CN108294802A - A kind of U-tube shape tissue ligation clip of double-layer structure and preparation method thereof - Google Patents
A kind of U-tube shape tissue ligation clip of double-layer structure and preparation method thereof Download PDFInfo
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- CN108294802A CN108294802A CN201810060437.2A CN201810060437A CN108294802A CN 108294802 A CN108294802 A CN 108294802A CN 201810060437 A CN201810060437 A CN 201810060437A CN 108294802 A CN108294802 A CN 108294802A
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- China
- Prior art keywords
- clip
- polyglycolide
- preparation
- double
- layer structure
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Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 51
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims abstract description 75
- 229920000954 Polyglycolide Polymers 0.000 claims abstract description 73
- -1 polytrimethylene carbonate Polymers 0.000 claims abstract description 58
- 229920000166 polytrimethylene carbonate Polymers 0.000 claims abstract description 56
- 239000000203 mixture Substances 0.000 claims abstract description 42
- 238000002156 mixing Methods 0.000 claims abstract description 9
- 230000002439 hemostatic effect Effects 0.000 claims abstract description 5
- 238000000034 method Methods 0.000 claims description 33
- 238000006243 chemical reaction Methods 0.000 claims description 17
- 238000001746 injection moulding Methods 0.000 claims description 12
- 239000002245 particle Substances 0.000 claims description 11
- 230000001954 sterilising effect Effects 0.000 claims description 11
- 238000002347 injection Methods 0.000 claims description 8
- 239000007924 injection Substances 0.000 claims description 8
- 239000003054 catalyst Substances 0.000 claims description 7
- 238000000748 compression moulding Methods 0.000 claims description 7
- KSBAEPSJVUENNK-UHFFFAOYSA-L tin(ii) 2-ethylhexanoate Chemical compound [Sn+2].CCCCC(CC)C([O-])=O.CCCCC(CC)C([O-])=O KSBAEPSJVUENNK-UHFFFAOYSA-L 0.000 claims description 7
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims description 6
- 238000000465 moulding Methods 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 6
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- 238000007151 ring opening polymerisation reaction Methods 0.000 claims description 5
- YFHICDDUDORKJB-UHFFFAOYSA-N trimethylene carbonate Chemical compound O=C1OCCCO1 YFHICDDUDORKJB-UHFFFAOYSA-N 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 230000015556 catabolic process Effects 0.000 abstract description 21
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- 125000004836 hexamethylene group Chemical group [H]C([H])([*:2])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[*:1] 0.000 abstract description 3
- 230000010148 water-pollination Effects 0.000 abstract description 3
- 238000005297 material degradation process Methods 0.000 abstract 1
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- 210000001519 tissue Anatomy 0.000 description 33
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- 230000000052 comparative effect Effects 0.000 description 10
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- 229920000642 polymer Polymers 0.000 description 8
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 7
- 239000000622 polydioxanone Substances 0.000 description 7
- BYEAHWXPCBROCE-UHFFFAOYSA-N 1,1,1,3,3,3-hexafluoropropan-2-ol Chemical compound FC(F)(F)C(O)C(F)(F)F BYEAHWXPCBROCE-UHFFFAOYSA-N 0.000 description 5
- 102000009123 Fibrin Human genes 0.000 description 5
- 108010073385 Fibrin Proteins 0.000 description 5
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 5
- 229950003499 fibrin Drugs 0.000 description 5
- 239000003643 water by type Substances 0.000 description 5
- 238000005303 weighing Methods 0.000 description 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- 108010000499 Thromboplastin Proteins 0.000 description 4
- 102000002262 Thromboplastin Human genes 0.000 description 4
- 125000004122 cyclic group Chemical group 0.000 description 4
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- 229910052751 metal Inorganic materials 0.000 description 4
- 239000002184 metal Substances 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 4
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- 238000007711 solidification Methods 0.000 description 4
- 230000008023 solidification Effects 0.000 description 4
- 229920002413 Polyhexanide Polymers 0.000 description 3
- 108090000190 Thrombin Proteins 0.000 description 3
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- 230000023555 blood coagulation Effects 0.000 description 3
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- PGOHTUIFYSHAQG-LJSDBVFPSA-N (2S)-6-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-1-[(2S,3R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-4-methylsulfanylbutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]pyrrolidine-2-carbonyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]-3-hydroxypropanoyl]amino]-4-methylpentanoyl]amino]-3-sulfanylpropanoyl]amino]-4-methylsulfanylbutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-hydroxybutanoyl]pyrrolidine-2-carbonyl]amino]-5-oxopentanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-3-hydroxybutanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]-5-oxopentanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]-5-oxopentanoyl]amino]-3-phenylpropanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]-4-oxobutanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]hexanoic acid Chemical compound CSCC[C@H](N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCCN)C(O)=O PGOHTUIFYSHAQG-LJSDBVFPSA-N 0.000 description 2
- 108010049003 Fibrinogen Proteins 0.000 description 2
- 102000008946 Fibrinogen Human genes 0.000 description 2
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- 108010094028 Prothrombin Proteins 0.000 description 2
- 102100027378 Prothrombin Human genes 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- OBETXYAYXDNJHR-UHFFFAOYSA-N alpha-ethylcaproic acid Natural products CCCCC(CC)C(O)=O OBETXYAYXDNJHR-UHFFFAOYSA-N 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 208000034158 bleeding Diseases 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000001772 blood platelet Anatomy 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
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- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000012258 culturing Methods 0.000 description 2
- 230000000593 degrading effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940012952 fibrinogen Drugs 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 229910052739 hydrogen Inorganic materials 0.000 description 2
- 239000001257 hydrogen Substances 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
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- 238000004519 manufacturing process Methods 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 229940039716 prothrombin Drugs 0.000 description 2
- 150000003384 small molecules Chemical group 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- QCVGEOXPDFCNHA-UHFFFAOYSA-N 5,5-dimethyl-2,4-dioxo-1,3-oxazolidine-3-carboxamide Chemical compound CC1(C)OC(=O)N(C(N)=O)C1=O QCVGEOXPDFCNHA-UHFFFAOYSA-N 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 102100029117 Coagulation factor X Human genes 0.000 description 1
- 102000002322 Egg Proteins Human genes 0.000 description 1
- 108010000912 Egg Proteins Proteins 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 108010014173 Factor X Proteins 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 229910000861 Mg alloy Inorganic materials 0.000 description 1
- 108010019160 Pancreatin Proteins 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
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- 230000009286 beneficial effect Effects 0.000 description 1
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- 230000001413 cellular effect Effects 0.000 description 1
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- 230000007812 deficiency Effects 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 235000014103 egg white Nutrition 0.000 description 1
- 210000000969 egg white Anatomy 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 229930182851 human metabolite Natural products 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000002357 laparoscopic surgery Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- CXHHBNMLPJOKQD-UHFFFAOYSA-N methyl hydrogen carbonate Chemical compound COC(O)=O CXHHBNMLPJOKQD-UHFFFAOYSA-N 0.000 description 1
- 229940055695 pancreatin Drugs 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229920006254 polymer film Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000007363 ring formation reaction Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000003319 supportive effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/005—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular materials
- A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L2300/206—Biguanides, e.g. chlorohexidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Materials Engineering (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Materials For Medical Uses (AREA)
Abstract
The present invention discloses a kind of U-tube shape tissue ligation clip of double-layer structure and preparation method thereof, and the hemostatic ligation clip includes inner and outer clamp clip, and the outer clip is U-typed hatch frame, is made of polyglycolide；The inner clip is in U-typed hatch frame, is made of polyglycolide and polytrimethylene carbonate blend；The inner and outer clamp clip is equipped with anti-delinking part, and the anti-delinking part includes being set to the T-shape conducting bar of outer clip inner side plane and being set to card slot compatible with the T-shape conducting bar on the inner clip medial plane；More preferably, more preferable with histocompatbility, the ligation clip of preparation is neither too hard, nor too soft, will not damage tissue for the blend material hydrophily of the present invention；Hexamethylene separately is added during Material synthesis, the slow release with material degradation can effective antibacterial promotion wound healing；By feed change molecular weight and blending ratio, it is suitable for the degradation rate of body different tissues material requested；And processing is simple, safety higher.
Description
Technical field
The present invention relates to a kind of surgery implement laparoscopic surgery special consumptive material more particularly to a kind of double-layer structure it is U-shaped
Tubular tissue ligation clip and preparation method thereof.
Background technology
Mainly there are ligature forceps and suture ligation in early stage ligation surgical operation, it is complicated due to the use of upper inconvenience, process,
It significantly increases operating time, expend doctor's energy, increase operation risk；Although the metal ligation clip intensity occurred later
Reach requirement, using upper also convenient very much, but since non-degradable absorbs, long-term existence is caused to be woven with difference to group in internal
The stimulation of degree, to generate the complication such as inflammation；Metal clip can influence the inspection of X-ray simultaneously, cause the mistake of doctor
Sentence.The degradable metal ligation clip occurred in recent years, mainly Mg alloys fail extensive use since its degradability is uncontrollable；
In addition the ligation clip that prepared by nondegradable plastics, also due to long-term existence in internal, can cause all kinds of complication such as inflammation, not
It can be universal.Currently, occurring some ligation clips for utilizing biodegradable material to prepare both at home and abroad, the poly- second of main material is handed over
Ester, polydioxanone and its blend, but have no and the ligation clip prepared is blended using biodegradable material, with metal
Folder, nonabsorable folder are compared, and the ligation clip of such degradation material can be within the regular hour by human body degradation absorption, base
The reaction of this foreign, good biocompatibility, therefore long-term foreign matter stimulation will not be generated to tissue, few intercurrent disease, and
The inspection of X-ray is not influenced.
The Absorbable clips of Johnson ＆ Johnson Medical Ltd and Hangzhou Medzone Biotechnologies Co., Ltd.'s production, are one
Kind single layer absorbable vessel ligature clamp, use is polydioxanone, and structure is V-shaped, and has latch hook at sealed place.
The Absorbable clips are needed to separate the tissue for being blocked in the sealed place in clip front end, could be completed before ligation operates and is closed tissue
Ligation operation, is otherwise easy that tissue is made to be hooked at the sealed place of clip, cannot normally close, and organizes to be drawn repeatedly
It pulls, to cause the injury to tissue.This has resulted in two important deficiencies：1) to the requirement of the skills involved in the labour of performer
It is high；2) it may not apply to acute bleeding, first press from both sides the operation (such as hepalobectomy) of separation etc. after closing.
The Absorbable clips of Hangzhou Shengshi Technology Co., Ltd.'s production, Chinese CN 101081310A patents, a kind of bilayer can
Blood vessel ligation clamp is absorbed, internal layer and outer layer are divided into, outer layer uses polyglycolide；Internal layer is polydioxanone, which exists
Degradation cycle is longer in human body, degradable to need 6 months or more, could be absorbed by the body completely within about 10 months；And product
Storage life it is shorter, only time a year and a half.
Invention content
In response to the problems existing in the prior art, the purpose of the present invention is to provide a kind of U-tube shape knot of tissue of double-layer structure
Prick folder and preparation method thereof.
To achieve the above object, the technical solution adopted by the present invention is：
A kind of U-tube shape tissue ligation clip of double-layer structure, the hemostatic ligation clip includes inner and outer clamp clip, the outer clip
For U-typed hatch frame, it is made of polyglycolide；The inner clip is in U-typed hatch frame, by polyglycolide polyglycolide and is gathered
Trimethylene carbonate blend is made；The inner and outer clamp clip is equipped with anti-delinking part, and the anti-delinking part includes being set to outer clip
The T-shape conducting bar of inner side plane and it is set to card slot compatible with the T-shape conducting bar on the inner clip medial plane.
Wherein, guide function is played in the mutual cooperation of the T-shape conducting bar and the card slot in the axial direction, radially
Position-limiting action is played, prevents it from falling off；The outer clip is polyglycolide, inner clip by polyglycolide and polytrimethylene carbonic acid simultaneously
Ester blend is made, and the ratio by controlling polyglycolide and polytrimethylene carbonate blend each component can drop curb pins
Solution rate is consistent and adjusts the degradation rate of blend to be applicable in the different position of human body.
Preferably, the top end face width of the T-shape conducting bar is less than the outer clip width, can save occupied space, make institute
The hemostatic ligation clip stated is compact-sized.
Preferably, the inner clip width and the outer clip are of same size, keep the hemostatic ligation clamping structure compacter,
It is convenient for mounting and clamping.
The present invention also provides a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure, including it is as follows
Step：
The preparation of S1, raw material
(a) preparation of polyglycolide：
Take a certain amount of glycolide in reaction kettle, the stannous octoate catalyst of 0.01% mass concentration be added, in vacuum or
Under person's condition of high voltage, be arranged 150-180 DEG C of reaction temperature, reaction time 5-7h, be then refluxed for purification, be granulated it is close to get product
Envelope preserves；
The preparation of the polyglycolide uses ring-opening polymerisation method, i.e., carries out ring-closure reaction with glycolic acid monomers, generates cyclic annular
Product glycolide purifies the cyclic products glycolide of generation, and the cyclic products purity is made to be higher than 99.92%；Then
Ring-opening polymerization, which is carried out, with the cyclic products glycolide forms polyglycolide；
(b) preparation of polytrimethylene carbonate：
It takes a certain amount of six-membered cyclic trimethylene carbonate monomer in reaction kettle, the octanoic acid of 0.01% mass concentration is added
Stannous catalyst prepares polytrimethylene carbonate, setting reaction under vacuum or condition of high voltage by ring-opening polymerization
150-180 DEG C of temperature, reaction time 3-5h is then refluxed for purification, granulation is sealed to get product；
(c) preparation of polyglycolide and polytrimethylene carbonate blend：
Take the polyglycolide that above-mentioned steps are prepared and polytrimethylene carbonate in mass ratio 100:0~70:30 is total
Mixed to squeeze out, granulation is sealed to get product；
S2, moulding process
The U-tube shape tissue ligation clip of the double-layer structure is using injection molding or compression molding；
The compression molding temperature is 225 DEG C；
The injection molding condition is 50-70 DEG C of mold preheating temperature, 190-210 DEG C of injection temperature, injection cycle 25-
35s is then heat-treated the U-tube shape tissue ligation clip of the injection molding product；；
S3, sterilizing, packaging.
Wherein, by the method for graft modification, in raw material polyglycolide and polytrimethylene carbonate polymer molecular chain
The upper PVAC polyvinylalcohol for introducing low molecular weight, introduces hydrophilic radical hydroxyl, greatly improves hydrophily, to increase and tissue
Between biocompatibility；Inner clip is made up of polyglycolide and polytrimethylene carbonate blending simultaneously, and preparation method is simpler
It is single, and catabolite is human metabolite；It is different due to the special three-dimensional interpenetrating polymer network structure of blend and degradation rate
Property, product is in degradation preliminary stage, and blend two-phase plays a supportive role jointly, and degradation rate is with polyglycolide and poly- Sanya
The variation of methyl carbonic blending ratio and change；Simultaneously in polyglycolide and polytrimethylene carbonate Material synthesis process
In, a certain amount of molecular weight polymers hexamethylene PHMB is added, with weak interaction hydrogen bond or hydrophilic work
Mode is combined with raw polymer, and PHMB small molecule chains are interspersed between raw molecule chain, with the degradation of product
Sustained release comes out, can the effective antibacterial healing for promoting wound；In addition, inner clip material is coloured using medical pigment, to
More convenient differentiation inner clip, outer clip, tissue promote safety to reduce operating error.
Preferably, polyglycolide, polytrimethylene carbonate and polyglycolide and polytrimethylene carbon in the step S1
Size is a diameter of 1.5-2mm, the particle of a length of 3mm after acid esters blend is granulated.
Preferably, in the step S1 gained polyglycolide, polytrimethylene carbonate product range of viscosities be 1.2-
3.5dL/g, melt index 25-65g/10min.
Preferably, the preparation method of the U-tube shape tissue ligation clip of a kind of double-layer structure, heat in the step S2
Treatment conditions are 40-60 DEG C of temperature, time 2-5h.
Preferably, the sterilization method in the step S3 is irradiation sterilization.
Compared with prior art, the beneficial effects of the invention are as follows：
(1) the U-tube shape tissue ligation clip of double-layer structure of the present invention, by the method for graft modification in raw material polyglycolide
Polyvinyl alcohol with low molecular weight is introduced on polytrimethylene carbonate polymer molecular chain, introduces hydrophilic radical hydroxyl, greatly
Improve hydrophily；The inner clip of the U-tube shape tissue ligation clip is blended using polyglycolide and polytrimethylene carbonate
Material is made, and material is neither too hard, nor too soft, and hydrophilicity is more preferably, more preferable with histocompatbility, will not damage tissue；Separately in raw material
Hexamethylene is added in polyglycolide and polytrimethylene carbonate building-up process, with weak interaction hydrogen bond
Or hydrophilic interaction mode is combined with raw polymer, and PHMB small molecule chains are interspersed between raw molecule chain, with product
Degradation and be sustained out can the effective antibacterial healing for promoting wound；
(2) outer clip of the U-tube shape tissue ligation clip of double-layer structure of the present invention uses polyglycolide material, degradation rate master
It to be controlled by changing polyglycolide polymers molecular weight；Inner clip also may be used in addition to by way of changing polymer molecular weight
Degradation rate is controlled by controlling the blending ratio of polyglycolide and polytrimethylene carbonate, to be applicable in the different portion of human body
Position；
(3) the U-tube shape tissue ligation clip of double-layer structure of the present invention is made up using intermingling material of injection molding, technique
Simply, convenient and easy, it is more suitable for mass producing, cost reduction while also greatly improves efficiency and yield rate；
(4) inner and outer clamp clip of the U-tube shape tissue ligation clip of double-layer structure of the present invention is equipped with anti-delinking part, the anticreep
Portion includes being set to the T-shape conducting bar of outer clip inner side plane and being set on the inner clip medial plane and the T-shape conducting bar
Guide function is played in the mutual cooperation of compatible card slot, the T-shape conducting bar and the card slot in the axial direction, radially
Position-limiting action is played, prevents it from falling off, is conducive to the clamping to tubular tissue in human body or other intraluminal tissues；And overall structure
It is compact, easy to use, easy to distinguish product and organize, not will produce dislocation, safety higher.
Description of the drawings
Fig. 1 is the structural schematic diagram of double-layer structure U-tube shape tissue ligation clip of the present invention；
Fig. 2 is the structural schematic diagram after the inner clip engages with outer clip；
Fig. 3 is the cross-sectional view after the inner clip engages with outer clip；
In figure：1, outer clip；11, T-shape conducting bar；2, inner clip；21, card slot.
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention
It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to
Limit the present invention.Unless stated otherwise, the present invention uses reagent, method and apparatus is the art conventional reagent, methods
And equipment.
Preparation method as one preferred, a kind of preparation side of the U-tube shape tissue ligation clip of double-layer structure
Method includes the following steps：
The preparation of S1, raw material
(a) preparation of polyglycolide：
Take a certain amount of glycolide in reaction kettle, be added 0.01% mass concentration stannous octoate catalyst, vacuum or
Condition of high voltage, is arranged 150-180 DEG C of reaction temperature, and reaction time 5-7h is then refluxed for purification, is granulated to seal to get product and protect
It deposits；
(b) preparation of polytrimethylene carbonate：
It takes a certain amount of six-membered cyclic trimethylene carbonate monomer in reaction kettle, the octanoic acid of 0.01% mass concentration is added
Stannous catalyst, vacuum or condition of high voltage prepare polytrimethylene carbonate by ring-opening polymerization, reaction temperature are arranged
150-180 DEG C, reaction time 3-5h, it is then refluxed for purification, granulation is sealed to get product；
(c) preparation of polyglycolide and polytrimethylene carbonate blend：
Take the polyglycolide that above-mentioned steps are prepared and polytrimethylene carbonate in mass ratio 100:0~70:30 is total
It is mixed to squeeze out, it is granulated, is chopped into a diameter of 1.5-2mm, the particle of a length of 3mm sizes；
S2, moulding process
The U-tube shape tissue ligation clip of the double-layer structure is using injection molding or compression molding；
The compression molding temperature is 225 DEG C；
The injection molding condition is 50-70 DEG C of mold preheating temperature, 190-210 DEG C of injection temperature, injection cycle 25-
35s is then heat-treated the U-tube shape tissue ligation clip of the injection molding；
S3, sterilizing, packaging.
It is furthermore preferred that a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure, in the step S1
Size is diameter after polyglycolide, polytrimethylene carbonate and polyglycolide and polytrimethylene carbonate blend are granulated
For 1.5-2mm, the particle of a length of 3mm.
It is furthermore preferred that a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure, in the step S1
Gained polyglycolide, polytrimethylene carbonate product range of viscosities be 1.2-3.5dL/g, melt index 25-65g/
10min。
It is furthermore preferred that a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure, in the step S2
Heat treatment condition is 40-60 DEG C of temperature, time 2-5h.
It is furthermore preferred that a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure, in the step S3
Sterilization method be irradiation sterilization.
Embodiment 1
The preparation of polyglycolide：
Take 200g glycolides in reaction kettle, be added 0.01% mass concentration stannous octoate catalyst, vacuum condition,
6h is reacted at 160 DEG C, it is 1.5-2mm, the particle of a length of 3mm sizes that reactant addition extruding machine, which is obtained grain size, at 160 DEG C
The above pellet is dried in vacuo 24 hours by polyglycolide at 40 DEG C.With fusion index instrument setting test condition be 230 DEG C/
2.16kg uses ASTMD1238 test methods to measure the melt index of polyglycolide as 50g/10min.
The Shooting Technique of the polyglycolide of above-mentioned preparation through the invention is processed into ligation clip outer clip.
The preparation of polytrimethylene carbonate：
It takes 200g six-membered cyclic trimethylene carbonate monomers in reaction kettle, 0.01% stannous octoate catalysis is added
Agent is reacted 4 hours at vacuum condition, 160 DEG C, waits for that reactant addition extruding machine is obtained 1.5-2mm sizes after reaction
Particle polytrimethylene carbonate, the above pellet is dried in vacuo at 40 DEG C and is weighed within 24 hours 198 grams, yield 99%.With
Hexafluoroisopropanol solution makees solvent, with Ubbelohde viscometer in 25 DEG C of waters bath with thermostatic control, measures the characteristic of polytrimethylene carbonate
Viscosity is 2.4dL/g.
Embodiment 2
The preparation of polyglycolide and polytrimethylene carbonate blend：Polyglycolide that Example 1 is prepared with
Polytrimethylene carbonate in mass ratio 100:0,200g blending extrusions of weighing are granulated, are chopped into a diameter of 1.5-2mm, a length of
The particle of 3mm sizes weighs to obtain pellet 196g, yield 98%.By above-mentioned pellet dissolution in hexafluoroisopropanol solution, with crow
The intrinsic viscosity that family name's viscosimeter measures blend in 25 DEG C of waters bath with thermostatic control is 3.48dL/g.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate blend through the invention is processed
At ligation clip inner clip.
Embodiment 3
The preparation of polyglycolide and polytrimethylene carbonate blend：Polyglycolide that Example 1 is prepared with
Polytrimethylene carbonate in mass ratio 90:10,200g blending extrusions of weighing are granulated, are chopped into a diameter of 1.5-2mm, a length of
The particle of 3mm sizes weighs to obtain pellet 196g, yield 98%.By above-mentioned pellet dissolution in hexafluoroisopropanol solution, with crow
The intrinsic viscosity that family name's viscosimeter measures blend in 25 DEG C of waters bath with thermostatic control is 3.62dL/g.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate blend through the invention is processed
At ligation clip inner clip.
Embodiment 4
The preparation of polyglycolide and polytrimethylene carbonate blend：Polyglycolide that Example 1 is prepared with
Polytrimethylene carbonate in mass ratio 80:20,200g blending extrusions of weighing are granulated, are chopped into a diameter of 1.5-2mm, a length of
The particle of 3mm sizes weighs to obtain pellet 198g, yield 99%.By above-mentioned pellet dissolution in hexafluoroisopropanol solution, with crow
Family name's viscosimeter measures the intrinsic viscosity 3.36dL/g of blend in 25 DEG C of waters bath with thermostatic control.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate blend through the invention is processed
At ligation clip inner clip.
Embodiment 5
The preparation of polyglycolide and polytrimethylene carbonate blend：Polyglycolide that Example 1 is prepared with
Polytrimethylene carbonate in mass ratio 70:30,200g blending extrusions of weighing are granulated, are chopped into a diameter of 1.5-2mm, a length of
The particle of 3mm sizes weighs to obtain pellet 197g, yield 98.5%.By above-mentioned pellet dissolution in hexafluoroisopropanol solution, use
The intrinsic viscosity that Ubbelohde viscometer measures blend in 25 DEG C of waters bath with thermostatic control is 3.85dL/g.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate blend through the invention is processed
At ligation clip inner clip.
Comparative example 1
The preparation of polyglycolide and polytrimethylene carbonate blend：, compared with Example 4, the difference is that, institute
Blend is stated by polyglycolide and polytrimethylene carbonate in mass ratio 50:50 ratios be blended, synthesis obtain polyglycolide with
The blend of polytrimethylene carbonate, the intrinsic viscosity measured according to the method for embodiment 4 are 2.18dL/g.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate blend through the invention is processed
At ligation clip inner clip.
Comparative example 2
The preparation of polyglycolide and polydioxanone blend, compared with Example 4, the difference is that, it is described
Blend is by polyglycolide and polydioxanone in mass ratio 80:20 ratios are blended, remaining is same as Example 4, synthesis
The blend of polyglycolide and polydioxanone is obtained, the intrinsic viscosity measured according to the method for embodiment 4 is
3.28dL/g。
The polyglycolide of above-mentioned preparation and the Shooting Technique of polydioxanone blend through the invention are processed into
Ligation clip inner clip.
Comparative example 3
The preparation of polyglycolide and polytrimethylene carbonate copolymer, compared with Example 4, the difference is that, institute
The preparation method for stating copolymer is as follows, and the polyglycolide that Example 1 is prepared and polytrimethylene carbonate are in mass ratio
80:20, it weighs polyglycolide and is placed in reaction kettle with the total 200g of polytrimethylene carbonate, the stannous octoate for being added 0.01% is urged
Agent is reacted 10 hours at vacuum condition, 140 DEG C, and reactant addition extruding machine is obtained a diameter of 1.5- at 140 DEG C
2mm, the particle of a length of 3mm sizes after being dried in vacuo the above pellet 24 hours at 40 DEG C, are surveyed according to the method for embodiment 4
Fixed intrinsic viscosity is 1.98dL/g.
The Shooting Technique of the polyglycolide of above-mentioned preparation and polytrimethylene carbonate copolymer through the invention is processed
At ligation clip inner clip.
Application examples 1
The ligation clip that through the invention prepared by the Shooting Technique, as shown in Figs. 1-3, the ligation clip includes inner clip 2
With outer clip 1, the outer clip 1 is U-typed hatch frame；The inner clip 2 is in U-typed hatch frame；In the inner clip 2 and outer clip 1
Equipped with anti-delinking part, the anti-delinking part includes to be set to the T-shape conducting bar 11 of 1 inner side plane of outer clip and be set to the inner clip 2
Card slot compatible with the T-shape conducting bar 11 21 on medial plane；The top end face width of the T-shape conducting bar 11 is less than described
1 width of outer clip；2 width of the inner clip and the outer clip 1 are of same size.Wherein, the outer clip by embodiment 1 Shooting Technique system
At the inner clip is made of the Shooting Technique of embodiment 2~5 and comparative example 1~3.
The above-mentioned ligation clip being prepared is subjected to simulated body fluid Degrading experiment.Every group of ligation grips 500 samples, accurately
It is put into the centrifuge tube (10 ligation clip/centrifuge tubes) of 50 50mL after weighing, the phosphoric acid buffer that the pH of 35mL is 7.4 is added
Solution.It is put into 37 DEG C of water bath with thermostatic control shaking table and is degraded with masking foil closing centrifuge tube, it is molten to change a phosphoric acid buffer every 2 weeks
Liquid.To after certain degradation time, it is filtered to remove buffer solution, the weight of ligation clip is measured after vacuum dried.Calculated weight
Conservation rate (ratio of the weight of ligation clip and the weight of ligation clip before degradation after degradation a period of time).Repetition is changed primary every 2 weeks
The step of phosphate buffer solution, the weight retention rate after the vascular ligation measured is clipped in above-mentioned degradation step is 0, is passed through at this time
Degradation time of the time crossed as the blood vessel ligation clamp sample.
Specific Shooting Technique condition and simulated body fluid degradation experiment result are as shown in table 1 below.
1 ligation clip injection molding experiment of table and simulated body fluid degradation experiment
| Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Comparative example 1 | Comparative example 2 | Comparative example 3 | |
| Viscosity (dL/g) | 3.48 | 3.62 | 3.36 | 3.85 | 2.18 | 3.28 | 1.98 |
| Mold preheats (DEG C) | 50 | 60 | 70 | 70 | 70 | 70 | 50 |
| Injection temperature (DEG C) | 190 | 200 | 210 | 210 | 210 | 210 | 190 |
| Injection time (s) | 25 | 30 | 35 | 35 | 35 | 35 | 25 |
| Heat treatment temperature (DEG C) | 40 | 50 | 60 | 50 | 60 | 60 | 40 |
| Heat treatment time (h) | 2 | 3 | 4 | 5 | 4 | 4 | 2 |
| Whether it is molded | It is | It is | It is | It is | It is no | It is | It is no |
| Degradation time (moon) | 4 | 5 | 6 | 8 | * | 10 | * |
*：Since the material can not be molded, therefore simulated body fluid Degrading experiment is not carried out.
As shown in Table 1, the intermingling material that prepared by mol ratio according to the invention can be according to note of the present invention
It moulds technique and prepares molding, and the degradation rate of molding U-shaped ligation clip is adjustable.
Application examples 2
The cell compatibility of blend is tested：Polyglycolide prepared by embodiment 2~5 and comparative example 1~3 and poly- Sanya
It is 100 one-tenth flat thin that methyl carbonic acid ester blend is hot pressed into average thickness with compression molding bed under 115 DEG C and 10MPa respectively
Then dense film is cut into the sequin of a diameter of 15mm by film with card punch, cleaned successively with tap water, redistilled water
It is placed in medicinal alcohol container 24 hours afterwards, is flushed three times with sterilizing tri-distilled water after taking-up, be fixed on 24 holes up with air
The hole bottom of tissue culturing plate sterilizes for 6 hours through ultraviolet light.1mL is added per hole to 24 hole tissue culturing plates after sterilizing
Cell suspension (1 × 105A/mL), in 37 DEG C, 5%CO2And cultivated in the incubator of saturated humidity after a certain period of time, it is fallen with fluorescence
Micro- sem observation cellular morphology is set, then culture solution is removed with micropipettor, is used in combination buffer solution to wash away and does not attach cell, most
Pancreatin is added afterwards the cell dissociation on polymer film gets off countings, calculating cell attachment rate.As a result it shows：4 hour cells paste
Attached rate is respectively 38%, 40%, 48%, 41%, 28%, 27%, 25%24 hour cell attaching rates are respectively 86%, 87%,
92%, 88%, 65%, 66%, 61% cell quantity significantly increases, and cell increases rapidly in material surface division growth.In vitro
Culture shows that polyglycolide has good cell compatibility with polytrimethylene carbonate blend.
Application examples 3
The thrombotest of ligation clip：
PT prothrombin times：Excessive calcic tissue thromboplastin is added in test plasma, again the blood plasma of calcification
Stuart factor is activated to become Xa in the presence of tissue factor, the latter makes prothombin be fibrin ferment, and fibrin ferment makes fiber egg
White original is changed into not hemolytic fibrin, measures the time needed for solidification, as test plasma prothrombin time (PT).
TT thrombin time tests：Suitable thrombin solution is added in test plasma, and fibrinogen is changed into insoluble
Fibrin measures solidification required time, as test plasma thrombin time (TT).
APTT activated partial thromboplastin time assay：Partial thromboplastin solution is added in test plasma, joins in calcium ion
With under, fibrinogen is changed into insoluble fibrin, the time required to measuring solidification, as test plasma activated partial blood coagulation
Movable enzyme time (APTT).
Blood vessel ligation clamp sample to be measured is cut into small pieces merging plastics detection box, in COATRON TECOIV PLUS
Detection in (TECO Inc., German).
Polyglycolide prepared by above-described embodiment 2~5 and comparative example 2 is molded into polytrimethylene carbonate blend
The ligation clip of type carries out thrombotest according to the method described above, is as a result shown in shown in table 2.
2 ligation clip thrombotest of table
| Sample | PT(s) | TT(s) | APTT(s) |
| Fresh and healthy blood plasma | 36.64 | 16.21 | 93.82 |
| Embodiment 2 | 32.56 | 14.36 | 91.86 |
| Embodiment 3 | 31.42 | 14.12 | 91.04 |
| Embodiment 4 | 30.12 | 13.05 | 90.13 |
| Embodiment 5 | 33.38 | 14.89 | 91.32 |
| Comparative example 2 | 35.12 | 15.55 | 93.36 |
As shown in Table 2, PT, TT and APTT time of healthy blood plasma are respectively 36.64 seconds, 16.21 seconds and 93.82 seconds.
PT, TT and the APTT of blood plasma in different proportion polyglycolide and the ligation clip of polytrimethylene carbonate blend injection molding
Time is respectively less than blank plasma, has certain hemostasis effect；Due to material and contacting blood, material surface will be inhaled rapidly
Protein is enclosed, the activation of the adherency and coagulation pathway of blood platelet and then will occur, eventually lead to blood coagulation.The surface light of material
Cleanliness, surface wettability and surface charge etc. can all influence blood coagulation.The blend prepared according to mol ratio of the present invention
The molding blood vessel ligation clamp in residence can attract protein, improve blood platelet ends of vessels adherency, promote ends of vessels blood
The effect of the solidification of liquid, can the quickly sealing blood vessels broken ends of fractured bone, achieve the purpose that shorten bleeding stopping period.
It although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
Understanding without departing from the principles and spirit of the present invention can carry out these embodiments a variety of variations, modification, replace
And modification, the scope of the present invention is defined by the appended.
Claims (8)
1. a kind of U-tube shape tissue ligation clip of double-layer structure, which is characterized in that the hemostatic ligation clip includes inner clip and outer
Folder, the outer clip are U-typed hatch frame, are made of polyglycolide；The inner clip is in U-typed hatch frame, by polyglycolide
It is made with polytrimethylene carbonate blend；The inner and outer clamp clip is equipped with anti-delinking part, and the anti-delinking part includes being set to
The T-shape conducting bar of outer clip inner side plane and it is set to card slot compatible with the T-shape conducting bar on the inner clip medial plane.
2. a kind of U-tube shape tissue ligation clip of double-layer structure according to claim 1, which is characterized in that the T-shape
The top end face width of conducting bar is less than the outer clip width.
3. a kind of U-tube shape tissue ligation clip of double-layer structure according to claim 1, which is characterized in that the inner clip
Width and the outer clip are of same size.
4. a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure described in claim 1, which is characterized in that packet
Include following steps：
The preparation of S1, raw material
(a) preparation of polyglycolide：
It takes a certain amount of glycolide in reaction kettle, the stannous octoate catalyst of 0.01% mass concentration is added, in vacuum or height
Under the conditions of pressure, 150-180 DEG C of reaction temperature is set, reaction time 5-7h is then refluxed for purification, is granulated to seal to get product and protect
It deposits；
(b) preparation of polytrimethylene carbonate：
It takes a certain amount of six-membered cyclic trimethylene carbonate monomer in reaction kettle, the stannous octoate of 0.01% mass concentration is added
Catalyst prepares polytrimethylene carbonate by ring-opening polymerization, reaction temperature is arranged under vacuum or condition of high voltage
150-180 DEG C, reaction time 3-5h, it is then refluxed for purification, granulation is sealed to get product；
(c) preparation of polyglycolide and polytrimethylene carbonate blend：
Take the polyglycolide that above-mentioned steps are prepared and polytrimethylene carbonate in mass ratio 100:0~70:30 blendings are squeezed
Go out, granulation is sealed to get product；
S2, moulding process
The U-tube shape tissue ligation clip of the double-layer structure is using injection molding or compression molding；
The compression molding temperature is 225 DEG C；
The injection molding condition be 50-70 DEG C of mold preheating temperature, 190-210 DEG C of injection temperature, injection cycle 25-35s, with
The U-tube shape tissue ligation clip of the injection molding is heat-treated afterwards；
S3, sterilizing, packaging.
5. a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure according to claim 4, feature exist
In polyglycolide, polytrimethylene carbonate and polyglycolide and polytrimethylene carbonate blend are made in the step S1
Size is a diameter of 1.5-2mm, the particle of a length of 3mm after grain.
6. a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure according to claim 4, feature exist
In, in the step S1 gained polyglycolide, polytrimethylene carbonate product range of viscosities be respectively 1.2-3.5dL/g,
Melt index is 25-65g/10min.
7. a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure according to claim 4, feature exist
In heat treatment condition is 40-60 DEG C of temperature, time 2-5h in the step S2.
8. a kind of preparation method of the U-tube shape tissue ligation clip of double-layer structure according to claim 4, feature exist
In the sterilization method in the step S3 is irradiation sterilization.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810060437.2A CN108294802B (en) | 2018-01-22 | 2018-01-22 | Double-layer U-shaped tubular tissue ligation clamp and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810060437.2A CN108294802B (en) | 2018-01-22 | 2018-01-22 | Double-layer U-shaped tubular tissue ligation clamp and preparation method thereof |
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| CN108294802A true CN108294802A (en) | 2018-07-20 |
| CN108294802B CN108294802B (en) | 2019-12-31 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111513793A (en) * | 2020-04-15 | 2020-08-11 | 浙江天松医疗器械股份有限公司 | Absorbable ligature clamp and disassembling method thereof |
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| US5306283A (en) * | 1992-06-30 | 1994-04-26 | American Cyanamid Company | Two-part surgical ligation clip |
| CN201831920U (en) * | 2010-05-20 | 2011-05-18 | 仁齐企业有限公司 | Improved structure of artery clamp |
| CN201958948U (en) * | 2011-03-04 | 2011-09-07 | 付吉东 | Novel vascular clamp |
| CN205322412U (en) * | 2015-12-24 | 2016-06-22 | 安瑞医疗器械(杭州)有限公司 | Controllable hemostatic clamp that drops |
| CN107137755A (en) * | 2017-06-07 | 2017-09-08 | 浙江微度医疗器械有限公司 | A kind of hemostatic ligation clip that can quickly absorb |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5306283A (en) * | 1992-06-30 | 1994-04-26 | American Cyanamid Company | Two-part surgical ligation clip |
| CN201831920U (en) * | 2010-05-20 | 2011-05-18 | 仁齐企业有限公司 | Improved structure of artery clamp |
| CN201958948U (en) * | 2011-03-04 | 2011-09-07 | 付吉东 | Novel vascular clamp |
| CN205322412U (en) * | 2015-12-24 | 2016-06-22 | 安瑞医疗器械(杭州)有限公司 | Controllable hemostatic clamp that drops |
| CN107137755A (en) * | 2017-06-07 | 2017-09-08 | 浙江微度医疗器械有限公司 | A kind of hemostatic ligation clip that can quickly absorb |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111513793A (en) * | 2020-04-15 | 2020-08-11 | 浙江天松医疗器械股份有限公司 | Absorbable ligature clamp and disassembling method thereof |
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| CN108294802B (en) | 2019-12-31 |
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