CN106983916A - Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler and preparation method - Google Patents
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler and preparation method Download PDFInfo
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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
- 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
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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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
- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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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
- 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
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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
- 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
- A61L31/148—Materials at least partially resorbable by the body
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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
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
Abstract
The invention discloses a kind of biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler and preparation method, the stapler includes main body tube 1, main body tube is made up of mesh skeleton structure sheaf 2 with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, hemispherical or half capsule shape Hydrophilic Nanofibrous film end-blocking 4 are connected at the two ends of main body tube, the biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler of the present invention, gastrointestinal contents is kept apart with tissue at gastrointestinal anastomosis, not only facilitate the growth healing accelerated outside gastrointestinal anastomosis, improve the chance of success of gastrointestinal anastomosis, farthest reduce the generation of anastomotic leakage；Prepared, can be degradable after anastomotic healing and excreted using biodegradability medical macromolecular materials, had no toxic side effect；Making step is simple, low manufacture cost, it is possible to decrease the medical expense of patient；Effectively shorten the wholistic therapy cycle of patient, it is to avoid the secondary pain brought to patient.
Description
Technical field
The invention belongs to surgical medical equipment technical field, it is related to a kind of biodegradable no-station pole canopy isolation alimentary canal
Capsule-type stapler and preparation method.
Background technology
Gastrointestinal anastomosis operation is that abdominal surgery is most basic, most common operating technology, while being also postoperative to be easier to occur simultaneously
Send out the operation of disease.Stomach intestines mouth fistula is the postoperative relatively common lethal complication of gastrointestinal anastomosis, and gastrointestinal anastomosis fistula refers to stomach and intestine
Defect at previous anastomotic, causes the content in enteron aisle to be flowed out from the defect, so as to induce infection, organ dysfunction, battalion
A series of lesions such as bad and body fluid loss are supported, patient is carried out after gastrointestinal procedures, and the probability of concurrent stomach intestines mouth fistula is about 2%-
50.4%.Clinical research shows that serious stomach intestines mouth fistula does not only result in the generation of other complication, or even dead, and extension is in hospital
Time, and patient's economy, the burden of spirit are added, greatly reduce the therapeutic effect of operation and the pre- aftereffect of operation
Really.Therefore, gastrointestinal anastomosis is postoperative, and how to promote previous anastomotic quickly to heal is that effective reduction the important way of postoperative complications occurs
Footpath.
Gastrointestinal anastomosis method mainly includes two methods of manual, Mechanical Suture, and manual method is time-honored identical method,
Completed using silk thread or absorbable thread manual suture, but the operation of this method is cumbersome, process takes, different operating doctor it
Between tact skill differ greatly.At present, Mechanical Suture is also a kind of promotion postoperative identical important means of alimentary canal, in manual kiss
The difficult specific position of valid operation, such as esophagus lower end, basin intralumenal anastomosis, with obvious advantage easily to operate.But
It is to remain anastomosis staple etc. throughout one's life due to the stapler non-degradable designed on current medical market, in anastomosis operation pneumoretroperitoneum different
Thing, this causes many pains to patient, sometimes even entail dangers to patient vitals.
The content of the invention
The purpose of the present invention is to overcome the deficiencies in the prior art to improve gastrointestinal anastomosis success rate there is provided one kind, avoid
There is dangerous gastrointestinal fistula, internal foreign residual and the low biodegradable no-station pole canopy isolation alimentary canal capsule-type of medical treatment cost
Stapler.
Second object of the present invention is to provide a kind of biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler
Preparation method.
Technical scheme is summarized as follows：
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and the main body tube is by netted
Skeleton structure layer 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, in main body tube
Two ends are connected to hemispherical or half capsule shape Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure is that weight average molecular weight is that 20-100 ten thousand PLLA, weight average molecular weight are 20-
1000000 poly- D- lactides, the poly- D that weight average molecular weight is 20-100 ten thousand, L- lactides, weight average molecular weight are 20-100's ten thousand
Poly- (L- lactide-co-glycolides) that PGA, weight average molecular weight are 20-100 ten thousand, weight average molecular weight are 20-100 ten thousand
Poly- 6-caprolactone, weight average molecular weight be 20-100 ten thousand PPDO and weight average molecular weight be the poly- of 20-100 ten thousand
At least one of TMC.
The material of hydrophobic nano tunica fibrosa be weight average molecular weight be 5-20 ten thousand poly- (L- lactide-co-glycolides),
At least one in the poly- 6-caprolactone that weight average molecular weight is 5-20 ten thousand and the PPDO that weight average molecular weight is 5-20 ten thousand
Kind.
Hydrophilic Nanofibrous membrane material is that weight average molecular weight is 0.5-14 ten thousand, alcoholysis degree 88-98% polyvinyl alcohol, again
Average molecular weight is that 0.5-20 ten thousand polyvinylpyrrolidone, glue intensity are that 100~200g Bloom gelatin, weight average molecular weight are
0.2-20 ten thousand polyacrylic acid, carboxymethyl cellulose, farina, cornstarch and the wood that viscosity is 300-4500mPa.s
At least one of sweet potato starch.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 1-10cm by melting extrusion method, length is 1-20cm, wall
Thickness is 0.1-0.5cm tubular mesh skeleton structure layer；
(2) hydrophobic nano fiber film material is dissolved in DMF and tetrahydrofuran, quality is made dense
The first spinning solution for 10%-33% is spent, is humidity 40%-60%, voltage in setting air using electrospinning device
For (+12kV)~(+15kV), (- 0.2kV)~(- 1.2kV), receiver tubular mesh skeleton structure layer distance is 10-20cm,
By 2-10mL, the first spinning solution is sucked in 10mL syringes, is 2-5mL/h in spinning speed, to tubular mesh skeleton structure
Layer carries out spinning 1-5h, obtains by mesh skeleton structure sheaf (2) and be coated on the hydrophobicity of mesh skeleton structure sheaf (2) outer surface
The main body tube of nanofiber film layer (3) composition；
(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, it is the second of 5%-33% that mass concentration, which is made,
Spinning solution is planted, is humidity 30%-50% in setting air, voltage is (+12kV)~(+16kV) using electrospinning device,
(- 0.5kV)~(- 1.5kV), receiver distance is 10-20cm, and second of spinning solution of 2-10mL is sucked into 10mL syringes
In, it is 2-5mL/h in spinning speed, carries out spinning 1-5h；Hemispherical or half capsule shape Hydrophilic Nanofibrous film end-blocking are prepared,
The receiver is that hemisphere or hemisphere and cylinder are integral；
(4) main body tube is linked together with two hemisphericals or half capsule shape Hydrophilic Nanofibrous film end-blocking.
The material of mesh skeleton structure is the PLLA that weight average molecular weight is 20-100 ten thousand, poly- D- lactides, poly-
D, L- lactide, PGA, poly- (L- lactide-co-glycolides), poly- 6-caprolactone, PPDO and poly- three
At least one of methylene cyclic carbonate ester.
The material of hydrophobic nano tunica fibrosa be weight average molecular weight be 5-20 ten thousand poly- (L- lactide-co-glycolides),
At least one of poly- 6-caprolactone and PPDO.
Hydrophilic Nanofibrous membrane material is that weight average molecular weight is 0.5-14 ten thousand, alcoholysis degree 88-98% polyvinyl alcohol, again
Average molecular weight is that 0.5-20 ten thousand polyvinylpyrrolidone, glue intensity are that 100~200g Bloom gelatin, weight average molecular weight are
0.2-20 ten thousand polyacrylic acid, carboxymethyl cellulose, farina, cornstarch and the wood that viscosity is 300-4500mPa.s
At least one of sweet potato starch.
Advantages of the present invention：
1. the biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler of the present invention, gastrointestinal contents and stomach and intestine are kissed
Tissue is kept apart at conjunction, is not only facilitated the growth healing accelerated outside gastrointestinal anastomosis, is improved the chance of success of gastrointestinal anastomosis, maximum
The generation of the reduction anastomotic leakage of degree；
2. prepared using biodegradability medical macromolecular materials, can be degradable after anastomotic healing and body be discharged
Outside, have no toxic side effect；
3. making step is simple, low manufacture cost, it is possible to decrease the medical expense of patient；
4. effectively shorten the wholistic therapy cycle of patient, it is to avoid the secondary pain brought to patient.
Brief description of the drawings
Fig. 1 is the article body pipe knot for constituting the biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler of the present invention
Structure schematic diagram.
Fig. 2 isolates the structural representation of alimentary canal capsule-type stapler for the biodegradable no-station pole canopy of the present invention.
Fig. 3 sweeps for the biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler hydrophobic nano tunica fibrosa of the present invention
Retouch electron micrograph.
Embodiment
The present invention is further illustrated with specific embodiment below in conjunction with the accompanying drawings.
Embodiment 1
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, sees Fig. 2, including main body tube 1, sees Fig. 1, main body tube
It is made up of mesh skeleton structure sheaf 2 and the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2,
The two ends of main body tube are connected to hemispherical Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure is the PLLA that weight average molecular weight is 1,000,000.
The material of hydrophobic nano tunica fibrosa is poly- (the L- lactide-co-glycolide) that weight average molecular weight is 200,000；
Hydrophilic Nanofibrous membrane material is the polyvinyl alcohol and glue intensity that weight average molecular weight is 0.5 ten thousand, alcoholysis degree 88%
It is 1 in mass ratio for 100g Bloom gelatin：1 mixture；
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 4cm by melting extrusion method, length is 10cm, and wall thickness is
0.1cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio:3 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, is made mass concentration for 10% the first spinning solution, using TL-Pro-BM type electrospinning devices, is setting
Air is determined for humidity 40%, and voltage is+12kV, -0.2kV, and receiver tubular mesh skeleton structure layer distance is 10cm, by 2mL
In the first spinning solution suction 10mL syringes, it is 2mL/h in spinning speed, spinning is carried out to tubular mesh skeleton structure layer
1h, is obtained by mesh skeleton structure sheaf 2 and 3 groups of hydrophobic nano fiber film layer for being coated on the outer surface of mesh skeleton structure sheaf 2
Into main body tube；
(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 33% is made
Silk solution, is humidity 30% in setting air, voltage is+12kV, -0.5kV, is connect using TL-Pro-BM type electrospinning devices
It is 20cm to receive device distance, and second of spinning solution of 2mL is sucked in 10mL syringes, is 2mL/h in spinning speed, carries out spinning
1h；Hemispherical Hydrophilic Nanofibrous film end-blocking is prepared, the receiver is hemisphere；
(4) main body tube and two hemispherical Hydrophilic Nanofibrous films are blocked, bonded using Mecrilate
Agent links together.
Embodiment 2
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and main body tube is by mesh skeleton
Structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, at the two ends of main body tube
It is connected to half capsule shape Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure is the PLLA that weight average molecular weight is 200,000 and weight average molecular weight is 200,000
Poly- D- lactides are 1 in mass ratio:1 mixing.
The material of hydrophobic nano tunica fibrosa is：The poly- 6-caprolactone and weight average molecular weight that weight average molecular weight is 200,000 be
200000 PPDO is 1 in mass ratio:1 mixing.
Hydrophilic Nanofibrous membrane material is preferred：The polyvinylpyrrolidone and glue intensity that weight average molecular weight is 200,000 be
100g Bloom gelatin is 1 in mass ratio:1 mixing.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 10cm by melting extrusion method, length is 1cm, and wall thickness is
0.5cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio:1 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, is made the first spinning solution that mass concentration is 33%, using electrospinning device, is wet in setting air
Degree 60%, voltage is+15kV, -1.2kV, and receiver tubular mesh skeleton structure layer distance is 20cm, by the first spinning of 10mL
Solution suction 10mL syringes in, spinning speed be 5mL/h, to tubular mesh skeleton structure layer carry out spinning 2h, obtain by
The main body that mesh skeleton structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2
Pipe；
(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 5% is made
Solution, is humidity 30% in setting air using electrospinning device, and voltage is+12kV, -1.5kV, and receiver distance is
10cm, second of spinning solution of 2mL is sucked in 10mL syringes, is 2mL/h in spinning speed, is carried out spinning 1h；Prepare half
Capsule shape Hydrophilic Nanofibrous film is blocked, and the receiver is that hemisphere and cylinder are integral；
(4) main body tube and two and half capsule shape Hydrophilic Nanofibrous films are blocked, it is viscous using Mecrilate
Knot agent links together.
Embodiment 3
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and main body tube is by mesh skeleton
Structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, at the two ends of main body tube
It is connected to hemispherical Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure：The PGA and weight average molecular weight that weight average molecular weight is 400,000 are 400,000 poly- (L-
Lactide-co-glycolide) it is 1 in mass ratio:The mixing of 1 ratio.
The material of hydrophobic nano tunica fibrosa：Weight average molecular weight for 100,000 poly- (L- lactide-co-glycolides) and again
The PPDO that average molecular weight is 100,000 is 1 in mass ratio:The mixing of 1 ratio.
Hydrophilic Nanofibrous membrane material：The carboxylic first that the polyacrylic acid and viscosity that weight average molecular weight is 20,000 are 1000mPa.s
Base cellulose is 1 in mass ratio:The mixing of 1 ratio.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 4cm by melting extrusion method, length is 10cm, and wall thickness is
0.3cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio：1 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, be made mass concentration be 18% the first spinning solution, using electrospinning device, be in setting air
Humidity 50%, voltage is+13kV, and -1.0kV, receiver tubular mesh skeleton structure layer distance is 15cm, by the first spinning of 8mL
In silk solution suction 10mL syringes, it is 4mL/h in spinning speed, spinning 2h is carried out to tubular mesh skeleton structure layer, obtained
By mesh skeleton structure sheaf 2 and being coated on the main body that the hydrophobic nano fiber film layer 3 of the outer surface of mesh skeleton structure sheaf 2 is constituted
Pipe；
(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 25% is made
Silk solution, is humidity 40% in setting air using electrospinning device, and voltage is+15kV, -0.7kV, and receiver distance is
12cm, second of spinning solution of 6mL is sucked in 10mL syringes, is 2mL/h in spinning speed, is carried out spinning 3h；Prepare half
Spherical Hydrophilic Nanofibrous film end-blocking, the receiver is hemisphere；
(4) main body tube and two hemispherical Hydrophilic Nanofibrous films are blocked, bonded using Mecrilate
Agent links together.
Embodiment 4
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and main body tube is by mesh skeleton
Structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, at the two ends of main body tube
It is connected to hemispherical Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure：Weight average molecular weight is 500,000 poly- D, and L- lactides and weight average molecular weight are 500,000
Poly- 6-caprolactone is 2 in mass ratio:The mixing of 1 ratio.
The material of hydrophobic nano tunica fibrosa：Weight average molecular weight for 80,000 poly- (L- lactide-co-glycolides) and again
The poly- 6-caprolactone that average molecular weight is 80,000 is 1 in mass ratio:The mixing of 1 ratio.
Hydrophilic Nanofibrous membrane material：Weight average molecular weight is 140,000, the polyvinyl alcohol and Weight-average molecular of alcoholysis degree 98%
The polyvinylpyrrolidone for 0.5 ten thousand is measured, is in mass ratio 1:The mixing of 1 ratio.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 1cm by melting extrusion method, length is 20cm, and wall thickness is
0.1cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio：1 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, be made mass concentration be 18% the first spinning solution, using electrospinning device, be in setting air
Humidity 50%, voltage is+13kV, and -1.0kV, receiver tubular mesh skeleton structure layer distance is 15cm, by the first spinning of 10mL
In silk solution suction 10mL syringes, it is 2mL/h in spinning speed, spinning 5h is carried out to tubular mesh skeleton structure layer, obtained
By mesh skeleton structure sheaf 2 and being coated on the main body that the hydrophobic nano fiber film layer 3 of the outer surface of mesh skeleton structure sheaf 2 is constituted
Pipe；(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 25% is made molten
Liquid, is humidity 50% in setting air, voltage is+15kV, and -0.7kV, receiver distance is 12cm using electrospinning device,
By in second of spinning solution suction 10mL syringe of 6mL, it is 2mL/h in spinning speed, carries out spinning 3h；Prepare hemispherical parent
Water nano tunica fibrosa is blocked, and the receiver is hemisphere；
(4) main body tube and two hemispherical Hydrophilic Nanofibrous films are blocked, bonded using Mecrilate
Agent links together.
Embodiment 5
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and main body tube is by mesh skeleton
Structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, at the two ends of main body tube
It is connected to hemispherical Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure：The PLLA and weight average molecular weight that weight average molecular weight is 300,000 are 300,000 poly-
D- lactides are 3 in mass ratio:The mixing of 1 ratio.
The material of hydrophobic nano tunica fibrosa：Weight average molecular weight for 60,000 poly- (L- lactide-co-glycolides) and again
The PPDO that average molecular weight is 60,000 is 1 in mass ratio:The mixing of 1 ratio.
Hydrophilic Nanofibrous membrane material：Glue intensity is 200g Bloom gelatin, weight average molecular weight is 0.2 ten thousand poly- third
Olefin(e) acid, is in mass ratio 1:The mixing of 1 ratio.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 4cm by melting extrusion method, length is 20cm, and wall thickness is
0.5cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio：1 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, be made mass concentration be 20% the first spinning solution, using electrospinning device, be in setting air
Humidity 50%, voltage is+13kV, and -1.0kV, receiver tubular mesh skeleton structure layer distance is 15cm, by the first spinning of 10mL
In silk solution suction 10mL syringes, it is 2mL/h in spinning speed, spinning 5h is carried out to tubular mesh skeleton structure layer, obtained
By mesh skeleton structure sheaf 2 and being coated on the main body that the hydrophobic nano fiber film layer 3 of the outer surface of mesh skeleton structure sheaf 2 is constituted
Pipe；(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 30% is made molten
Liquid, is humidity 50% in setting air, voltage is+16kV, and -0.5kV, receiver distance is 12cm using electrospinning device,
By in second of spinning solution suction 10mL syringe of 10mL, it is 2mL/h in spinning speed, carries out spinning 5h；Prepare hemispherical
Hydrophilic Nanofibrous film is blocked, and the receiver is hemisphere；
(4) main body tube and two hemispherical Hydrophilic Nanofibrous films are blocked, bonded using Mecrilate
Agent links together.
Embodiment 6
Biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, including main body tube 1, and main body tube is by mesh skeleton
Structure sheaf 2 is constituted with the hydrophobic nano fiber film layer 3 for being coated on the outer surface of mesh skeleton structure sheaf 2, at the two ends of main body tube
It is connected to hemispherical Hydrophilic Nanofibrous film end-blocking 4.
The material of mesh skeleton structure：Poly- (L- lactide-co-glycolides) and divide equally again that weight average molecular weight is 200,000
Son amount is 200,000 poly- 6-caprolactone, is in mass ratio 2:The mixing of 1 ratio.
The material of hydrophobic nano tunica fibrosa：Weight average molecular weight for 110,000 poly- (L- lactide-co-glycolides) and again
The PPDO that average molecular weight is 110,000 is 2 in mass ratio:The mixing of 1 ratio.
Hydrophilic Nanofibrous membrane material：Viscosity is 4500mPa.s carboxymethyl cellulose, cornstarch and para arrowroot
Powder, is in mass ratio 1:1:The mixing of 1 ratio.
Biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, comprises the following steps：
(1) mesh skeleton structural material is made into a diameter of 3cm by melting extrusion method, length is 15cm, and wall thickness is
0.3cm tubular mesh skeleton structure layer；
(2) it is 1 hydrophobic nano fiber film material to be dissolved in into volume ratio：1 N,N-dimethylformamide and tetrahydrofuran
In the mixed solvent, be made mass concentration be 22% the first spinning solution, using electrospinning device, be in setting air
Humidity 40%, voltage is+12kV, and -1.0kV, receiver tubular mesh skeleton structure layer distance is 15cm, by the first spinning of 10mL
In silk solution suction 10mL syringes, it is 2mL/h in spinning speed, spinning 5h is carried out to tubular mesh skeleton structure layer, obtained
By mesh skeleton structure sheaf 2 and being coated on the main body that the hydrophobic nano fiber film layer 3 of the outer surface of mesh skeleton structure sheaf 2 is constituted
Pipe；(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 30% is made molten
Liquid, is humidity 40% in setting air, voltage is+15kV, and -0.5kV, receiver distance is 12cm using electrospinning device,
By in second of spinning solution suction 10mL syringe of 10mL, it is 2mL/h in spinning speed, carries out spinning 5h；Prepare hemispherical
Hydrophilic Nanofibrous film is blocked, and the receiver is hemisphere；
(4) main body tube and two hemispherical Hydrophilic Nanofibrous films are blocked, bonded using Mecrilate
Agent links together.
The poly- D that the poly- D- lactides for being 1,000,000 with weight average molecular weight, weight average molecular weight are 200,000, L- lactides, weight are equal
Molecular weight is 1,000,000 poly- D, PGA that L- lactides, weight average molecular weight are 200,000, weight average molecular weight be 1,000,000 it is poly-
Poly- (L- lactide-co-glycolides) that glycolide, weight average molecular weight are 1,000,000, weight average molecular weight be 200,000 it is poly- to dioxy
The polytrimethylene ring carbon acid that PPDO that cyclohexanone, weight average molecular weight are 1,000,000, weight average molecular weight are 200,000
Ester, weight average molecular weight are 1,000,000 polytrimethylene cyclic carbonate ester, and it is 200,000 that the weight average molecular weight in the present embodiment is substituted respectively
Poly- (L- lactide-co-glycolides)；Substituted respectively in the present embodiment for 1,000,000 poly- 6-caprolactone with weight average molecular weight
Weight average molecular weight be 200,000 poly- 6-caprolactone, other same the present embodiment, prepare corresponding biodegradable no-station pole canopy every
From alimentary canal capsule-type stapler.
Poly- (the L- lactide-co-glycolides) that is 50,000 with weight average molecular weight, the poly- ε that weight average molecular weight is 50,000-oneself
Poly- (the L- that the weight average molecular weight that the PPDO that lactone and weight average molecular weight are 5 substitutes the present embodiment respectively is 110,000
Lactide-co-glycolide), other same the present embodiment prepare corresponding biodegradable no-station pole canopy isolation alimentary canal capsule
Type stapler.
The carboxymethyl cellulose that the polyacrylic acid for being 200,000 with weight average molecular weight, viscosity are 300mPa.s substitutes this reality respectively
The viscosity for applying example is 4500mPa.s carboxymethyl cellulose, and the cornstarch of the present embodiment, Qi Tatong are substituted with farina
The present embodiment, prepares corresponding biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler.
Biodegradable no-station pole canopy isolates the use of alimentary canal capsule-type stapler：
The two ends that biodegradable no-station pole canopy of the present invention isolates alimentary canal capsule-type stapler are inserted respectively before gastrointestinal anastomosis
In the broken ends of fractured bone for entering two gastric tubes to be anastomosed, the broken ends of fractured bone of gastric tube one and stapler are continuously sutured one with absorbable suture
Week, then stapler and another broken ends of fractured bone are sutured, and two broken ends of fractured bone gastric tubes are sutured.Because gastric tube anastomosis is by of the invention complete
Separate, it is to avoid contact of the wound with intestinal contents, intestinal contents will not be polluted to previous anastomotic, so as to effectively protect kiss
Heal up.
Alimentary canal capsule is isolated according to the biodegradable no-station pole canopy that the preferred dimensions such as the age of patient, intestines position match
Type stapler.
Carried out using the stapler of the present invention after anastomosis operation, extracorporeal simulating experiment proves to drop completely in 30-300 days
Solution, internal noresidue.
The stapler of the present invention uses polyethylene glycol (molecular weight is 500-5000) to carry out smearing processing before implanting,
It can be completely dissolved in 3-6 hours after implanting, polyethylene glycol plays a part of absorbing water and lubricated.
The present invention not only helps and reconstruction of digestive tract anastomosis operation step is made a concentrated effort to finish in operation, and can also assist digestion
Road completes one-stage anastomosis, it is to avoid alimentary canal is temporary to greatest extent under physiology, the even extreme pathologic condition such as inflammation oedema expansion
When property and permanent stoma.It is postoperative to prevent the generation of anastomotic leakage, so as to avoid the related complication of postoperative lethal；Art
The stapler can be degradable and excludes external, foreign residual afterwards.Can effectively it make up in traditional alimentary tract anastomosis product body
Permanent foreign matter residual, can not at utmost avoid anastomotic leakage generation shortcoming.Stapler of the present invention, can not only increase hand
The security of art, reduction operation lethal complication, it is to avoid postoperative doctor-patient dispute and contradiction, improves doctor-patient relationship.Moreover, may be used also
Tumor patient relpase rate is reduced, patient's secondary digestion road is eliminated and also receives operation.
Experimental example 1
Alimentary canal capsule-type stapler is isolated to embodiment 1-6 biodegradable no-station pole canopy, degradation property detection is carried out,
Specifically detection method is：
By the main body tube of the stapler of precise quality, (quality is designated as m1) and hemisphere/capsule membrane (quality for note m2),
It is placed in different types of in-vitro simulated degradation solution, under the conditions of 37 DEG C of setting, is slowly shaken in shaking bath, and when specified
Between be spaced, be drawn off, cleaned 4 times using ultra-pure water, be dried under vacuum to constant weight, weigh weight, main body tube quality is designated as m3, half
The quality of ball/capsule membrane is designated as m4。
Mass loss rate is calculated as follows：
Biodegradable no-station pole canopy isolation alimentary canal capsule-type stapler degraded situation is as shown in table 1.
In-vitro simulated degradation experiment result statistics under stapler prepared by the embodiment 1 to 6 of table 1., different condition
Note *：Degrading experiment 1：Simulated intestinal fluid (pH=5), by stapler immersion wherein, carries out in-vitro simulated degraded；
Degrading experiment 2：Simulated intestinal fluid (pH=8), by stapler immersion wherein, simulated intestinal fluid immersion degraded.
Claims (8)
1. biodegradable no-station pole canopy isolates alimentary canal capsule-type stapler, it is characterized in that including main body tube (1), the main body tube
It is by mesh skeleton structure sheaf (2) and is coated on hydrophobic nano fiber film layer (3) group of mesh skeleton structure sheaf (2) outer surface
Into, be connected at the two ends of main body tube hemispherical or half capsule shape Hydrophilic Nanofibrous film end-blocking (4).
2. biodegradable no-station pole canopy according to claim 1 isolates alimentary canal capsule-type stapler, it is characterized in that described
The material of mesh skeleton structure is that weight average molecular weight is that 20-100 ten thousand PLLA, weight average molecular weight are 20-100 ten thousand
Poly- D- lactides, weight average molecular weight are 20-100 ten thousand poly- D, and L- lactides, weight average molecular weight are handed over for 20-100 ten thousand poly- second
The poly- ε that poly- (L- lactide-co-glycolides) that ester, weight average molecular weight are 20-100 ten thousand, weight average molecular weight are 20-100 ten thousand-
Caprolactone, weight average molecular weight are that 20-100 ten thousand PPDO and weight average molecular weight are 20-100 ten thousand polytrimethylene
At least one of cyclic carbonate ester.
3. biodegradable no-station pole canopy according to claim 1 isolates alimentary canal capsule-type stapler, it is characterized in that described
The material of hydrophobic nano tunica fibrosa is poly- (L- lactide-co-glycolides), the Weight-average molecular that weight average molecular weight is 5-20 ten thousand
At least one of the poly- 6-caprolactone that amount is 5-20 ten thousand and the PPDO that weight average molecular weight is 5-20 ten thousand.
4. biodegradable no-station pole canopy according to claim 1 isolates alimentary canal capsule-type stapler, it is characterized in that described
Hydrophilic Nanofibrous membrane material is that weight average molecular weight is 0.5-14 ten thousand, alcoholysis degree 88-98% polyvinyl alcohol, weight average molecular weight
It is that 100~200g Bloom gelatin, weight average molecular weight are 0.2-20 ten thousand for 0.5-20 ten thousand polyvinylpyrrolidone, glue intensity
Polyacrylic acid, viscosity for 300-4500mPa.s carboxymethyl cellulose, farina, cornstarch and tapioca in
It is at least one.
5. biodegradable no-station pole canopy isolates the preparation method of alimentary canal capsule-type stapler, it is characterized in that comprising the following steps：
(1) mesh skeleton structural material is made into a diameter of 1-10cm by melting extrusion method, length is 1-20cm, and wall thickness is
0.1-0.5cm tubular mesh skeleton structure layer；
(2) hydrophobic nano fiber film material is dissolved in DMF and tetrahydrofuran, mass concentration, which is made, is
10%-33% the first spinning solution, is humidity 40%-60% in setting air using electrospinning device, voltage for (+
12kV)~(+15kV), (- 0.2kV)~(- 1.2kV), receiver tubular mesh skeleton structure layer distance is 10-20cm, by 2-
In 10mL the first spinning solution suction 10mL syringes, it is 2-5mL/h in spinning speed, tubular mesh skeleton structure layer is entered
Row spinning 1-5h, obtains by mesh skeleton structure sheaf (2) and is coated on the hydrophobic nano of mesh skeleton structure sheaf (2) outer surface
The main body tube of fiber film layer (3) composition；
(3) material of Hydrophilic Nanofibrous film is dissolved in ultra-pure water, second of spinning that mass concentration is 5%-33% is made
Silk solution, is humidity 30%-50% in setting air using electrospinning device, and voltage is (+12kV)~(+16kV), (-
0.5kV)~(- 1.5kV), receiver distance is 10-20cm, and second of spinning solution of 2-10mL is sucked in 10mL syringes,
It is 2-5mL/h in spinning speed, carries out spinning 1-5h；Prepare hemispherical or half capsule shape Hydrophilic Nanofibrous film end-blocking, institute
It is that hemisphere or hemisphere and cylinder are integral to state receiver；
(4) main body tube is linked together with two hemisphericals or half capsule shape Hydrophilic Nanofibrous film end-blocking.
6. method according to claim 5, it is characterized in that it is 20- that the material of the mesh skeleton structure, which is weight average molecular weight,
1000000 PLLA, poly- D- lactides, poly- D, L- lactides, PGA, poly- (the poly- second friendship of L- lactide-cos
Ester), poly- 6-caprolactone, at least one of PPDO and polytrimethylene cyclic carbonate ester.
7. method according to claim 5, it is characterized in that the material of the hydrophobic nano tunica fibrosa is weight average molecular weight
At least one of poly- (L- lactide-co-glycolides), poly- 6-caprolactone and PPDO for 5-20 ten thousand.
8. method according to claim 5, it is characterized in that the Hydrophilic Nanofibrous membrane material is that weight average molecular weight is
0.5-14 ten thousand, alcoholysis degree 88-98% polyvinyl alcohol, weight average molecular weight are 0.5-20 ten thousand polyvinylpyrrolidone, glue intensity
It is 300-4500mPa.s's for polyacrylic acid that 100~200g Bloom gelatin, weight average molecular weight are 0.2-20 ten thousand, viscosity
At least one of carboxymethyl cellulose, farina, cornstarch and tapioca.
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