CN112138280B - Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease - Google Patents
Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease Download PDFInfo
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- CN112138280B CN112138280B CN202010990446.9A CN202010990446A CN112138280B CN 112138280 B CN112138280 B CN 112138280B CN 202010990446 A CN202010990446 A CN 202010990446A CN 112138280 B CN112138280 B CN 112138280B
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- flexible
- wall
- tubular shell
- gastroesophageal reflux
- esophagus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
Abstract
The invention particularly discloses a therapeutic apparatus with an infinite electric stimulation function for treating gastroesophageal reflux disease, which comprises a contraction device, an in-vivo control device, an operation device and an in-vitro control device, and is characterized in that the contraction device is attached to the outer wall of an esophagus and is close to the position of a cardiac, the contraction device comprises a tubular shell with an open end, a flexible lining symmetrically arranged on the inner wall of the tubular shell, and a plurality of electric elements integrated on the inner surface of the flexible lining, an inner cavity is formed between the inner surface of the tubular shell and the inner surface of the flexible lining, the upper end and the lower end of the inner cavity are encapsulated to form a closed cavity, and the in-vivo control unit responds to a control instruction sent by the in-vitro control device to control the operation device to change the flexible lining to contract the sphincter of the lower section of the esophagus so as to play a role of preventing reflux.
Description
Technical Field
The invention relates to the technical field of bioengineering, in particular to a therapeutic apparatus with an infinite electric stimulation function for treating gastroesophageal reflux disease.
Background
Gastroesophageal reflux disease (gastroesophageal reflux disease, GERD), a generic term for gastroesophageal reflux and esophageal mucosa injury diseases in which the esophageal cavity is caused by excessive contact (or exposure) with the contents of the upper digestive tract; refers to a disease in which reflux of stomach and duodenum contents into the esophagus or even the oral cavity causes clinical symptoms and/or esophageal inflammation. Reflux mainly comprises gastric acid and pepsin, and can also comprise duodenal juice, cholic acid, pancreatic juice and the like, and the disease is more likely to occur clinically after gastric mostly resection, gastrointestinal anastomosis and esophageal intestinal anastomosis. The occurrence of gastroesophageal reflux and its complications is multifactorial, including defects in the oesophageal itself in the anti-reflux mechanism, such as lower oesophageal sphincter dysfunction and oesophageal body movement abnormalities; there are also dysfunction of many mechanical factors outside the esophagus.
GERD is very common in western countries, with about 7% -15% of the population having gastroesophageal reflux symptoms, with the incidence increasing with age, 40-60 years of age being the peak age of onset, and men and women being indiscriminate, most reports suggest that in gastroesophageal reflux patients, men are significantly more than women. Investigation showed that the ratio of incidence of men and women was 2.4:1. in recent years, GERD has a significant upward trend in asia-pacific areas. GERD can severely affect the quality of life of patients, often manifested as acid regurgitation, heartburn, throat and poststernal discomfort; symptoms associated with the outside of the esophagus, such as chest pain, cough, hoarseness, aspiration pneumonia, and other lung aspiration syndromes, and even choking death, can also occur.
About half of patients with GERD have inflammatory lesions such as esophageal mucosa erosion and ulcer under the endoscope, and are called reflux esophagitis; however, a significant proportion of patients with gastroesophageal reflux disease may have no manifestations of reflux esophagitis under the endoscope, which is known as endoscopic gastroesophageal reflux disease.
At present, three main treatment modes exist for GERD: (1) Drug therapy is the primary treatment for GERD, but it is difficult to maintain long-term efficacy; (2) The fundoplication is a traumatic operation, and a part of patients have obvious dysphagia or abdominal distension after operation; (3) The radio frequency treatment of the sphincter of the lower esophagus is endoscopic minimally invasive treatment, the radio frequency ablation electrode needle in clinical application at present adopts an air bag to insert the electrode needle into tissue to be subjected to radio frequency ablation treatment, the esophagus is blocked during treatment, cooling water in the esophagus can flow out to the pharyngeal portion in a flushing mode, and the risk of being inhaled into the trachea by a patient exists.
Disclosure of Invention
Aiming at the technical problems in the treatment, the invention provides a therapeutic apparatus with an infinite electric stimulation function for resisting gastroesophageal reflux disease, which is operated by an external remote control internal device, and the internal device can be safely stored in a body for a long time and has the function of timely assisting in esophageal contraction and preventing gastroesophageal reflux.
The invention adopts the technical scheme that:
the utility model provides a therapeutic instrument with unlimited electric stimulation function's anti gastroesophageal reflux disease, includes constriction device, internal controlling means, operating means and external controlling means, constriction device is located the lower esophageal sphincter outside and the laminating of esophagus outer wall and is close to the position of cardiac, constriction device includes tubular casing that has open end, symmetrical arrangement in tubular casing inner wall's flexible inside lining, a plurality of electric elements of integration at flexible inside lining internal surface, form the inner chamber and encapsulate the inner chamber upper and lower end and form sealed cavity between tubular casing internal surface and the flexible inside lining internal surface, internal controlling means responds to the control command that external controlling means sent and controls operating means and change flexible inside lining and shrink the esophagus wall.
Preferably, the operation device hydraulically operates the constriction device, the operation device comprising a bi-directional pump and a fluid reservoir connected to the bi-directional pump, the in-body control device controlling the bi-directional pump to pump hydraulic fluid from within the expandable reservoir into the two lumens in the tubular housing to move the two flexible liners against the esophageal wall.
Preferably, the tubular shell is made of polytetrafluoroethylene, an opening is formed in the side wall of the tubular shell and penetrates through the longitudinal side wall of the tubular shell, two sides of the opening are connected in a locking mode, and the tubular shell is conveniently sleeved on the esophagus.
Preferably, the flexible lining is made of polytetrafluoroethylene film, and the width of the flexible lining is 2/3 of the diameter of the tubular shell.
Preferably, the electrical elements are arranged laterally along the inner surface of the flexible liner to form at least 4 columns of electrical element paths, each electrical element path comprising at least 4 electrical elements arranged longitudinally along the inner surface of the liner.
Preferably, the inner surface of the flexible lining is also provided with a pressure sensor attached to the esophagus wall.
Compared with the prior art, the invention has the beneficial effects that:
the present invention contemplates that when the flow in the lumen is stopped by laparoscopically implanting an anti-reflux esophagitis constriction device having an infinite electrical stimulation function to constrict the esophageal wall in time, the internal control device is adapted to control the electrical elements to simultaneously and cyclically stimulate the constricted wall portion, while the control device is adapted to control the electrical elements to vary the stimulation of the esophageal wall in response to sensing a patient physiological parameter or a device functional parameter, i.e., a pressure parameter of the esophageal wall. The gastroesophageal reflux prevention device has the advantages that gastroesophageal reflux is effectively prevented, the quality of life is obviously improved, long treatment course and poor compliance of drug treatment and various complications caused by surgical operation are avoided, meanwhile, the physiological structure of the gastroesophageal junction is not changed through the in-vitro control device, and the safety and flexibility in treatment are greatly improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of the therapeutic apparatus of the present invention implanted in a patient;
FIGS. 2-4 are longitudinal sections of the constriction device of the present invention;
fig. 5 is a structural view of the hydraulic operating principle of the compression device.
Wherein, 1-constriction device; 101-a tubular housing; 102-flexible liner; 103-lumen; 104-an electrical component; 2-operating means; 201-an expandable memory; 202-a bi-directional pump; 3-an in vivo control device; 4-an in vitro control device.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the 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 invention, as 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 made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
An anti-gastroesophageal reflux disease therapeutic apparatus with an infinite electric stimulation function as shown in fig. 1 includes a constriction device 1, an in-vivo control device 3, an operation device 2, and an in-vitro control device 4.
Specifically, the in-vivo control device 3 is adhered by polytetrafluoroethylene patches and fixed on diaphragm by a suture, an external interface is arranged on a shell of the in-vivo control device 3, and an in-vivo wireless transceiver module, an in-vivo control module, a stimulation signal generation module, an energy supply module and a pressure signal processing module which are integrated on the same control main board are arranged in the in-vivo control device. The energy supply module comprises an energy collection unit, a power management unit and an energy storage unit, wherein the in-vivo wireless receiving and transmitting module is connected with the in-vivo control module and is used for bidirectional wireless communication between the in-vitro control device and the in-vivo control device, the received stimulation signal parameters and various control instructions sent by the in-vitro control device are transmitted to the in-vivo control module, the esophageal wall pressure parameters output by the in-vivo control module are transmitted to the in-vitro control device to be received and stored, in addition, the in-vivo wireless receiving and transmitting module is further connected with the energy collection module, energy is extracted from a high-frequency electromagnetic wave signal received by the signal receiving device, the energy is processed into stable direct current suitable for charging through the power management module and is temporarily stored in the energy storage module (such as a flexible battery), and the energy storage module supplies stable energy to the in-vivo control module for relevant operation.
The in-vivo control module is also connected with the operation device 2, the operation device 2 hydraulically operates the constriction device 1, the operation device 2 comprises a bidirectional pump 202 and a fluid reservoir 201, the fluid reservoir 201 is connected with the bidirectional pump 202, and the in-vivo control module receives a control command sent by the in-vitro control device and further controls the bidirectional pump 202 to pump the hydraulic fluid in the fluid reservoir 201 to the constriction device, so that the esophagus wall is gently compressed in a compressed state (as shown in fig. 5).
The constriction device 1 is located at a position where the outer side of the sphincter of the lower esophageal segment is attached to the outer wall of the esophagus and is close to the cardia, the constriction device 1 comprises a tubular shell 101 with an open end, a flexible liner 102 symmetrically arranged on the inner wall of the tubular shell 101, and a plurality of electric elements 104 integrated on the inner surface of the flexible liner 102, an inner cavity 103 is formed between the inner surface of the tubular shell 101 and the inner surface of the flexible liner 102, and the upper end and the lower end of the inner cavity are packaged to form a closed cavity. The flexible liner 102 is made of polytetrafluoroethylene film, and the width of the flexible liner 102 is set to be 2/3 of the diameter of the tubular shell 101, so that the flexible liner can be conveniently extruded to form a contracted state by extruding the esophagus wall when expanding. The bi-directional pump 202 is communicated with the two inner cavities 103 through a hose, hydraulic fluid is pumped into the inner cavities 103, the volume of the inner cavities 103 is increased, the flexible lining 102 is forced to squeeze the esophagus wall, the distance of the esophagus inner cavity is reduced, the pressure parameter of the current esophagus wall is measured through the pressure sensor arranged on the inner surface of the flexible lining 102 and fed back to the pressure signal processing module, the original signal output by the pressure sensor is amplified and converted into a digital signal to be provided for the in-vivo control module, the in-vivo control module controls the output parameter-adjustable electric pulse signal to be output by the stimulation signal generating module to stimulate the esophagus wall through the stimulation signal generating module to further realize contraction, and the process is shown in fig. 2-4.
In the present invention, the electrical elements 104 are arranged laterally along the inner surface of the flexible liner to form at least 4 columns of electrical element paths, each electrical element path comprising at least 4 electrical elements arranged longitudinally along the inner surface of the liner. When the therapeutic device is in its stimulated state, it is important that different parts of the esophageal wall are stimulated in a manner that substantially maintains their natural physiological properties over time to prevent injury to the region, so that the internal control unit controls the pulse signal generation module to function as bi-directional electrical pulses (i.e., positive and negative pulse combinations) on the electrical components, the desired stimulation effect being achieved by varying the different pulse parameters, the pulse current should be between 1 and 30mA, and the pulse repetition frequency is suitably about 10Hz. To maintain the stimulation effect at any time, the internal control unit controls the pulse generation module to continuously energize each electrical element path in series in a direction opposite to the flow direction in the patient's esophageal lumen. So that each electrical element path that is not currently stimulated returns to substantially normal blood circulation before it is stimulated again.
In order to facilitate the fixing of the constriction device 1 to the esophageal wall, an opening is provided in the side wall of the tubular housing 101 and extends through the longitudinal side wall of the tubular housing 101, the two sides of the opening being connected in a snap-fit manner, said tubular housing 101 being of a polytetravinyl chloride material.
The extracorporeal control apparatus 4 of the present invention may employ a hand-held wireless remote control which can be conveniently operated by the patient to turn the constriction device on and off, the wireless remote control also being designed to be applied to the patient's body as a wristwatch. Such a watch-type remote controller may issue control signals that cause the patient's body to follow the signal-responsive equipment of the implanted device.
The above description is only of the preferred embodiments of the present invention, and is not intended to limit the present invention. Any simple modification, variation and equivalent variation of the above embodiments according to the technical substance of the invention still fall within the scope of the technical solution of the invention.
Claims (3)
1. The utility model provides a therapeutic apparatus with infinite electric stimulation function for treating gastroesophageal reflux disease, includes constriction device, internal controlling means, operating means and external controlling means, characterized in that, constriction device is located the lower esophageal sphincter outside and the outer wall laminating of esophagus and is close to the position of cardiac, constriction device includes tubular casing that has open end, the flexible inside lining of symmetrical arrangement in tubular casing inner wall, a plurality of electric elements of integration in flexible inside lining internal surface, form the inner chamber between tubular casing internal surface and the flexible inside lining internal surface and encapsulate the inner chamber upper and lower extreme and form sealed cavity, internal controlling means responds to the control command that external controlling means sent and controls operating means to change flexible inside lining and contract lower esophageal sphincter;
the operating device hydraulically operates the constriction device, the operating device comprising a bi-directional pump and a fluid reservoir, the fluid reservoir being connected to the bi-directional pump, the in-body control device controlling the bi-directional pump to pump hydraulic fluid from within the expandable reservoir into two lumens within the tubular housing to move the two flexible liners against the esophageal wall;
the tubular shell is made of polytetrafluoroethylene, an opening is formed in the side wall of the tubular shell and penetrates through the longitudinal side wall of the tubular shell, and two sides of the opening are connected in a locking manner, so that the tubular shell is conveniently sleeved on an esophagus;
the flexible lining is made of polytetrafluoroethylene film, and the width of the flexible lining is 2/3 of the diameter of the tubular shell.
2. A gastroesophageal reflux disease-resistant therapeutic device with electro-static stimulation function according to claim 1, wherein the electrical elements are arranged transversely along the inner surface of the flexible liner to form at least 4 rows of electrical element paths, each electrical element path comprising at least 4 electrical elements arranged longitudinally along the inner surface of the liner.
3. The therapeutic apparatus for gastroesophageal reflux disease with an infinite electric stimulation function according to claim 1, wherein the inner surface of the flexible lining is further provided with a pressure sensor attached to the esophageal wall.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010990446.9A CN112138280B (en) | 2020-09-19 | 2020-09-19 | Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010990446.9A CN112138280B (en) | 2020-09-19 | 2020-09-19 | Therapeutic apparatus with infinite electric stimulation function for resisting gastroesophageal reflux disease |
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| CN112138280A CN112138280A (en) | 2020-12-29 |
| CN112138280B true CN112138280B (en) | 2023-06-02 |
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Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US6463935B1 (en) * | 2000-02-10 | 2002-10-15 | Obtech Medical Ag | Controlled heartburn and reflux disease treatment |
| US6470892B1 (en) * | 2000-02-10 | 2002-10-29 | Obtech Medical Ag | Mechanical heartburn and reflux treatment |
| US6432040B1 (en) * | 2000-09-14 | 2002-08-13 | Nizam N. Meah | Implantable esophageal sphincter apparatus for gastroesophageal reflux disease and method |
| US9668690B1 (en) * | 2001-05-01 | 2017-06-06 | Intrapace, Inc. | Submucosal gastric implant device and method |
| ITMI20012046A1 (en) * | 2001-10-03 | 2003-04-03 | Sintesi S R L | ANTI-REFLUX GASTRO-ESOPHAGEAL VALVE PROSTHESIS |
| US20050228505A1 (en) * | 2004-03-29 | 2005-10-13 | Cornet Douglas A | Device and method for treating gastroesophageal reflux disease |
| EP1779821A1 (en) * | 2005-10-26 | 2007-05-02 | Etervind AB | Adjustable gastric band |
| US7881797B2 (en) * | 2006-04-25 | 2011-02-01 | Valentx, Inc. | Methods and devices for gastrointestinal stimulation |
| US20090012546A1 (en) * | 2007-07-03 | 2009-01-08 | Synecor, Llc | Devices for treating gastroesophageal reflux disease and hiatal hernia, and methods of treating gastroesophageal reflux disease and hiatal hernia using same |
| BRPI0817871B8 (en) * | 2007-10-11 | 2021-06-22 | Implantica Patent Ltd | device for controlling the flow in an organ of the body |
| WO2009096857A1 (en) * | 2008-01-29 | 2009-08-06 | Milux Holding Sa | A device, system and method for treating obesity |
| CN105213066B (en) * | 2014-06-25 | 2017-04-19 | 中国人民解放军第二军医大学 | Synthesized patch with wireless stimulation function and used for resisting reflux esophagitis |
| CN104688546A (en) * | 2015-02-13 | 2015-06-10 | 广州军区广州总医院 | Stomach tube preventing aspiration |
| CN110860038A (en) * | 2019-12-30 | 2020-03-06 | 南京智映博康医疗器械有限公司 | In-vivo passive electrical stimulation device for treating gastroesophageal reflux disease |
| CN110975146A (en) * | 2019-12-30 | 2020-04-10 | 南京智映博康医疗器械有限公司 | Wireless energy supply in-vivo active electrical stimulation device for treating gastroesophageal reflux disease |
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