CN110974504A - Covered stent, preparation method thereof and weight-reducing stent system comprising covered stent - Google Patents

Covered stent, preparation method thereof and weight-reducing stent system comprising covered stent Download PDF

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Publication number
CN110974504A
CN110974504A CN201911309487.0A CN201911309487A CN110974504A CN 110974504 A CN110974504 A CN 110974504A CN 201911309487 A CN201911309487 A CN 201911309487A CN 110974504 A CN110974504 A CN 110974504A
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CN
China
Prior art keywords
stent
stent graft
covered stent
delivery
covered
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Pending
Application number
CN201911309487.0A
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Chinese (zh)
Inventor
孟亚
李少军
杨习锋
曾晨光
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Guangzhou Sun Shing Biotech Co ltd
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Guangzhou Sun Shing Biotech Co ltd
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Priority to CN201911309487.0A priority Critical patent/CN110974504A/en
Publication of CN110974504A publication Critical patent/CN110974504A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/003Implantable devices or invasive measures inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0036Intragastrical devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18Materials at least partially X-ray or laser opaque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/16Materials with shape-memory or superelastic properties

Abstract

The weight-reducing stent system comprises a covered stent and a conveying device, wherein the covered stent is conveyed to the stomach through the conveying device, the self-expansion force of the covered stent plays a role in occupying space to reduce the volume in the stomach, the food consumption of an obese patient can be reduced through the space occupying effect, so that the diet control is achieved in the aspect of diet. The conveying type weight-losing bracket system does not need a trauma operation, and can effectively solve complications such as intestinal obstruction and the like caused by the existing products. The covered stent comprises: a stent and a coating coat attached on the surface of the stent. The delivery device comprises a delivery catheter and a delivery sheath, wherein the delivery sheath and the delivery catheter are mainly made of nylon and polyurethane high polymer materials, and the delivery sheath is positioned inside the delivery catheter and connected with the covered stent.

Description

Covered stent, preparation method thereof and weight-reducing stent system comprising covered stent
Technical Field
The invention relates to the technical field of medical instruments, in particular to a covered stent and a preparation method thereof, and further relates to a conveying type weight-reducing stent system comprising the covered stent.
Background
Obesity (adiposity) is generally defined as the amount of fat stored in the body that exceeds 20% of the ideal body weight, rather than the actual body weight that exceeds 20% of the ideal body weight. It is also possible to judge obese subjects clinically by visual inspection in combination with the latter definition. The latter definition of obesity is not applicable to certain individuals in particular, such as bodybuilders and weight-lifts. Obesity can be caused by many diseases, so obesity is not a disease name but a symptom. Obesity is a common, ancient group of metabolic disorders. When the eating calorie of the human body is more than the consumed calorie, the excessive calorie is stored in the body in the form of fat, the amount of which exceeds the normal physiological requirement, and when the excessive calorie reaches a certain value, obesity develops. The normal male adult adipose tissue accounts for about 15-18% of the body weight, and the female adult adipose tissue accounts for about 20-25%. With age, the proportion of body fat increases correspondingly. Obesity is known as obesity in which the body weight is increased by 20% over the standard body weight or the body mass index BMI (weight (Kg)/height (m) squared) is greater than 24. If the disease has no obvious etiology, the person can be called simple obesity; those with a definite etiology are called secondary obesity.
In 1998, Wangwen et al reported that the research on epidemic characteristics of obesity in adults in China, which is carried out in 7 months to 6 months in 1995, adopted the WHO diagnostic standard to investigate community groups living in 11 provinces (cities) in China for 5 years and more than 5 years, including 42751 people among residents living in 20-74 years, wherein 18631 people are male and 24120 people are female. The results show that the total overweight prevalence rate of 11 provinces (cities) was 18.28% and the obesity prevalence rate was 2.48% by 1990 national population standardization, and both women were significantly higher than men. From the age group, the prevalence rates of overweight of both men and women increase with the age, and reach the highest value in the age of 50-59 years, and slightly decrease in people over 60 years; female obesity rates have been increasing, reaching a maximum in the group over 60 years of age, and male obesity prevalence rates have also varied significantly among age groups.
The two major links in the treatment of obesity are the reduction of caloric intake and the increase of caloric expenditure. Emphasizes the comprehensive treatment mainly based on behaviors, diet and sports, and is supplemented with medicines or operation treatment if necessary. Secondary obesity should be treated against the cause of the disease. Various complications and accompanying diseases should be treated accordingly. The current treatment development trend is as follows: bariatric balloons known to be approved according to the FDA are currently marketed. According to clinical feedback, except two accidental death patients (death caused by a weight-reducing saccule is not found) in the weight-reducing process, the weight-reducing success rate of other treated patients can obtain good effect. The balloon is made of silica gel, is placed into the stomach through a catheter, is inflated or perfused with normal saline, and finally is separated from the catheter, and is retained. The saccule can effectively reduce the food intake of the obesity patient through the space occupying effect. Generally, doctors can achieve the treatment effect by continuously observing the clinical characteristics of patients after the balloon is implanted, usually implanted for 4-6 months, and taken out through a catheter or excreted in vivo.
At the same time, the swallow weight-reducing saccule is developed at home and abroad, and the saccule is divided into degradable saccule and non-degradable saccule. The degradable balloon is prepared from polylactic acid and a copolymer thereof in principle, and the balloon with different degradation time is synthesized by molecular weight.
Disclosure of Invention
The invention provides a weight-reducing stent system which comprises a covered stent and a conveying system device, wherein the covered stent is conveyed to the stomach through the conveying device after being compressed and is withdrawn from the conveying device, a spheroid is formed through the self-expansion force of the covered stent in the process that the covered stent is withdrawn from the conveying device, and the occupied space effect is played in the stomach, so that the food consumption of obese patients can be reduced through the occupied space effect, the diet control is achieved in the aspect of diet, new diet habits are formed after a period of time, and the compressed and recovered sheath tube has the function of food control. The conveying type weight-losing support system does not need a trauma operation, and can effectively solve complications such as intestinal obstruction and the like caused by the existing products used in clinic.
The technical scheme of the weight-reducing bracket system comprises the following steps:
covered stent
The covered stent comprises a stent and a covered coat attached to the surface of the stent, wherein the covered coat has complete sealing property and can be combined with the surface of the stent in sewing, leaching, static spinning, spraying and other modes. The bracket is made of one or more than two materials of nickel, titanium, cobalt-chromium alloy and stainless steel. Preferably, the stent is made of a high-elasticity nickel titanium wire or a stainless steel material. The coating is made of one or more than two materials of Polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), silica gel, latex and polyurethane.
The covered stent can also be made of degradable materials, and is made of polylactic acid, polycaprolactone and copolymers thereof.
The preferable nickel-titanium wire and silica gel of the covered stent are compositely processed, and then the preparation method of the covered stent comprises the following steps:
weaving a prefabricated shape on a weaving machine by using a nickel-titanium wire (nickel-titanium memory alloy wire);
placing the woven prefabricated shape into a prefabricated mold, and carrying out high-temperature shaping through a high-temperature shaping furnace to obtain a shaped metal bracket;
preparing two-component liquid silica gel;
placing the shaped metal bracket in liquid silica gel prepared in advance, and leaching for several times;
and vulcanizing and molding the leached metal support, and thermally welding and plugging the edge of the leached metal support to obtain the covered support.
The stent graft may be cylindrical, ellipsoidal, or irregular in shape.
A plurality of cameras can be arranged in the covered stent, and doctors can observe in real time according to the feedback condition of patients.
The coating can be added with contrast materials, such as platinum-iridium alloy, tantalum ring, tantalum wire, and nickel-titanium tube built-in developing materials.
(II) conveying device
The conveying device comprises a conveying catheter and a conveying sheath, the conveying sheath is located inside the conveying catheter and connected with the covered stent, the conveying sheath can push and recover the covered stent, namely, the covered stent automatically falls off after being conveyed to the stomach through the conveying sheath and automatically expands through metal memory property, the silica gel on the surface of the released covered stent has ductility and is also expanded along with the stent, and the conveying sheath is compressed and recovered along the conveying catheter in a pull buckle mode after the covered stent achieves a treatment effect.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts;
FIG. 1 is a schematic diagram of the operation of a stent graft;
FIG. 2 is a schematic view of the stent graft in the stomach.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The technical scheme of the weight-reducing bracket system comprises the following steps:
covered stent
The covered stent comprises a stent and a covered coat attached to the surface of the stent, wherein the covered coat has complete sealing property and can be combined with the surface of the stent in sewing, leaching, static spinning, spraying and other modes. The bracket is made of one or more than two materials of nickel, titanium, cobalt-chromium alloy and stainless steel. Preferably, the stent is made of a high-elasticity nickel titanium wire or a stainless steel material. The coating is made of one or more than two materials of Polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), silica gel, latex and polyurethane.
The covered stent can also be made of degradable materials, and is made of polylactic acid, polycaprolactone and copolymers thereof.
The preferable nickel-titanium wire and silica gel of the covered stent are compositely processed, and then the preparation method of the covered stent comprises the following steps:
weaving a prefabricated shape on a weaving machine by using a nickel-titanium wire (nickel-titanium memory alloy wire);
placing the woven prefabricated shape into a prefabricated mold, and carrying out high-temperature shaping through a high-temperature shaping furnace to obtain a shaped metal bracket;
preparing two-component liquid silica gel;
placing the shaped metal bracket in liquid silica gel prepared in advance, and leaching for several times;
and vulcanizing and molding the leached metal support, and thermally welding and plugging the edge of the leached metal support to obtain the covered support.
The stent graft may be cylindrical, ellipsoidal, or irregular in shape.
A plurality of cameras can be arranged in the covered stent, and doctors can observe in real time according to the feedback condition of patients.
The coating can be added with contrast materials, such as platinum-iridium alloy, tantalum ring, tantalum wire, and nickel-titanium tube built-in developing materials.
(II) conveying device
The conveying device comprises a conveying catheter and a conveying sheath, the conveying sheath is located inside the conveying catheter and connected with the covered stent, the conveying sheath can push and recover the covered stent, namely, the covered stent automatically falls off after being conveyed to the stomach through the conveying sheath and automatically expands through metal memory property, silica gel on the surface of the released covered stent has ductility and is also expanded along with the stent, and the covered stent is compressed and recovered along the conveying catheter in a pull buckle mode after reaching the treatment effect.
The preparation method of the weight-reducing bracket system comprises the following steps:
selecting high-elasticity nickel-titanium braided wires, and braiding a metal braided tube with the outer diameter of 15mm and the length of 20mm by a braiding machine;
machining a heat setting die into a spheroid with the outer diameter of 15 mmd;
sleeving the knitted metal stent braided tube into a heat setting mold, and pressing and holding two ends of the knitted metal stent braided tube by iron wires to enable the stent to be matched with the mold;
starting a high-temperature vacuum drying furnace, setting the temperature at 500 ℃ for 4 hours, and carrying out high-temperature shaping;
and after heat setting, naturally cooling and taking out the components to obtain the spherical memory alloy support, wherein the sealing end of the support is subjected to laser welding, and an internal thread is attached to one end of the support.
Selecting medical grade PET knitting silk, and knitting the medical grade PET knitting silk into a microporous knitted tube with a nano structure by a knitting machine, wherein the inner diameter of the microporous knitted tube is 15 mm.
The medical PET woven pipe sleeved balloon body stent is sewn by using a metal sewing needle to be attached to the surface to obtain a stent one piece.
Processing a conveying conduit by extrusion and injection molding, wherein the conduit is made of nylon and has an outer diameter of 5 mm;
connecting one end of the luer connector with a catheter and firmly bonding the luer connector with glue;
one end of the thread device is connected with the other end of the conduit and can be used for connecting the internal thread of the bracket;
the covered stent and the conveying system thereof are prepared by cleaning, drying, sizing, inner packaging and sterilizing.
The size of the weight-reducing bracket system prepared by the method can be selected according to the size of the stomach in the patient and the judgment of a doctor.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (7)

1. A stent graft, comprising: the stent is made of one or more than two materials of nickel, titanium, cobalt-chromium alloy and stainless steel, and the coating coat is made of one or more than two materials of polytetrafluoroethylene, polyethylene terephthalate, silica gel, latex and polyurethane.
2. The stent graft of claim 1, wherein the stent graft is fabricated by composite processing of nickel titanium wire and silica gel.
3. The stent graft of claim 1, wherein a contrast material is added to the coating.
4. The stent graft of claim 1, wherein a plurality of cameras are disposed within the stent graft.
5. The method of preparing a stent graft of claim 1, comprising: weaving the prefabricated shape on a weaving machine through a metal wire; placing the woven prefabricated shape into a prefabricated mold, and carrying out high-temperature shaping through a high-temperature shaping furnace to obtain a shaped metal bracket; preparing two-component liquid silica gel; placing the shaped metal bracket in liquid silica gel prepared in advance, and leaching for several times; and vulcanizing and molding the leached metal support, and thermally welding and plugging the edge of the leached metal support to obtain the covered support.
6. A bariatric stent system comprising the stent graft of any one of claims 1-4.
7. The bariatric stent system as claimed in claim 6 further comprising a delivery device including a delivery catheter and a delivery sheath, both of said delivery catheter and said delivery sheath being formed of polyurethane or nylon by an extrusion process or by compounding with braided metal wire, said delivery sheath being disposed within said delivery catheter and connected to said stent graft.
CN201911309487.0A 2019-12-18 2019-12-18 Covered stent, preparation method thereof and weight-reducing stent system comprising covered stent Pending CN110974504A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112932754A (en) * 2021-02-03 2021-06-11 上海睦虞医疗科技有限公司 Small intestine nutrition isolation weight-losing tube
CN113057777A (en) * 2021-05-06 2021-07-02 哈尔滨医科大学 Weight-losing device with intragastric support

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102670338A (en) * 2012-06-11 2012-09-19 上海中山医疗科技发展公司 Pre-bent aortic membrane-covered stent and manufacturing method thereof
CN103598929A (en) * 2013-11-28 2014-02-26 先健科技(深圳)有限公司 Thoracic aorta covered stent
CN105769404A (en) * 2016-04-30 2016-07-20 王东 Volume-reducing stomach stent

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102670338A (en) * 2012-06-11 2012-09-19 上海中山医疗科技发展公司 Pre-bent aortic membrane-covered stent and manufacturing method thereof
CN103598929A (en) * 2013-11-28 2014-02-26 先健科技(深圳)有限公司 Thoracic aorta covered stent
CN105769404A (en) * 2016-04-30 2016-07-20 王东 Volume-reducing stomach stent

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112932754A (en) * 2021-02-03 2021-06-11 上海睦虞医疗科技有限公司 Small intestine nutrition isolation weight-losing tube
CN113057777A (en) * 2021-05-06 2021-07-02 哈尔滨医科大学 Weight-losing device with intragastric support

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