CN113304399A

CN113304399A - Implanted tibial nerve stimulation system

Info

Publication number: CN113304399A
Application number: CN202110677194.9A
Authority: CN
Inventors: 罗军; 施晋旻; 邵鼎轶; 王超
Original assignee: Shanghai Lixiao Medical Technology Co ltd
Current assignee: Shanghai Lixiao Medical Technology Co ltd
Priority date: 2021-06-18
Filing date: 2021-06-18
Publication date: 2021-08-27

Abstract

The invention relates to an implanted tibial nerve stimulation system, and belongs to the technical field of medical instruments. Comprises an implantation stimulator, a transmitter, a controller and a program-controlled instrument; an implantation stimulator is arranged in the ankle and close to the tibial nerve, and a transmitter is correspondingly arranged outside the ankle; the program control instrument is connected with the emitter through the controller; the emitter and the implantation stimulator are provided with wireless power supply devices. The implanted stimulator obtains a power source in a wireless power supply mode, so that the volume of an implanted part is reduced, and risks related to a battery are avoided; the implantation stimulator is arranged in a cuboid shape and is provided with a fixing hole, so that the implantation stimulator is convenient to fix and is not easy to displace; the receiving coil and the emitter implanted in the stimulator have large head-on area, so that the efficiency of wireless power supply is improved; the stimulation contact point implanted on the surface of the stimulator is arranged in a plane shape, so that the stimulation efficiency is high.

Description

Implanted tibial nerve stimulation system

Technical Field

The invention relates to an implanted tibial nerve stimulation system, and belongs to the technical field of medical instruments.

Background

Overactive bladder (OAB) is a bladder disease that is mainly characterized by an urgent and sudden urge to urinate. Typical symptoms include frequent urination, urgency, bladder spasms, and urine leakage. Possible causes of OAB include neurological disorders, diabetes, acute urinary tract infections, and bladder occupancy (e.g., tumors or cystolith). OAB can significantly affect quality of life (e.g., cause sleep disruption and social isolation) and is often associated with depression and anxiety. The current major methods of treating OAB are behavioral training and drug therapy, but studies have shown that up to 80% of OAB patients fail to adhere to continued behavioral and drug therapy in the first year of treatment initiation. According to the existing research, stimulation on partial nerves (such as sacral nerve and tibial nerve) can improve the detrusor contraction and the bladder fullness feeling of a patient, and further realize the treatment of OAB.

Conventional implantable neurostimulation systems include a host that outputs stimulation energy and electrode leads that deliver the stimulation to the body. Sacral nerve stimulators, for example, are a common implantable nerve stimulation system for treating OAB. The sacral nerve stimulator usually comprises a host and at least 1 electrode. The disadvantages of this system are as follows: 1. the implanted part has larger volume, and the incision and the space required by implantation are both larger. 2. The implanted portion contains a battery and may rupture and leak, and may need to be re-implanted after the battery is depleted. 3. Since the implanted portion contains the complete working system, it is difficult to halt the system in the event of a failure. Resulting in sustained uncontrolled stimulation of the nerve, causing injury to the patient. 4. Because the electrode lead is thin, in order to ensure that the electrode reaches a designated position at any angle and can effectively stimulate during rotation, the contact is in a circular ring shape, and the shape can lead the current to be in a transmitting shape, thus wasting the electric energy in non-nerve parts such as muscles or fat. There are also improvements to the above problems, such as chinese patent, patent No. CN 107362447A. A cylindrical glass stimulator is mentioned. Which reduces the size by a batteryless design. However, this design has the following problems: 1. both glass and cylindrical shapes tend to cause difficulties in fixation, including sliding up and down and rotation. Once this occurs, the stimulating current cannot affect the nerve, resulting in ineffective treatment. 2. The installation mode is fixed on the tibial nerve trunk through a silica gel button, but as the implantation time is as long as several years, the friction between the stimulator and the nerve can cause neuritis and the like after long-term accumulation. 3. The corresponding area of the receiving coil in the cylindrical stimulator is small, and the wireless power supply efficiency is not improved favorably. 4. The cylindrical electrode current diverges to the periphery, resulting in lower efficiency.

Disclosure of Invention

The invention aims to solve the technical problem of how to obtain a safe and reliable implanted tibial nerve stimulation system.

In order to solve the above problems, the present invention provides an implantable tibial nerve stimulation system; comprises an implantation stimulator, a transmitter, a controller and a program-controlled instrument; an implantation stimulator is arranged in the ankle and close to the tibial nerve, and a transmitter is correspondingly arranged outside the ankle; the program control instrument is connected with the emitter through the controller; the emitter and the implantation stimulator are provided with wireless power supply devices.

Preferably, the controller comprises a first battery, a first microcontroller, a buzzer, a display module, a key, a first memory and a first bluetooth module; the battery I is respectively connected with the microcontroller I, the buzzer, the display module, the key, the memory I and the Bluetooth module I; the buzzer, the display module, the key, the first memory and the first Bluetooth module are respectively connected with the first microcontroller.

Preferably, the transmitter comprises a second battery, a second microcontroller, a second radio modulation module, a transmitting coil, a second bluetooth module and a second memory; the battery II is respectively connected with the microcontroller II, the radio modulation module, the transmitting coil, the Bluetooth module II and the memory II; the microcontroller II is connected with the transmitting coil through the radio modulation module; and the second microcontroller is respectively connected with the second Bluetooth module and the second memory.

Preferably, the implanted stimulator includes a stimulation contact, a receiving coil, a radio coupling circuit, a microcontroller three, and a stimulation generation circuit; the radio coupling circuit is connected with the receiving coil; the radio coupling circuit is connected with the third microcontroller and the stimulus generating circuit; the microcontroller is connected with the stimulating contact through a stimulating generating circuit.

Preferably, the implanted stimulator includes stimulation contacts, a receiving coil, a radio coupling circuit, and a stimulation generation circuit; the radio coupling circuit is connected with the receiving coil; the wireless coupling circuit is connected to the stimulation contacts through the stimulation generating circuit.

Preferably, the implant stimulator is shaped like a flaky cuboid, and two ends and corners of the cuboid are provided with circular arcs or chamfers; both ends of the cuboid are also provided with fixing holes.

Preferably, a receiving coil is provided along the edge of the interior of the housing of the implantable stimulator.

Preferably, the side of the implanted stimulator near the tibial nerve is provided with at least two stimulation contacts.

Preferably, the surface of the implant stimulator is provided with grooves and barbs.

Preferably, an ID chip used for corresponding matching with the transmitter is arranged in the implantation stimulator.

Compared with the prior art, the invention has the following beneficial effects:

the implantation stimulator obtains a power source in a wireless power supply mode, reduces the volume of an implanted part, and avoids risks related to a battery (such as the need of surgical extraction and re-implantation after the power of the battery leaks and is exhausted); the implanted stimulator is arranged in a cuboid shape and the fixing hole is convenient to fix, and the implanted stimulator is not easy to shift; the receiving coil and the transmitter which are implanted into the stimulator have the largest frontal area, so that the efficiency of wireless power supply is improved; the stimulating contact point on the surface of the implanted stimulator is arranged in a plane shape, and the stimulating efficiency is higher than that of the cylindrical stimulating contact point in the prior art. In order to achieve the same nerve stimulation intensity, the planar shape of the stimulation contact arranged on the surface of the implant stimulator can save more than 80% of power compared with the cylindrical design. For wireless power, electromagnetic waves are transmitted through human tissue, which absorbs and dissipates electromagnetic energy, referred to as the electromagnetic wave absorption ratio or Specific Absorption Rate (SAR). More efficient power transfer may reduce radio radiated emissions in wireless powering, i.e., reduce SAR values. The design of the shape is therefore of great importance to the health of the operator.

Drawings

FIG. 1 is a schematic view of the present invention in a worn configuration;

FIG. 2 is a schematic diagram of the main components of the present invention;

FIG. 3 is a schematic diagram of a controller according to the present invention;

FIG. 4 is a schematic diagram of the transmitter structure of the present invention;

fig. 5 is a schematic diagram of the components of the inventive implantable stimulator.

Fig. 6 is a schematic structural diagram of an implantable stimulator according to the present invention.

Fig. 7 is a schematic diagram of the current effect of the implanted stimulator of the present invention.

Wherein, the graph A shows that the implantation stimulator is arranged as a cylinder in the prior art; b is a sheet cuboid-shaped implanted stimulator according to the invention;

fig. 8 is a second schematic structural diagram of an implantable stimulator of the present invention.

Fig. 9 is a third schematic structural diagram of an implantable stimulator of the present invention.

Fig. 10 is a schematic diagram of a stimulation waveform of an implanted stimulator of the present invention.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in fig. 1-10, the present invention provides an implantable tibial nerve stimulation system; comprises an implantation stimulator 40, a transmitter 30, a controller 20 and a programmable controller 10; an implantation stimulator 40 is arranged in the ankle and close to the tibial nerve, and a transmitter 30 is correspondingly arranged outside the ankle; the program controller 10 is connected with the transmitter 30 through the controller 20; wireless power supply means are provided in the transmitter 30 and the implanted stimulator 40. The controller 20 comprises a first battery 201, a first microcontroller 206, a buzzer 205, a display module 203, a key 204, a first memory 207 and a first Bluetooth module 208; the first battery 201 is respectively connected with the first microcontroller 206, the buzzer 205, the display module 203, the key 204, the first memory 207 and the first Bluetooth module 208; the buzzer 205, the display module 203, the key 204, the first memory 207 and the first bluetooth module 208 are respectively connected with the first microcontroller 206. The transmitter 30 comprises a second battery 301, a second microcontroller 303, a radio modulation module 304, a transmitting coil 305, a second Bluetooth module 306 and a second memory 307; the second battery 301 is respectively connected with the second microcontroller 303, the second radio modulation module 304, the transmitting coil 305, the second bluetooth module 306 and the second memory 307; the second microcontroller 303 is connected with the transmitting coil 305 through a radio modulation module 304; the second microcontroller 303 is connected with the second bluetooth module 306 and the second memory 307 respectively. The implanted stimulator 40 includes stimulation contacts 401, a receiving coil 402, a radio coupling circuit 403, a microcontroller three 404, and a stimulation generation circuit 405; the radio coupling circuit 403 is connected to the receiving coil 402; the radio coupling circuit 403 is connected with the third microcontroller 404 and the stimulus generating circuit 405; microcontroller three 404 is connected to stimulation contacts 401 through stimulation generation circuit 405. Or the implanted stimulator 40 includes stimulation contacts 401, a receiving coil 402, a radio coupling circuit 403, and a stimulation generation circuit 405; the radio coupling circuit 403 is connected 402 with the receiving coil; the radio coupling circuit 403 is connected to the stimulus contact 401 through the stimulus generation circuit 405. The implant stimulator 40 is shaped like a sheet cuboid, and two ends and corners of the cuboid are provided with circular arcs or chamfers; the rectangular parallelepiped is further provided with fixing holes 406 at both ends. Along the edges of the interior of the housing of the implant stimulator 40 are receiving coils 402. The side of the implanted stimulator 40 near the tibial nerve is provided with at least two stimulation contacts 401. The implant stimulator 40 is provided with grooves and barbs on its surface. The implanted stimulator 40 is provided with an ID chip for corresponding matching with the transmitter 30.

Fig. 1 is a schematic view showing the wearing structure of the present invention, in which the implanted portion and the transmitter are constructed, and the implanted stimulator 40 is fixed near the tibial nerve. The transmitter 30 is secured at the ankle by a strap, facing the implanted stimulator 40.

Fig. 2 is a schematic diagram of the main components of the present invention, which includes: the programmer 10, operated by the physician, can set the stimulation parameters in ranges, such as frequency range, stimulation intensity range, pulse width, waveform format, etc., so that the patient can only adjust within a certain range. The programmer 10 may be implemented using a PC or tablet and software based thereon. The controller 20, operated by the patient, may start and stop the system, adjust relevant stimulation parameters, such as stimulation intensity, stimulation pattern, and display relevant system information, such as stimulation status, connection status with the transmitter, remaining power, etc. Communicating with transmitter 30 via bluetooth. The transmitter 30, which is fixed to the outside of the ankle of the patient during treatment, wirelessly powers the implanted stimulator 40. Communicate with the controller 20 via bluetooth. The stimulator 40 is implanted in the ankle near the tibial nerve. The nerve is stimulated with wireless power from transmitter 30.

FIG. 3 is a schematic diagram of the controller according to the present invention; the controller 20 is constituted by: the battery 201 is preferably a rechargeable battery, such as a lithium polymer battery. The battery management circuit 202 is configured to perform charging and state monitoring on the battery 201. And the display module 203 is used for displaying the system state, including the electric quantity, the stimulation mode, the stimulation intensity, the stimulation time and the possible fault state. The keys 204 comprise a switch machine key, a start-stop key, a mode selection and stimulation intensity adjustment key; a buzzer 205 for alerting the patient when a preset condition is triggered, such as a device failure; a microcontroller 206 for overall system control and signal processing; a memory 207 for storing relevant stimulation parameters and device information, such as calibration coefficients, treatment logs, default stimulation parameters, etc.; bluetooth module 208 communicates with transmitter 30 and delivers information including stimulation parameters delivered to transmitter 30 by controller 20, stimulation status and device status delivered to controller 20 by transmitter 30, etc.

FIG. 4 is a schematic diagram of the transmitter of the present invention; the transmitter 30 is composed of the following components: the battery 301 is preferably a rechargeable battery, such as a lithium polymer battery. The battery management circuit 302 is used for charging and monitoring the state of the battery 301. A microcontroller 303 for overall control and signal processing of the transmitter 30 system; a radio modulation module 304, which modulates the signal into a radio frequency, typically 6.78MHz or 13.56MHz, and transmits the radio frequency to a transmitting coil 305; a transmit coil 305 through which power is transmitted to the implanted stimulator 40; and a bluetooth module 306 in bidirectional communication with the controller 20. The memory 307 stores the relevant device information and the treatment information.

FIG. 5 is a schematic view of the structure of the implantable stimulator 40 of the present invention; the implanted stimulator 40 functional module consists of: a stimulation contact 401 for delivering the stimulation signal generated by the stimulation generation circuit 405 to the nerve. At least 2 contacts are respectively a positive electrode and a negative electrode, and current flows from the positive electrode to the negative electrode to stimulate nerves. A receiving coil 402 for receiving the wireless powering energy of the transmitting coil 305. And the wireless coupling circuit 403 is used for conditioning the energy of the receiving coil 402 after being coupled, and converting the energy into energy to be supplied to the implanted stimulator 40 for use. A microcontroller 404 for overall control and signal processing of the system of the implant stimulator 40; the stimulus generating circuit 405 outputs a corresponding stimulus waveform under the control of the microcontroller 404. The modulation parameters include stimulation intensity, frequency, pulse width, waveform shape, etc.

Fig. 6 shows a schematic view of the first embodiment of the inventive implantable stimulator 40, which includes fastening holes 406 at both ends of the implantable stimulator 40 for suture fastening. The whole implanted stimulator 40 is a flaky cuboid with the length of 10-30mm, the width of 5-15mm and the thickness of 2-5 mm. The cuboid shape is beneficial to being placed along the texture direction of muscle tissues, avoids causing foreign body sensation to human bodies, and can reduce the stress bending fatigue of the shell. The two ends and the corners of the implantation stimulator 40 are designed to be circular arcs or chamfers, so that friction on nerves or muscle tissues, which may cause neuritis or tendonitis, is avoided; the housing material of the implant stimulator 40 is an insulating material, which may be PEEK, TPU, PU or PTFE, and the stimulation contact 401 is a metal material, preferably platinum-iridium alloy. The implant stimulator 40 has fixation holes 406 at both ends for fixation of the suture near the nerve to prevent displacement. The stimulation waveform parameters of the implanted stimulator 40 include: the current is 0-20mA, the frequency is 0-100Hz, and the pulse width is 50-500 us. The structure of the implanted stimulator 40 is schematically shown in fig. 6: including a receiving coil 402 at the inner edge of the housing, a fixation hole 406, two stimulating contacts 401 on the side proximate to the nerve, etc. The fixing holes 406 and the stimulating contacts 401 are inside the receiving coil 402 to ensure that the receiving coil 402 can reach the maximum area to improve the wireless power transmission efficiency.

FIG. 7 is a schematic diagram illustrating the current application of the implantable stimulator of the present invention; the stimulation contacts 401 face the side of the nerve, which can improve stimulation efficiency. Fig. 7, diagram a shows the prior art implant stimulator configured as a cylinder with stimulation contacts on the top and current paths evenly diverging around the periphery of the implant stimulator, whereas the present invention, shown in diagram B, shows the implant stimulator configured as a cuboid with stimulation contacts designed to face the nerve and most of the current paths on one side of the nerve. The stimulating contact point on the surface of the implanted stimulator is arranged in a plane shape, and the stimulating efficiency is higher than that of the cylindrical stimulating contact point in the prior art.

To achieve the same nerve stimulation intensity, the present design may save more than 80% of power over the cylindrical design. For wireless power, electromagnetic waves are transmitted through human tissue, which absorbs and dissipates electromagnetic energy, referred to as the electromagnetic wave absorption ratio or Specific Absorption Rate (SAR). More efficient power transfer may reduce radio radiated emissions in wireless powering, i.e., reduce SAR values. The design of the shape is therefore of great importance to the health of the operator. The planar electrode design is beneficial to improving the wireless transmission efficiency and reducing the transmitting power. This reduction can reduce the absorption of radiation (SAR value) by the human body, which is beneficial to human health.

Other preferred embodiments:

1. in the above scheme, the controller can be combined with the transmitter to form a new transmitter. I.e. with control functions on the transmitter. To simplify system development.

2. The implant stimulator 40 may take the shape of fig. 8, the depression may be used as a suture, and the depression may be gradually filled during tissue repair at the implantation site to help secure the implant stimulator 40 against displacement.

3. If the implant stimulator 40 is secured to the tibial nerve by means of a suture, it is necessary to make a complete incision near the wound and use a larger incision to facilitate the surgeon's suture manipulation. To reduce the incision, the design of fig. 9 can be used, the implant stimulator surface is designed to be rugged, and a bi-directional barb design is added, and the incision is achieved by means of sheath injection. The barb hooks the tissue at the placing position to prevent displacement, and after a period of time, the muscle and the soft tissue can grow and fill the groove to fix the implanted stimulator, so that the fixation can be strengthened. As shown in fig. 9.

4. An ID chip is provided within the implant stimulator 40 containing a unique ID, and the transmitter 30 records and stores the ID of the implant stimulator during the first pairing. The ID is checked before each subsequent treatment, and the treatment can be started by checking the ID with the stored ID. Prevent the transmitter 30 from erroneously starting wireless power transmission when it is close to other electronic devices, resulting in damage to other devices.

5. The rechargeable batteries and circuit portions in the controller 20 and transmitter 30 may be replaced with dry cell batteries to simplify the design.

6. A vibration module and buzzer may be added to the transmitter 30 to allow the patient to still be alerted if they are disconnected from the controller 20.

7. Considering that a complex design of the implantation device has a higher failure risk than a simple design, the microcontroller 404 inside the implantation stimulator 40 may be eliminated, and instead, the coupling circuit is directly used to receive the wireless power supply signal, and then the wireless power supply signal is filtered, shaped, and converted into a stimulation waveform, as shown in fig. 10. The filter shaping circuit is formed by basic discrete components, and can realize higher reliability.

Description of the system of the invention:

1. the implant stimulator 40 is implanted near the tibial nerve of the ankle by incision or injection. And is fixed near the nerve by means of suturing.

2. Since there is no power source internal to the implanted stimulator, power is supplied wirelessly by transmitter 30. (similar to the wireless charger of the mobile phone, except that the mobile phone is implanted in the body, and the charger is placed at the ankle outside the body)

3. The transmitter 30 has no manually operable part.

4. The transmitter 30 is wirelessly powered by commands sent by the bluetooth of the controller 20 to cause the implanted portion to operate.

5. Controller 20 may set the relevant stimulation parameters and then send them to emitter 30 for implementation by emitter 30.

6. The programming meter 10 has a larger setting range than the controller 20, which corresponds to authorizing a portion of the setting functions to the controller 20 for operation. For example, the programmer 10 may set 10 different parameters, while the controller 20 may set only 5. And the setting range is limited, for example, the stimulation intensity is adjustable in a practical 0-100 level, the range of the patient set by the program-controlled instrument 10 is 20-40 level, and the patient can only be adjusted in 20-40 level.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. An implantable tibial nerve stimulation system; the method is characterized in that: comprises an implantation stimulator, a transmitter, a controller and a program-controlled instrument; an implantation stimulator is arranged in the ankle and close to the tibial nerve, and a transmitter is correspondingly arranged outside the ankle; the program control instrument is connected with the emitter through the controller; the emitter and the implantation stimulator are provided with wireless power supply devices.

2. The implantable tibial nerve stimulation system of claim 1, wherein: the controller comprises a first battery, a first microcontroller, a buzzer, a display module, a key, a first memory and a first Bluetooth module; the battery I is respectively connected with the microcontroller I, the buzzer, the display module, the key, the memory I and the Bluetooth module I; the buzzer, the display module, the key, the first memory and the first Bluetooth module are respectively connected with the first microcontroller.

3. The implantable tibial nerve stimulation system of claim 2, wherein: the transmitter comprises a second battery, a second microcontroller, a second radio modulation module, a transmitting coil, a second Bluetooth module and a second memory; the battery II is respectively connected with the microcontroller II, the radio modulation module, the transmitting coil, the Bluetooth module II and the memory II; the microcontroller II is connected with the transmitting coil through the radio modulation module; and the second microcontroller is respectively connected with the second Bluetooth module and the second memory.

4. The implantable tibial nerve stimulation system of claim 3, wherein: the implant stimulator comprises a stimulation contact, a receiving coil, a radio coupling circuit, a microcontroller III and a stimulation generation circuit; the radio coupling circuit is connected with the receiving coil; the radio coupling circuit is connected with the third microcontroller and the stimulus generating circuit; the microcontroller is connected with the stimulating contact through a stimulating generating circuit.

5. The implantable tibial nerve stimulation system of claim 3, wherein: the implant stimulator includes a stimulation contact, a receiving coil, a radio coupling circuit, and a stimulation generation circuit; the radio coupling circuit is connected with the receiving coil; the wireless coupling circuit is connected to the stimulation contacts through the stimulation generating circuit.

6. An implantable tibial nerve stimulation system according to any one of claims 4 and 5, wherein: the implant stimulator is shaped like a flaky cuboid, and two ends and corners of the cuboid are provided with circular arcs or chamfers; both ends of the cuboid are also provided with fixing holes.

7. The implantable tibial nerve stimulation system of claim 6, wherein: and a receiving coil is arranged along the edge of the inside of the shell of the implantation stimulator.

8. The implantable tibial nerve stimulation system of claim 7, wherein: at least two stimulating contacts are arranged on one side of the implanted stimulator close to the tibial nerve.

9. The implantable tibial nerve stimulation system of claim 8, wherein: the surface of the implantation stimulator is provided with grooves and barbs.

10. The implantable tibial nerve stimulation system of claim 9, wherein: an ID chip used for being correspondingly matched with the transmitter is arranged in the implantation stimulator.