An implantable neural electrical stimulation system

Abstract

The present invention relates to an implantable neural electrical stimulation system, which is characterized by comprising a first shell and a second shell; a wireless receiving coil and a wireless receiving module are arranged in the first shell for being arranged in the subcutaneous tissue of a user, the wireless receiving module is fixedly connected to one end of two electrodes, and the other end of the two electrodes passes through the first shell and is fixedly connected to an electrode-tissue connecting unit; the second shell is arranged on the user's skin surface corresponding to the first shell, and a central processing module, a wireless transmitting coil, a wireless transmitting module and a power supply module are arranged in the second shell; the central processing module is used to drive the wireless transmitting module to generate an electromagnetic signal of corresponding amplitude and frequency; the wireless transmitting coil is used to output the electromagnetic signal, and the wireless receiving coil is used to sense the electromagnetic signal and generate an induced current; the wireless receiving module is used to modulate the induced current and convert it into an electrical stimulation signal; the electrode-tissue connecting unit is used to transmit the electrical stimulation signal. The present invention can be widely used in the field of implantable medical devices.

Description

Technical Field

[0001] The invention relates to an implantable neural electrical stimulation system, belonging to the field of implantable medical devices. Background Art

[0002] Nerve and muscle electrical stimulation is a treatment method that uses the stimulation of electric current to promote the regeneration of damaged peripheral nerves and prevent atrophy of target muscles after denervation. The commonly used neuromuscular electrical stimulation systems in clinical practice mainly include: 1) Transcutaneous electrical stimulation, which is to attach electrodes to the skin and control the current by adjusting the voltage and the resistance between the electrode and the skin interface. However, it may cause tissue damage, pain, and discomfort, and it cannot be accurately placed on the target nerves and muscles. It has limitations in specificity and parameter adjustment, and cannot accurately stimulate the target area. When stimulating peripheral nerves, the electrodes should be as close as possible to the stimulated nerve fibers to selectively activate the nerve fibers; when stimulating muscles, the cathode of the electrode is placed at the motor point (usually located in the middle of the muscle belly) and the anode is placed at the distal end of the cathode. 2) Adjustable implantable electrical stimulation, which is to implant electrodes while repairing nerves surgically. It can be precisely placed and is expected to become a treatment option for peripheral nerve injuries. However, implantable medical devices need to solve their power supply problems. Traditional active implantable devices rely on batteries for power supply, and there are problems such as large system size, regular battery replacement, continuous discharge and battery leakage risks, which greatly hinder the development of clinical applications.

[0003] Therefore, it is urgent to study how to provide an implantable neural and muscle electrical stimulation system that is small in size, can be powered, and has good biocompatibility and tissue safety. Summary of the invention

[0004] In view of the above problems, an object of the present invention is to provide an implantable neural electrical stimulation system with good biocompatibility and tissue safety.

[0005] To achieve the above-mentioned object, the present invention adopts the following technical scheme: an implantable neural electrical stimulation system, comprising a first housing and a second housing;

[0006] The first shell used for being arranged in the subcutaneous tissue of the user is provided with a wireless receiving coil and a wireless receiving module, the wireless receiving module is fixedly connected to one end of two electrodes, and the other ends of the two electrodes pass through the first shell and are fixedly connected to the electrode-tissue connecting unit; the second shell is arranged on the user's skin surface corresponding to the position of the first shell, and the second shell is provided with a central processing module, a wireless transmitting coil, a wireless transmitting module and a power supply module;

[0007] The central processing module is used to drive the wireless transmission module to generate an electromagnetic signal of corresponding amplitude and frequency according to the implantation position and depth of the first shell;

[0008] The wireless transmitting coil and the wireless receiving coil form a coupling coil, the wireless transmitting coil is used to output electromagnetic signals, and the wireless receiving coil is used to sense electromagnetic signals and generate induced currents;

[0009] The wireless receiving module is used to modulate the induced current and convert it into an electrical stimulation signal;

[0010] The electrode tissue connection unit is used to transmit electrical stimulation signals;

[0011] The power module is used to supply power to various electrical components of the implantable neural electrical stimulation system.

[0012] Preferably, the first shell is made of non-degradable biocompatible insulating material.

[0013] Preferably, the first shell is made of polytetrafluoroethylene.

[0014] Preferably, the electrode is made of a biodegradable material in which a metal magnesium wire is coated with a chitosan coating.

[0015] Preferably, the electrode-tissue connecting unit is made of biodegradable material.

[0016] Preferably, the electrode tissue connection unit uses a single-sided exposed magnesium wire coated with a chitosan coating when connected to a user's nerve, and uses a single-sided exposed magnesium sheet with an insulating surface coated with a chitosan coating when connected to a user's muscle.

[0017] Preferably, the central processing module adopts a programmable single chip microcomputer, and a parameter setting unit, a data receiving unit and a data processing unit are arranged in the central processing module;

[0018] The parameter setting unit is used to pre-set the relationship between the distance between the wireless receiving coil and the wireless transmitting coil and the transmission voltage and the required voltage value;

[0019] The data receiving unit is used to receive the implantation position and depth of the first shell when it is implanted;

[0020] The data processing unit is used to generate an analog or digital output signal of specified amplitude and frequency according to the implantation position and depth of the first shell when implanted and pre-set parameters, and then drive the wireless transmission module to generate an electromagnetic signal of corresponding amplitude and frequency.

[0021] Preferably, the electrical stimulation signal modulated and converted by the wireless receiving module is a low-frequency electrical stimulation signal of 50 mV and 20 Hz.

[0022] Preferably, the power module is provided with a charging interface for connecting a charging plug of a power source to charge the power module, or the connecting plug directly supplies power to various electrical components of the implantable neural electrical stimulation system.

[0023] Preferably, the power module uses a lithium battery.

[0024] The present invention adopts the above technical solution, which has the following advantages:

[0025] 1. The present invention is provided with a first part and a second part, which communicate and power supply by wireless electromagnetic induction, and can accurately position the electrode tissue connection unit on the subcutaneous tissue to be stimulated, and provide an electrical stimulation signal that promotes nerve regeneration after signal processing. When implementing electrical stimulation, the second part can be placed on the corresponding outer surface of the skin. The stimulation time is controllable, and accurate operation of nerve and muscle electrical stimulation in time and space can be achieved, thereby maximizing the electrical stimulation effect, avoiding the pain of transcutaneous electrical stimulation, and having good biocompatibility and tissue safety.

[0026] 2 The first part of the present invention has no battery, and there is no risk of battery replacement and leakage. The electrodes and electrode tissue connection units are made of biodegradable materials, and the subcutaneous part in the body is covered with non-degradable biomaterials. There is no need for deep dissection and secondary removal. Even if it is removed, only a small superficial incision is required, which has little trauma and is simple to operate, and has good safety and reliability.

[0027] 3. The first part in the present invention is implanted subcutaneously. When in use, the first part is placed on the skin surface at a position corresponding to the first part. The first part is powered by the second part through the principle of wireless electromagnetic induction. The two as a system give appropriate electrical stimulation to the target nerves and muscles, and can be widely used in the field of implantable medical devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a structural schematic diagram of the system of the present invention. DETAILED DESCRIPTION

[0029] The present invention is described in detail below in conjunction with the accompanying drawings. However, it should be understood that the accompanying drawings are provided only for a better understanding of the present invention and should not be construed as limiting the present invention. In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and should not be construed as indicating or implying relative importance.

[0030] like Figure 1 As shown, the implantable neural electrical stimulation system provided by the present invention includes a first part 1 and a second part 2.

[0031] The first part 1 is used to be set in the subcutaneous tissue of the user. The first part 1 includes a first shell 11, a wireless receiving coil 12, a wireless receiving module 13, an electrode 14 and an electrode-tissue connecting unit 15. The wireless receiving coil 12 and the wireless receiving module 13 are arranged in the first shell 11. The wireless receiving module 13 is fixedly connected to one end of the two electrodes 14. The other ends of the two electrodes 14 pass through the first shell 11 and are fixedly connected to the electrode-tissue connecting unit 15. The electrode-tissue connecting unit 15 is used to transmit the electrical stimulation signal to the target subcutaneous tissue of the user.

[0032] The second part 2 is arranged on the skin surface of the user corresponding to the position of the first part 1. The second part 2 includes a second shell 21, a central processing module 22, a wireless transmitting coil 23, a wireless transmitting module 24 and a power module 25. The second shell 21 is provided with a central processing module 22, a wireless transmitting coil 23, a wireless transmitting module 24 and a power module 25. The central processing module 22 is used to drive the wireless transmitting module 23 to generate an electromagnetic signal of corresponding amplitude and frequency according to the implantation position and depth of the first part 1, and send it to the wireless transmitting coil 24. The wireless transmitting coil 24 and the wireless receiving coil 12 form a coupling coil. The wireless transmitting coil 24 is used to output an electromagnetic signal, and the wireless receiving coil 12 is used to sense the electromagnetic signal and generate an induced current. The wireless receiving module 13 is used to modulate the induced current generated by the wireless receiving coil 12 into an electrical stimulation signal, and transmit it to the electrode tissue connection unit 15 through the electrode 14, and the electrode tissue connection unit 15 performs electrical stimulation. The power module 25 is used to power each electrical component of the present invention.

[0033] In a preferred embodiment, the first shell 11 is made of a non-degradable insulating material with good biocompatibility, such as polytetrafluoroethylene.

[0034] In a preferred embodiment, when the electrical stimulation signal modulated and converted by the wireless receiving module 13 is a low-frequency electrical stimulation signal of 50 mV and 20 Hz, it has a promoting effect on nerve regeneration.

[0035] In a preferred embodiment, the electrode 14 may be made of a biodegradable material in which a metal magnesium wire is coated with a chitosan coating.

[0036] In a preferred embodiment, the electrode-tissue connection unit 15 is made of biodegradable material, and when connected to the user's nerve, a single-sided exposed magnesium wire is coated with a chitosan coating; when connected to the user's muscle, a single-sided exposed magnesium sheet is used, and the insulating surface is coated with a chitosan coating, that is, the surface that contacts the user's target stimulation tissue is metal magnesium, and the non-contact surface is coated with a chitosan coating to ensure insulation. The electrode-tissue connection unit 15 is a transition structure between the electrode and the subcutaneous tissue, and its structure is different when connected to different subcutaneous tissues.

[0037] In a preferred embodiment, the central processing module 22 can adopt a programmable single chip microcomputer, and a parameter setting unit, a data receiving unit and a data processing unit are provided in the central processing module 22. The parameter setting unit is used to preset the relationship between the distance between the wireless receiving coil 12 and the wireless transmitting coil 24 and the transmission voltage, as well as the required voltage value. The data receiving unit is used to receive the implantation position and depth of the first part 1 when implanted. The data processing unit is used to generate an analog or digital output signal of a specified amplitude and frequency according to the implantation position and depth of the first part 1 when implanted, the preset relationship between the distance between the wireless receiving coil 12 and the wireless transmitting coil 24 and the transmission voltage, and the required voltage value, and then drive the wireless transmitting module 24 to generate an electromagnetic signal of the corresponding amplitude and frequency.

[0038] In a preferred embodiment, the wireless receiving module 13 includes a modulation circuit, which is composed of necessary capacitors and resistors and other components. It is a prior art, and the specific structure is not described in detail here. The wireless receiving module 13 can modulate the high-frequency induced current generated by the wireless receiving coil 12 into the required low-frequency regulated voltage signal, and output it to the electrode tissue connection unit 15 through the electrode 14.

[0039] In a preferred embodiment, the power module 25 is provided with a charging interface for connecting a charging plug of a 220V power supply to charge the power module, or the connecting plug directly supplies power to various electrical components of the present invention.

[0040] In a preferred embodiment, the power module 25 may use a lithium battery to provide a stable 5V operating voltage.

[0041] The following describes in detail the use of the implantable neural electrical stimulation system of the present invention through specific embodiments:

[0042] 1) Place the first part 1 on the subcutaneous tissue near the wound of the user, and connect the electrode tissue connecting unit 15 to the nerve or muscle to be electrically stimulated.

[0043] 2) Suture the incision normally and mark the position of the first part 1 outside the skin.

[0044] 3) When electrical stimulation therapy is required after surgery, the second part 2 is placed on the skin surface corresponding to the position of the first part 1 and the power module 25 is turned on.

[0045] 4) The central processing module 22 generates an analog or digital output signal of a specified amplitude and frequency according to the implantation position and depth of the first part 1, the preset distance between the wireless receiving coil 12 and the wireless transmitting coil 24 and the changing relationship between the transmission voltage and the required voltage value, and then drives the wireless transmitting module 24 to generate an electromagnetic signal of the corresponding amplitude and frequency, and sends it to the wireless transmitting coil 23 to output the electromagnetic signal.

[0046] The distance between the wireless receiving coil 12 and the wireless transmitting coil 24 will affect the output voltage value and output efficiency. When the transmission voltage remains unchanged, the farther the distance (i.e., the deeper the implantation), the lower the voltage generated by the wireless receiving coil 12 and the lower the transmission efficiency. Therefore, after the electrical stimulation system is manufactured, it is necessary to first determine the relationship between the distance between the wireless receiving coil 12 and the wireless transmitting coil 24 and the transmission voltage, and then adjust the output voltage value of the wireless transmitting coil 24 according to the implantation depth and the required voltage value.

[0047] 5) The wireless receiving coil 12 senses the electromagnetic signal to generate an induced current, and sends it to the wireless receiving module 13 .

[0048] 6) The wireless receiving module 13 modulates the induced current generated by the wireless receiving coil 12 into an electrical stimulation signal, and sends it to the electrode tissue connecting unit 15 through the electrode 14. The electrode tissue connecting unit 15 transmits the electrical stimulation signal to the target subcutaneous tissue of the user.

[0049] 7) After nerve regeneration is completed, a small incision is made to remove the first part 1 except the electrode 14 and the electrode tissue connection unit 15. If the patient has no requirements, it can be left in the subcutaneous tissue, and the electrode 14 and the electrode tissue connection unit 5 will degrade by themselves. In addition, the treatment time can be freely controlled as needed.

[0050] The above embodiments are only used to illustrate the present invention, wherein the structure, connection mode and manufacturing process of each component may be changed. Any equivalent transformations and improvements based on the technical solution of the present invention should not be excluded from the protection scope of the present invention.

Claims

1. An implantable neural electrical stimulation system, characterized in that: It comprises a first shell and a second shell, wherein the first shell is made of a non-degradable biocompatible insulating material; The first shell used for being arranged in the subcutaneous tissue of the user is provided with a wireless receiving coil and a wireless receiving module, the wireless receiving module is fixedly connected to one end of two electrodes, and the other ends of the two electrodes pass through the first shell and are fixedly connected to the electrode-tissue connecting unit; the second shell is arranged on the user's skin surface corresponding to the position of the first shell, and the second shell is provided with a central processing module, a wireless transmitting coil, a wireless transmitting module and a power supply module; The central processing module is used to drive the wireless transmission module to generate an electromagnetic signal of corresponding amplitude and frequency according to the implantation position and depth of the first shell; The wireless transmitting coil and the wireless receiving coil form a coupling coil, the wireless transmitting coil is used to output electromagnetic signals, and the wireless receiving coil is used to sense electromagnetic signals and generate induced currents; The wireless receiving module is used to modulate the induced current and convert it into an electrical stimulation signal; The electrode tissue connection unit is used to transmit electrical stimulation signals; The power module is used to supply power to various electrical components of the implantable neural electrical stimulation system; The electrode is made of a biodegradable material with a metal magnesium wire coated with a chitosan coating; The electrode tissue connection unit is made of biodegradable material; The electrode tissue connection unit uses a single-sided exposed magnesium wire coated with a chitosan coating when connected to a user's nerve, and uses a single-sided exposed magnesium sheet and an insulating surface coated with a chitosan coating when connected to a user's muscle.

2. An implantable neural electrical stimulation system as claimed in claim 1, characterized in that: The first shell is made of polytetrafluoroethylene.

3. An implantable neural electrical stimulation system as claimed in claim 1, characterized in that: The central processing module adopts a programmable single chip microcomputer, and is provided with a parameter setting unit, a data receiving unit and a data processing unit; The parameter setting unit is used to pre-set the relationship between the distance between the wireless receiving coil and the wireless transmitting coil and the transmission voltage and the required voltage value; The data receiving unit is used to receive the implantation position and depth of the first shell when it is implanted; The data processing unit is used to generate an analog or digital output signal of specified amplitude and frequency according to the implantation position and depth of the first shell when implanted and pre-set parameters, and then drive the wireless transmission module to generate an electromagnetic signal of corresponding amplitude and frequency.

4. An implantable neural electrical stimulation system according to any one of claims 1 to 3, characterized in that: The electrical stimulation signal modulated and converted by the wireless receiving module is a low-frequency electrical stimulation signal of 50mV and 20Hz.

5. An implantable neural electrical stimulation system according to any one of claims 1 to 3, characterized in that: The power module is provided with a charging interface, which is used to connect a charging plug of a power source to charge the power module, or to connect the plug to directly power various electrical components of the implantable neural electrical stimulation system.

6. An implantable neural electrical stimulation system according to any one of claims 1 to 3, characterized in that: The power module adopts a lithium battery.

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