CN104887305A - Bone screw - Google Patents

Bone screw Download PDF

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Publication number
CN104887305A
CN104887305A CN201510365635.6A CN201510365635A CN104887305A CN 104887305 A CN104887305 A CN 104887305A CN 201510365635 A CN201510365635 A CN 201510365635A CN 104887305 A CN104887305 A CN 104887305A
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CN
China
Prior art keywords
rod section
bone
bone screw
material layer
screw
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201510365635.6A
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Chinese (zh)
Other versions
CN104887305B (en
Inventor
李开南
石春霞
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hebei Ruinuo Medical Instrument Co Ltd
Original Assignee
Hebei Ruinuo Medical Instrument Co Ltd
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Publication date
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Priority to CN201510365635.6A priority Critical patent/CN104887305B/en
Publication of CN104887305A publication Critical patent/CN104887305A/en
Application granted granted Critical
Publication of CN104887305B publication Critical patent/CN104887305B/en
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Classifications

    • 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
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • A61B17/8635Tips of screws
    • 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
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • 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
    • A61L31/04Macromolecular 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • 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
    • A61L2400/00Materials characterised by their function or physical properties

Abstract

The invention relates to a bone screw. The bone screw comprises a screw pole and a screw cap, the screw pole comprises a polish rod section and a screw rod section, a degradable material layer is compounded on the peripheral circumferential surface of the polish rod section, and the outer diameter of the degradable material layer is less than or equal to the large diameter of the screw rod section. The screw pole and screw cap are made of metal material; the degradable material layer is prepared from one or the polymer of polylactic acid, polyglycolic acid, poly trimethylene carbonate, polydioxanone and poly epsilon-caprolactone. Through operation, the bone screw is stable in fixing effect and avoided from sliding after the fracture part of a patient is fixed and before the degradable material layer is degraded; in the later degradation process of the degradable material layer and after the complete degradation of the degradable material layer, the bone moves slightly to stimulate the full healing of the bone, the achievement ratio of operation is improved, and the healing effect of the fracture part is better.

Description

A kind of bone screw
Technical field
The present invention relates to a kind of bone surgery set, specifically a kind of bone screw.
Background technology
In bone surgery, traditional fracture processing method bone screw or bone screw is added that nail-plate fixed system is directly pressed on bone, to align and to stablize breaking part.Bone screw or add that nail-plate fixed system is all made up of metal material mostly, bone screw adds that nail-plate is rigidly connected, for the healing stabilizes of fracture provides guarantee.But this processing mode Problems existing, one be rigidly connected may produce on screw-bone interface increase stress time, its load will make screw or steel plate absorb and carry most of stress again from bone conduction to screw to plate, produce stress shielding, after steel plate screw is removed, likely produce bone and again rupture.Two is small movements that rigid structure fixedly inhibits fracture portions, and this small movements is useful to induction section callus formation and breakage and reunion.
Chinese patent application CN103491890A discloses a kind of bone screw with multiple form of threads of Distal cortex locking and bone flexible engagement, its structure comprises the threaded front waist section being configured for and engaging with cortical bone, threaded middle part and be configured for the not threaded neck section of carrying out restrained motion in the nearside cortex of bone.The neck section of this bone screw and the surrounding bone of fixed position have the gap of, and structure is not firm, from postoperative, just have the small movements of bone, and making to fracture in the early stage, fracture site place is effectively and be more formed uniformly callus in agglutination.But, compare with traditional bone screw-rigidly fixing of nail-plate fixed system, the poor stability at initial stage, may slippage be occurred, thus the rear effect of impact operation.
The cervical region of tradition bone screw is simple without spiro rod section, and itself and surrounding bone exist certain gap, can not play the effect of firm surrounding bone after surgery; And existing complete thread screw, although can fix surrounding bone immediately, initial stage and the small movements lacking bone all the time at a specified future date, be unfavorable for the prognosis of fracturing.
Summary of the invention
Object of the present invention is just to provide a kind of bone screw, to solve existing bone screw and surrounding bone can not to stablize surrounding bone or there is not gap with surrounding bone the prognosis and the small movements and being unfavorable for lacking bone all the time in initial stage and long term is fractured after surgery at once problem because there is gap.
The present invention is achieved in that a kind of bone screw, comprise nail bar and nut, described nail bar comprises polished rod section and spiro rod section, and the peripheral circumferential face of described polished rod section is compounded with degradation material layer, and the outside dimension of described degradation material layer is not more than the large footpath of described spiro rod section.
The described spiro rod section of described nail bar is located at the nail bar leading portion be close to screw tip end.
The described spiro rod section of described nail bar is located at the nail bar back segment be close to nut.
The diameter of the described polished rod section of described nail bar is 1.0-4.6mm, and the diameter of described spiro rod section is 1.4-8.1mm.
The length of the described polished rod section of described nail bar is greater than 0.1 mm.
The length of described degradation material layer is not more than the length of described polished rod section.
Described nut is provided with external screw thread or does not establish external screw thread.
Described nail bar and described nut are made up of metal material; Described degradation material layer is made up of the copolymer of any one material in polylactic acid, polyglycolic acid, PTMC, Ju diethyleno dioxide ketone or poly-epsilon-caprolactone or above-mentioned at least two or more material; The strength maintenance time of described degradation material layer was 2-24 weeks.
Hydroxyapatite, calcium phosphate ceramic or bioactive glass material can be added in described copolymer.
The strength maintenance time of described degradation material layer was 4-8 weeks.
Bone screw of the present invention can be used as spongy bone bone screw, pressurization lag screw or location hold-down screw.
Bone screw of the present invention can with common metal blade plate with the use of, also can with pressurized metal blade plate with the use of, also can with locking metal bone fracture plate with the use of.
Bone screw of the present invention can with intramedullary needle with the use of.
Bone screw of the present invention is by the polished rod section composite degradable material layer at bone screw, can the initial stage plays the effect of its surrounding bone firm immediately after surgery, and along with the degraded of degradation material layer, intensity reduces gradually, fracture small movements increases gradually simultaneously, Promotive union, last degradation material layer is broken and be completely absorbed.
The present invention arranges polished rod section and composite degradable material layer thereon on bone screw, use this bone screw, on screw, the degradation material layer of compound can play the effect of its surrounding bone firm at once after surgery, along with the degraded of degradation material layer, intensity progressively reduces, produce the gap between screw and bone gradually, fracture small movements increases gradually, and this small movements is of value to, and the incrustation of induction fracture face bone is formed, Promotive union simultaneously; Finally, degradation material layer is broken and absorbed completely by human body.
Bone screw of the present invention by operation, before the degraded of degradation material layer, is had comparatively stable fixed effect, can not produce slippage after patients with fractures position is fixing; And in the degradation process of the degradation material layer in later stage and after degraded completely, have again the small movements of bone, so just can stimulate comprehensive healing of bone, make success rate of operation improve, the healing effect of fracture site is better.
Accompanying drawing explanation
Fig. 1, Fig. 2 are the structural representations of bone screw of the present invention two kinds of embodiments.
Fig. 3-Fig. 6 is four kinds of using state reference diagrams of bone screw of the present invention.
Detailed description of the invention
By the following examples the present invention is further described specifically.What be necessary to herein means out is that following examples are only for the present invention is described further; limiting the scope of the invention can not be interpreted as; this art skilled person makes some nonessential improvement and adjustment according to the invention described above content to the present invention, still belongs to protection scope of the present invention.
As shown in Figure 1 and Figure 2, bone screw comprises the nut 1 and nail bar be made up of metal material; Can car external screw thread on nut 1, also can be do not establish externally threaded bright finish.Nail bar is the columniform reducing body of rod, nail bar is divided into polished rod section 2 and spiro rod section 3 two ingredients by the reducing line along middle part, the spiro rod section 3 of nail bar is located at the nail bar leading portion (Fig. 1) be close to screw tip end, also can be located at the back segment (Fig. 2) of the nail bar adjacent with nut 1.The peripheral circumferential face of polished rod section 2 is compounded with degradation material layer 4; The outside dimension of degradation material layer 4 is not more than the large footpath of spiro rod section 3.The length of the polished rod section 2 of nail bar should be greater than 0.1 mm; The length of degradation material layer 4 is equal to or slightly less than the length of polished rod section 2.
Degradation material layer 4 is made up of the copolymer of any one material in polylactic acid, polyglycolic acid, PTMC, Ju diethyleno dioxide ketone or poly-epsilon-caprolactone or above-mentioned at least two or more material.The degradation material layer 4 be made up of above-mentioned arbitrary single material or copolymeric material, should ensure that its strength maintenance time reached for 2-24 weeks, be preferably for 4-8 weeks.Also hydroxyapatite, calcium phosphate ceramic or bioactive glass material can be added in above-mentioned copolymer material.
In Fig. 3, bone screw of the present invention passes from the fracture line 5 of spongy bone 6, directly that fracture portions is fastening.
In Fig. 4, bone screw of the present invention and metal bone fracture plate with the use of, steel plate 7 is tightened together with nearside bone 8, medullary cavity 9, distally bone 10 cross-under.
Fig. 5, Fig. 6 be bone screw of the present invention and intramedullary needle with the use of occupation mode.
Embodiment 1
This bone screw is as the application of cancellous bone screw, and its diameter is 4.5mm, and the large footpath (i.e. major diameter of thread) of spiro rod section 3 is 4.5mm, and the diameter of polished rod section 2 is 3.2mm, and the length of polished rod section 2 is 20mm; Utilize hot injection, Ju diethyleno dioxide ketone is molded in the polished rod section 2 of bone screw, form degradation material layer 4.Degradation material layer 4 is close to the circumferential surface of polished rod section 2, and its length is 20mm, and thickness is 0.6mm.Degradation material layer 4 also can adopt other usual manners to be compound to the circumferential surface of polished rod section 2.
Embodiment 2
This bone screw is as the application of cancellous bone screw, and its diameter is 2.5mm, and the large footpath of spiro rod section 3 is 2.5mm, and the diameter of polished rod section 2 is 1.8mm, and the length of polished rod section 2 is 20mm; Utilize hot injection, Poly-L-lactide is molded in the polished rod section 2 of bone screw, form degradation material layer 4.Degradation material layer 4 is close to the circumferential surface of polished rod section 2, and its length is 11mm, and thickness is 0.3mm.
Embodiment 3
This bone screw is as the screw of locking and pressurizing steel plate, and its diameter is 4.5mm, and the large footpath of spiro rod section 3 is 4.5mm, and the diameter of polished rod section 2 is 3.0mm, and the length of polished rod section 2 is 40mm, and the cylindrical of nut 1 is shaped with external screw thread; Utilize hot injection, Ju diethyleno dioxide ketone is molded in the polished rod section 2 of bone screw, form degradation material layer 4.Degradation material layer 4 is close to the circumferential surface of polished rod section 2, and its length is 35mm, and thickness is 0.7mm.
Embodiment 4
This bone screw is as the screw of locking and pressurizing steel plate, and its diameter is 4.5mm, and the large footpath of spiro rod section 3 is 4.5mm, and the diameter of polished rod section 2 is 3.2mm, and the length of polished rod section 2 is 11mm; Utilize hot injection, polylactic-co-glycolic acid is molded in the polished rod section 2 of bone screw, form degradation material layer 4.Degradation material layer 4 is close to the circumferential surface of polished rod section 2, and its length is 10mm, and thickness is 0.6mm.
Embodiment 5
This bone screw is as the screw of locking and pressurizing steel plate, and its diameter is 3.5mm, and the large footpath of spiro rod section 3 is 3.5mm, and the diameter of polished rod section 2 is 2.4mm, and the length of polished rod section 2 is 25mm, and the cylindrical of nut 1 is shaped with external screw thread; Utilize hot injection, polyglycolic acid is molded in the polished rod section 2 of bone screw, form degradation material layer 4.Degradation material layer 4 is close to the circumferential surface of polished rod section 2, and its length is 25mm, and thickness is 0.5mm.
Carry out degradation experiment to the bone screw in embodiment 1-5, experiment condition is: temperature 37 DEG C, in phosphate buffered solution.Testing method is conventional method, detects data as shown in table 1.
table 1: the degradation time experiment of degradation material layer
Embodiment 1 2 3 4 5
The strength maintenance time (week) 5 20 6 8 2

Claims (13)

1. a bone screw, comprise nail bar and nut, it is characterized in that, described nail bar comprises polished rod section and spiro rod section, the peripheral circumferential face of described polished rod section is compounded with degradation material layer, and the outside dimension of described degradation material layer is not more than the large footpath of described spiro rod section.
2. bone screw according to claim 1, is characterized in that, the described spiro rod section of described nail bar is located at the nail bar leading portion be close to screw tip end.
3. bone screw according to claim 1, is characterized in that, the described spiro rod section of described nail bar is located at the nail bar back segment be close to nut.
4. bone screw according to claim 1, is characterized in that, the diameter of the described polished rod section of described nail bar is 1.0-4.6mm, and the diameter of described spiro rod section is 1.4-8.1mm.
5. bone screw according to claim 1, is characterized in that, the length of the described polished rod section of described nail bar is greater than 0.1 mm.
6. bone screw according to claim 1, is characterized in that, the length of described degradation material layer is not more than the length of described polished rod section.
7. bone screw according to claim 1, is characterized in that, described nut is provided with external screw thread or does not establish external screw thread.
8. bone screw according to claim 1, is characterized in that, described nail bar and described nut are made up of metal material; Described degradation material layer is made up of the copolymer of any one material in polylactic acid, polyglycolic acid, PTMC, Ju diethyleno dioxide ketone or poly-epsilon-caprolactone or above-mentioned at least two or more material; The strength maintenance time of described degradation material layer was 2-24 weeks.
9. bone screw according to claim 8, is characterized in that, is added with hydroxyapatite, calcium phosphate ceramic or bioactive glass material in described copolymer.
10. bone screw according to claim 8, is characterized in that, the strength maintenance time of described degradation material layer was 4-8 weeks.
11. 1 kinds of bone screws according to claim 1, is characterized in that, as spongy bone bone screw, pressurization lag screw or location hold-down screw.
12. 1 kinds of bone screws according to claim 1, is characterized in that, above-mentioned bone screw can with common metal blade plate with the use of, also can with pressurized metal blade plate with the use of, also can with locking metal bone fracture plate with the use of.
13. 1 kinds of bone screws according to claim 1, is characterized in that, above-mentioned bone screw can with intramedullary needle with the use of.
CN201510365635.6A 2015-06-29 2015-06-29 A kind of bone screw Active CN104887305B (en)

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CN104887305B CN104887305B (en) 2018-03-27

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105596076A (en) * 2016-02-26 2016-05-25 创辉医疗器械江苏有限公司 Micro-motion locking screw
CN106725785A (en) * 2016-12-24 2017-05-31 上海施必康医疗器械有限公司 A kind of orthopaedics internal fixation system
CN107349006A (en) * 2017-08-31 2017-11-17 河北瑞诺医疗器械股份有限公司 A kind of locking bone fracture plate device
CN109223147A (en) * 2018-10-22 2019-01-18 秦家燕 A kind of new and effective type spicule that is drawn out easily
CN109223156A (en) * 2018-10-20 2019-01-18 贾云云 A kind of novel outer fixed bone spicule structure
CN110585490A (en) * 2019-09-16 2019-12-20 上理检测技术(上海)有限公司 Micro-motion compression steel plate

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5108399A (en) * 1988-09-17 1992-04-28 Boehringer Ingelheim Gmbh Device for osteosynthesis and process for producing it
US5364400A (en) * 1992-02-14 1994-11-15 American Cyanamid Co. Interference implant
CN2582552Y (en) * 2002-11-19 2003-10-29 武汉理工大学 Biodegradable internal fitting bone screw and its mating screw tap and rotary screw
CN2699846Y (en) * 2004-06-03 2005-05-18 安洪 Degradable bone screw made by nanometer hydroxyapatite composite material
US20100249850A1 (en) * 2009-03-24 2010-09-30 Stabiliz Orthopedics, LLC Orthopedic Fixation Device with Bioresorbable Layer
CN101889896A (en) * 2010-07-05 2010-11-24 苏州市百得医疗器械有限公司 Hydroxyapatite bone screw
CN104434291A (en) * 2014-12-24 2015-03-25 叶川 Functional anti-looseness absorbable screw used in orthopaedics department
CN204814153U (en) * 2015-06-29 2015-12-02 河北瑞诺医疗器械股份有限公司 Meet bone screw

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5108399A (en) * 1988-09-17 1992-04-28 Boehringer Ingelheim Gmbh Device for osteosynthesis and process for producing it
US5364400A (en) * 1992-02-14 1994-11-15 American Cyanamid Co. Interference implant
CN2582552Y (en) * 2002-11-19 2003-10-29 武汉理工大学 Biodegradable internal fitting bone screw and its mating screw tap and rotary screw
CN2699846Y (en) * 2004-06-03 2005-05-18 安洪 Degradable bone screw made by nanometer hydroxyapatite composite material
US20100249850A1 (en) * 2009-03-24 2010-09-30 Stabiliz Orthopedics, LLC Orthopedic Fixation Device with Bioresorbable Layer
CN101889896A (en) * 2010-07-05 2010-11-24 苏州市百得医疗器械有限公司 Hydroxyapatite bone screw
CN104434291A (en) * 2014-12-24 2015-03-25 叶川 Functional anti-looseness absorbable screw used in orthopaedics department
CN204814153U (en) * 2015-06-29 2015-12-02 河北瑞诺医疗器械股份有限公司 Meet bone screw

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105596076A (en) * 2016-02-26 2016-05-25 创辉医疗器械江苏有限公司 Micro-motion locking screw
CN106725785A (en) * 2016-12-24 2017-05-31 上海施必康医疗器械有限公司 A kind of orthopaedics internal fixation system
CN106725785B (en) * 2016-12-24 2019-12-06 上海施必康医疗器械有限公司 Internal fixation system for orthopedics department
CN107349006A (en) * 2017-08-31 2017-11-17 河北瑞诺医疗器械股份有限公司 A kind of locking bone fracture plate device
CN109223156A (en) * 2018-10-20 2019-01-18 贾云云 A kind of novel outer fixed bone spicule structure
CN109223156B (en) * 2018-10-20 2021-10-12 任敏 External fixation spicule structure
CN109223147A (en) * 2018-10-22 2019-01-18 秦家燕 A kind of new and effective type spicule that is drawn out easily
CN109223147B (en) * 2018-10-22 2021-09-10 桂林医学院附属医院 Bone needle easy to pull out
CN110585490A (en) * 2019-09-16 2019-12-20 上理检测技术(上海)有限公司 Micro-motion compression steel plate
CN110585490B (en) * 2019-09-16 2022-05-20 上理检测技术(上海)有限公司 Micro-motion pressurizing steel plate

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