CN104586484A - Spinal implantation unit and preparation method thereof - Google Patents

Spinal implantation unit and preparation method thereof Download PDF

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Publication number
CN104586484A
CN104586484A CN201310533796.2A CN201310533796A CN104586484A CN 104586484 A CN104586484 A CN 104586484A CN 201310533796 A CN201310533796 A CN 201310533796A CN 104586484 A CN104586484 A CN 104586484A
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CN
China
Prior art keywords
medicine
spinal column
unit
silicone rubber
implants
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
CN201310533796.2A
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Chinese (zh)
Other versions
CN104586484B (en
Inventor
田芳
高耀平
林忠
陈伟
张静
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.)
Suzhou Minimally Invasive Spinal Trauma Medical Technology Co ltd
Shanghai Microport Orthopedics Co Ltd
Original Assignee
SUHZOU HEALTH MEDICAL TREATMENT APPARATUS CO Ltd
Shanghai Microport Orthopedics Co Ltd
Priority date (The priority date 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 date listed.)
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Publication date
Application filed by SUHZOU HEALTH MEDICAL TREATMENT APPARATUS CO Ltd, Shanghai Microport Orthopedics Co Ltd filed Critical SUHZOU HEALTH MEDICAL TREATMENT APPARATUS CO Ltd
Priority to CN201310533796.2A priority Critical patent/CN104586484B/en
Priority to PCT/CN2014/088452 priority patent/WO2015062408A1/en
Publication of CN104586484A publication Critical patent/CN104586484A/en
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Publication of CN104586484B publication Critical patent/CN104586484B/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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7031Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
    • 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
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to the field of medical equipment, in particular to a spinal implantation unit. The spinal implantation unit comprises an elastic section and is characterized in that liquid state silicone rubber containing drugs and curing agents is added into the elastic section, and a silicone rubber body carried with drugs is formed at a normal temperature after curing is completed. The invention further relates to a method for preparing the spinal implantation unit. The spinal implantation unit has the functions of relieving pain diseases caused by focus point adhesion, compression and the like, eliminating chondral calcification, enabling the drugs to be decomposed and absorbed, and removing the edema and hypertrophy of ligamentum flavum and posterior longitudinal ligament.

Description

A kind of spinal column implants unit and preparation method thereof
Technical field
The present invention relates to medical instruments field.Specifically, the present invention is applied to orthopedic spinal internal fixtion field, relates to a kind of spinal column and implants unit and preparation method thereof.
Background technology
The compressing that before and after bone surgery, adhesion causes is the large problem of a puzzlement doctor, can affect success rate of operation.Preoperative adhesion phenomenon brings difficulty and risk to operation, and postoperative adhesion phenomenon causes operative failure, increases the probability of second operation.Meanwhile, orthopaedics implant complete mission need take out time, also can strengthen operation risk.If implant is loaded with anti-inflammatory drug and slowly release performance inhibitory action, then can alleviate or eliminate adhesion symptom.
The compressing that cartilaginous calcification causes is the problem of a puzzlement doctor equally, and reject risk during operation high, Possibility of Regeneration is large.If the medicine that implant is loaded with decomposition, absorbs, and slowly release, just eliminate the compressing because calcification causes by treatment.
The compressing that the ligamenta flava that inflammation causes, posterior longitudinal ligament edema, plumpness cause, also can be loaded with anti-inflammation drugs by implant after surgery, be treated by slow releasing.
Suitable control pain is for of crucial importance any postoperative patients, and the significant physiology of patient and psychological benefit are given in pain relief.Effective alleviating pain not only means recovery from illness (such as, emotion, sleep, quality of life etc.) happier more smoothly, and it can also reduce the outbreak of chronic pain syndrome.
Along with popularizing of bone surgery, raising postoperative rehabilitation situation is had higher requirement.Carry out large quantifier elimination and clinical observation with regard to common phenomena such as postoperative infection, adhesion, pain, focus healings both at home and abroad, and invented multiple method for this reason and prevent, alleviate, eliminate these postoperative complications, improve surgical quality.
By medical apparatus and instruments together with medicine efficient set, conventional Post operation can be replaced to take, inject the medicines such as a large amount of antibacterial, hormone, pain relieving, and this local target administration, better effects if, side effect is less.Current existing technology is as follows:
Chinese patent application No.02136332.3, denomination of invention is " medicine releasing control method of implantable medical devices ".Inorganic material and macromolecular material premium properties separately combine by this invention, more existing pure organic or pure inorganic coating method, there is obvious advantage, protein drug can be suitable for and other are to the long-term control release of the comparatively responsive medicine of the external conditions such as heat, light.
" biomedical engineering's progress " the 31st volume the 4th phase in 2010, paper name is called " preparation of titanium alloy implant surfaces infection coating and In Vitro Bacteriostasis performance study thereof ".This paper with polylactic acid (PDLLA) for carrier, adopt the method for solvent cast (solvent-casting), prepare the PDLLA coating of year mould through the ages rope (VCM) at titanium alloy implant matrix surface, expected that carrying out anti-bacteria by Vancomycin infects.
Chinese patent application No.201110232842.6, denomination of invention is " Anti-infection medical titanium alloy ".This invention adds appropriate copper on the chemical composition basis of existing medical titanium alloy Ti6Al7Nb, after special heat resistanceheat resistant process, in the matrix of medical titanium alloy, separates out a kind of titanium copper phase, thus gives medical titanium alloy bacterial-infection resisting function.
Chinese patent application No.200810147918.3, denomination of invention is " bacterial inhibition biological active titanium or titanium alloy embedded material and its preparation method and application ".This invention with bio-medical level titanium or titanium alloy for base material, the material of analytical pure chloride ion-containing is added deionized water and is mixed with electrolyte solution, use anodized surface modification treatment technology, DC voltage 1-100V is applied between material anode and negative electrode, processing time 1-200 second, obtain biological active titanium or titanium alloy that surface creates biocidal property Ti-Cl group and biological activity Ti-OH group, these Ti-Cl groups are hydrolyzed the-ClO producing and have bacteriostasis and sterilization effect under physiological environment xion.
Chinese patent application No.200910051827.4, denomination of invention is " a kind of medication coat for vertebral internal fixation screw and Synthesis and applications ".This invention relates to medication coat for vertebral internal fixation screw and Synthesis and applications, and this medication coat thickness is 30 ~ 300 microns.Screw to be soaked in the PBS being dissolved with the carbodiimides of 0.2mol/L and the N-hydroxy-succinamide of 0.05mol/L 30 minutes; Bis phosphoric acid salt and other drug are dissolved in distilled water, screw are soaked 24 hours in this solution, to obtain final product.This medication coat screw can be applicable in vertebral internal fixation and improves bone mass, reduces fracture risk.
Chinese patent application No.201110088034.7, denomination of invention is " method that medical apparatus surface implements the solid medicine controlled release of medicine carrying ".This invention makes equipment surfaces roughening by physics or chemical method, implements isostatic pressed process and make medicine and apparatus matrix strong bonded after carrying out drug coat, overcomes the medicine that the direct medicine carrying of equipment surfaces causes and comes off, achieve the object of Drug controlled release.
Visible, prior art is all carry out various process at implant surface, such as medication coat, ooze the method such as copper ion, anodized surface modification treatment technology to reach antibacterial object, but medicine layer is very thin, the time of drug release is naturally just few, wants the maintenance drug effect of about 1 year just not realize.In addition, because these implants have very large friction with osseous tissue and apparatus in the process of implant into body, screw enters after in sclerotin may be left few medicine, and drug effect can be had a greatly reduced quality.
Summary of the invention
The present invention be derived from applicant at first Chinese patent application No.201210248135.0, denomination of invention is " a kind of spinal column dynamic stability implant unit ", and the content of this earlier application is introduced in present specification in full, and as the part of disclosure.
Specifically, the present invention adds specific curative drug in the silicone rubber part of described implantation unit, prevention of postoperative adhesion, infection and focus treatment.After product implant into body, silicone rubber pharmaceutical carrier effectively discharges medicine gradually and slowly diffuses into around body foci, and operation consent focus and Post operation produced problem are issued to healing truly in Drug therapy.
The invention provides a kind of spinal column and implant unit, comprise stretch section, it is characterized in that, containing the silicon rubber body being loaded with medicine in described stretch section.
According to the present invention, it is dynamic rod that described spinal column implants unit.
According to the present invention, described in be loaded with medicine silicon rubber body be arranged in groove and/or through hole that described stretch section is arranged.
According to the present invention, the silicon rubber body being loaded with medicine is the fluid silicone rubber added in stretch section containing medicine and firming agent, ambient temperature curingly forms.
According to the present invention, medicine used is corticosteroid hormone or α epinephrine, and wherein said corticosteroid hormone is selected from clonidine, fluocinolone acetonide, dexamethasone, sulindac, sulfasalazine or its combination.
According to the present invention, medicine used is antibiotic medicine, such as, and antibiotics.
According to the present invention, the weight ratio of medicine and fluid silicone rubber, between 10% ~ 50%, can be determined by the thickness of silicon rubber body and the length of slow-release time being loaded with medicine.
According to the present invention, depending on needs of patients, the rate of release of medicine every day can be controlled in and is less than 100 μ g/kg (weight in patients).It will be appreciated by those skilled in the art that this rate of release depends on dose (concentration) used, the thickness being loaded with the silicon rubber body of medicine and kind etc., can arbitrarily regulate.
According to the present invention, be loaded with the thickness B of the silicon rubber body of medicine between 1.5mm-5mm.
It will be appreciated by those skilled in the art that except dynamic rod, as long as other spinal columns of the present invention implant unit containing silicone rubber, just silicone rubber can be used as pharmaceutical carrier.
In addition, the present invention does not have particular/special requirement to silicone rubber, as long as it can implant into body for a long time, meets security requirement, and can solidify at normal temperatures.
Dose of the present invention (concentration) and be loaded with the thickness of silicon rubber body of medicine and slow-release time has certain dependency, can determine according to actual needs.Such as, in concentration one timing, thickness takes large values, and slow-release time can extend.Spinal column of the present invention is implanted unit Chinese medicine slow release and is three months or half a year, even reaches 1 year.
The present invention also provides a kind of and prepares the method that spinal column implants unit, comprises following operative step:
There is provided spinal column to implant unit, described spinal column is implanted unit and is comprised stretch section,
Implant unit to spinal column to clean, dry,
The fluid silicone rubber containing medicine and firming agent is injected in described stretch section, ambient temperature curing, form the silicon rubber body being loaded with medicine.
According to the present invention, in the groove and/or through hole of stretch section, inject the fluid silicone rubber containing medicine and firming agent.
According to the present invention, fluid silicone rubber, weight ratio between medicine and firming agent are 100:(10 ~ 50): (0.4 ~ 0.6).
The present invention utilizes silicone rubber in implant as pharmaceutical carrier.Silicone rubber is a kind of porous, adsorbable material, when curative drug is dissolved in wherein as bioactive substance, Ludox molecule all can produce it and adsorb effectively and uniformly, discharge slowly along with the prolongation of time, and save its corresponding pharmacological property, there is stable chemical nature, nontoxic feature simultaneously.Silicone rubber has good infiltration and permeability, is desirable Thermosensitive Material Used for Controlled Releasing of Medicine.Medicine make use of this characteristic of silicone rubber just, carries out effective Co ntrolled release and slowly diffusion through silicone rubber.In addition, in implant, silicone rubber has certain thickness, and the time of comparable common implant coating drug release is long, and silicon rubber body can be considered a medicament reservoir.
Implant of the present invention has anti, alleviating pain effect, and be dispersed in silicone rubber substrate in particulate form by steroid medicine, α epinephrine or antibiotic medicine, medicine can slowly release, and release time can extend to about 1 year.This medicine carrying implant simpler, only by medicine and silicone rubber mixing, at normal temperatures curing molding, need expand the range of choice of medicine.
Beneficial effect of the present invention is embodied in:
Implant has the pain pertinacious disease of the generation such as adhesion, compressing removing focus point;
Implant has removing cartilaginous calcification, the function make it decompose, absorbing;
Implant has removes ligamenta flava, the edema of posterior longitudinal ligament, plump function.
Accompanying drawing explanation
In order to more clearly describe technical scheme of the present invention, briefly introduce below in conjunction with accompanying drawing.Obviously, these accompanying drawings are only some detailed description of the invention that the application records.Technical scheme of the present invention includes but not limited to these accompanying drawings.
Fig. 1 illustrates dynamic rod, wherein 1, dynamic rod, and 2, helicla flute, 3, through hole.
Fig. 2 illustrates in stretch section the silicon rubber body being loaded with medicine, and wherein thickness is B.
Detailed description of the invention
In order to understand the present invention further, below in conjunction with embodiment, preferred version of the present invention is described.These describe and just illustrate that spinal column of the present invention implants the feature and advantage of unit, but not limit the scope of the invention.
Embodiment 1
Dynamic rod, after machined completes, cleans up greasy dirt with ultrasonic washing unit, then in the cleaning shop of 100,000 grades, carries out extreme trace cleaning, oven dry with ultrasonic washing unit.Dynamic rod as shown in Figure 1.
Select the fluid silicone rubber that can implant for a long time, first medicine (clonidine) is added in this fluid silicone rubber and fully mix thoroughly, add the firming agent (0.5wt%) supporting with fluid silicone rubber, after fully mixing thoroughly, form the fluid silicone rubber containing medicine and firming agent, move into syringe, then be injected in the helicla flute of dynamic rod.Ambient temperature curing 24 hours.As shown in Figure 2, wherein thickness B is 3mm to the silicon rubber body shape being loaded with medicine after solidification.
Fluid silicone rubber: medicine: firming agent=100:30:0.5(weight ratio).
The rate of release of medicine every day controls be less than 100 μ g/kg (weight in patients), and pharmaceutical release time can reach half a year.
Embodiment 2
Identical with embodiment 1, except choice of drug α epinephrine and thickness B are except 2mm.Dynamic rod is implanted near intervertebral disc, shares the activity of intervertebral disc and stressed function, prevents the further regression of intervertebral disc.Dynamic rod carries α epinephrine, can treat degenerative disc disease and comprise intervertebral disk hernia.
Embodiment 3
Identical with embodiment 1, the weight ratio except the fluid silicone rubber injected in the through hole in the middle of the dynamic rod containing medicine and firming agent, medicine and fluid silicone rubber be 40% and thickness be except 5mm.Inject the fluid silicone rubber containing medicine and firming agent in through hole, can increase drug loading, pharmaceutical release time reaches 1 year.
The explanation of above embodiment just understands core concept of the present invention for helping.Should be understood that; for the ordinary skill in the art; under the premise without departing from the principles of the invention, some improvement and modification can also be carried out to unit of the present invention and method, but these improve and modification also falls in the scope of the claims in the present invention request protection.

Claims (9)

1. spinal column implants a unit, comprises stretch section, it is characterized in that, containing the silicon rubber body being loaded with medicine in described stretch section.
2. spinal column as claimed in claim 1 implants unit, it is characterized in that, it is dynamic rod that described spinal column implants unit.
3. spinal column as claimed in claim 2 implants unit, and it is characterized in that, the thickness range being loaded with the silicon rubber body of medicine is 1.5mm-5mm.
4. spinal column as claimed in claim 1 implants unit, it is characterized in that, described in be loaded with medicine silicon rubber body be arranged in groove and/or through hole that described stretch section is arranged.
5. spinal column as claimed in claim 1 implants unit, and it is characterized in that, described medicine is corticosteroid hormone, α epinephrine or antibiotic medicine.
6. spinal column as claimed in claim 5 implants unit, it is characterized in that, described corticosteroid hormone is selected from clonidine, fluocinolone acetonide, dexamethasone, sulindac, sulfasalazine or its combination.
7. prepare the method that spinal column as claimed in claim 1 implants unit, comprise following operative step:
There is provided a kind of spinal column to implant unit, described spinal column is implanted unit and is comprised stretch section,
Implant unit to described spinal column to clean, dry,
The fluid silicone rubber containing medicine and firming agent is injected in described stretch section, ambient temperature curing, form the silicon rubber body being loaded with medicine.
8. method as claimed in claim 7, is characterized in that, injects the fluid silicone rubber containing medicine and firming agent in the groove and/or through hole of stretch section.
9. method as claimed in claim 7, is characterized in that, the weight ratio of described fluid silicone rubber, medicine and firming agent three is 100:(10 ~ 50): (0.4 ~ 0.6).
CN201310533796.2A 2013-10-31 2013-10-31 A kind of backbone implantation unit and preparation method thereof Active CN104586484B (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201310533796.2A CN104586484B (en) 2013-10-31 2013-10-31 A kind of backbone implantation unit and preparation method thereof
PCT/CN2014/088452 WO2015062408A1 (en) 2013-10-31 2014-10-13 Spine implant unit and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201310533796.2A CN104586484B (en) 2013-10-31 2013-10-31 A kind of backbone implantation unit and preparation method thereof

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CN104586484B CN104586484B (en) 2018-03-23

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Families Citing this family (2)

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CN108852564B (en) * 2018-05-07 2019-08-09 福州大学 Artificial disc after arthroplasty based on metal-rubber
EP3897414A4 (en) 2018-12-21 2022-09-28 Paradigm Spine, LLC. Modular spine stabilization system and associated instruments

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CN1947802A (en) * 2006-10-26 2007-04-18 上海交通大学医学院附属新华医院 Slow release type testis prosthesis and its application
EP1838251A1 (en) * 2004-11-20 2007-10-03 Dajue Wang Spinal prostheses
CN101130106A (en) * 2007-09-28 2008-02-27 清华大学 Method of producing artificial prosthesis of disci intervertebrales nucleus pulposus
WO2008100590A1 (en) * 2007-02-14 2008-08-21 Flex Technology Inc Flexible spine components
US20100247600A1 (en) * 2009-03-24 2010-09-30 Warsaw Orthopedic, Inc. Therapeutic drug eluting implant cover and method of making the same
CN102106750A (en) * 2011-02-17 2011-06-29 上海微创骨科医疗科技有限公司 Spinal column dynamic connection rod
CN102260410A (en) * 2011-07-13 2011-11-30 大连海洋大学 Long-acting antibacterial organic silicon rubber material and preparation method thereof
CN103167845A (en) * 2010-07-12 2013-06-19 美敦力瓦斯科尔勒公司 Method of making a stent with hollow struts

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Publication number Priority date Publication date Assignee Title
CN1338948A (en) * 1999-02-14 2002-03-06 许健健 Sustained release implant, methods for preparation thereof and for treating cancer
EP1838251A1 (en) * 2004-11-20 2007-10-03 Dajue Wang Spinal prostheses
CN1947802A (en) * 2006-10-26 2007-04-18 上海交通大学医学院附属新华医院 Slow release type testis prosthesis and its application
WO2008100590A1 (en) * 2007-02-14 2008-08-21 Flex Technology Inc Flexible spine components
US20080221620A1 (en) * 2007-02-14 2008-09-11 Krause William R Flexible spine components
CN101130106A (en) * 2007-09-28 2008-02-27 清华大学 Method of producing artificial prosthesis of disci intervertebrales nucleus pulposus
US20100247600A1 (en) * 2009-03-24 2010-09-30 Warsaw Orthopedic, Inc. Therapeutic drug eluting implant cover and method of making the same
CN103167845A (en) * 2010-07-12 2013-06-19 美敦力瓦斯科尔勒公司 Method of making a stent with hollow struts
CN102106750A (en) * 2011-02-17 2011-06-29 上海微创骨科医疗科技有限公司 Spinal column dynamic connection rod
CN102260410A (en) * 2011-07-13 2011-11-30 大连海洋大学 Long-acting antibacterial organic silicon rubber material and preparation method thereof

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WO2015062408A1 (en) 2015-05-07

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