CN116492124A - Adjustable balloon system and adjusting method - Google Patents
Adjustable balloon system and adjusting method Download PDFInfo
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- CN116492124A CN116492124A CN202310691023.0A CN202310691023A CN116492124A CN 116492124 A CN116492124 A CN 116492124A CN 202310691023 A CN202310691023 A CN 202310691023A CN 116492124 A CN116492124 A CN 116492124A
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- 238000007789 sealing Methods 0.000 claims abstract description 100
- 238000005452 bending Methods 0.000 claims abstract description 19
- 239000007788 liquid Substances 0.000 claims description 31
- 210000002784 stomach Anatomy 0.000 claims description 30
- 239000000243 solution Substances 0.000 claims description 13
- 238000002513 implantation Methods 0.000 claims description 10
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 9
- 229920001971 elastomer Polymers 0.000 claims description 9
- 210000003238 esophagus Anatomy 0.000 claims description 9
- 239000000741 silica gel Substances 0.000 claims description 9
- 229910002027 silica gel Inorganic materials 0.000 claims description 9
- 238000001839 endoscopy Methods 0.000 claims description 7
- 238000002347 injection Methods 0.000 claims description 7
- 239000007924 injection Substances 0.000 claims description 7
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- 238000007599 discharging Methods 0.000 claims description 3
- 239000000499 gel Substances 0.000 claims description 3
- 238000003780 insertion Methods 0.000 claims description 3
- 230000037431 insertion Effects 0.000 claims description 3
- 238000002360 preparation method Methods 0.000 claims description 3
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Classifications
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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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 invention discloses an adjustable balloon system and an adjusting method, wherein the adjustable balloon system comprises a balloon, a connecting catheter and an inflating catheter; the adjustable balloon system further comprises a sealing cover and an accelerator; the two ends of the connecting conduit are respectively provided with a connecting end and a pre-bending end, one end of the connecting conduit, which is close to the pre-bending end, is connected with the balloon, the pre-bending end is positioned in the inner cavity of the balloon, and one end of the pre-bending end is sleeved with a self-closing sealing plug; the filling conduit and the sealing cover can be movably disassembled and assembled with the connecting end of the connecting conduit; two ends of the filling catheter are respectively connected with a luer connector and a three-way stop valve, and the accelerator is sleeved outside the balloon and the connecting catheter in a balloon compression state. The invention can adjust the stable placement of the saccule system and the volume adjustment after the saccule system is placed according to the self requirement of a patient, so as to adjust the weight-losing effect, realize the quantitative correction of diet, ensure the accurate control of weight reduction, meet the different weight-losing requirements of different users and improve the applicability.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an adjustable balloon system and an adjusting method.
Background
With the continuous development of society and the continuous improvement of living standard of people, the obese people are also increasing. With the increasing attention of people to obesity, various weight-losing methods are developed, and most weight-losing modes have no obvious effect, so that people start to hope to have a simple and uninfluenced weight-losing method which can help people to lose weight quickly.
Scientific studies have shown that the root cause of obesity is that energy intake exceeds energy expenditure, and calories are mainly derived from energy supply substances in ingested foods, and therefore scientific weight-loss methods should be carried out directly or indirectly around the reduction of energy intake. However, the conventional weight-reducing methods such as medicines, sports, operations and the like cannot achieve satisfactory weight-reducing effects, the root cause is that the reduction of energy intake is not solved, and the intragastric balloon implantation is a novel weight-reducing means which can increase stomach satiety through balloon inflation so as to reduce the energy intake of users, so that the method is gradually attracting attention. However, in the prior art, in order to ensure the stability and safety of the use of the conventional intragastric balloon, a specific volume is often adopted, so that excessive restrictions are brought to the weight-reducing staff, the intragastric balloon is not well suitable for different weight-reducing patients, the weight-reducing requirements of different people cannot be met, and certain use limitations exist, so that an adjustable balloon system and an adjusting method are urgently needed to solve the problems.
Disclosure of Invention
The present invention is directed to an adjustable balloon system and an adjusting method, which solve the above-mentioned problems in the prior art.
In order to achieve the above object, the solution of the present invention is: an adjustable balloon system comprising a balloon, a connecting catheter, and an inflation catheter; the adjustable balloon system further comprises a sealing cover and an accelerator; the connecting catheter is a bendable catheter, two ends of the connecting catheter are respectively provided with a connecting end and a pre-bending end, the connecting ends are provided with self-closing sealing sheets, one end, close to the pre-bending end, of the connecting catheter is connected with the balloon, the pre-bending end is positioned in the inner cavity of the balloon, and one end of the pre-bending end is sleeved with a self-closing sealing plug; the filling conduit and the sealing cover can be movably disassembled and assembled with the connecting end of the connecting conduit; two ends of the filling conduit are respectively connected with a luer connector and a three-way stop valve, the filling conduit is connected with a connecting end of the connecting conduit through the luer connector, and the other two ports of the three-way stop valve are respectively connected with a syringe and a solution bag; the sealing cover is used for sealing a connecting end port of the connecting catheter after the filling catheter is disassembled; the facilitator is sleeved outside the balloon and the connecting catheter in the compressed state of the balloon, so that the balloon and the connecting catheter can be fixed at the tail end of the endoscope through the facilitator and sent into the stomach of a user.
Further, the balloon is prepared from an acid-resistant silica gel elastomer, and the volume of the balloon is 400-700 ml.
Further, a sleeve is arranged at the connecting end, a connecting hole is arranged in the center of the sleeve, a connector end matched with the connecting hole is arranged on the luer connector, and the self-closing sealing piece is arranged at the connecting hole and used for sealing the connecting hole; the self-closing sealing piece is prepared from elastic rubber or elastic silica gel, an open slot is formed in the center of the self-closing sealing piece, the open slot can be one of a Chinese character 'Yi' -shaped, a Chinese character 'Shi' -shaped or a Chinese character 'mi' -shaped, the open slot is in a sealing state in a normal state, and the open slot is opened after the connector end of the luer connector is inserted, so that the connecting catheter and the filling catheter are mutually communicated.
Furthermore, the top of the sealing cover is provided with a connecting hole matched with the bottom of the sleeve, and a sealing gasket is arranged in the connecting hole.
Further, the injection capacity of the injector is 50-60 ml, and the injection end of the injector is also connected with a luer connector for connecting a three-way stop valve.
Further, the self-closing sealing plug comprises a shell, a spring and a plug body; the shell is sleeved on the pre-bent end, a flow guide cavity is arranged in the shell, and at least one through hole communicated with the flow guide cavity is formed in the outer side wall of the shell; the plug body is arranged in the flow guide cavity in a sliding way, and the spring is fixed at the top of the plug body and connected with the inner wall of the top of the flow guide cavity, so that the plug body is blocked between the flow guide cavity and the through hole under the action of the spring; the bottom of the plug body is provided with a first diversion hole, the outer side wall of the plug body is at least provided with a second diversion hole corresponding to the position of the through hole, the second diversion hole is communicated with the first diversion hole, and when the spring is compressed or stretched under the stress, the through hole can be communicated with the diversion cavity through the first diversion hole and the second diversion hole on the plug body.
Further, a cavity for accommodating the balloon is arranged in the center of the accelerator, and one end of the accelerator is a tip and is used for being connected with an endoscope.
The invention also provides an adjusting method of the adjustable balloon system, which is applied to the adjustable balloon system and comprises the following steps:
s1, performing preparation work of endoscopy according to a hospital procedure, and taking conscious sedation measures on a patient;
s2, performing endoscopy on a patient to evaluate whether a contraindicated device or other contraindicated symptoms exist;
s3, taking out the endoscope, thoroughly wiping the endoscope according to a hospital procedure, taking out the adjustable balloon system from the package, sequentially splitting all the parts, and then placing the parts on an operation platform one by one;
s4, fixing the accelerator at the distal end of the endoscope, rolling the uninflated balloon and the connecting catheter in the accelerator, enabling the tail end of the balloon to protrude 3mm from the accelerator end, positioning the connecting catheter at the proximal end hole of the accelerator, connecting the filling catheter with the connecting end of the connecting catheter through a luer connector, ensuring that the luer connector is tightly inserted into the connecting end, smearing medical lubricating gel or other lubricating substance on the outer side of the whole accelerator, putting the endoscope and the accelerator with the balloon and the connecting catheter together as a whole into the throat of a patient, and pushing the endoscope into the esophagus and the stomach according to a conventional insertion mode of the endoscope;
s5, after the endoscope reaches the stomach, connecting the other two ports of the three-way stop valve on the filling catheter with the syringe and the solution bag respectively, injecting 500ml of gas or liquid into the balloon, and pulling the endoscope to the proximal end to confirm whether the balloon is released from the accelerator;
s6, placing the tip of the endoscope on one side of a connecting catheter in the middle of the esophagus, pulling out the filling catheter, separating the filling catheter from the connecting catheter, fixing a sealing cover at the connecting end of the connecting catheter to seal the connecting catheter, pushing the saccule and the connecting catheter with the sealing cover into the stomach together through the tip of the endoscope after sealing, and removing the endoscope to finish the intragastric implantation of the adjustable saccule system;
s7, after the adjustable balloon system is fully implanted, checking through an endoscope to confirm whether the balloon and the connecting catheter are leaked, if all are normal, capturing the connecting end of the connecting catheter through the endoscope, pulling the connecting end to the tip of the endoscope, pulling the connecting end up through the movement of the endoscope, removing the sealing cover, reinserting the filling catheter, connecting the connecting end of the connecting catheter through a luer connector, and then loosening the filling catheter to enable the connecting end to slowly slide into the throat;
s8, observing the position of the balloon in the stomach through an endoscope, confirming that the balloon, the connecting catheter and the filling catheter are not twisted or folded, if the balloon, the connecting catheter and the filling catheter are twisted or folded, pulling the filling catheter to move by the tip of the endoscope, unlocking the twisted or folded position, then respectively connecting the other two ports of the three-way stop valve on the filling catheter with the syringe and the solution bag, supplementing or discharging gas or liquid injected into the balloon until the gas or liquid in the balloon reaches a proper volume, stopping, and repeating the step S6 to separate the filling catheter from the connecting catheter, connect the sealing cover with the connecting catheter, and then removing the endoscope.
Further, in step S5, the balloon is inflated or filled and if any resistance is encountered, the endoscope needs to be repositioned until the gas or liquid stops after it is easily flowing.
Further, when the adjustable balloon system needs to be taken out, the state of the balloon and the connecting catheter can be checked through an endoscope, the sealing cover is replaced by the filling catheter in a mode of step S7, then the gas or liquid in the balloon is emptied in a mode of step S8, and finally the balloon is grasped through grasping forceps or a clamp, so that the balloon is propped against the tip of the endoscope, and the balloon is taken out from the esophagus of a patient through the endoscope.
The beneficial effects of the invention compared with the prior art are as follows:
(1) The invention can occupy the stomach space in the stomach of a human body through the imbedding and expanding of the saccule, thereby leading a user to generate satiety, reducing meal and achieving the effect of losing weight;
(2) According to the invention, after the filling catheter is connected with the connecting catheter through the luer connector, the volume of the balloon can be regulated by the syringe and the solution bag connected with the other two ports of the three-way stop valve after the balloon is placed in the stomach, so that a user can adjust the weight-reducing effect according to the self requirement, the quantitative correction of diet is realized, the accurate control of weight reduction is ensured, the different weight-reducing requirements of different users are met, and the applicability is improved;
(3) According to the invention, through the arrangement of the sealing cover, the gas or liquid injected into the balloon can be prevented from leaking from one end of the connecting catheter after the filling catheter is disassembled, so that the stable use of the balloon is ensured;
(4) According to the invention, the connecting end and the pre-bending end of the connecting catheter are respectively provided with the self-closing sealing plug and the self-closing sealing piece, so that the connecting catheter can have certain tightness before the sealing cover is not used, the possibility of gas or liquid leakage in the balloon is reduced, and the stability of the balloon in use is further improved;
(5) According to the invention, through the arrangement of the accelerator, the balloon and the connecting catheter can be wrapped in the compressed state, so that the accelerator can be placed along with the movement of the endoscope after being connected with the endoscope, the stomach of the balloon is placed in the stomach, the implantation risk is reduced, and the pain of a patient during implantation is reduced;
(6) The adjusting method is applied to the adjustable balloon system, can realize stable placement and volume adjustment after placement of the adjustable balloon system, can meet different weight-losing requirements of different people, and has wider applicability.
Drawings
FIG. 1 is a schematic elevational view of an adjustable balloon system of the present invention after connection to an inflation catheter in a balloon compressed state;
FIG. 2 is a schematic illustration of the present invention in a normal cross-section after connection to an inflation catheter in the inflated condition of an adjustable balloon system;
FIG. 3 is a schematic illustration of the front cross-section of the adjustable balloon system of the present invention after the balloon is inflated and connected to a sealing cap;
FIG. 4 is an enlarged schematic view of the structure of FIG. 2A according to the present invention;
FIG. 5 is an enlarged schematic view of the structure of FIG. 3B according to the present invention;
FIG. 6 is a schematic view of a partial cross-sectional structure of the junction of the pre-bent tip and the self-closing plug of the present invention;
FIG. 7 is a schematic view of the bottom view of the junction of the sleeve and the self-closing sealing plate of the present invention;
fig. 8 is a schematic perspective view of the accelerator according to the present invention.
In the drawings, the list of components represented by the various numbers is as follows:
1. a balloon; 2. a connecting conduit; 21. a connecting end; 211. a sleeve; 212. a connection hole; 22. pre-bending the end head; 3. a luer fitting; 31. a connector end; 4. a filling catheter; 5. a three-way stop valve; 6. a self-closing sealing plug; 61. a housing; 611. a through hole; 62. a spring; 63. a plug body; 631. a diversion hole I; 632. a second diversion hole; 7. sealing cover; 71. a sealing gasket; 8. a facilitator; 9. a self-closing sealing piece; 91. an open slot.
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
Embodiment one:
as shown in fig. 1-8, an adjustable balloon system includes a balloon 1, a connecting catheter 2, and an inflation catheter 4; the adjustable balloon system further comprises a sealing cover 7 and an accelerator 8; the connecting catheter 2 is a bendable catheter, two ends of the connecting catheter 2 are respectively provided with a connecting end head 21 and a pre-bending end head 22, the connecting end head 21 is provided with a self-closing sealing piece 9, one end, close to the pre-bending end head 22, of the connecting catheter 2 is connected with the balloon 1, the pre-bending end head 22 is positioned in the inner cavity of the balloon 1, and one end of the pre-bending end head 22 is sleeved with the self-closing sealing plug 6; the filling conduit 4 and the sealing cover 7 can be movably assembled and disassembled with the connecting end head 21 of the connecting conduit 2; two ends of the filling conduit 4 are respectively connected with a luer connector 3 and a three-way stop valve 5, the filling conduit 4 is connected with a connecting end 21 of the connecting conduit 2 through the luer connector 3, and the other two ports of the three-way stop valve 5 are respectively connected with a syringe and a solution bag; the sealing cover 7 is used for sealing a port of the connecting end head 21 of the connecting catheter 2 after the filling catheter 4 is disassembled; the promoter 8 is sleeved outside the balloon 1 and the connecting catheter 2 in the compressed state of the balloon 1, so that the balloon 1 and the connecting catheter 2 can be fixed at the tail end of an endoscope through the promoter 8 and sent into the stomach of a user; wherein, the saccule 1 can be inflated by self inflation or liquid filling (the liquid filled and injected is normal saline), when the saccule 1 is placed in the stomach of a human body, the saccule 1 can move freely and occupy the stomach space by inflation, so that a user can feel full, thereby reducing meal and achieving the effect of losing weight; after the filling catheter 4 is connected with the connecting catheter 2 through the luer connector 3, the volume of the balloon 1 can be regulated by a syringe and a solution bag connected with the other two ports of the three-way stop valve 5 after the balloon is placed in the stomach, so that a user can adjust the weight-losing effect according to the self requirement, realize the quantitative correction of diet, ensure the accurate control of weight reduction, meet the different weight-losing requirements of different users, and improve the applicability; the sealing cover 7 can ensure that the gas or liquid injected into the balloon 1 can not leak from one end of the connecting catheter 2 after the filling catheter 4 is disassembled, thereby ensuring the stable use of the balloon 1; the arrangement of the self-closing sealing plug 6 and the self-closing sealing piece 9 can enable the connecting conduit 2 to have certain tightness before the sealing cover 7 is not used, reduce the possibility of gas or liquid leakage in the balloon 1, and further improve the stability of the balloon 1 in use; the arrangement of the accelerator 8 can enable the balloon 1 to wrap the balloon 1 and the connecting catheter 2 in a compressed state, so that the accelerator 8 can be placed along with the movement of the endoscope after being connected with the endoscope, the stomach placement of the balloon 1 is facilitated, the implantation risk is reduced, and the pain of a patient during implantation is reduced;
in a specific implementation manner of this example, the balloon 1 is made of an acid-resistant silica gel elastomer, and the volume of the balloon 1 is 400-700 ml; the balloon 1 prepared from the acid-resistant silica gel elastomer has good elasticity and acid resistance, so that the balloon 1 can stably expand the volume and reduce the corrosion of gastric acid to the balloon 1 when being used in the stomach, and the service life of the balloon 1 is prolonged; the volume of the balloon 1 is the volume of gas or liquid which can be filled into the balloon 1, and the maximum volume is not more than 700ml, so that side effects (such as gastric perforation and rupture) caused by overfilling of the balloon 1 are prevented, and the harm to human bodies is reduced;
in a specific implementation manner of this embodiment, a sleeve 211 is disposed at the connection end 21, a connection hole 212 is disposed in the center of the sleeve 211, a connector end 31 matched with the connection hole 212 is disposed on the luer connector 3, and the self-closing sealing piece 9 is disposed at the connection hole 212 and is used for sealing the connection hole 212; the self-closing sealing piece 9 is prepared by elastic rubber or elastic silica gel, an opening groove 91 is arranged in the center of the self-closing sealing piece 9, the opening groove 91 can be one of a 'one' -shaped, a 'cross' -shaped or a 'rice' -shaped structure (as shown in the figure) is preferred, the opening groove 91 is in a sealing state in a normal state, and the opening groove 91 is opened after the connector end 31 of the luer connector 3 is inserted, so that the connecting catheter 2 and the filling catheter 4 are mutually communicated; the self-closing sealing piece 9 at the connecting hole 212 can be in a sealing state in a normal state, and the opening slot 91 is opened after the connector end 31 of the luer connector 3 is inserted, so that under the condition that no pipeline is connected to the connecting end 21 of the connecting catheter 2, sealing can be realized through the self-closing sealing piece 9, meanwhile, the self-closing sealing piece 9 prepared by elastic rubber or elastic silica gel has good elastic and rebound effects, when the connector end 31 of the luer connector 3 is inserted into the opening slot 91 of the self-closing sealing piece 9, the self-closing sealing piece 9 can be extruded and opened, connection and mutual communication of the connecting catheter 2 and the filling catheter 4 are realized, liquid or gas can be fed into or led out of the balloon 1 through the filling catheter 4 and the connecting catheter 2, volume adjustment of the balloon 1 is realized, and when the filling catheter 4 is detached from the connecting end 21 of the connecting catheter 2, the self-closing sealing piece 9 can be automatically rebound and closed, and sealing of the connecting catheter 2 is realized;
in a specific implementation manner of this embodiment, a connecting hole matched with the bottom of the sleeve 211 is formed at the top of the sealing cover 7, and a sealing gasket 71 is arranged in the connecting hole; wherein, the sealing cover 7 can be fixed at the sleeve 211 in a spiral or clamping way, and the connecting hole can be used for accommodating the end part of the sleeve 211 so as to increase the connection tightness between the sealing cover 7 and the connecting end head 21; the sealing gasket 71 can be made of rubber or silica gel, so that the sealing performance of the joint of the sealing cover 7 and the sleeve 211 can be improved through the sealing gasket 71, and the sealing effect of the sealing cover 7 is further improved;
in a specific implementation manner of this embodiment, the injection capacity of the syringe is 50-60 ml, and the injection end of the syringe is also connected with a luer connector 3 (not shown in the figure) for connecting a three-way stop valve 5; after the injector is connected with the three-way stop valve 5 through the luer connector 3, the connection tightness of the injector and the three-way stop valve 5 can be ensured, and leakage of injection or gas can be reduced;
in a specific implementation of this embodiment, the self-closing sealing plug 6 comprises a housing 61, a spring 62 and a plug body 63; the shell 61 is sleeved on the pre-bent end 22, a diversion cavity is arranged in the shell 61, at least one through hole 611 communicated with the diversion cavity is arranged on the outer side wall of the shell 61, and the number of the through holes 611 is preferably two; the plug body 63 is slidably arranged in the diversion cavity, and the spring 62 is fixed at the top of the plug body 63 and connected with the inner wall of the top of the diversion cavity, so that the plug body 63 is blocked between the diversion cavity and the through hole 611 under the action of the spring 62; the bottom of the plug body 63 is provided with a first diversion hole 631, the outer side wall of the plug body 63 is provided with at least one second diversion hole 632 corresponding to the position of the through hole 611, the number of the second diversion holes 632 is preferably two, the second diversion holes 632 are communicated with the first diversion hole 631, and when the spring 62 is stressed to be compressed or stretched, the through hole 611 can be communicated with the diversion cavity through the first diversion hole 631 and the second diversion hole 632 on the plug body 63; wherein, the bottom of the shell 61 is also provided with an assembly hole for connecting the pre-bent end 22, so as to ensure that the self-closing sealing plug 6 can be clamped or in threaded connection with the pre-bent end 22; after the plug body 63 is movably arranged in the diversion cavity through the spring 62, when the balloon 1 is inflated or filled with liquid, air pressure or hydraulic pressure directly acts on the plug body 63 and presses the spring 62 to compress, the plug body 63 moves upwards in the diversion cavity and enables the through hole 611 to be communicated with the diversion cavity, so that injected gas or liquid can be ensured to be fed into the balloon 1 through the through hole 611, and the volume of the balloon 1 is adjusted; when the gas or liquid in the balloon 1 needs to be pumped out, the negative pressure generated by pumping out or pumping out will pull the spring 62 to stretch and push the plug 63 to descend along the diversion cavity, and the through hole 611 can be communicated with the diversion cavity through the diversion hole one 631 and the diversion hole two 632 to ensure that the gas or liquid in the balloon 1 can be pumped out; when the balloon 1 does not need to inject or discharge gas or liquid, the plug 63 can block the communication gap between the through hole 611 and the diversion cavity under the action of the spring 62, so as to ensure that the connecting conduit 2 can have enough sealing effect at the pre-bending end 22, and further reduce the leakage of the gas or liquid;
in a specific implementation of this embodiment, the center of the accelerator 8 is provided with a cavity for accommodating the balloon 1, and one end of the accelerator 8 is a tip for connecting an endoscope.
The invention also provides an adjusting method of the adjustable balloon system, which is applied to the adjustable balloon system and comprises the following steps:
s1, performing preparation work of endoscopy according to a hospital procedure, and taking conscious sedation measures on a patient;
s2, performing endoscopy on a patient to evaluate whether a contraindicated device or other contraindicated symptoms exist; among other contraindicated devices or other contraindicated conditions include, but are not limited to, patients less than 18 years old, pregnant patients, patients with history of gastrointestinal inflammation (including ulcers, any erosive gastritis, grade 3-4 esophagitis, barrett's esophagus, or special inflammation such as crohn's disease or ulcerative colitis), severe coagulation dysfunction (upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia), congenital or acquired gastrointestinal abnormalities (such as occlusions or stenosis), mood/eating disorders, disordered medications, systemic lupus erythematosus, scleroderma or other diagnosed or symptomatic autoimmune connective tissue diseases, medical conditions (cardiopulmonary disease), any other medical condition that may increase endoscopy or risk of weight loss, past gastric, esophageal-gastric weight loss or duodenal surgery, clinically significant esophageal gas, esophageal compartment, stenosis, annular or reticulum, movement disorders of the gastrointestinal tract (severe disorders, gastric or chronic constipation), need for known medications (such as non-steroidal ulcers), non-planned correction of allergy or unsupernicity of the user's behavior, non-monitored or the like, non-medical conditions of the user's diet;
s3, taking out the endoscope, thoroughly wiping the endoscope according to a hospital procedure, taking out the adjustable balloon system from the package, sequentially splitting all the parts, and then placing the parts on an operation platform one by one;
s4, fixing the accelerator 8 at the distal end of the endoscope, rolling the uninflated balloon 1 and the connecting catheter 2 in the accelerator 8, enabling the tail end of the balloon 1 to protrude 3mm from the end head of the accelerator 8, positioning the connecting catheter 2 at the proximal end hole of the accelerator 8, connecting the filling catheter 4 with the connecting end head 21 of the connecting catheter 2 through the luer connector 3, ensuring that the luer connector 3 is tightly inserted into the connecting end head 21, smearing medical lubricating gel or other lubricating substance on the outer side of the whole accelerator 8, putting the endoscope and the accelerator 8 with the balloon 1 and the connecting catheter 2 together as a whole into the throat of a patient, and pushing the endoscope into the esophagus and the stomach according to a conventional insertion mode of the endoscope;
s5, after the endoscope reaches the stomach, connecting the other two ports of the three-way stop valve 5 on the filling catheter 4 with a syringe and a solution bag respectively, then injecting 500ml of gas or liquid into the balloon 1, and if any resistance is met in the inflation or filling process of the balloon 1, repositioning the endoscope until the gas or liquid is easy to flow and then stops, and then pulling the endoscope proximally to confirm whether the balloon 1 is released from the accelerator 8;
s6, placing the tip of the endoscope on one side of the connecting catheter 2 in the middle of the esophagus, pulling out the filling catheter 4 to separate the filling catheter 4 from the connecting catheter 2, fixing the sealing cover 7 at the connecting end 21 of the connecting catheter 2 to seal the connecting catheter, pushing the balloon 1 and the connecting catheter 2 with the sealing cover 7 into the stomach together through the tip of the endoscope after sealing, and removing the endoscope to finish the intragastric implantation of the adjustable balloon system;
s7, after the adjustable balloon system is fully implanted, checking through an endoscope to confirm whether the balloon 1 and the connecting catheter 2 are leaked, if all are normal, capturing the connecting end head 21 of the connecting catheter 2 through the endoscope, pulling the connecting end head 21 to the tip of the endoscope to prevent the connecting end head 21 from being clamped at the connecting position, pulling the connecting end head 21 up through the movement of the endoscope, removing (preserving) the sealing cover 7, reinserting the filling catheter 4, connecting the filling catheter 4 with the connecting end head 21 of the connecting catheter 2 through the luer connector 3, and then loosening the filling catheter 4 to enable the filling catheter 4 to slowly slide into the throat;
s8, observing the position of the balloon 1 in the stomach through an endoscope, confirming that the balloon 1, the connecting catheter 2 and the filling catheter 4 are not twisted or folded, if the balloon 1, the connecting catheter 2 and the filling catheter 4 are twisted or folded, pulling the tip of the endoscope to move the filling catheter 4, untwisting the twisted or folded part, connecting the other two ports of the three-way stop valve 5 on the filling catheter 4 with a syringe and a solution bag respectively, supplementing or discharging gas or liquid injected into the balloon 1 until the gas or liquid in the balloon 1 reaches a proper volume, stopping, and repeating the step S6 to separate the filling catheter 4 from the connecting catheter 2, connecting the sealing cover 7 with the connecting catheter 2, and removing the endoscope.
In a specific implementation manner of this embodiment, when the adjustable balloon system needs to be taken out, the state of the balloon 1 and the connecting catheter 2 can be checked by an endoscope, the sealing cover 7 is replaced by the filling catheter 4 in a manner of step S7, then the gas or liquid in the balloon 1 is emptied in a manner of step S8, finally the balloon 1 is grasped by grasping forceps or a clip, so that the balloon 1 is propped against the tip of the endoscope, and the balloon 1 is taken out from the esophagus of the patient by the endoscope;
it should be noted that the adjustable balloon system provided by the present invention has a maximum lifetime of 12 months, and can be temporarily used for weight loss in morbid obese patients (BMI 40 and above or BMI35 and concomitant diseases) prior to bariatric surgery or other surgery, to reduce surgical sutures, and also temporarily used for weight loss in overweight or obese patients (BMI > 27).
In summary, the adjustable balloon system and the adjusting method provided by the invention can occupy the stomach space in the stomach of a human body through the imbedding and expanding of the balloon 1, so that a user can feel satiety, thereby reducing meal and achieving the effect of losing weight; after the filling catheter 4 is connected with the connecting catheter 2 through the luer connector 3, the volume of the balloon 1 can be regulated by a syringe and a solution bag connected with the other two ports of the three-way stop valve 5 after the balloon is placed in the stomach, so that a user can adjust the weight-losing effect according to the self requirement, realize the quantitative correction of diet, ensure the accurate control of weight reduction, meet the different weight-losing requirements of different users, and improve the applicability; the sealing cover 7 can ensure that the gas or liquid injected into the balloon 1 can not leak from one end of the connecting catheter 2 after the filling catheter 4 is disassembled, thereby ensuring the stable use of the balloon 1; the arrangement of the self-closing sealing plug 6 and the self-closing sealing piece 9 can enable the connecting conduit 2 to have certain tightness before the sealing cover 7 is not used, reduce the possibility of gas or liquid leakage in the balloon 1, and further improve the stability of the balloon 1 in use; the arrangement of the accelerator 8 can enable the balloon 1 to wrap the balloon 1 and the connecting catheter 2 in a compressed state, so that the accelerator 8 can be connected with the endoscope to realize the placement of the balloon 1 along with the movement of the endoscope, the stomach placement of the balloon 1 is facilitated, the implantation risk is reduced, and the pain of a patient during implantation is reduced.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms should not be understood as necessarily being directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Further, one skilled in the art can engage and combine the different embodiments or examples described in this specification.
While embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications, alternatives and variations may be made to the above embodiments by one of ordinary skill in the art within the scope of the invention.
Claims (10)
1. An adjustable balloon system comprising a balloon (1), a connecting catheter (2) and an inflation catheter (4); the method is characterized in that: the device also comprises a sealing cover (7) and a promoter (8); the connecting catheter (2) is a bendable catheter, two ends of the connecting catheter (2) are respectively provided with a connecting end head (21) and a pre-bending end head (22), a self-closing sealing piece (9) is arranged at the connecting end head (21), one end, close to the pre-bending end head (22), of the connecting catheter (2) is connected with the balloon (1), the pre-bending end head (22) is positioned in an inner cavity of the balloon (1), and one end of the pre-bending end head (22) is sleeved with a self-closing sealing plug (6); the filling conduit (4) and the sealing cover (7) can be movably assembled and disassembled with the connecting end (21) of the connecting conduit (2); two ends of the filling conduit (4) are respectively connected with a luer connector (3) and a three-way stop valve (5), the filling conduit (4) is connected with a connecting end (21) of the connecting conduit (2) through the luer connector (3), and the other two ports of the three-way stop valve (5) are respectively connected with a syringe and a solution bag; the sealing cover (7) is used for sealing a port of a connecting end head (21) of the connecting catheter (2) after the filling catheter (4) is disassembled; the accelerator (8) is sleeved outside the balloon (1) and the connecting catheter (2) in the compressed state of the balloon (1), so that the balloon (1) and the connecting catheter (2) can be fixed at the tail end of an endoscope through the accelerator (8) and sent into the stomach of a user.
2. An adjustable balloon system according to claim 1 and wherein: the balloon (1) is prepared from an acid-resistant silica gel elastomer, and the volume of the balloon (1) is 400-700 ml.
3. An adjustable balloon system according to claim 1 and wherein: the connecting end (21) is provided with a sleeve (211), the center of the sleeve (211) is provided with a connecting hole (212), the luer connector (3) is provided with a connector end (31) matched with the connecting hole (212), and the self-closing sealing piece (9) is arranged at the connecting hole (212) and used for sealing the connecting hole (212); the self-closing sealing piece (9) is prepared through elastic rubber or elastic silica gel, an open slot (91) is formed in the center of the self-closing sealing piece (9), the open slot (91) can be one of a shape like one Chinese character 'yi', a shape like ten Chinese character 'mi' or a shape like Chinese character 'mi', the open slot (91) is in a sealing state in a normal state, and the open slot (91) is opened after the connector end (31) of the luer connector (3) is inserted, so that the connecting guide tube (2) and the filling guide tube (4) are mutually communicated.
4. An adjustable balloon system according to claim 3 and wherein: the top of the sealing cover (7) is provided with a connecting hole matched with the bottom of the sleeve (211), and a sealing gasket (71) is arranged in the connecting hole.
5. An adjustable balloon system according to claim 1 and wherein: the injection capacity of the injector is 50-60 ml, and the injection end of the injector is also connected with a luer connector (3) for connecting a three-way stop valve (5).
6. An adjustable balloon system according to claim 1 and wherein: the self-closing sealing plug (6) comprises a shell (61), a spring (62) and a plug body (63); the shell (61) is sleeved on the pre-bent end (22), a flow guide cavity is formed in the shell (61), and at least one through hole (611) communicated with the flow guide cavity is formed in the outer side wall of the shell (61); the plug body (63) is arranged in the diversion cavity in a sliding way, and the spring (62) is fixed at the top of the plug body (63) and is connected with the inner wall of the top of the diversion cavity, so that the plug body (63) is blocked between the diversion cavity and the through hole (611) under the action of the spring (62); the bottom of the plug body (63) is provided with a first diversion hole (631), the outer side wall of the plug body (63) is at least provided with a second diversion hole (632) corresponding to the position of the through hole (611), the second diversion hole (632) is communicated with the first diversion hole (631), and when the spring (62) is stressed to be compressed or stretched, the through hole (611) can be communicated with the diversion cavity through the first diversion hole (631) and the second diversion hole (632) on the plug body (63).
7. An adjustable balloon system according to claim 1 and wherein: the center of the accelerator (8) is provided with a cavity for accommodating the balloon (1), and one end of the accelerator (8) is a tip and is used for being connected with an endoscope.
8. A method of adjusting an adjustable balloon system as claimed in any one of claims 1 to 7, comprising the steps of:
s1, performing preparation work of endoscopy according to a hospital procedure, and taking conscious sedation measures on a patient;
s2, performing endoscopy on a patient to evaluate whether a contraindicated device or other contraindicated symptoms exist;
s3, taking out the endoscope, thoroughly wiping the endoscope according to a hospital procedure, taking out the adjustable balloon system from the package, sequentially splitting all the parts, and then placing the parts on an operation platform one by one;
s4, fixing the accelerator (8) at the distal end of the endoscope, rolling the uninflated balloon (1) and the connecting catheter (2) in the accelerator (8), enabling the tail end of the balloon (1) to protrude out of the end head of the accelerator (8) for 3mm, positioning the connecting catheter (2) at a proximal end hole of the accelerator (8), connecting the filling catheter (4) with the connecting end head (21) of the connecting catheter (2) through the luer connector (3), ensuring that the luer connector (3) is tightly inserted into the connecting end head (21), smearing medical lubricating gel or other lubricating substance on the outer side of the whole accelerator (8), putting the endoscope and the accelerator (8) with the balloon (1) and the connecting catheter (2) into a patient as a whole, and pushing the endoscope into the esophagus and the stomach according to a conventional insertion mode of the endoscope;
s5, after the endoscope reaches the stomach, connecting the other two ports of the three-way stop valve (5) on the filling catheter (4) with a syringe and a solution bag respectively, injecting 500ml of gas or liquid into the balloon (1), and then pulling the endoscope to the proximal end to confirm whether the balloon (1) is released from the accelerator (8);
s6, placing the tip of the endoscope on one side of a connecting catheter (2) in the middle of an esophagus, pulling out an inflating catheter (4), separating the inflating catheter (4) from the connecting catheter (2), fixing a sealing cover (7) at a connecting end (21) of the connecting catheter (2) to seal the connecting catheter, pushing the balloon (1) and the connecting catheter (2) provided with the sealing cover (7) into the stomach together through the tip of the endoscope after sealing, and removing the endoscope to finish intragastric implantation of the adjustable balloon system;
s7, after the adjustable balloon system is fully implanted, checking through an endoscope to confirm whether the balloon (1) and the connecting catheter (2) are leaked, if all are normal, capturing the connecting end head (21) of the connecting catheter (2) through the endoscope, pulling the connecting end head (21) to the tip of the endoscope, pulling up the connecting end head (21) through the movement of the endoscope, removing the sealing cover (7), reinserting the filling catheter (4), connecting the filling catheter (4) with the connecting end head (21) of the connecting catheter (2) through the luer connector (3), and then loosening the filling catheter (4) to enable the filling catheter (4) to slowly slide into the throat;
s8, observing the position of the balloon (1) in the stomach through an endoscope, confirming that the balloon (1), the connecting catheter (2) and the filling catheter (4) are not twisted or folded, if the balloon is twisted or folded, pulling the filling catheter (4) to move by the tip of the endoscope, untwisting the twisted or folded part, then respectively connecting the other two ports of the three-way stop valve (5) on the filling catheter (4) with a syringe and a solution bag, supplementing or discharging gas or liquid injected into the balloon (1) until the gas or liquid in the balloon (1) reaches a proper volume, stopping, and repeating the step S6 to separate the filling catheter (4) from the connecting catheter (2), connect the sealing cover (7) with the connecting catheter (2), and removing the endoscope.
9. A method of adjusting an adjustable balloon system according to claim 7 and wherein: in step S5, the balloon (1) is inflated or filled and if any resistance is encountered, the endoscope needs to be repositioned until the gas or liquid stops after it is easy to flow.
10. A method of adjusting an adjustable balloon system according to claim 7 and wherein: when the adjustable balloon system needs to be taken out, the state of the balloon (1) and the connecting catheter (2) can be checked through an endoscope, the sealing cover (7) is replaced by the filling catheter (4) in a step S7 mode, then the gas or liquid in the balloon (1) is emptied in a step S8 mode, finally the balloon (1) is grabbed through grabbing pliers or clamps, the balloon (1) is propped against the tip of the endoscope, and the balloon (1) is taken out of the esophagus of a patient through the endoscope.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310691023.0A CN116492124A (en) | 2023-06-12 | 2023-06-12 | Adjustable balloon system and adjusting method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310691023.0A CN116492124A (en) | 2023-06-12 | 2023-06-12 | Adjustable balloon system and adjusting method |
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| CN116492124A true CN116492124A (en) | 2023-07-28 |
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| CN202310691023.0A Pending CN116492124A (en) | 2023-06-12 | 2023-06-12 | Adjustable balloon system and adjusting method |
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| CN (1) | CN116492124A (en) |
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- 2023-06-12 CN CN202310691023.0A patent/CN116492124A/en active Pending
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