CN106983916B - Biodegradable tension-free isolated alimentary tract capsule type anastomat and preparation method - Google Patents
Biodegradable tension-free isolated alimentary tract capsule type anastomat and preparation method Download PDFInfo
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Abstract
The invention discloses a biodegradable tension-free isolated alimentary canal capsule type anastomat and a preparation method, wherein the anastomat comprises a main body tube 1, the main body tube consists of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2, and two ends of the main body tube are respectively connected with a hemispherical or semi-capsule hydrophilic nanofiber membrane end cap 4; the anastomosis joint is prepared from biodegradable medical high polymer materials, can be completely degraded and discharged out of a body after healing of an anastomosis joint, and has no toxic or side effect; the manufacturing steps are simple, the manufacturing cost is low, and the medical expense of a patient can be reduced; effectively shortens the whole treatment period of the patient and avoids secondary pain brought to the patient.
Description
Technical Field
The invention belongs to the technical field of surgical medical instruments, and relates to a biodegradable tension-free isolated alimentary tract capsule type anastomat and a preparation method thereof.
Background
The gastrointestinal anastomosis operation is the most basic and common operation technique of abdominal surgery, and is also an operation which is easy to cause complications after the operation. The gastrointestinal fistula is a common lethal complication after gastrointestinal anastomosis, and is characterized in that the gastrointestinal anastomosis fistula refers to gastrointestinal anastomosis defect, so that contents in intestinal tracts flow out of the defect part, a series of pathological changes such as infection, organ dysfunction, malnutrition and body fluid loss are induced, and the probability of complication of the gastrointestinal fistula after gastrointestinal surgery of a patient is about 2% -50.4%. Clinical studies show that severe gastrointestinal fistula not only causes other complications and even death, prolongs hospitalization, but also increases economic and mental burden on patients, and greatly reduces the treatment effect of surgery and the prognosis effect of surgery. Therefore, after the gastrointestinal anastomosis, how to promote the rapid healing of the anastomotic stoma is an important way for effectively reducing the occurrence of postoperative complications.
The gastrointestinal anastomosis method mainly comprises two methods of manual anastomosis and instrument anastomosis, wherein the manual method is a long-history anastomosis method and is completed by manual suture of silk threads or absorbable threads, but the method is complicated in operation, time-consuming in process and large in difference of manual skills among different operating doctors. At present, instrument anastomosis is also an important means for promoting digestive tract postoperative anastomosis, and has the obvious advantage of simple and convenient operation at special positions which are difficult to operate by a manual anastomosis method, such as lower esophagus anastomosis, pelvic cavity anastomosis and the like. However, since the anastomat designed in the current medical market is not degradable, foreign matters such as staples and the like remain in the abdominal cavity after anastomosis operation, which causes much pain to the patient and sometimes even endangers the life of the patient.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a biodegradable tension-free digestive tract isolation capsule-type anastomat which can improve the success rate of gastrointestinal anastomosis, avoid gastrointestinal fistula danger, has no foreign body residue in vivo and has low medical cost.
The second purpose of the invention is to provide a preparation method of the biodegradable tension-free isolated alimentary canal capsule type anastomat.
The technical scheme of the invention is summarized as follows:
the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical or semi-capsule hydrophilic nanofiber membrane end closures 4.
The material of the reticular skeleton structure is at least one of poly-L-lactide with the weight-average molecular weight of 20-100 ten thousand, poly-D, L-lactide with the weight-average molecular weight of 20-100 ten thousand, polyglycolide with the weight-average molecular weight of 20-100 ten thousand, poly (L-lactide-co-glycolide) with the weight-average molecular weight of 20-100 ten thousand, poly-epsilon-caprolactone with the weight-average molecular weight of 20-100 ten thousand, polydioxanone with the weight-average molecular weight of 20-100 ten thousand and polytrimethylene cyclic carbonate with the weight-average molecular weight of 20-100 ten thousand.
The hydrophobic nanofiber membrane is made of at least one of poly (L-lactide-co-glycolide) with the weight-average molecular weight of 5-20 ten thousand, poly-epsilon-caprolactone with the weight-average molecular weight of 5-20 ten thousand and poly-p-dioxanone with the weight-average molecular weight of 5-20 ten thousand.
The hydrophilic nanofiber membrane material is at least one of polyvinyl alcohol with the weight-average molecular weight of 0.5-14 ten thousand and the alcoholysis degree of 88-98%, polyvinylpyrrolidone with the weight-average molecular weight of 0.5-20 ten thousand, gelatin with the glue strength of 100-200 g Bloom, polyacrylic acid with the weight-average molecular weight of 0.2-20 ten thousand, carboxymethyl cellulose with the viscosity of 300-4500mPa.s, potato starch, corn starch and tapioca starch.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 1-10cm, the length of 1-20cm and the wall thickness of 0.1-0.5cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nanofiber membrane material in N, N-dimethylformamide and tetrahydrofuran to prepare a first spinning solution with the mass concentration of 10-33%, setting the air humidity to be 40-60%, the voltage to be (+12 kV- (+15kV), (-0.2kV) (-1.2kV), and the distance of a tubular reticular framework structure layer of a receiver to be 10-20cm by adopting electrostatic spinning equipment, sucking 2-10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 1-5h at the spinning speed of 2-5mL/h to obtain a main tube consisting of the reticular framework structure layer (2) and a hydrophobic nanofiber membrane layer (3) coated on the outer surface of the reticular framework structure layer (2);
(3) dissolving a material of a hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 5-33%, setting the air humidity to be 30-50%, the voltage to be (+12 kV- (+16kV), (-0.5kV) (-1.5kV) and the receiver distance to be 10-20cm by adopting electrostatic spinning equipment, sucking 2-10mL of the second spinning solution into a 10mL injector, and spinning for 1-5h at the spinning speed of 2-5 mL/h; preparing a hemispherical or semi-capsule hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere or a hemisphere and a cylinder which are integrated;
(4) connecting the main tube with two hemispheric or semi-capsule hydrophilic nanofiber membrane seal ends together.
The material of the reticular skeleton structure is at least one of poly-L-lactide, poly-D, L-lactide, polyglycolide, poly (L-lactide-co-glycolide), poly-epsilon-caprolactone, polydioxanone and polytrimethylene cyclic carbonate with the weight-average molecular weight of 20-100 ten thousand.
The hydrophobic nanofiber membrane is made of at least one of poly (L-lactide-co-glycolide) with the weight-average molecular weight of 5-20 ten thousand, poly-epsilon-caprolactone and polydioxanone.
The hydrophilic nanofiber membrane material is at least one of polyvinyl alcohol with the weight-average molecular weight of 0.5-14 ten thousand and the alcoholysis degree of 88-98%, polyvinylpyrrolidone with the weight-average molecular weight of 0.5-20 ten thousand, gelatin with the glue strength of 100-200 g Bloom, polyacrylic acid with the weight-average molecular weight of 0.2-20 ten thousand, carboxymethyl cellulose with the viscosity of 300-4500mPa.s, potato starch, corn starch and tapioca starch.
The invention has the advantages that:
1. the biodegradable tension-free isolated alimentary canal capsule type anastomat disclosed by the invention isolates gastrointestinal contents from tissues at the gastrointestinal anastomosis part, thereby being beneficial to accelerating the growth and healing outside the gastrointestinal anastomosis, improving the success probability of the gastrointestinal anastomosis and reducing the occurrence of anastomotic fistula to the maximum extent;
2. the anastomosis joint is prepared from biodegradable medical high polymer materials, can be completely degraded and discharged out of a body after healing of an anastomosis joint, and has no toxic or side effect;
3. the manufacturing steps are simple, the manufacturing cost is low, and the medical expense of a patient can be reduced;
4. effectively shortens the whole treatment period of the patient and avoids secondary pain brought to the patient.
Drawings
Fig. 1 is a structural view illustrating a main body tube constituting a biodegradable tension-free isolated gastrointestinal capsule-type anastomat of the present invention.
Fig. 2 is a schematic structural diagram of the biodegradable tension-free isolated alimentary canal capsule-type anastomat of the present invention.
Fig. 3 is a scanning electron microscope photograph of the biodegradable tensionless isolated gastrointestinal capsule type anastomat hydrophobic nanofiber membrane of the present invention.
Detailed Description
The invention is further described with reference to the following figures and specific embodiments.
Example 1
A biodegradable tension-free digestive tract isolation capsule anastomat is shown in figure 2 and comprises a main body tube 1 shown in figure 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical hydrophilic nanofiber membrane end caps 4.
The material of the reticular framework structure is poly-L-lactide with the weight average molecular weight of 100 ten thousand.
The hydrophobic nanofiber membrane is made of poly (L-lactide-co-glycolide) with the weight-average molecular weight of 20 ten thousand;
the hydrophilic nanofiber membrane material is prepared from polyvinyl alcohol with the weight-average molecular weight of 0.5 ten thousand and the alcoholysis degree of 88% and gelatin with the glue strength of 100g Bloom in a mass ratio of 1: 1;
the preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 4cm, the length of 10cm and the wall thickness of 0.1cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nanofiber membrane material in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran in a volume ratio of 1:3 to prepare a first spinning solution with the mass concentration of 10%, setting the air humidity to be 40% and the voltage to be +12kV and-0.2 kV by adopting TL-Pro-BM type electrostatic spinning equipment, setting the distance between a tubular reticular framework structure layer of a receiver to be 10cm, sucking 2mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 1h at the spinning speed of 2mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2;
(3) dissolving a material of a hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 33%, setting the humidity of air to be 30%, the voltage to be +12kV and-0.5 kV and the receiver distance to be 20cm by adopting TL-Pro-BM type electrostatic spinning equipment, sucking 2mL of the second spinning solution into a 10mL injector, and spinning for 1h at the spinning speed of 2 mL/h; preparing a hemispherical hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere;
(4) the main tube and two hemispherical hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Example 2
A biodegradable tension-free digestive tract isolation capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with a semi-capsule hydrophilic nanofiber membrane sealing end 4.
The material of the reticular skeleton structure is a mixture of poly-L-lactide with the weight-average molecular weight of 20 ten thousand and poly-D-lactide with the weight-average molecular weight of 20 ten thousand according to the mass ratio of 1: 1.
The hydrophobic nanofiber membrane is prepared from the following materials: poly-epsilon-caprolactone having a weight average molecular weight of 20 ten thousand and polydioxanone having a weight average molecular weight of 20 ten thousand were mixed in a mass ratio of 1: 1.
The hydrophilic nanofiber membrane material is preferably: polyvinylpyrrolidone having a weight average molecular weight of 20 ten thousand and gelatin having a gel strength of 100g Bloom were mixed in a mass ratio of 1: 1.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 10cm, the length of 1cm and the wall thickness of 0.5cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nanofiber membrane material in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran in a volume ratio of 1:1 to prepare a first spinning solution with the mass concentration of 33%, setting the air humidity to be 60%, the voltage to be +15kV and-1.2 kV by adopting electrostatic spinning equipment, setting the distance of a tubular reticular framework structure layer of a receiver to be 20cm, sucking 10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 2h at the spinning speed of 5mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2;
(3) dissolving a material of a hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 5%, adopting electrostatic spinning equipment, sucking 2mL of the second spinning solution into a 10mL injector under the conditions that the humidity of air is set to be 30%, the voltage is +12kV, -1.5kV and the distance of a receiver is 10cm, and spinning for 1h at the spinning speed of 2 mL/h; preparing a semi-capsule hydrophilic nanofiber membrane end cap, wherein the receiver is a hemisphere and a cylinder which are integrated;
(4) the main tube and two half-capsule hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Example 3
A biodegradable tension-free digestive tract isolation capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical hydrophilic nanofiber membrane sealing ends 4.
Material of the net-like skeleton structure: polyglycolide having a weight average molecular weight of 40 ten thousand and poly (L-lactide-co-glycolide) having a weight average molecular weight of 40 ten thousand were mixed in a mass ratio of 1: 1.
Material of hydrophobic nanofiber membrane: poly (L-lactide-co-glycolide) having a weight average molecular weight of 10 ten thousand and polydioxanone having a weight average molecular weight of 10 ten thousand were mixed in a mass ratio of 1: 1.
Hydrophilic nanofiber membrane material: polyacrylic acid having a weight average molecular weight of 2 ten thousand and carboxymethyl cellulose having a viscosity of 1000mpa.s were mixed in a mass ratio of 1: 1.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 4cm, the length of 10cm and the wall thickness of 0.3cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nano-fiber membrane material in a solvent with a volume ratio of 1: preparing a first spinning solution with the mass concentration of 18% in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran (1), adopting electrostatic spinning equipment, setting the humidity of air to be 50%, the voltage to be +13kV, -1.0kV, the distance of a receiver tubular reticular framework structure layer to be 15cm, sucking 8mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 2h at the spinning speed of 4mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2;
(3) dissolving a material of the hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 25%, adopting electrostatic spinning equipment, sucking 6mL of the second spinning solution into a 10mL injector under the conditions that the humidity of air is set to be 40%, the voltage is +15kV, -0.7kV and the distance of a receiver is 12cm, and spinning for 3 hours at the spinning speed of 2 mL/h; preparing a hemispherical hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere;
(4) the main tube and two hemispherical hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Example 4
A biodegradable tension-free digestive tract isolation capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical hydrophilic nanofiber membrane sealing ends 4.
Material of the net-like skeleton structure: poly-D, L-lactide with a weight average molecular weight of 50 ten thousand and poly-e-caprolactone with a weight average molecular weight of 50 ten thousand were mixed in a mass ratio of 2: 1.
Material of hydrophobic nanofiber membrane: poly (L-lactide-co-glycolide) having a weight average molecular weight of 8 ten thousand and poly-e-caprolactone having a weight average molecular weight of 8 ten thousand were mixed in a mass ratio of 1: 1.
Hydrophilic nanofiber membrane material: polyvinyl alcohol having a weight average molecular weight of 14 ten thousand and an alcoholysis degree of 98% and polyvinyl pyrrolidone having a weight average molecular weight of 0.5 ten thousand were mixed in a mass ratio of 1: 1.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 1cm, the length of 20cm and the wall thickness of 0.1cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nano-fiber membrane material in a solvent with a volume ratio of 1: preparing a first spinning solution with the mass concentration of 18% in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran (1), adopting electrostatic spinning equipment, setting the humidity of air to be 50%, the voltage to be +13kV, -1.0kV, the distance of a receiver tubular reticular framework structure layer to be 15cm, sucking 10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 5 hours at the spinning speed of 2mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2; (3) dissolving a material of a hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 25%, adopting electrostatic spinning equipment, sucking 6mL of the second spinning solution into a 10mL injector under the conditions that the humidity of air is set to be 50%, the voltage is +15kV, -0.7kV and the distance of a receiver is 12cm, and spinning for 3 hours at the spinning speed of 2 mL/h; preparing a hemispherical hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere;
(4) the main tube and two hemispherical hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Example 5
A biodegradable tension-free digestive tract isolation capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical hydrophilic nanofiber membrane sealing ends 4.
Material of the net-like skeleton structure: poly-L-lactide having a weight average molecular weight of 30 ten thousand and poly-D-lactide having a weight average molecular weight of 30 ten thousand were mixed in a mass ratio of 3: 1.
Material of hydrophobic nanofiber membrane: poly (L-lactide-co-glycolide) having a weight average molecular weight of 6 ten thousand and polydioxanone having a weight average molecular weight of 6 ten thousand were mixed in a mass ratio of 1: 1.
Hydrophilic nanofiber membrane material: gelatin with the glue strength of 200g Bloom and polyacrylic acid with the weight-average molecular weight of 0.2 ten thousand are mixed according to the mass ratio of 1: 1.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 4cm, the length of 20cm and the wall thickness of 0.5cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nano-fiber membrane material in a solvent with a volume ratio of 1: preparing a first spinning solution with the mass concentration of 20% in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran (1), adopting electrostatic spinning equipment, setting the humidity of air to be 50%, the voltage to be +13kV, -1.0kV, the distance of a receiver tubular reticular framework structure layer to be 15cm, sucking 10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 5 hours at the spinning speed of 2mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2; (3) dissolving a material of the hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 30%, adopting electrostatic spinning equipment, sucking 10mL of the second spinning solution into a 10mL injector under the conditions that the humidity of air is set to be 50%, the voltage is +16kV, -0.5kV and the distance of a receiver is 12cm, and spinning for 5 hours at the spinning speed of 2 mL/h; preparing a hemispherical hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere;
(4) the main tube and two hemispherical hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Example 6
A biodegradable tension-free digestive tract isolation capsule type anastomat comprises a main body tube 1, wherein the main body tube is composed of a net-shaped framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the net-shaped framework structure layer 2, and two ends of the main body tube are respectively connected with hemispherical hydrophilic nanofiber membrane sealing ends 4.
Material of the net-like skeleton structure: poly (L-lactide-co-glycolide) having a weight average molecular weight of 20 ten thousand and poly-e-caprolactone having a weight average molecular weight of 20 ten thousand were mixed in a mass ratio of 2: 1.
Material of hydrophobic nanofiber membrane: poly (L-lactide-co-glycolide) having a weight average molecular weight of 11 ten thousand and polydioxanone having a weight average molecular weight of 11 ten thousand were mixed in a mass ratio of 2: 1.
Hydrophilic nanofiber membrane material: mixing carboxymethyl cellulose with the viscosity of 4500mPa.s, corn starch and tapioca starch according to the mass ratio of 1:1: 1.
The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
(1) preparing a tubular reticular framework structure layer with the diameter of 3cm, the length of 15cm and the wall thickness of 0.3cm from the reticular framework structure material by a melt extrusion method;
(2) dissolving a hydrophobic nano-fiber membrane material in a solvent with a volume ratio of 1: preparing a first spinning solution with the mass concentration of 22% in a mixed solvent of N, N-dimethylformamide and tetrahydrofuran (1), adopting electrostatic spinning equipment, setting the air humidity to be 40%, the voltage to be +12kV and-1.0 kV, setting the distance between a tubular reticular framework structure layer of a receiver to be 15cm, sucking 10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 5 hours at the spinning speed of 2mL/h to obtain a main tube consisting of a reticular framework structure layer 2 and a hydrophobic nanofiber membrane layer 3 coated on the outer surface of the reticular framework structure layer 2; (3) dissolving a material of the hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 30%, adopting electrostatic spinning equipment, sucking 10mL of the second spinning solution into a 10mL injector under the conditions that the humidity of air is set to be 40%, the voltage is +15kV, -0.5kV and the distance of a receiver is 12cm, and spinning for 5 hours at the spinning speed of 2 mL/h; preparing a hemispherical hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere;
(4) the main tube and two hemispherical hydrophilic nanofiber membranes are capped and connected together by alpha-methyl cyanoacrylate adhesive.
Respectively replacing poly (L-lactide-co-glycolide) with the weight average molecular weight of 20 ten thousand in the embodiment by poly-D-lactide with the weight average molecular weight of 100 ten thousand, poly-D, L-lactide with the weight average molecular weight of 100 ten thousand, polyglycolide with the weight average molecular weight of 20 ten thousand, polyglycolide with the weight average molecular weight of 100 ten thousand, poly (L-lactide-co-glycolide) with the weight average molecular weight of 100 ten thousand, polydioxanone with the weight average molecular weight of 20 ten thousand, polytrimethylenecyclic carbonate with the weight average molecular weight of 20 ten thousand and polytrimethylenecyclic carbonate with the weight average molecular weight of 100 ten thousand; the poly-epsilon-caprolactone with the weight average molecular weight of 100 ten thousand is used for replacing the poly-epsilon-caprolactone with the weight average molecular weight of 20 ten thousand in the embodiment, and the corresponding biodegradable tension-free digestive tract isolation capsule type anastomat is prepared in the same way as in the embodiment.
Poly (L-lactide-co-glycolide) with a weight average molecular weight of 5 ten thousand, poly-epsilon-caprolactone with a weight average molecular weight of 5 ten thousand and polydioxanone with a weight average molecular weight of 5 were used to replace the poly (L-lactide-co-glycolide) with a weight average molecular weight of 11 ten thousand in this example, respectively, and the corresponding biodegradable tension-free isolated gastrointestinal tract capsule-type anastomat was prepared in the same manner as in this example.
Polyacrylic acid with the weight-average molecular weight of 20 ten thousand and carboxymethyl cellulose with the viscosity of 300mPa.s are respectively used for replacing the carboxymethyl cellulose with the viscosity of 4500mPa.s in the embodiment, potato starch is used for replacing the corn starch in the embodiment, and the corresponding biodegradable tension-free digestive tract capsule type anastomat is prepared in the same way as the embodiment.
The use of the biodegradable tension-free isolated alimentary tract capsule type anastomat comprises the following steps:
before gastrointestinal anastomosis, two ends of the biodegradable tension-free isolated gastrointestinal tract capsule type anastomat are respectively inserted into the broken ends of two gastrointestinal tubes to be anastomosed, one broken end of the gastrointestinal tube and the anastomat are continuously sutured for a circle by an absorbable suture line, then the anastomat and the other broken end are sutured, and the gastrointestinal tubes at the two broken ends are sutured. Because the anastomotic site of the gastrointestinal tube is completely separated by the invention, the contact between the wound and the intestinal contents is avoided, and the intestinal contents can not cause pollution to the anastomotic orifice, thereby effectively protecting the anastomotic orifice.
According to the age, the intestinal part and the like of the patient, the biodegradable tension-free isolated alimentary canal capsule type anastomat with matched size is selected.
After the anastomat is used for performing anastomosis operation, in-vitro simulation experiments prove that the anastomat can be completely degraded within 30 to 300 days and has no residue in vivo.
Before being implanted into a body, the anastomat of the invention adopts polyethylene glycol (with molecular weight of 500-.
The invention not only is beneficial to accelerating the completion of the steps of the digestive tract reconstruction anastomosis operation in the operation, but also can assist the digestive tract to complete one-stage anastomosis to the maximum extent under the extreme pathological conditions of physiology, even inflammatory edema expansion and the like, thereby avoiding the temporary and permanent stomas of the digestive tract. The occurrence of anastomotic fistula can be prevented after the operation, thereby avoiding the related complications of lethality after the operation; the anastomat can be completely degraded and removed from the body after operation, and has no foreign substance residue. Can effectively make up for the defects that the permanent foreign matters in the body of the traditional alimentary canal anastomosis product are remained and the anastomosis fistula can not be avoided to the maximum extent. The anastomat provided by the invention can increase the safety of the operation, reduce lethal complications of the operation, avoid disputes and contradictions between doctors and patients after the operation and improve doctor-patient relationships. Moreover, the recurrence rate of the tumor patients can be reduced, and the secondary digestive tract reduction operation of the patients can be eliminated.
Experimental example 1
The biodegradable tensionless isolated alimentary canal capsule-type anastomat of the embodiments 1-6 is subjected to degradation performance detection, and the specific detection method comprises the following steps:
the main tube of the anastomat (the mass is recorded as m) with accurately weighed mass1) And hemisphere/capsule membrane (mass m)2) Placing the mixture in different types of in-vitro simulated degradation solutions, slowly oscillating the mixture in a water bath shaker at the set temperature of 37 ℃, taking out the mixture at a specified time interval, cleaning the mixture for 4 times by using ultrapure water, drying the mixture in vacuum to constant weight, weighing the mixture, and recording the mass of a main pipe as m3The mass of the hemisphere/capsule membrane is recorded as m4。
The mass loss rate was calculated according to the following formula:
the degradation of the biodegradable tension-free isolated gastrointestinal capsule-type anastomat is shown in table 1.
TABLE 1 statistics of results of in vitro simulated degradation experiments for staplers prepared in examples 1 to 6 under different conditions
Note that: degradation test 1: simulating small intestine liquid (pH is 5), soaking the anastomat in the simulated small intestine liquid, and performing in-vitro simulated degradation; degradation test 2: simulated small intestine fluid (pH 8), the stapler was soaked in it, simulating small intestine fluid soaking degradation.
Claims (4)
1. The preparation method of the biodegradable tension-free isolated alimentary tract capsule type anastomat is characterized by comprising the following steps of:
1) preparing a tubular reticular framework structure layer with the diameter of 1-10cm, the length of 1-20cm and the wall thickness of 0.1-0.5cm from the reticular framework structure material by a melt extrusion method;
2) dissolving a hydrophobic nanofiber membrane material in N, N-dimethylformamide and tetrahydrofuran to prepare a first spinning solution with the mass concentration of 10-33%, setting the air humidity to be 40-60%, the voltage to be (+12 kV- (+15kV), (-0.2kV) (-1.2kV), and the distance of a tubular reticular framework structure layer of a receiver to be 10-20cm by adopting electrostatic spinning equipment, sucking 2-10mL of the first spinning solution into a 10mL injector, and spinning the tubular reticular framework structure layer for 1-5h at the spinning speed of 2-5mL/h to obtain a main tube (1) consisting of the reticular framework structure layer (2) and a hydrophobic nanofiber membrane layer (3) coated on the outer surface of the reticular framework structure layer (2);
3) dissolving a material of a hydrophilic nanofiber membrane in ultrapure water to prepare a second spinning solution with the mass concentration of 5-33%, setting the air humidity to be 30-50%, the voltage to be (+12 kV- (+16kV), (-0.5kV) (-1.5kV) and the receiver distance to be 10-20cm by adopting electrostatic spinning equipment, sucking 2-10mL of the second spinning solution into a 10mL injector, and spinning for 1-5h at the spinning speed of 2-5 mL/h; preparing a hemispherical or semi-capsule hydrophilic nanofiber membrane end seal, wherein the receiver is a hemisphere or a hemisphere and a cylinder which are integrated;
4) connecting the main tube with two hemispheric or semi-capsule hydrophilic nanofiber membrane seal ends together.
2. The method as set forth in claim 1, wherein the material of the network-like skeleton structure is at least one of poly-L-lactide, poly-D, L-lactide, polyglycolide, poly (L-lactide-co-glycolide), poly-e-caprolactone, polydioxanone, and polytrimethylene cyclic carbonate having a weight average molecular weight of 20 to 100 ten thousand.
3. The method as set forth in claim 1, wherein the material of the hydrophobic nanofiber membrane is at least one of poly (L-lactide-co-glycolide) having a weight average molecular weight of 5-20 ten thousand, poly-e-caprolactone and polydioxanone.
4. The method as claimed in claim 1, wherein the hydrophilic nanofiber membrane material is at least one of polyvinyl alcohol having a weight average molecular weight of 0.5-14 ten thousand and an alcoholysis degree of 88-98%, polyvinyl pyrrolidone having a weight average molecular weight of 0.5-20 ten thousand, gelatin having a gel strength of 100-200 g Bloom, polyacrylic acid having a weight average molecular weight of 0.2-20 ten thousand, carboxymethyl cellulose having a viscosity of 300-4500 mPa-s, potato starch, corn starch, and tapioca starch.
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