CN114129325A - Degradable self-sealing valve and preparation method thereof, intragastric implanted balloon and preparation method thereof - Google Patents
Degradable self-sealing valve and preparation method thereof, intragastric implanted balloon and preparation method thereof Download PDFInfo
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- CN114129325A CN114129325A CN202111457314.0A CN202111457314A CN114129325A CN 114129325 A CN114129325 A CN 114129325A CN 202111457314 A CN202111457314 A CN 202111457314A CN 114129325 A CN114129325 A CN 114129325A
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- 238000007789 sealing Methods 0.000 title claims abstract description 70
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000007788 liquid Substances 0.000 claims abstract description 98
- 239000011347 resin Substances 0.000 claims abstract description 31
- 229920005989 resin Polymers 0.000 claims abstract description 31
- 239000000463 material Substances 0.000 claims description 24
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 12
- 229920001577 copolymer Polymers 0.000 claims description 12
- 239000002904 solvent Substances 0.000 claims description 11
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 10
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims description 8
- 239000007943 implant Substances 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 238000003466 welding Methods 0.000 claims description 7
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims description 4
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims description 3
- 229920000954 Polyglycolide Polymers 0.000 claims description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 3
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 3
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 3
- 229920001610 polycaprolactone Polymers 0.000 claims description 3
- 239000004632 polycaprolactone Substances 0.000 claims description 3
- 239000000622 polydioxanone Substances 0.000 claims description 3
- -1 polytrimethylene carbonate Polymers 0.000 claims description 3
- 229920000166 polytrimethylene carbonate Polymers 0.000 claims description 3
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 3
- 238000005304 joining Methods 0.000 claims description 2
- 239000010408 film Substances 0.000 claims 9
- 239000010409 thin film Substances 0.000 claims 4
- 239000012528 membrane Substances 0.000 claims 1
- 238000013461 design Methods 0.000 abstract description 9
- 230000015556 catabolic process Effects 0.000 abstract description 6
- 238000006731 degradation reaction Methods 0.000 abstract description 6
- 239000012567 medical material Substances 0.000 abstract description 2
- 210000002784 stomach Anatomy 0.000 description 13
- 239000000243 solution Substances 0.000 description 12
- 238000009661 fatigue test Methods 0.000 description 5
- 238000002513 implantation Methods 0.000 description 5
- 230000009286 beneficial effect Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 230000004580 weight loss Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- 235000012631 food intake Nutrition 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 235000006694 eating habits Nutrition 0.000 description 2
- 239000002504 physiological saline solution Substances 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
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- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 208000003243 intestinal obstruction Diseases 0.000 description 1
- 230000008450 motivation Effects 0.000 description 1
- 230000036186 satiety Effects 0.000 description 1
- 235000019627 satiety Nutrition 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/24—Check- or non-return valves
-
- 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
- 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
Abstract
The invention relates to the technical field of medical materials, and provides a degradable self-sealing valve and a preparation method thereof, and an intragastric implanted balloon and a preparation method thereof. The degradable self-sealing valve comprises two degradable films which are attached and connected, a liquid inlet channel is formed between the two connected degradable films, the liquid inlet channel is provided with a liquid inlet end and a liquid outlet end which are opposite, and the width of the liquid inlet end is larger than that of the liquid outlet end. The preparation method of the degradable self-sealing valve comprises the following steps: two degradable films are attached and connected. The intragastric implanted balloon comprises a resin balloon body and a degradable self-sealing valve, wherein the resin balloon body is provided with a liquid inlet, the opening width of the liquid inlet is the same as the width of a liquid inlet end, and the liquid inlet is communicated with the liquid inlet end. The design that the feed liquor end width of this application inlet channel is great is convenient for this internal liquid of resin sacculus behind the self-sealing valve degradation can discharge more fast, and the design that goes out the liquid end width less then more effectively prevents the reverse leakage of liquid in the sacculus, more helps sealedly.
Description
Technical Field
The invention relates to the field of medical materials, in particular to a degradable self-sealing valve and a preparation method thereof, an intragastric implanted balloon and a preparation method thereof.
Background
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.
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.
The self-sealing valve plays a significant role in the balloon. If the liquid injection channel and the liquid discharge channel of the balloon are consistent and are positioned on the degradable self-sealing valve, the size of the channels directly influences the sealing performance of the balloon and the discharge rate of the liquid in the balloon. The channel is too large, and the balloon sealing performance is poor; the passage is too small, and after the degradable material is degraded, the liquid discharge rate of the balloon is slow, so that the displacement of the balloon can be caused, and the intestinal obstruction risk is caused. In addition, the length of the valve also affects the sealing of the balloon. The length is too short, and the sealing effect cannot be achieved; when the length is too long, the size is large after being folded, which is not beneficial to being filled into capsules.
In view of this, the present application is specifically made.
Disclosure of Invention
Objects of the present invention include, for example, providing a degradable self-sealing valve and a method of making the same, an intragastric implant balloon and a method of making the intragastric implant balloon, which aim to ameliorate at least one of the problems mentioned in the background.
Embodiments of the invention may be implemented as follows:
in a first aspect, the present invention provides a degradable self-sealing valve, which comprises two degradable films attached and connected to each other, wherein a liquid inlet channel is formed between the two connected degradable films, the liquid inlet channel has a liquid inlet end and a liquid outlet end which are opposite, and the width of the liquid inlet end is greater than that of the liquid outlet end.
In an optional embodiment, the two degradable films have the same shape and size, the width of one end of each degradable film in the length direction is greater than that of the other end, and the two degradable films are connected in the following manner: the long edge edges of two opposite sides of one degradable film are connected with the long edge edges of two opposite sides of the other degradable film.
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.
In an optional embodiment, the length of the degradable film is 1.5-5 cm;
preferably, the length of the liquid inlet end is 1.0-1.5 cm.
In an alternative embodiment, the two degradable films are connected by bonding or laser welding;
preferably, the thickness of the degradable film is 0.05-0.1 mm.
In an alternative embodiment, the degradable film is made from at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-glycolide copolymer, polylactide-caprolactone copolymer, polylactide-trimethylene carbonate, polyglycolide-caprolactone copolymer, and polydioxanone.
In a second aspect, the present invention provides a method for preparing a degradable self-sealing valve according to any one of the previous embodiments, comprising:
two degradable films are attached and connected.
In an alternative embodiment, the joining the two degradable films further comprises preparing the degradable films:
coating the solution dissolved with the degradable material on a plate-shaped die, volatilizing the solvent, and demolding to obtain a degradable film material;
preferably, the mass concentration of the degradable material in the degradable material solution is 10-20%;
preferably, the solvent in the degradable material solution is at least one of tetrahydrofuran, dichloromethane and chloroform.
In a third aspect, the present invention provides an intragastric implantation balloon, which includes a resin balloon body and a degradable self-sealing valve disposed in the resin balloon body, wherein the degradable self-sealing valve is as defined in any one of the foregoing embodiments or is manufactured by the manufacturing method of the foregoing embodiments, the resin balloon body has a liquid inlet, an opening width of the liquid inlet is the same as a width of the liquid inlet, and the liquid inlet is communicated with the liquid inlet.
In a fourth aspect, the present invention provides a method of preparing an intragastric implant balloon as in the previous embodiments, comprising:
connecting the two resin half balloons with the degradable self-sealing valve, and forming a resin balloon body after the two resin half balloons are connected;
preferably, the connection means is bonding or laser welding.
The beneficial effects of the embodiment of the invention include, for example:
because the liquid inlet of the resin balloon body is as wide as the liquid inlet end of the liquid inlet channel, the liquid in the resin balloon body can be discharged more quickly after the self-sealing valve is degraded due to the design of the large width of the liquid inlet end of the liquid inlet channel, and the liquid in the balloon can be more effectively prevented from reversely leaking due to the design of the small width of the liquid outlet end, so that the sealing is facilitated.
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 structural diagram of a degradable self-sealing valve provided in an embodiment of the present application;
FIG. 2 is a schematic view of an intragastric implanted balloon provided by an embodiment of the present application after insertion into a catheter;
FIG. 3 is a schematic representation of the intragastric implant balloon of FIG. 2 taken along a midline;
fig. 4 is a schematic drawing of the structure of the view of fig. 3 after the catheter has been withdrawn.
Icon: 100-degradable self-sealing valve; 101-a liquid inlet channel; 102-a liquid inlet end; 103-liquid outlet end; 110-degradable films; 111-connecting edges; 10-intragastric implantation of a balloon; 11-a resin balloon body; 12-a catheter; 13-liquid inlet.
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 with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. indicate an orientation or a positional relationship based on that shown in the drawings or that the product of the present invention is used as it is, this is only for convenience of description and simplification of the description, and it does not indicate or imply that the device or the element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.
Furthermore, the appearances of the terms "first," "second," and the like, if any, are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.
Referring to fig. 1 to 4, an embodiment of the present application provides a degradable self-sealing valve 100, which includes two degradable films 110 attached and connected to each other, a liquid inlet channel 101 is formed between the two connected degradable films 110, the liquid inlet channel 101 has a liquid inlet end 102 and a liquid outlet end 103 opposite to each other, and a width of the liquid inlet end 102 is greater than a width of the liquid outlet end 103.
The embodiment of the present application further provides an intragastric implantation balloon 10, including the degradable self-sealing valve 100 provided in the embodiment of the present application, 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 102, and the liquid inlet 13 is communicated with the liquid inlet 102.
The degradable self-sealing valve 100 provided by the embodiment of the application can be gradually degraded along with the time, is arranged in the resin balloon body 11, implants the resin balloon body 11 into the stomach of a human body, and injects normal saline into the resin balloon through the catheter 12 inserted into the liquid inlet channel 101, so that the resin balloon body 11 is expanded, and the degradable self-sealing valve occupies a certain space in the stomach of the human body to indirectly reduce the volume of the stomach to assist the weight losing effect. Because 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 liquid inlet end 102 of the liquid inlet channel 101 with a larger width facilitates the rapid discharge of the liquid in the resin balloon body 11 after the degradation of the self-sealing valve, and the design of the liquid outlet end 103 with a smaller width prevents the reverse leakage of the liquid in the balloon more effectively, which is more beneficial to sealing.
Further, the shape and size of two degradable films 110 are the same, the width of one end of each degradable film 110 in the length direction is greater than the width of the other end, and the connection mode of the two degradable films 110 is as follows: the two opposite long side edges of one degradable film 110 are connected with the two opposite long side edges of the other degradable film 110. As shown in fig. 1, the shaded portion of the edge of the degradable self-sealing valve 100 in fig. 1 is a connecting edge 111 of two degradable films 110.
Preferably, the two degradable films 110 are connected by bonding or laser welding.
The liquid inlet channel 101 is actually a gap between two degradable films 110, and the shape design of the degradable films 110 can realize that the material consumption of the degradable films 110 is less on the premise that one end of the liquid inlet channel 101 is large and the other end is small.
Preferably, in order to realize the rapid discharge of the liquid after the degradable self-sealing valve 100 is degraded, the width of the liquid inlet end 102 is 2.5-3 cm, and in order to realize a good sealing effect, the width of the liquid outlet end 103 is 1.5-2.5 mm.
Further, the length of the liquid inlet end 102 is 1.0-1.5 cm.
Preferably, in order to achieve stable degradation of degradable film 110, degradable film 110 is made of at least one of polyglycolide, polylactide, polyvinyl alcohol, polycaprolactone, polytrimethylene carbonate, polylactide-glycolide copolymer, polylactide-caprolactone copolymer, polylactide-trimethylene carbonate, polyglycolide-caprolactone copolymer, and polydioxanone.
The preparation method of the degradable self-sealing valve 100 provided by the embodiment of the application comprises the following steps:
two degradable films 110 are attached and connected.
The method specifically comprises the following steps:
s1, preparing the degradable film 110:
the solution in which the degradable material is dissolved is applied to a plate-like mold, and the solvent is volatilized, and the degradable film 110 material is obtained by demolding.
Preferably, the solvent is evaporated by drying at room temperature for about 20 hours.
Preferably, in order to obtain the degradable film 110 with sufficient strength and good flexibility, the mass concentration of the degradable material in the degradable material solution is 10% to 20%.
Further, the solvent in the degradable material solution is at least one of tetrahydrofuran, dichloromethane and chloroform.
And S2, adhering the two degradable films 110, and connecting the long edges of the two degradable films by adopting a bonding or laser welding mode.
The preparation method of the intragastric implantation balloon 10 provided by the embodiment of the application comprises the following steps:
the two resin half balloons are connected with the degradable self-sealing valve 100, and the resin balloon body 11 is formed after the two resin half balloons are connected.
Preferably, the connection means is bonding or laser welding.
The intragastric implantation balloon 10 provided by the application is implanted into the stomach of a human body in a mode that: one end of a 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 enters the stomach of a human body in a swallowing mode, normal saline is injected into the resin balloon through the catheter 12 after entering the stomach of the human body, the balloon is expanded, the expanded balloon occupies the space of the stomach, and the effects of indirectly reducing the volume of the stomach and assisting weight loss are achieved.
The degradable self-sealing valve 100 and the preparation method thereof provided by the present application are specifically described below with reference to specific embodiments.
Example 1
The preparation method of the degradable self-sealing valve 100 provided by the embodiment of the application comprises the following steps:
pouring a degradable material solution with 12% mass concentration, the solute of which is polylactide-glycolide copolymer, the solvent of which is tetrahydrofuran, onto a glass plate, coating a layer of the degradable solution layer by using a coating machine, and airing the solution to obtain the degradable film 110 material with the thickness of 0.05 mm.
The degradable film 110 is obtained by cutting the degradable film 110 into the shape shown in fig. 1, the width of the uppermost end of the degradable film 110 is 3cm (the width corresponding to the inlet end 102 of the inlet channel 101 is approximately 3cm), the length of the upper end is 1cm, and the width of the lowermost end of the degradable film 110 is 2mm (the width corresponding to the outlet end 103 of the inlet channel 101 is approximately 2 mm). The total length of the degradable film 110 is 1.5 cm.
Example 2
This embodiment is substantially the same as embodiment 1 except that:
the solute is polylactide-caprolactone copolymer, the solvent is dichloromethane, and the thickness of the prepared degradable film 110 material is 0.058 mm.
Example 3
This embodiment is substantially the same as embodiment 1 except that:
the solute is polylactide-trimethylene carbonate, the solvent is chloroform, and the thickness of the prepared degradable film 110 material is 0.062 mm.
Example 4
This embodiment is substantially the same as embodiment 1 except that:
the solute is polyglycolide-caprolactone copolymer, the solvent is chloroform, and the thickness of the prepared degradable film 110 material is 0.066 mm.
Examples 5 to 7
Examples 5-7 are essentially the same as example 1, except that: the degradable films 110 of examples 5 to 7 have lengths of 2cm, 2.5cm and 3cm, respectively.
Experimental example 1
The degradable self-sealing valves 100 prepared in examples 1 to 7 were assembled with a polyurethane balloon body having a thickness of 0.07mm to obtain an intragastric implant balloon 10 having a volume of 500ml, and experiments were performed. The specific experimental mode is as follows: 400-550 ml of physiological saline is injected into the balloon through the catheter 12. And weighing the prepared ball body, and putting the ball body into a fatigue testing machine for fatigue testing. The fatigue machine frequency was set to about 15-20 times/min, the total frequency was set to 200 times (time about 5 min), the fatigue machine pressure was about 150N; after the test was completed, the spheres were weighed again. The sealing performance of the ball body is judged through the change of the mass. Two sets were made for each example. The results are recorded in the table below.
TABLE 1 test conditions for sealability of the examples
As can be seen from the above table, the degradable self-sealing valve provided by the embodiment of the present application has good sealing performance.
Experimental example 2
The experimental group of this experimental example, which was different from example 1 only in the size of the self-sealing valve as shown in table 2, was prepared according to the similar preparation method to example 1. And (3) assembling the self-sealing valve of each experimental group with a polyurethane balloon body with the thickness of 0.07mm to obtain the intragastric implanted balloon 10 with the volume of 500ml, and carrying out experiments. 400-550 ml of physiological saline is injected into the balloon through the catheter 12. And weighing the prepared ball body, and putting the ball body into a fatigue testing machine for fatigue testing. The fatigue machine frequency was set to about 3 times/min. When the fatigue test is carried out for about 4 months, the self-sealing valve film is degraded and broken, the balloon sealing property is invalid, and the liquid in the balloon is discharged. After the liquid was drained for 5min, the weight of the balloon was weighed again. The rate of drainage of the liquid within the balloon was evaluated by comparing the quality of the balloon before and after degradation.
Table 2 liquid discharge rate test results of each experimental group
As can be seen from the above table, when the length of the upper end of the valve is 1cm and the narrowest portion of the lower end is 2mm, the wider the width of the upper end of the valve, the faster the liquid discharge speed and the larger the discharge amount. The application provides a flowing back is fast after each experiment group degradation.
In summary, according to the degradable self-sealing valve 100 and the manufacturing method thereof provided by the embodiment of the invention, the design that the width of the liquid inlet end 102 of the liquid inlet channel 101 is large is convenient for the liquid in the resin balloon body 11 to be discharged more quickly after the self-sealing valve is degraded, and the design that the width of the liquid outlet end 103 is small is more effective in preventing the liquid in the balloon from reversely leaking, which is more beneficial to 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, and the like, can further ensure that the self-sealing valve has good sealing performance and faster liquid discharge rate after degradation.
According to the intragastric implanted balloon 10 and the preparation method thereof, provided by the embodiment of the invention, the degradable self-sealing valve 100 is arranged, so that the sealing performance is good, and the drainage speed of the degraded sealing valve is high.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (10)
1. The degradable self-sealing valve is characterized by comprising two degradable films which are attached and connected, wherein a liquid inlet channel is formed between the two connected degradable films, the liquid inlet channel is provided with a liquid inlet end and a liquid outlet end which are opposite in position, and the width of the liquid inlet end is greater than that of the liquid outlet end.
2. The degradable self-sealing valve according to claim 1, wherein said two degradable thin films have the same shape and size, one end of each degradable thin film in the length direction is wider than the other end, and the two degradable thin films are connected in the way that: the long edge edges of two opposite sides of one degradable film are connected with the long edge edges of two opposite sides of the other degradable film.
3. The degradable self-sealing valve according to claim 1, wherein the width of said inlet end is 2.5-5 cm and the width of said outlet end is 0.5-3 mm.
4. The degradable self-sealing valve according to claim 3, wherein said degradable thin film has a length of 1.5-5 cm;
preferably, the length of the liquid inlet end is 1.0-1.5 cm.
5. The degradable self-sealing valve according to any one of claims 1 to 4, wherein two degradable films are connected by means of bonding or laser welding;
preferably, the thickness of the degradable film is 0.05-0.1 mm.
6. The degradable self-sealing valve according to claim 3, wherein said degradable membrane is made of 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.
7. The method for preparing the degradable self-sealing valve according to any one of claims 1 to 6, comprising:
two degradable films are attached and connected.
8. The method of claim 7, wherein the step of joining two degradable films further comprises the steps of:
coating the solution dissolved with the degradable material on a plate-shaped die, volatilizing the solvent, and demolding to obtain a degradable film material;
preferably, the mass concentration of the degradable material in the degradable material solution is 10-20%;
preferably, the solvent in the degradable material solution is at least one of tetrahydrofuran, dichloromethane and chloroform.
9. An intragastric implant balloon, which is characterized by comprising a resin balloon body and the degradable self-sealing valve which is arranged in the resin balloon body and is prepared by the degradable self-sealing valve as claimed in any one of claims 1 to 6 or the preparation method as claimed in claim 7 or 8, wherein the resin balloon body is provided with 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 is communicated with the liquid inlet end.
10. The method of making an intragastric implant balloon of claim 9, comprising:
connecting two resin semi-balloons with the degradable self-sealing valve, wherein the two resin semi-balloons are connected to form the resin balloon body;
preferably, the connection means is bonding or laser welding.
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| CN202111457314.0A CN114129325A (en) | 2021-12-02 | 2021-12-02 | Degradable self-sealing valve and preparation method thereof, intragastric implanted balloon and preparation method thereof |
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