CN1210070C - High molecular human body implant and its preparing method and use - Google Patents
High molecular human body implant and its preparing method and use Download PDFInfo
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- CN1210070C CN1210070C CN 00132607 CN00132607A CN1210070C CN 1210070 C CN1210070 C CN 1210070C CN 00132607 CN00132607 CN 00132607 CN 00132607 A CN00132607 A CN 00132607A CN 1210070 C CN1210070 C CN 1210070C
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- 239000007943 implant Substances 0.000 title claims abstract description 38
- 238000000034 method Methods 0.000 title claims abstract 5
- 239000000463 material Substances 0.000 claims abstract description 28
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 23
- 238000002360 preparation method Methods 0.000 claims abstract description 8
- 238000005516 engineering process Methods 0.000 claims abstract description 4
- 238000007731 hot pressing Methods 0.000 claims abstract description 3
- 239000011347 resin Substances 0.000 claims abstract description 3
- 229920005989 resin Polymers 0.000 claims abstract description 3
- 238000002513 implantation Methods 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 8
- 238000005452 bending Methods 0.000 claims description 7
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 claims description 6
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 4
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 210000003625 skull Anatomy 0.000 claims description 4
- 102000007350 Bone Morphogenetic Proteins Human genes 0.000 claims description 3
- 108010007726 Bone Morphogenetic Proteins Proteins 0.000 claims description 3
- 229940112869 bone morphogenetic protein Drugs 0.000 claims description 3
- CADZRPOVAQTAME-UHFFFAOYSA-L calcium;hydroxy phosphate Chemical compound [Ca+2].OOP([O-])([O-])=O CADZRPOVAQTAME-UHFFFAOYSA-L 0.000 claims description 3
- OTMSDBZUPAUEDD-UHFFFAOYSA-N Ethane Chemical compound CC OTMSDBZUPAUEDD-UHFFFAOYSA-N 0.000 claims description 2
- 239000004952 Polyamide Substances 0.000 claims description 2
- 229920002647 polyamide Polymers 0.000 claims description 2
- 230000003068 static effect Effects 0.000 claims description 2
- 229920002521 macromolecule Polymers 0.000 claims 4
- URNTXHJZMAQBOV-UHFFFAOYSA-N [N].C(=C)N1C(CCC1)=O Chemical compound [N].C(=C)N1C(CCC1)=O URNTXHJZMAQBOV-UHFFFAOYSA-N 0.000 claims 1
- 230000035876 healing Effects 0.000 abstract description 8
- 230000015556 catabolic process Effects 0.000 abstract description 7
- 238000006731 degradation reaction Methods 0.000 abstract description 7
- 206010030113 Oedema Diseases 0.000 abstract 1
- 239000000835 fiber Substances 0.000 abstract 1
- 238000007493 shaping process Methods 0.000 abstract 1
- 210000000689 upper leg Anatomy 0.000 description 4
- 238000009825 accumulation Methods 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 208000010392 Bone Fractures Diseases 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
- 210000002758 humerus Anatomy 0.000 description 2
- 210000004409 osteocyte Anatomy 0.000 description 2
- 210000002303 tibia Anatomy 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- 206010018910 Haemolysis Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 238000005481 NMR spectroscopy Methods 0.000 description 1
- 206010070834 Sensitisation Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 210000000544 articulatio talocruralis Anatomy 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 210000001503 joint Anatomy 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000008313 sensitization Effects 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
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- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The present invention discloses a preparation technology for macromolecular implants of human bodies, a method and the purpose of the implants. Materials provided by the present invention are prepared by hot pressing resin fibers by a formula provided by the present invention, and have high strength and good toughness in a bone healing period after being implanted. A shape can be reprocessed according to requirements. The materials start degradation at the twenty-fourth week after being implanted, and can be completely absorbed in one year and a half to two years. Dropsy and sinus tracts are not generated, and the materials can be prepared into fixing blocks, shaping blocks, fastening pieces and suture for reconnecting injured and fractured bones. Thus, cost is greatly reduced. The present invention is an ideal macromolecular implant of human bodies.
Description
Technical field:
The present invention relates to a kind of human body absorbable polymer body implant, and preparation method thereof, product and its purposes.
Background technology
At present Finland and some countries of Europe, medically, for fixation of bone fragments used a kind of, human body absorbable polymer body implant material, and made hold-down bars and the bone screw that is used for fixing knochenbruch with this material.This material is to refer to that with poly-second glue fat (being called for short PGA) and poly-third glue (being called for short PLA) is that raw material is processed into through high molecular polymerization.(PLA) and (PGA) made hold-down bars and bone screw have following shortcoming in medical application;
1. about degree of degradation
Body implant should be in reasonable time behind implant into body, and is dissolved or dissolve under the condition that does not produce harmful material, and this is dissolved or dissolve and be called degraded.(PLA) and degree of degradation (PGA) all too early and too fast, they also do not begin healing at knochenbruch and just begin degraded, perhaps having degraded is over, and has lost hiring of supporting fully and protect.Even if the speed of better (PLA) of performance degraded is also faster than the healing rate of knochenbruch.
2. about intensity
When the human body knochenbruch connect again, knochenbruch was beginning healing the 8th week, therefore requires the fixture of implantation, in eight weeks after implantation and longer time, must maintain enough intensity.But clinical trial shows, though (PLA) and (PGA) its shear strength can reach 170MPa and 200MPa respectively before implantation, its bending strength can reach 200MPa and 250MPa respectively, but implant back its shear strength of eight weeks and drop to 160MPa and 0MPa respectively, its bending strength drops to 140MPa respectively and 0MPa. the tenth week its shear strength of back drops to 160MPa and 0MPa respectively, its bending strength drops to 120MPa and 0MPa respectively, after this speed of Xia Jianging faster (seeing attached list 1).Therefore (PLA) and the hold-down bars of (PGA) making and bone screw can only be used for connecing again of the little human body knochenbruch of stressed load, as metacarpal joint, ankle joint etc.
3. be easy to generate sinus tract
Because degradation speed is too fast behind the implant into body, medical statistics shows, behind (PLA) and body implant implant into body (PGA), patient about 10% is arranged, in eight to 12 weeks after operation, implant produces fluid accumulation, has 8% patient to produce sinus tract in operation place.Bring very big misery to patient, also make troubles to medical treatment and nursing.
4. because (PLA) He (PGA) degradation speed is too fast, intensity is low, as the implant into body thing, can only make hold-down bars and little load bone screw, the knochenbruch synthetism of stressed big load high-order bit can not be used.
5. (PLA) and (PGA) material price costliness, the bone screw of a φ 4.5mm is wanted 1500 yuan-2000 yuan (length differences), and the hold-down bars of a φ 3mm is wanted 500 yuan-1000 yuan.
Summary of the invention:
The purpose that high molecular human body embedding article of the present invention will reach technically is:
1. develop new body implant material,
2. its degree of degradation of appropriate reduction makes it to guarantee fully the healing of knochenbruch; Improve the intensity of material, guarantee the tree property of material;
3. in medical application, do not produce fluid accumulation, do not cause sinus tract;
4. enlarging the range of application of body implant, is service for patients better;
5. accelerate the healing of knochenbruch;
6. reduce the price of body implant greatly.
The purposes of invention:
This implant can be made following product: fixed block: intramedullary needle, spinal column, bone sleeve pipe, skull and fixed bar; Make dressing stick: bone clamping plate, fixed bar, bone sleeve pipe and skull; Make fastener: bone screw and operation suture thread.
The specific embodiment
The present invention is achieved by the following scheme, and through years of researches, through animal and clinical trial, the raw material of body implant body proposed by the invention composition is: (purity of raw materials is analytical pure)
| Raw material | Weight ratio in body implant of the present invention |
| Polyamide | 25％～70％ |
| Nitrogen one vinyl pyrrolidone | 2％～20％ |
| Methyl methacrylate | 2％～20％ |
| Calcium hydroxy phosphate | 7％～15％ |
| Bone morphogenetic protein(BMP) | 0.00001％～0.0005％ |
| Acetone | 7％～20％ |
| Ether | 20％～30％ |
| Ethane | 20％～35％ |
| Toluene | 10％～30％ |
The all components percentage by weight be combined into 100%.
Above material, because needed product difference, the position difference that product uses, the needed ratio of its each product are slightly different, above material forms through resin hot pressing.
Material of the present invention can be made various knochenbruch and connect body implant again, the body implant on various bones road, as be used for femur and tibia, the humerus of arm and the intramedullary needle that the radius knochenbruch connects again of thigh; Can manufacture synthetism thing---the bone clamping plate of shoulder bone fracture; Synthetism implants such as the high-strength bone screw of using in the time of can also making the human body operation, bone sleeve pipe.Can also make medical operation suture thread.More than these products because the product difference, the position difference of implant into body in the use, biochemistry, electrobiology, kinestate are different with required mechanical strength on concrete position, when concrete preparation, the present invention in the given proportion, proportioning separately is slightly different.
The present invention has following advantage:
1. high molecular human body embedding article material disclosed in this invention, good biocompatibility, nineteen ninety-five has been passed through the detection of medical high polymer product quality inspection center of State Pharmaceutical Administration.Detection return on qualifications (seeing attached list 2) such as no antibacterial toxicity, aseptic and acute general toxicity, haemolysis, Intradermal stimulation and sensitization of skin have been obtained.
2. high molecular human body embedding article disclosed in this invention, through the strictness test, before implantation, its modulus of elasticity in static bending E bends=4500MPa;
Modulus of elasticity in comperssion E pressure=5500MPa;
Bending strength σ bends=150MPa;
Comprcssive strength σ pressure=100MPa.
The product that this implant is made, it begins degraded around implanting back the 20, and a year and a half to two year is just absorbed fully.After the implantation, intensity reduces not obvious.Improve the intensity of material, reduced its degree of degradation rightly, made it to guarantee fully the healing of knochenbruch, and guaranteed the toughness of material.
3. high molecular human body embedding article material disclosed in this invention, in medical application, do not produce fluid accumulation, do not cause sinus tract, greatly facilitate postoperative nursery work, and in the time of a year and a half to two year, absorb fully gradually, do not need to perform an operation again, can save a large amount of blood plasma, medical expense, and alleviate patient's misery greatly.
4. high molecular human body embedding article material disclosed in this invention, enlarged the range of application of body implant, material of the present invention can be made the body implant that various knochenbruch connect again, the body implant of various skeletons, as be used for femur and tibia, the humerus of arm and the intramedullary needle that the radius knochenbruch connects again of thigh; The synthetism thing that can manufacture shoulder bone fracture is the bone clamping plate one by one; Synthetism implants such as the high-strength bone screw of using in the time of can also making the human body operation angles, bone sleeve pipe.Can also make medical operation suture thread, be service for patients better.
5. the made product of high molecular human body embedding article material disclosed in this invention can be accelerated knochenbruch
The healing of page 3, material of the present invention contains bone morphogenetic protein(BMP), can induce the growth of osteocyte, contains calcium hydroxy phosphate, can promote the osteocyte growth, therefore quickens to resolve symphysis significantly.
6. the needed raw material of material of the present invention is taken from domesticly fully, and the price of its product has only (PLA) and 1/5-1/10 (PGA), greatly reduces the price of product, has reduced cost.
7. material of the present invention has cutting ability well, can cut according to the needs of operation.
8. material of the present invention is nonmagnetic, does not influence X-ray examination, ultrasound diagnosis and nuclear magnetic resonance check after the implantation.
Claims (4)
1. the preparation method of a human body macromolecule implant, the feature of its preparation method are that its preparation method is divided into weight ratio and its preparation technology's method of the material composition of this implant;
1). the weight ratio of its composition of raw material is:
Raw material human body of the present invention is planted
Go into the weight ratio of thing
Polyamide 25%～70%
Nitrogen-vinyl pyrrolidone 2%～20%
Methymethacrylate 2%～20%
Calcium hydroxy phosphate 7%～15%
Bone morphogenetic protein(BMP) 0.00001%～0.0005%
Acetone 7%～20%
Ether 20%～30%
Ethane 20%～35%
Toluene 10%～30%
All components percentage by weight sum is 100%;
2). its preparation technology's method is: the material to above composition of raw material weight ratio forms through resin hot pressing.
2. the human body macromolecule implant of making according to the described method of claim 1, the feature of its implant be, this implant before implant into body, its
Modulus of elasticity in static bending E bends=4500MPa;
Modulus of elasticity in comperssion E pressure=5500MPa;
Bending strength σ bends=150MPa;
Comprcssive strength σ pressure=100MPa.
3. human body macromolecule implant according to claim 2 is characterized in that: the product that this material is made, after implantation the 20 around begin degraded, a year and a half to two year is just absorbed fully.
4. the purposes of human body macromolecule implant according to claim 2 is characterized in that, the made product of this implant can be made fixed block: intramedullary needle, spinal column, bone sleeve pipe, skull and fixed bar; Can make dressing stick: bone clamping plate, fixed bar, bone sleeve pipe and skull; Make fastener: bone screw and operation suture thread.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00132607 CN1210070C (en) | 2000-11-16 | 2000-11-16 | High molecular human body implant and its preparing method and use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00132607 CN1210070C (en) | 2000-11-16 | 2000-11-16 | High molecular human body implant and its preparing method and use |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97119073A Division CN1089009C (en) | 1997-10-22 | 1997-10-22 | Polymer human implant and its preparation method, product and use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1351891A CN1351891A (en) | 2002-06-05 |
| CN1210070C true CN1210070C (en) | 2005-07-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 00132607 Expired - Fee Related CN1210070C (en) | 2000-11-16 | 2000-11-16 | High molecular human body implant and its preparing method and use |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1210070C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301511A (en) * | 2013-06-20 | 2013-09-18 | 王惠 | Complex implant for fixing human skeletons |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105561401B (en) * | 2015-12-29 | 2020-06-02 | 深圳市昌华生物医学工程有限公司 | Composite fiber, manufacturing method and orthopedic binding wire |
-
2000
- 2000-11-16 CN CN 00132607 patent/CN1210070C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103301511A (en) * | 2013-06-20 | 2013-09-18 | 王惠 | Complex implant for fixing human skeletons |
| WO2014201763A1 (en) * | 2013-06-20 | 2014-12-24 | Wang Hui | Composite implant for fixing human skeleton |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1351891A (en) | 2002-06-05 |
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