CN116688253A - Injection gel and method for endoscopic submucosal dissection - Google Patents
Injection gel and method for endoscopic submucosal dissection Download PDFInfo
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- CN116688253A CN116688253A CN202310487778.9A CN202310487778A CN116688253A CN 116688253 A CN116688253 A CN 116688253A CN 202310487778 A CN202310487778 A CN 202310487778A CN 116688253 A CN116688253 A CN 116688253A
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- Prior art keywords
- gel
- solution
- eluent
- endoscopic submucosal
- submucosal dissection
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- 238000002347 injection Methods 0.000 title claims abstract description 23
- 239000007924 injection Substances 0.000 title claims abstract description 23
- 238000012323 Endoscopic submucosal dissection Methods 0.000 title claims abstract description 19
- 238000000034 method Methods 0.000 title claims abstract description 18
- 239000000243 solution Substances 0.000 claims abstract description 41
- 239000000499 gel Substances 0.000 claims abstract description 38
- 210000004400 mucous membrane Anatomy 0.000 claims abstract description 23
- 239000003480 eluent Substances 0.000 claims abstract description 21
- 229940030225 antihemorrhagics Drugs 0.000 claims abstract description 18
- 239000002874 hemostatic agent Substances 0.000 claims abstract description 18
- KZFDVWZZYOPBQZ-UHFFFAOYSA-K bismuth;potassium;2-hydroxypropane-1,2,3-tricarboxylate Chemical group [K+].[Bi+3].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KZFDVWZZYOPBQZ-UHFFFAOYSA-K 0.000 claims abstract description 13
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 12
- 239000000654 additive Substances 0.000 claims abstract description 11
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims abstract description 10
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims abstract description 10
- 230000000996 additive effect Effects 0.000 claims abstract description 10
- 239000000661 sodium alginate Substances 0.000 claims abstract description 10
- 235000010413 sodium alginate Nutrition 0.000 claims abstract description 10
- 229940005550 sodium alginate Drugs 0.000 claims abstract description 10
- 239000001509 sodium citrate Substances 0.000 claims abstract description 10
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 10
- 229920001661 Chitosan Polymers 0.000 claims abstract description 9
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 claims abstract description 8
- 108010001336 Horseradish Peroxidase Proteins 0.000 claims abstract description 8
- 239000001913 cellulose Substances 0.000 claims abstract description 8
- 229920002678 cellulose Polymers 0.000 claims abstract description 8
- 230000009286 beneficial effect Effects 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims abstract description 7
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 claims abstract description 4
- 229960005019 pantoprazole Drugs 0.000 claims abstract description 4
- 229920000867 polyelectrolyte Polymers 0.000 claims abstract description 4
- 229940126409 proton pump inhibitor Drugs 0.000 claims abstract description 4
- 239000000612 proton pump inhibitor Substances 0.000 claims abstract description 4
- 108010010803 Gelatin Proteins 0.000 claims abstract description 3
- 239000008273 gelatin Substances 0.000 claims abstract description 3
- 229920000159 gelatin Polymers 0.000 claims abstract description 3
- 235000019322 gelatine Nutrition 0.000 claims abstract description 3
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 3
- 210000003205 muscle Anatomy 0.000 claims abstract description 3
- 239000000945 filler Substances 0.000 claims description 19
- 150000003839 salts Chemical class 0.000 claims description 14
- 208000027418 Wounds and injury Diseases 0.000 claims description 13
- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 claims description 13
- 230000000694 effects Effects 0.000 claims description 13
- 229910052901 montmorillonite Inorganic materials 0.000 claims description 13
- 239000002245 particle Substances 0.000 claims description 11
- 239000003086 colorant Substances 0.000 claims description 10
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 9
- 229910021389 graphene Inorganic materials 0.000 claims description 9
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 8
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 8
- 238000005520 cutting process Methods 0.000 claims description 8
- 210000001035 gastrointestinal tract Anatomy 0.000 claims description 8
- KHLVKKOJDHCJMG-QDBORUFSSA-L indigo carmine Chemical compound [Na+].[Na+].N/1C2=CC=C(S([O-])(=O)=O)C=C2C(=O)C\1=C1/NC2=CC=C(S(=O)(=O)[O-])C=C2C1=O KHLVKKOJDHCJMG-QDBORUFSSA-L 0.000 claims description 8
- 229960003988 indigo carmine Drugs 0.000 claims description 8
- 235000012738 indigotine Nutrition 0.000 claims description 8
- 239000004179 indigotine Substances 0.000 claims description 8
- 230000003902 lesion Effects 0.000 claims description 8
- BELBBZDIHDAJOR-UHFFFAOYSA-N Phenolsulfonephthalein Chemical compound C1=CC(O)=CC=C1C1(C=2C=CC(O)=CC=2)C2=CC=CC=C2S(=O)(=O)O1 BELBBZDIHDAJOR-UHFFFAOYSA-N 0.000 claims description 7
- 229960003531 phenolsulfonphthalein Drugs 0.000 claims description 7
- 229950003937 tolonium Drugs 0.000 claims description 7
- HNONEKILPDHFOL-UHFFFAOYSA-M tolonium chloride Chemical compound [Cl-].C1=C(C)C(N)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 HNONEKILPDHFOL-UHFFFAOYSA-M 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 210000004877 mucosa Anatomy 0.000 claims description 5
- 238000011084 recovery Methods 0.000 claims description 5
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 4
- 229960004157 rabeprazole Drugs 0.000 claims description 4
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 claims description 4
- 208000025865 Ulcer Diseases 0.000 claims description 3
- 230000002378 acidificating effect Effects 0.000 claims description 3
- 150000001413 amino acids Chemical class 0.000 claims description 3
- IQFVPQOLBLOTPF-HKXUKFGYSA-L congo red Chemical compound [Na+].[Na+].C1=CC=CC2=C(N)C(/N=N/C3=CC=C(C=C3)C3=CC=C(C=C3)/N=N/C3=C(C4=CC=CC=C4C(=C3)S([O-])(=O)=O)N)=CC(S([O-])(=O)=O)=C21 IQFVPQOLBLOTPF-HKXUKFGYSA-L 0.000 claims description 3
- 239000013078 crystal Substances 0.000 claims description 3
- 230000002439 hemostatic effect Effects 0.000 claims description 3
- 210000003097 mucus Anatomy 0.000 claims description 3
- 102000004169 proteins and genes Human genes 0.000 claims description 3
- 108090000623 proteins and genes Proteins 0.000 claims description 3
- 230000028327 secretion Effects 0.000 claims description 3
- 239000000779 smoke Substances 0.000 claims description 3
- 239000002904 solvent Substances 0.000 claims description 3
- 210000001519 tissue Anatomy 0.000 claims description 3
- 231100000397 ulcer Toxicity 0.000 claims description 3
- 239000004927 clay Substances 0.000 claims description 2
- 230000035876 healing Effects 0.000 claims description 2
- 230000001681 protective effect Effects 0.000 claims description 2
- 238000002224 dissection Methods 0.000 claims 1
- 239000012153 distilled water Substances 0.000 claims 1
- 150000002500 ions Chemical class 0.000 claims 1
- 238000007493 shaping process Methods 0.000 claims 1
- 238000010186 staining Methods 0.000 claims 1
- 230000029663 wound healing Effects 0.000 abstract description 2
- 210000004379 membrane Anatomy 0.000 abstract 1
- 239000012528 membrane Substances 0.000 abstract 1
- 206010052428 Wound Diseases 0.000 description 12
- 239000011575 calcium Substances 0.000 description 6
- 241000282887 Suidae Species 0.000 description 3
- 230000000740 bleeding effect Effects 0.000 description 3
- 238000000465 moulding Methods 0.000 description 3
- 238000000926 separation method Methods 0.000 description 3
- 239000002689 soil Substances 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 235000015110 jellies Nutrition 0.000 description 2
- 239000008274 jelly Substances 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 210000000754 myometrium Anatomy 0.000 description 2
- 238000012404 In vitro experiment Methods 0.000 description 1
- 208000005016 Intestinal Neoplasms Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 102000003992 Peroxidases Human genes 0.000 description 1
- 229920002385 Sodium hyaluronate Polymers 0.000 description 1
- 208000005718 Stomach Neoplasms Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 239000004227 calcium gluconate Substances 0.000 description 1
- 229960004494 calcium gluconate Drugs 0.000 description 1
- 235000013927 calcium gluconate Nutrition 0.000 description 1
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 206010017758 gastric cancer Diseases 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 201000002313 intestinal cancer Diseases 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 229960004048 pantoprazole sodium Drugs 0.000 description 1
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 description 1
- 108040007629 peroxidase activity proteins Proteins 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 201000011549 stomach cancer Diseases 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000004876 tela submucosa Anatomy 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/045—Gelatin
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
-
- 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
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
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- Inorganic Chemistry (AREA)
- Materials For Medical Uses (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses an injection gel and a method for endoscopic submucosal dissection, and the injection gel comprises a forming agent, a hemostatic agent, an additive and an eluent. The forming agent consists of A, B solution: the solution A consists of one or more of gelatin, acrylamide, chitosan, sodium alginate, cellulose and the like; the solution B contains Ca 2+ 、Ni 2+ 、Zn 2+ Any combination of plasma, polyelectrolyte complex, etc. or horseradish peroxidase, etc. The hemostatic agent adopts one of proton pump inhibitors (minoprazole, pantoprazole and the like). The eluent is bismuth potassium citrate, EDTA-2Na, sodium citrate, etc. The material can be rapidly molded under the mucous membrane skin of the alimentary canal to adhere lesionsThe membrane layer is effectively separated from the intrinsic muscle layer, so that the operation efficiency is improved. In addition, gel remained on the mucous membrane tissues after operation can be eluted, which is beneficial to wound healing. The invention is safe and reliable, is simple and convenient to use, and has wide application prospect in the clinical field.
Description
Technical Field
The invention relates to the technical field of injection gel, in particular to injection gel and a method for endoscopic submucosal dissection.
Background
With the development of the endoscope minimally invasive technology, stomach cancer, intestinal cancer, precancerous lesions and gastrointestinal submucosa diseases can be discovered and treated in early stage. Such lesions may be resected endoscopically, and endoscopic submucosal dissection ESD (endoscopicsubmucosaldissecfion) may be used. ESD treatment is one of the recently emerging endoscopic minimally invasive treatment means at home and abroad, has the advantages of no change of the anatomical structure of the digestive tract, no wound on the body surface, small wound, little bleeding, quick recovery and the like, and is suitable for the excision treatment of the benign tumors under the mucous membrane of the upper digestive tract, colon and rectum such as esophagus, stomach, duodenum and the like, the early canceration of mucous membrane and canceration-prone lesions. Because of the special minimally invasive advantages, the medical device is advocated by doctors and patients.
The key link in the treatment process is to perform submucosal injection at the edge of the focus to lift the focus and separate the focus from the myometrium, thereby facilitating the operation of ESD and completely cutting off the focus without damaging the intrinsic myometrium and avoiding the occurrence of complications such as perforation or bleeding of the digestive tract. However, the currently commonly used injection liquid comprises physiological saline, glycerofructose, sodium hyaluronate and the like, and the material cannot be shaped under the mucous membrane, is resolved along with pinhole leakage, has poor lifting effect on focus and needs to be injected for many times in operation. The submucosal injection formula and the application thereof disclosed in application number 202180000780.8 can be obtained by radiating, heat energy, ultrasonic wave or ultraviolet irradiation on materials, have the defects of radiation danger, complicated operation and the like, have no elution function, and the residual gel can prolong the wound healing.
Therefore, there is a need to develop an injection gel that can be injected submucosally and set rapidly, and a method that can elute the residual gel.
Disclosure of Invention
In view of the drawbacks of the prior art, it is an object of the present invention to provide an injection gel and a method for endoscopic submucosal dissection to solve the problems set forth in the background art.
The invention solves the technical problems by adopting the following technical scheme:
the invention provides an injection gel for endoscopic submucosal dissection, which comprises a forming agent, a hemostatic agent, an additive and an eluent. The forming agent consists of a solution A and a solution B: the solution A is composed of one or more of acrylic acid, acrylamide, chitosan, sodium alginate, cellulose and the like; the solution B is as follows: with Ca content 2+ 、Ni 2+ 、Zn 2+ Any combination of plasma, polyelectrolyte complex, etc. or horseradish peroxidase, etc. The additive consists of indigo carmine, toluidine blue, phenol red, congo red, crystal violet and other coloring agents and montmorillonite, graphene and other particle fillers. The hemostatic agent adopts one of proton pump inhibitors (such as minoprazole, rabeprazole, pantoprazole, etc.). The eluent is bismuth potassium citrate, EDTA-2Na, sodium citrate, etc.
Further, the A-type solution is composed of acrylic acid (0-20 mg/mL), acrylamide (0-10 mg/mL), chitosan (0-5 mg/mL), sodium alginate (0-20 mg/mL) and cellulose (0-3 mg/mL);
the type B solution used consisted of: ca (Ca) 2+ Salt (1-15 g/L), ni 2+ Salt (0-15 g/L), zn 2+ Salts (1-15 g/L), glutaraldehyde (0-16 mL/L), horseradish peroxidase (0-10 mL/100 mL);
further, the additive comprises a coloring agent and a particle filler, wherein the coloring agent comprises indigo carmine (1-20 mL/L), toluidine blue (0-10 mL/L), phenol red (0-15 mL/L) and the like; the particle filler is composed of montmorillonite (0.1-15 g/mL), graphene (1-15 mg/mL), etc.
Further, the molding agent material used may be subjected to group modification;
further, the used eluent is: bismuth potassium citrate (1-50 g/mL), EDTA-2Na (0-10 g/mL), sodium citrate (0-13 g/mL);
further, the solvents used were triple distilled sterilized water or PBS buffer;
further, the method for using the endoscopic submucosal dissection injection gel comprises the following steps: the A-type solution and the B-type solution containing the proper amounts of the additives in the method of claim 1 are respectively injected at the same position to mix the two solutions uniformly, so that a jelly-shaped gel cushion layer can be formed within 30 seconds, the mucous membrane layer of a lesion area is lifted to be effectively separated from the intrinsic muscle layer, the complete excision of the lesion is facilitated, and unnecessary risks caused by cutting through the digestive tract in the excision process are avoided.
Furthermore, after the stripping of the diseased mucosa area is completed, the eluent with proper concentration can be injected or coated at the incision to make the eluent contact with the gel remained in the tissues around the incision, and the gel is gradually dissolved and eluted, thereby being beneficial to detumescence and healing of the incision.
Furthermore, the strength of gelatin can be improved by adding the filler, so that a better mucous membrane elevation effect is achieved;
furthermore, the smoke degree in the mucous membrane stripping process can be effectively reduced by using the Mongolian clay particles in the filler;
furthermore, montmorillonite particles in the filler have a layered structure, and can be used for component adsorption of hemostatic agents with small molecular structures. The hemostatic agent is gradually released from the Mongolian soil in the electric frequency cutting process, and has hemostatic function.
Furthermore, the montmorillonite in the filler has the effect of protecting the mucous membrane, and can protect the mucous membrane after the operation of peeling off; the bismuth potassium citrate component in the protective eluent can promote the secretion of mucus, and is complexed with protein and amino acid under acidic condition to deposit on ulcer mucosa, which is beneficial to recovery of wound.
Compared with the prior art, the invention has the following beneficial effects:
the invention has excellent effect, the jelly-shaped gel can be formed after the solution A and the solution B are mixed, the reaction is rapid, and both in vitro experiments and animal experiments show that the mucous membrane layer is obviously raised after the submucosal injection, the gel shape is kept lasting, and the operation of cutting focus is facilitated;
the discharging effect in the electric knife cutting process is improved, the smoke is reduced, and the operation visual field of doctors is improved;
the prognosis effect is excellent, the hemostatic agent and the Mongolian soil are released in the cutting process, and the hemostatic agent and the Mongolian soil play a role in stopping bleeding and protecting mucous membranes near wounds;
the invention is made of edible materials, is safe and reliable for human bodies, and has no abnormal reaction, inflammatory cell infiltration, tissue edema or necrosis and other conditions in 3 months after submucosal injection;
the bismuth potassium citrate component in the eluent can promote the secretion of mucus, and is complexed with protein and amino acid under acidic condition to deposit on ulcer mucosa, which is beneficial to recovery of wound.
Drawings
FIG. 1 is an endoscopic surgical view of embodiment 1;
fig. 2 shows wound recovery 7 days after surgery in example 1.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
An injection gel for endoscopic submucosal dissection according to this embodiment specifically includes a molding agent, a hemostatic agent, an additive, and an eluent. The forming agent consists of a solution A and a solution B: the solution A is composed of one or more of acrylic acid, acrylamide, chitosan, sodium alginate, cellulose and the like; the solution B is as follows: with Ca content 2+ 、Ni 2+ 、Zn 2+ Plasma, polyelectrolyte complex, etc. orHorseradish peroxidase, etc. The additive consists of indigo carmine, toluidine blue, phenol red, congo red, crystal violet and other coloring agents and montmorillonite, graphene and other particle fillers. The hemostatic agent adopts one of proton pump inhibitors (such as minoprazole, rabeprazole, pantoprazole, etc.). The eluent is bismuth potassium citrate, EDTA-2Na, sodium citrate, etc.
The A-type solution of the embodiment consists of acrylic acid (0-20 mg/mL), acrylamide (0-10 mg/mL), chitosan (0-5 mg/mL), sodium alginate (0-20 mg/mL) and cellulose (0-3 mg/mL);
the type B solution used consisted of: ca (Ca) 2+ Salt (1-15 g/L), ni 2+ Salt (0-15 g/L), zn 2+ Salts (1-15 g/L), glutaraldehyde (0-16 mL/L), horseradish peroxidase (0-10 mL/100 mL);
the additive comprises a coloring agent and a particle filler, wherein the coloring agent comprises indigo carmine (1-20 mL/L), toluidine blue (0-10 mL/L), phenol red (0-15 mL/L) and the like; the particle filler is composed of montmorillonite (0.1-15 g/mL), graphene (1-15 mg/mL), etc.
The molding agent material of the embodiment can be subjected to group modification;
the eluent in this example is: bismuth potassium citrate (1-50 g/mL), EDTA-2Na (0-10 g/mL), sodium citrate (0-13 g/mL);
the solvent used in this example was triple distilled sterilized water or PBS buffer;
the preparation method comprises the steps of taking 50mg/L of chitosan and 200mg/L of sodium alginate as a solution A, taking calcium gluconate as a solution B, taking 1mg/L of montmorillonite as a filler, taking 0.2mg/L of pantoprazole sodium as a hemostatic agent, and taking 5mL/100mL of indigo carmine as a coloring agent. The prepared gel padding has excellent gel forming effect and is in a jelly shape without fluidity. The water resistance of the injection gel in PBS solution reaches more than 24 hours. The A, B solution is respectively injected (before and after separation) at the same position of the pig digestive tract by an injector for an endoscope, the formed cushion layer has obvious lifting effect on mucous membrane, and the injection pressure is less than 2.6kgf. After the mucous membrane is stripped, the wound is cleaned by eluent of combination of bismuth potassium citrate (1 g/mL), EDTA-2Na (0.2 g/mL) and sodium citrate (0.3 g/mL). The experimental procedure is shown in figure 1. After 7d the experimental pigs were reviewed and the wound was substantially healed as shown in figure 2.
The A-type solution comprises acrylic acid (20 mg/mL), chitosan (5 mg/mL), sodium alginate (20 mg/mL), cellulose (3 mg/mL), and Ca 2+ Salt (1 g/mL), zn 2+ Salt (1 g/mL), horseradish peroxidase (1 mL/100 mL) as a B solution, graphene (1 mg/mL) as a filler, 0.2mg/L of minoprazole as a hemostatic agent, and 5mL/100mL of indigo carmine as a coloring agent. The prepared gel padding has excellent gel forming effect and is in a jelly shape without fluidity. The water resistance of the injection gel in PBS solution reaches more than 48 hours. The A, B solution is respectively injected (before and after separation) at the same position of the pig digestive tract by an injector for an endoscope, the formed cushion layer has obvious lifting effect on mucous membrane, and the injection pressure is less than 2.6kgf. After the mucous membrane is stripped, the wound is cleaned by eluent of combination of bismuth potassium citrate (2 g/mL), EDTA-2Na (0.4 g/mL) and sodium citrate (0.4 g/mL). Animals and pigs were reviewed 7d later and the wound healed substantially.
The A-type solution comprises acrylic acid (20 mg/mL), acrylamide (10 mg/mL), sodium alginate (10 mg/mL), and Ca 2+ Salt (15 g/L), ni 2+ Salt (15 g/L), zn 2+ Salt (15 g/L), glutaraldehyde (16 mL/L), horseradish peroxidase (10 mL/L) as B solution, 1mg/L of montmorillonite as filler, 0.2mg/L rabeprazole as hemostatic, and toluidine blue (10 mL/L) and phenol red (15 mL/L) as coloring agents. The water resistance of the injection gel in PBS solution reaches more than 36 h. The A, B solution is respectively injected (before and after separation) at the same position of the pig digestive tract by an injector for an endoscope, the formed cushion layer has obvious lifting effect on mucous membrane, and the injection pressure is less than 4.87kgf. After the mucous membrane is stripped, the wound is cleaned by eluent of combination of bismuth potassium citrate (3 g/mL), EDTA-2Na (0.2 g/mL) and sodium citrate (0.6 g/mL). The experimental pigs were reviewed 7d later and the wound healed substantially.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.
Claims (10)
1. An injectable gel for endoscopic submucosal dissection characterized by: the hemostatic agent comprises a forming agent, a hemostatic agent, an additive and an eluent;
the forming agent consists of a solution A and a solution B:
the solution A is composed of one or more of acrylic acid, acrylamide, chitosan, sodium alginate and cellulose;
the solution B is as follows: with Ca content 2+ 、Ni 2+ 、Zn 2+ Any combination of divalent ions, polyelectrolyte complex or horseradish peroxidase;
the additive consists of one or more fillers selected from indigo carmine, toluidine blue, phenol red, congo red, crystal violet coloring agent, montmorillonite and graphene;
the hemostatic agent adopts one of proton pump inhibitor, and one of minoprazole, rabeprazole and pantoprazole, and the eluent is one of bismuth potassium citrate, EDTA-2Na and sodium citrate.
2. An injectable gel for endoscopic submucosal dissection according to claim 1, wherein the type a solution is composed of acrylic acid (0-20 mg/mL), acrylamide (0-10 mg/mL), chitosan (0-5 mg/mL), sodium alginate (0-20 mg/mL), cellulose (0-3 mg/mL);
the type B solution used consisted of: ca (Ca) 2+ Salt (1-15 g/L), ni 2+ Salt (0-15 g/L), zn 2+ Salt (1-15 g/L), glutaraldehyde (0-16 mL/L), horseradish peroxidase (0-10 mL/100 mL).
3. An injectable gel for endoscopic submucosal dissection according to claim 1, wherein the staining agent consists of indigo carmine (1-20 mL/L), toluidine blue (0-10 mL/L), phenol red (0-15 mL/L); the particle filler consists of montmorillonite (0.1-15 g/mL) and graphene (1-15 mg/mL).
4. An injectable gel for endoscopic submucosal dissection according to claim 1, wherein the shaping agent material is group-modified.
5. An injectable gel for endoscopic submucosal dissection according to claim 1, using the following eluent: bismuth potassium citrate (1-50 g/L), EDTA-2Na (0-10 g/L), sodium citrate (0-13 g/L).
6. An injectable gel for endoscopic submucosal dissection according to claim 1, wherein the solvent is triple distilled water or PBS buffer.
7. A method of using the injection gel of any one of claims 1-6 for endoscopic submucosal dissection, characterized in that: the method comprises the following steps: the A-type solution and the B-type solution containing the additive as claimed in claim 1 are injected respectively at the same positions to mix the two solutions uniformly, so that a jelly-shaped gel cushion layer can be formed within 30 seconds, the mucous membrane layer of a lesion area is lifted to be effectively separated from the intrinsic muscle layer, the complete excision of the lesion is facilitated, and unnecessary risks caused by cutting through the digestive tract in the excision process are avoided.
8. The method for injecting gel for endoscopic submucosal dissection according to claim 7, wherein after the dissection of the lesion mucosa area is completed, the eluent is coated on the incision to make the eluent contact with the gel remained in the tissues around the incision, and the gel is gradually dissolved and eluted, so that the incision is beneficial to detumescence and healing.
9. The method for injecting gel for endoscopic submucosal dissection according to claim 8, wherein the filler is added to improve the strength of the gelatin to achieve the effect of continuous elevation of mucous membrane;
the smoke degree in the mucous membrane stripping process can be effectively reduced by using the Mongolian clay and the graphene particles in the filler.
10. The method for injecting gel for endoscopic submucosal dissection according to claim 8, wherein montmorillonite and graphene particles in the filler have a layered structure, and can be used for absorbing hemostatic agents with small molecular structures, and the hemostatic agents are gradually released from the montmorillonite in the electric frequency cutting process, so that the hemostatic agent has a hemostatic function;
the montmorillonite in the filler has the effect of protecting the mucous membrane, and can protect the mucous membrane after the peeling operation; the bismuth potassium citrate component in the protective eluent can promote the secretion of mucus, and is complexed with protein and amino acid under acidic condition to deposit on ulcer mucosa, which is beneficial to recovery of wound.
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| CN202310487778.9A CN116688253A (en) | 2023-05-04 | 2023-05-04 | Injection gel and method for endoscopic submucosal dissection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202310487778.9A CN116688253A (en) | 2023-05-04 | 2023-05-04 | Injection gel and method for endoscopic submucosal dissection |
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