A sealing and releasing structure for an in vivo implant

Abstract

The present application provides an in vivo implantable balloon system, specifically, it relates to a closure and release structure of an in vivo implantable balloon system. The in vivo implant includes a balloon, a catheter and a filler, a degradable sheet is coupled to the balloon, a non-continuous fixing hole is opened at the coupling portion between the degradable sheet and the balloon body, a cover sheet is arranged outside the degradable sheet, the balloon body is connected to the cover sheet through the fixing hole, and the degradable sheet is fixed between the two. In the in vivo implant closure and release structure of the present application, the cover sheet and the balloon body are made of the same type of material, and are connected together at the fixing hole position by bonding or welding, and the connection strength of the same material is relatively high. The degradable sheet is located between the balloon body and the cover sheet, and is fixed by the fixing hole. This structure can avoid premature separation between the degradable sheet and the balloon body under the gastric acid environment in the body.

Description

Technical Field

[0001] The present application relates to an in vivo implantable balloon system, in particular to a sealing and releasing structure of the in vivo implantable balloon system. Background Art

[0002] Over the past 20 years, the incidence of obesity has soared worldwide, including adult obesity, obesity in the elderly, and obesity in adolescents and children. According to statistics from the World Health Organization, in 2014, 15% of adult women and 11% of adult men were obese worldwide, which means that in 2014, there were nearly one billion obese adults in the world. What is not optimistic is that China's obese population has surpassed the United States. In 2016, there were 89.6 million obese people in China (the obese population in the United States was 87.8 million), of which 43.2 million were males and 46.4 million were females. Obesity is often 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 great concern.

[0003] At present, the main treatments for obesity include: diet control, lifestyle intervention, drug therapy and surgical treatment. However, simple diet control, lifestyle intervention and drug therapy are difficult to achieve satisfactory weight loss results; although weight loss surgery is effective, it is difficult for patients to accept it due to cultural, medical level and surgical complications. Implantable medical devices for weight loss, which simulate the mechanism of surgical treatment of obesity, including intragastric balloons, have just emerged in recent years. Because they are safe, simple, effective and reversible, they have received widespread attention and will become the main effective means of weight loss in the future.

[0004] At present, several types of intragastric balloons have been launched abroad, especially those that can be swallowed by oneself without gastroscopy, which is the direction of future weight loss methods. Such balloons are often coupled with degradable materials as a sealing and release channel for the filling inside the balloon. After the balloon is swallowed into the human stomach, it is filled with fillings to form an expanded state. The degradable material of the expanded balloon maintains structural integrity in the body for a certain period of time, serving as a barrier to the filling inside the balloon to prevent the filling from leaking out. After this structural integrity is maintained for a period of time, the degradable material ruptures, the filling inside the balloon is released through the rupture, and the empty balloon shell is discharged from the body through the natural cavity under the peristalsis of the gastrointestinal tract. The advantage of this design is that the swallowing and discharge of the balloon are both through the natural cavity of the human body, without the help of gastroscopy and anesthesia, etc., which is patient-friendly. The disadvantage is that the degradable material and the main material of the balloon are generally made of different types of materials. Conventional bonding or welding methods are difficult to ensure the durability of the coupling strength between the two in the gastric acid environment. Once the degradable material and the main material of the balloon are separated prematurely, the expected effect of weight loss cannot be achieved. Summary of the invention

[0005] The present application provides a sealing and releasing structure of an in vivo implant, so that the degradable material and the balloon main body material can be coupled together for a long time and are not easy to separate.

[0006] The present application provides an in vivo implant sealing and releasing structure, wherein the in vivo implant comprises a balloon, a catheter and a filler, wherein a degradable sheet is coupled to the balloon, and wherein a non-continuous fixing hole is provided at the coupling portion between the degradable sheet and the balloon body, and a cover sheet is provided outside the degradable sheet, and the balloon body is connected to the cover sheet at the fixing hole to fix the degradable sheet between the two.

[0007] Preferably, one end of the catheter is connected to a self-sealing valve on the balloon.

[0008] Preferably, the balloon comprises an upper balloon and a lower balloon, wherein the upper balloon has at least one opening as a release channel for a filler in the balloon.

[0009] Preferably, the self-sealing valve comprises an upper self-sealing valve and a lower self-sealing valve, wherein a catheter hole is opened on the lower self-sealing valve, and the circumference of the catheter hole is not greater than the outer diameter of the catheter.

[0010] Preferably, the upper self-sealing valve and the upper balloon are an integral whole, or are made of different materials connected together by bonding or welding.

[0011] Preferably, the lower layer self-sealing valve and the lower layer balloon are an integral whole, or are made of different materials connected together by bonding or welding.

[0012] Preferably, the upper layer balloon and the upper layer self-sealing valve are combined with the lower layer balloon and the lower layer self-sealing valve at the edges by bonding or welding.

[0013] Preferably, the degradable sheet is circular, oval, square or other shapes, and has a circle of discontinuous fixing holes near the outer edge.

[0014] Preferably, the upper balloon and the lower balloon are made of flexible materials such as silicone rubber or polyurethane.

[0015] Preferably, the material of the cover sheet is the same as or similar to that of the upper balloon and the lower balloon.

[0016] Preferably, the degradable sheet is a polylactic acid-based copolymer.

[0017] Preferably, the degradable sheet is polydioxanone.

[0018] Preferably, the degradable sheet is polylactic acid-caprolactone copolymer or polylactic acid-trimethylene carbonate copolymer.

[0019] Preferably, the thickness of the degradable film is 10-300 microns.

[0020] Preferably, the degradable sheet is coupled between the upper balloon and the cover sheet and is locked by the fixing hole.

[0021] Preferably, the fixing holes on the degradable sheet are one circle or more than two circles.

[0022] The present application provides a method for manufacturing a closing and releasing structure, characterized in that: one end of the catheter is connected to the self-closing valve on the balloon, the balloon comprises an upper balloon and a lower balloon, wherein the upper balloon has at least one opening as a release channel for the filling in the balloon, the self-closing valve comprises an upper self-closing valve and a lower self-closing valve, wherein the lower self-closing valve has a catheter hole, the circumference of the catheter hole is not greater than the outer diameter of the catheter, the upper balloon and the upper self-closing valve are combined with the lower balloon and the lower self-closing valve at the edge by bonding or welding, and after the combination is completed, the upper balloon and the lower balloon are turned over through the release channel on the upper balloon to form the balloon, the upper self-closing valve and the lower self-closing valve form the self-closing valve, and the self-closing valve enters the interior of the balloon.

[0023] Preferably, the catheter penetrates the self-closing valve from outside the balloon, passes out from the catheter hole on the self-closing valve, and enters the balloon, so as to fill the balloon with a filler.

[0024] Preferably, glue is applied around the release channel of the upper balloon, and the degradable sheet with the fixing holes is covered on the glue around the release channel, and the glue overflows from the fixing holes of the degradable sheet.

[0025] Preferably, the cover sheet is added to the surface of the degradable sheet, and the cover sheet is bonded to the upper balloon at the fixing hole.

[0026] In the in vivo implant sealing and releasing structure of the present application, the cover sheet and the balloon body are made of the same material and are connected together at the fixing hole by bonding or welding. The connection strength of the same material is high. The degradable sheet is located between the balloon body and the cover sheet and is fixed by the fixing hole. This structure can avoid premature separation between the degradable sheet and the balloon body in the gastric acid environment in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A schematic diagram of a sealing and releasing structure of an in vivo implant according to one embodiment of the present application;

[0028] Figure 2 The structure and manufacturing method of a balloon system according to one embodiment of the present application;

[0029] Figure 3 The structure and manufacturing method of a balloon system according to one embodiment of the present application;

[0030] Figure 4 is a schematic diagram of a degradable sheet according to one embodiment of the present application;

[0031] Figure 5 The structure and manufacturing method of a balloon system according to one embodiment of the present application;

[0032] Figure 6 is a schematic diagram of an annular cover sheet according to one embodiment of the present application;

[0033] Figure 7 The structure and manufacturing method of a balloon system according to one embodiment of the present application;

[0034] Figure 8 A schematic diagram of a sealing and releasing structure of an in vivo implant according to another embodiment of the present application;

[0035] Fig. 9 The structure and manufacturing method of the balloon system according to another embodiment of the present application;

[0036] Fig.10 The structure and manufacturing method of the balloon system according to another embodiment of the present application;

[0037] Fig.11 is a schematic diagram of a degradable sheet according to another embodiment of the present application;

[0038] Fig.12 The structure and manufacturing method of the balloon system according to another embodiment of the present application;

[0039] Fig.13 is a schematic diagram of a square cover sheet according to another embodiment of the present application;

[0040] Fig.14 The present invention provides a structure and manufacturing method of a balloon system according to another embodiment of the present application. DETAILED DESCRIPTION

[0041] See attached Figure 1, showing a schematic diagram of the sealing and releasing structure of an in vivo implant according to an embodiment of the present application. Preferably, the implant is an in vivo implantable balloon system, such as an intragastric balloon system. Those skilled in the art can easily imagine that the balloon system of the present application can be a balloon system for other purposes, such as a skin expansion balloon, etc. The in vivo implantable balloon system 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 the self-sealing 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 provided on the outer surface of the degradable sheet.

[0042] The structure and manufacturing method of the balloon system of this embodiment will be described in detail below with reference to the accompanying drawings. Figure 2 The balloon 100 includes an upper balloon 110 and a lower balloon 120, wherein the upper balloon 110 has at least one opening as a release channel 130 for the filling in the balloon. The self-sealing valve 300 includes an upper self-sealing valve 310 and a lower self-sealing valve 320, wherein the lower self-sealing valve 320 has a catheter hole 311, and the circumference of the catheter hole 311 is not greater than the outer diameter of the catheter 200. The upper self-sealing valve 310 and the upper balloon 110 can be a whole, or they can be connected together by bonding or welding with different materials. Similarly, the lower self-sealing valve 320 and the lower balloon 120 can be a whole, or they can be connected together by bonding or welding with different materials.

[0043] The upper balloon 110 and the upper self-sealing valve 310 are combined with the lower balloon 120 and the lower self-sealing valve 320 at the edges by bonding or welding. After the combination is completed, the upper balloon 110 and the lower balloon 120 are turned over through the release channel 130 on the upper balloon 110, and the upper self-sealing valve 310 and the lower self-sealing valve 320 form a self-sealing valve 300, and the self-sealing valve 300 enters the interior of the balloon 100. The catheter 200 penetrates the self-sealing valve 300 from the outside of the balloon, passes out from the catheter hole 311 on the self-sealing valve, and enters the balloon 100, so as to fill the balloon 100 with a filler. Figure 3 .

[0044] See also Figure 4 The degradable sheet 400 is circular, and has a circle of discontinuous fixing holes 401 near the outer edge. The size and shape of the fixing holes 401 are not limited. Figure 5 , glue is applied to the shadowed part around the release channel 130 of the upper balloon 110, and the degradable sheet 400 with the fixing hole 401 is covered on the glue around the release channel 130, and the glue overflows from the fixing hole 401 of the degradable sheet 400. Then, the surface of the degradable sheet 400 is coated with the following Figure 6The annular cover sheet 500 shown in FIG. 4 is bonded to the upper balloon 110 at the fixing hole 401. Figure 7 .

[0045] 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 or similar to that of the upper layer balloon 110 and the lower layer balloon 120. The cover sheet 500 is firmly bonded to the upper layer balloon 110 and can withstand long-term immersion in gastric acid.

[0046] The degradable sheet 400 may 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. It is coupled between the upper balloon 110 and the cover sheet 500 and locked by the fixing hole 401. It is not easy to separate from the upper balloon 110. The glue tape around the fixing hole 401 plays a sealing role. In other embodiments, the degradable material is polydioxanone.

[0047] The use 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 quickly dissolves in the intragastric environment, and the filler is transported into the balloon 100 through the extracorporeal end of the catheter 200. The filler can be a liquid or a 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 filler inside the balloon 100, the self-sealing valve 300 automatically closes the liquid channel to prevent the leakage of the filler inside the balloon. The balloon 100 occupies the intragastric volume for a long time to achieve the purpose of weight loss. After being implanted in 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 filler inside the balloon is discharged into the patient's stomach, the volume of the balloon is reduced, and finally it is naturally excreted from the body with gastrointestinal peristalsis.

[0048] See attached Figure 8 , showing a schematic diagram of the sealing and releasing structure of an in vivo implant according to another embodiment of the present application. Preferably, the implant is an in vivo implantable balloon system, such as an intragastric balloon system. Those skilled in the art can easily imagine that the balloon system of the present application can be a balloon system for other purposes, such as a skin expansion balloon, etc. The in vivo implantable balloon system 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 the self-sealing 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 provided on the outer surface of the degradable sheet.

[0049] The structure and manufacturing method of the balloon system according to another embodiment of the present application are described in detail below with reference to the accompanying drawings. Fig. 9The balloon 100 includes an upper balloon 110 and a lower balloon 120, wherein the upper balloon 110 has at least one opening as a release channel 140 for the filling material in the balloon. The self-sealing valve 300 includes an upper self-sealing valve 310 and a lower self-sealing valve 320, wherein the lower self-sealing valve 320 has a catheter hole 311, and the circumference of the catheter hole 311 is not greater than the outer diameter of the catheter 200. The upper self-sealing valve 310 and the upper balloon 110 can be an integral body, or they can be connected together by bonding or welding with different materials. Similarly, the lower self-sealing valve 320 and the lower balloon 120 can be an integral body, or they can be connected together by bonding or welding with different materials.

[0050] The upper balloon 110 and the upper self-sealing valve 310 are combined with the lower balloon 120 and the lower self-sealing valve 320 at the edges by bonding or welding. After the combination is completed, the upper balloon 110 and the lower balloon 120 are turned over through the release channel 140 on the upper balloon 110, and the upper self-sealing valve 310 and the lower self-sealing valve 320 form a self-sealing valve 300, and the self-sealing valve 300 enters the interior of the balloon 100. The catheter 200 penetrates the self-sealing valve 300 from the outside of the balloon, passes out from the catheter hole 311 on the self-sealing valve, and enters the balloon 100, so as to fill the balloon 100 with a filler. Fig.10 .

[0051] See also Fig.11 The degradable sheet 410 is square, and has two circles of discontinuous fixing holes 411 near the outer edge. The size and shape of the fixing holes 411 are not limited. Fig.12 , glue is applied to the shadowed part around the release channel 140 of the upper balloon 110, and the degradable sheet 410 with the fixing holes 411 is covered on the glue around the release channel 140, and the glue overflows from the fixing holes 411 of the degradable sheet 410. Then, the surface of the degradable sheet 410 is coated with the following Fig.13 The square cover sheet 510 shown in the figure is bonded to the upper balloon 110 at the fixing hole 411. Fig.14 .

[0052] 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 is firmly bonded to the upper layer balloon 110 and can withstand long-term immersion in gastric acid.

[0053] 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. It is coupled between the upper balloon 110 and the cover sheet 510, locked by the fixing hole 411, and is not easily separated from the upper balloon 110. The glue tape around the fixing hole 411 plays a sealing role. In other embodiments, the degradable material is polydioxanone.

[0054] The degradable sheet 410 can also be an ellipse or other arbitrary shapes. The fixing holes 411 on the degradable sheet 410 can be two circles or more. The use 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 quickly dissolves in the intragastric environment, and the filler is transported into the balloon 100 through the external end of the catheter 200. The filler can be liquid or gas. The balloon 100 changes from the initial compressed state to the expanded state. After the filling is completed, the catheter 200 is pulled out. Under the pressure of the filler inside the balloon 100, the self-sealing valve 300 automatically closes the liquid channel to prevent the leakage of the filler inside 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 in 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 filler in the balloon is discharged into the patient's stomach, the volume of the balloon is reduced, and finally it is naturally discharged from the body with gastrointestinal peristalsis.

Claims

1. An in vivo implant sealing and releasing structure, the in vivo implant comprising a balloon, a catheter and a filler, the balloon being coupled with a degradable sheet, characterized in that: A non-continuous fixing hole is provided at the coupling portion between the degradable sheet and the balloon body, and a cover sheet is provided outside the degradable sheet. The balloon body is connected to the cover sheet through the fixing hole to fix the degradable sheet between the two. 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 filling in the balloon. The material of the cover sheet is the same as or similar to that of the upper layer balloon and the lower layer balloon.

2. The closing and releasing structure according to claim 1, characterized in that: One end of the catheter is connected to a self-sealing valve on the balloon.

3. The closing and releasing structure according to claim 2, characterized in that: The self-sealing valve comprises an upper self-sealing valve and a lower self-sealing valve, wherein the lower self-sealing valve is provided with a catheter hole, and the circumference of the catheter hole is not greater than the outer diameter of the catheter.

4. The closing and releasing structure according to claim 3, characterized in that: The upper self-sealing valve and the upper balloon are an integral whole, or are made of different materials connected together by bonding or welding.

5. The closing and releasing structure according to claim 3, characterized in that: The lower layer self-sealing valve and the lower layer balloon are an integral whole, or are made of different materials connected together by bonding or welding.

6. The closing and releasing structure according to claim 3, characterized in that: The upper layer balloon and the upper layer self-sealing valve are combined with the lower layer balloon and the lower layer self-sealing valve at the edges by bonding or welding.

7. The closing and releasing structure according to claim 1, characterized in that: The degradable sheet is in a circular, oval, square or other shape, and has a circle of discontinuous fixing holes near the outer edge.

8. The closing and releasing structure according to claim 1, characterized in that: The upper balloon and the lower balloon are made of silicone rubber or polyurethane.

9. The closing and releasing structure according to claim 1, characterized in that: The degradable sheet is a polylactic acid-based copolymer.

10. The closing and releasing structure according to claim 1, characterized in that: The degradable sheet is polydioxanone.

11. The closing and releasing structure according to claim 9, characterized in that: The degradable sheet is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.

12. The closing and releasing structure according to claim 1, characterized in that: The thickness of the degradable film is 10-300 microns.

13. The closing and releasing structure according to claim 1, characterized in that: The degradable sheet is coupled between the upper balloon and the cover sheet and is locked by the fixing hole.

14. The closing and releasing structure according to claim 1, characterized in that: The fixing holes on the degradable sheet are one circle or more than two circles.

15. A sealing and releasing structure according to any one of claims 1 to 14, characterized in that: The implant is an in vivo implantable balloon system.

16. The closing and releasing structure according to claim 15, characterized in that: The balloon system is an intragastric balloon system.

17. The closing and releasing structure according to claim 15, characterized in that: The balloon system is a skin expansion balloon system.

18. A method for manufacturing a sealing and releasing structure as claimed in any one of claims 1 to 14, characterized in that: One end of the catheter is connected to the self-sealing valve on the balloon, the balloon comprises an upper balloon and a lower balloon, wherein the upper balloon has at least one opening as a release channel for the filling in the balloon, the self-sealing valve comprises an upper self-sealing valve and a lower self-sealing valve, wherein the lower self-sealing valve has a catheter hole, the circumference of the catheter hole is not greater than the outer diameter of the catheter, the upper balloon and the upper self-sealing valve are combined with the lower balloon and the lower self-sealing valve at the edge by bonding or welding, and after the combination is completed, the catheter hole is released through the upper balloon. The release channel of the upper balloon is flipped, the upper balloon and the lower balloon form the balloon, the upper self-closing valve and the lower self-closing valve form the self-closing valve, and the self-closing valve enters the interior of the balloon; glue is applied around the release channel of the upper balloon, and the degradable sheet with the fixing hole is covered on the glue around the release channel, and the glue overflows from the fixing hole of the degradable sheet; the cover sheet is added to the surface of the degradable sheet, and the cover sheet is bonded to the upper balloon at the fixing hole.

19. The method according to claim 18, characterized in that: The catheter penetrates the self-sealing valve from outside the balloon, passes out from the catheter hole on the self-sealing valve, and enters the balloon, so as to fill the balloon with a filler.

Images