw main body 120 has external threads.
  • the nut 110 may be made of non-degradable materials with strong mechanical properties such as stainless steel and titanium alloy.
  • the screw assembly 100 for bone fixation further includes a connecting member 130.
  • the nut 110 and the screw main body 120 are detachably connected by a connecting piece 130.
  • the connecting piece 130 is integrally connected with the nut 110.
  • the connecting piece 130 has an external thread.
  • the end surface of the screw body 120 and the nut 110 has a matching groove with an internal thread.
  • the connecting piece 130 has threads with the matching groove. connect.
  • the connecting piece 130 is integrally connected with the screw body 120, the connecting piece 130 has an external thread, the end surface of the nut 110 and the screw body 120 is fitted with a fitting groove with an internal thread, and the connecting piece 130 is connected with the fitting groove. Threaded connection.
  • the connecting member 130 may be made of a degradable absorbent material or a non-degradable material.
  • the connecting piece 130 When the connecting piece 130 is integrally connected with the nut 110, the connecting piece 130 is non-degradable; when the connecting piece 130 is integrally connected with the screw body 120, the connecting piece 130 is degradable and absorbent, and the connecting piece 130 is made of degradable absorbent material.
  • the connecting member 130 is a magnesium column.
  • the screw body 120 is made of a degradable absorbent material.
  • the screw body 120 is a magnesium or magnesium alloy screw.
  • the pointed end of the screw body 120 away from the nut 110 can have any shape.
  • the pointed end of the screw body 120 away from the nut 110 has a smooth curved surface. structure.
  • the round head design of the screw body 120 away from the pointed end of the nut 110 can prevent the screw body 120 from stimulating the soft tissue around the bone after the screw body 120 is implanted.
  • the end surface of the nut 110 away from the screw body 120 has a screwing groove 111 or a boss (not shown in the drawings), wherein the screwing groove 111 is a non-circular groove, and the boss is a non-circular groove.
  • the nut 110 of the screw assembly 100 for bone fixation of the present invention uses non-circular grooves such as quincunx grooves, or star-shaped grooves, hexagonal grooves, etc., or non-circular cylindrical structure bosses, which can make the nut 110 bear Large torque without wear and slippage.
  • the head of the nut 110 at one end away from the screw main body 120 has a cylindrical, spherical, conical or spherical crown shape.
  • the outer surface of the nut 110 has a degradable or non-degradable film or coating
  • the outer surface of the screw body 120 has a degradable film or coating.
  • the outer surface of the connector 130 It has a degradable or non-degradable film or coating.
  • the connector 130 can be degraded and absorbed, the outer surface of the connector 130 has a degradable film or coating.
  • the outer surface of the screw body 120 and the connecting member 130 form a degradable and biocompatible film, which can control magnesium or magnesium alloy
  • the degradation rate of magnesium or magnesium alloy parts is improved, the mechanical properties of magnesium or magnesium alloy parts can be improved, and the electrochemical reaction caused by the direct contact of two materials with different electrode potentials can be avoided, and the corrosion degradation of magnesium or magnesium alloy parts can be avoided.
  • the thin film/plating film or coating may be an oxide film (e.g. MgO), ceramic material (e.g. hydroxyapatite (HA)), polymer (e.g. polylactic acid (PLA)).
  • the screw assembly 100 of the present invention can be used for bone fixation with stable mechanical properties and low cost.
  • the screw assembly 100 is used to cooperate with the bone plate 200 to fix the bone 20 and help the fractured bone 20 to heal.
  • the degradation products released after the degradable and absorbable screw body 120 is partially degraded will stimulate the surrounding bones 20 and tissues, and promote the formation of new bones.
  • the rigidity of the fracture fixation structure will gradually decrease, which can achieve dynamic fracture fixation, or can avoid or reduce the "stress shielding effect" caused by the traditional rigid "screw-plate” system.
  • the load on the bone 20 near the fracture site will gradually increase to realize the gradual transmission of force at the fracture healing site, promote fracture healing and accelerate callus remodeling or reconstruction, avoiding delayed union or nonunion of fractures, and achieving better fracture healing. Good repair effect of bone 20.
  • the nut 110 in the screw assembly 100 for bone fixation of the present invention is made of non-degradable biocompatible materials with strong mechanical properties such as stainless steel, titanium alloy, etc., which can ensure the strength of the entire screw assembly 100 and make the nut 110 It can withstand large torque without wear and slippage, so as to achieve the required fixed stability.
  • the screw body 120 is a magnesium or magnesium alloy screw, which degrades and releases magnesium ions at a location near the fracture and raises the local pH value to be alkaline, which is conducive to the growth of new bone near the fracture site and fracture healing. As the screw body 120 degrades, new bone tissue will be formed at the position of the degraded original screw body 120 and fill up the gap of the position, which can reduce the risk of fracture again during and after the implant removal operation in the future.
  • This embodiment provides a bone fixing device 10.
  • a bone fixation device 10 includes a bone plate 200 and the screw assembly 100 for bone fixation described in Embodiment 1.
  • the bone plate 200 has a plurality of fixing through holes 210 penetrating along its thickness direction, and the screw body 120 is used for mating with the fixing through holes 210.
  • the end of the screw main body 120 away from the nut 110 protrudes from the bone plate 200, so that the screw main body 120 can be inserted into the bone 20 after passing through the bone plate 200.
  • the length of the screw body 120 is greater than the thickness of the bone plate 200.
  • the inner diameter of the fixing through hole 210 is smaller than the maximum outer diameter of the head of the nut 110.
  • the bone fixing device 10 of the present invention has stable mechanical properties, can realize the fixation of the bone 20, and helps the fracture position to be repaired and healed quickly.
  • the outer peripheral surface of the end of the nut 110 close to the screw main body 120 has an external thread
  • the fixing through hole 210 has an internal thread.
  • the external thread of the nut 110 and The matching design of the internal threads of the fixing through hole 210 can realize the mutual locking of the two, so as to produce a more rigid and stable structure.
  • the non-degradable nut 110 will continue to be locked on the bone plate 200 and will not loosen.
  • the fixing through hole 210 is a countersunk hole, and the nut 110 is adapted to the fixing through hole 210. After the nut 110 is matched with the fixing through hole 210, the nut 110 is flush with the bone plate 200 or the nut 110 is located in the fixing through hole 210, that is, the nut 110 is lower than the surface of the bone plate 200.
  • the cap 110 is not protruding to prevent the screw cap 110 from irritating the soft tissues around the bone 20, thereby avoiding discomfort and pain to the surgeon after the implantation operation.
  • the bone fixing device 10 further includes a non-degradable screw 300.
  • the non-degradable screw 300 is used to cooperate with the fixing through hole 210.
  • the non-degradable screw 300 and the screw assembly 100 are used in combination to fix the bone plate 200 to the bone to achieve the required fracture fixation stability.
  • the screw assembly 100 of Example 1 is used near the fracture site to achieve later degradation and promote fracture healing, and the non-degradable screw 300 is used away from the fracture site to achieve the overall fracture fixation structure. The required mechanical strength and stability, and continue to fix the bone plate 200 on the bone after the screw body 120 is degraded, to prevent the bone plate 200 from shifting.
  • the non-degradable screw 300 is made of non-degradable metal.
  • the non-degradable screw 300 is a titanium screw. It is not difficult to understand that the non-degradable screw 300 may also be composed of non-degradable biocompatible metals such as titanium alloy, stainless steel and the like.
  • the pointed end of the non-degradable screw 300 may have any shape.
  • the pointed end of the non-degradable screw 300 has a smooth curved surface structure.
  • the rounded design of the pointed end of the non-degradable screw 300 can prevent the non-degradable screw 300 from irritating the soft tissue around the bone after implantation.
  • the surface of the bone plate 200 for mating with the bone 20 has a plurality of recessed relief grooves 220, and the fixing through holes 210 and the relief grooves 220 are distributed in a staggered manner. Please refer to FIG. 8 and FIG. 9 together.
  • the surface of the bone plate 200 of the present invention has a plurality of recessed relief grooves 220. It fits and does not need to be pressed against the bone, which can reduce the damage of the bone plate 200 to the blood supply of the periosteum and hinder the formation of callus.
  • the outer surface of the bone plate 200 and the outer surface of the nut 110 have a degradable or non-degradable film or coating
  • the outer surface of the screw body 120 has a degradable film or coating.
  • the outer surface of the connecting member 130 has a degradable or non-degradable film or coating.
  • the connecting member 130 is degradable and absorbing, the outer surface of the connecting member 130 has a degradable film or coating.
  • the outer surface of the screw body 120 and the connecting member 130 form a degradable and biocompatible film, which can control magnesium or magnesium alloy
  • the degradation rate of magnesium or magnesium alloy parts is improved, the mechanical properties of magnesium or magnesium alloy parts can be improved, and the electrochemical reaction caused by the direct contact of two materials with different electrode potentials can be avoided, and the corrosion degradation of magnesium or magnesium alloy parts can be avoided.
  • the thin film/plating film or coating may be an oxide film (e.g. MgO), ceramic material (e.g. hydroxyapatite (HA)), polymer (e.g. polylactic acid (PLA)).

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Abstract

一种用于骨骼(20)固定的螺钉组件(100)及骨骼固定装置(10)。用于骨骼(20)固定的螺钉组件(100)包括不可降解的螺帽(110)以及可降解吸收的螺钉主体(120)，螺帽(110)与螺钉主体(120)的一端可拆卸式连接，螺钉主体(120)的外周面具有外螺纹。骨骼固定装置(10)包括接骨板(200)以及螺钉组件(100)，接骨板(200)沿着其厚度方向贯穿有若干个固定通孔(210)，螺钉组件(100)的螺钉主体(120)与固定通孔(210)配合之后，螺钉主体(120)远离螺帽(110)的一端突出于接骨板(200)。螺钉组件(100)可用于骨骼(20)固定，力学性能稳定、成本低，螺钉组件(100)用于与接骨板(200)配合来实现骨骼(20)的固定，并能够促进骨折愈合和加速骨痂重塑或改建，避免骨折的延迟愈合或不愈合。

Description

用于骨骼固定的螺钉组件及骨骼固定装置 技术领域
本发明涉及医疗器械领域，特别是涉及一种用于骨骼固定的螺钉组件及骨骼固定装置。
背景技术
目前临床使用的医用金属多为不锈钢、钛合金等不可降解的生物相容材料。当植入物在人体内的骨折固定功能完成后，多数情况下需要再次进行手术移除，这将会增加患者在经济及身心上的负担。
由传统医用金属材料制的植入物具有良好的力学性能，能够实现早期的刚性固定(Rigid fixation)，尤其适用于承重骨(如股骨，胫骨)骨折上。但由于传统医用金属的机械性能(如密度和弹性模量)与人骨不匹配，而且整个固定系统的力学性能不能随骨愈合过程动态变化，引致出现了骨科遇到的“应力遮挡效应”。这会导致骨质疏松或骨废用性退化，影响骨愈合后的强度。
纯镁(Mg)或镁合金的密度和弹性模量与人骨相近及匹配，能减少或避免“应力遮挡效应”。它们还有生物可降解吸收的特性，而且镁元素属于人体必需的微量元素。此外，有不少科学研究发现并证明，以生物可降解吸收的纯镁及镁合金为材质的植入物在骨折愈合初期及有稳定的生物力学环境的前提下，还可以激发骨的再生能力，在治疗骨质疏松性骨折、骨坏死和腱骨愈合等领域蕴藏着巨大的潜能。但是，由生物可降解吸收材料(如镁及镁合金)制备的植入物的力学性能仍有不足，由于镁的弹性模量比传统医用金属低，会较容易发生变形及断裂的问题，暂时难以替代传统金属植入物在特定医疗用途上(如承重骨骨折) 的应用。
发明内容
基于此，有必要提供一种力学性能稳定、成本低的用于骨骼固定的螺钉组件及骨骼固定装置。
一种用于骨骼固定的螺钉组件，包括不可降解的螺帽以及可降解吸收的螺钉主体，所述螺帽与所述螺钉主体的一端可拆卸式连接，所述螺钉主体的外周面具有外螺纹。
在其中一个实施例中，所述用于骨骼固定的螺钉组件还包括连接件，所述螺帽与所述螺钉主体通过所述连接件可拆卸式连接。
在其中一个实施例中，所述连接件与所述螺帽一体式连接，所述连接件具有外螺纹，所述螺钉主体与所述螺帽配合的端面具有带内螺纹的配合槽，所述连接件与所述配合槽螺纹连接；
或者，所述连接件与所述螺钉主体一体式连接，所述连接件具有外螺纹，所述螺帽与所述螺钉主体配合的端面具有带内螺纹的配合槽，所述连接件与所述配合槽螺纹连接。
在其中一个实施例中，当所述连接件与所述螺帽一体式连接时，所述连接件为不可降解；当所述连接件与所述螺钉主体一体式连接时，所述连接件为可降解吸收。
在其中一个实施例中，所述螺钉主体远离所述螺帽的尖头端呈圆滑状的曲面结构。
在其中一个实施例中，所述螺帽远离所述螺钉主体的端面具有拧动槽或者凸柱，所述拧动槽为非圆形槽，所述凸柱为非圆形柱状结构。
在其中一个实施例中，所述螺帽远离所述螺钉主体一端的头部呈柱形、球形、锥形或者球冠形。
在其中一个实施例中，所述螺帽的外表面具有可降解或不可降解的薄膜或涂层，所述螺钉主体的外表面具有可降解的薄膜或涂层，当所述连接件不可降解时，所述连接件的外表面具有可降解或不可降解的薄膜或涂层，当所述连接件可降解吸收时，所述连接件的外表面具有可降解的薄膜或涂层。
一种骨骼固定装置，包括接骨板以及所述的用于骨骼固定的螺钉组件，所述接骨板沿着其厚度方向贯穿有若干个固定通孔，所述螺钉组件的螺钉主体与所述固定通孔配合之后，所述螺钉主体远离所述螺帽的一端突出于所述接骨板。
在其中一个实施例中，所述固定通孔具有内螺纹，所述螺帽靠近所述螺钉主体的一端的外周面具有外螺纹，所述螺帽的外螺纹与所述固定通孔螺纹配合。
在其中一个实施例中，所述固定通孔为沉头孔，所述螺帽与所述固定通孔适配，所述螺帽与所述固定通孔配合后所述螺帽与所述接骨板齐平或者所述螺帽位于所述固定通孔内。
在其中一个实施例中，所述骨骼固定装置还包括不可降解螺钉，所述不可降解螺钉用于与所述固定通孔配合。
在其中一个实施例中，所述不可降解螺钉由不可降解的生物相容材料制成。
在其中一个实施例中，所述不可降解螺钉的尖头端呈圆滑状的曲面结构。
在其中一个实施例中，所述接骨板用于与骨骼配合的表面具有多个凹陷的让位槽，所述固定通孔与所述让位槽错位分布。
在其中一个实施例中，所述接骨板的外表面、所述螺帽的外表面均具有可降解或不可降解的薄膜或涂层，所述螺钉主体的外表面具有可降解的薄膜或涂层，当所述连接件不可降解时，所述连接件的外表面具有可降解或不可降解的 薄膜或涂层，当所述连接件可降解吸收时，所述连接件的外表面具有可降解的薄膜或涂层。
本发明用于骨骼固定的螺钉组件可用于骨骼固定，力学性能稳定、成本低，螺钉组件用于与接骨板配合来实现骨骼的固定，并帮助断裂骨骼的愈合。可降解吸收的螺钉主体部分降解后释放的降解产物会刺激其周围骨骼和组织，促进新骨的形成。随着螺钉主体的降解，骨折固定结构的刚性会逐渐降低，这可以实现骨折固定的动态化，或可以避免或减少因传统的刚性“螺钉-钢板”系统所产生的“应力遮挡效应”。因此，骨折位置附近的骨骼需承受的负载会逐渐增加，这可以刺激骨折愈合和加速骨再生，同时避免骨折的延迟愈合或不愈合，达至更好的骨骼愈合及重塑效果。
本发明用于骨骼固定的螺钉组件中的螺帽由不锈钢、钛合金等机械性能较强的、不可降解的生物相容材料制成，能够保证整个螺钉组件的强度，使螺帽可承受较大扭力而不会发生磨损、滑丝现象，以实现所需的固定稳定性。螺钉主体为镁或镁合金螺钉，在骨折附近位置降解并释放出镁离子和提升局部pH值成偏碱性，有利于骨折部位附近的新骨生长及骨折愈合。随着螺钉主体的降解，会在降解后的原螺钉主体位置处形成新的骨组织，并填满该位置间隙，可以减少在日后植入物移除手术期间及之后再次骨折的风险。
本发明用于骨骼固定的螺钉组件的螺帽使用非圆形槽的如梅花形槽、或星形槽、六角形槽等，或者设置成非圆形柱状结构的凸柱，可使得螺帽承受较大扭力而不会发生磨损、滑丝现象。
本发明的骨骼固定装置，力学性能稳定，能够实现骨骼固定，帮助骨折位置快速修复愈合。
本发明的骨骼固定装置的螺帽的外螺纹与接骨板的固定通孔的内螺纹匹 配，可实现两者互相锁定，以产生更刚性和稳定的结构。
本发明的骨骼固定装置的所述接骨板用于与骨骼配合的表面具有多个凹陷的让位槽，所述固定通孔与所述让位槽错位分布，如此设置，接骨板不与骨头表面贴合并且也不用压贴骨头，可减少接骨板对骨膜血液供应的破坏和阻碍骨痂形成。
本发明的骨骼固定装置的固定通孔为沉头孔，螺帽与所述固定通孔适配，螺帽与所述固定通孔配合后螺帽与接骨板齐平或者螺帽位于所述固定通孔内，因此螺帽不会突出并刺激骨骼周围的软组织，避免造成植入手术后手术者的不适感和疼痛感。
本发明的骨骼固定装置还使用了不可降解螺钉，不可降解螺钉与螺钉组件混合使用，两者将接骨板固定到骨头上，以实现所需的骨折固定稳定性，在骨折位置的附近使用螺钉组件，以实现后期的降解，并促进骨折愈合，在远离骨折位置处使用不可降解螺钉，以达到整体骨折固定结构所需的力学强度及稳定性,并在螺钉主体降解之后继续固定接骨板在骨头上，防止接骨板移位。
本发明的骨骼固定装置的螺帽靠近所述螺钉主体的一端的外周面具有外螺纹，所述螺帽的外螺纹与所述固定通过螺纹配合，当螺钉主体完全降解后,不能降解的螺帽会继续锁定在接骨板上，不会松脱。
附图说明
图1为本发明实施例1所述的用于骨骼固定的螺钉组件剖面示意图；
图2为图1所示的用于骨骼固定的螺钉组件的俯视示意图；
图3为本发明实施例1所述的用于骨骼固定的螺钉组件剖面示意图；
图4为本发明实施例2所述的骨骼固定装置剖面示意图；
图5为本发明实施例2所述的骨骼固定装置剖面示意图；
图6为本发明实施例2所述的接骨板俯视示意图；
图7为本发明实施例2所述的接骨板剖面示意图；
图8为图5所示的骨骼固定装置与骨骼固定示意图；
图9为图8所示的骨骼固定装置与螺钉主体降解后示意图。
10：骨骼固定装置；100：螺钉组件；110：螺帽；111：拧动槽；120：螺钉主体；130：连接件；200：接骨板；210：固定通孔；220：让位槽；300：不可降解螺钉；20：骨骼。
具体实施方式
为了便于理解本发明，下面将参照相关附图对本发明进行更全面的描述。附图中给出了本发明的较佳实施例。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
需要说明的是，当元件被称为“固定于”另一个元件，它可以直接固定在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。当一个元件被认为是“安装在”另一个元件，它可以是直接安装在另一个元件或者可能同时存在居中元件。当一个元件被认为是“设在”另一个元件，它可以是直接设在另一个元件或者可能同时存在居中元件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的 术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
实施例1
请参阅图1所示，本实施例提供了一种用于骨骼固定的螺钉组件100。用于骨骼固定的螺钉组件100包括不可降解的螺帽110以及可降解吸收的螺钉主体120，螺帽110与螺钉主体120的一端可拆卸式连接，螺钉主体120的外周面具有外螺纹。螺帽110可由不锈钢、钛合金等机械性能较强的不可降解材料制成。
用于骨骼固定的螺钉组件100还包括连接件130。螺帽110与螺钉主体120通过连接件130可拆卸式连接。
请参阅图3所示，连接件130与螺帽110一体式连接，连接件130具有外螺纹，螺钉主体120与螺帽110配合的端面具有带内螺纹的配合槽，连接件130与配合槽螺纹连接。或者，参见图1所示，连接件130与螺钉主体120一体式连接，连接件130具有外螺纹，螺帽110与螺钉主体120配合的端面具有带内螺纹的配合槽，连接件130与配合槽螺纹连接。
连接件130可以是可降解吸收材料制成或者不可降解材料制成。
当连接件130与螺帽110一体式连接时，连接件130为不可降解；当连接件130与螺钉主体120一体式连接时，连接件130为可降解吸收，连接件130为可降解吸收材料制成，例如连接件130为镁柱。
螺钉主体120为可降解吸收材料制成。例如，螺钉主体120为镁或镁合金螺钉。
进一步地，螺钉主体120远离螺帽110的尖头端可以呈任意形状，优选地，请一并参阅图1及图3所示，螺钉主体120远离螺帽110的尖头端呈圆滑状的曲面结构。螺钉主体120远离螺帽110的尖头端的圆头设计可防止螺钉主体120植入后刺激骨头周围的软组织。
进一步地，参见图2所示，螺帽110远离螺钉主体120的端面具有拧动槽111或者凸柱(附图未示出)，其中，拧动槽111为非圆形槽，凸柱为非圆形柱状结构。本发明用于骨骼固定的螺钉组件100的螺帽110使用非圆形槽的如梅花形槽、或星形槽、六角形槽等，或者非圆形柱状结构凸柱，可使得螺帽110承受较大扭力而不会发生磨损、滑丝现象。
进一步地，螺帽110远离螺钉主体120一端的头部呈柱形、球形、锥形或者球冠形。
优选地，螺帽110的外表面具有可降解或不可降解的薄膜或涂层，螺钉主体120的外表面具有可降解的薄膜或涂层，当连接件130不可降解时，连接件130的外表面具有可降解或不可降解的薄膜或涂层，当连接件130可降解吸收时，连接件130的外表面具有可降解的薄膜或涂层。例如：当采用镁或镁合金材料制备成螺钉主体120、连接件130时，螺钉主体120的外表面以及连接件130的外表面形成可降解、生物兼容的薄膜，该薄膜可以调控镁或镁合金的降解速度、改善镁或镁合金部件的机械性能，并且能够避免因两种不同电极电位的材料的直接接触而引起的电化学反应、避免加快镁或镁合金部件的腐蚀降解。薄膜/镀膜或涂层可以是氧化膜(例如MgO)、陶瓷材料(例如羟磷灰石(HA))、聚合物(例如聚乳酸(PLA))。
本发明的螺钉组件100可用于骨骼固定，力学性能稳定、成本低，螺钉组件100用于与接骨板200配合来实现骨骼20的固定，并帮助断裂骨骼20的愈合。可降解吸收的螺钉主体120部分降解后释放的降解产物会刺激其周围骨骼20和组织，促进新骨的形成。随着螺钉主体120的降解，骨折固定结构的刚性会逐渐降低，这可以实现骨折固定的动态化，或可以避免或减少因传统的刚性“螺钉-钢板”系统所产生的“应力遮挡效应”。因此，骨折位置附近的骨骼20 需承受的负载会逐渐增加，实现骨折愈合处的力的渐进传递，促进骨折愈合和加速骨痂重塑或改建，避免骨折的延迟愈合或不愈合，达至更好的骨骼20的修复效果。
本发明用于骨骼固定的螺钉组件100中的螺帽110由不锈钢、钛合金等机械性能较强的、不可降解的生物相容材料制成，能够保证整个螺钉组件100的强度，使螺帽110可承受较大扭力而不会发生磨损、滑丝现象，以实现所需的固定稳定性。螺钉主体120为镁或镁合金螺钉，在骨折附近位置降解并释放出镁离子和提升局部pH值成偏碱性，有利于骨折部位附近的新骨生长及骨折愈合。随着螺钉主体120的降解，会在降解后的原螺钉主体120位置处形成新的骨组织，并填满该位置间隙，可以减少在日后植入物移除手术期间及之后再次骨折的风险。
实施例2
本实施例提供了一种骨骼固定装置10。
一种骨骼固定装置10包括接骨板200以及实施例1所述的用于骨骼固定的螺钉组件100。参见图4所示，接骨板200沿着其厚度方向贯穿有若干个固定通孔210，螺钉主体120用于与固定通孔210配合。当螺钉组件100的螺钉主体120穿过固定通孔210及与其配合之后，螺钉主体120远离螺帽110的一端突出于接骨板200，以实现螺钉主体120在穿过骨板200之后能够插入骨骼20。优选地，螺钉主体120的长度大于接骨板200的厚度。
优选地，固定通孔210的内径小于螺帽110的头部的最大外径。
本发明的骨骼固定装置10，力学性能稳定，能够实现骨骼20固定，帮助骨折位置快速修复愈合。
进一步地，请一并参阅图3所示，螺帽110靠近螺钉主体120的一端的外周面具有外螺纹，固定通孔210具有内螺纹，请参阅图4所示，螺帽110的外螺纹与固定通孔210的内螺纹匹配的设计可实现两者互相锁定，以产生更刚性和稳定的结构。另外，当螺钉主体120完全降解后,不能降解的螺帽110会继续锁定在接骨板200上，不会松脱。
进一步地，请一并参阅图4及图5所示，固定通孔210为沉头孔，螺帽110与固定通孔210适配。螺帽110与固定通孔210配合后，螺帽110与接骨板200齐平或者螺帽110位于固定通孔210内，也即螺帽110低于与接骨板200的表面，如此设置可使得螺帽110不突出，防止螺帽110刺激骨骼20周围的软组织，避免造成植入手术后手术者的不适感和疼痛感。
进一步地，骨骼固定装置10还包括不可降解螺钉300。不可降解螺钉300用于与固定通孔210配合。本发明的骨骼固定装置10中，透过不可降解螺钉300与螺钉组件100的混合使用，两者将接骨板200固定到骨头上，以实现所需的骨折固定稳定性。请参阅图8所示，在骨折位置的附近使用实施例1的螺钉组件100，以实现后期的降解，并促进骨折愈合，在远离骨折位置处使用不可降解螺钉300，以达到整体骨折固定结构所需的力学强度及稳定性,并在螺钉主体120降解之后继续固定接骨板200在骨头上，防止接骨板200移位。
进一步地，不可降解螺钉300为不降解金属制成。例如，不可降解螺钉300为钛螺钉。不难理解，不可降解螺钉300还可以是由诸如钛合金、不锈钢等之类的不降解的生物相容金属组成。
进一步地，不可降解螺钉300的尖头端可以呈任何形状。优选地，在一个实施例中，不可降解螺钉300的尖头端呈圆滑状的曲面结构。不可降解螺钉300的尖头端的圆头设计可防止不可降解螺钉300植入后刺激骨头周围的软组织。
进一步地，接骨板200用于与骨骼20配合的表面具有多个凹陷的让位槽220，固定通孔210与让位槽220错位分布。请一并参阅图8及图9所示，本发明设置接骨板200的表面具有多个凹陷的让位槽220，固定通孔210与让位槽220错位分布，使得接骨板200不与骨头表面贴合并且也不用压贴骨头，可减少接骨板200对骨膜血液供应的破坏和阻碍骨痂形成。
优选地，接骨板200的外表面、螺帽110的外表面具有可降解或不可降解的薄膜或涂层，螺钉主体120的外表面具有可降解的薄膜或涂层，当连接件130不可降解时，连接件130的外表面具有可降解或不可降解的薄膜或涂层，当连接件130可降解吸收时，连接件130的外表面具有可降解的薄膜或涂层。例如：当采用镁或镁合金材料制备成螺钉主体120、连接件130时，螺钉主体120的外表面以及连接件130的外表面形成可降解、生物兼容的薄膜，该薄膜可以调控镁或镁合金的降解速度、改善镁或镁合金部件的机械性能，并且能够避免因两种不同电极电位的材料的直接接触而引起的电化学反应、避免加快镁或镁合金部件的腐蚀降解。薄膜/镀膜或涂层可以是氧化膜(例如MgO)、陶瓷材料(例如羟磷灰石(HA))、聚合物(例如聚乳酸(PLA))。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (16)

  1. 一种用于骨骼固定的螺钉组件，其特征在于，包括不可降解的螺帽以及可降解吸收的螺钉主体，所述螺帽与所述螺钉主体的一端可拆卸式连接，所述螺钉主体的外周面具有外螺纹。
  2. 根据权利要求1所述的用于骨骼固定的螺钉组件，其特征在于，所述用于骨骼固定的螺钉组件还包括连接件，所述螺帽与所述螺钉主体通过所述连接件可拆卸式连接。
  3. 根据权利要求2所述的用于骨骼固定的螺钉组件，其特征在于，所述连接件与所述螺帽一体式连接，所述连接件具有外螺纹，所述螺钉主体与所述螺帽配合的端面具有带内螺纹的配合槽，所述连接件与所述配合槽螺纹连接；
    或者，所述连接件与所述螺钉主体一体式连接，所述连接件具有外螺纹，所述螺帽与所述螺钉主体配合的端面具有带内螺纹的配合槽，所述连接件与所述配合槽螺纹连接。
  4. 根据权利要求2所述的用于骨骼固定的螺钉组件，其特征在于，当所述连接件与所述螺帽一体式连接时，所述连接件为不可降解；当所述连接件与所述螺钉主体一体式连接时，所述连接件为可降解吸收。
  5. 根据权利要求1-4任意一项所述的用于骨骼固定的螺钉组件，其特征在于，所述螺钉主体远离所述螺帽的尖头端呈圆滑状的曲面结构。
  6. 根据权利要求1-4任意一项所述的用于骨骼固定的螺钉组件，其特征在于，所述螺帽远离所述螺钉主体的端面具有拧动槽或者凸柱，所述拧动槽为非圆形槽，所述凸柱为非圆形柱状结构。
  7. 根据权利要求1-4任意一项所述的用于骨骼固定的螺钉组件，其特征在于，所述螺帽远离所述螺钉主体一端的头部呈柱形、球形、锥形或者球冠形。
  8. 根据权利要求2-4任意一项所述的用于骨骼固定的螺钉组件，其特征在于，所述螺帽的外表面具有可降解或不可降解的薄膜或涂层，所述螺钉主体的外表面具有可降解的薄膜或涂层，当所述连接件不可降解时，所述连接件的外表面具有可降解或不可降解的薄膜或涂层，当所述连接件可降解吸收时，所述连接件的外表面具有可降解的薄膜或涂层。
  9. 一种骨骼固定装置，其特征在于，包括接骨板以及权利要求1-8任意一项所述的用于骨骼固定的螺钉组件，所述接骨板沿着其厚度方向贯穿有若干个固定通孔，所述螺钉组件的螺钉主体与所述固定通孔配合之后，所述螺钉主体远离所述螺帽的一端突出于所述接骨板。
  10. 根据权利要求9所述的骨骼固定装置，其特征在于，所述固定通孔具有内螺纹，所述螺帽靠近所述螺钉主体的一端的外周面具有外螺纹，所述螺帽的外螺纹与所述固定通孔螺纹配合。
  11. 根据权利要求9所述的骨骼固定装置，其特征在于，所述固定通孔为沉头孔，所述螺帽与所述固定通孔适配，所述螺帽与所述固定通孔配合后所述螺帽与所述接骨板齐平或者所述螺帽位于所述固定通孔内。
  12. 根据权利要求9-11任意一项所述的骨骼固定装置，其特征在于，所述骨骼固定装置还包括不可降解螺钉，所述不可降解螺钉用于与所述固定通孔配合。
  13. 根据权利要求12所述的骨骼固定装置，其特征在于，所述不可降解螺钉由不可降解的生物相容材料制成。
  14. 根据权利要求12所述的骨骼固定装置，其特征在于，所述不可降解螺钉的尖头端呈圆滑状的曲面结构。
  15. 根据权利要求9-11任意一项所述的骨骼固定装置，其特征在于，所述 接骨板用于与骨骼配合的表面具有多个凹陷的让位槽，所述固定通孔与所述让位槽错位分布。
  16. 根据权利要求9-11任意一项所述的骨骼固定装置，其特征在于，所述接骨板的外表面、所述螺帽的外表面均具有可降解或不可降解的薄膜或涂层，所述螺钉主体的外表面具有可降解的薄膜或涂层，当所述连接件不可降解时，所述连接件的外表面具有可降解或不可降解的薄膜或涂层，当所述连接件可降解吸收时，所述连接件的外表面具有可降解的薄膜或涂层。
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