Electrode system

Abstract

The utility model provides an electrode system. The electrode system comprises an implantation unit and a program control unit, wherein the implantation unit is in wireless communication connection with the program control unit; the implantation unit comprises an electrode and a stimulator, the electrode and the stimulator are connected through a wire, the electrode is made of a biocompatible material, a plurality of electrode plates are arranged on the surface of the electrode, and the electrode plates are connected to the stimulator through wires; the program control unit comprises a program control instrument, the program control instrument is in wireless communication connection with the stimulator, the electrode is made of a nickel-titanium alloy material, the nickel-titanium alloy has a unique shape memory effect and superelasticity and can recover to a preset shape under a specific temperature condition, and the electrode in the electrode system can be flatly unfolded to form a plane under a power-on condition, so that the electrode system is convenient to use. The electrode is recovered to be tubular after being powered off, so that the electrode is more convenient to implant and take out, the fitting degree of the electrode and the surface of the spinal cord is higher, the electrical stimulation effect is improved, and the electrode has the advantages of simplicity and convenience in operation, high efficiency and long service life.

Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of electrode, in particular to an electrode system. BACKGROUND

[0002] Spinal cord stimulation (SCS) is to implant electrodes in the epidural space of the spinal canal or near the peripheral nerves, through the stimulator implanted in the body to send electric pulses, stimulate the dorsal column of the spinal cord, spinal nerve root, dorsal root ganglion or peripheral nerves, adjust the function of the nervous system to achieve the purpose of relieving pain, which is a minimally invasive reversible, effective and safe nerve control therapy.

[0003] Traditional electrodes are divided into columnar electrodes and paste electrodes, wherein the columnar electrode has small surgical operation trauma and only needs to be sent to the corresponding epidural space through a puncture needle, but the columnar electrode cannot meet the effect of stimulating the bilateral affected limbs at the same time due to small coverage area; although the paste electrode can cover the bilateral patients at the same time, the paste electrode needs to open part of the vertebral plate during the operation process, and the trauma is relatively large and the operation process is complex, so that the patient is afraid of the operation.

[0004] Therefore, it is urgent to redesign a new electrode system to solve the above problems. INVENTION CONTENTS

[0005] The utility model provides an electrode system to solve the technical problem proposed in the above background art.

[0006] The utility model provides an electrode system, the electrode system includes implant unit and program control unit, and implant unit and program control unit are connected through wireless communication;

[0007] The implant unit includes an electrode and a stimulator, the electrode and the stimulator are connected by a wire, the electrode is made of biocompatible material, a plurality of electrode pieces are arranged on the surface of the electrode, and the electrode pieces are connected to the stimulator by wires.

[0008] The program control unit includes a program control instrument, and the program control instrument is connected to the stimulator through wireless communication.

[0009] Optionally, the electrode is made of nickel-titanium alloy material, the nickel-titanium alloy has unique shape memory effect and super elasticity, and can restore to the pre-set shape under specific temperature conditions, that is, the electrode can be flatly unfolded into a plane under the condition of power-on, and the electrode restores to a tubular shape after power-off, so as to facilitate implantation and removal, and improve the adhesion to the surface of the spinal epidural space.

[0010] Optionally, the electrode pieces are embedded on the surface of the electrode, the outer side of the electrode piece is used for outputting a stimulation signal to stimulate the spinal nerve, and the inner side of the electrode piece is used for connecting the wire, and the arrangement and number of the electrode pieces are designed according to the needs to realize effective stimulation on a specific area.

[0011] Optionally, the end of the lead wire is connected with a waterproof connector, and the waterproof connector is connected with the electrode sheet to ensure safe use of the electrode in a humid environment.

[0012] The lead wire is used to transmit a stimulation signal of the stimulator to the electrode sheet.

[0013] Optionally, the lead wire has an electromagnetic shielding layer inside to reduce the influence of external electromagnetic interference on the electric stimulation signal.

[0014] Optionally, the stimulator is provided with a microprocessor and a power module, the microprocessor is connected with the power module, the microprocessor is used to receive external instructions and control the on-off state and intensity of the electric current, and the power module is used to provide the required power for the electrode.

[0015] The stimulator is used to adjust the on-off state of the electric current signal to control the shape conversion of the electrode and realize the regulation and control of various parameters of the electrode, including the electric current, voltage, frequency and pulse width.

[0016] Optionally, the power module is a rechargeable battery, which can improve the use time of the stimulator.

[0017] Optionally, the stimulator is provided with a power management module, the power management module is connected with the power module, and the power management module is used to monitor the state of the power module and send a warning signal when the power is lower than a preset value.

[0018] Optionally, the program control unit further comprises a program control charger and an external program control instrument, the stimulator is provided with a wireless charging module, the program control charger corresponds to the charging module, and the program control charger can wirelessly charge the stimulator to ensure that the stimulator can be normally used.

[0019] Optionally, the external program control instrument is wirelessly connected with the stimulator to adjust and monitor the physiological parameters of the patient, help medical staff to understand the physiological condition of the patient in real time, and take corresponding treatment measures in time.

[0020] The beneficial effects of the utility model are as follows:

[0021] The electrode in the electrode system can be unfolded into a plane under the condition of being electrified, and is restored into a tubular shape after being de-energized, so that the electrode is more convenient in the implantation and removal process, and has higher adhesion to the surface of the spinal cord, thereby improving the electric stimulation effect, and has the advantages of simple operation, high efficiency and long service life. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0023] Fig. 1 is a structural schematic diagram of an electrode system provided by the present application;

[0024] Fig. 2 is a structural schematic diagram of a stimulator provided by the present application;

[0025] Fig. 3 is a perspective view of an implant unit provided by the present application;

[0026] Fig. 4 is a partial structural schematic diagram of an implant unit provided by the present application. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present application will be described clearly and completely in combination with the drawings in the embodiments of the present application. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, it should be noted that, in order to facilitate the description, only the parts related to the present application are shown in the drawings, but not all the structures. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0028] In this document, reference to“an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase“in an embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive of one another. Those skilled in the art will understand that the embodiments described herein are merely examples of the application and are not the only way in which the application can be practiced.

[0029] Please refer to Figs. 1 to 4 The electrode system of the present application comprises an implant unit and a programming unit, and the implant unit and the programming unit are connected in wireless communication.

[0030] The implant unit comprises an electrode 1 and a stimulator 2, and the electrode 1 and the stimulator 2 are connected through a lead wire 3. The electrode 1, the stimulator 2 and the lead wire 3 are all implanted in a living body.

[0031] Optionally, the electrode 1 is made of a biocompatible material. Preferably, the electrode 1 is made of a nickel-titanium alloy material, which has a unique shape memory effect and super-elasticity, and can restore to a pre-set shape under certain temperature conditions, i.e. the electrode 1 can be flatly unfolded under the condition of being electrified, so that the electrode 1 is more easily attached to the surface of the epidural space of the spinal cord, to improve the adhesion of the electrode 1 to the surface of the spinal cord, thereby improving the effect of electrical stimulation, and also reducing the displacement problem.

[0032] When the electrode 1 is de-energized, it restores to a tubular shape, so as to be implanted and removed by minimally invasive surgery, and to reduce damage to the surrounding tissues and reduce the risk of surgery.

[0033] The nickel-titanium alloy has good biocompatibility, which can reduce tissue reaction and improve patient comfort.

[0034] In addition, the electrode 1 is provided with a plurality of electrode pieces 101 embedded on the surface of the electrode 1. The outer side of the electrode piece 101 is used to output a stimulation signal to stimulate the spinal cord nerves, and the inner side of the electrode piece 101 is used to connect the lead wire 3. The arrangement and number of the electrode pieces 101 are designed according to the needs to achieve effective stimulation of specific areas.

[0035] Specifically, the manufacturing steps of the electrode 1 are as follows:

[0036] S1, preparing a nickel-titanium alloy material: mixing nickel and titanium in a certain proportion, and preparing a nickel-titanium alloy material by melting, casting and other processes to ensure that the material has excellent memory effect and biocompatibility;

[0037] S2, forming processing: the prepared nickel-titanium alloy material is subjected to extrusion, stretching and heat treatment processes to make the electrode 1 into the required shape, which ensures that the electrode 1 has good mechanical strength and flexibility, can adapt to the complex spinal cord structure in the human body, and ensures that the electrode 1 is flat after being electrified, has an ideal coverage area / width of the electrode 1 is moderate;

[0038] S3, surface treatment: the formed nickel-titanium alloy electrode 1 is subjected to surface treatment, including polishing, cleaning and passivation treatment, to remove surface impurities and oxides, and to improve the electrical conductivity, biocompatibility and corrosion resistance of the electrode 1;

[0039] S4, electrode assembly: the surface-treated nickel-titanium alloy electrode 1 is assembled with the stimulator 2 and the lead wire 3 to ensure that the electrode 1 can stably conduct current and reliably connect with the external stimulation device;

[0040] S5, performance test: the assembled spinal cord electrical stimulation electrode 1 is subjected to electrical performance, mechanical performance and biocompatibility tests to ensure that it can provide stable and effective electrical stimulation in actual use and avoid adverse reactions to human tissues.

[0041] Referring to Figs. 1 to 4 The stimulator 2 is used to adjust the on-off state of the current signal to control the shape conversion of the electrode 1, and at the same time realize the regulation of various parameters of the electrode 1, including current, voltage, frequency and pulse width, so as to realize electric stimulation of different intensity and frequency, and adapt to the treatment needs of different patients.

[0042] Among them, the stimulator 2 is provided with a microprocessor and a power module, the microprocessor is connected with the power module, the microprocessor is used to receive external instructions and control the on-off and intensity of the current, and the power module is used to provide the required power for the electrode 1.

[0043] Preferably, the power module is a rechargeable battery, which can improve the use time of the stimulator 2.

[0044] In addition, the stimulator 2 is provided with a power management module, the power management module is connected with the power module, and the power management module is used to monitor the state of the power module and send a warning signal when the power is lower than the preset value. The initial parameters of the stimulator 2, including the intensity of the current, the on-off frequency, etc., are used to ensure the stability of the electrode 1 during the implantation process.

[0045] Referring to Figs. 1 to 4 The lead 3 is used to transmit the stimulation signal of the stimulator 2 to the electrode sheet 101.

[0046] Among them, one end of the lead 3 is connected with a waterproof connector, the waterproof connector is connected with the electrode sheet 101, so as to ensure the safe use of the electrode 1 in a humid environment.

[0047] In addition, the lead 3 has an electromagnetic shielding layer to reduce the influence of external electromagnetic interference on the electric stimulation signal.

[0048] Referring to Figs. 1 to 2 The program control unit includes a program control instrument, and the program control instrument is in wireless communication connection with the stimulator 2. The patient can set the parameters of the stimulator 2 through the program control instrument, including controlling the frequency, pulse width and amplitude of the stimulator 2.

[0049] Among them, the program control unit further includes a program control charger and an external program control instrument, the stimulator 2 is provided with a wireless charging module, the program control charger corresponds to the charging module, and the program control charger can wirelessly charge the stimulator 2 to ensure that the stimulator 2 can be used continuously and normally.

[0050] In addition, the external program control instrument is in wireless communication connection with the stimulator 2, and the external program control instrument is mainly placed at the medical staff, so as to facilitate the medical staff to adjust and monitor the physiological parameters of the patient, and help the medical staff to understand the physiological condition of the patient in real time, so as to take corresponding treatment measures in time.

[0051] In specific use, the patient is placed in a proper position, and the specific implantation site of the epidural space of the spinal cord and the condition of the epidural space are determined through an imaging device. The surgical area is fully disinfected with a disinfectant liquid to ensure a sterile operation environment. Local anesthesia or general anesthesia is adopted, and the most appropriate anesthesia mode is selected according to the specific condition. The puncture needle reaches the epidural space, and the electrode 1 is implanted in a tubular state to reach the target height spinal cord level. The position of the electrode 1 is monitored in real time under the assistance of the imaging device to ensure that the electrode 1 is accurately positioned at the target segment. The electrode 1 is connected with the stimulator 2 through the lead wire 3, and after being powered on, the tubular electrode 1 is flattened in the epidural space, and the stimulator 2 can reproduce the preoperative pain site of the patient by setting different parameters. The electrode 1, the stimulator 2 and the lead wire 3 are sutured and fixed by using a suture instrument. After the operation, the patient is routinely monitored, and the recovery condition of the implantation site of the electrode 1 is observed.

[0052] In the present application, the electrode 1 is powered off in a tubular state when being implanted, so that the electrode 1 can be implanted and taken out through a minimally invasive surgical method, the damage to the surrounding tissues is reduced, the operation risk is reduced, and the risk of easy displacement is also reduced.

[0053] When the electrode 1 is powered on and expanded, the electrode 1 can be attached to the surface of the epidural space of the spinal cord, so that the attachment of the electrode 1 to the surface of the spinal cord is improved, and the effect of the electric stimulation is improved. Meanwhile, the electrode 1 made of nickel-titanium alloy has good biocompatibility, can reduce the tissue reaction and improve the comfort of the patient.

[0054] The above only describes the embodiments of the present application, and does not limit the patent range of the present application, and any equivalent structure or equivalent process conversion according to the content of the present application specification and drawings, or direct or indirect application in other related technical fields, are also included in the patent protection range of the present application.

Claims

1. An electrode system, characterized by, The application relates to an implant unit and a program control unit, wherein the implant unit and the program control unit are connected through wireless communication, the implant unit comprises an electrode and a stimulator, the electrode and the stimulator are connected through a wire, the electrode is made of biocompatible material, and a plurality of electrode pieces are arranged on the surface of the electrode and connected to the stimulator through the wire. The program control unit comprises a program control instrument, and the program control instrument is connected to the stimulator through wireless communication.

2. An electrode system according to claim 1, wherein, The electrode is made of nickel-titanium alloy material.

3. An electrode system according to claim 2, wherein, The electrode pieces are embedded on the surface of the electrode, the outer side of the electrode pieces is used for outputting a stimulation signal to stimulate the spinal cord nerves, and the inner side of the electrode pieces is used for connecting the wire.

4. An electrode system according to claim 3, wherein, One end of the wire is connected with a waterproof connector, and the waterproof connector is connected with the electrode pieces.

5. The electrode system of claim 1, wherein, The wire is provided with an electromagnetic shielding layer.

6. The electrode system of claim 1, wherein, The stimulator is provided with a microprocessor and a power module, the microprocessor is connected to the power module, the microprocessor is used for receiving external instructions and controlling the on-off and intensity of the current, and the power module is used for providing the required power for the electrode.

7. An electrode system according to claim 6, wherein, The power module is a rechargeable battery.

8. An electrode system according to claim 6, wherein, The stimulator is provided with a power management module, the power management module is connected to the power module, and the power management module is used for monitoring the state of the power module and sending a warning signal when the power is lower than a preset value.

9. The electrode system of claim 1, wherein, The program control unit further comprises a program control charger and an external program control instrument, the stimulator is provided with a wireless charging module, and the program control charger corresponds to the charging module.

10. An electrode system according to claim 9, wherein, The external program control instrument is connected to the stimulator through wireless communication.

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