CN204562353U - The biological screw of a kind of non-degradable type - Google Patents
The biological screw of a kind of non-degradable type Download PDFInfo
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- CN204562353U CN204562353U CN201520204174.XU CN201520204174U CN204562353U CN 204562353 U CN204562353 U CN 204562353U CN 201520204174 U CN201520204174 U CN 201520204174U CN 204562353 U CN204562353 U CN 204562353U
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Abstract
The biological screw of a kind of non-degradable type, the adapter screw comprising screw body and fix with screw body end, described screw body is provided with inverted trapezoidal and rotates screw thread, the end that itself and adapter screw fix becomes middle part webbing along thin nut, the surrounding of described nut has the bayonet socket of multiple depression, the link of adapter screw and screw body, to there being multiple projection that can fix at described bayonet socket, is provided with the alveolus of depression in the middle part of the other end of adapter screw.Non-degradable biological activity cancellous bone screw of the present utility model, with inverted trapezoidal screw thread design, adds the early stage anti-pull-out strength of screw, due to PA66/G or GO material can with autologous bone bony union, effectively can prevent screw loosening, and take out without the need to second operation.The research success of the biological screw of non-degradable of the present utility model, will fill up the blank of non-degradable biological activity cancellous bone screw clinically, fixedly provides another kind of optional internal fixation material, for patient brings glad tidings for cancellous bone fracture.
Description
Technical field
This utility model relates to orthopedic implant instrument field, particularly the biological screw of a kind of non-degradable type.
Background technology
Over nearly 20 years, China's orthopedic medical device market development is swift and violent, particularly the Eleventh Five-Year Plan period, China's orthopedic medical device market is by the scale development of 32.8 hundred million yuans of 2006 to 57.7 hundred million yuans in 2009, and compound growth rate is up to 20.7%.By 2015, Chinese orthopaedics implantation instrument market will rise to 16,600,000,000 yuans, become global orthopaedics implantation instrument second largest market.
Joint type, wound class and spinal column class are the large main flow category product of orthopedic medical device three.Wherein, take bone screw as the wound class apparatus of representative, be scale accounting the maximum in three large products, reach 38%.Therefore, constantly opening up new technique in this technical field, develop new product, is the important ring capturing orthopedic medical device market.
China's orthopedics patient enormous amount, the orthopedic instrument that the needs of patients of B&J wound is a large amount of, and the ligament being widely used in extremity cancellous bone fracture, vertebral fracture and Cruciate ligament reconstruction of cancellous bone screw fixing in the middle of, the medical market that holder is huge.Current cancellous bone screw is mainly metal material, particularly the metallic screw of titanium alloy material is widely used in clinical, but in long-term application practice, find that metal material exists the unavoidable problems such as the high and biological activity of stress shielding, elastic modelling quantity is poor, thus cause healing time prolongation, healing quality reduction, and metal material generally needs second operation to take out, not only increase the financial burden of patient and country, and increase patient suffering, expend medical resource.The negative effect of metal internal fixation material to union of fracture has expedited the emergence of the research and development of bioactive materials, from 80 years last century poly-lactic acid material be used for clinical since, various associated bioactive materials development is swift and violent, once be considered to substitute traditional metal material, but in process of clinical application subsequently, find that poly-lactic acid material exists mechanical strength difference, the problems such as the difficult control of degraded and cytotoxicity, in the later stage nineties gradually by orthopedist and patient abandon, be mainly used in decorative sursery at present, during pediatric surgery and ligamentaum cruciatum are fixed, at ankle surgery, apply on a small quantity in the non-bearing bone internal fixtion such as hands surgery.After the investigation and application of polylactic acid material meets with bottleneck, multiple biological activity bone alternate material is have developed in worldwide, based on composite, as hydroxyapatite/polylactic acid, hydroxyapatite/calcium sulfate, carbon fiber enhancement polylactic acid material etc., the poor reparation that can only be used for non-weight bearing position Cranial defect of mechanical strength due to this this material, can not be used as internal fixation material.
Bone screw in the market, according to material, be divided into traditional metal and emerging nonmetal two classes, can be divided into degradable and non-degradable two class according to degrade, there is following shortcoming in it respectively:
1) traditional titanium alloy bone screw, elastic modelling quantity is large, and biological activity is poor, causes stress shielding.Screw surrounding bone is organized and is born less stress for a long time, loosens gradually, has both affected pre existing fracture healing, has again the new risk sending out fracture.Simultaneously also due to fixing too firm, do not have in fracture healing process " fine motion " of local, the fracture after healing is insecure.Generally need second operation to take out, increase patient suffering and financial burden, cause medical resource consumption.
2) current nonmetal degradable bone screw, mechanical strength is too little, easily ruptures, cause fixing unsuccessfully during implantation and after implanting.Degradation material can only stable existence several weeks, and just start degraded, the bony union of fracture at least needs 3 months, and degradable screw just lost effective fixation before union of fracture.
3) nonmetal degradable bone screw, in degradation process, produces cytotoxicity, and causes local inflammation to react.Lack biological activity, both cannot with autologous osseous tissue bony union, can not promote that bone growth heals.
4) current nonmetal non-degradable type bone screw, though there is not degradable screw to lose constant intensity and the Cytotoxic problem of catabolite too early, but, still mechanical strength is not enough, face the risk of fracture, cause fixing unsuccessfully.
5) current all nonmetal bone screws, no matter be degradable or non-degradable type, because mechanical strength is not enough, when being screwed into osseous tissue with screwdriver, nut alveolus easily damages, therefore, nut shape takes particular design more, needs the screwdriver made specially could mate with the alveolus of nut.In operation, use this type of bone screw if want, then hospital must be equipped with the equipment such as corresponding screwdriver specially, adds Financial cost, is unfavorable for marketing.
There is provided a kind of non-degradable biological screw based on this, have excellent biologic activity and mechanical property concurrently, again can with autologous bone bony union, and effectively can prevent screw loosening, screw pulling test strength is high, and takes out without the need to second operation and just seem very necessary.
Utility model content
For solving above-mentioned prior art Problems existing, the purpose of this utility model is to provide a kind of non-degradable biological screw, has excellent biologic activity and mechanical property concurrently, again can with autologous bone bony union, and effectively can prevent screw loosening, and there is higher screw pulling test strength.
For achieving the above object, the technical solution of the utility model is:
The biological screw of a kind of non-degradable type, the adapter screw comprising screw body and fix with screw body end, described screw body is provided with inverted trapezoidal and rotates screw thread, the end that itself and adapter screw fix becomes middle part webbing along thin nut, the surrounding of described nut has the bayonet socket of multiple depression, the link of adapter screw and screw body, to there being multiple projection that can fix at described bayonet socket, is provided with the alveolus of depression in the middle part of the other end of adapter screw.
Further, described adapter screw is cylindric, equal with the link girth of screw body, and each lobed interior of the link of adapter screw caves inward.
Further, described adapter screw projection and be 4 with the bayonet socket on the screw body of its adaptation.
Further, the depression alveolus of adapter screw is corner alveolus or hexagonal alveolus.
Further, described adapter screw adopts rustless steel or titanium alloy to make.
Further, described screw body adopts polyamide 66 and graphene composite material to obtain.
Further, in described screw body, the mass fraction of Graphene accounts for 1%.
Further, the preparation method of described screw body comprises the steps:
Step one, every 1g single-layer graphene use high-energy ultrasonic instrument (purchased from Shanghai than bright Instrument Ltd., BILON92-II) in 40mlDMF (DMF), frequency 25kHz, power 400W, time 40min, obtain Graphene DMF dispersion liquid;
Step 2, every 1g Graphene is dissolved in the corresponding 10mlDMF of every 1g polyamide 66 in DMF (DMF) to 4g polyamide 66 by mechanical agitation, obtains polyamide 66 solution;
Step 3, band churned mechanically there-necked flask in; add above-mentioned polyamide 66 solution and Graphene DMF (N; dinethylformamide) dispersion liquid; carry out ultrasound wave and powerful mechanical agitation; 4 hours persistent period, pour mixture into open-top receptacle, drying 10 hours in 50 DEG C of baking ovens; obtained membranaceous solid crushing is become granule or powder, namely obtains Graphene/polyamide 66 master batch
Step 4, every 100g Graphene/polyamide 66 master batch and 1900g polyamide 66 dry 24h in 100 DEG C of vacuum drying ovens, then fully mix, add parallel dual-screw extruding machine (purchased from Rhea high polymer Equipment Limited, Nanjing, TSE-30A) and carry out graininess polyamide 66/graphene composite material that extrusion granulating obtains Graphene mass fraction 1%;
Step 5, by step 4 gained granule dry 24h in 100 DEG C of vacuum drying ovens, add injection machine (purchased from Ningbo span machinery, BOLE 160/120C), use corresponding mould injection mo(u)lding, obtain the biological screw body of polyamide 66/graphene composite material.
Relative to prior art, the beneficial effects of the utility model are:
1, compared with metal current material bone screw, this utility model elastic modelling quantity is little, close to Human Cortex's bone, avoids " stress shielding " effect;
2, compared with current nonmetallic materials bone screw, this utility model mechanical strength is good, implant neutralization implant after not frangibility, fracture fixation is firm;
3, this utility model is without the need to taking out by second operation, owing to having good biocompatibility, even if long-term existence is in body, does not also affect normal physiological function;
4, this utility model has better biological activity, effectively promotes bone growth, promotes union of fracture;
5, this utility model adopts special afterbody design, does not need special screwdriver, and the risk that when reducing implantation, fracture or nut alveolus damage
6, non-degradable biological activity cancellous bone screw is with its special inverted trapezoidal screw thread design, adds the early stage anti-pull-out strength of screw, simultaneously due to n-HA/PA66 material can with autologous bone bony union, effectively can prevent screw loosening, and take out without the need to second operation.The research success of the biological screw of non-degradable of the present utility model, the blank of non-degradable biological activity cancellous bone screw clinically will be filled up, fixedly provide another kind of optional internal fixation material for cancellous bone fracture, for patient brings glad tidings, produce huge economic and social benefit.Also the material substitution such as polyether-ether-ketone, polyethylene polyamide 66 can be used in this utility model.
Accompanying drawing explanation
Fig. 1 is structural representation of the present utility model.
Fig. 2 is combinative structure schematic diagram of the present utility model.
Wherein, 1-screw body, 2-adapter screw, 3-inverted trapezoidal rotates screw thread, 4-nut, 5-bayonet socket, and 6-is protruding, 7-alveolus.
Detailed description of the invention
Below in conjunction with the drawings and the specific embodiments, this utility model scheme is described in further detail:
As shown in Figure 1, the biological screw of a kind of non-degradable type, the adapter screw 2 comprising screw body 1 and fix with screw body 1 end, as shown in Figure 2, described screw body 1 is provided with inverted trapezoidal and rotates screw thread 3, the end that itself and adapter screw 2 fix becomes middle part webbing along thin nut 4, the surrounding of described nut 4 has the bayonet socket 5 of multiple depression, the link of adapter screw 2 and screw body 1, to there being multiple projection 6 that can fix at described bayonet socket 5, is provided with the alveolus 7 of depression in the middle part of the other end of adapter screw 2.
Further, described adapter screw 2 is cylindric, equal with the link girth of screw body 1, and each protruding 6 inside of the link of adapter screw 2 cave inward.
Further, described adapter screw 2 projection 6 and be 4 with the bayonet socket 5 on the screw body 1 of its adaptation.
Further, the depression alveolus 7 of adapter screw 2 is corner alveolus or hexagonal alveolus.
Further, described adapter screw 2 adopts rustless steel or titanium alloy to make.
Further, described screw body 1 adopts polyamide 66 and graphene composite material to obtain.
Further, in described screw body 1, the mass fraction of Graphene accounts for 1%.
Further, the preparation method of described screw body 1 comprises the steps:
Step one, every 1g single-layer graphene use high-energy ultrasonic instrument (purchased from Shanghai than bright Instrument Ltd., BILON92-II) in 40mlDMF (DMF), frequency 25kHz, power 400W, time 40min, obtain Graphene DMF dispersion liquid;
Step 2, every 1g Graphene is dissolved in the corresponding 10mlDMF of every 1g polyamide 66 in DMF (DMF) to 4g polyamide 66 by mechanical agitation, obtains polyamide 66 solution;
Step 3, band churned mechanically there-necked flask in; add above-mentioned polyamide 66 solution and Graphene DMF (N; dinethylformamide) dispersion liquid; carry out ultrasound wave and powerful mechanical agitation; 4 hours persistent period, pour mixture into open-top receptacle, drying 10 hours in 50 DEG C of baking ovens; obtained membranaceous solid crushing is become granule or powder, namely obtains Graphene/polyamide 66 master batch
Step 4, every 100g Graphene/polyamide 66 master batch and 1900g polyamide 66 dry 24h in 100 DEG C of vacuum drying ovens, then fully mix, add parallel dual-screw extruding machine (purchased from Rhea high polymer Equipment Limited, Nanjing, TSE-30A) and carry out graininess polyamide 66/graphene composite material that extrusion granulating obtains Graphene mass fraction 1%;
Step 5, by step 4 gained granule dry 24h in 100 DEG C of vacuum drying ovens, add injection machine (purchased from Ningbo span machinery, BOLE 160/120C), use corresponding mould injection mo(u)lding, obtain the biological screw body of polyamide 66/graphene composite material.
Two, preparation process
Part A (screw body)
The preparation (Graphene mass fraction 20%) of 1, polyamide 66/Graphene master batch
By 1g single-layer graphene (according to the preparation of method described in Chinese patent application 200910067708.8) at 40mlDMF (N, dinethylformamide) in high-energy ultrasonic instrument (purchased from Shanghai than bright Instrument Ltd., BILON92-II), frequency 25kHz, power 400W, time 40min, obtains Graphene DMF dispersion liquid;
Polyamide 66 (1g Graphene is to 4g polyamide 66) is dissolved in (the corresponding 10mlDMF of 1g polyamide 66) in DMF (DMF) by mechanical agitation, obtains polyamide 66 solution;
In the churned mechanically there-necked flask of band; add above-mentioned polyamide 66 solution and Graphene DMF (N; dinethylformamide) dispersion liquid; carry out ultrasound wave and powerful mechanical agitation; 4 hours persistent period, pour mixture into open-top receptacle, drying 10 hours in 50 DEG C of baking ovens; obtained membranaceous solid crushing is become granule or powder, namely obtains Graphene/polyamide 66 master batch
2, the preparation of polyamide 66/Graphene (Graphene mass fraction 1%)
The dry 24h in 100 DEG C of vacuum drying ovens by 100g Graphene/polyamide 66 master batch and 1900g polyamide 66, then fully mix, add parallel dual-screw extruding machine (purchased from Rhea high polymer Equipment Limited, Nanjing, TSE-30A) and carry out extrusion granulating.Parameter is as table 1:
Table 1
Obtain graininess polyamide 66/graphene composite material (Graphene mass fraction 1%)
3, injection molding prepares screw
By above-mentioned polyamide 66/graphene composite material (Graphene mass fraction 1%) granule dry 24h in 100 DEG C of vacuum drying ovens, add injection machine (purchased from Ningbo span machinery, BOLE160/120C), use corresponding mould injection mo(u)lding, obtain the biological screw (part A) of polyamide 66/graphene composite material, parameter is as table 2-5:
Table 2: temperature setting (unit: degree Celsius, DEG C)
| One section | Two-stage nitration | Three sections |
| 280 | 275 | 260 |
Table 3: Speed Setting (Grams Per Second, g/s)
Table 4: pressure setting (unit: MPa, Mpa)
Table 5: time setting (unit: second, s)
Meanwhile, prepare mechanical test batten and cell experiment thin slice, carry out mechanics properties testing and biological activity, histocompatibility detects.
Mechanics properties testing:
: part B (adapter screw):
Obtained by CNC milling machine
Three, Performance Detection
1, mechanics properties testing
Use microcomputer controlled electronic universal tester (purchased from Rui Geer Instrument Ltd. of Shenzhen, RG3050) performance as table 6:
Table 6
Structure and working principle of the present utility model is:
Operation principle: utilize hexagonal or corner screw to tighten screw body 1 by adapter screw 2, fixing appropriate after, pull out adapter screw 2, complete implant procedure, owing to being in depression in the middle part of adapter screw 2 bayonet socket 6 end, what be convenient to be combined with nut 4 is tightr, and is designed by the fixing of bayonet socket 6 with depression 5, intensity is larger, therefore can prevent relative to plain screw cause because nut alveolus damages in tightening twist tight or this problem of damage is caused to screw.This utility model screw body 1 and adapter screw 2 form biological screw system, unitary design, because adapter screw 3 afterbody is designed to the various conventional cell design such as corner or interior hexagonal in common metal screw, normal screws cutter is used to get final product pedicle screw body, convenient to implant, and in implantation process not easy fracture.
1) material of screw is improved:
Utility model people once developed nanometer hydroxyapatite/polyamide 66 (n-HA/PA66) composite biological material with independent intellectual property right.This material has excellent biologic activity and mechanical property, and researched and developed into artificial vertebral body and be successfully applied to and clinically reach 10 years, its safety and effectiveness are extensively confirmed.
On the basis of this material, prepare polyamide 66/graphene oxide or graphene oxide composite material.
Utilize graphene oxide (GO) or Graphene (G) enhancing to high polymer bone tissue engineering scaffold to mend tough characteristic, promote the mechanical property of bone screw, reduce when implanting and the risk of fracture after implanting.
Utilize G or GO to promote cell proliferation, promote to increase the characteristic of Osteoblast Differentiation the biological activity of this material, make screw and osseous tissue bony union.Screw except as conventional titanium alloy screw with bone physical bond except, also form bioconjugation, further improve fixing stability, improve resistance to plucking output capacity.Meanwhile, can also Oesteoblast growth be promoted, promote Osteoblast Differentiation.
2) structure of screw is improved:
1, particular design is carried out to screw afterbody, and introduce " biological adapter screw ".Should " adapter " be connected with screw body when screw dispatches from the factory, adapter is metal material, the alveolus of the Common Shape such as hexagonal alveolus in afterbody employing conventional metals screw.During pedicle screw, do not need to use special device, use existing conventional screw driver for orthopaedics, can implant smoothly.After to be implanted, then " biological adapter screw " is separated with screw body.This design solves nut alveolus and is easily damaged this problem by screwdriver, significantly promotes the success rate of implantation.Further, owing to not needing user to be equipped with special screwdriver, surgeon is easy to accept, and is conducive to marketing.Current cancellous bone screw is based on titanium alloy material, and absorbable biological material is mainly used in the fixing of non-weight bearing bone, does not also have the non-degradable biological activity cancellous bone screw that a kind of biomechanics is excellent both at home and abroad;
2, through the non-degradable biological activity cancellous bone screw of improvement design when not affecting screw body and being screwed into, special nut designs, significantly promotes the success rate of implantation.Further, owing to not needing user to be equipped with special screwdriver, surgeon is easy to accept, and is conducive to marketing;
Cancellous bone screw designed by this utility model is the non-degradable biomaterial close to cortical bone intensity, comparatively metal material, biological activity is good, and elastic modelling quantity is close to human body natural's bone, exist in fracture healing process " fine motion " of certain limit, knitting quality can be improved; Compared with absorbable material, without the cytotoxicity of catabolite, there is better biomechanical property, can directly and host bone heal, enough constant intensities can be provided.
The above, be only detailed description of the invention of the present utility model, but protection domain of the present utility model is not limited thereto, and any change of expecting without creative work or replacement, all should be encompassed within protection domain of the present utility model.Therefore, the protection domain that protection domain of the present utility model should limit with claims is as the criterion.
Claims (6)
1. the biological screw of non-degradable type, it is characterized in that, the adapter screw comprising screw body and fix with screw body end, described screw body is provided with inverted trapezoidal and rotates screw thread, the end that itself and adapter screw fix becomes middle part webbing along thin nut, the surrounding of described nut has the bayonet socket of multiple depression, and the link of adapter screw and screw body, to there being multiple projection that can fix at described bayonet socket, is provided with the alveolus of depression in the middle part of the other end of adapter screw.
2. the biological screw of non-degradable type according to claim 1, it is characterized in that, described adapter screw is cylindric, equal with the link girth of screw body, and each lobed interior of the link of adapter screw caves inward.
3. the biological screw of non-degradable type according to claim 1, is characterized in that, the projection of described adapter screw and be 4 with the bayonet socket on the screw body of its adaptation.
4. the biological screw of non-degradable type according to claim 1, it is characterized in that, the depression alveolus of adapter screw is corner alveolus or hexagonal alveolus.
5. the biological screw of non-degradable type according to claim 1, is characterized in that, described adapter screw adopts rustless steel or titanium alloy to make.
6. the biological screw of non-degradable type according to claim 1, is characterized in that, described screw body adopts polyamide 66 and graphene composite material to obtain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520204174.XU CN204562353U (en) | 2015-04-07 | 2015-04-07 | The biological screw of a kind of non-degradable type |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520204174.XU CN204562353U (en) | 2015-04-07 | 2015-04-07 | The biological screw of a kind of non-degradable type |
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| Publication Number | Publication Date |
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| CN204562353U true CN204562353U (en) | 2015-08-19 |
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| CN201520204174.XU Expired - Fee Related CN204562353U (en) | 2015-04-07 | 2015-04-07 | The biological screw of a kind of non-degradable type |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104921800A (en) * | 2015-04-07 | 2015-09-23 | 重庆医科大学 | Non-degradable biological screw |
| CN106806049A (en) * | 2015-12-02 | 2017-06-09 | 珠海和凡医药股份有限公司 | A kind of medical application of novel graphite alkene material |
-
2015
- 2015-04-07 CN CN201520204174.XU patent/CN204562353U/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104921800A (en) * | 2015-04-07 | 2015-09-23 | 重庆医科大学 | Non-degradable biological screw |
| CN104921800B (en) * | 2015-04-07 | 2018-03-30 | 重庆医科大学 | A kind of non-degradable type biology screw |
| CN106806049A (en) * | 2015-12-02 | 2017-06-09 | 珠海和凡医药股份有限公司 | A kind of medical application of novel graphite alkene material |
| CN106806049B (en) * | 2015-12-02 | 2018-10-16 | 珠海和凡医药股份有限公司 | A kind of preparation method and medical application of novel graphite alkene material |
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| C14 | Grant of patent or utility model | ||
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| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20150819 Termination date: 20190407 |