CN100556376C - The preparation method of stomach and intestine anastomosis bracket - Google Patents
The preparation method of stomach and intestine anastomosis bracket Download PDFInfo
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- CN100556376C CN100556376C CN 200710071563 CN200710071563A CN100556376C CN 100556376 C CN100556376 C CN 100556376C CN 200710071563 CN200710071563 CN 200710071563 CN 200710071563 A CN200710071563 A CN 200710071563A CN 100556376 C CN100556376 C CN 100556376C
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Abstract
The invention discloses a kind of preparation method of stomach and intestine anastomosis bracket, may further comprise the steps: 1) lactone and/or the cyclic carbonate with hydroxy carboxylic acid is raw material, under the effect of catalyst, is prepared into mixture by ring-opening polymerisation in vacuum environment; 2) with said mixture by solution-cast, melt extrude, fusion injection moulding or melting model be pressed onto in the mould cavity of given shape, shaped support; 3) above-mentioned shaped support is packed after sterilization treatment.The invention also discloses the stomach and intestine anastomosis bracket of making according to the method described above, the degradation time of this support can mate with the cycle of gastrointestinal tract postoperative wound healing.
Description
Technical field
The present invention relates to a kind of stomach and intestine anastomosis bracket and preparation method thereof.
Background technology
The gastrointestinal tract anastomosis operation is one of modal operation of surgery, as stomach-esophagus coincide, stomach-intestinal coincide, small intestinal-esophagus coincide, intestinal-intestinal coincide, anus-intestinal coincide etc.The gastrointestinal tract anastomosis that extensively adopts clinically mainly contains two kinds at present: manual suture method and anastomat stitching method.These two kinds of sewing methods have many defectives such as big, the time-consuming and expense costliness of difficulty, and above-mentioned identical method also has complication such as the anastomotic leakage of postoperative and anastomotic stricture.It is unique a kind of stapling apparatus that does not have stitching that the present a kind of gastrointestinal tract that adopts does not clinically have the identical anastomotic stoma snap-fastener (Murphy button) of stitching, but because this installation cost height, especially the anastomosis ring card will cause the phenomenon of anastomotic stoma necrosis to anastomotic stoma extruding tension.
Alcond had once proposed to be used for the operating anastomosis bracket of pipe (USP 4674506).But the patent of Alcond has only proposed to be used for the design of human body pipe support, does not relate to used problem of materials.Because the biotic environment of human body different tissues is widely different, the material and the support of support must be designed simultaneously, and significance of application is just arranged.
On the basis of Alcond, the patent of Jessen (USP 5192289) is to propose to prepare support with polyglycolic acid.Schob etc. to the evaluation undertaken by the zoopery of the support of polyglycolic acid preparation (TheAmerican Journal of Surgery, 1997, vol.173, pp312-319).Because the degradation rate of polyglycolic acid homopolymer is constant, can't satisfy human body different tissues environment to the requirement in scaffold degradation cycle, this method can't obtain the regulatable polymeric stent of degradation cycle.
Lv Yi has proposed a kind of biliary duct jejunum anastomotic scaffold (200510022718.1) of conehead magnetic end.But the material to support does not propose clear and definite description, only proposes to apply on its support one deck titanium.Parylene is a kind of non-biodegradable material, and its biocompatibility waits checking.
Cai Xiujun etc. have proposed a kind of support (200520116391X) that the gallbladder intestinal coincide that is used for, shape to support is described in detail, mentioned available macromolecular material, comprised absorbing the family macromolecule material in the non-body, but do not carried out concrete description at being fit to the identical macromolecule of gallbladder intestinal.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of stomach and intestine anastomosis bracket and preparation method thereof, and this anastomosis bracket is prepared from by the degradable high polymer material with good biocompatibility.
In order to solve the problems of the technologies described above, the invention provides a kind of preparation method of stomach and intestine anastomosis bracket, may further comprise the steps:
1), be raw material with the lactone and/or the cyclic carbonate of hydroxy carboxylic acid, in vacuum environment, under the effect of catalyst, be prepared into mixture by ring-opening polymerisation, described mixture is homopolymer or copolymer; The weight of catalyst is 0.005～0.5 of raw material, and reaction temperature is that 140～180 ℃, time are 5～12 hours.
2), with said mixture by solution-cast, melt extrude, fusion injection moulding or melting model be pressed onto in the mould cavity of given shape, shaped support;
3), above-mentioned shaped support is packed after sterilization treatment.
Improvement as preparation method of the present invention: the lactone of hydroxy carboxylic acid is Acetic acid, hydroxy-, bimol. cyclic ester, lactide or caprolactone, and cyclic carbonate is a trimethylene carbonate; Catalyst is a stannous octoate.
The present invention also provides the stomach and intestine anastomosis bracket of making according to the method described above.
Stomach and intestine anastomosis bracket of the present invention is the support of catheter-like, and long 10mm～100mm, internal diameter are 5mm～50mm, wall thickness 0.5mm～5mm.Outer surface at the support two ends is provided with annular projection.
Stomach and intestine anastomosis bracket of the present invention is at the human gastrointestinal tract clinical operation, develops according to the special biotic environment of gastrointestinal, and it has utilized the biodegradated polymer materal can be in the systemic characteristic of human body; Used in the body that is prepared from as raw material, by ring-opening polymerisation with the lactone of hydroxy carboxylic acid and/or cyclic carbonate and can absorb macromolecular material with different biomechanics characteristic and degradation cycle.Therefore, stomach and intestine anastomosis bracket of the present invention belongs to the regulatable polymeric stent of degradation cycle.Stomach and intestine anastomosis bracket of the present invention can be designed to the catheter-like of all size, uses the difference of position and human body individuality with human body in the satisfied operation.The annular projection that outer surface at the support two ends is provided with is convenient to the ligation of clinical operation.
The present invention is by the bioenvironmental characteristics at the gastrointestinal tract different parts, adopt the certified good biocompatible raw material compound body absorbable macromolecular scaffold material that has, and the machine-shaping technology by producing in batches, prepare the polymeric stent that is used for the gastrointestinal tract anastomosis.The degradation time that its outstanding characteristics are supports can mate with the cycle of gastrointestinal tract postoperative wound healing; By regulating the molecular structure of macromolecular material, the support that can obtain having different hard and soft degree characteristics; That such support has is simple to operate, the anastomosis operation time short, can obviously suppress anastomotic stricture, can promote advantage such as wound healing.
The specific embodiment
The preparation method of embodiment 1, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation glycolide-lactide copolymer:
The inferior stannum of Acetic acid, hydroxy-, bimol. cyclic ester, lactide and the octoate catalyst of purifying is added in the polymerization reaction kettle with 95: 5: 0.1 ratio of weight ratio.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 160 ℃, polyreaction 6 hours.After reaction finishes, discharging.The molecular weight of resulting polymers is 260,000, molecular weight distribution 1.5.
2), fusion injection moulding:
Above-mentioned polymer by the fusion injection molding way, is processed into the catheter-like support of length 30mm, internal diameter 10mm, wall thickness 2mm, on the outer surface at these left and right two ends of support, is provided with and highly is the annular projection of 1mm.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for stomach esophagus anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.Behind the fortnight, this anastomosis bracket is absorbed by the body gradually; After one month, this anastomosis bracket is absorbed fully.
The preparation method of embodiment 2, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation Acetic acid, hydroxy-, bimol. cyclic ester-lactide-trimethylene carbonate copolymer:
With the inferior stannum of Acetic acid, hydroxy-, bimol. cyclic ester, lactide, trimethylene carbonate and the octoate catalyst of purifying with weight ratio 90: 5: 5: 0.5 ratio adds in the polymerization reaction kettle.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 140 ℃, polyreaction 8 hours.After reaction finishes, discharging.The molecular weight of resulting polymers is 120,000, molecular weight distribution 1.8.
2), fusion mold pressing:
Above-mentioned polymer is pulverized, added in the mould, on vulcanizing press, be heated to 110 ℃, pressure 5Mpa; Pressure relief after 10 minutes, cooling and demolding.Catheter-like stent length 40mm, the internal diameter 20mm, the wall thickness 5mm that are prepared into are provided with on the outer surface at these left and right two ends of support and highly are the annular projection of 2mm.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for the gastrointestinal anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.After 10 days, anastomosis bracket is absorbed by the body gradually, and after 20 days, anastomosis bracket is absorbed fully.
The preparation method of embodiment 3, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation Acetic acid, hydroxy-, bimol. cyclic ester-trimethylene carbonate copolymer
The inferior stannum of Acetic acid, hydroxy-, bimol. cyclic ester, trimethylene carbonate and the octoate catalyst of purifying is added in the polymerization reaction kettle with 95: 5: 0.01 ratio of weight ratio.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 160 ℃, polymerization 10 reaction hour.After reaction finishes, discharging.The molecular weight of resulting polymers is 160,000, molecular weight distribution 1.3.
2), fusion injection moulding:
Above-mentioned polymer by the fusion injection molding way, is processed into the catheter-like support of length 35mm, internal diameter 12mm, wall thickness 2.5mm, on the outer surface at these left and right two ends of support, is provided with and highly is the annular projection of 1.5mm.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for intestinal intestinal anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.In view of the wriggling characteristics of intestinal, such material has higher pliability.After one week, anastomosis bracket is absorbed by the body gradually, and after 20 days, anastomosis bracket is absorbed fully.
The preparation method of embodiment 4, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation lactide-caprolactone-trimethylene carbonate copolymer
With the inferior stannum of lactide, caprolactone, trimethylene carbonate and the octoate catalyst of purifying with weight ratio 60: 30: 10: 0.01 ratio adds in the polymerization reaction kettle.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 160 ℃, polyreaction 10 hours.After reaction finishes, discharging.The molecular weight of resulting polymers is 80,000, molecular weight distribution 1.2.
2), solution-cast:
With the fully dissolving in dichloromethane of above-mentioned polymer, be made into concentration and be 38% solution.Add in the extruder after leaving standstill the air bubble of removing in the solution.Under the pressure of 0.6MPa, macromolecular solution is extruded, after the air bath drying of 60cm, be frozen into the catheter-like support that internal diameter 5mm, wall thickness 0.5mm, length can be selected between 10mm～100mm through solidification liquid.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for intestinal intestinal anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.In view of the wriggling characteristics of intestinal, such material has higher pliability.After 3 week, anastomosis bracket is absorbed by the body gradually, and after 40 days, anastomosis bracket is absorbed fully.
The preparation method of embodiment 5, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation Acetic acid, hydroxy-, bimol. cyclic ester-lactide-caprolactone-trimethylene carbonate copolymer (following umber all refers to weight portion):
Acetic acid, hydroxy-, bimol. cyclic ester, lactide and the stannous octoate catalyst of purifying are added in the polymerization reaction kettle with the rate of charge of 10 parts, 90 parts and 0.01 part respectively, and evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 150 ℃, polyreaction 3 hours.
Add 50 parts of caprolactones and 50 parts of trimethylene carbonates again by closed conduit in polymeric kettle, 170 ℃ of following polyreactions 6 hours obtain rubber-like block type copolymer.After reaction finishes, discharging.The molecular weight of resulting polymers is 280,000, molecular weight distribution 1.6.
2), melt extrude:
With the mode of above-mentioned polymer, be processed into internal diameter 40mm, the catheter-like support of wall thickness 5mm by melt extruding; Cut into the length of 10mm～100mm then as required.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for intestinal intestinal anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.In view of the wriggling characteristics of intestinal, such material has higher pliability.After 3 week, anastomosis bracket is absorbed by the body gradually, and after 40 days, anastomosis bracket is absorbed fully.
The preparation method of embodiment 6, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), preparation Acetic acid, hydroxy-, bimol. cyclic ester homopolymer:
The Acetic acid, hydroxy-, bimol. cyclic ester and the inferior stannum of octoate catalyst of purifying are added in the polymerization reaction kettle with 100: 0.1 ratio of weight ratio.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 160 ℃, polyreaction 12 hours.After reaction finishes, discharging.The molecular weight of resulting polymers is 260,000, molecular weight distribution 1.1.
2), fusion injection moulding:
Above-mentioned polymer by the fusion injection molding way, is processed into the catheter-like support of length 30mm, internal diameter 10mm, wall thickness 2mm, on the outer surface at these left and right two ends of support, is provided with and highly is the annular projection of 1mm.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for stomach esophagus anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.Such material has certain strong and unyielding property.After 7 days, anastomosis bracket is absorbed by the body gradually, and after 10 days, anastomosis bracket is absorbed fully.
The preparation method of embodiment 7, a kind of stomach and intestine anastomosis bracket, carry out following steps successively:
1), trimethylene carbonate homopolymer:
The trimethylene carbonate and the inferior stannum of octoate catalyst of purifying are added in the polymerization reaction kettle with 100: 0.05 ratio of weight ratio.Evacuation charges into drying nitrogen.After the circulation of 3 evacuation-inflated with nitrogen, be warming up to 180 ℃, polyreaction 9 hours.After reaction finishes, discharging.The molecular weight of resulting polymers is 80,000, molecular weight distribution 1.6.
2), fusion injection moulding:
Above-mentioned polymer by the fusion injection molding way, is processed into the catheter-like support of length 30mm, internal diameter 10mm, wall thickness 2mm, on the outer surface at these left and right two ends of support, is provided with and highly is the annular projection of 1mm.Shaped support that Here it is.
3), with above-mentioned shaped support after the sterilization treatment of routine, pack.
This support is used for stomach esophagus anastomosis operation, puts into position to be coincide; Bundle knot mode by the Folium Nelumbinis bag can reach and avoid anastomotic leakage, can reach and promote wound healing and avoid purpose such as anastomotic stricture again.In view of the wriggling characteristics of intestinal, such material has higher pliability.After 2 week, anastomosis bracket is absorbed by the body gradually, and after 20 days, anastomosis bracket is absorbed fully.
At last, it is also to be noted that what more than enumerate only is several specific embodiments of the present invention.Obviously, the invention is not restricted to above embodiment, many distortion can also be arranged.All distortion that those of ordinary skill in the art can directly derive or associate from content disclosed by the invention all should be thought protection scope of the present invention.
Claims (1)
1, a kind of preparation method of stomach and intestine anastomosis bracket is characterized in that may further comprise the steps:
1), be raw material with the lactone and/or the cyclic carbonate of hydroxy carboxylic acid, in vacuum environment, under the effect of catalyst, be prepared into mixture by ring-opening polymerisation, described mixture is homopolymer or copolymer; The weight ratio of catalyst and raw material is 0.005～0.5: 100, and reaction temperature is that 140～180 ℃, time are 5～12 hours; The lactone of described hydroxy carboxylic acid is at least a in Acetic acid, hydroxy-, bimol. cyclic ester, lactide and the caprolactone, and described cyclic carbonate is a trimethylene carbonate, and described catalyst is a stannous octoate;
2), with said mixture by solution-cast, melt extrude, fusion injection moulding or melting model be pressed onto in the mould cavity of given shape, shaped support;
3), above-mentioned shaped support is packed after sterilization treatment;
The gained stomach and intestine anastomosis bracket is the support of catheter-like, and long 10mm～100mm, internal diameter are 5mm～50mm, wall thickness 0.5mm～5mm; Outer surface at described support two ends is provided with annular projection.
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| CN 200710071563 CN100556376C (en) | 2007-10-09 | 2007-10-09 | The preparation method of stomach and intestine anastomosis bracket |
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| CN 200710071563 CN100556376C (en) | 2007-10-09 | 2007-10-09 | The preparation method of stomach and intestine anastomosis bracket |
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Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US8613880B2 (en) | 2010-04-21 | 2013-12-24 | Abbott Cardiovascular Systems Inc. | Post electron beam conditioning of polymeric medical devices |
| CN102793951A (en) * | 2012-08-29 | 2012-11-28 | 哈尔滨医科大学 | Medical intestinal anastomosis ring made of degradable magnesium alloy |
| CN106983916B (en) * | 2017-04-26 | 2022-04-19 | 温州生物材料与工程研究所 | Biodegradable tension-free isolated alimentary tract capsule type anastomat and preparation method |
| CN107185053A (en) * | 2017-05-22 | 2017-09-22 | 湖北中创医疗用品有限公司 | Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof |
| CN108577916B (en) * | 2018-03-08 | 2020-10-23 | 戴庆涛 | Preparation method of anastomat for gastrointestinal surgery |
| CN109893683A (en) * | 2019-03-14 | 2019-06-18 | 杭州越阡生物科技有限公司 | A kind of application and products thereof of biodegradation material in preparation children's alimentary tract anastomosis ring |
| CN113413491B (en) * | 2021-04-30 | 2022-11-04 | 中国科学院大学温州研究院(温州生物材料与工程研究所) | PTMC-b-PEG-b-PTMC copolymer-based bio-flexible elastomer intestinal anastomosis stent and preparation method thereof |
| CN113288505B (en) * | 2021-04-30 | 2023-02-03 | 中国科学院大学温州研究院(温州生物材料与工程研究所) | PTMC-based intestinal anastomosis stent of bioabsorbable flexible elastomer and preparation method thereof |
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Non-Patent Citations (1)
| Title |
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| 胃肠道吻合的沿革. 黄从云等.中华胃肠外科杂志，第8卷第6期. 2005 * |
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