CN114376701A - High-strength screw - Google Patents

High-strength screw Download PDF

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Publication number
CN114376701A
CN114376701A CN202111571974.1A CN202111571974A CN114376701A CN 114376701 A CN114376701 A CN 114376701A CN 202111571974 A CN202111571974 A CN 202111571974A CN 114376701 A CN114376701 A CN 114376701A
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CN
China
Prior art keywords
screw
copolymers
core
copolymer
housing
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Granted
Application number
CN202111571974.1A
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Chinese (zh)
Other versions
CN114376701B (en
Inventor
王迪
张宇
于越
李艳红
丛占福
温明哲
宗政
丛丽芳
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CHANGCHUN SINOBIOMATERIALS CO LTD
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CHANGCHUN SINOBIOMATERIALS CO LTD
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Priority to CN202111571974.1A priority Critical patent/CN114376701B/en
Publication of CN114376701A publication Critical patent/CN114376701A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/866Material or manufacture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/028Other inorganic materials not covered by A61L31/022 - A61L31/026
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials 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
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

Abstract

The invention discloses a high-strength screw which comprises a screw shell and a screw core body, wherein the screw core body is embedded in the screw shell, and the elastic modulus of the screw core body is 1-3 GPa and/or the elongation at break is 3-10%. The high-strength screw can be used for treating tibiofibular syndesmosis injury, and in the using process, even if the screw shell is broken, the screw core body can still be connected with the broken screw shell, so that the generation of malocclusion is avoided. The high-strength screw has the advantages of stable and reliable structure and difficult failure, and is favorable for healing of the tibiofibular syndesmosis injury part and recovering the function of the ankle joint.

Description

High-strength screw
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a high-strength screw.
Background
Ankle fractures are the most common intra-articular fractures, and the stability of the ankle is of great significance in maintaining its function. The tibiofibular union is an important structure for maintaining the stability of the ankle joint and has the function of transmitting and regulating the bone load. The combined injury of the lower tibiofibula is usually accompanied by fracture of ankle joint, and is generally caused by outward rotation or abduction of talus under the action of external force. The integrity of tibiofibular union is the basis for the function of the ankle joint, and therefore, if the tibiofibular union is not properly treated in time after the injury occurs, the regulatory mechanism of load transmission is destroyed, and the ankle joint is unstable, thereby inducing osteoarthritis.
Screw fixation is a common method for treating the injury of the tibiofibular syndesmosis, and metal screws or absorbable screws are adopted to fix the tibiofibular syndesmosis in the past, but although the method is widely accepted, the current screws commonly used in clinic still have some problems.
The fibula has a certain movement relative to the tibia, and a strong internal fixation method will hinder the physiological movement of the normal tibiofibular syndesmosis. When the metal screw bears a load, the screw is loosened or broken due to continuous shearing force, and the broken metal screw can be kept for a long time after the operation, so that the human body is adversely affected. In order to avoid the loosening or the breakage of the screw caused by the shearing force during the load bearing, the patient needs a period of time to forbid the activity after the operation, and the metal screw can be taken out before the load bearing activity after the healing of the combined injury of the lower tibiofibula, which can cause secondary injury to the patient and influence the functional recovery of the patient. Secondly, long-term implantation of metal screws may lead to foreign body reactions and infections; and the stress shielding effect can be brought to cause the problems of osteoporosis and the like.
The absorbable screw solves the problem of stress shielding and foreign body reaction caused by long-term implantation. But the absorbable screw can be degraded gradually, the mechanical strength is reduced gradually after the absorbable screw is implanted into a human body, the fracture risk is higher, and the cross section of the fractured screw has malocclusion, thereby causing adverse effects on peripheral soft tissues and muscle tissues.
Disclosure of Invention
The invention aims to provide a high-strength screw, which can solve the negative influence on human body caused by malocclusion after the screw is broken.
In order to solve the technical problems, the technical scheme provided by the invention is as follows:
a high-strength screw comprises a screw shell and a screw core body, wherein the screw core body is embedded in the screw shell, and at least one of the following conditional expressions is satisfied by the screw core body: the elastic modulus is 1-3 Gpa; the elongation at break is 3% -10%.
Furthermore, a through hole extending along the axial direction is formed in the screw shell, and the screw core body is fixedly installed in the through hole.
Further, the screw core includes a middle portion and an end portion, and an outer diameter of the end portion is larger than an inner diameter of the through hole, so that the screw core is prevented from being separated from the screw housing.
Furthermore, clamping grooves are formed in two ends of the through hole of the screw shell, protrusions are arranged at the end portion of the screw core body, and the protrusions are accommodated in the clamping grooves.
Further, the screw core body is a linear braided fabric in a tensioning state, and the outer diameter of the linear braided fabric is consistent with the inner diameter of the through hole in size.
Further, the protrusion is a fixed knot.
Further, the material of the screw housing comprises an absorbable material.
Further, the material of the screw shell comprises one or more of polylactic acid and a copolymer thereof, polycaprolactone and a copolymer thereof, polydioxanone and a copolymer thereof, and polyglycolic acid and a copolymer thereof; or one or more of hydroxyapatite, beta-calcium phosphate and calcium sulfate is blended with one or more of polylactic acid and a copolymer thereof, polycaprolactone and a copolymer thereof, polydioxanone and a copolymer thereof, polyglycolic acid and a copolymer thereof, and the mass sum of the hydroxyapatite, the beta-calcium phosphate and the calcium sulfate in the mixture accounts for 1-20%.
Further, the material of the screw housing comprises polyetheretherketone.
Further, the material of the screw core body comprises one or more of polyethylene terephthalate, polyethylene, polypropylene, polylactic acid and copolymers thereof, polycaprolactone and copolymers thereof, polydioxanone and copolymers thereof, polyglycolic acid and copolymers thereof.
The invention has the beneficial effects that:
the high-strength screw can be used for treating tibiofibular syndesmosis injury, and in the using process, even if the screw shell is broken, the screw core body in the screw shell can still be connected with the broken screw shell, so that the generation of malocclusion is avoided. The high-strength screw has the advantages of stable and reliable structure and difficult failure, and is favorable for healing of the tibiofibular syndesmosis injury part and recovering the function of the ankle joint.
Drawings
Fig. 1 is a side cross-sectional view of a high strength screw of the present invention in a preferred embodiment.
The reference numerals include:
100-screw shell 110-through hole 120-clamping groove
200-screw core 210-middle part 220-end part
230-projection
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present invention more clearly apparent, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.
It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be construed as limiting the invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
Referring to fig. 1, a preferred embodiment of the present invention is a high-strength screw including a screw housing 100 and a screw core 200, wherein the screw core 200 is embedded in the screw housing 100, and the screw core 200 has an elastic modulus of 1-3 GPa and/or an elongation at break of 3% -10%. The high-strength screw can treat tibiofibular syndesmosis injury, and a fracture part can be fixed by the screw. The screw core 200 is firmly fixed in the screw shell 100, even if the screw shell 100 is broken in the using process, the screw core 200 can still be connected with the broken screw shell 100, and the negative influence on the human body of a patient caused by the wrong teeth of the screw shell 100 is avoided. The high-strength screw has an excellent fixing effect and can ensure the healing of the tibiofibular syndesmosis injury part. The above components are described in further detail below.
In order to facilitate the embedding of the screw core 200 inside the screw housing 100, in a preferred embodiment of the present application, the screw housing 100 is a hollow screw and is provided with a through hole 110 extending in an axial direction, and the screw core 200 is fixedly installed in the through hole 110.
The screw core 200 may be a cylinder or an irregular shape, and the specific shape of the screw core 200 is not limited in this application as long as the screw core 200 has an elastic modulus of 1 to 3GPa and/or an elongation at break of 3% to 10%, and extends in the axial direction of the screw housing 100, so as to prevent the screw housing 100 from being dislocated after being broken.
Preferably, the screw core 200 includes a middle portion 210 and an end portion 220, and the outer diameter of the end portion 220 is larger than the inner diameter of the through hole 110, preventing the screw core 200 from being separated from the screw housing 100.
Further, two ends of the through hole 110 are provided with concave-shaped slots 120, and the bottoms of the slots 120 are communicated with the through hole 110. The end portion 220 is provided with a protrusion 230, and the protrusion 230 is embedded in the slot 120 to prevent the protrusion 230 from protruding out of the outer surface of the screw housing 100.
In a preferred embodiment of the present application, the screw core 200 is a wire braid in a tensioned state, the outer diameter of the wire braid is the same size as the inner diameter of the through hole 110, and the protrusion 230 is a fixed knot. After the wire braid is inserted into the through hole 110, both ends are tied and fixed to form the protrusion 230, and at this time, the wire braid is in a tensioned state in the screw housing 100.
In a preferred embodiment of the present application, the screw housing 100 is preferably made of an absorbable material. The material of the screw shell 100 comprises one or more of polylactic acid and a copolymer thereof, polycaprolactone and a copolymer thereof, polydioxanone and a copolymer thereof, polyglycolic acid and a copolymer thereof; or one or more of hydroxyapatite, beta-calcium phosphate and calcium sulfate and one or more of polylactic acid and a copolymer thereof, polycaprolactone and a copolymer thereof, polydioxanone and a copolymer thereof, polyglycolic acid and a copolymer thereof are blended to obtain a mixture, wherein the mass sum of the hydroxyapatite, the beta-calcium phosphate and the calcium sulfate in the mixture accounts for 1-20%. Wherein, the polylactic acid and the copolymer thereof, the polycaprolactone and the copolymer thereof, the polydioxanone and the copolymer thereof, and the polyglycolic acid and the copolymer thereof are obtained by copolymerizing two or more than two of the polylactic acid, the polycaprolactone, the polydioxanone and the polyglycolic acid.
In another preferred embodiment of the present application, the screw housing 100 is preferably made of a non-absorbable material. Specifically, the material of the screw housing 100 includes polyetheretherketone.
The screw core body 200 is made of one or more of polyethylene terephthalate, polyethylene, polypropylene, polylactic acid and copolymers thereof, polycaprolactone and copolymers thereof, polydioxanone and copolymers thereof, and polyglycolic acid and copolymers thereof. Wherein, the polylactic acid and the copolymer thereof, the polycaprolactone and the copolymer thereof, the polydioxanone and the copolymer thereof, and the polyglycolic acid and the copolymer thereof are obtained by copolymerizing two or more than two of the polylactic acid, the polycaprolactone, the polydioxanone and the polyglycolic acid.
Example 1
In the present embodiment, the screw housing 100 is formed by injection molding of polylactic acid and hydroxyapatite at a mass ratio of 9: 1. The screw core 200 is made of polyethylene terephthalate yarn, and is woven on a machine to form a round braided wire fabric. The screw core 200 has an elastic modulus of 2GPa and an elongation at break of 7%.
Example 2
In the present embodiment, the screw housing 100 is made of a non-absorbable material by injection molding. The screw core 200 is a cylinder made of polyethylene terephthalate, and the elastic modulus of the screw core 200 is 1 GPa.
Example 3
In this embodiment, the screw shell 100 is obtained by injection molding of polylactic acid, polycaprolactone, hydroxyapatite, and calcium sulfate at a mass ratio of 8:1:0.8: 0.2. The screw core 200 is a circular braided wire fabric formed by weaving polyethylene terephthalate yarns and polylactic acid monofilaments on a machine. Wherein the mass ratio of the polyethylene terephthalate yarns to the polylactic acid monofilaments is 9: 1. The screw core 200 has an elastic modulus of 3GPa and an elongation at break of 5%.
Example 4
In the present embodiment, the screw housing 100 is made of polyetheretherketone by injection molding. The screw core 200 is an irregular cylindrical body with uneven diameter and made of polypropylene, polylactic acid and poly (L-lactic-co-glycolic acid) (the content of lactic acid monomer accounts for 85%). Wherein the mass ratio of the polypropylene to the polylactic acid to the poly (L-lactic-co-glycolic acid) (the content of lactic acid monomer accounts for 85%) is 8:1: 1. The elongation at break of the screw core 200 obtained was 3%.
Example 5
In this embodiment, the screw casing 100 is made of polylactic acid, polydioxanone, polyglycolic acid, and hydroxyapatite by injection molding at a mass ratio of 8:0.5:0.5: 1. The screw core 200 is formed by weaving polyethylene terephthalate yarns, polycaprolactone monofilaments and polydioxanone monofilaments on a machine to form a round braided wire. Wherein the mass ratio of the polyethylene terephthalate yarns, the polycaprolactone monofilaments to the polydioxanone monofilaments is 8:1: 1. The screw core 200 has an elastic modulus of 2GPa and an elongation at break of 5%.
Example 6
In this embodiment, the screw casing 100 is made of poly-L-lactic-co-glycolic acid and hydroxyapatite by injection molding according to a mass ratio of 9:1, wherein the lactic acid monomer accounts for 85% of the copolymer. The screw core 200 is made of polyethylene terephthalate yarn, and is woven on a machine to form a round braided wire fabric. The screw core 200 has an elongation at break of 5%.
Example 7
In the present embodiment, the screw housing 100 is made of poly-L-lactic acid-caprolactone copolymer material by injection molding, wherein the lactic acid monomer accounts for 90%. The screw core 200 is made of polyethylene terephthalate yarn, and is woven on a machine to form a round braided wire fabric. The screw core 200 has an elongation at break of 7%.
The foregoing is only a preferred embodiment of the present invention, and many variations in the detailed description and the application range can be made by those skilled in the art without departing from the spirit of the present invention, and all changes that fall within the protective scope of the invention are therefore considered to be within the scope of the invention.

Claims (10)

1. A high-strength screw, characterized by comprising a screw housing (100) and a screw core (200), wherein the screw core (200) is embedded in the screw housing (100), and the screw core (200) at least satisfies any one of the following conditional expressions: the elastic modulus is 1-3 GPa; the elongation at break is 3% -10%.
2. The high-strength screw according to claim 1, wherein a through hole (110) extending in the axial direction is formed in the screw housing (100), and the screw core (200) is fixedly mounted in the through hole (110).
3. The high strength screw according to claim 1, wherein the screw core (200) comprises a middle portion (210) and an end portion (220), the end portion (220) having an outer diameter larger than an inner diameter of the through hole (110) preventing the screw core (200) from being detached from the screw housing (100).
4. The high-strength screw according to claim 3, wherein both ends of the through hole (110) are provided with clamping grooves (120), the end portion (220) is provided with protrusions (230), and the protrusions (230) are accommodated in the clamping grooves (120).
5. The high strength screw according to claim 4, wherein the screw core (200) is a wire braid in a tensioned state, the outer diameter of the wire braid conforming to the inner diameter dimension of the through hole (110).
6. The high strength screw according to claim 4 or 5, wherein the protrusion (230) is a fixation knot.
7. The high strength screw according to claim 1, wherein the material of the screw housing (100) comprises an absorbable material.
8. The high strength screw according to claim 7, wherein the material of the screw housing (100) comprises one or more of polylactic acid and its copolymers, polycaprolactone and its copolymers, polydioxanone and its copolymers, polyglycolic acid and its copolymers; or one or more of hydroxyapatite, beta-calcium phosphate and calcium sulfate and one or more of polylactic acid and a copolymer thereof, polycaprolactone and a copolymer thereof, polydioxanone and a copolymer thereof, polyglycolic acid and a copolymer thereof are blended to obtain a mixture, wherein the mass sum of the hydroxyapatite, the beta-calcium phosphate and the calcium sulfate in the mixture accounts for 1-20%.
9. The high strength screw according to claim 1, wherein the material of the screw housing (100) comprises polyetheretherketone.
10. The high strength screw according to claim 1, wherein the material of the screw core (200) comprises one or more of polyethylene terephthalate, polyethylene, polypropylene, polylactic acid and its copolymers, polycaprolactone and its copolymers, polydioxanone and its copolymers, polyglycolic acid and its copolymers.
CN202111571974.1A 2021-12-21 2021-12-21 High-strength screw Active CN114376701B (en)

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CN114376701B CN114376701B (en) 2023-02-14

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CN212634431U (en) * 2020-04-17 2021-03-02 江苏博瑞工具有限公司 Twist drill for cutting annular hole
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CN213954115U (en) * 2020-10-11 2021-08-13 晋亿实业股份有限公司 High-damage-torque-reduction bearing screw
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GB898518A (en) * 1959-10-24 1962-06-14 Glanzstoff Ag A process for the manufacture of rubber strips having a high elasticity modulus and which are suitable for use as inserts for articles made of rubber or elastic plastics
CN1165221A (en) * 1996-02-15 1997-11-19 贝克特股份有限公司 Steel cord adapted for reinforcement of elastomer
CN2629658Y (en) * 2003-08-08 2004-08-04 中南大学湘雅医院 Lower tibiofibula combined hook-bolt
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