CN100469402C - Implantable electroacupuncture treatment device - Google Patents

Abstract

The invention belongs to the technical field of implantable medical instruments, and is characterized in that it consists of electrodes implanted in corresponding acupoints in the human body and a pulse generator. Programmable settings, the battery of the pulse generator can be wirelessly charged percutaneously based on electromagnetic coupling; the pulse generator and electrodes can be split or one-piece structure, with multiple stimulation contacts, can form a monopolar stimulation or bipolar stimulation model. The implantable electroacupuncture treatment device of the present invention is convenient to use, has precise and stable stimulation parameters, flexible parameter adjustment, good compatibility and adaptability of electrodes, long service life, and can be used for long-term electrical stimulation of acupoints.

Description

Implantable electroacupuncture treatment device

technical field

The invention relates to an implantable electric acupuncture treatment device, which belongs to the technical field of implantable medical instruments.

Background technique

Acupuncture and moxibustion is a unique method of treating diseases in China. It is a treatment method of "treating the inside from the outside". At present, acupuncture and moxibustion has been recognized almost all over the world. It is reported that acupuncture and moxibustion are effective in treating more than 300 kinds of diseases, among which there are more than 100 kinds of diseases with remarkable effects. In the practical application of acupuncture and moxibustion, it has developed from hand-twisting needles to electro-acupuncture, that is, after the needles are inserted into acupoints to get qi, current pulses are passed through the needles, and the combination of acupuncture and electric stimulation is used to prevent and treat diseases. It replaces human beings for long-term continuous needle movement, saves manpower, and can control the amount of stimulation more objectively.

When using electroacupuncture to treat diseases, some diseases only need several treatments, but some chronic diseases, especially chronic nervous system diseases, require long-term treatment, such as pain, Parkinson's disease, Alzheimer's, depression, drug addiction, etc. Addiction etc. Most of the existing electroacupuncture treatment devices are instruments used outside the body. When using them, it is first necessary to find out the position of the acupoints, then insert or paste electrodes on the acupoints, and then energize for stimulation. In vitro acupoint electroacupuncture certainly has the advantages of simple devices and economical advantages, but in this percutaneous electrical stimulation therapy, all operations such as positioning of acupoints and pasting of electrodes are completely dependent on manual work, and the reliability, consistency and quantification of treatment In addition, most patients cannot be hospitalized or treated in outpatient clinics for a long time, and the treatment operated by patients or their families cannot guarantee timeliness and accuracy. In this case, the study of implantable electroacupuncture treatment devices, implanting pulse generators and electrodes under the skin at the same time to realize automatic timing start of the treatment device, or the way patients manually start electrical stimulation, will be able to greatly improve the quality of electroacupuncture. The stability and reliability of the treatment have important medical significance and application prospects.

At present, there are no research reports on implantable electroacupuncture treatment devices in China. In the prior art, US patents 5,094,242 and 5,211,175 disclose a method and device for implanting electroacupuncture. This electroacupuncture therapeutic instrument is essentially semi-implanted. The device, that is, the pulse generator is outside the body, and the receiving circuit and needle electrodes are implanted at the acupuncture points in the body; when in use, the pulse generator outside the body transmits electromagnetic pulses through the antenna, and the receiving circuit in the body transfers the pulse electromagnetic energy induced by the coil to the electrodes , to stimulate the corresponding acupoints, the bottom of the receiving circuit packaging shell is used as the positive pole, and the needle-shaped electrode is used as the negative pole. The overall scheme of US Patent 6,377,853 is the same as the above-mentioned patent, but some improvements have been made, including the use of multi-strand twisted wires as the wires of the needle-shaped electrodes to improve the softness, and increase the protection at the interface between the needle-shaped electrodes and the receiving circuit packaging shell Device to prevent the interface from being damaged and cracked, and fixation measures are added near the electrode contacts to prevent electrode displacement.

The treatment process of the existing semi-implantable electroacupuncture treatment device is the process in which the external pulse generator emits and the internal device receives electromagnetic energy. This solution has many defects in application. For example, the treatment process cannot be separated from the external device and must be manually performed. Operate external devices for treatment, which is inconvenient for patients, especially elderly patients; the stimulation current parameters not only depend on the parameters of the external pulse generator, but also are affected by the coupling status of the internal and external coils. During the treatment process, the external pulse generator can only be kept stationary In order to keep the stimulation parameters stable, the patient cannot move freely during treatment, and it is basically impossible to guarantee the same parameters in different treatments.

Contents of the invention

Aiming at the deficiencies of the prior art, the purpose of the present invention is to provide an implantable electroacupuncture treatment device, which can realize implantable electrostimulation treatment with convenient and reliable use on human acupoints, stable and accurate parameters.

The feature of the present invention is that the device includes a pulse generator and electrodes, and the pulse generator and electrodes are made into an integrated cylindrical structure, wherein the pulse generator is packaged into a cylinder, and the packaging material of the shell is made of polyurethane or silicone rubber. , or ceramics, or biocompatible materials including metal materials; the electrode contacts are pasted on both ends of the pulse generator, or any part in the middle, and are connected to the output terminal of the output control circuit inside the pulse generator . When the pulse generator is packaged with metal material, each electrode contact is electrically insulated from the shell of the pulse generator.

The present invention is also characterized in that two electrode contacts are optionally used as positive and negative poles to form a bipolar stimulation mode.

The present invention is also characterized in that the pulse generator includes:

The charging part is composed of a coil, a charging management circuit, and a battery connected in series. The coil receives the electromagnetic energy emitted by the external charger through electromagnetic coupling. The frequency is between tens of kilohertz and hundreds of kilohertz, and the implanted pulse generates The coil of the device and the transmitting coil of the external charger are coupled and placed in parallel axes. The former is cylindrical with a cylindrical magnetic core inside, and the latter is flat with a flat square or round magnetic core inside. The material is ferrite, amorphous, microcrystalline, ultrafine crystal or permalloy;

In the pulse generation part, the input terminal is connected to the output terminal of the battery in the charging part, and the pulse frequency is between 1 and 250 Hz. It can output constant frequency pulses or alternate pulses of different frequencies, and can output continuously or intermittently;

In the communication part, the input end is connected with the coil in the charging part and the output end of the battery;

A microprocessor, the input terminal of which is connected to the output terminal of the battery in the charging part, and the control signal output terminals of the microprocessor are respectively connected to the corresponding input terminals of the pulse generation part and the communication part;

The output control part is a multiplex select switch, the control signal input terminal is connected with the corresponding output terminal of the microprocessor, the pulse signal input terminal of the output control part is connected with the corresponding output terminal of the pulse generation part, and the output Each output of the control part is connected to the corresponding electrode contact;

A reed switch, the control signal output terminal is connected with the corresponding input terminal of the microprocessor.

Compared with the prior art, the present invention has the following beneficial effects: (1) The implantable electroacupuncture treatment device of the present invention has a reasonable and reliable structure and is suitable for long-term implantation; , Running for a long time, not only the treatment process is completely controllable and repeatable, avoiding the uncertainty in the treatment of the existing technology, but also the treatment process does not require the assistance of medical staff or family members, which greatly saves human resources; (3) Use internal batteries As a power source, the amplitude, period, pulse width, timing and other parameters of the electrical stimulation pulse applied to the acupuncture points can be precisely controlled; (4) the use of percutaneous wireless charging technology can greatly extend the service life of the implantable electroacupuncture treatment device, not only It is conducive to more effective treatment of diseases, and can reduce the economic burden of patients.

Description of drawings

Fig. 1 is a schematic diagram of circuit principle of the present invention;

Fig. 2 is a schematic diagram of the coupling between the internal coil and the external coil of the wireless percutaneous charging of the present invention;

Fig. 3 is a schematic diagram of one of the embodiments of the present invention;

Fig. 4 is the schematic diagram of the second embodiment of the present invention;

Fig. 5 is a schematic diagram of the third embodiment of the present invention.

Detailed ways

In order to achieve the purpose of the above invention, the implantable electroacupuncture treatment device is composed of electrodes and pulse generators implanted in corresponding acupoints in the human body. The electrode contains more than two stimulation contacts. In the monopolar stimulation mode, the pulse generator shell is used as the positive pole, and one electrode contact is used as the negative pole; in the bipolar stimulation mode, two electrode contacts are selected as the positive and negative poles respectively. The pulse generator contains a coil, charge management circuit, battery, microprocessor, pulse generation circuit, output control circuit, communication circuit, and reed switch, where:

The coil, charging management circuit and battery are connected in sequence to form the power supply of the pulse generator. The coil receives the electromagnetic energy emitted by the external charger through electromagnetic coupling. The frequency is between tens of kilohertz and hundreds of kilohertz, controlled by the charging management circuit. Charge the battery, and then supply power to the microcontroller, pulse generating circuit and communication circuit, and the coil of the implanted pulse generator is coupled with the transmitting coil of the external charger in a parallel axis. The former is cylindrical, and there is a cylindrical A magnetic core, the latter being flat, with a flat square or round magnetic core inside, wherein the material of the magnetic core is ferrite, amorphous, microcrystalline, nanocrystalline or permalloy;

The microprocessor integrates DA converter, timer, FLASH memory, RAM memory and serial communication port, and its output terminal is connected with the input terminal of pulse generation circuit, communication circuit and output control circuit;

The microprocessor controls the DA converter to output the control pulse. After the pulse generating circuit, the amplitude, pulse width, period and other parameters are accurate, flexible and adjustable, and the stimulation pulse with automatic charge balance is obtained. The output control circuit is under the control of the microcontroller. The different contacts of the strobe pulse generator shell or electrodes are used as positive and negative poles, and the stimulation pulses are transmitted to the corresponding stimulation targets. The pulse frequency is between 1 and 250 Hz. It can output constant frequency pulses or alternate pulses of different frequencies. Output, both continuous output and intermittent output;

The coil and the communication circuit together constitute the communication function module of the implantable pulse generator, and under the control of the serial port of the microcontroller, use 2ASK modulation to transmit binary data information with the program-controlled device outside the body;

When an external magnetic field is applied by a magnet outside the body, the reed switch is closed, and the microprocessor detects the action of the reed switch to control the switching of the working state of the pulse generator.

Furthermore, the implantable pulse generator has two working states of automatic mode and magnetic control mode, and the respective working parameters can be set by the in vitro program control device. The pulse generator works in the automatic mode by default, and the magnet mode is started by brushing the control magnet outside the body. Realize instant electrical stimulation therapy.

Further, the electrode and the pulse generator can be of a split structure: the outer surface of the wire of the electrode is coated with insulating material and inserted into the insulating tube, and the electrode contacts are ring-shaped, which are placed on the outer surface of the insulating tube at a certain distance, and connected to the outer surface of the insulating tube. The wires are welded together; or, the outer surface of multiple wires is coated with insulating material or separately sheathed into an insulating tube, and then parallel or twisted together, and the tips of the wires are exposed as stimulating contacts. Wherein, the wire can be in a spiral shape.

Further, the pulse generator and the electrode can be an integrated cylindrical structure, the pulse generator is packaged into a cylinder, and the electrode contacts are pasted on both ends of the cylindrical pulse generator and any part in the middle, and connected with the pulse generator connected to the circuit inside.

The pulse generator is controlled by a microprocessor, and has two working states of automatic mode and magnetic control mode, and the respective working parameters can be set by external program-controlled devices. The pulse generator usually works in the automatic mode, and can send a series of pulse trains at regular intervals according to the doctor's settings for stimulation treatment. If the stimulation pulse amplitude in the automatic mode is set to zero, no stimulation is usually performed. When the magnet brushes over the implanted pulse generator, the pulse generator enters the magnetic control mode and sends the stimulation pulse with the set parameters. The magnetic control working mode takes into account the commonly used treatment methods at present, that is, several treatments are performed every day, for example, stimulation is performed 4 times a day, each time for 30 minutes, or every 5 minutes for 30 seconds. The pulse generator is powered by a rechargeable lithium battery, and is wirelessly charged through the skin with an in vitro charger based on the principle of electromagnetic coupling.

Electrodes require good biocompatibility, high stability, and multiple electrode contacts for power supply stimulation selection, so that the selection of electrical stimulation targets is more flexible. Even if the electrodes are displaced to a certain extent, the contacts used for activation can also be programmed to change To achieve as effective electrical stimulation as possible without causing system failure.

The above characteristics ensure that the implantable electroacupuncture treatment device is easy to use (automatic stimulation or magnet-activated stimulation), stable and accurate stimulation parameters (battery power supply, microprocessor control), long service life (wireless charging), relatively Compared with the prior art, the advantages of good capacitance (multi-electrode contact combination) are significantly improved.

As shown in Figure 1, the implantable pulse generator of the present invention consists of a coil 11, a charging management circuit 12, a battery 13, a microprocessor 14, a pulse generating circuit 15, an output control circuit 16, a communication circuit 17 and a reed switch 18 poses.

The coil 11, the charging management circuit 12 and the battery 13 constitute the power source of the implantable pulse generator. The battery is a lithium-ion battery. At present, implantable lithium-ion batteries are progressing rapidly. The charging and discharging cycles of existing commercial products have reached more than 1,000 times, with a weight as low as 0.2 grams, which meets the needs of miniature implantable electroacupuncture treatment devices. demand. The coil receives the electromagnetic energy emitted by the external charger, and is controlled by the charging management circuit to charge the lithium battery, manage the charging progress, control the charging current and the battery temperature. The charging management circuit can be selected from an existing integrated circuit chip, such as BQ24200 of TI Company.

The microprocessor 14 selects a highly integrated low-power single-chip microcomputer, has multiple power-saving modes, and integrates FLASH, RAM, timer, serial communication port, DA converter, etc. The microprocessor 14 controls one or more DA converters to output control pulses, and the pulse generating circuit 15 can obtain stimulation pulses with accurate, flexible and adjustable parameters such as amplitude, pulse width, and cycle, and automatic charge balance. The casing of the pulse generator and multiple contacts of the electrodes can be programmed as stimulating contacts. The core of the output control circuit 16 is a multi-channel strobe switch. The contacts are used as positive and negative poles, and the stimulation pulses are transmitted to the corresponding stimulation targets to realize electrical stimulation therapy.

The coil 11 and the communication circuit 17 jointly constitute the communication function module of the implantable pulse generator. Under the control of the serial port of the microcontroller 14, the binary data information is transmitted with the program-controlled device outside the body by 2ASK modulation.

The reed switch 18 is a magnetically sensitive device, which can be normally open. When an external magnetic field is applied with a magnet, the reed switch 18 is pulled in. The microprocessor 14 detects the pull-in action of the reed switch 18. Under program control, The pulse generator will switch to magnetic control stimulation mode after the magnet is removed.

As shown in Figure 2, the coil 11 of the implantable pulse generator and the transmitting coil 33 of the external charger are placed in a parallel axis manner, and the shell 34 of the implantable pulse generator and the skin tissue 35 of the human body are separated in the middle, and two Magnetic cores are included inside the coils to improve electromagnetic coupling efficiency. The shapes, sizes, and magnetic cores of the transmitting coil 33 and the receiving coil 11 are different: the receiving coil 11 implanted in the body is required to reduce the volume and weight as much as possible, so the interior is a cylindrical magnetic core 31 with a smaller volume; The transmitting coil 33 outside the body is flat, and its area is much larger than that of the receiving coil 11 , and there are one or more flat circular or square magnetic cores 32 inside. The flat transmitting coil can generate a uniformly distributed magnetic field 36 in a larger plane. Because the size and weight of the implantable pulse generator are strictly limited, especially the thickness is required to be thin, even within 5mm, so the coil 11 can be welded and fixed on the circuit board, and the coil and the circuit board are parallel to the shell 34, which can not only strengthen the The tolerance performance of the position of the transmitting coil and the receiving coil, the charging process is simple and stable, and it is beneficial to the installation and assembly of the coil and the circuit board.

Examples are given below to further illustrate the structure of the implantable electroacupuncture treatment device.

Example 1:

As shown in Figure 3, the pulse generator and electrodes of the implantable electroacupuncture treatment device have a split structure. The pulse generator 20 is sealed by biocompatible materials such as polyurethane, silicone rubber, ceramics or metal, from which a plurality of wires 22 are drawn and connected to the electrode contacts 21 to realize the electrical connection from the pulse generating circuit to the electrode contacts. The electrode contact 21 is made of platinum or platinum-iridium alloy material, which is processed into a circular shape; the wire 22 is made of stainless steel, platinum, platinum-iridium alloy or cobalt-based alloy material, and the outer surface is coated with insulating material and inserted into the insulating tube 23 . The wire 22 can be helical, so it has better flexibility; the insulating tube 23 is made of biocompatible material, polyurethane or silicon rubber can be selected. The electrode contacts 21 are sleeved on the outer surface of the insulating tube 23 at a certain distance, and are welded together with the wires 22 . Therefore, the plurality of wires are insulated from each other and from the human body tissue through the insulating tube 23, and the stimulation electric pulse realizes the stimulation treatment of meridian points through the electrode contacts. There can be multiple electrode contacts 21, and only two are shown in the figure for illustration.

Example 2:

As shown in Figure 4, the pulse generator and electrodes of the implantable electroacupuncture treatment device have a split structure. The pulse generator 20 is sealed by biocompatible materials such as polyurethane, silicone rubber, ceramics or metal, from which a plurality of wires 24 are drawn. The wire 24 is made of platinum or platinum-iridium alloy material, and the outer surface is coated with insulating material or inserted in an insulating tube to form an insulating layer 25 . The insulating layer 25 is made of biocompatible material, such as polyurethane or silicon rubber. A plurality of insulated wires are parallel or twisted together as electrodes, and the tip of the wire 24 is exposed as a stimulating contact. The wire can be helical, which not only has better flexibility, but also the helical electrode contact is not easy to loose after implanted in human tissue and healed, which is beneficial to the position fixation of the electrode contact. There may be multiple electrodes formed by the combination of the wire 24 and the insulating layer 25, and only two electrodes are shown in the figure for illustration.

In Embodiment 1 and Embodiment 2, the implantable electroacupuncture treatment device has two modes of monopolar stimulation and bipolar stimulation, and multiple contacts of the shell of the pulse generator 20 and electrodes can be programmed as stimulation contacts. . If the pulse generator 20 is encapsulated by metal, then its shell can be directly used as a stimulating contact to form a monopolar stimulation mode, that is, the pulse generator shell is positive, and a contact of the selected electrode is used as the negative pole; if the pulse generator 20 consists of Polyurethane, silicone rubber or pottery and other non-conductive materials can be packaged with metal foil 20' on its inner surface close to the wire, and connected to the circuit in the pulse generator 20, which can also be used as the positive pole of the monopolar stimulation mode. In bipolar stimulation mode, select the two electrode contacts of the electrode as the positive and negative poles, respectively.

Example 3:

As shown in FIG. 5 , the pulse generator and electrodes of the implantable electroacupuncture treatment device have an integrated cylindrical structure. The implantable pulse generator 26 is packaged into a cylindrical shape, and the shell packaging material is biocompatible materials such as polyurethane, silicone rubber, ceramics or metal, and the electrode contacts 27 can be pasted on both ends of the cylindrical pulse generator 26, and the middle Any position, and be connected with the circuit in the pulse generator 26. If the casing material of the pulse generator 26 is metal, the electrode contacts 27 need to be insulated from the casing. There may be multiple electrode contacts 27 located in the middle of the shell of the pulse generator 26, and only one is shown in the figure for illustration.

Due to the development of micro-implantable batteries, microelectronic technology and MEMS technology, the implantable electro-acupuncture treatment device proposed by the present invention can realize rich electrical stimulation functions with a small size and weight. In particular, the cylindrical micro-implantable electroacupuncture treatment device, due to its cylindrical shape and small size, may be easily implanted in meridians or acupoints through similar injection methods to achieve satisfactory therapeutic effects.

The above-mentioned method is only a preferred embodiment of the present invention. For those of ordinary skill in the art, on the basis of the implantable, rechargeable, and multi-electrode contact electroacupuncture therapeutic apparatus disclosed in the present invention, it is easy to imagine that it It is applicable to various implantable functional electrical stimulation systems, and is not limited to the system structure described in the specific embodiments of the present invention. Therefore, the above-described methods are only preferred and not limiting.

Claims (4)

1. Implantable electroacupuncture treatment device, characterized in that: the device includes a pulse generator and electrodes, and the pulse generator and electrodes are made into an integrated cylindrical structure, wherein the pulse generator is packaged into a cylindrical shape, and the shell package The material uses biocompatible materials including polyurethane, or silicone rubber, or ceramics, or metal materials; the electrode contacts are pasted on the two ends of the pulse generator, or any part in the middle, and connected with the pulse generator The output terminal of the internal output control circuit is connected. 2. The implantable electroacupuncture treatment device according to claim 1, characterized in that: when the pulse generator is packaged with metal materials, each electrode contact is electrically insulated from the shell of the pulse generator. 3. The implantable electroacupuncture treatment device according to claim 1, characterized in that two electrode contacts are selected as positive and negative poles to form a bipolar stimulation mode. 4. The implantable electroacupuncture treatment device according to claim 1, characterized in that: the pulse generator comprises: The charging part is composed of a coil, a charging management circuit, and a battery connected in series. The coil receives the electromagnetic energy emitted by the external charger through electromagnetic coupling. The frequency is between tens of kilohertz and hundreds of kilohertz, and the implanted pulse generates The coil of the device and the transmitting coil of the external charger are coupled and placed in parallel axes. The former is cylindrical with a cylindrical magnetic core inside, and the latter is flat with a flat square or round magnetic core inside. The material is ferrite, amorphous, microcrystalline, ultrafine crystal or permalloy; In the pulse generation part, the input terminal is connected to the output terminal of the battery in the charging part, and the pulse frequency is between 1 and 250 Hz. It can output constant frequency pulses or alternate pulses of different frequencies, and can output continuously or intermittently; In the communication part, the input end is connected with the coil in the charging part and the output end of the battery; A microprocessor, the input terminal of which is connected to the output terminal of the battery in the charging part, and the control signal output terminals of the microprocessor are respectively connected to the corresponding input terminals of the pulse generation part and the communication part; The output control part is a multiplex select switch, the control signal input terminal is connected with the corresponding output terminal of the microprocessor, the pulse signal input terminal of the output control part is connected with the corresponding output terminal of the pulse generation part, and the output Each output of the control part is connected to the corresponding electrode contact; A reed switch, the control signal output terminal is connected with the corresponding input terminal of the microprocessor.

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