CN101766835A - Metal anastomotic nail absorbable in vivo and preparation method thereof - Google Patents
Metal anastomotic nail absorbable in vivo and preparation method thereof Download PDFInfo
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- CN101766835A CN101766835A CN201010300983A CN201010300983A CN101766835A CN 101766835 A CN101766835 A CN 101766835A CN 201010300983 A CN201010300983 A CN 201010300983A CN 201010300983 A CN201010300983 A CN 201010300983A CN 101766835 A CN101766835 A CN 101766835A
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Abstract
The invention relates to a metal anastomotic nail absorbable in vivo and a preparation method thereof, which belong to the technical field of medical appliances. The metal anastomotic nail has a U-shaped structure and comprises a nail body and two nail legs which are arranged at two ends of the nail body respectively; and the anastomotic nail is made of magnesium alloy. The magnesium alloy comprises the following components in percentage by weight: 0.01 to 10 percent of Zn, 0.01 to 5 percent of Ca, 0.001 to 5 percent of Fe, 0.01 to 5 percent of Mn and the balance of Mg. The metal anastomotic nail can be continuously absorbed and has good biocompatibility.
Description
Technical field
What the present invention relates to is a kind of device of technical field of medical instruments, specifically is a kind of metal anastomotic nail absorbable in vivo and preparation method thereof.
Background technology
Anastomosis staple is the medical apparatus and instruments that the alternative traditional-handwork that uses on the present clinical medicine is sewed up, and is easy to use, sews up in operation fast, easy and simple to handle, can obviously shorten and organize open-assembly time, reduces wound and hemorrhage, effectively reduces postoperative complication.The anastomosis staple material of current clinical use mainly contains rustless steel, titanium or titanium alloy etc.These metal materials all are inert materials, non-degradable in human body, so anastomosis staple can forever exist as foreign body in human body, slowly discharges chip even toxic, irritating ion, cause the serious inflammatory reaction of surrounding tissue, reduce the biocompatibility and the safety of apparatus.Fall into the abdominal cavity if anastomat comes off, then may cause other problems.Can absorb anastomosis staple can address these problems.Anastomosis staple can be absorbed by the body voluntarily behind the operation wound heal, does not have adverse effects such as foreign body reaction, can improve the success rate of operation and the safety of apparatus.
Magnesium and magnesium alloy current potential are very low, corrosion degraded in containing the solution of chloride ion easily.Body fluid such as blood of human body are rich in chloride ion, thereby magnesium and alloy thereof can be absorbed by the body.Magnesium elements is the 4th cation of enriching in the human body, and the important nutrient that is absolutely necessary is closely related with the effect of human body 300 plurality of enzymes, and is most important to the effect of health.In addition, human body can pass through the unnecessary magnesium elements of the effective metabolism of kidney, so the magnesium ion that the corrosion degraded produces can excrete by urine.Therefore magnesium and magnesium alloy have good biological safety basis, can be as the degradable metallic biomaterial.Aluminium element generally acknowledges to have neurotoxicity, influences a series of important physical functions of organism.Rare earth element also can accumulate at human body, can toxigenicity in addition cause the surrounding tissue pathological changes (Wang Yang, Nie Liuwang, Chen Qilong. the biological safety of rare earth element is inquired into. biology magazine .2004,21 (2): 4-6).
Find through retrieval prior art, Chinese patent literature CN2686539, open day 2005-3-23, put down in writing a kind of " anastomosis staple of digestive tract stapler ", constituted U-shaped shape roughly by nail hat, nail lower limb, described nail lower limb has kink, the top of this kink is nail lower limb top, the bottom of this kink bends inwards at the kink place with respect to nail lower limb top for nail lower limb bottom, nail lower limb bottom, and the nail leg length of nail lower limb is 4.84 millimeters-4.92 millimeters.But the prior art has only designed overall dimensions, and its essence still is traditional non-degradable nail.
Summary of the invention
The present invention is directed to the prior art above shortcomings, a kind of metal anastomotic nail absorbable in vivo and preparation method thereof is provided.This anastomosis staple can be continued to absorb, and dies away after the scalpel edge healing, has excellent biological compatibility.
The present invention is achieved by the following technical solutions:
The present invention relates to a kind of metal anastomotic nail absorbable in vivo, described anastomosis staple is the U-shaped structure, comprises a nail body and is arranged at two nail lower limbs following closely the body two ends respectively, and this anastomosis staple is made by magnesium alloy.
Described nail height 3.0-20.0mm, the long 3.0-20.0mm of nail lower limb.
The component of described magnesium alloy and mass percent are followed successively by 0.01%-10%Zn, 0.01%-5%Ca, 0.001%-5%Fe, 0.01%-5%Mn, and surplus is Mg.
The cross sectional shape of described anastomosis staple is circular or square, and wherein the diameter of section of the anastomosis staple of circular cross-section is 0.1-3.0mm, the long 0.1-3.0mm in the cross section of the anastomosis staple of square-section, wide 0.1-3.0mm.
Be respectively equipped with tip on the described nail lower limb, conveniently squeeze into tissue.
The present invention relates to the preparation method of above-mentioned metal anastomotic nail absorbable in vivo, may further comprise the steps:
The first step, under protective atmosphere, pure magnesium is melted in crucible; add 0.01%-10%Zn, 0.01%-5%Ca, 0.001%-5%Fe, 0.01%-5%Mn successively according to mass percent afterwards; after stirring and being incubated, be cast into alloy cast ingot; handle through hot extrusion or hot rolling at last, make elementary blank.
Described protective atmosphere is meant any in following three kinds:
A) mist of sulfur hexafluoride and carbon dioxide;
B) argon;
C) mist of argon, sulfur hexafluoride and carbon dioxide;
Fusion temperature in the described crucible is 650 ℃-800 ℃;
Second step, elementary blank is cut turning processing, obtain metal anastomotic nail absorbable.
Anastomosis staple involved in the present invention can be continued to absorb in vivo, dies away after the scalpel edge healing, does not have the permanent zest to surrounding tissue, has excellent biological compatibility, has solved the problem that inertia anastomosis staples such as titanium exist.This nail does not contain rare earth, aluminum etc. in addition has the element of genotoxic potential to human body, guarantee biological safety, and employed alloying element comprises that Zn, Ca, Mn, Fe are the elements to the human body beneficial.
Description of drawings
Fig. 1 is the metal anastomotic nail absorbable sketch map.
The specific embodiment
Below embodiments of the invention are elaborated, present embodiment is being to implement under the prerequisite with the technical solution of the present invention, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
Embodiment 1
Melting 94wt%Mg-6wt%Zn alloy, 350 ℃ of heat treatments are hot extruded into elementary blank after 3 hours, 200 ℃ of extrusion temperatures.Last machining metal anastomotic nail absorbable.
The metal anastomotic nail absorbable nail body 1 long 4mm of present embodiment preparation, nail foot 2 long 30mm, the nail foot has tip.The cross section is circular, diameter 0.6mm.
Melting 99wt%Mg-1wt%Ca alloy, 400 ℃ of heat treatments are hot extruded into elementary blank after 3 hours, 250 ℃ of extrusion temperatures.Last machining metal anastomotic nail absorbable.
The metal anastomotic nail absorbable cross sectional shape of present embodiment preparation is a square, length of side 0.4mm.Nail height 3.5mm, the long 4mm of nail foot, nail foot end has tip.This nail is immersed in 1 liter of simulated body fluid external, a week back weight degraded 10%.
Melting 99wt%Mg-3wt%Zn-0.8wt%Mn alloy, 400 ℃ of heat treatments are hot extruded into elementary blank after 3 hours, 250 ℃ of extrusion temperatures.Last machining cross section is circular metal anastomotic nail absorbable.
The nail height 10mm of the absorbed anastomosis staple of present embodiment preparation, the long 8mm of nail foot, and have tip, diameter of section 0.9mm.Wherein follow closely body part three-point bending strength 500MPa.Soak 1 all backs weight-loss ratio 20% in the external normal saline, and find that after tested nail body three-point bending strength is about 400MPa.Certain mechanical property can be kept in the proof degradation process, the mechanics requirement of wound healing process can be satisfied.
Embodiment 4
Melting 94.9wt%Mg-5wt%Zn-0.1wt%Fe alloy, 360 ℃ of heat treatments are rolled into elementary blank after 4 hours, and hot-rolled temperature is 300 degree.Last machining cross section is rectangular metal anastomotic nail absorbable.
The metal anastomotic nail absorbable of present embodiment preparation, nail height 7mm, the long 8mm of nail foot has tip.The long 0.6mm in cross section, wide 0.2mm.External being immersed in 1 liter of simulated body fluid, degraded fully illustrates that the Fe element can effectively regulate and control degradation rate after 2 weeks.
Embodiment 5
Melting 93.2wt%Mg-6wt%Zn-0.8wt%Ca alloy, 360 ℃ of heat treatments are hot extruded into elementary blank after 4 hours, extrusion temperature 300 degree.Last machining cross section is circular metal anastomotic nail absorbable.
The metal anastomotic nail absorbable nail height 3.5mm of present embodiment preparation, the long 4mm of nail foot has tip.Diameter of section 0.3mm.Sew up the new zealand rabbit caecum with it.Find after one month that anastomosis staple is absorbed 40%, wound healing is good; Histology proof anastomosis staple surrounding tissue is normal, and explanation can absorb inflammatory reaction or the allergy that anastomosis staple does not bring out surrounding tissue.
Embodiment 6
Melting 93.9wt%Mg-0.5wt%Mn-5wt%Zn-0.6wt%Ca alloy, 400 ℃ of heat treatments are rolled into elementary blank after 3 hours, hot-rolled temperature 300 degree.Last machining cross section is rectangular metal anastomotic nail absorbable.
The metal anastomotic nail absorbable of present embodiment preparation, nail height 6mm, the long 7mm of nail foot.The cross section is a rectangle, wherein long 1.0mm, wide 1.0mm.Utilize this can absorb anastomosis staple and sew up the beasle dog esophagus edge of a knife.Draw materials after 2 months, find that the edge of a knife is almost recovered, anastomosis staple decomposes 50%.Do not see inflammatory reaction or other harmful effects in the nail surrounding tissue.
Claims (7)
1. metal anastomotic nail absorbable in vivo, described anastomosis staple is the U-shaped structure, comprise a nail body and be arranged at two nail lower limbs following closely the body two ends respectively, it is characterized in that, described anastomosis staple is made by magnesium alloy, the component of this magnesium alloy and mass percent are followed successively by 0.01%-10%Zn, 0.01%-5%Ca, 0.001%-5%Fe, 0.01%-5%Mn, and surplus is Mg.
2. metal anastomotic nail absorbable in vivo according to claim 1 is characterized in that, described nail height 3.0-20.0mm, the long 3.0-20.0mm of nail lower limb.
3. metal anastomotic nail absorbable in vivo according to claim 1 is characterized in that, is respectively equipped with tip on the described nail lower limb.
4. metal anastomotic nail absorbable in vivo according to claim 1 is characterized in that, the cross sectional shape of described anastomosis staple is circular or square.
5. the preparation method of a metal anastomotic nail absorbable in vivo according to claim 1 is characterized in that, may further comprise the steps:
The first step, under protective atmosphere, pure magnesium is melted in crucible, add 0.01%-10%Zn, 0.01%-5%Ca, 0.001%-5%Fe, 0.01%-5%Mn successively according to mass percent afterwards, after stirring and being incubated, be cast into alloy cast ingot, handle through hot extrusion or hot rolling at last, make elementary blank;
Second step, elementary blank is cut turning processing, obtain metal anastomotic nail absorbable.
6. the preparation method of metal anastomotic nail absorbable in vivo according to claim 5 is characterized in that, described protective atmosphere is meant any in following three kinds:
A) mist of sulfur hexafluoride and carbon dioxide;
B) argon;
C) mist of argon, sulfur hexafluoride and carbon dioxide.
7. the preparation method of metal anastomotic nail absorbable in vivo according to claim 5 is characterized in that, the described fusion temperature that melts in crucible is 650 ℃-800 ℃.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010300983A CN101766835A (en) | 2010-02-01 | 2010-02-01 | Metal anastomotic nail absorbable in vivo and preparation method thereof |
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| CN201010300983A CN101766835A (en) | 2010-02-01 | 2010-02-01 | Metal anastomotic nail absorbable in vivo and preparation method thereof |
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Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102824203A (en) * | 2011-06-14 | 2012-12-19 | 常州市康迪医用吻合器有限公司 | Surgical fitting nail for kidney-shape forming and forming groove thereof |
| WO2012171423A1 (en) * | 2011-06-14 | 2012-12-20 | 常州市康迪医用吻合器有限公司 | Kidney-shaped surgical stapler nail and shaping groove therefor |
| CN102950235A (en) * | 2012-11-23 | 2013-03-06 | 江苏风和医疗器材有限公司 | Preparation method of anastomosis nail |
| CN102950234A (en) * | 2012-11-23 | 2013-03-06 | 江苏风和医疗器材有限公司 | Anastomosis nail preparation device |
| CN103110977A (en) * | 2013-01-29 | 2013-05-22 | 爱宝骨科有限公司 | Biodegradable copper-containing coating pure magnesium anastomosis nail and preparation method thereof |
| CN103330582A (en) * | 2013-06-06 | 2013-10-02 | 常熟市亨利医疗器械有限公司 | Absorbable suturing nail for foreskin incision stitching instrument |
| CN103519857A (en) * | 2013-10-11 | 2014-01-22 | 苏州奥芮济医疗科技有限公司 | Absorbable metal closing nail in body and of three-dimensional structure and forming method thereof |
| WO2015010478A1 (en) * | 2013-07-24 | 2015-01-29 | 无锡市神康医疗器械设备有限公司 | Disposable circumcision anastomat suturing nail |
| CN105640601A (en) * | 2016-04-08 | 2016-06-08 | 苏州奥芮济医疗科技有限公司 | In-vivo absorbable metal surgical staple and preparation method thereof |
| CN108348647A (en) * | 2015-08-26 | 2018-07-31 | 伊西康有限责任公司 | Nail including covering |
| CN110477982A (en) * | 2019-07-24 | 2019-11-22 | 中国科学院金属研究所 | Anti- calculus anastomosis staple of degradable antibacterial suitable for urinary system and preparation method thereof |
| CN112245665A (en) * | 2020-09-28 | 2021-01-22 | 兰州理工大学 | Degradable magnesium alloy anastomosis nail and preparation method thereof |
| CN113528912A (en) * | 2021-07-12 | 2021-10-22 | 中山大学附属第六医院 | In-vivo absorbable metal anastomosis nail and preparation method thereof |
-
2010
- 2010-02-01 CN CN201010300983A patent/CN101766835A/en active Pending
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012171423A1 (en) * | 2011-06-14 | 2012-12-20 | 常州市康迪医用吻合器有限公司 | Kidney-shaped surgical stapler nail and shaping groove therefor |
| CN102824203A (en) * | 2011-06-14 | 2012-12-19 | 常州市康迪医用吻合器有限公司 | Surgical fitting nail for kidney-shape forming and forming groove thereof |
| CN102824203B (en) * | 2011-06-14 | 2015-05-06 | 常州市康迪医用吻合器有限公司 | Surgical fitting nail for kidney-shape forming and forming groove thereof |
| CN102950235B (en) * | 2012-11-23 | 2015-02-04 | 江苏风和医疗器材有限公司 | Preparation method of anastomosis nail |
| CN102950235A (en) * | 2012-11-23 | 2013-03-06 | 江苏风和医疗器材有限公司 | Preparation method of anastomosis nail |
| CN102950234A (en) * | 2012-11-23 | 2013-03-06 | 江苏风和医疗器材有限公司 | Anastomosis nail preparation device |
| CN103110977A (en) * | 2013-01-29 | 2013-05-22 | 爱宝骨科有限公司 | Biodegradable copper-containing coating pure magnesium anastomosis nail and preparation method thereof |
| CN103330582A (en) * | 2013-06-06 | 2013-10-02 | 常熟市亨利医疗器械有限公司 | Absorbable suturing nail for foreskin incision stitching instrument |
| WO2015010478A1 (en) * | 2013-07-24 | 2015-01-29 | 无锡市神康医疗器械设备有限公司 | Disposable circumcision anastomat suturing nail |
| CN103519857A (en) * | 2013-10-11 | 2014-01-22 | 苏州奥芮济医疗科技有限公司 | Absorbable metal closing nail in body and of three-dimensional structure and forming method thereof |
| CN108348647A (en) * | 2015-08-26 | 2018-07-31 | 伊西康有限责任公司 | Nail including covering |
| CN105640601A (en) * | 2016-04-08 | 2016-06-08 | 苏州奥芮济医疗科技有限公司 | In-vivo absorbable metal surgical staple and preparation method thereof |
| CN105640601B (en) * | 2016-04-08 | 2017-08-15 | 苏州奥芮济医疗科技有限公司 | Metal anastomotic nail absorbable in vivo and preparation method thereof |
| CN110477982A (en) * | 2019-07-24 | 2019-11-22 | 中国科学院金属研究所 | Anti- calculus anastomosis staple of degradable antibacterial suitable for urinary system and preparation method thereof |
| CN112245665A (en) * | 2020-09-28 | 2021-01-22 | 兰州理工大学 | Degradable magnesium alloy anastomosis nail and preparation method thereof |
| CN113528912A (en) * | 2021-07-12 | 2021-10-22 | 中山大学附属第六医院 | In-vivo absorbable metal anastomosis nail and preparation method thereof |
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