WO2022188617A1

WO2022188617A1 - Closure and release structure for in-vivo implant

Info

Publication number: WO2022188617A1
Application number: PCT/CN2022/077163
Authority: WO
Inventors: 石秀凤; 张强; 陆兰
Original assignee: 常州至善医疗科技有限公司
Priority date: 2021-03-09
Filing date: 2022-02-22
Publication date: 2022-09-15

Abstract

An in-vivo implant balloon system, in particular a closure and release structure for the in-vivo implant balloon system. An in-vivo implant comprises a balloon (100), a catheter (200) and filler, wherein a degradable sheet (400) is coupled to the balloon (100); the portion where the degradable sheet (400) is coupled to a balloon body is provided with discontinuous fixing holes (401); a cover sheet (500) is provided on the outside of the degradable sheet (400); the balloon body is connected to the cover sheet (500) by means of the fixing holes (401); and the degradable sheet (400) is fixed between the balloon body and the cover sheet. The cover sheet (500) and the balloon body are made of the same material and are connected together at the fixing holes (401) by means of bonding or welding, with the connection strength of the same material being high. This structure can prevent premature separation between the degradable sheet (400) and the balloon body in an in-vivo gastric acid environment.

Description

A closure and release structure for an in vivo implant

technical field

The present application relates to an in vivo implantable balloon system, in particular, to a closure and release structure of the in vivo implantable balloon system.

Background technique

Over the past 20 years, the incidence of obesity, including obesity in adults, obesity in the elderly, and obesity in adolescents and children, has soared worldwide. According to the World Health Organization statistics, in 2014, 15% of adult women and 11% of adult men in the world were obese, which means that in 2014, nearly one billion adults in the world were obese. What is not optimistic is that China's obese population has overtaken that of the United States. In 2016, there were 89.6 million obese people in China (87.8 million obese people in the United States), of which 43.2 million were men and 46.4 million were women. Obesity is usually accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea and certain tumors. Therefore, how to effectively control weight and prevent and control the occurrence of complications is a topic of interest.

At present, the main treatment methods of obesity include: diet control, life intervention, drug treatment and surgical treatment. However, simple diet control, life intervention and drug treatment are difficult to achieve satisfactory weight loss effect; although the effect of weight loss surgery is obvious, it is difficult for patients to accept it due to cultural, medical level and surgical complications. Implantable medical devices for weight loss, simulating the mechanism of surgical treatment of obesity, including intragastric balloons, have just emerged in recent years. Because of their safety, simplicity, effectiveness, and recovery, they have received widespread attention and will become the main weight loss in the future. effective means.

At present, several types of intragastric balloons have been marketed abroad, especially the intragastric balloons that do not need to be delivered by gastroscope and swallowed by themselves, which is the direction of future weight loss methods. Such balloons are often coupled with degradable materials that act as a closure and release channel for the filling within the balloon. After the balloon is swallowed into the human stomach, it is filled with filler into an inflated state. The degradable material of the balloon in the inflated state maintains the structural integrity within a certain period of time, and acts as a barrier for the filler in the balloon to prevent the filler from leaking out. After maintaining this structural integrity for a period of time, the degradable material ruptures, the filler in the balloon is released through the rupture, and the empty balloon shell is excreted through the natural lumen under the peristalsis of the gastrointestinal tract. The advantage of this design is that the swallowing and expelling of the balloon are all through the natural orifice of the human body, without the need for gastroscope and anesthesia, etc., and it is friendly to patients. However, it is difficult for conventional bonding or welding methods to ensure the durability of the coupling strength of the two in the gastric acid environment. Once the degradable material and the balloon body material are separated prematurely, the expected effect of weight reduction will not be achieved.

SUMMARY OF THE INVENTION

The present application provides a sealing and releasing structure of an implant in vivo, so that the degradable material and the balloon body material can be coupled together for a long time without being easily separated.

The present application provides an in vivo implant sealing and releasing structure, the in vivo implant includes a balloon, a catheter and a filler, and a degradable sheet is coupled to the balloon, and is characterized in that: the degradable sheet is combined with The coupling part of the balloon body is provided with a discontinuous fixing hole, and a cover sheet is arranged outside the degradable sheet. The balloon body is connected with the cover sheet at the fixing hole, and the degradable sheet is fixed between the two.

Preferably, one end of the catheter is connected to a self-closing valve on the balloon.

Preferably, the balloon includes an upper-layer balloon and a lower-layer balloon, wherein at least one opening is formed on the upper-layer balloon as a release channel for the filling in the balloon.

Preferably, the self-closing valve comprises an upper-layer self-closing valve and a lower-layer self-closing valve, wherein the lower-layer self-closing valve is provided with a conduit hole, and the circumference of the conduit hole is not greater than the outer diameter of the conduit.

Preferably, the upper-layer self-closing valve and the upper-layer balloon are integral, or are connected by different materials through bonding or welding.

Preferably, the lower layer self-closing valve and the lower layer balloon are integral, or are connected together by different materials through bonding or welding.

Preferably, the upper-layer balloon and the upper-layer self-closing valve are combined with the lower-layer balloon and the lower-layer self-closing valve by bonding or welding at the edges.

Preferably, the degradable sheet is circular, oval, square or other shapes, and a circle of discontinuous fixing holes is opened near the outer edge.

Preferably, the upper layer balloon and the lower layer balloon are made of flexible materials such as silicone rubber or polyurethane.

Preferably, the material of the cover sheet is the same as or similar to that of the upper-layer balloon and the lower-layer balloon.

Preferably, the degradable sheet is a polylactic acid-based copolymer.

Preferably, the degradable sheet is polydioxanone.

Preferably, the degradable sheet is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.

Preferably, the film thickness of the degradable sheet is 10-300 microns.

Preferably, the degradable sheet is coupled between the upper layer balloon and the cover sheet, and is locked by the fixing hole.

Preferably, the fixing holes on the degradable sheet are one circle or more than two circles.

The present application provides a method for making a sealing and releasing structure, characterized in that: one end of the catheter is connected to a self-closing valve on the balloon, the balloon includes an upper-layer balloon and a lower-layer balloon, wherein the upper-layer balloon There is at least one opening on the balloon as a release channel for the filling in the balloon, and the self-closing valve includes an upper-layer self-closing valve and a lower-layer self-closing valve, wherein the lower-layer self-closing valve is provided with a conduit hole, and the conduit hole is provided with a conduit hole. The circumference is not greater than the outer diameter of the catheter. The upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve by bonding or welding at the edge. The release channel on the upper-layer balloon is turned over, the upper-layer balloon and the lower-layer balloon form the balloon, the upper-layer self-closing valve and the lower-layer self-closing valve form the self-closing valve, so The self-closing valve enters the interior of the balloon.

Preferably, the catheter penetrates the self-sealing valve from outside the balloon, passes through a catheter hole on the self-closing valve, and enters the balloon for filling and filling the balloon. thing.

Preferably, glue is dotted around the release channel of the upper layer balloon, the degradable sheet with the fixing hole is covered on the glue around the release channel, and the glue is removed from the degradable sheet overflow in the fixing hole.

Preferably, the cover sheet is added on the surface of the degradable sheet, and the cover sheet is bonded with the upper layer balloon at the fixing hole.

In the closure and release structure of the in-vivo implant of the present application, the cover sheet and the balloon body are made of the same kind of material, and are connected together by bonding or welding at the position of the fixing hole, and the connection strength of the same kind of material is high. The degradable sheet is located between the balloon body and the cover sheet, and is fixed through the fixing hole. This structure avoids premature separation between the degradable sheet and the balloon body in the acid environment of the stomach.

Description of drawings

FIG. 1 is a schematic diagram of a sealing and releasing structure of an implant in vivo according to an embodiment of the present application;

2 is a structure and a manufacturing method of a balloon system according to an embodiment of the present application;

3 is a structure and a manufacturing method of a balloon system according to an embodiment of the present application;

4 is a schematic diagram of a degradable sheet according to an embodiment of the present application;

5 is a structure and a manufacturing method of a balloon system according to an embodiment of the present application;

6 is a schematic diagram of an annular cover sheet according to an embodiment of the present application;

FIG. 7 is a structure and a manufacturing method of a balloon system according to an embodiment of the present application;

FIG. 8 is a schematic diagram of a sealing and releasing structure of an implant in vivo according to another embodiment of the present application;

9 is a structure and a manufacturing method of a balloon system according to another embodiment of the present application;

10 is a structure and a manufacturing method of a balloon system according to another embodiment of the present application;

11 is a schematic diagram of a degradable sheet according to another embodiment of the present application;

FIG. 12 is a structure and a manufacturing method of a balloon system according to another embodiment of the present application;

13 is a schematic diagram of a square cover sheet according to another embodiment of the present application;

FIG. 14 shows the structure and manufacturing method of a balloon system according to another embodiment of the present application.

Detailed ways

Referring to FIG. 1 , a schematic diagram of the closure and release structure of the in vivo implant according to an embodiment of the present application is shown. Preferably, the implant is a balloon system implanted in vivo, such as an intragastric balloon system. Those skilled in the art can easily think that the balloon system of the present application can be a balloon system for other purposes, such as a skin dilation balloon Wait. The implanted balloon system in vivo includes: a balloon 100, a catheter 200 and a filler (not shown in the figure). The balloon 100 is wrapped in a capsule before swallowing, and one end of the catheter 200 is connected to a self-closing valve 300 on the balloon 100 . A degradable sheet 400 is coupled to the main body of the balloon 100 , and a cover sheet 500 is formed on the outer surface of the degradable sheet.

The structure and manufacturing method of the balloon system of this embodiment will be described in detail below with reference to the accompanying drawings. Referring to FIG. 2 , the balloon 100 includes an upper-layer balloon 110 and a lower-layer balloon 120 , wherein the upper-layer balloon 110 has at least one opening as a release channel 130 for the filling in the balloon. The self-closing valve 300 includes an upper layer self-closing valve 310 and a lower layer self-closing valve 320, wherein the lower layer self-closing valve 320 is provided with a conduit hole 311, and the circumference of the conduit hole 311 is not greater than the outer diameter of the conduit 200. The upper-layer self-closing valve 310 and the upper-layer balloon 110 may be integral, or may be connected together by different materials through bonding or welding. Likewise, the lower layer self-closing valve 320 and the lower layer balloon 120 may be integral, or may be connected together by means of bonding or welding of different materials.

The upper-layer balloon 110 and the upper-layer self-closing valve 310 are combined with the lower-layer balloon 120 and the lower-layer self-closing valve 320 by bonding or welding at the edges. The balloon 110 and the lower layer balloon 120 form the balloon 100 , the upper layer self-closing valve 310 and the lower layer self-closing valve 320 form the self-closing valve 300 , and the self-closing valve 300 enters the interior of the balloon 100 . The catheter 200 penetrates the self-closing valve 300 from outside the balloon, passes through the catheter hole 311 on the self-closing valve, and enters the balloon 100 for filling the balloon 100 with filler, as shown in FIG. 3 .

Referring to FIG. 4 , the degradable sheet 400 is circular, and a circle of discontinuous fixing holes 401 is opened near the outer edge. The size and shape of the fixing holes 401 are not limited. As shown in FIG. 5 , put glue on the shaded part around the release channel 130 of the upper layer balloon 110 , and cover the degradable sheet 400 with the fixing hole 401 on the glue around the release channel 130 . 401 overflows. Then, a ring-shaped cover sheet 500 as shown in FIG. 6 is added on the surface of the degradable sheet 400 , and the cover sheet 500 is bonded with the upper layer balloon 110 at the fixing hole 401 , as shown in FIG. 7 .

The upper layer balloon 110 and the lower layer balloon 120 are made of flexible materials such as silicone rubber or polyurethane. The material of the cover sheet 500 is the same as or similar to that of the upper layer balloon 110 and the lower layer balloon 120 , the cover sheet 500 and the upper layer balloon 110 are firmly bonded and can withstand long-term immersion in gastric acid.

The degradable sheet 400 can be a polylactic acid-based copolymer, preferably, the degradable material is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer, the film thickness is 10-300 microns, and is coupled to the upper layer The space between the balloon 110 and the cover sheet 500 is locked by the fixing hole 401 and is not easily separated from the upper-layer balloon 110 , and the adhesive tape around the fixing hole 401 plays a sealing role. In other approaches, the degradable material is polydioxanone.

The usage of the intragastric balloon according to the present application is as follows: after the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the gastric environment, and the filling is delivered into the balloon 100 through the extracorporeal end of the catheter 200 The filling can be liquid or gas. The balloon 100 changes from an initial compressed state to an expanded state. After filling, the catheter 200 is pulled out, and under the pressure of the filling in the balloon 100, the self-closing valve 300 automatically closes the liquid channel to block the leakage of the filling in the balloon. The balloon 100 occupies the volume in the stomach for a long time to achieve the purpose of weight loss. After being implanted into the human body for a period of time, the degradable sheet 400 is hydrolyzed and ruptured, the release channel 130 is opened, the structural integrity of the balloon is destroyed, the filling in the balloon is discharged into the patient's stomach, the volume of the balloon is reduced, and finally the volume of the balloon is reduced with the gastrointestinal tract. Peristalsis is naturally excluded from the body.

Referring to FIG. 8 , a schematic diagram of the closure and release structure of the in vivo implant according to another embodiment of the present application is shown. Preferably, the implant is a balloon system implanted in vivo, such as an intragastric balloon system. Those skilled in the art can easily think that the balloon system of the present application can be a balloon system for other purposes, such as a skin dilation balloon Wait. The implanted balloon system in vivo includes: a balloon 100, a catheter 200 and a filler (not shown in the figure). The balloon 100 is wrapped in a capsule before swallowing, and one end of the catheter 200 is connected to a self-closing valve 300 on the balloon 100 . A degradable sheet 410 is coupled to the main body of the balloon 100 , and a cover sheet 510 is formed on the outer surface of the degradable sheet.

The structure and manufacturing method of a balloon system according to another embodiment of the present application will be described in detail below with reference to the accompanying drawings. Referring to FIG. 9 , the balloon 100 includes an upper-layer balloon 110 and a lower-layer balloon 120 , wherein the upper-layer balloon 110 has at least one opening as a release channel 140 for the filling in the balloon. The self-closing valve 300 includes an upper layer self-closing valve 310 and a lower layer self-closing valve 320, wherein the lower layer self-closing valve 320 is provided with a conduit hole 311, and the circumference of the conduit hole 311 is not greater than the outer diameter of the conduit 200. The upper-layer self-closing valve 310 and the upper-layer balloon 110 may be integral, or may be connected together by different materials through bonding or welding. Likewise, the lower layer self-closing valve 320 and the lower layer balloon 120 may be integral, or may be connected together by means of bonding or welding of different materials.

The upper layer balloon 110 and the upper layer self-closing valve 310 are combined with the lower layer balloon 120 and the lower layer self-closing valve 320 by bonding or welding at the edge. The balloon 110 and the lower layer balloon 120 form the balloon 100 , the upper layer self-closing valve 310 and the lower layer self-closing valve 320 form the self-closing valve 300 , and the self-closing valve 300 enters the interior of the balloon 100 . The catheter 200 penetrates the self-closing valve 300 from outside the balloon, passes through the catheter hole 311 on the self-closing valve, and enters the balloon 100 for filling the balloon 100 with filler, as shown in FIG. 10 .

Referring to FIG. 11 , the degradable sheet 410 is square, and has two discontinuous fixing holes 411 near the outer edge. The size and shape of the fixing holes 411 are not limited. As shown in FIG. 12 , put glue on the shaded part around the release channel 140 of the upper layer balloon 110 , and cover the degradable sheet 410 with the fixing hole 411 on the glue around the release channel 140 . 411 overflows. Then, a square cover sheet 510 as shown in FIG. 13 is added to the surface of the degradable sheet 410 , and the cover sheet 510 is bonded to the upper layer balloon 110 at the fixing hole 411 , as shown in FIG. 14 .

The upper layer balloon 110 and the lower layer balloon 120 are made of flexible materials such as silicone rubber or polyurethane. The material of the cover sheet 510 is the same as or similar to that of the upper layer balloon 110 and the lower layer balloon 120 , the cover sheet 510 and the upper layer balloon 110 are firmly bonded and can withstand long-term immersion in gastric acid.

The degradable sheet 410 can be a polylactic acid-based copolymer, preferably, the degradable material is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer, the film thickness is 10-300 microns, and is coupled to the upper layer The space between the balloon 110 and the cover sheet 510 is locked by the fixing hole 411 and is not easily separated from the upper-layer balloon 110 , and the adhesive tape around the fixing hole 411 plays a sealing role. In other approaches, the degradable material is polydioxanone.

The degradable sheet 410 may also be oval or any other shape. The fixing holes 411 on the degradable sheet 410 may be two or more rounds. The usage of the intragastric balloon according to the present application is as follows: after the patient swallows the capsule containing the balloon 100 and part of the catheter 200, the capsule dissolves rapidly in the gastric environment, and the filling is delivered into the balloon 100 through the extracorporeal end of the catheter 200 The filling can be liquid or gas. The balloon 100 changes from an initial compressed state to an expanded state. After filling, the catheter 200 is pulled out, and under the pressure of the filling in the balloon 100, the self-closing valve 300 automatically closes the liquid channel to block the leakage of the filling in the balloon. The balloon 100 occupies the volume in the stomach for a long time to achieve the purpose of weight loss. After being implanted into the human body for a period of time, the degradable sheet 410 is hydrolyzed and ruptured, the release channel 140 is opened, the structural integrity of the balloon is destroyed, the filling in the balloon is discharged into the patient's stomach, the volume of the balloon is reduced, and finally the volume of the balloon is reduced with the gastrointestinal tract. Peristalsis is naturally excluded from the body.

Claims

An in-vivo implant sealing and releasing structure, the in-vivo implant includes a balloon, a catheter and a filler, and a degradable sheet is coupled to the balloon, characterized in that: the degradable sheet and the main body of the balloon are The coupling part of the device is provided with discontinuous fixing holes, and there is a cover sheet outside the degradable sheet, the balloon body is connected with the cover sheet through the fixing hole, and the degradable sheet is fixed between the two.
The closing and releasing structure of claim 1, wherein one end of the catheter is connected to a self-closing valve on the balloon.
The closure and release structure according to claim 1, wherein the balloon comprises an upper layer balloon and a lower layer balloon, wherein the upper layer balloon has at least one opening as a release channel for the filler in the balloon.
The closing and releasing structure according to claim 1, wherein the self-closing valve comprises an upper self-closing valve and a lower self-closing valve, wherein the lower self-closing valve is provided with a conduit hole, and the circumference of the conduit hole is not larger than the outer diameter of the conduit.
The closing and releasing structure according to claim 1, wherein the upper layer self-closing valve and the upper layer balloon are integral, or are connected together by different materials by means of bonding or welding.
The closing and releasing structure according to claim 1, wherein the lower layer self-closing valve and the lower layer balloon are integral, or are connected together by different materials through bonding or welding.
The sealing and releasing structure according to claim 1, wherein the upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve by bonding or welding at the edges. together.
The closure and release structure according to claim 1, wherein the degradable sheet is circular, oval, square or other shapes, and a circle of discontinuous fixing holes is opened near the outer edge.
The closure and release structure according to claim 1, wherein the upper layer balloon and the lower layer balloon are made of flexible materials such as silicone rubber or polyurethane.
The closing and releasing structure according to claim 3, wherein the material of the cover sheet is the same as or similar to that of the upper layer balloon and the lower layer balloon.
The closure and release structure of claim 1, wherein the degradable sheet is a polylactic acid based copolymer.
The closure and release structure of claim 1, wherein the degradable sheet is polydioxanone.
The closure and release structure according to claim 11, wherein the degradable sheet is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
The closure and release structure according to claim 1, wherein the film thickness of the degradable sheet is 10-300 microns.
The closure and release structure according to claim 3, wherein the degradable sheet is coupled between the upper layer balloon and the cover sheet, and is locked by the fixing hole.
The closing and releasing structure according to claim 1, wherein the fixing hole on the degradable sheet is one or more circles.
A method of making the closure and release structure of claims 1-16, wherein one end of the catheter is connected to a self-closing valve on the balloon, the balloon comprising an upper layer balloon and a lower layer Balloon, wherein there is at least one opening on the upper layer of the balloon as a release channel for the filling in the balloon, and the self-closing valve includes an upper layer self-closing valve and a lower layer self-closing valve, wherein the lower layer self-closing valve is provided with a catheter hole. The circumference of the catheter hole is not greater than the outer diameter of the catheter, and the upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve by bonding or welding at the edge. At the same time, after the combination is completed, it is turned over through the release channel on the upper-layer balloon, the upper-layer balloon and the lower-layer balloon form the balloon, and the upper-layer self-closing valve and the lower-layer self-closing valve form the The self-closing valve enters the interior of the balloon.
The method according to claim 17, wherein the catheter penetrates the self-sealing valve from outside the balloon, passes through a catheter hole on the self-closing valve, and enters the balloon, Used to fill the balloon with filler.
The method according to claim 18, wherein: glue is applied around the release channel of the upper layer balloon, and the degradable sheet with the fixing hole is covered around the release channel. On the glue, the glue overflows from the fixing hole of the degradable sheet.
The method according to claim 19, wherein the cover sheet is applied on the surface of the degradable sheet, and the cover sheet is bonded to the upper layer balloon at the fixing hole.
16. A closure and release structure according to claims 1-16, wherein the implant is an in vivo implantation balloon system.
The closure and release structure of claim 21, wherein the balloon system is an intragastric balloon system.
The closure and release structure of claim 21, wherein the balloon system is a skin dilation balloon system.