CN117695456A - Drainage tube coated with hydrogel for hepatobiliary surgery - Google Patents
Drainage tube coated with hydrogel for hepatobiliary surgery Download PDFInfo
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- CN117695456A CN117695456A CN202311853772.5A CN202311853772A CN117695456A CN 117695456 A CN117695456 A CN 117695456A CN 202311853772 A CN202311853772 A CN 202311853772A CN 117695456 A CN117695456 A CN 117695456A
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- 239000000017 hydrogel Substances 0.000 title claims abstract description 73
- 238000001356 surgical procedure Methods 0.000 title claims abstract description 14
- 239000010410 layer Substances 0.000 claims abstract description 66
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000000499 gel Substances 0.000 claims abstract description 12
- 239000011241 protective layer Substances 0.000 claims abstract description 12
- 239000000243 solution Substances 0.000 claims description 60
- 239000002245 particle Substances 0.000 claims description 36
- 239000000843 powder Substances 0.000 claims description 29
- 239000000463 material Substances 0.000 claims description 27
- 229920002635 polyurethane Polymers 0.000 claims description 27
- 239000004814 polyurethane Substances 0.000 claims description 27
- 238000004108 freeze drying Methods 0.000 claims description 22
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 20
- 239000002243 precursor Substances 0.000 claims description 20
- 239000004698 Polyethylene Substances 0.000 claims description 17
- -1 polyethylene Polymers 0.000 claims description 17
- 229920000573 polyethylene Polymers 0.000 claims description 17
- 239000011248 coating agent Substances 0.000 claims description 16
- 238000000576 coating method Methods 0.000 claims description 16
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 15
- 239000012153 distilled water Substances 0.000 claims description 15
- 229920006264 polyurethane film Polymers 0.000 claims description 15
- 229920001296 polysiloxane Polymers 0.000 claims description 14
- 238000002791 soaking Methods 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 12
- 230000008961 swelling Effects 0.000 claims description 12
- 229920001661 Chitosan Polymers 0.000 claims description 10
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 10
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 10
- 238000004140 cleaning Methods 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 10
- 238000002156 mixing Methods 0.000 claims description 10
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 10
- 239000011550 stock solution Substances 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 8
- 229960002901 sodium glycerophosphate Drugs 0.000 claims description 7
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 239000007853 buffer solution Substances 0.000 claims description 5
- VGBWDOLBWVJTRZ-UHFFFAOYSA-K cerium(3+);triacetate Chemical compound [Ce+3].CC([O-])=O.CC([O-])=O.CC([O-])=O VGBWDOLBWVJTRZ-UHFFFAOYSA-K 0.000 claims description 5
- 238000010438 heat treatment Methods 0.000 claims description 5
- 239000005457 ice water Substances 0.000 claims description 5
- 239000003960 organic solvent Substances 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- 238000005096 rolling process Methods 0.000 claims description 5
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 5
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 5
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 5
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims description 5
- 238000001291 vacuum drying Methods 0.000 claims description 5
- 239000012528 membrane Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 239000008176 lyophilized powder Substances 0.000 claims description 2
- 210000000013 bile duct Anatomy 0.000 abstract description 18
- 238000005520 cutting process Methods 0.000 abstract description 5
- 210000004185 liver Anatomy 0.000 abstract description 5
- 230000008093 supporting effect Effects 0.000 abstract description 5
- 238000010521 absorption reaction Methods 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 11
- 239000013558 reference substance Substances 0.000 description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 6
- 239000000741 silica gel Substances 0.000 description 6
- 229910002027 silica gel Inorganic materials 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 210000003445 biliary tract Anatomy 0.000 description 5
- 210000000941 bile Anatomy 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 210000001953 common bile duct Anatomy 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 239000002504 physiological saline solution Substances 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- 230000003872 anastomosis Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 239000007863 gel particle Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000000643 oven drying Methods 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 238000011076 safety test Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 239000004575 stone Substances 0.000 description 1
- 239000002352 surface water Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 239000011240 wet gel Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
-
- 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)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a drainage tube covered with hydrogel for liver and gall surgery, which comprises a short arm and a long arm vertically communicated with the short arm, wherein the short arm consists of 2 thin sheets which can be rolled inwards from two ends to the center, the inner layer of the thin sheet is a gel layer with a protective layer, and the outer layer is a bottom layer; the front short arm can be internally coiled into a size which can be directly put into an incision, when in use, the short arm is swelled due to the water absorption of the gel layer, can be spread along the direction of the bile duct, plays roles of supporting and drainage, not only avoids cutting short arms in the operation implementation site, but also is suitable for bile ducts with different thicknesses, and is widely applied to children or patients with thickened inner walls of bile ducts and thinner inner diameters of bile ducts.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and relates to a drainage tube coated with hydrogel for liver and gall surgery.
Background
The T-shaped drainage tube is a biliary tract drainage tube commonly used for liver and gall surgery and is widely applied to various biliary tract surgeries such as cholangiotomy stone extraction, biliary tract shaping, biliary tract tumor excision, biliary tract anastomosis and the like. The T-shaped drainage tube is formed by vertically connecting a vertical tube (long arm) with the length of 40 cm-50 cm and a horizontal tube (short arm) with the length of 2 cm-4 cm, when the T-shaped drainage tube is used, the common bile duct is cut, the short arm is put in, then the bile duct is sutured along the junction of the opening of the drainage tube and the short arm, and the long arm is led out of the body after the retention of the short arm is completed.
The conventional T-shaped drainage tube is generally an integral rubber tube or a silicone tube, and because the incision length of the common bile duct is only about 1cm and even a few millimeters, the operation is very inconvenient when the short arm is put in, the length of the short arm needs to be cut on the operation site according to the condition, and meanwhile, the cutting of the short arm is not too short in order to ensure the supporting effect of the short arm. This not only wastes valuable surgical time, but also places higher demands on the physician's experience and skill.
In order to solve the problem that the short arm needs to be cut on site when the T-shaped drainage tube is placed, the T-shaped drainage tube which is convenient to place, good in supporting effect and free from cutting the short arm needs to be provided.
Disclosure of Invention
The invention aims to solve the problem that a short arm needs to be cut on site when a T-shaped drainage tube is placed, and provides a T-shaped drainage tube coated with hydrogel, wherein the short arm can be rolled inwards before use.
The technical scheme adopted by the invention is that the drainage tube for liver and gall surgery covered with hydrogel is a T-shaped drainage tube and comprises a short arm and a long arm vertically communicated with the short arm, and is characterized in that the short arm consists of 2 thin sheets which can be rolled inwards from two ends to the center, the inner layer of the thin sheet is a gel layer with a protective layer, and the outer layer is a bottom layer.
Further, the gel layer is covered with a hydrogel dry powder particle layer and then covered with a protective layer of polyurethane semipermeable membranes.
Preferably, the swelling degree of the hydrogel dry powder particles is 5-8, and the particle size of the swelled hydrogel particles is 0.4-0.7 mm.
Optimally, the particle size of the hydrogel dry powder particles is 10-15 mu m, and the density is 0.010g/cm 3 ～0.012g/cm 3 。
Specifically, the hydrogel dry powder is polyethylene glycol-chitosan-sodium glycerophosphate lyophilized powder.
More specifically, the bottom layer is a silica gel layer or a polyethylene layer with the thickness of 0.3-0.5 mm.
The specific preparation process of the hydrogel-coated drainage tube for liver and gall surgery is as follows:
s1, preparing a T-shaped silicone tube or a polyethylene tube, wherein 2 short arms are silicone strips or polyethylene strips with the thickness of 0.3-0.5 mm, the length of 2-3 cm and the width of 0.4-0.6 cm, namely the bottom layer, the short arms and the long arms are integrally formed, and the long arms are hollow silicone tubes or polyethylene tubes;
s2, preparation of gel layers: 8-10 parts of chitosan is dissolved in 30-40 parts of acetic acid solution with the mass concentration of 1% -2%, and the solution is stirred at room temperature until the chitosan is completely dissolved, so that a solution A is prepared, and the solution A is stored at the temperature of 4 ℃; 2 to 4 parts of beta-sodium glycerophosphate is dissolved in 40 to 50 parts of sodium bicarbonate and sodium carbonate buffer solution to obtain solution B, and the solution B is preserved at the temperature of 4 ℃; mixing the solution A and the solution B under the ice water bath condition at the stirring speed of 30 rpm-50 rpm, and dripping 20-30 parts of polyethylene glycol to obtain a hydrogel precursor solution;
s3, freeze drying: coating a hydrogel precursor solution on a bottom layer, freeze-drying a T-shaped silicone tube or a polyethylene tube coated with hydrogel at a cold trap temperature of minus 20 ℃ to minus 18 ℃ and a vacuum degree of 4Pa to 6Pa for 6h to 8h, taking out, coating a layer of hydrogel precursor solution for the second time, freeze-drying at the cold trap temperature of minus 20 ℃ to minus 18 ℃ and the vacuum degree of 4Pa to 6Pa for 3h to 4h, taking out, coating a layer of hydrogel precursor solution for the third time, and freeze-drying at the cold trap temperature of minus 20 ℃ to minus 18 ℃ and the vacuum degree of 4Pa to 6Pa for 18h to 24h to prepare a hydrogel dry powder particle layer;
s4, preparing and covering a protective layer: adding 10 parts of acrylic acid, 1 part of dilute hydrochloric acid with the mass concentration of 10% -15% and 0.2-0.3 part of cerium acetate into 80-90 parts of distilled water by mass, and stirring to obtain hydrophilic stock solution; soaking, cleaning and drying polyurethane master batches in an ethanol solution, and adding 1 part by mass of polyurethane master batches into 60-80 parts by mass of tetrahydrofuran at room temperature to dissolve the polyurethane master batches to obtain a polyurethane material; at N 2 Under the protection of (2), mixing hydrophilic stock solution and polyurethane material, heating to 40-60 ℃, reacting for 2-4 h, cleaning with ethanol and distilled water, soaking in distilled water for 6-10 h, and vacuum drying to obtain polyurethane film material; flattening and fixing the short arm, covering polyurethane film material on the hydrogel dry powder particle layer, and oven drying to removeRemoving the organic solvent in the polyurethane film material, and rolling and fixing the two ends of the short arm inwards.
Compared with the prior art, the invention has the following beneficial effects:
the T-shaped drainage tube comprises a short arm which can be rolled inwards from two ends to the center and a long arm which is vertically communicated with the short arm. The short arm is a thin sheet rich in gel layer and silica gel or polyethylene bottom layer, hydrogel particles in the gel layer are dry particles before use, so that the short arm can be rolled inwards to be in a size capable of being directly placed into an incision, after the short arm is placed into the incision, after physiological saline is slowly injected in a leak testing process, the hydrogel particles can be quickly swelled, the short arm is stretched along the direction of a bile duct, and the short arm can play a role in supporting and draining. The gel layer is covered with the polyurethane semipermeable membrane, so that the gel layer not only can play a role in reinforcing gel particles before use, but also can disperse water molecules after flushing water, and the hydrogel particles can absorb water rapidly. The invention not only avoids cutting short arms in the operation implementation site, but also is suitable for bile ducts with different thicknesses, and is widely applied to children or patients with thickened inner walls of bile ducts and thinner inner diameters of bile ducts.
The hydrogel and the protective layer used in the invention are stable in a weak alkaline environment such as bile, and are applied in a simulated body for 14 days, and the surface of a short arm is complete and has no damage.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely, and it is apparent that the described embodiments 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.
The specific conditions are not noted in the examples, and the process may be carried out under conventional conditions; the reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
For convenience of description, the following parts by weight are described.
Example 1
S1, preparing a T-shaped silicone tube: the 2 short arms are silica gel strips with the thickness of 0.4mm, the length of 2cm and the width of 0.5cm, namely the bottom layer, the short arms and the long arms are integrally formed, and the long arms are hollow silica gel strips;
s2, preparation of a hydrogel layer: dissolving 10 parts of chitosan in 40 parts of acetic acid solution with the mass concentration of 1%, stirring at room temperature until the chitosan is completely dissolved to prepare solution A, and preserving at the temperature of 4 ℃; dissolving 3 parts of beta-sodium glycerophosphate in 45 parts of sodium bicarbonate and sodium carbonate buffer solution to obtain solution B, and preserving at 4 ℃; mixing the solution A and the solution B under the ice water bath condition at the stirring speed of 50rpm, and dropwise adding 25 parts of polyethylene glycol to obtain a hydrogel precursor solution;
s3, freeze drying: coating the hydrogel precursor solution on a bottom layer, freeze-drying a T-shaped silicone tube coated with hydrogel at the cold trap temperature of-19 ℃ and the vacuum degree of 5Pa for 7h, taking out, coating a layer of hydrogel precursor solution for the second time, freeze-drying at the cold trap temperature of-19 ℃ and the vacuum degree of 5Pa for 3.5h, taking out, coating a layer of hydrogel precursor solution for the third time, and freeze-drying at the cold trap temperature of-19 ℃ and the vacuum degree of 5Pa for 20h to prepare a hydrogel dry powder particle layer;
s4, preparing and covering a protective layer: adding 10 parts of acrylic acid, 1 part of dilute hydrochloric acid with the mass concentration of 15% and 0.25 part of cerium acetate into 90 parts of distilled water, and stirring to obtain hydrophilic stock solution; soaking, cleaning and drying polyurethane master batches in an ethanol solution, and adding 1 part of polyurethane master batches into 70 parts of tetrahydrofuran at room temperature to dissolve the polyurethane master batches to obtain a polyurethane material; at N 2 Under the protection of (2), mixing hydrophilic stock solution and polyurethane material, heating to 50 ℃, reacting for 4 hours, cleaning with ethanol and distilled water, soaking in distilled water for 10 hours, and vacuum drying to obtain polyurethane film material; and flattening and fixing the short arm, covering the polyurethane film material on the hydrogel dry powder particle layer, drying to remove the organic solvent in the polyurethane film material, and inwards rolling and fixing the two ends of the short arm for 2 circles.
Example two
S1, preparing a T-shaped polyethylene pipe: the 2 short arms are polyethylene strips with the thickness of 0.3mm, the length of 2.5cm and the width of 0.4cm, namely the bottom layer, the short arms and the long arms are integrally formed, and the long arms are hollow polyethylene pipes;
s2, preparation of a hydrogel layer: 9 parts of chitosan is dissolved in 40 parts of acetic acid solution with the mass concentration of 1.5%, the solution is stirred at room temperature until the chitosan is completely dissolved, so that a solution A is prepared, and the solution A is stored at the temperature of 4 ℃; dissolving 4 parts of beta-sodium glycerophosphate in 40 parts of sodium bicarbonate and sodium carbonate buffer solution to obtain solution B, and preserving at 4 ℃; mixing the solution A and the solution B under the ice water bath condition at the stirring speed of 40rpm, and dropwise adding 20 parts of polyethylene glycol to obtain a hydrogel precursor solution;
s3, freeze drying: coating a hydrogel precursor solution on a bottom layer, freeze-drying a T-shaped polyethylene tube coated with hydrogel at the cold trap temperature of-18 ℃ and the vacuum degree of 6Pa for 6 hours, taking out, coating a layer of hydrogel precursor solution for the second time, freeze-drying at the cold trap temperature of-18 ℃ and the vacuum degree of 6Pa for 4 hours, taking out, coating a layer of hydrogel precursor solution for the third time, and freeze-drying at the cold trap temperature of-18 ℃ and the vacuum degree of 6Pa for 18 hours to prepare a hydrogel dry powder particle layer;
s4, preparing and covering a protective layer: adding 10 parts of acrylic acid, 1 part of dilute hydrochloric acid with the mass concentration of 10% and 0.20 part of cerium acetate into 85 parts of distilled water, and stirring to obtain hydrophilic stock solution; soaking, cleaning and drying polyurethane master batches in an ethanol solution, and adding 1 part of polyurethane master batches into 80 parts of tetrahydrofuran at room temperature for dissolution to obtain a polyurethane material; at N 2 Under the protection of (2), mixing hydrophilic stock solution and polyurethane material, heating to 60 ℃, reacting for 2 hours, cleaning with ethanol and distilled water, soaking in distilled water for 8 hours, and vacuum drying to obtain polyurethane film material; and flattening and fixing the short arm, covering the polyurethane film material on the hydrogel dry powder particle layer, drying to remove the organic solvent in the polyurethane film material, and inwards rolling and fixing the two ends of the short arm for 2 circles.
Example III
S1, preparing a T-shaped silicone tube: the 2 short arms are silica gel strips with the thickness of 0.5mm, the length of 3.0cm and the width of 0.6cm, namely the bottom layer, the short arms and the long arms are integrally formed, and the long arms are hollow silica gel strips;
s2, preparation of a hydrogel layer: dissolving 8 parts of chitosan in 40 parts of acetic acid solution with the mass concentration of 2.0%, stirring at room temperature until the chitosan is completely dissolved to prepare solution A, and preserving at the temperature of 4 ℃; dissolving 2 parts of beta-sodium glycerophosphate in 50 parts of sodium bicarbonate and sodium carbonate buffer solution to obtain solution B, and preserving at 4 ℃; mixing the solution A and the solution B under the ice water bath condition at the stirring speed of 30rpm, and dropwise adding 30 parts of polyethylene glycol to obtain a hydrogel precursor solution;
s3, freeze drying: coating the hydrogel precursor solution on a bottom layer, freeze-drying a T-shaped silicone tube coated with hydrogel at the cold trap temperature of-20 ℃ and the vacuum degree of 4Pa for 8 hours, taking out, coating a layer of hydrogel precursor solution for the second time, freeze-drying at the cold trap temperature of-20 ℃ and the vacuum degree of 4Pa for 3 hours, taking out, coating a layer of hydrogel precursor solution for the third time, and freeze-drying at the cold trap temperature of-20 ℃ and the vacuum degree of 4Pa for 24 hours to prepare a hydrogel dry powder particle layer;
s4, preparing and covering a protective layer: adding 10 parts of acrylic acid, 1 part of dilute hydrochloric acid with the mass concentration of 12% and 0.30 part of cerium acetate into 80 parts of distilled water, and stirring to obtain hydrophilic stock solution; soaking, cleaning and drying polyurethane master batches in an ethanol solution, and adding 1 part of polyurethane master batches into 60 parts of tetrahydrofuran at room temperature for dissolution to obtain a polyurethane material; at N 2 Under the protection of (2), mixing hydrophilic stock solution and polyurethane material, heating to 40 ℃, reacting for 3 hours, cleaning with ethanol and distilled water, soaking in distilled water for 6 hours, and vacuum drying to obtain polyurethane film material; and flattening and fixing the short arm, covering the polyurethane film material on the hydrogel dry powder particle layer, drying to remove the organic solvent in the polyurethane film material, and inwards rolling the two ends of the short arm for 3 circles and fixing.
Comparative example one
The embodiment of comparative example one is the same as example one except that the amounts of the relevant materials in the "step S2" are shown in Table 1 (same example one, not shown), and the hydrogel dry powder particles of comparative example one are taken as the controls 1-1 to 1-3.
Table 1: comparative example one comparative table of the amount of materials used in the S2 step (unit: parts)
Comparative example two
The second embodiment of the comparative example is identical to the first embodiment except that the freeze-drying parameters in "step S3" are shown in Table 2 (not shown in the same example I), and the hydrogel dry powder particles of the comparative example I are used as the controls 2-1 to 2-3.
Table 2: parameter comparison table of step S3 in comparative example two
| Parameters (parameters) | Temperature (temperature) | Vacuum degree | Time of first time | Time of the second time | Time of the third time |
| Unit (B) | ℃ | Pa | h | h | h |
| Reference substance 2-1 | -40 | 5 | 7 | 4 | 20 |
| Reference substance 2-2 | -19 | 2 | 7 | 4 | 20 |
| Reference substances 2-3 | -19 | 5 | 7 | 0 | 20 |
Analysis and testing
1. The hydrogel dry powder particles were tested and the results are shown in table 3.
The swelling degree testing method comprises the following steps:
soaking hydrogel dry powder particles with a certain mass (M) in water for 2 hours, drying the surface water by using filter paper, weighing until the constant weight of wet gel reaches the swelling balance, recording the mass (M) after the constant weight, and calculating the equilibrium swelling degree of a sample by using the following formula, namely the swelling degree: swelling degree= (M-M)/M.
Table 3: summary of the results of the property test for each hydrogel dry powder particle
| Inspection item | Particle size of dry powder | Density of | Swelling degree | After swelling |
| Unit (B) | μm | g/cm 3 | —— | mm |
| Example 1 | 12 | 0.011 | 6 | 0.5 |
| Example 2 | 10 | 0.010 | 5 | 0.4 |
| Example 3 | 15 | 0.012 | 8 | 0.7 |
| Reference substance 1-1 | 11 | 0.015 | 12 | 1.3 |
| Reference substance1-2 | 12 | 0.008 | 3 | 0.2 |
| Reference substances 1-3 | 11 | 0.016 | 15 | 1.8 |
| Reference substance 2-1 | 8 | 0.012 | 6 | 0.3 |
| Reference substance 2-2 | 20 | 0.013 | 5 | 1.1 |
| Reference substances 2-3 | 10 | 0.011 | 6 | 0.6 |
2. Application testing
(1) Description of application modes:
in the in vitro simulated operation implementation process, the small intestine of the animal with the inner diameter of 0.6 mm-12 cm is selected to replace the bile duct. Before use, the broken arm of the prepared T-shaped drainage tube is rolled inwards from two ends, and the short arm is directly placed in a bile duct incision (the incision is 8-10 mm), and the long arm is sutured and fixed. After suturing, normal saline is injected from the long arm for leakage test, the normal saline extends the arm to flow into the bile duct, and as the protective layer of polyurethane is a semipermeable membrane, moisture can permeate, the hydrogel dry powder particle layer absorbs water to swell, and the short arm is propped open and supported in the bile duct.
When the wound is taken out, the short arm can be directly pulled out to suture the wound.
(2) Examples and comparative examples sample preparation applications
The embodiment of the invention can be rolled inwards to be in a size which can be directly put into an incision before use, and can be quickly swelled after physiological saline is slowly injected, so that the short arm can be unfolded along the direction of the bile duct, and the functions of supporting and drainage are well achieved.
The invention not only avoids cutting short arms in the operation implementation site, but also is suitable for bile ducts with different thickness, and is widely applied to children or patients with thickened inner walls of bile ducts and thinner inner diameters of bile ducts
In the comparative examples, such as control 1-1, control 1-3 or control 2-2, the swelling degree is too high or the particle size of the dry powder is too large, and the thickness of the short arm after swelling is too high, so that the inner diameter is narrow or the dry powder cannot be used for bile ducts with thinner inner diameter; the control 1-2 or the control 2-1 can not fully stretch the short arm due to too small swelling degree or dry powder particle size; in the reference 2-3, the hydrogel dry powder particle layers are unevenly distributed due to the too small number of coating and freeze-drying times of the hydrogel layers, and the effect of rapid water absorption and stretching cannot be achieved by the short arms.
3. Safety test
The short arm prepared in the example was immersed in a simulated bile solution for 20 days, and the surface condition of the short arm was observed and recorded, and the results are shown in table 4.
Table 4: record table for simulating soaking condition in bile solution by short arm
| Inspection item | Day 3 | Day 7 | Day 12 | Day 14 | Day 15 | Day 17 | Day 20 |
| Example 1 | A | A | A | A | A | B | B |
| Example 2 | A | A | A | A | B | B | B |
| Example 3 | A | A | A | A | A | B | B |
In the table:
the surface of the grade A is complete and is not damaged;
class B-surface is substantially intact, slightly broken;
class C-surface portion breaks.
Claims (7)
1. The drainage tube is a T-shaped drainage tube and comprises a short arm and a long arm vertically communicated with the short arm, and is characterized in that the short arm consists of 2 thin sheets which can be rolled inwards from two ends to the center, the inner layer of the thin sheet is a gel layer with a protective layer, and the outer layer of the thin sheet is a bottom layer.
2. The hydrogel-coated drainage tube for hepatobiliary surgery of claim 1, wherein said gel layer is coated with a layer of hydrogel dry powder particles and further coated with a protective layer of a polyurethane semipermeable membrane.
3. The drainage tube for hepatobiliary surgery coated with hydrogel according to claim 2, wherein the swelling degree of the hydrogel dry powder particles is 5-8, and the particle size of the swollen hydrogel particles is 0.4-0.7 mm.
4. The drainage tube for hepatobiliary surgery coated with hydrogel according to claim 2, wherein said hydrogel dry powder particles have a particle size of 10 μm to 15 μm and a density of 0.010g/cm 3 ～0.012g/cm 3 。
5. The hydrogel-coated drainage tube for hepatobiliary surgery according to claim 1, wherein said hydrogel dry powder is a polyethylene glycol-chitosan-sodium glycerophosphate lyophilized powder.
6. The drainage tube for hepatobiliary surgery covered with hydrogel according to claim 1, wherein said bottom layer is a silicone layer or a polyethylene layer with a thickness of 0.3mm to 0.5 mm.
7. The hydrogel-coated drainage tube for hepatobiliary surgery according to claim 1, wherein the specific preparation process is:
s1, preparing a T-shaped silicone tube or a polyethylene tube, wherein 2 short arms are silicone strips or polyethylene strips with the thickness of 0.3-0.5 mm, the length of 2-3 cm and the width of 0.4-0.6 cm, namely the bottom layer, the short arms and the long arms are integrally formed, and the long arms are hollow silicone tubes or polyethylene tubes;
s2, preparation of gel layers: 8-10 parts of chitosan is dissolved in 30-40 parts of acetic acid solution with the mass concentration of 1% -2%, and the solution is stirred at room temperature until the chitosan is completely dissolved, so that a solution A is prepared, and the solution A is stored at the temperature of 4 ℃; 2 to 4 parts of beta-sodium glycerophosphate is dissolved in 40 to 50 parts of sodium bicarbonate and sodium carbonate buffer solution to obtain solution B, and the solution B is preserved at the temperature of 4 ℃; mixing the solution A and the solution B under the ice water bath condition at the stirring speed of 30 rpm-50 rpm, and dripping 20-30 parts of polyethylene glycol to obtain a hydrogel precursor solution;
s3, freeze drying: coating a hydrogel precursor solution on a bottom layer, freeze-drying a T-shaped silicone tube or a polyethylene tube coated with hydrogel at a cold trap temperature of minus 20 ℃ to minus 18 ℃ and a vacuum degree of 4Pa to 6Pa for 6h to 8h, taking out, coating a layer of hydrogel precursor solution for the second time, freeze-drying at the cold trap temperature of minus 20 ℃ to minus 18 ℃ and the vacuum degree of 4Pa to 6Pa for 3h to 4h, taking out, coating a layer of hydrogel precursor solution for the third time, and freeze-drying at the cold trap temperature of minus 20 ℃ to minus 18 ℃ and the vacuum degree of 4Pa to 6Pa for 18h to 24h to prepare a hydrogel dry powder particle layer;
s4, preparing and covering a protective layer: adding 10 parts of acrylic acid, 1 part of dilute hydrochloric acid with the mass concentration of 10-15% and 0.2-0.3 part of cerium acetate into 80-90 parts of distilled water by mass, and stirring to obtain hydrophilic stock solutionThe method comprises the steps of carrying out a first treatment on the surface of the Soaking, cleaning and drying polyurethane master batches in an ethanol solution, and adding 1 part by mass of polyurethane master batches into 60-80 parts by mass of tetrahydrofuran at room temperature to dissolve the polyurethane master batches to obtain a polyurethane material; at N 2 Under the protection of (2), mixing hydrophilic stock solution and polyurethane material, heating to 40-60 ℃, reacting for 2-4 h, cleaning with ethanol and distilled water, soaking in distilled water for 6-10 h, and vacuum drying to obtain polyurethane film material; and flattening and fixing the short arm, covering the polyurethane film material on the hydrogel dry powder particle layer, drying to remove the organic solvent in the polyurethane film material, and rolling and fixing the two ends of the short arm inwards.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102793952A (en) * | 2012-08-20 | 2012-11-28 | 山东省立医院 | Gel material for preventing intestinal adhesion |
| CN209108384U (en) * | 2018-04-11 | 2019-07-16 | 辛建 | A kind of anti-gallbladder leakage T-type drainage tube |
| CN115920141A (en) * | 2022-12-12 | 2023-04-07 | 广东省人民医院 | Antibacterial and antimicrobial adhesive drainage tube and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102793952A (en) * | 2012-08-20 | 2012-11-28 | 山东省立医院 | Gel material for preventing intestinal adhesion |
| CN209108384U (en) * | 2018-04-11 | 2019-07-16 | 辛建 | A kind of anti-gallbladder leakage T-type drainage tube |
| CN115920141A (en) * | 2022-12-12 | 2023-04-07 | 广东省人民医院 | Antibacterial and antimicrobial adhesive drainage tube and preparation method thereof |
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