Esophageal sphincter nerve stimulator

Abstract

The invention discloses an esophageal sphincter nerve stimulator which comprises a nerve stimulator body and two electrodes, the nerve stimulator body is connected with the two electrodes through a wire, the two electrodes are arranged at the front end of the probing end of the wire, and the nerve stimulator body provides stimulation treatment for esophageal sphincter muscles through the wire; mild electric signals are automatically sent to weak or dysfunctional lower esophageal sphincter muscles of a patient all day long, and long-term reflux is provided to control the nerve stimulator to automatically stimulate the lower esophageal sphincter muscles, so that the lower esophageal sphincter muscles work normally without causing any feeling to the patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to an esophageal sphincter nerve stimulator. Background Art

[0002] Gastroesophageal reflux refers to the reflux of gastric and duodenal contents into the esophagus, causing symptoms such as heartburn. Depending on whether it causes esophageal mucosal erosion or ulcers, it is divided into reflux esophagitis (RE) and non-erosive reflux disease (NERD).

[0003] Gastroesophageal reflux can be classified according to its frequency: physiological reflux and pathological reflux.

[0004] Physiological reflux: Gastroesophageal reflux occasionally occurs after a meal but does not cause clinical symptoms or pathological damage.

[0005] Pathological reflux: Frequent gastroesophageal reflux, or long-term reflux, or even reflux at night, is gastroesophageal reflux disease.

[0006] Reflux esophagitis is more serious than gastroesophageal reflux, and is also accompanied by a variety of complications such as esophageal stenosis, ulcers and gastrointestinal bleeding. Therefore, clinically, if the patient's condition continues to worsen, their daily work and life will be greatly disturbed. Many people are living a life worse than death because of gastric reflux.

[0007] Currently, there are relatively many treatment options for gastric reflux. For patients with mild symptoms, changing their lifestyle (such as losing weight, raising the head of the bed, quitting smoking, etc.) can effectively alleviate the condition. If reflux symptoms cannot be improved by changing their lifestyle, systematic drug treatment can be started.

[0008] However, when medications are ineffective, patients can be treated surgically. Unfortunately, so far only fundoplication has a clear therapeutic effect on gastric reflux, and it is currently recognized as the best anti-reflux surgical method. However, fundoplication also has many complications, such as dysphagia, lower esophageal stenosis, bleeding, perforation, malnutrition, etc. Therefore, foreign innovative companies are constantly developing new technologies to treat gastric reflux. For example, new gastric reflux treatment technologies such as magnetic ring sphincter enhancement are also being promoted in Europe and the United States, but there are not many studies and insufficient evidence from evidence-based medicine.

[0009] Although Johnson & Johnson acquired Torax Medical, the original creator of magnetic ring sphincter enhancement, sales in Europe and the United States have been disappointing five years later. It can be seen that magnetic ring sphincter enhancement is not an effective treatment. Summary of the invention

[0010] The object of the present invention is to provide an esophageal sphincter nerve stimulator to solve the problems raised in the above background technology.

[0011] To achieve the above-mentioned purpose, the present invention provides the following technical solution: an esophageal sphincter nerve stimulator, comprising a nerve stimulator and two electrodes, wherein the nerve stimulator and the two electrodes are connected by a wire, and the two electrodes are arranged at the front end of the wire insertion end, and the nerve stimulator provides stimulation therapy to the esophageal sphincter muscle through the wire.

[0012] Preferably, the two electrodes are elliptical in shape, and when the wire is inserted into the esophagus, the electrodes are placed in the lower part of the esophagus.

[0013] Preferably, the diameter of the wire is not greater than 2 mm.

[0014] Preferably, it also includes a wireless external editor, which wirelessly controls the neurostimulator.

[0015] Preferably, the neurostimulator is plugged and fixed to the wire, and the neurostimulator is placed subcutaneously.

[0016] Preferably, the neurostimulator, electrodes and leads are placed via minimally invasive laparoscopic surgery; after surgery, the wireless external editor is wirelessly programmed by the physician; if necessary, the stimulation therapy can be adjusted during future follow-up visits by the physician.

[0017] Preferably, a stimulation point in contact with a nerve is provided at the end of the electrode, and the stimulation point maintains contact with the nerve.

[0018] Preferably, the electrode is made of one or more of silver, platinum alloy, nickel, and nickel alloy, and the outer jacket of the electrode is made of a medical polymer insulating tube. The medical polymer material used in the medical polymer insulating tube can be selected from one or more of nylon, polyurethane, and polytetrafluoroethylene.

[0019] Beneficial effects: The beneficial effects of the present invention are: An esophageal sphincter neurostimulator of the present invention provides long-term reflux control by automatically sending mild electrical signals to the patient's weak or dysfunctional lower esophageal sphincter muscles throughout the day. The neurostimulator automatically stimulates the lower esophageal sphincter muscles to function normally without causing any sensation to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the structure of an esophageal sphincter nerve stimulator of the present invention.

[0021] In the attached figure: a neurostimulator 1, an electrode 2, and a wire 3. DETAILED DESCRIPTION

[0022] The technical solution of this patent is further described in detail below in conjunction with specific implementation methods.

[0023] An esophageal sphincter nerve stimulator comprises a nerve stimulator 1 and two electrodes 2, wherein the nerve stimulator 1 and the two electrodes 2 are connected by a wire 3, the two electrodes 2 are arranged at the front end of the insertion end of the wire 3, and the nerve stimulator 1 provides stimulation therapy to the esophageal sphincter muscle through the wire 3; the two electrodes 2 are elliptical, and when the wire 3 is inserted into the esophagus, the electrodes 2 are placed in the lower part of the esophagus; the diameter of the wire 3 is not greater than 2 mm; it also comprises a wireless external editor, and the wireless external editor wirelessly controls the nerve stimulator 1; the nerve stimulator 1 is plugged and fixed with the wire 3, and the nerve stimulator 1 is placed subcutaneously (abdomen); the nerve stimulator 1, the electrode 2 and the wire 3 are placed through minimally invasive laparoscopic surgery; after the surgery, the wireless external editor is wirelessly programmed by the doctor; if necessary, the stimulation therapy can be adjusted in the doctor's future follow-up.

[0024] The end of the electrode is provided with a stimulation point in contact with the nerve, and the stimulation point maintains contact with the nerve; the electrode is made of one or more of silver, platinum alloy, nickel, and nickel alloy, and the outer jacket of the electrode is made of a medical polymer insulating tube, and the medical polymer material used in the medical polymer insulating tube can be selected from one or more of nylon, polyurethane, and polytetrafluoroethylene.

[0025] The present invention provides long-term reflux control by automatically sending mild electrical signals to the patient's weak or dysfunctional lower esophageal sphincter muscles throughout the day. The neurostimulator automatically stimulates the lower esophageal sphincter muscles to function normally without any feeling to the patient.

[0026] The neurostimulator delivers stimulation therapy to the esophageal sphincter muscle via a lead wire. The device battery is expected to last approximately 7 (Generation 2 device) or 10 (Generation 1 device) years with the recommended stimulation algorithm. The neurostimulator and lead wire are placed via a minimally invasive laparoscopic procedure. After surgery, the wireless external editor is wirelessly programmed by the physician. If needed, stimulation therapy can be adjusted during future follow-up visits by the physician.

[0027] It has the following advantages: The procedure is simple and only requires the placement of 2 small electrodes of the wire in the lower esophagus and the placement of the neurostimulator under the skin (in the abdomen); The operation time is short, only 1 hour; Minimally invasive treatment, laparoscopic surgery; Do not change the patient's physiological structure and avoid adverse gastrointestinal reactions; Quick recovery.

[0028] The above specific embodiments further illustrate the purpose, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above are only specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

[0029] In the description of the present invention, it is necessary to understand that the terms indicating orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0030] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or the positions or positional relationships in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0032] In addition, the terms "horizontal", "vertical", "overhanging" and the like do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0033] In the present invention, unless otherwise clearly specified and limited, a first feature being above or below a second feature may include the first and second features being in direct contact, or may include the first and second features not being in direct contact but being in contact through another feature between them. Moreover, a first feature being above, above, and above a second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being below, below, and below a second feature includes the first feature being directly below and obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

Claims

1. An esophageal sphincter nerve stimulator, characterized in that: The invention comprises a nerve stimulator and two electrodes. The nerve stimulator and the two electrodes are connected by a wire. The two electrodes are arranged at the front end of the wire insertion end. The nerve stimulator provides stimulation therapy to the esophageal sphincter muscle through the wire.

2. The esophageal sphincter nerve stimulator according to claim 1, characterized in that: The two electrodes are oval in shape. When the wire is inserted into the esophagus, the electrodes are placed in the lower part of the esophagus.

3. An esophageal sphincter nerve stimulator according to claim 2, characterized in that: The diameter of the wire is no greater than 2 mm.

4. The esophageal sphincter nerve stimulator according to claim 1, characterized in that: Also included is a wireless external editor that wirelessly controls the neurostimulator.

5. The esophageal sphincter nerve stimulator according to claim 1, characterized in that: The neurostimulator is plugged and fixed with the lead wire and is placed subcutaneously.

6. The esophageal sphincter nerve stimulator according to claim 1, characterized in that: The neurostimulator, electrodes and leads are placed via minimally invasive laparoscopic surgery; after surgery, the wireless external editor is wirelessly programmed by the physician; if necessary, the stimulation therapy can be adjusted during future follow-up visits by the physician.

7. An esophageal sphincter nerve stimulator according to claim 1 or 2, characterized in that: The electrode tip is provided with a stimulation point in contact with the nerve, and the stimulation point maintains contact with the nerve.

8. An esophageal sphincter nerve stimulator according to claim 1, 2 or 7, characterized in that: The electrode is made of one or more of silver, platinum alloy, nickel, and nickel alloy. The outer jacket of the electrode is made of a medical polymer insulating tube. The medical polymer material used in the medical polymer insulating tube can be selected from one or more of nylon, polyurethane, and polytetrafluoroethylene.

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