CN115040300A - Closing and releasing structure of implant in body - Google Patents
Closing and releasing structure of implant in body Download PDFInfo
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- CN115040300A CN115040300A CN202110255405.XA CN202110255405A CN115040300A CN 115040300 A CN115040300 A CN 115040300A CN 202110255405 A CN202110255405 A CN 202110255405A CN 115040300 A CN115040300 A CN 115040300A
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- 239000007943 implant Substances 0.000 title claims abstract description 17
- 239000000463 material Substances 0.000 claims abstract description 37
- 239000000945 filler Substances 0.000 claims abstract description 27
- 238000001727 in vivo Methods 0.000 claims abstract description 20
- 238000003466 welding Methods 0.000 claims abstract description 14
- 230000008878 coupling Effects 0.000 claims abstract description 5
- 238000010168 coupling process Methods 0.000 claims abstract description 5
- 238000005859 coupling reaction Methods 0.000 claims abstract description 5
- 238000007789 sealing Methods 0.000 claims description 21
- 210000005077 saccule Anatomy 0.000 claims description 20
- 239000003292 glue Substances 0.000 claims description 14
- 229920001577 copolymer Polymers 0.000 claims description 12
- 238000004519 manufacturing process Methods 0.000 claims description 12
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 4
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 4
- 239000000622 polydioxanone Substances 0.000 claims description 4
- 239000004626 polylactic acid Substances 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 229920002379 silicone rubber Polymers 0.000 claims description 4
- 238000000034 method Methods 0.000 claims 3
- 230000010339 dilation Effects 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 abstract description 5
- 230000002028 premature Effects 0.000 abstract description 2
- 238000000926 separation method Methods 0.000 abstract description 2
- 239000013585 weight reducing agent Substances 0.000 description 7
- 208000008589 Obesity Diseases 0.000 description 6
- 235000020824 obesity Nutrition 0.000 description 6
- 210000002784 stomach Anatomy 0.000 description 6
- 239000007788 liquid Substances 0.000 description 4
- 230000009747 swallowing Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 230000002496 gastric effect Effects 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 230000037213 diet Effects 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000007654 immersion Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000008855 peristalsis Effects 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 206010002091 Anaesthesia Diseases 0.000 description 1
- 208000032928 Dyslipidaemia Diseases 0.000 description 1
- 241000167880 Hirundinidae Species 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 208000017170 Lipid metabolism disease Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000007683 Pediatric Obesity Diseases 0.000 description 1
- 230000037005 anaesthesia Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000003631 expected effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000000366 juvenile effect Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 208000031225 myocardial ischemia Diseases 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 201000002859 sleep apnea Diseases 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 238000011277 treatment modality Methods 0.000 description 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/003—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
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- Health & Medical Sciences (AREA)
- Child & Adolescent Psychology (AREA)
- Obesity (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The present application provides an in vivo implanted balloon system, and in particular, to a closure and release structure of an in vivo implanted balloon system. The implant in vivo comprises a sacculus, a catheter and a filler, wherein a degradable sheet is coupled on the sacculus, a discontinuous fixing hole is formed in the coupling part of the degradable sheet and a sacculus main body, a cover sheet is arranged outside the degradable sheet, the sacculus main body is connected with the cover sheet through the fixing hole, and the degradable sheet is fixed between the degradable sheet and the cover sheet. According to the in vivo implant closing and releasing structure, the cover plate and the balloon main body are made of the same material and are connected together in the fixing hole position in a bonding or welding mode, and the connecting strength of the same material is high. The degradable sheet is positioned between the balloon main body and the cover sheet and is fixed through the fixing holes. This configuration avoids premature separation between the degradable sheet and the balloon body in the gastric acid environment in the body.
Description
Technical Field
The present application relates to an in vivo implanted balloon system, and in particular, to a closure and release structure for an in vivo implanted balloon system.
Background
The incidence of obesity, including adult obesity, geriatric obesity and juvenile and childhood obesity, has risen dramatically over the past 20 years worldwide. According to the world health organization statistics, 15% of adult females and 11% of adult males are obese worldwide in 2014, which means that nearly one billion adults are obese worldwide in 2014. It is not optimistic that the obese population in china has overtaken the united states, 8960 million obese people in 2016 (8780 million obese people in the united states), with 4320 million men and 4640 million women. Obesity is usually accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea, certain tumors, etc., and therefore how to effectively control body weight, prevent and control the occurrence of complications is a topic of great interest.
Currently the main treatment modalities for obesity include: diet control, life intervention, drug therapy and surgical therapy. However, satisfactory weight loss effect is difficult to achieve by simple diet control, life intervention and drug treatment; although the effect of weight reduction surgery is obvious, the weight reduction surgery is difficult to accept by patients due to culture, medical level, surgery complications and the like. Implantable medical devices for weight reduction, which simulate the mechanism of surgical operation for treating obesity, including the intragastric balloon, have been recently developed in the years, and have attracted extensive attention because of safety, simplicity, effectiveness and recoverability, and become the main effective means for weight reduction in the future.
At present, several types of intragastric balloons are on the market abroad, and particularly, the intragastric balloon which is swallowed by oneself without being sent through a gastroscope is the direction of future weight-reducing means. Degradable materials are often coupled to such balloons as closure and release channels for the filler in the balloon. The saccule is swallowed into the stomach of a human body and then is filled with the filler to form an expansion state, and the degradable material of the expansion state saccule keeps the structural integrity in the human body within a certain time to be used as a barrier of the filler in the saccule and prevent the filler from leaking. The structural integrity is maintained for a period of time, the degradable material ruptures, the filler in the balloon is released through the rupture, and the empty balloon shell is expelled from the body through the natural orifice under the peristaltic action of the gastrointestinal tract. The design has the advantages that the swallowing and the discharging of the saccule are all through the natural orifice of the human body, the patient is friendly without the help of gastroscope, anesthesia and the like, the defects are that the degradable material and the main material of the saccule are generally selected from different materials, the durability of the coupling strength of the degradable material and the main material of the saccule in the gastric acid environment is difficult to ensure by the conventional bonding or welding mode, and once the degradable material and the main material of the saccule are separated too early, the expected effect of weight reduction can not be achieved.
Disclosure of Invention
The application provides a closure and release structure of implant in vivo for can couple together for a long time between degradable material and the sacculus host material, be difficult for separating.
The application provides an implant closure and release structure in vivo, implant in vivo includes sacculus, pipe and filler, there is degradable piece, its characterized in that on the coupling of sacculus: the coupling part of the degradable sheet and the balloon main body is provided with discontinuous fixing holes, a cover sheet is arranged outside the degradable sheet, and the balloon main body is connected with the cover sheet at the fixing holes to fix the degradable sheet between the degradable sheet and the balloon main body.
Preferably, one end of the catheter is connected to a self-sealing valve on the balloon.
Preferably, the balloon comprises an upper balloon and a lower balloon, wherein the upper balloon is provided with at least one opening as a release channel of the filler in the balloon.
Preferably, the self-closing valve comprises an upper layer self-closing valve and a lower layer self-closing valve, wherein a duct hole is formed in the lower layer self-closing valve, and the circumference of the duct hole is not larger than the outer diameter of the duct.
Preferably, the upper layer self-closing valve and the upper layer balloon are integrated or are made of different materials and are connected together through bonding or welding.
Preferably, the lower self-closing valve is integral with the lower balloon, or is made of different materials and is bonded or welded together.
Preferably, the upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve at the edges in a bonding or welding mode.
Preferably, the degradable sheet is circular, oval, square or other shape, and a circle of discontinuous fixing holes are opened near the outer edge.
Preferably, the upper layer balloon and the lower layer balloon are made of flexible materials such as silicon rubber or polyurethane.
Preferably, the cover sheet is made of the same material as or close to that of the upper layer balloon and the lower layer balloon.
Preferably, the degradable sheet is a polylactic acid-based copolymer.
Preferably, the degradable sheet is polydioxanone.
Preferably, the degradable sheet is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
Preferably, the degradable sheet film has a thickness of 10 to 300 micrometers.
Preferably, the degradable sheet is coupled between the upper balloon and the cover sheet and locked by the fixing holes.
Preferably, the fixing hole on the degradable sheet is one circle or more than two circles.
The present application provides a method of making a closure and release structure characterized by: one end of the catheter is connected with a self-closing valve on the saccule, the saccule comprises an upper saccule and a lower saccule, wherein the upper balloon is provided with at least one opening as a release channel of the filler in the balloon, the self-sealing valve comprises an upper self-sealing valve and a lower self-sealing valve, wherein the lower layer self-closing valve is provided with a conduit hole, the perimeter of the conduit hole is not more than the outer diameter of the conduit, the upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve at the edges in a bonding or welding mode, and the combined balloon is turned over through the release channel on the upper layer balloon, the upper layer balloon and the lower layer balloon form the balloon, the upper layer self-closing valve and the lower layer self-closing valve form the self-closing valve, and the self-closing valve enters the balloon.
Preferably, the catheter penetrates into the self-closing valve from the outside of the balloon, penetrates out of a catheter hole in the self-closing valve, and enters into the balloon for filling the balloon with filler.
Preferably, glue is dotted around the release channel of the upper balloon, 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.
Preferably, the cover sheet is added on the surface of the degradable sheet, and the cover sheet is bonded with the upper layer balloon at the fixing holes.
According to the in vivo implant closing and releasing structure, the cover plate and the balloon main body are made of the same material and are connected together in the fixing hole position in a bonding or welding mode, and the connecting strength of the same material is high. The degradable sheet is positioned between the balloon main body and the cover sheet and is fixed through the fixing holes. The structure can avoid the premature separation between the degradable sheet and the balloon body in the gastric acid environment in vivo.
Drawings
Fig. 1 is a schematic view of an in vivo implant closure and release configuration according to one embodiment of the present application;
FIG. 2 illustrates the structure and method of making a balloon system according to one embodiment of the present application;
FIG. 3 illustrates the structure and method of making a balloon system according to one embodiment of the present application;
FIG. 4 is a schematic view of a degradable sheet according to an embodiment of the present application;
FIG. 5 illustrates the structure and method of making a balloon system according to one embodiment of the present application;
FIG. 6 is a schematic view of a circular patch according to one embodiment of the present application;
FIG. 7 illustrates the structure and method of making a balloon system according to one embodiment of the present application;
fig. 8 is a schematic view of an in vivo implant closure and release configuration according to another embodiment of the present application;
FIG. 9 is a structure and method of making a balloon system according to another embodiment of the present application;
FIG. 10 is a structure and method of making a balloon system according to another embodiment of the present application;
FIG. 11 is a schematic view of a degradable sheet according to another embodiment of the present application;
FIG. 12 is a structure and method of making a balloon system according to another embodiment of the present application;
FIG. 13 is a schematic view of a square shaped coverslip according to another embodiment of the present application;
fig. 14 illustrates the structure and fabrication of a balloon system according to another embodiment of the present application.
Detailed Description
Referring to fig. 1, a schematic view of an in vivo implant closing and releasing structure according to one embodiment of the present application is shown. Preferably, the implant is an intracorporeal implanted balloon system, such as an intragastric balloon system, and it will be apparent to those skilled in the art that the balloon system of the present application may be a balloon system for other purposes, such as a skin-expanding balloon or the like. An in vivo implantable balloon system comprising: balloon 100, catheter 200, and a filler (not shown). The balloon 100 is encapsulated prior to swallowing and the catheter 200 is connected at one end to a self-closing valve 300 on the balloon 100. The main body of the balloon 100 is coupled with a degradable sheet 400, and the outer surface of the degradable sheet is provided with a layer of cover sheet 500.
The structure and manufacturing method of the balloon system of this embodiment are described in detail below with reference to the accompanying drawings. Referring to fig. 2, the balloon 100 includes an upper layer balloon 110 and a lower layer balloon 120, wherein the upper layer balloon 110 has at least one opening for releasing the balloon filler 130. The self-sealing valve 300 comprises an upper layer self-sealing valve 310 and a lower layer self-sealing valve 320, wherein a conduit hole 311 is formed in the lower layer self-sealing valve 320, and the circumference of the conduit hole 311 is not larger than the outer diameter of the conduit 200. The upper self-sealing valve 310 and the upper balloon 110 may be an integral body, or may be made of different materials and connected together by bonding or welding. Similarly, the lower self-sealing valve 320 and the lower balloon 120 may be integral or may be made of different materials and bonded or welded together.
The upper layer balloon 110 and the upper layer self-closing valve 310 are combined with the lower layer balloon 120 and the lower layer self-closing valve 320 through bonding or welding at the edges, the combination is turned over through the release channel 130 on the upper layer balloon 110, the upper layer balloon 110 and the lower layer balloon 120 form the balloon 100, the upper layer self-closing valve 310 and the lower layer self-closing valve 320 form the self-closing valve 300, and the self-closing valve 300 enters the balloon 100. The catheter 200 is inserted into the self-sealing valve 300 from outside the balloon, and is inserted into the balloon 100 through the catheter hole 311 of the self-sealing valve, so as to fill the balloon 100 with filler, as shown in fig. 3.
Referring to fig. 4, the degradable sheet 400 is circular, and a circle of discontinuous fixing holes 401 are opened near the outer edge, and the size and shape of the fixing holes 401 are not limited. As shown in fig. 5, glue is dotted on the shaded part around the release channel 130 of the upper balloon 110, and the degradable sheet 400 with the fixing holes 401 is covered on the glue around the release channel 130, and the glue overflows from the fixing holes 401 of the degradable sheet 400. Then, a ring-shaped cover sheet 500 as shown in fig. 6 is added on the surface of the degradable sheet 400, and the cover sheet 500 is bonded with the upper balloon 110 at the fixing holes 401, as shown in fig. 7.
The upper balloon 110 and the lower balloon 120 are made of flexible materials such as silicon rubber or polyurethane. The material of the cover sheet 500 is the same as or close to that of the upper layer saccule 110 and the lower layer saccule 120, and the cover sheet 500 is firmly adhered to the upper layer saccule 110 and can withstand long-term immersion in gastric acid.
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 thickness of the film is 10-300 micrometers, the film is coupled between the upper layer balloon 110 and the cover sheet 500, and is locked by the fixing hole 401 and is not easily separated from the upper layer balloon 110, and the glue tape around the fixing hole 401 plays a role in sealing. In other embodiments, the degradable material is polydioxanone.
The intragastric balloon according to the present application is used as follows: after swallowing the capsule containing balloon 100 and a portion of catheter 200, the patient quickly dissolves in the gastric environment and delivers a fill material, which may be a liquid or a gas, into balloon 100 through the extracorporeal end of catheter 200. Balloon 100 changes from an initial compressed state to an expanded state. After the filling, the catheter 200 is pulled out, and the self-sealing valve 300 automatically closes the liquid passage under the pressure of the filler in the balloon 100, so as to prevent the filler in the balloon from leaking. The balloon 100 occupies the volume in the stomach for a long time, and the purpose of weight reduction is achieved. After the degradable tablet 400 is implanted into a human body for a period of time, the degradable tablet 400 is hydrolyzed and broken, the release channel 130 is opened, the structural integrity of the balloon is damaged, the filler in the balloon is discharged into the stomach of a patient, the volume of the balloon is reduced, and finally the balloon is naturally discharged out of the body along with the gastrointestinal peristalsis.
Referring to fig. 8, a schematic view of an in vivo implant closure and release configuration is shown, according to another embodiment of the present application. Preferably, the implant is an intracorporeal implanted balloon system, such as an intragastric balloon system, and it will be apparent to those skilled in the art that the balloon system of the present application may be a balloon system for other purposes, such as a skin-expanding balloon or the like. An in vivo implantable balloon system comprising: balloon 100, catheter 200, and a filler (not shown). The balloon 100 is encapsulated prior to swallowing and the catheter 200 is connected at one end to a self-closing valve 300 on the balloon 100. The main body of the balloon 100 is coupled with a degradable sheet 410, and the outer surface of the degradable sheet is provided with a layer of cover sheet 510.
The structure and manufacturing method of a balloon system according to another embodiment of the present application will be described in detail below with reference to the accompanying drawings. Referring to fig. 9, the balloon 100 includes an upper layer balloon 110 and a lower layer balloon 120, wherein the upper layer balloon 110 has at least one opening for releasing the balloon filler 140. The self-closing valve 300 comprises an upper layer self-closing valve 310 and a lower layer self-closing valve 320, wherein a conduit hole 311 is formed in the lower layer self-closing valve 320, and the circumference of the conduit hole 311 is not larger than the outer diameter of the conduit 200. The upper layer self-closing valve 310 and the upper layer balloon 110 may be an integral body, or may be made of different materials and connected together by bonding or welding. Similarly, the lower self-sealing valve 320 and the lower balloon 120 may be integral or may be made of different materials that are bonded or welded together.
The upper layer balloon 110 and the upper layer self-closing valve 310 are combined with the lower layer balloon 120 and the lower layer self-closing valve 320 through bonding or welding at the edges, the combination is turned over through the release channel 140 on the upper layer balloon 110, the upper layer balloon 110 and the lower layer balloon 120 form the balloon 100, the upper layer self-closing valve 310 and the lower layer self-closing valve 320 form the self-closing valve 300, and the self-closing valve 300 enters the balloon 100. The catheter 200 is inserted into the self-sealing valve 300 from outside the balloon, and is inserted into the balloon 100 through the catheter hole 311 of the self-sealing valve, so as to fill the balloon 100 with the filler, as shown in fig. 10.
Referring to fig. 11, the degradable sheet 410 is square, and two discontinuous fixing holes 411 are formed near the outer edge, and the size and shape of the fixing holes 411 are not limited. As shown in fig. 12, glue is dotted on the shadow around the release channel 140 of the upper balloon 110, 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, a square cover sheet 510 as shown in fig. 13 is added on the surface of the degradable sheet 410, and the cover sheet 510 is adhered with the upper balloon 110 at the fixing holes 411, as shown in fig. 14.
The upper balloon 110 and the lower balloon 120 are made of flexible materials such as silicon rubber or polyurethane. The material of cover sheet 510 is the same as or close to that of upper balloon 110 and lower balloon 120, and cover sheet 510 is firmly adhered to upper balloon 110, so that the cover sheet can withstand long-term immersion in gastric acid.
The degradable sheet 410 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 thickness of the film is 10-300 micrometers, the film is coupled between the upper layer balloon 110 and the cover sheet 510, and is locked by the fixing hole 411 and is not easily separated from the upper layer balloon 110, and the glue tape around the fixing hole 411 plays a role in sealing. In other embodiments, the degradable material is polydioxanone.
The degradable sheet 410 may also be oval or any other shape. The fixing hole 411 of the degradable sheet 410 can be two or more circles. The intragastric balloon according to the present application is used as follows: after the patient swallows the capsule containing the balloon 100 and a part of the catheter 200, the capsule is quickly dissolved in the stomach environment, and the filler which can be liquid or gas is conveyed into the balloon 100 through the external end of the catheter 200. Balloon 100 changes from an initial compressed state to an expanded state. After the filling, the catheter 200 is pulled out, and the liquid passage is automatically closed by the self-closing valve 300 under the pressure of the filler in the balloon 100, so as to prevent the filler in the balloon from leaking. The balloon 100 occupies the volume in the stomach for a long time, and the purpose of weight reduction is achieved. After the degradable sheet 410 is implanted into a human body for a period of time, the degradable sheet 410 is hydrolyzed and broken, the release channel 140 is opened, the structural integrity of the balloon is damaged, the filler in the balloon is discharged into the stomach of a patient, the volume of the balloon is reduced, and finally the filler is naturally discharged out of the body along with the gastrointestinal peristalsis.
Claims (23)
1. An in vivo implant closure and release structure, the in vivo implant comprising a balloon, a catheter and a filler, the balloon having a degradable sheet coupled thereto, characterized in that: the coupling part of the degradable sheet and the balloon main body is provided with discontinuous fixing holes, a cover sheet is arranged outside the degradable sheet, and the balloon main body is connected with the cover sheet through the fixing holes to fix the degradable sheet between the degradable sheet and the balloon main body.
2. The closure and release structure according to claim 1, wherein: one end of the catheter is connected with a self-closing valve on the balloon.
3. The closure and release structure according to claim 1, wherein: the sacculus includes upper sacculus and lower floor's sacculus, has at least one opening on the upper balloon as the release passageway of sacculus intussuseption.
4. The closure and release structure according to claim 1, wherein: the self-closing valve comprises an upper layer self-closing valve and a lower layer self-closing valve, wherein a conduit hole is formed in the lower layer self-closing valve, and the circumference of the conduit hole is not larger than the outer diameter of the conduit.
5. The closure and release structure according to claim 1, wherein: the upper layer self-closing valve and the upper layer balloon are integrated or are connected together by different materials in a bonding or welding mode.
6. The closure and release structure according to claim 1, wherein: the lower layer self-closing valve and the lower layer balloon are integrated or are connected together by different materials in a bonding or welding mode.
7. The closure and release structure according to claim 1, wherein: the upper layer sacculus and the upper layer self-closing valve are combined with the lower layer sacculus and the lower layer self-closing valve at the edge in a bonding or welding mode.
8. The closure and release structure according to claim 1, wherein: the degradable sheet is round, oval, square or other shapes, and a circle of discontinuous fixing holes are formed at the position close to the outer edge.
9. A closure and release structure according to claim 1, wherein: the upper layer sacculus and the lower layer sacculus are made of flexible materials such as silicon rubber or polyurethane.
10. The structure of claim 3, wherein: the cover sheet is made of the same material as or close to that of the upper layer saccule and the lower layer saccule.
11. The closure and release structure according to claim 1, wherein: the degradable sheet is a polylactic acid-based copolymer.
12. The closure and release structure according to claim 1, wherein: the degradable sheet is polydioxanone.
13. The structure of claim 11, wherein: the degradable sheet is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
14. A closure and release structure according to claim 1, wherein: the thickness of the degradable sheet film is 10-300 microns.
15. A closure and release structure according to claim 3, wherein: the degradable sheet is coupled between the upper balloon and the cover sheet and locked by the fixing holes.
16. The closure and release structure according to claim 1, wherein: the fixing hole on the degradable sheet is one circle or more than two circles.
17. A method of making the closure and release structure of claims 1-16, wherein: one end of the catheter is connected with the self-closing valve on the saccule, the saccule comprises an upper saccule and a lower saccule, wherein the upper balloon is provided with at least one opening as a release channel of the filler in the balloon, the self-sealing valve comprises an upper self-sealing valve and a lower self-sealing valve, wherein the lower layer self-closing valve is provided with a conduit hole, the perimeter of the conduit hole is not more than the outer diameter of the conduit, the upper layer balloon and the upper layer self-closing valve are combined with the lower layer balloon and the lower layer self-closing valve at the edges in a bonding or welding mode, and the combined balloon is turned over through the release channel on the upper layer balloon, the upper layer balloon and the lower layer balloon form the balloon, the upper layer self-closing valve and the lower layer self-closing valve form the self-closing valve, and the self-closing valve enters the balloon.
18. The method of claim 17, wherein: the catheter penetrates into the self-closing valve from the outside of the balloon, penetrates out of a catheter hole in the self-closing valve, enters the balloon and is used for filling filler into the balloon.
19. The method of claim 18, wherein: and (3) dispensing glue around the release channel of the upper layer balloon, covering the degradable sheet with the fixing holes on the glue around the release channel, and enabling the glue to overflow from the fixing holes of the degradable sheet.
20. The method of claim 19, wherein: and the cover plate is added on the surface of the degradable sheet and is adhered with the upper layer balloon at the fixing hole.
21. A closure and release structure according to claims 1-16, wherein: the implant is an in vivo implanted balloon system.
22. The structure of claim 21, wherein: the balloon system is an intragastric balloon system.
23. A closure and release structure according to claim 21, wherein: the balloon system is a skin dilation balloon system.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110255405.XA CN115040300A (en) | 2021-03-09 | 2021-03-09 | Closing and releasing structure of implant in body |
| PCT/CN2022/077163 WO2022188617A1 (en) | 2021-03-09 | 2022-02-22 | Closure and release structure for in-vivo implant |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110255405.XA CN115040300A (en) | 2021-03-09 | 2021-03-09 | Closing and releasing structure of implant in body |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115040300A true CN115040300A (en) | 2022-09-13 |
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| CN211980949U (en) * | 2020-04-20 | 2020-11-20 | 苏州万祥科技股份有限公司 | Self-fixing electronic connecting sheet |
| CN216090953U (en) * | 2021-03-09 | 2022-03-22 | 常州至善医疗科技有限公司 | Closing and releasing structure of implant in body |
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| CN216090953U (en) * | 2021-03-09 | 2022-03-22 | 常州至善医疗科技有限公司 | Closing and releasing structure of implant in body |
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