CN114145893A - Swallowable intragastric water balloon and preparation method and set thereof - Google Patents
Swallowable intragastric water balloon and preparation method and set thereof Download PDFInfo
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- CN114145893A CN114145893A CN202111464669.2A CN202111464669A CN114145893A CN 114145893 A CN114145893 A CN 114145893A CN 202111464669 A CN202111464669 A CN 202111464669A CN 114145893 A CN114145893 A CN 114145893A
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Images
Classifications
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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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0036—Intragastrical devices
-
- 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
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/003—Implantable devices or invasive measures inflatable
-
- 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than 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
Abstract
The invention relates to the technical field of medical materials, and discloses a swallowable intragastric water balloon and a preparation method and a suit thereof. A swallowable intragastric water balloon comprising: the self-sealing valve is positioned in the resin balloon and is communicated with the liquid inlet, and the self-sealing valve is made of degradable materials. The preparation method comprises the following steps: the two resin half-balloons and the sealing valve were connected. The intragastric water balloon implantation suit comprises a catheter, a degradable capsule and the swallowable intragastric water balloon; one end of the conduit is inserted into the self-sealing valve and connected with the self-sealing valve, the swallowable intragastric water balloon and one end of the conduit inserted into the self-sealing valve are arranged in the degradable capsule in a folding mode, and the other end of the conduit extends out of the degradable capsule. The water ball has the advantages that the actual time of the water ball in the stomach of a person is consistent with the expected time, gastric irritation and gastric ulcer are not easily caused, the water ball is convenient to manufacture, and the cost is low.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a swallowable intragastric water balloon and a preparation method and a suit thereof.
Background
Overweight and obesity are important risk factors for cardiovascular disease, diabetes, certain cancers, and other chronic diseases. The prevalence of obesity has risen dramatically worldwide over the last few decades, and is a major health problem that has contributed to the economic burden of contemporary society. The world health organization has recently predicted that by 2030 nearly 60% of the world's population may be overweight or obese.
Traditional treatments for obesity include lifestyle changes and drug therapies, but rarely achieve the goal of significant weight loss over a long period of time. Surgery has proven to be the only long-term effective method for weight loss and for ameliorating the obesity-related concomitant diseases. However, the invasiveness, safety and possible adverse effects of surgery in the long term post-surgery make patients who undergo surgery less than 1% of their population eligible. In the last two decades, countries in the europe and the united states have gradually turned the means of weight loss to non-invasive weight loss. With the increasing number of people who are overweight and obese, the design and development of a convenient and noninvasive weight-reducing medical instrument have great social value and commercial value.
An intragastric water balloon (IGB) is a noninvasive weight losing method which is most widely used for I-grade and II-grade obese patients in the United states, and the occupied balloon is placed in the stomach for 4-12 months, so that the stomach capacity is reduced, the satiety is enhanced, and the weight is reduced by reducing the food intake. The IGB placement period (1) enables an initial desired weight loss, increases patient confidence in weight loss, and continues the motivation for weight loss. (2) The IGB occupies the stomach cavity for a long time, so that the eating habit of the patient can be changed, the food intake and the food intake times of the patient are limited, and the eating habit of the patient is remodeled.
However, the insertion and removal of the balloon mostly requires endoscopic operation, which causes adverse reactions with anesthesia: abdominal cramps, anesthetic allergies, cardiac arrest, digestive tract injury or perforation (3 ‰), throat irritation, profuse sweating, hypotension, and laryngeal spasm. Therefore, it is necessary to design an intragastric balloon system which does not need endoscopic operation for insertion and extraction, and adverse reactions are reduced as much as possible when the requirement of weight reduction is met.
At present, a swallowable intragastric balloon system which can be put into and taken out without endoscopic operation is available on the market abroad. The ball body is folded and filled into a swallowable capsule, and a one-way self-sealing valve is designed in the ball body and is connected with the conduit; after entering the stomach, the capsule is disintegrated, and liquid with proper volume can be injected into the sphere through the catheter in vitro; and then, the catheter is pulled out, the one-way self-sealing valve is automatically closed, and the sealing performance of the ball body is good. After the balloon is placed in the stomach for a proper time, the degradable material on the surface of the sphere or in the sphere is degraded and broken, the sealing property of the sphere is destroyed, the liquid in the sphere is discharged, and the balloon is naturally discharged out of the body through the gastrointestinal tract. As the whole treatment process does not need endoscope operation, the swallowable intragastric balloon system has great development prospect in the weight reduction field. Domestic patent CN201811025986.2 also discloses a similar swallowable intragastric balloon system.
The patent CN201811025986.2 discloses a balloon insertion device, wherein a catheter is pulled out after fluid is delivered into the balloon through the catheter. The degradable material is distributed on the surface of the balloon in the form of a patch, and after the balloon is placed for a proper time, the degradable material is degraded, the fluid release channel is opened, and the liquid is discharged. The saccule is naturally discharged out of the body through the gastrointestinal tract.
The disadvantages of this structure are: (1) the patch has a complex structure and is inconvenient to operate; (2) the mechanical property and the degradation property of the degradable material are greatly influenced by the peristaltic force of the stomach and the chemical environment in the stomach, so that the actual degradation time is possibly inconsistent with the expected time; (3) because the degradable material and the main sphere material are not the same material, the mechanical properties of the whole sphere are different, so that the mechanical properties of the whole sphere are not uniform, the mechanical action and deformation of different parts of the sphere on the stomach wall are inconsistent during gastric contraction, and gastric irritation and gastric ulcer are easily caused. (4) Visualization of the balloon is not considered.
In view of this, the invention is particularly proposed.
Disclosure of Invention
The object of the present invention is to provide a swallowable intragastric water balloon and a method for its preparation and a kit, aimed at improving at least one of the problems mentioned in the background.
The invention is realized by the following steps:
in a first aspect, the present invention provides a swallowable intragastric balloon comprising: the self-sealing valve is positioned in the resin balloon, is connected with the resin balloon and is communicated with the liquid inlet, and the self-sealing valve is made of degradable materials.
In an optional embodiment, the self-sealing valve comprises two degradable films, the two degradable films are attached to each other, two opposite side edges of one degradable film are correspondingly connected with two opposite side edges of the other degradable film one by one, and a gap between the two degradable films is communicated with the liquid inlet;
preferably, the connection mode is bonding or laser welding;
preferably, the thickness of the degradable film is 0.01-0.1 mm.
In alternative embodiments, the degradable material comprises at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-glycolide copolymers, polylactide-caprolactone copolymers, polylactide-trimethylene carbonate, polyglycolide-caprolactone copolymers, and polydioxanone;
preferably, the material of the resin balloon is at least one of polyurethane and silicone rubber;
preferably, the resin balloon is doped with a contrast agent, and the content of the contrast agent accounts for 0.5-1.5% of the mass of the resin balloon.
In an optional embodiment, the wall thickness of the resin balloon is 0.01-0.1 mm;
preferably, the volume of the fully-expanded resin balloon is 100-1000 ml.
In a second aspect, the present invention provides a method of preparing a swallowable intragastric balloon as in any one of the preceding embodiments, comprising: connecting the two resin half balloons with a sealing valve, and forming the resin balloons after the two resin half balloons are connected;
in an alternative embodiment, the attachment means is adhesive bonding or laser welding.
In an alternative embodiment, a method of making a resin half-balloon comprises:
attaching the resin solution to a mold with a hemispherical wall surface, and volatilizing the solvent to obtain a resin semi-balloon;
preferably, the mass concentration of the resin in the resin solution is 5-20%;
preferably, the solvent used in the resin solution includes at least one of tetrahydrofuran, dichloromethane, chloroform, hexafluoroisopropanol, toluene, and xylene.
In an alternative embodiment, a method of making a sealing valve comprises: attaching two identical degradable films, and then connecting the two opposite side edges of one degradable film with the two opposite side edges of the other degradable film in a one-to-one correspondence manner;
in an alternative embodiment, a method of preparing a degradable film comprises:
attaching a solution containing a degradable material to a mold with a plane, and volatilizing the solvent to obtain a degradable film material;
preferably, the solvent in the solution of the degradable material is at least one selected from tetrahydrofuran, dichloromethane, trichloromethane and hexafluoroisopropanol;
preferably, the mass concentration of the degradable material in the solution of the degradable material is 5-20%.
In a third aspect, the present invention provides an intragastric water balloon implantation kit comprising a catheter, a degradable capsule and a swallowable intragastric water balloon as in any one of the preceding embodiments or as made by the method of preparation of any one of the preceding embodiments;
one end of the conduit is inserted into the self-sealing valve and connected with the self-sealing valve, the swallowable intragastric water balloon and one end of the conduit inserted into the self-sealing valve are arranged in the degradable capsule in a folding mode, and the other end of the conduit extends out of the degradable capsule.
In an optional embodiment, the degradable capsule is made of a material which can disintegrate in a gastric acid environment for 10-20 min;
preferably, the degradable capsule is made of gelatin or degradable plant material.
In an alternative embodiment, the material of the catheter is the same as that of the resin balloon;
preferably, the outer diameter of the conduit is 2 mm-16 mm, and the wall thickness is 0.3-0.5 mm;
preferably, the length of the conduit is greater than or equal to 45 cm;
preferably, the catheter is provided with a scale.
The invention has the following beneficial effects:
because the self-sealing valve is made of degradable materials and is positioned in the resin balloon, the mechanical property and the degradation property of the self-sealing valve are slightly influenced by the peristaltic force of the stomach and the chemical environment in the stomach, and therefore, the actual degradation time is consistent with the expected degradation time; due to the fact that the self-sealing valve is endowed with the degradable performance, the resin balloon does not need to be additionally designed, the mechanical performance of the resin balloon is more excellent compared with that of the existing degradable balloon, even if the stomach contracts, the force and the deformation of all parts of the sphere on the stomach wall are basically consistent, and the gastric irritation and the gastric ulcer are not easily caused; in addition, the internal water globule of swallowable stomach that this application provided realizes discharging simple structure outside the degradation back, and the preparation is convenient, and is with low costs.
The swallowable intragastric water balloon and intragastric water balloon implantation suit provided by the application is suitable for being used for BMI (BMI) more than or equal to 27kg/m2Weight loss treatment for overweight or obese patients. The balloon can be placed in or taken out without the operation of an endoscope. After the capsule enters the stomach through the oral cavity of a patient, the capsule is quickly disintegrated in a gastric juice environment, and the saccule is exposed in the stomach; injecting a certain amount of physiological saline containing methylene blue into the body through a catheter in vitro, and then pulling out the catheter; the self-sealing valve is automatically closed; after a period of time, the degradable material is degraded, the sealing valve is invalid, the liquid of the ball body is discharged, and the saccule is naturally discharged from the gastrointestinal tract of the human body.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
FIG. 1 is a schematic diagram of a swallowable intragastric balloon provided by an embodiment of the present application;
fig. 2 is a schematic structural view of the intragastric water balloon implantation kit provided in the embodiments of the present application.
Icon: 100-swallowable intragastric water balloon; 110-a resin balloon; 111-a liquid inlet; 120-a self-sealing valve; 10-implantation set of intragastric water balloon; 11-a catheter; 12-degradable capsules; 13-graduation.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
The swallowable intragastric water balloon 100 provided herein, and methods and kits for making the same, are described in detail below.
As shown in fig. 1 and 2, an embodiment of the present invention provides a swallowable intragastric water balloon 100, comprising: the self-sealing valve comprises a resin balloon 110 and a self-sealing valve 120, wherein a liquid inlet 111 is formed in the resin balloon 110, the self-sealing valve 120 is located in the resin balloon 110, is connected with the resin balloon 110 and is communicated with the liquid inlet 111, and the self-sealing valve 120 is made of degradable materials.
When the swallowable intragastric water balloon 100 provided by the embodiment of the application is used, one end of the conduit 11 is embedded in the self-sealing valve 120, the water balloon is compressed and swallowed into the stomach together with one end of the conduit 11, physiological saline is injected into the water balloon through the conduit 11 to expand and strut the water balloon, after the water balloon is expanded, the conduit 11 is pulled out by applying a slight force, and the expanded water balloon occupies the space in the stomach of a human body, so that the effect of reducing the volume of the stomach is achieved, and the effect of assisting weight loss is achieved; after the water ball is in the stomach for a period of time, the self-sealing valve 120 is degraded, liquid in the water ball is discharged from the liquid inlet 111, the volume of the water ball is reduced, and finally the water ball is discharged out of the body; furthermore, methylene blue with the mass concentration of about 1 percent can be added into the physiological saline, and the degradation or the rupture of the water ball can be judged according to whether urine discharged by people shows blue color or not. According to the water ball provided by the application, the self-sealing valve 120 is made of degradable materials, and the self-sealing valve 120 is located inside the resin ball bag 110, so that the mechanical property and the degradation property of the water ball are slightly influenced by the peristaltic force of the stomach and the chemical environment in the stomach, and therefore the actual degradation time is consistent with the expected degradation time; due to the fact that the self-sealing valve 120 is endowed with degradability, the resin balloon 110 does not need to be additionally designed, the resin balloon 110 is more excellent in mechanical property compared with the existing degradable balloon, even when the stomach contracts, force and deformation of all parts of the balloon on the stomach wall are basically consistent, and stomach stimulation and gastric ulcer are not prone to being caused; in addition, the swallowable intragastric water balloon 100 provided by the embodiment of the application realizes simple structure discharged outside after degradation, is convenient to manufacture and has low cost.
Preferably, in order to ensure that the resin balloon 110 has good flexibility, the material of the resin balloon 110 is at least one of polyurethane and silicone rubber.
Further, in order to ensure good flexibility and sufficient mechanical properties of the resin balloon 110, the wall thickness of the resin balloon 110 is 0.01 to 0.1 mm.
Specifically, the self-sealing valve 120 includes two degradable films, the two degradable films are attached to each other, two opposite side edges of one degradable film are connected to two opposite side edges of the other degradable film in a one-to-one correspondence manner, and a gap between the two degradable films is communicated with the liquid inlet 111. In use, the conduit 11 is inserted between the two degradable films from the inlet 111.
Preferably, the connection mode between the two degradable films is bonding or laser welding.
Specifically, in order to ensure the stable degradation in physiological saline, the degradable material is at least one of polylactide copolymer and polydioxanone. Generally, the two materials or the mixture of the two materials are selected, and the degradation can be controlled within 2-6 months.
Further, in order to ensure that the self-sealing valve 120 can be degraded accurately within a preset time and prevent the water ball from generating a foreign body sensation after being implanted, the thickness of the degradable film is 0.01-0.1 mm.
Preferably, in order to facilitate the observation of the water balloon in the stomach of a human body from the outside, the resin balloon 110 is doped with a contrast agent, and the content of the contrast agent is about 20% of the mass of the resin balloon 110. The resin balloon 110 containing the contrast agent is transparent to the human body and is imaged by X-rays.
Preferably, in order to achieve an effective auxiliary weight-reducing effect, the volume of the resin balloon 110 after being completely expanded is 100-1000 ml.
The embodiment of the present application provides a method for preparing the swallowable intragastric water balloon 100, which comprises the following steps: and connecting the two resin half balloons with a sealing valve, and forming the resin balloons after the two resin half balloons are connected.
The preparation method comprises the following steps:
s1 preparation of resin half balloon
And adhering the resin solution to a mold with a hemispherical wall surface to form a hemispherical resin solution layer, and volatilizing the solvent in the resin solution layer to obtain the resin semi-balloon.
Preferably, the mass concentration of the resin in the resin solution is 5-20%;
preferably, the solvent used in the resin solution is at least one selected from the group consisting of tetrahydrofuran, dichloromethane, chloroform, hexafluoroisopropanol, toluene and xylene.
S2, the preparation method of the degradable film comprises the following steps:
and attaching the solution containing the degradable material to a mold with a plane to form a flaky degradable solution layer, and volatilizing the solvent in the degradable solution layer to obtain the degradable film material. The size of the degradable film material is controlled by the size of the die, and when the obtained degradable film material is larger, the degradable film material can be cut into a target size to obtain a degradable film; it is of course also possible to directly produce degradable films of the targeted size.
Preferably, the solvent in the solution of the degradable material is at least one selected from tetrahydrofuran, dichloromethane, trichloromethane and hexafluoroisopropanol.
Preferably, the mass concentration of the degradable material in the solution of the degradable material is 5-20%.
S3, assembling
After the two degradable films are attached, the long sides thereof are connected together by bonding or laser welding to obtain the self-sealing valve 120.
The two resin half-balloons and the self-sealing valve 120 were joined together by laser welding.
The embodiment of the application provides an intragastric water balloon implantation set 10, which comprises a catheter 11, a degradable capsule 12 and the swallowable intragastric water balloon 100 or the swallowable intragastric water balloon 100 prepared by the preparation method.
One end of the conduit 11 is inserted into the self-sealing valve 120 and connected with the self-sealing valve 120, the swallowable intragastric water balloon 100 and one end of the conduit 11 inserted into the self-sealing valve 120 are folded and arranged in the degradable capsule 12, and the other end of the conduit 11 extends out of the degradable capsule 12.
The connection between the catheter 11 and the self-sealing valve 120 is only for temporarily fixing the catheter 11, and the tightness of the connection between the catheter 11 and the self-sealing valve should not be too strong, so that the catheter 11 can be easily pulled out without breaking the water balloon structure after the balloon is inflated. The connection of the conduit 11 to the self-sealing valve 120 may be by bonding or laser welding.
Through above-mentioned design, make the user can swallow the sacculus to the stomach through swallowing degradable capsule 12, degradable capsule 12 is disintegrating relatively fast under the gastric acid effect, and degradable capsule 12 disintegrates the back, when the expected degradable capsule 12 after disintegrating, injects the normal saline that contains methylene blue into resin sacculus 110 and makes resin sacculus 110 inflation, and the back is accomplished in the water injection, takes out pipe 11 outside the human body, and self-sealing valve 120 is closed.
Preferably, the degradable capsule 12 is made of a material which disintegrates in the gastric acid environment for 10 to 20 min. Specifically, the degradable capsule 12 is made of gelatin or degradable plant material.
Preferably, in order to reduce the foreign body sensation during the capsule swallowing process, the material of the catheter 11 is the same as that of the resin balloon 110. In order to further reduce the foreign body sensation and ensure the smoothness of the physiological saline injection process, the outer diameter of the catheter 11 is 2 mm-16 mm, and the wall thickness is 0.3-0.5 mm.
Preferably, to ensure convenience of use, the length of the catheter 11 is greater than or equal to 45 cm.
Preferably, in order to visually visualize the length of the tube 11 swallowed into the stomach, the position of the capsule in the body is marked, and the tube 11 is provided with a scale 13.
The features and properties of the present invention are described in further detail below with reference to examples.
The concentrations mentioned throughout this application are mass concentrations.
Example 1
The present embodiment provides a swallowable intragastric balloon 100 and method of making and intragastric balloon implantation kit 10.
The preparation method of the swallowable intragastric water balloon 100 comprises the following steps:
s1 preparation of resin half balloon
Pouring a solution containing 10% of polyurethane, 0.05% of contrast agent and chloroform as a solvent into a hemispherical mold, so that the solution is completely adhered to the inner wall of the mold to form a polyurethane solution layer, pouring out the redundant solution, and volatilizing the solvent of the polyurethane solution layer to obtain the polyurethane semi-balloon with the wall thickness of 0.03 mm.
S2 preparation of degradable film
Pouring a 10% polylactide copolymer solution with tetrahydrofuran as a solvent on a flat plate mould, so that the polylactide copolymer solution forms a solution layer on the flat plate mould, volatilizing the solvent of the solution layer to obtain a degradable membrane material, and cutting the degradable membrane material into a target membrane with the size of 0.02 mm.
S3, assembling
The two degradable films are welded into the self-sealing valve 120 by laser, and the 2 resin half-balloons and the self-sealing valve 120 are connected together by laser welding to obtain the swallowable intragastric water balloon 100.
The intragastric balloon implantation set 10 comprises a polyurethane catheter 11, a gelatin capsule and the swallowable intragastric balloon 100 prepared by the method.
The assembly method comprises the following steps: one end of the catheter 11 is inserted between the two degradable films, the catheter 11 and the self-sealing valve 120 are fixed by laser welding after insertion, and then one end of the catheter 11 connected with the water balloon which can be implanted into the stomach is folded into the degradable capsule 12.
The outer diameter of the length of the conduit 11 is 3mm, the wall thickness is 0.4mm, the length is 60cm, and the outer wall of the conduit 11 is provided with scales.
Example 2
This embodiment is substantially the same as embodiment 1 except that:
in the step S1, the resin for preparing the resin half balloon was silicone rubber, the solvent used was toluene, and the wall thickness of the prepared half balloon was 0.04 mm.
In the step S2, the material for preparing the degradable film is polydioxanone, the used solvent is dichloromethane, and the thickness of the prepared degradable film is 0.03 mm.
Example 3
This embodiment is substantially the same as embodiment 1 except that:
in the step S1, the resin for preparing the resin half balloon was silicone rubber, the solvent used was dichloromethane, and the wall thickness of the prepared half balloon was 0.01 mm.
In the step S2, the material for preparing the degradable film is polydioxanone, the solvent is dichloromethane, and the thickness of the prepared degradable film is 0.01 mm.
Example 4
This embodiment is substantially the same as embodiment 1 except that:
in the step S1, the resin for preparing the resin half balloon is silicone rubber, the solvent used is chloroform, and the wall thickness of the prepared half balloon is 0.1 mm.
In the step S2, the material of the degradable film is polyvinyl alcohol, the solvent is chloroform, and the thickness of the degradable film is 0.1 mm.
Example 5
This embodiment is substantially the same as embodiment 1 except that:
in the step S1, the resin for preparing the resin half balloon was silicone rubber, the solvent used was toluene, and the wall thickness of the prepared half balloon was 0.05 mm.
In the step S2, the degradable film is prepared from polyglycolide-trimethylene carbonate, the solvent is tetrahydrofuran, and the thickness of the prepared degradable film is 0.05 mm.
Examples of the experiments
The intragastric water balloon implant sets prepared in examples 1-5 were tested for performance. The results are recorded in the table below.
Table 1 results of performance test of each example
As can be seen from the above table, the swallowable intragastric water balloon 100 and the intragastric water balloon implantation kit 10 provided by the embodiments of the present application have better performance.
In conclusion, the swallowable intragastric water balloon and the intragastric water balloon implanting set provided by the application have the advantages that the self-sealing valve is made of degradable materials, the self-sealing valve is located inside the resin balloon, the mechanical property and the degradation property of the self-sealing valve are slightly influenced by the peristaltic force of the stomach and the chemical environment in the stomach, and therefore the actual degradation time is consistent with the expected degradation time; due to the fact that the self-sealing valve is endowed with the degradable performance, the resin balloon does not need to be additionally designed, the mechanical performance of the resin balloon is more excellent compared with that of the existing degradable balloon, even if the stomach contracts, the force and the deformation of all parts of the sphere on the stomach wall are basically consistent, and the gastric irritation and the gastric ulcer are not easily caused; in addition, the deglutible intragastric water balloon provided by the embodiment of the application is simple in structure, convenient to manufacture and low in cost, and is discharged out of the body after being degraded.
The swallowable intragastric water balloon and intragastric water balloon implantation suit provided by the application is suitable for being used for BMI (BMI) more than or equal to 27kg/m2Weight loss treatment for overweight or obese patients. The balloon can be placed in or taken out without the operation of an endoscope. After the capsule enters the stomach through the oral cavity of a patient, the capsule is quickly disintegrated in the gastric juice environmentThe balloon is exposed in the stomach; injecting a certain amount of physiological saline containing methylene blue into the body through a catheter in vitro, and then pulling out the catheter; the self-sealing valve is automatically closed; after 2-6 months, the degradable material is degraded, the sealing valve is invalid, the liquid of the ball body is discharged, and the balloon is naturally discharged from the gastrointestinal tract of the human body.
The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A swallowable intragastric water balloon, comprising: the self-sealing valve is positioned in the resin balloon, is connected with the resin balloon and is communicated with the liquid inlet, and the self-sealing valve is made of degradable materials.
2. The swallowable intragastric water balloon of claim 1, wherein the self-sealing valve comprises two degradable membranes, the two degradable membranes are attached to each other, opposite side edges of one degradable membrane are connected with opposite side edges of the other degradable membrane in a one-to-one correspondence manner, and a gap between the two degradable membranes is communicated with the liquid inlet;
preferably, the connection mode is bonding or laser welding;
preferably, the thickness of the degradable film is 0.01-0.1 mm.
3. The swallowable intragastric water balloon of claim 1, wherein the degradable material comprises at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-glycolide copolymers, polylactide-caprolactone copolymers, polylactide-trimethylene carbonate, polyglycolide-caprolactone copolymers, and polydioxanone;
preferably, the material of the resin balloon is at least one of polyurethane and silicone rubber;
preferably, a contrast agent is doped in the resin balloon, and the content of the contrast agent accounts for 0.5-1.5% of the mass of the resin balloon.
4. The swallowable intragastric water balloon of claim 1, wherein the resin balloon has a wall thickness of 0.01-0.1 mm;
preferably, the volume of the fully-expanded resin balloon is 100-1000 ml.
5. A method of preparing a swallowable intragastric water balloon as claimed in any one of claims 1 to 4, comprising: connecting the two resin half balloons with the sealing valve, wherein the two resin half balloons are connected to form the resin balloon;
preferably, the connection means is bonding or laser welding.
6. The method of manufacturing of claim 5, wherein the method of manufacturing the resin half balloon comprises:
attaching a resin solution to a mold with a hemispherical wall surface, and volatilizing a solvent to obtain the resin semi-balloon;
preferably, the mass concentration of the resin in the resin solution is 5-20%;
preferably, the solvent used in the resin solution includes at least one of tetrahydrofuran, dichloromethane, chloroform, hexafluoroisopropanol, toluene, and xylene.
7. The method for producing according to claim 5, wherein the method for producing the sealing valve comprises: attaching two identical degradable films, and then connecting the two opposite side edges of one degradable film with the two opposite side edges of the other degradable film in a one-to-one correspondence manner;
preferably, the preparation method of the degradable film comprises the following steps:
attaching a solution containing a degradable material to a mold with a plane, and volatilizing the solvent to obtain a degradable film material;
preferably, the solvent in the solution of the degradable material is at least one selected from tetrahydrofuran, dichloromethane, trichloromethane and hexafluoroisopropanol;
preferably, the mass concentration of the degradable material in the solution of the degradable material is 5-20%.
8. An intragastric water balloon implantation kit, which is characterized by comprising a catheter, a degradable capsule and the swallowable intragastric water balloon as defined in any one of claims 1 to 4 or prepared by the preparation method as defined in any one of claims 5 to 7;
one end of the catheter is inserted into the self-sealing valve and connected with the self-sealing valve, the swallowable intragastric water balloon and one end of the catheter inserted into the self-sealing valve are arranged in the degradable capsule in a folded mode, and the other end of the catheter extends out of the degradable capsule.
9. The intragastric water balloon implantation kit according to claim 8, wherein the degradable capsule is made of a material that disintegrates in a gastric acid environment for 5-20 min;
preferably, the degradable capsule is made of gelatin or degradable plant materials.
10. The intragastric water balloon implantation kit according to claim 8, wherein the material of said catheter is the same as the material of said resin balloon;
preferably, the outer diameter of the conduit is 2 mm-16 mm, and the wall thickness is 0.3-0.5 mm;
preferably, the length of the conduit is greater than or equal to 45 cm;
preferably, the catheter is provided with a scale.
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