A device for spinal cord stimulation

Abstract

The present invention discloses a device for spinal cord stimulation, which includes a programmer, a wireless power supply device, an electrode module, and a wireless power receiving device. The electrode module includes a left electrode, a right electrode, a left guiding tube, a right guiding tube, and a water sac. A hollow blind hole is provided at the head end of the left electrode. The left guiding tube is slidably sleeved outside the head end of the left electrode, and the length of the left guiding tube is slightly longer than the hollow blind hole at the head end of the left electrode. The right guiding tube is hollow, and the right electrode is slidably placed inside the right guiding tube. There is a hollow pipeline inside the right electrode, and the water sac is slidably placed inside the right electrode. The electrode module is detachably electrically connected to the wireless power receiving device and is placed inside the patient's body. The programmer and the wireless power supply device are electrically connected through a USB interface and are placed outside the patient's body. The present invention proposes a brand-new SCS scheme, which reduces the doctor's surgical volume, reduces the surgical trauma for the patient, reduces the patient's economic expenditure, reduces potential safety hazards, and does not affect magnetic resonance imaging.

Description

Technical Field

[0001] The present invention belongs to the field of medical equipment, and in particular relates to a device for spinal cord electrical stimulation. Background Art

[0002] Spinal cord stimulation (SCS) is a neuromodulation method that involves inserting a stimulating electrode into the epidural space of the spinal canal to stimulate the sensory neurons in the posterior horn of the spinal cord and the posterior column conduction bundle through electric current, thereby blocking the conduction of pain signals and achieving the purpose of treating pain. Currently, SCS technology is widely used in the treatment of neuropathic pain, cerebral ischemia, angina pectoris due to coronary heart disease, cancer pain, and other fields at home and abroad. Studies have shown that SCS can alleviate neuropathic pain induced by various causes and improve the quality of life of patients.

[0003] The SCS surgery is usually performed in two stages. In the first stage, electrodes are implanted under local anesthesia, and an electrical stimulation test is performed during the operation to preliminarily evaluate the effect of SCS. After the first stage of surgery, trial treatment can be performed for one week. If the patient's pain is relieved satisfactorily, an implantable pulse generator (IPG) can be placed in a second stage.

[0004] Postoperative regulation of SCS can depolarize peripheral nerve tissue to generate action potentials, thereby producing abnormal sensations. Commonly used SCS regulation parameters mainly include voltage, pulse width and frequency. Adjusting the above stimulation parameters can achieve individualized treatment effects during the treatment process.

[0005] The technical solutions currently used, especially the methods of use, are mainly derived from the contents described in the patent [US] External Pulse Generator Device and Associated Methods for Trial Nerve Stimulation-US2020254267A1 and its family patents.

[0006] The main problems with its use are:

[0007] 1. Because IPG is an expensive and non-reusable implantable device, and the implantation surgery is traumatic and expensive, the implantation is performed in two steps, which increases hospitalization time and costs.

[0008] 2. The implantation of the test electrode needs to reduce surgical trauma as much as possible. The surgical method of implantation through spinal puncture was chosen to avoid opening the vertebral body. This resulted in the conductor being thin and soft, and it was difficult to control the implantation direction during the implantation process, and it was easy to deviate from the central axis. At the same time, because the implanted part is long, it is more difficult to adjust when it deviates. In the actual operation, the conductor wire needs to be continuously pulled out and rotated through the puncture needle and then inserted again. It often takes multiple or even dozens of adjustments to achieve a satisfactory effect.

[0009] 3. The test electrode implanted by lumbar puncture in the first step is small and simple in structure, and the test result cannot fully reflect the effect after the electrode is implanted. The implanted IPG is large in size and hard in texture. The current surgical method is mostly to bury it under the skin of the front side of the waist where the skin is soft and less active, to reduce the patient's discomfort after implantation. This leads to the need to change the patient's position after the electrode is implanted during the operation, which may cause surgical complications such as electrode deviation and affect the surgical effect.

[0010] 4. The implanted IPG contains a battery, which may pose a safety and durability risk, and will also impose certain limitations on the magnetic field strength of the MRI examination. Summary of the invention

[0011] In order to solve the above technical problems, the present invention is achieved through the following technical solutions:

[0012] A device for spinal cord electrical stimulation comprises a program controller, a wireless power supply device, an electrode module and a wireless power receiving device, wherein the electrode module comprises a left electrode, a right electrode, a left guide tube, a right guide tube and a water bag, wherein a hollow blind hole is arranged at the head end of the left electrode, a left guide tube is slidably sleeved on the outer side of the head end of the left electrode, and the length of the left guide tube is slightly longer than the hollow blind hole at the head end of the left electrode; the right guide tube is hollow, the right electrode is slidably placed inside the right guide tube, a hollow pipe is arranged inside the right electrode, and the water bag is slidably placed inside the right electrode; the electrode module is detachably electrically connected to the wireless power receiving device and is placed inside a patient; the program controller and the wireless power supply device are electrically connected via a USB interface and are placed outside the patient.

[0013] The program controller comprises a power supply, a control circuit, a pulse generator, a screen, buttons and a shell.

[0014] The wireless power supply device comprises a power transmission line, tempered glass, an independent coil, a magnetic isolation sheet, a control circuit, a shell and a hydrogel layer; the wireless power receiving device comprises a power transmission line, tempered glass, an independent coil, a magnetic isolation sheet, a control circuit, a shell and a biocompatible polymer material coating.

[0015] The left guide pipe has four one-way valves arranged in an equidistant circumferential distribution inside the head end.

[0016] The water bag comprises an expansion part and a water delivery part. The expansion part is soft and thin and has a plurality of annular protrusions on the surface. The water delivery part has a smaller pipe diameter and a thicker pipe wall.

[0017] An annular protrusion is arranged on the outer edge of the head end of the right electrode, and an annular concave platform is arranged on the inner edge of the head end of the right guide tube.

[0018] A metal ring is built into the head end of the left guide tube, an electromagnet ring is built into the head end of the right guide tube, and a conducting wire is buried in the wall of the right guide tube.

[0019] Another object of the present invention is to provide a method for using a device for spinal cord electrical stimulation:

[0020] (1) During use, the left guiding catheter is sleeved on the front end of the left electrode, the right electrode is placed inside the right guiding catheter, and the water sac extends along the inside of the right electrode;

[0021] (2) Through the puncture needle for lumbar puncture, the left electrode, the right electrode, the left guiding catheter, the right guiding catheter and the water sac are adjusted in position within the spinal canal through intraoperative X-ray fluoroscopy. After the position meets the requirements, the electromagnetic ring built in the front end of the right guiding catheter is energized to generate an electromagnetic field, which attracts the metal ring built in the front end of the left guiding catheter, so that the front ends of the left guiding catheter and the right guiding catheter are butted;

[0022] (3) Then push the water sac so that half of the inflated part of the water sac enters the blind hole at the front end of the left electrode, and the other half remains in the empty tube at the front end of the right electrode. At this time, a certain amount of physiological saline is filled into the water sac through the water delivery part of the water sac, so that the inflated part of the water sac expands and squeezes the inner walls of the left electrode and the right electrode, forming a locking structure;

[0023] (4) Subsequently, slowly withdraw the right guiding catheter. Due to the electromagnetic ring, the left guiding catheter is also withdrawn along with the right guiding catheter;

[0024] (5) Then insert the ends of the left electrode and the right electrode into the connection holes of the transmission line of the wireless power receiving device, place the wireless power receiving device at a suitable position in the body and suture the wound;

[0025] (6) The programmer and the wireless power transmitting device are connected through a USB interface and placed outside the body;

[0026] (7) The wireless power receiving device is built with a Bluetooth module and automatically connects to the programmer after being powered on;

[0027] (8) During electrical stimulation, the wireless power transmitting device is attached to the patient through the hydrogel on its surface, corresponding to the position of the wireless power receiving device in the patient's body, and electrical transmission is performed, thereby realizing spinal cord electrical stimulation.

[0028] Another object of the present invention is to provide a system implementation principle of a device for spinal cord electrical stimulation:

[0029] (1) Programmer: Through the screen and buttons, instructions are sent to the control system, thereby controlling the pulse generator to generate pulse electrical signals, and the pulse electrical signals are transmitted to the wireless power transmitting device through the transmission line.

[0030] (2) Wireless power transmitting device: After receiving the pulse electrical signal, through the control circuit and the coil, the pulse electrical signal can be converted into an electromagnetic signal and the electromagnetic signal is transmitted to the wireless power receiving device.

[0031] (3) Wireless power receiving device: Through the control circuit and coil, it converts the received electromagnetic signal into a pulsed electrical signal to supply power to the electrode; in addition, the wireless power receiving device is built-in with a Bluetooth module, which automatically connects to the programmer after being powered on, and through the programmer, the control of a specific electrode can be achieved.

[0032] The beneficial effects of the present invention are:

[0033] The present invention designs a device for spinal cord electrical stimulation. Based on the existing technical principle of SCS, a completely new technical solution is proposed. The implantation mode is changed from a two-step operation to a one-step operation; the surgical method is changed from implanting by cutting the vertebral body to only implanting by puncture; the test electrode is improved to a test permanent dual-purpose electrode; the device layout is changed from an implantable generator to an external generator. Based on the above improvements, there are the following specific advantages:

[0034] 1. Greatly reduce the surgical volume of doctors;

[0035] 2. Reduce the surgical trauma and pain for patients;

[0036] 3. Reduce the economic expenditure of patients;

[0037] 4. There is no battery in the body, greatly reducing the safety hazard;

[0038] 5. It will not affect magnetic resonance imaging. Description of the Drawings

[0039] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0040] Figure 1 It is a schematic diagram of the overall structure of a device for spinal cord electrical stimulation;

[0041] Figure 2 It is a partial schematic diagram of the electrode module of a device for spinal cord electrical stimulation;

[0042] Figure 3 It is a schematic diagram of the electrode connection of a device for spinal cord electrical stimulation;

[0043] In the drawings, the list of components represented by each reference numeral is as follows:

[0044] 1. Programmer; 2. Wireless power transmission device; 3. Electrode module; 301. Left electrode; 302. Right electrode; 303. Left guiding tube; 304. Right guiding tube; 305. Water sac; 306. Metal ring; 307. Electromagnetic iron ring; 308. Check valve; 4. Wireless power receiving device. Detailed implementation mode

[0045] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0046] Embodiment

[0047] Refer to Figures 1 to 3 As shown, a device for spinal cord electrical stimulation includes a programmer 1, a wireless power transmission device 2, an electrode module 3, and a wireless power receiving device 4. The electrode module 3 includes a left electrode 301, a right electrode 302, a left guiding tube 303, a right guiding tube 304, and a water sac 305. The head end of the left electrode 301 is provided with a hollow blind hole. A left guiding tube 303 is slidably sleeved outside the head end of the left electrode 301, and the length of the left guiding tube 303 is slightly longer than the hollow blind hole at the head end of the left electrode 301. The right guiding tube 304 is hollow, and the right electrode 302 is slidably placed inside the right guiding tube 304. There is a hollow pipeline inside the right electrode 302, and the water sac 305 is slidably placed inside the right electrode 302. The electrode module 3 is detachably electrically connected to the wireless power receiving device 4 and is placed inside the patient. The programmer 1 and the wireless power transmission device 2 are electrically connected through a USB interface and are placed outside the patient.

[0048] The programmer 1 includes a power supply, a control circuit, a pulse generator, a screen, a button, and a housing.

[0049] The wireless power transmission device 2 includes a power line, toughened glass, an independent coil, a magnetic isolation sheet, a control circuit, a housing, and a hydrogel layer; the wireless power receiving device 4 includes a power line, toughened glass, an independent coil, a magnetic isolation sheet, a control circuit, a housing, and a biocompatible polymer material coating.

[0050] There are four check valves 308 evenly distributed in a circumferential manner inside the head end of the left guiding tube 303.

[0051] The water sac 305 includes an expansion part and a water delivery part. The expansion part is soft and thin, with several annular protrusions on the surface. The water delivery part has a smaller diameter and a thicker pipe wall.

[0052] An annular protrusion is provided at the outer edge of the head end of the right electrode 302, and an annular concave platform is provided at the inner edge of the head end of the right guiding tube 304.

[0053] A metal ring 306 is disposed inside the head end of the left guiding tube 303, an electromagnet ring 307 is disposed inside the head end of the right guiding tube 304, and wires are embedded in the wall of the right guiding tube (304).

[0054] Through the above-mentioned device and method, the SCS implantation mode is changed from a two-step operation to a one-step operation; the surgical method is changed from implanting through an incision in the vertebral body to only implanting through puncture; the test electrode is improved to a test permanent dual-purpose electrode; the device layout is changed from an implantable generator to an external generator. This greatly reduces the amount of surgery for doctors; reduces surgical trauma and pain for patients; reduces the economic expenditure of patients; there is no battery in the body, greatly reducing potential safety hazards; and it will not affect magnetic resonance imaging.

[0055] The preferred embodiments of the present invention disclosed above are only used to help illustrate the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to the specific embodiments described. Obviously, many modifications and variations can be made according to the content of this specification. These embodiments are selected and specifically described in this specification to better explain the principles and practical applications of the present invention, so that those skilled in the art can understand and utilize the present invention well. The present invention is only limited by the claims and their full scope and equivalents.

Claims

1. A device for spinal cord electrical stimulation, comprising a programmer (1), a wireless power supply device (2), an electrode module (3) and a wireless power receiving device (4), characterized in that: The electrode module (3) includes a left electrode (301), a right electrode (302), a left guiding tube (303), a right guiding tube (304), and a water sac (305). A hollow blind hole is provided at the head end of the left electrode (301). A left guiding tube (303) is slidably sleeved outside the head end of the left electrode (301), and the length of the left guiding tube (303) is slightly longer than the hollow blind hole at the head end of the left electrode (301). The right guiding tube (304) is hollow, and the right electrode (302) is slidably placed inside the right guiding tube (304). There is a hollow pipeline inside the right electrode (302), and the water sac (305) is slidably placed inside the right electrode (302). The electrode module (3) is detachably electrically connected to the wireless power receiving device (4) and is placed inside the patient's body. The programmer (1) and the wireless power transmitting device (2) are electrically connected through a USB interface and are placed outside the patient's body. A metal ring (306) is built in the head end of the left guiding tube (303), and an electromagnet ring (307) is built in the head end of the right guiding tube (304). The wire is buried in the wall of the right guiding tube (304). The water sac (305) includes an expansion part and a water delivery part, and there are several annular protrusions on the surface of the expansion part.

2. The device for spinal cord electrical stimulation according to claim 1, characterized in that, The programmer (1) includes a power supply, a control circuit, a pulse generator, a screen, buttons, and a housing.

3. The device for spinal cord electrical stimulation according to claim 1, characterized in that, The wireless power transmitting device (2) includes a power line, toughened glass, an independent coil, a magnetic isolation sheet, a control circuit, a housing, and a hydrogel layer. The wireless power receiving device (4) includes a power line, toughened glass, an independent coil, a magnetic isolation sheet, a control circuit, a housing, and a biocompatible polymer material coating.

4. The device for spinal cord electrical stimulation according to claim 1, characterized in that, There are four one-way valves (308) evenly distributed in a circumferential manner inside the head end of the left guiding tube (303).

5. The device for spinal cord electrical stimulation according to claim 1, characterized in that, A circular protrusion is provided on the outer edge of the head end of the right electrode (302), and a circular concave platform is provided on the inner edge of the head end of the right guiding tube (304).

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