Transesophageal vagus nerve electrical stimulation and stomach tube integrated device

Abstract

The invention provides a transesophageal vagus nerve electrical stimulation and stomach tube integrated device which comprises a double-channel mechanism which comprises a stomach tube and a wire conduit which are parallel, a conveying channel is arranged in the stomach tube, and a wire channel is arranged in the wire conduit; the outer catheter is sleeved outside the stomach tube and the conduit tube; the electrical stimulation device comprises an adjustable electrode array, a wire and an electrode controller; the adjustable electrode array is sleeved on the tube wall of the bottom of the outer guide tube; the electrode controller is positioned outside the top end of the outer catheter; the top end of the wire is connected with the electrode controller, and the bottom end of the wire is connected with the adjustable electrode array. In combination with the function of the stomach tube, nutrition support is provided, meanwhile, the vagus nerve trunk is accurately stimulated, the limitation of existing VNS is overcome, and the device has the advantages of being non-invasive, safe, small in side effect, high in stimulation efficiency and the like. In addition, a nutrition delivery function is integrated through the stomach tube, and the comprehensive treatment requirements of patients suffering from coma, dysphagia, gastroesophageal reflux and the like are met.

Description

Technical Field

[0001] The present invention relates to a transesophageal vagus nerve electrical stimulation and gastric tube integrated device. Background Art

[0002] Coma is a severe state of impaired consciousness, typically caused by brain injury, anoxic encephalopathy, or neurological disease. It can last for weeks to months and may even progress to a chronic vegetative state. The recovery of consciousness in comatose patients is highly unpredictable, leading to numerous challenges in treatment and care. Prolonged coma not only affects the patient's state of consciousness but is also often accompanied by a range of complications, including gastroesophageal reflux and swallowing disorders, which are common and serious health issues.

[0003] Gastroesophageal reflux is a common phenomenon in comatose patients during prolonged bed rest. Due to the impaired swallowing reflex caused by coma, gastric contents can easily flow back into the esophagus, causing complications such as aspiration and respiratory infections, seriously impacting the patient's recovery. Swallowing disorders, caused by damage or dysfunction of the vagus nerve, prevent patients from swallowing normally, increasing the risk of malnutrition, aspiration pneumonia, and respiratory failure. These problems not only complicate the recovery process for comatose patients, but also significantly reduce their quality of life and further complicate treatment.

[0004] Currently, the treatment of comatose patients relies primarily on drug intervention and neuromodulation techniques. Vagus nerve stimulation (VNS), as an emerging neuromodulation method, has made significant progress in neuroscience and clinical practice in recent years. Studies have shown that VNS can effectively activate the ascending reticular system, improve cerebral cortical function, and enhance cerebral blood perfusion, with the potential to promote the recovery of consciousness in comatose patients. VNS technology has also demonstrated good results in the treatment of epilepsy, depression, and neurorehabilitation.

[0005] In addition to restoring consciousness in comatose patients, VNS also has potential clinical applications in the treatment of swallowing disorders and gastroesophageal reflux. Swallowing disorders are often closely related to damage or dysfunction of the vagus nerve, which is responsible for regulating the movement of the esophagus and the swallowing reflex of the throat. Stimulating the vagus nerve through VNS can enhance the motor function of the esophagus and improve the swallowing reflex, thereby effectively alleviating swallowing disorders. In addition, VNS also has a positive effect on the treatment of gastroesophageal reflux. Studies have shown that by enhancing the motility of the stomach and esophagus and increasing the pressure of the lower esophageal sphincter, the symptoms caused by gastroesophageal reflux can be alleviated, the risk of aspiration can be reduced, and the quality of life of patients can be improved.

[0006] In the prior art, Chinese patent 202311249685.9 discloses an awakening system for rehabilitation of consciousness disorders, which includes a programmable module for setting multiple stimulation point combinations and multiple stimulation parameter combinations; an implantable spinal cord stimulation module for outputting stimulation signals in sequence according to multiple stimulation point combinations and multiple stimulation parameter combinations; an acquisition module for collecting EEG signals and EMG signals when the stimulation signals act on patients with consciousness disorders; a processing module for processing the EEG signals and EMG signals to obtain human body indicators, and determining the optimal stimulation point combination and the optimal stimulation parameter combination from multiple stimulation point combinations and multiple stimulation parameter combinations based on the human body indicators.

[0007] Chinese patent 201910633280.2 discloses a trans-auricular vagus nerve electrical stimulation coma awakening therapeutic device, which includes an in-ear protrusion, a charging interface, a power button, electrodes, control buttons, an LCD screen and an electrode lead-out cable. The electrode is an electrode at one end of the electrical stimulation and can be removably adhered to the surface of the ear. The in-ear protrusion, which serves as the other end electrode of the electrical stimulation, has a conductive silicone film attached to the surface and is worn on the ear in conjunction with the electrode. The charging interface can be directly connected to a power source for charging, and can also serve as an electrical stimulation output interface for the lead-out electrode cable. The control button sets the corresponding stimulation parameters and displays them on the LCD screen. The LCD screen also displays Bluetooth connection information, battery power information, and real-time electrical stimulation parameter information.

[0008] Chinese patent 201910347896.3 discloses a coma awakening treatment device based on transcutaneous median nerve electrical stimulation, which includes a power adapter, a lithium battery, a charge and discharge protection circuit, a common-mode power amplifier, a programmable chip, a display screen, a wireless communication module, electrode wires and electrode sheets.

[0009] The defects of the above technical solution are: high surgical risk, weak stimulation effect and limited efficacy.

[0010] Therefore, how to provide an integrated device that is non-invasive, safe, has few side effects, and has high stimulation efficiency has become a problem that the industry needs to solve. Summary of the Invention

[0011] In view of the shortcomings of the prior art, the purpose of the present invention is to provide an integrated electrical stimulation gastric tube device, which is non-invasive and safe, has few side effects and high stimulation efficiency.

[0012] In order to achieve the above objectives, the present invention provides an integrated transesophageal vagus nerve electrical stimulation and gastric tube device, comprising:

[0013] The dual-channel mechanism includes a gastric tube and a guide wire tube in parallel, wherein the gastric tube is a delivery channel and the guide wire tube is a guide wire channel;

[0014] External catheter, which is placed outside the gastric tube and guide wire;

[0015] An electrical stimulation device includes an adjustable electrode array, a wire, and an electrode controller; the adjustable electrode array is sleeved on the wall of the bottom of the outer catheter; the electrode controller is located outside the top end of the outer catheter; the wire passes through the wire tube, its top end is connected to the electrode controller, and its bottom end is connected to the adjustable electrode array.

[0016] In the present invention, the delivery channel and the wire channel are independent in structure and do not interfere with each other; the delivery channel is used to deliver drugs and nutrients; and the wire channel is used for the wires of the electrical stimulation device to pass through.

[0017] In the present invention, the electrical stimulation area (the area of action of the adjustable electrode array after the external catheter is inserted into place) corresponds to the distribution area of the anterior trunk and posterior trunk of the vagus nerve in the anatomy of the thoracic esophagus.

[0018] When in use, the lower end of the dual-channel mechanism is placed in the stomach for conventional intragastric drug administration and nutritional support functions.

[0019] The adjustable electrode array is made of flexible conductive material and can be adhered to the wall of the outer catheter.

[0020] The integrated device of the present invention is made of biocompatible materials and can be used continuously for several days to meet the long-term management needs of the ICU. It has the ability to electrically stimulate the vagus nerve through the esophagus while realizing the basic functions of a gastric tube, such as nutrient delivery and drug administration.

[0021] In the present invention, the electrical stimulation device is integrated with the vagus nerve through the esophagus and the gastric tube. Through non-invasive electrical stimulation technology, it directly acts on the vagus nerve, utilizing its regulatory effect on the central nervous system to promote the awakening of comatose patients; at the same time, combined with the function of the gastric tube to provide continuous nutritional support, it is mainly used for awakening and nutritional support of comatose patients.

[0022] According to another specific embodiment of the present invention, a limiting ring is provided at the top end of the outer catheter to prevent the catheter from being inserted too deep.

[0023] According to another specific embodiment of the present invention, the adjustable electrode array includes a plurality of independently adjustable annular electrodes, all of which are sleeved on the wall of the bottom of the outer catheter.

[0024] According to another specific embodiment of the present invention, a magnetic position marker or X-ray development material is provided on the electrode to facilitate positioning confirmation under clinical imaging.

[0025] According to another specific embodiment of the present invention, positioning scales are provided on the wall of the outer catheter to ensure accurate positioning of the electrode after insertion.

[0026] According to another embodiment of the present invention, the device further includes an anti-reflux mechanism comprising an inflation balloon and an inflation tube. The inflation tube is parallel to the gastric tube and the guidewire, and the outer catheter is sheathed over the gastric tube, the guidewire, and the inflation tube. The inflation balloon and the inflation tube are connected, and the inflation balloon is positioned below the bottom end of the outer catheter. When inflated, the balloon can closely contact the fundus of the stomach and abut the lower opening of the lower esophageal sphincter, thereby ensuring accurate positioning of the outer catheter and preventing displacement during stimulation.

[0027] According to another specific embodiment of the present invention, the adjustable electrode array is located above the inflatable balloon, and the inflatable balloon can prevent the adjustable electrode array from moving downward into the stomach.

[0028] The integrated device of this invention combines vagus nerve electrical stimulation with the function of a gastric tube. An adjustable electrode array is placed in the lower esophagus (the anterior and posterior trunks of the vagus nerve) and connected to an electrical stimulator via a wire to ensure that the stimulation signal is effectively transmitted to the vagus nerve. The integrated device of this invention has completed prototype development and conducted preliminary functional verification. The following is a summary of the research results:

[0029] 1. Device prototype structure and function testing

[0030] In experimental animals (C57BL / 6 mice and SD rats), the integrated device successfully achieved intubation and stable positioning in the thoracic esophagus. Imaging localization confirmed that the adjustable electrode array precisely adhered to the anterior and posterior vagus nerve anatomy. The electrodes exhibited excellent flexibility, and no tissue damage or bleeding occurred during intubation, demonstrating the device's suitability for practical use.

[0031] During vagus nerve stimulation, the animals' heart rate, heart rate variability (HRV), and other cardiovascular indicators were monitored. Heart rate variability (HRV) was used to verify effective vagus nerve activation. Results showed that the heart rate in the vagus nerve stimulation group decreased significantly by approximately 20–30%, while representative HRV indicators (standard deviation of normal RR intervals, SDNN, and root mean square difference, RMSSD) increased significantly by approximately 50–80%. SDNN increased from 5.6±1.2ms to 9.5±1.6ms, and RMSSD increased from 4.8±0.9ms to 8.7±1.4ms. These results confirmed that the increase in parasympathetic nerve activity was most pronounced, confirming successful vagus nerve activation.

[0032] 2. Experiment on the awakening model of comatose animals

[0033] A traumatic brain injury-induced coma model was established, and the mice were divided into a stimulation group and a control group. The stimulation group received vagus nerve electrical stimulation using the integrated device. Under the same nutritional intervention conditions, the average awakening time of the mice in the stimulation group was 2-4 hours earlier, and the average LORR score (used to assess the animal's recovery of consciousness) improved from 0 to 6 (out of a maximum of 7 points), a significant improvement compared to the control group (p<0.05), indicating that the device has a clear wake-promoting effect.

[0034] 3. Nutritional support function verification

[0035] The delivery channel is stable, ensuring smooth fluid administration. There's no reflux, blockage, or slippage, making it suitable for routine ICU gastric tube use. Nutritional delivery and electrical stimulation can be performed concurrently without cross-interference.

[0036] 4. Safety Assessment

[0037] All experimental animals showed no significant adverse reactions during the intervention period, with stable body temperature, weight, and basic vital signs. No significant inflammation or edema was observed in the tissues of the electrically stimulated area, demonstrating that the integrated device exhibited good biocompatibility and safety in this animal model.

[0038] Preliminary research results show that the integrated device can achieve effective and controllable vagus nerve electrical stimulation in animal models, and has a significant effect in promoting consciousness recovery; at the same time, it performs well in nutritional support, safety and ease of operation, verifying the technical feasibility and clinical application potential.

[0039] The present invention solves the technical problems of high surgical risk, weak stimulation effect and limited efficacy of general electrical stimulation methods. It combines the function of the gastric tube to accurately stimulate the vagus nerve trunk while providing nutritional support, overcomes the limitations of existing VNS, and has the advantages of non-invasive safety, small side effects and high stimulation efficiency. In addition, by integrating the nutritional delivery function through the gastric tube, the comprehensive treatment needs of patients with coma, dysphagia and gastroesophageal reflux can be met. The present invention will provide a safer, more effective and convenient means of awakening for patients with severe coma, promote the application of vagus nerve electrical stimulation in the field of neurorehabilitation, and has important medical value and social significance.

[0040] The present invention will be described in further detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 is a schematic diagram of the overall structure of the integrated device of Example 1;

[0042] Figure 2 This is another overall structural diagram of the integrated device of Example 1

[0043] Figure 3 This is a schematic diagram of the method of using the integrated device of Example 1. DETAILED DESCRIPTION

[0044] Example 1

[0045] This embodiment provides an integrated transesophageal vagus nerve electrical stimulation and gastric tube device (referred to as "integrated device" in the accompanying drawings), such as Figure 1 and 2 As shown, it includes: a dual-channel mechanism 1, an external catheter 2, an electrical stimulation device 3, and an anti-reflux mechanism 4.

[0046] The dual-channel mechanism 1 includes a parallel stomach tube 101 and a guide wire tube 102 . The stomach tube 101 contains a delivery channel, and the guide wire tube 102 contains a guide wire channel.

[0047] The anti-reflux mechanism 4 includes an inflation balloon 401 and an inflation tube 402 ; the inflation tube 402 is parallel to the gastric tube 101 and the guide tube 102 , and the inflation balloon 401 and the inflation tube 402 are connected; the inflation balloon 401 is located below the bottom end of the outer catheter 2 .

[0048] The outer catheter 2 is placed over the stomach tube 101, the guide tube 102, and the inflation tube 402. A stop ring 201 is provided at the top of the outer catheter 2 to prevent over-insertion. Positioning scales 202 are provided on the wall of the outer catheter 2 to ensure accurate electrode positioning after insertion.

[0049] The electrical stimulation device 3 includes an adjustable electrode array 31, a wire (not shown), and an electrode controller (not shown); the adjustable electrode array 31 is sleeved on the wall of the bottom of the outer catheter 2; the electrode controller is located outside the top end of the outer catheter 2; the wire passes through the wire tube 102, its top end is connected to the electrode controller, and its bottom end is connected to the adjustable electrode array 31. The adjustable electrode array is located above the inflatable balloon 401. The adjustable electrode array 31 includes a plurality of independently adjustable ring electrodes 301, all of which are sleeved on the wall of the bottom of the outer catheter 2. The ring electrodes 301 are provided with magnetic position markers or X-ray development materials to facilitate confirmation of positioning under clinical imaging.

[0050] In this embodiment, the limiting ring 201, positioning scale 202 and other structures provided on the outer catheter 2 can ensure that the adjustable electrode array 31 is accurately positioned after the outer catheter 2 is inserted into the esophagus, and the electrical stimulation interval can be fine-tuned by the external handle.

[0051] like Figure 3 As shown, an inflatable balloon is provided below the bottom end of the outer catheter 2. When inflated, the balloon can be in close contact with the bottom of the stomach and abut against the lower opening of the lower esophageal sphincter to achieve accurate positioning of the outer catheter and prevent displacement of the outer catheter during stimulation.

[0052] Although the present invention is disclosed above with reference to preferred embodiments, this is not intended to limit the scope of the present invention. Any person skilled in the art may make slight modifications without departing from the scope of the present invention. In other words, any equivalent modifications made in accordance with the present invention should be included within the scope of the present invention.

Claims

1. A transesophageal vagus nerve electrical stimulation and gastric tube integrated device, characterized in that: include: A dual-channel mechanism includes a gastric tube and a guide wire tube in parallel, wherein the gastric tube contains a delivery channel and the guide wire tube contains a guide wire channel; an outer catheter, which is placed outside the gastric tube and the guide wire tube; An electrical stimulation device includes an adjustable electrode array, a wire, and an electrode controller; the adjustable electrode array is sleeved on the wall of the bottom of the outer tube; the electrode controller is located outside the top end of the outer tube; the wire passes through the wire tube, its top end is connected to the electrode controller, and its bottom end is connected to the adjustable electrode array.

2. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: The top end of the outer tube is provided with a limiting ring to prevent the outer tube from being inserted too deep.

3. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: The adjustable electrode array includes a plurality of independently adjustable annular electrodes, all of which are sleeved on the wall of the bottom of the outer catheter.

4. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: The electrodes are provided with magnetic position markers or X-ray developing materials.

5. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: Positioning scales are provided on the tube wall of the outer catheter.

6. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: It further includes an anti-reflux mechanism, which includes an inflation balloon and an inflation tube; the inflation tube is parallel to the gastric tube and the guide tube, and the outer catheter is sleeved outside the gastric tube, the guide tube, and the inflation tube; the inflation balloon is connected to the inflation tube; and the inflation balloon is located below the bottom end of the outer catheter.

7. The transesophageal vagus nerve electrical stimulation and gastric tube integrated device according to claim 1, characterized in that: The adjustable electrode array is located above the inflatable balloon.

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