Degradable self-sealing valve and method of making same, intragastrically implantable balloon and method of making same

Abstract

The present application relates to the technical field of medical materials, and provides a degradable self-sealing valve, a preparation method thereof, and a gastric implant balloon and a preparation method thereof.The degradable self-sealing valve comprises two pieces of degradable film that are attached and connected, a liquid inlet channel is formed between the two pieces of degradable film, the liquid inlet channel has opposite liquid inlet ends and liquid outlet ends, and the width of the liquid inlet end is greater than that of the liquid outlet end.The preparation method of the degradable self-sealing valve comprises the following steps: attaching two pieces of degradable film and connecting them.The gastric implant balloon comprises a resin balloon body and a degradable self-sealing valve, the resin balloon body has a liquid inlet opening, the opening width of the liquid inlet opening is the same as the width of the liquid inlet end, and the liquid inlet opening is in communication with the liquid inlet end.The design of the larger width of the liquid inlet end of the liquid inlet channel facilitates the faster discharge of liquid in the resin balloon body after the self-sealing valve degrades, and the design of the smaller width of the liquid outlet end more effectively prevents the reverse leakage of liquid in the balloon and is more conducive to sealing.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical materials, in particular to a degradable self-sealing valve and a preparation method thereof, and an intragastric implant balloon and a preparation method thereof. BACKGROUND

[0002] Intragastric balloon (IGB) is the most widely used non-invasive weight loss method in the United States for patients with class I and class II obesity. By placing a space-occupying balloon in the stomach for 4-12 months, the stomach volume is reduced, the satiety is enhanced, and the food intake is reduced, thereby reducing the body weight. During the placement of IGB, (1) the initial ideal weight loss can be achieved, increasing the patient's confidence in weight loss and the motivation to continue losing weight. (2) The long-term occupation of the stomach cavity by IGB can change the patient's eating habits, limit the patient's food intake and eating frequency, and reshape the patient's eating habits.

[0003] At present, a swallowable intragastric balloon system has been marketed abroad, which does not need endoscopic operation for placement and removal. The balloon is folded into a swallowable capsule, a one-way self-sealing valve is designed in the balloon, and the balloon is connected with a catheter; after entering the stomach, the capsule disintegrates, and the balloon can be injected with a proper volume of liquid through the catheter in vitro; then, the catheter is pulled out, the one-way self-sealing valve is automatically closed, and the balloon is sealed. After placing the balloon in the stomach for a proper time, the degradation material on the surface of the balloon or inside the balloon degrades and breaks, the balloon seal is damaged, the liquid in the balloon is discharged, and the balloon is naturally discharged out of the body through the gastrointestinal tract. Since the entire treatment process does not need endoscopic operation, this swallowable intragastric balloon system has great development prospects in the field of weight loss.

[0004] The self-sealing valve plays an important role in the balloon. If the liquid injection channel and the discharge channel of the balloon are consistent and located on the degradable self-sealing valve, the size of the channel directly affects the sealing of the balloon and the discharge rate of the liquid in the balloon. If the channel is too large, the sealing of the balloon is poor; if the channel is too small, after the degradable material degrades, the discharge rate of the liquid in the balloon is slow, which may cause displacement of the balloon and cause the risk of intestinal obstruction. In addition, the length of the valve also affects the sealing of the balloon. If the length is too short, the sealing effect is not achieved; if the length is too long, the volume is large after folding, which is not conducive to being loaded into the capsule.

[0005] In view of this, the present application is proposed. SUMMARY

[0006] The present application relates to the field of medical materials, in particular to a degradable self-sealing valve and a preparation method thereof, and an intragastric implant balloon and a preparation method thereof.

[0007] Embodiments of the present application can be implemented as follows:

[0008] In a first aspect, the present application provides a degradable self-sealing valve, comprising two pieces of degradable film which are attached and connected, and a liquid inlet channel is formed between the two pieces of degradable film, the liquid inlet channel has opposite liquid inlet end and liquid outlet end, the width of the liquid inlet end is greater than the width of the liquid outlet end.

[0009] In an optional embodiment, the two pieces of degradable film have the same shape and size, the width of one end of each piece of degradable film in the length direction is greater than the width of the other end, and the two pieces of degradable film are connected in the following manner: the opposite long edge of one piece of degradable film is connected with the opposite long edge of the other piece of degradable film.

[0010] In an optional embodiment, the width of the liquid inlet end is 2.5-5 cm, and the width of the liquid outlet end is 0.5-3 mm.

[0011] In an optional embodiment, the length of the degradable film is 1.5-5 cm.

[0012] Preferably, the length of the liquid inlet end is 1.0-1.5 cm.

[0013] In an optional embodiment, the two pieces of degradable film are connected by adhesion or laser welding.

[0014] Preferably, the thickness of the degradable film is 0.05-0.1 mm.

[0015] In an optional embodiment, the degradable film is made of at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-co-glycolide, polylactide-co-caprolactone, polylactide-trimethylene carbonate, polyglycolide-trimethylene carbonate, polyglycolide-co-caprolactone and poly-p-dioxanone.

[0016] In a second aspect, the present application provides a preparation method of the degradable self-sealing valve according to any one of the preceding embodiments, comprising:

[0017] Attaching the two pieces of degradable film and connecting them.

[0018] In an optional embodiment, the preparation method further comprises preparing the degradable film before connecting the two pieces of degradable film.

[0019] Coating the solution containing the degradable material on a plate-shaped mold, volatilizing the solvent, and demolding to obtain the degradable film material.

[0020] Preferably, the mass concentration of the degradable material in the degradable material solution is 10%-20%.

[0021] Preferably, the solvent in the degradable material solution is at least one of tetrahydrofuran, dichloromethane and trichloromethane.

[0022] In a third aspect, the present invention provides an intragastric implant balloon, comprising a resin balloon body and a degradable self-sealing valve such as any one of the aforementioned embodiments or a degradable self-sealing valve prepared by the preparation method of the aforementioned embodiment, arranged in the resin balloon body, the resin balloon body having a liquid inlet, the opening width of the liquid inlet being the same as the width of the liquid inlet end, and the liquid inlet being connected to the liquid inlet end.

[0023] In a fourth aspect, the present invention provides a method for preparing the intragastric implantable balloon according to the aforementioned embodiment, comprising:

[0024] Connecting the two resin hemi-balloons and the degradable self-sealing valve to form a resin balloon body;

[0025] Preferably, the connection method is bonding or laser welding.

[0026] The beneficial effects of the embodiments of the present invention include, for example:

[0027] Since the liquid inlet of the resin balloon body and the liquid inlet end of the liquid inlet channel have the same width, the larger width design of the liquid inlet end of the liquid inlet channel facilitates faster discharge of the liquid in the resin balloon body after the self-sealing valve degrades, while the smaller width design of the liquid outlet end is more effective in preventing the liquid in the balloon from leaking back, which is more conducive to sealing. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 A schematic structural diagram of a degradable self-sealing valve provided in an embodiment of the present application;

[0030] Figure 2 This is a schematic diagram of an intragastric balloon implanted in an embodiment of the present application after a catheter is inserted;

[0031] Figure 3 for Figure 2 Schematic diagram of the structure of the intragastric implanted balloon after cutting along the midline;

[0032] Figure 4 for Figure 3 Schematic diagram of the structures in the view after the catheter is removed.

[0033] Icon: 100 - degradable self-sealing valve; 101 - liquid inlet channel; 102 - liquid inlet end; 103 - liquid outlet end; 110 - degradable film; 111 - connecting edge; 10 - gastric implant balloon; 11 - resin balloon body; 12 - catheter; 13 - liquid inlet. DETAILED DESCRIPTION

[0034] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings can be arranged and designed in various different configurations.

[0035] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0036] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0037] In the description of the present application, it should be noted that if the terms "upper", "lower", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present application is usually placed, which is only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0038] In addition, if the terms "first", "second" and the like appear, they are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0039] It should be noted that the features in the embodiments of the present application can be combined with each other without conflict.

[0040] Please refer to Figures 1-4 The embodiments of the present application provide a degradable self-sealing valve 100, which includes two pieces of degradable film 110 that are attached and connected, and a liquid inlet channel 101 is formed between the two pieces of degradable film 110 that are connected, the liquid inlet channel 101 has a liquid inlet end 102 and a liquid outlet end 103 that are opposite in position, and the width of the liquid inlet end 102 is greater than the width of the liquid outlet end 103.

[0041] The embodiment of the present application also provides a gastric implant balloon 10, which comprises the degradable self-sealing valve 100 provided by the embodiment of the present application, and the resin balloon body 11 has a liquid inlet 13, the opening width of the liquid inlet 13 is the same as the width of the liquid inlet end 102, and the liquid inlet 13 is in communication with the liquid inlet end 102.

[0042] The degradable self-sealing valve 100 provided by the embodiment of the present application will gradually degrade over time, is arranged in the resin balloon body 11, and is implanted into the stomach of a human body. By injecting normal saline into the resin balloon through the catheter 12 inserted into the liquid inlet channel 101, the resin balloon body 11 is inflated, occupies a certain space in the stomach of the human body, and indirectly reduces the stomach capacity to assist in weight loss. Since the liquid inlet 13 of the resin balloon body 11 has the same width as the liquid inlet end 102 of the liquid inlet channel 101, the design of the larger width of the liquid inlet end 102 of the liquid inlet channel 101 facilitates the faster discharge of the liquid in the resin balloon body 11 after the degradation of the self-sealing valve, and the design of the smaller width of the liquid outlet end 103 more effectively prevents the liquid in the balloon from leaking in the reverse direction, and is more helpful for sealing.

[0043] Further, the two pieces of degradable film 110 have the same shape and size, the width of one end of each piece of degradable film 110 in the length direction is greater than the width of the other end, and the two pieces of degradable film 110 are connected in the following manner: the opposite two long edge edges of one piece of degradable film 110 are connected with the opposite two long edge edges of the other piece of degradable film 110. As shown in Figure 1 , the edge shadow part of the degradable self-sealing valve 100 in Figure 1 is the connecting edge 111 of the two pieces of degradable film 110.

[0044] Preferably, the two pieces of degradable film 110 are connected in the manner of adhesion or laser welding.

[0045] The liquid inlet channel 101 is actually the gap between the two pieces of degradable film 110, and the shape design of the above degradable film 110 can realize the condition that one end of the liquid inlet channel 101 is large and the other end is small, and the material of the degradable film 110 is less used.

[0046] Preferably, in order to realize the fast discharge of the liquid after the degradation of the degradable self-sealing valve 100, the width of the liquid inlet end 102 is 2.5-3 cm, and in order to realize the good sealing effect, the width of the liquid outlet end 103 is 1.5-2.5 mm.

[0047] Further, the length of the liquid inlet end 102 is 1.0-1.5 cm.

[0048] Preferably, to achieve stable degradation of the degradable film 110, the degradable film 110 is made of at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-co-glycolide, polylactide-co-caprolactone, polylactide-trimethylene carbonate, polyglycolide-trimethylene carbonate, polyglycolide-co-caprolactone and poly-p-dioxanone.

[0049] The preparation method of the degradable self-sealing valve 100 provided by the embodiments of the present application comprises:

[0050] The two pieces of degradable film 110 are attached and connected.

[0051] Specifically, the preparation method comprises:

[0052] S1, preparing the degradable film 110:

[0053] The solution containing the degradable material is coated on the plate-shaped mold, the solvent is volatilized, and the degradable film 110 material is obtained by demolding.

[0054] Preferably, the volatilization of the solvent is performed at room temperature for about 20 hours.

[0055] Preferably, to obtain the degradable film 110 with sufficient strength and good softness, the mass concentration of the degradable material in the degradable material solution is 10% to 20%.

[0056] Further, the solvent in the degradable material solution is at least one of tetrahydrofuran, dichloromethane and trichloromethane.

[0057] S2, the two pieces of degradable film 110 are attached and the long edges of the two pieces of degradable film 110 are connected by adhesion or laser welding.

[0058] The preparation method of the gastric implant balloon 10 provided by the embodiments of the present application comprises:

[0059] The two resin half balloons and the degradable self-sealing valve 100 are connected, and the two resin half balloons are connected to form the resin balloon body 11.

[0060] Preferably, the connection mode is adhesion or laser welding.

[0061] The gastric implant balloon 10 provided by the present application is implanted into the stomach of the human body in the following way: one end of the catheter 12 made of the same material as the resin balloon is inserted into the degradable self-sealing valve 100 and temporarily fixed with the degradable self-sealing valve 100, the balloon is compressed, and the balloon is inserted into the stomach of the human body by swallowing or other methods, and physiological saline is injected into the resin balloon through the catheter 12 after the balloon is inserted into the stomach of the human body, the balloon is inflated, and the inflated balloon occupies the space of the stomach, achieving the effect of indirectly reducing the stomach capacity and thus assisting in weight loss.

[0062] The degradable self-sealing valve 100 and the preparation method thereof provided in the application will be described in detail below in combination with specific examples.

[0063] Example 1

[0064] The degradable self-sealing valve 100 and the preparation method thereof provided in the example of the application are as follows:

[0065] A degradable material solution with a solute of polylactide-co-glycolide copolymer, a solvent of tetrahydrofuran and a mass concentration of 12% is poured on a glass plate, a coating machine is used to coat a layer of the degradable solution, and after the solution is dried, a degradable film 110 material with a thickness of 0.05 mm is obtained.

[0066] The degradable film 110 material is cut into a shape as shown in Figure 1 The uppermost end of the degradable film 110 has a width of 3 cm (corresponding to the width of the liquid inlet end 102 of the liquid inlet channel 101, which is approximately 3 cm), and the upper end has a length of 1 cm. The lowermost end of the degradable film 110 has a width of 2 mm (corresponding to the width of the liquid outlet end 103 of the liquid inlet channel 101, which is approximately 2 mm). The total length of the degradable film 110 is 1.5 cm.

[0067] Example 2

[0068] The example is basically the same as example 1, and the only difference is that:

[0069] The solute is polylactide-co-caprolactone copolymer, the solvent is dichloromethane, and the thickness of the prepared degradable film 110 material is 0.058 mm.

[0070] Example 3

[0071] The example is basically the same as example 1, and the only difference is that:

[0072] The solute is polylactide-co-trimethylene carbonate, the solvent is trichloromethane, and the thickness of the prepared degradable film 110 material is 0.062 mm.

[0073] Example 4

[0074] The example is basically the same as example 1, and the only difference is that:

[0075] The solute is polyglycolide-co-caprolactone copolymer, the solvent is trichloromethane, and the thickness of the prepared degradable film 110 material is 0.066 mm.

[0076] Examples 5-7

[0077] Examples 5-7 are substantially identical to Example 1, except that the length of the degradable film 110 in Examples 5-7 is 2 cm, 2.5 cm, and 3 cm, respectively.

[0078] Experimental Example 1

[0079] The degradable self-sealing valves 100 prepared in Examples 1-7 were assembled with a polyurethane balloon body having a thickness of 0.07 mm to obtain a gastric implant balloon 10 having a volume of 500 ml, and experiments were performed. The specific experimental method was as follows: 400-550 ml of normal saline was injected into the balloon through the catheter 12. The prepared balloon was weighed and placed in a fatigue testing machine for fatigue testing. The frequency of the fatigue machine was set to about 15-20 times per minute, the total frequency was set to 200 times (about 5 minutes), and the pressure of the fatigue testing machine was about 150 N; after the experiment, the balloon was weighed again. The sealing property of the balloon was determined by the change in mass. Two groups were prepared for each example. The results were recorded in the following table.

[0080] Table 1 Sealing property test results of each example

[0081]

[0082]

[0083] As can be seen from the above table, the degradable self-sealing valve provided in the examples has good sealing property.

[0084] Experimental Example 2

[0085] The experimental groups of this experimental example were prepared according to a preparation method similar to that of Example 1, and the only difference between the experimental groups of this experimental example and Example 1 was the size of the self-sealing valve as shown in Table 2. The self-sealing valves of each experimental group were assembled with a polyurethane balloon body having a thickness of 0.07 mm to obtain a gastric implant balloon 10 having a volume of 500 ml, and experiments were performed. 400-550 ml of normal saline was injected into the balloon through the catheter 12. The prepared balloon was weighed and placed in a fatigue testing machine for fatigue testing. The frequency of the fatigue machine was set to about 3 times per minute. When the fatigue test was performed for about 4 months, the self-sealing valve film was degraded and ruptured, the balloon sealing property was lost, and the liquid in the balloon was discharged. After 5 minutes of liquid discharge, the weight of the balloon was measured again. By comparing the mass of the balloon before and after degradation, the discharge rate of the liquid in the balloon was evaluated.

[0086] Table 2 Discharge rate test results of each experimental group

[0087]

[0088] As can be seen from the above table, when the upper end length of the valve is 1 cm and the narrowest part of the lower end is 2 mm, the wider the upper end width of the valve is, the faster the liquid discharge speed is, and the greater the discharge amount is. The liquid discharge speed of each experimental group provided in the application is fast after degradation.

[0089] In summary, the degradable self-sealing valve 100 and the preparation method thereof provided in the embodiments of the application, the design of the wide liquid inlet end 102 of the liquid inlet channel 101 facilitates the liquid in the resin balloon body 11 to be discharged faster after the self-sealing valve is degraded, and the design of the narrow liquid outlet end 103 effectively prevents the liquid in the balloon from leaking reversely, and is more helpful for sealing. Further, the length of the self-sealing valve, the width of the liquid inlet end 102 and the liquid outlet end 103 of the liquid inlet channel 101 can further ensure that the self-sealing valve has good sealing performance and a faster liquid discharge rate after degradation.

[0090] The gastric implant balloon 10 and the preparation method thereof provided in the embodiments of the application have good sealing performance and fast liquid discharge speed after the self-sealing valve is degraded due to the provision of the degradable self-sealing valve 100 provided in the application.

[0091] The above is only a specific embodiment of the application, but the protection scope of the application is not limited thereto, any person skilled in the art can easily think of changes or replacements within the technical range disclosed in the application, which should be covered in the protection scope of the application. Therefore, the protection scope of the application should be subject to the protection scope of the claims.

Claims

1. An intragastric balloon comprising: The resin balloon body and the biodegradable self-sealing valve arranged in the resin balloon body; The biodegradable self-sealing valve comprises two pieces of biodegradable film which are attached and connected, and a liquid inlet channel is formed between the two pieces of biodegradable film, the liquid inlet channel has opposite liquid inlet end and liquid outlet end, the width of the liquid inlet end is greater than the width of the liquid outlet end; The two pieces of biodegradable film have the same shape and size, the width of one end of each piece of biodegradable film in the length direction is greater than the width of the other end, and the two pieces of biodegradable film are connected in the following manner: the opposite long edge of one piece of biodegradable film is connected with the opposite long edge of the other piece of biodegradable film; The resin balloon body has a liquid inlet, the opening width of the liquid inlet is the same as the width of the liquid inlet end, and the liquid inlet communicates with the liquid inlet end; The width of the liquid inlet end is 2.5-5 cm, and the width of the liquid outlet end is 0.5-3 mm; The length of the biodegradable film is 1.5-5 cm; The length of the liquid inlet end is 1.0-1.5 cm.

2. The intragastric implant balloon of claim 1, wherein, The connection mode of the two pieces of biodegradable film is adhesion or laser welding.

3. The intragastric implant balloon of claim 2, wherein, The thickness of the biodegradable film is 0.05-0.1 mm.

4. The intragastric implant balloon of claim 2, wherein, The biodegradable film is made of at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-co-glycolide, polylactide-co-caprolactone, polylactide-trimethylene carbonate, polyglycolide-trimethylene carbonate, polyglycolide-co-caprolactone and polydioxanone.

5. The intragastric implant balloon of claim 1, wherein, The preparation method of the biodegradable self-sealing valve comprises: Attaching the two pieces of biodegradable film and connecting them.

6. The intragastric implant balloon of claim 5, wherein, Before connecting the two pieces of biodegradable film, the biodegradable film is prepared: A solution containing biodegradable material is coated on a plate-shaped mold, the solvent is volatilized, and the biodegradable film material is demolded.

7. The intragastric implant balloon of claim 6, wherein, The mass concentration of biodegradable material in the biodegradable material solution is 10%-20%.

8. The intragastric implant balloon of claim 6, wherein, The solvent in the biodegradable material solution is at least one of tetrahydrofuran, dichloromethane and trichloromethane.

9. The method of claim 1-8, wherein the gastric implant balloon is prepared by the steps of: Comprise: Two resin half balloons and the biodegradable self-sealing valve are connected, and the two resin half balloons are connected to form the resin balloon body.

10. The method of claim 9, wherein, The connection mode is adhesion or laser welding.

Images