CN116439877A - Degradable digestive tract stent and preparation method thereof - Google Patents
Degradable digestive tract stent and preparation method thereof Download PDFInfo
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- CN116439877A CN116439877A CN202310317389.1A CN202310317389A CN116439877A CN 116439877 A CN116439877 A CN 116439877A CN 202310317389 A CN202310317389 A CN 202310317389A CN 116439877 A CN116439877 A CN 116439877A
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- 210000001035 gastrointestinal tract Anatomy 0.000 title claims abstract description 164
- 238000002360 preparation method Methods 0.000 title abstract description 9
- 230000005855 radiation Effects 0.000 claims abstract description 91
- 230000004048 modification Effects 0.000 claims abstract description 43
- 238000012986 modification Methods 0.000 claims abstract description 43
- 238000000034 method Methods 0.000 claims description 19
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 14
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 11
- 239000011347 resin Substances 0.000 claims description 3
- 229920005989 resin Polymers 0.000 claims description 3
- 230000000968 intestinal effect Effects 0.000 abstract description 22
- 230000009471 action Effects 0.000 abstract description 8
- 230000002980 postoperative effect Effects 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 20
- 230000000694 effects Effects 0.000 description 12
- 238000012360 testing method Methods 0.000 description 11
- 230000035876 healing Effects 0.000 description 7
- 230000015556 catabolic process Effects 0.000 description 5
- 238000006731 degradation reaction Methods 0.000 description 5
- 230000003872 anastomosis Effects 0.000 description 3
- 125000006850 spacer group Chemical group 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 230000007062 hydrolysis Effects 0.000 description 2
- 238000006460 hydrolysis reaction Methods 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000011902 gastrointestinal surgery Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 230000005226 mechanical processes and functions Effects 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 230000008855 peristalsis Effects 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
-
- 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
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/045—Stomach, intestines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- 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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Abstract
The invention relates to the technical field of medical equipment, and discloses a degradable digestive tract stent and a preparation method thereof, wherein the degradable digestive tract stent comprises a middle section and an expansion end communicated with two ends of the middle section, the middle section and the expansion end are integrally formed, and the degradable digestive tract stent adopts radiation modification treatment; the stent is not damaged by the intestinal environment and the mechanical action of the intestinal environment within 0-10 days, can be damaged by the intestinal environment and the mechanical action of the intestinal environment after 28 days, is expected to completely disintegrate and then is discharged out of the patient, so that the digestive tract surgical operation using the degradable digestive tract stent is safer and more convenient, more accords with the physiological characteristics, the patient is better to recover, the postoperative life quality of the patient is further improved, and the preparation method provided by the application enables the degradable digestive tract stent to meet the expected performance requirement of the product through the specific stent tube thickness and the radiation modification treatment mode.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a degradable digestive tract stent and a preparation method thereof.
Background
The degradable digestive tract stent is a medical instrument used in digestive tract reconstruction operation of anorectal and gastrointestinal surgery and used for assisting anastomosis of digestive tract rows or anastomosis after short-term diversion. The degradable digestive tract stent can play a role in supporting the cavity tract or blocking the cavity tract, and is beneficial to reconstruction and anastomosis of the digestive tract (such as intestinal tract). The intestinal canal bracket in the prior art has a tubular structure with a thin middle part and thick two ends, the structure can ensure that the intestinal canal bracket is not easy to displace in use, as disclosed in the publication No. CN115054304A, the intestinal canal bracket is an integrally formed middle section and a second main body, the middle section and the second main body are passages, and meanwhile, the second main body also adopts degradable materials.
After the healing period of the digestive tract reconstruction, the degradable digestive tract stent needs to be periodically detached to restore the smooth and functional digestive tract, so that the degradable digestive tract stent is usually made of degradable materials. The degradable digestive tract stent made of degradable materials can be disintegrated and discharged under the action of intestinal peristalsis after being set to a controllable in-vivo crushing period. The degradable materials generally adopted are materials with high biological affinity, such as polylactic acid, polyethylene materials and the like. The applicant finds that the degradable digestive tract stent is required to be completely fixed at the anastomotic site of the broken ends in the intestinal cavity within 0-10 days of the healing process of intestinal tissues in clinical application research, and cannot be damaged, deformed and displaced during the period, and the degradable digestive tract stent is subjected to hydrolysis under the influence of the intestinal environment and gradually crushed and separated from the intestinal cavity under the action of intestinal mechanics within 10-28 days of intestinal healing, so that the degradable digestive tract stent and the preparation method thereof are required to be provided clinically in view of the situation.
Disclosure of Invention
In order to realize the ideal operation expectation, the application provides a degradable digestive tract stent and a preparation method thereof, wherein the stent has the functions of being not destroyed by the environment and the mechanical action of the intestinal tract within 0-10 days of use by setting a specific wall thickness and adopting specific radiation treatment, and achieves the destroyed technical effect by the environment and the mechanical action of the intestinal tract after the 28 th of use, thereby meeting the physiological needs of intestinal tract healing and function recovery. The degradation time of the degradable digestive tract stent is regulated and controlled by adopting a radiation method, and the method has the technical characteristics of safety, no pollution, simple operation and easy industrialization.
The specific technical scheme of the invention is as follows:
the degradable digestive tract stent comprises a middle section and expansion ends communicated with two ends of the middle section, wherein the middle section and the expansion ends are integrally formed, and the degradable digestive tract stent is subjected to radiation modification treatment.
The application provides a degradable digestive tract support, this support include the interlude and with the expansion end of interlude both ends intercommunication, this support is through setting for specific wall thickness and radiation modification treatment for the support can bear intestinal environment and mechanical function down function not destroyed in 0-10 days in the use, and degradable digestive tract support is under the technical characteristics that receives intestinal environment influence and mechanical effect down at the 28 th of use, its function is destroyed. In order to achieve the technical effects, the degradable digestive tract stent achieves the proper mechanical properties in different time periods of application, so that the degradable digestive tract stent can achieve the technical effects through specific wall thickness design and radiation modification. The thickness of the stent wall has an important influence on the mechanical property of the degradable digestive tract stent with the application time of 0-10 days, the stent wall is too thin, so that the mechanical property of the stent is insufficient and cannot be required for clinical use, and the mechanical property of the stent is too strong due to the too thick stent wall, so that the stent cannot be damaged at the preset time after the 28 th step of use.
Further, a degradable spacer can be arranged in the middle section of the degradable digestive tract bracket; the degradable gut stent provided with the septum can be used in surgical procedures requiring short-term blockage and re-routing of the gut.
Preferably, the thickness of the wall of the degradable digestive tract stent is more than 0.83-1 mm,
preferably, the outer diameter of the end, far away from the middle section, of the expansion end is larger than that of the middle section, the expansion end of the degradable digestive tract stent is in a horn shape, can be supported in the intestinal cavity and is fixed at the position where the intestinal cavity needs to be anastomosed or blocked, the degradable digestive tract stent is prevented from being displaced in a preset period, and the using effect of the stent is ensured.
Preferably, the degradable digestive tract stent material is a degradable resin; the degradable resin can be degraded in human body, and gradually degraded with time and discharged out of human body.
Further, the degradable digestive tract stent is made of polyvinyl alcohol; the polyvinyl alcohol can be degraded quickly in organisms, and the products are water and carbon dioxide, so that the polyvinyl alcohol has no toxicity and no harm and has strong biocompatibility.
A method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent.
The method comprises the steps of firstly placing PGA raw materials into a mould to be processed into a preform, then carrying out radiation modification treatment on the preform, wherein G60 is used as a radiation source for radiation modification, the radiation dosage is 30-40 Kgy, under the specific radiation treatment condition, the degradation speed of the prepared degradable digestive tract stent in an intestinal cavity is accelerated, the expected purpose is achieved by controlling the radiation dosage and the wall thickness of the stent, the degradation period of the degradable digestive tract stent can be regulated and controlled, the stent can be disintegrated at preset time and discharged out of a patient when the raw requirements of operation and healing of the digestive tract of a patient are met, and the method for using the radiation modification treatment is simple, easy to operate and easy to industrialize and popularize.
Preferably, in step (2), the radiation source is G60.
Preferably, the radiation modifying condition in the step (2) is a radiation dose of 30-40 Kgy.
Compared with the prior art, the application has the following technical effects:
(1) The degradable digestive tract stent provided by the application can be used within 0-10 days, can not be subjected to hydrolysis under the influence of intestinal environment, and can not be damaged by the mechanical action of intestinal tracts. After the 28 th day of stent use, can be destroyed by intestinal environment and pressure, disintegrate according to expectations, and discharge the technical effect outside the patient, so that the digestive tract surgery using the degradable digestive tract stent is safer and more convenient, accords with physiological characteristics better, and the patient recovers better, thereby further improving the postoperative life quality of the patient.
(2) According to the preparation method of the degradable digestive tract stent, the degradable digestive tract stent can meet the expected performance requirement of a product through the specific stent wall thickness and the radiation modification treatment mode, and the preparation method has the technical effects of being simple in process, easy to operate and easy to industrially popularize.
Drawings
FIG. 1 is a cross-sectional view of the degradable digestive tract stent of examples 1 to 3 and comparative examples 1 to 5 of the present invention.
FIG. 2 is a cross-sectional view of the degradable digestive tract stent of examples 4 to 5 of the present invention
In the figure, the intermediate section 1, the flared end 2 and the septum 3.
Detailed Description
The invention is further described below with reference to examples.
Example 1:
as shown in fig. 1, a degradable digestive tract stent (model 22H) comprises a middle section 1 and an expansion end 2 communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract stent is made of polyvinyl alcohol, the wall thickness of the degradable digestive tract stent is 0.83mm, and the degradable digestive tract stent is subjected to radiation modification treatment;
a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 30Kgy.
Example 2:
as shown in FIG. 1, the degradable digestive tract stent (model 24H) comprises a middle section and expansion ends communicated with two ends of the middle section, wherein the middle section and the expansion ends are integrally formed, the degradable digestive tract stent is made of polyvinyl alcohol, the outer diameter of the middle section is 22-38 mm, the wall thickness of the degradable digestive tract stent is 0.77mm, and the degradable digestive tract stent is subjected to radiation modification treatment; a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 35Kgy.
Example 3:
as shown in FIG. 1, the degradable digestive tract stent (model number is 38H) comprises a middle section and expansion ends communicated with two ends of the middle section, wherein the middle section and the expansion ends are integrally formed, the degradable digestive tract stent is made of polyvinyl alcohol, the outer diameter of the middle section is 22-38 mm, the wall thickness of the degradable digestive tract stent is 0.99mm, and the degradable digestive tract stent is subjected to radiation modification treatment; a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 40Kgy.
Example 4:
as shown in fig. 2, a degradable digestive tract bracket (model 22 HB) comprises a middle section and expansion ends communicated with two ends of the middle section, wherein the middle section and the expansion ends are integrally formed, and a spacer 3 is arranged in the middle section; the degradable digestive tract stent is made of polyvinyl alcohol, the thickness of the wall of the degradable digestive tract stent is 0.85mm, and the degradable digestive tract stent is subjected to radiation modification treatment; a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 35Kgy.
Example 5:
as shown in fig. 2, a degradable digestive tract stent (model 26 HB) comprises a middle section and expansion ends communicated with two ends of the middle section, wherein the middle section and the expansion ends are integrally formed, and a spacer is arranged in the middle section; the degradable digestive tract stent is made of polyvinyl alcohol, the thickness of the wall of the degradable digestive tract stent is 0.86mm, and the degradable digestive tract stent is subjected to radiation modification treatment; a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 35Kgy.
Comparative example 1: (without irradiation)
A degradable digestive tract bracket (model 22H) comprises a middle section and an expansion end communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract bracket is made of polyvinyl alcohol, and the wall thickness of the degradable digestive tract bracket is 0.83mm;
a method for preparing a degradable digestive tract stent, comprising the following steps: PGA was fabricated into degradable gut scaffolds.
Comparative example 2: (insufficient radiation dose)
A degradable digestive tract bracket (model 22H) comprises a middle section and an expansion end communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract bracket is made of polyvinyl alcohol, the wall thickness of the degradable digestive tract bracket is 0.83mm, and the degradable digestive tract bracket is subjected to radiation modification treatment;
a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 25Kgy.
Comparative example 3: (radiation dose is too high)
A degradable digestive tract bracket (model 22H) comprises a middle section and an expansion end communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract bracket is made of polyvinyl alcohol, the wall thickness of the degradable digestive tract bracket is 0.83mm, and the degradable digestive tract bracket is subjected to radiation modification treatment;
a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 45Kgy.
Comparative example 4: (the tube wall is too thin)
A degradable digestive tract bracket (model 22H) comprises a middle section 1 and an expansion end 2 communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract bracket is made of polyvinyl alcohol, the thickness of the pipe wall of the degradable digestive tract bracket is 0.7mm, and the degradable digestive tract bracket is subjected to radiation modification treatment;
a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 30Kgy.
Comparative example 5: (excessive wall thickness)
The degradable digestive tract stent (model 22H) comprises a middle section and an expansion end communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, the degradable digestive tract stent is made of polyvinyl alcohol, the wall thickness of the degradable digestive tract stent is 1.5mm, and the degradable digestive tract stent is subjected to radiation modification treatment;
a method for preparing a degradable digestive tract stent, comprising the following steps:
(1) Preparing a preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the prefabricated body prepared in the step (1) under a radiation source for radiation modification to prepare the degradable digestive tract stent, wherein the radiation source is G60, and the radiation dose is 30Kgy.
Detection example:
the degradable digestive tract scaffolds prepared in examples 1 to 5 and comparative examples 1 to 5 were subjected to mechanical property test, and the degradable digestive tract scaffolds were placed in an environment simulating the healing process of intestinal canal, and the maximum crushing pressures of the degradable digestive tract scaffolds at 0 day, 10 day and 28 day were respectively tested, and the maximum crushing pressures were tested as follows: the axial pressure applied to the degradable digestive tract stent by a pressure tester is adopted, the pressure when the degradable digestive tract stent is broken is recorded, and the experimental result is shown in table 1;
TABLE 1 maximum crushing pressure of degradable digestive tract scaffolds
As shown in table 1, the results of examples 1 to 3 show that: at the beginning of the test, the maximum crushing pressures of examples 1 to 3 were higher, far greater than the maximum pressure (20N) generated by the intestinal tract. The maximum crushing pressure of examples 1-3 was still far greater than the maximum pressure generated by the intestinal tract at test day 10. The maximum crushing pressure for examples 1-3 was far less than the minimum pressure (10N) generated by the intestine at day 28 of the test. The above results show that the radiation treatment has no significant difference in the structural strength of the degradable digestive tract stent, and the degradable PGA material adopted in the application is in the intestinal tract and can be degraded under the action of the intestinal tract, and the degradable digestive tract stent of examples 1-3 can reach the technical effects that the structure of the degradable digestive tract stent is not destroyed, the structure of the degradable digestive tract stent is destroyed by the intestinal tract after 28 days, and the degradable digestive tract stent is discharged out of the body as expected; the results of comparative example 1 show that: at the beginning of the test, the maximum crushing pressure of comparative example 1 was not different from that of example 1. The maximum crushing pressure of comparative example 1 was rapidly reduced at test day 10, but still much greater than the maximum pressure (20N) generated by the intestinal tract. At day 28 of the test, the maximum crushing pressure of comparative example 1 was still greater than the maximum pressure (20N) generated by the intestinal tract. In comparative example 1, the material was not subjected to radiation treatment, so that the degradable digestive tract stent could not be disintegrated in an expected time and discharged outside the body, and external auxiliary measures were required to be applied to damage the degradable digestive tract stent or disintegrate in an expected time, so that the application effect was poor. From the above results, it is known that the radiation treatment can increase the degradation rate of the degradable digestive tract stent in the intestinal tract, regulate the degradation period of the degradable digestive tract stent, and enable the stent to disintegrate at a preset time and be discharged out of the patient's body while meeting the raw requirements of surgery and healing of the digestive tract of patients.
Comparative example 2 shows that at test day 28, the maximum destructive power of comparative example 2 is higher than the minimum pressure generated by the intestinal tract; comparative example 3 shows that the maximum breaking pressure of comparative example 3 has been less than the maximum pressure generated by the intestinal tract at test day 10, comparative example 4 shows that the maximum breaking pressure of comparative example 4 has been less than the maximum pressure generated by the intestinal tract at test day 10, and comparative example 5 shows that the maximum breaking pressure of comparative example 5 is significantly higher than the minimum pressure generated by the intestinal tract at test day 28; from the above results, it is apparent that the radiation dose of the radiation treatment and the wall thickness of the degradable digestive tract stent have significant effects on the degradable digestive tract stent, and the produced degradable digestive tract stent has the technical effects that the structure is not destroyed within 0 to 10 days in the intestinal tract, is destroyed by the intestinal tract after 28 days, and is discharged out of the body as expected only by the specific combination of the radiation dose and the wall thickness of the stent. Beyond and below the radiation dose disclosed herein and the wall thickness of the degradable gut stent, the performance of the present application to provide a degradable gut stent is not achieved.
The foregoing description is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and any simple modification, variation and equivalent transformation of the above embodiment according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.
Claims (9)
1. The degradable digestive tract stent is characterized by comprising a middle section (1) and an expansion end (2) communicated with two ends of the middle section, wherein the middle section and the expansion end are integrally formed, and the degradable digestive tract stent adopts radiation modification treatment.
2. The degradable digestive tract stent of claim 1, wherein the wall thickness of the degradable digestive tract stent is 0.83-1 mm.
3. A degradable digestive tract stent according to claim 1, characterized in that a baffle (3) is provided in the intermediate section.
4. A degradable digestive tract stent as claimed in claim 1 wherein the outer diameter of the end of the expanded end remote from the intermediate section is greater than the outer diameter of the intermediate section.
5. A degradable digestive tract stent as claimed in claim 1, wherein the material of the degradable digestive tract stent is a degradable resin.
6. A degradable digestive tract stent as claimed in claim 5 wherein the material of the degradable digestive tract stent is polyvinyl alcohol.
7. A method for preparing the degradable digestive tract stent according to any one of claims 1 to 6, comprising the following steps:
(1) Preparing a degradable digestive tract stent preform: making PGA into a preform;
(2) And (3) performing radiation modification treatment on the preform: and (3) placing the preform prepared in the step (1) under a radiation source for radiation modification to prepare the intestinal tract anastomat.
8. The method of claim 7, wherein the radiation source in step (2) is G60.
9. The method for preparing a degradable digestive tract stent according to claim 7, wherein the radiation modification condition in the step (2) is a radiation dose of 30-40 kgy.
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