A miniature implantable spinal cord neurostimulator

Abstract

The present invention relates to the field of nerve stimulation technology, specifically a miniature implantable spinal cord nerve stimulator, comprising electrodes, a stimulator body, and a control system; the electrodes, the stimulator body, and the control system cooperate to operate, the electrodes and the stimulator body are connected and arranged in an integrated manner without an extension wire, the stimulator body is sunk below the spinous process of the spine, and the upper end line is flush with the remaining spinous processes of the spine; the control system includes: a main controller unit, a radio frequency unit, a channel decoding unit, a transmitter unit, a power splitter / combiner unit, a main power supply unit, an energy storage unit, an electrical stimulation unit, an array electrode unit, and a posture recognition unit. By implanting a miniature spinal cord nerve stimulator in combination with spinal nerve decompression and spinal fixation in the early stage of spinal cord injury, the stimulator has a small size and a short electrode lead, and there is no implant protrusion after surgery, making full use of the golden window period after spinal cord injury, creating favorable conditions for spinal cord injury rehabilitation, and improving the rehabilitation effect.

Description

Technical Field

[0001] The invention relates to the technical field of nerve stimulation, in particular to a miniature implantable spinal cord nerve stimulator. Background Art

[0002] Spinal cord injury (SCI) refers to damage to the neural structures in the spinal canal (including the spinal cord, nerve roots and cauda equina) due to various reasons, and the occurrence of sensory, motor, reflex and urinary and bowel dysfunction at or below the level of injury. Studies have shown that there are 3.74 million patients with spinal cord injury in China, and about 90,000 new patients with spinal cord injury are added each year.

[0003] Spinal cord injury is extremely harmful. If the recovery of limb function cannot be effectively promoted, it will lead to complications such as respiratory problems, pressure sores, urinary tract infections, and renal failure, which are life-threatening. Urinary system complications are the most serious among spinal cord injury patients. 74% of patients have experienced urinary incontinence within three months, and each patient has an average of 10 urinary system complications per year. Within 5 years after the injury, the incidence of upper urinary tract injury in patients increases rapidly, which is 30 times that of normal people. The main caregivers of patients with spinal cord injury often carry heavy physical, psychological and economic burdens, which affects the health of the caregivers and reduces their quality of life accordingly.

[0004] Conventional treatment options for spinal cord injury neural repair mainly include surgical decompression of the injured area, neural bridging, neural regulation and cell therapy. In the specific application of neural regulation, epidural stimulation training can activate neural circuits, promote neural remodeling and functional recovery in patients with complete spinal cord injury, and improve trunk stability.

[0005] Existing spinal cord nerve stimulators cannot be placed at the same time as combined spinal fixation surgery, and the spinal fixation surgery and spinal cord nerve stimulator implantation surgery are performed separately; at the same time, the spinal cord nerve stimulator is buried in the subcutaneous tissue above the buttocks, resulting in a more obvious implant protrusion visible on the surface of the body, and the electrode leads are long and easily pulled and displaced.

[0006] In summary, in order to reduce the pain burden of patients with spinal cord injury and obtain the greatest clinical benefit with minimal surgical trauma, the present invention proposes a miniature implantable spinal cord nerve stimulator. Summary of the invention

[0007] The object of the present invention is to provide a miniature implantable spinal cord neurostimulator to solve the problems raised in the above-mentioned background technology.

[0008] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a miniature implantable spinal cord nerve stimulator, comprising electrodes, a stimulator body, and a control system; the electrodes, the stimulator body, and the control system cooperate to operate, the electrodes and the stimulator body are connected and arranged in an integrated manner without an extended wire, the stimulator body is sunken below the spinous process of the spine, the upper end line is flush with the remaining spinous processes of the spine, and there is no depression or implant protrusion in the posterior view of the spine after surgery, and the spinal cord nerve stimulator is implanted at the same time as the spinal fixation bracket surgery to move the treatment window of the damaged spinal cord nerve rehabilitation forward, and then through ultra-low dose stimulation, the repair of the damaged spinal cord and nerves is promoted, and the prognosis effect is improved;

[0009] The control system includes: a main controller unit, a radio frequency unit, a channel decoding unit, a transmitter unit, a power splitter / combiner unit, a main power supply unit, an energy storage unit, an electrical stimulation unit, an array electrode unit, and a posture recognition unit;

[0010] The main controller unit is encapsulated inside the stimulator body and is used for parallel decoding of dual channels, encoding settings of the transmitter and control of other peripheral units;

[0011] The radio frequency unit is used to send and receive radio frequency information, energy and coding;

[0012] The channel decoding unit corresponds to the radio frequency unit one by one, and is a dual-channel parallel structure, including a channel 1 decoding unit and a channel 2 decoding unit. The radio frequency signal after filtering in the radio frequency unit is sent to the channel 1 decoding unit and the channel 2 decoding unit for synchronous decoding, which can improve the decoding efficiency and decoding accuracy and improve the signal transmission quality;

[0013] A transmitter unit, used for sending a radio frequency coded signal to the outside;

[0014] A power splitter / combiner unit is used to combine and distribute the power of the RF signal;

[0015] A main power supply unit, used to generate the electric potential required by the neurostimulator and adaptively adjust the system power supply according to the load power;

[0016] An energy storage unit, used to store energy and provide the energy to a main power supply unit;

[0017] An electrical stimulation unit, used for generating a specific spinal cord electrical stimulation signal according to the control of the main control unit;

[0018] The electrode includes an array electrode unit, which is integrated with the stimulator body without extension wires or connecting wires, and is used to transmit the electrical pulses generated by the electrical stimulation unit to specific electrode sites;

[0019] The posture recognition unit is used to identify changes in the patient's body position and to close-loop control the electrical stimulation output of the main controller according to the characteristics of different body positions and postures.

[0020] Compared with the prior art, the beneficial effects of the present invention are: the miniature spinal cord nerve stimulator can be implanted in combination with spinal nerve decompression and spinal fixation in the early stage of spinal cord injury; the miniature spinal cord nerve stimulator is small in size and the electrode leads are short enough, the stimulator sinks into the spinous process at the site of spinal cord injury, and the stimulator is firmly fixed to the spinal fixation bracket to eliminate the risk of displacement. At the same time, there is no protrusion of the implant on the body surface after surgery, creating favorable conditions for spinal cord injury rehabilitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A system block diagram of a miniature implantable spinal cord neurostimulator;

[0022] Figure 2 A side view of a miniature implantable spinal cord neurostimulator;

[0023] Figure 3 This is a posterior view of a miniature implantable spinal cord neurostimulator;

[0024] Figure 4 A micro-implantable spinal cord neurostimulator and paddle-shaped array electrode after implantation;

[0025] Figure 5 A rear view of a micro implantable spinal cord neurostimulator and a double-column isotropic array electrode after implantation;

[0026] Figure 6 This is a rear view of a micro implantable spinal cord neurostimulator and dual-column anisotropic electrodes after implantation;

[0027] Among them: main controller unit 10, RF 1 unit 201, RF 2 unit 202, channel 1 decoding unit 301, channel 2 decoding unit 302, transmitter unit 40, power splitter / combiner unit 50, main power supply unit 60, energy storage unit 70, electrical stimulation unit 80, array electrode unit 90, posture recognition unit 100. DETAILED DESCRIPTION

[0028] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0029] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and the like are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", and the like may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0030] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0031] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0032] See also Figure 1-Figure 6 A miniature implantable spinal cord nerve stimulator comprises an electrode, a stimulator body and a control system. The electrode, the stimulator body and the control system work in coordination. The electrode and the stimulator body are connected in an integrated manner without any extension wires. The stimulator body is sunken below the spinous process of the spine, and the upper end line is flush with the other spinous processes of the spine. After surgery, there is no depression or implant protrusion in the posterior view of the spine. By implanting a spinal cord nerve stimulator at the same time as the spinal fixation surgery, the treatment window for the rehabilitation of damaged spinal cord nerves is moved forward, and then ultra-low dose stimulation is used to promote the repair of damaged spinal cord and nerves and improve the prognosis.

[0033] The control system includes: a main controller unit 10, a radio frequency unit, a channel decoding unit, a transmitter unit 40, a power splitter / combiner unit 50, a main power supply unit 60, an energy storage unit 70, an electrical stimulation unit 80, an array electrode unit 90, and a posture recognition unit 100;

[0034] The main control unit 10 is encapsulated inside the stimulator body and is used for decoding and processing the dual channels in parallel, setting the encoding of the transmitter and controlling other peripheral units;

[0035] The radio frequency unit is used to send and receive radio frequency information, energy and coding;

[0036] The channel decoding unit corresponds to the radio frequency unit one by one, and is a dual-channel parallel structure, including a channel 1 decoding unit 301 and a channel 2 decoding unit 302. The radio frequency signal after filtering in the radio frequency unit is sent to the channel 1 decoding unit 301 and the channel 2 decoding unit 302 for synchronous decoding, which can improve the decoding efficiency and decoding accuracy, and improve the signal transmission quality;

[0037] The transmitter unit 40 is used to send the radio frequency coded signal to the outside;

[0038] A power splitter / combiner unit 50, used for combining and distributing power of radio frequency signals;

[0039] A main power supply unit 60, used to generate the potential required by the neurostimulator and adaptively adjust the system power supply according to the load power;

[0040] An energy storage unit 70, used to store energy and provide the energy to the main power supply unit 60;

[0041] The electrical stimulation unit 80 is used to generate a specific spinal cord electrical stimulation signal according to the control of the main control unit 10;

[0042] The electrode includes an array electrode unit 90, which is integrated with the stimulator body without extension wires or connecting wires, and is used to transmit the electrical pulses generated by the electrical stimulation unit 80 to specific electrode sites;

[0043] The posture recognition unit 100 is used to recognize changes in the patient's body position and to close-loop control the electrical stimulation output of the main controller according to different body position and posture characteristics.

[0044] In an embodiment of the present invention, the stimulator body includes a stimulator housing, and the stimulator housing is provided with four arc-shaped bendable fixing ears, which are used to fix the stimulator body to the spinal support during the implementation of spinal fixation surgery, thereby avoiding secondary implantation in traditional surgery;

[0045] In one embodiment of the present invention, the main controller unit 10 is configured as a multi-core structure processor, which can perform parallel computing processing; the radio frequency unit is configured as a dual-antenna design structure, which is distributed on the left and right sides of the spinal cord nerve stimulator, and is a micro-curved surface structure, and the curved surface can fit the human vertebral lamina. The radio frequency unit is divided into a radio frequency 1 unit 201 and a radio frequency 2 unit 202. Each radio frequency unit is composed of an electric / magnetic field tuner unit, a filter unit, an integrator unit, and an isolation unit, and is used to receive radio frequency information and radio frequency energy from the outside, and transmit the radio frequency code generated by the main controller unit to the external space field. At the same time, the radio frequency 1 unit 201 and the radio frequency 2 unit 202 are configured to be in a completely independent operating state;

[0046] The transmitter unit 40 is set to the carrier modulation format, the transmission power, the interval of the radio frequency unit parallel transmission or serial transmission, and the redundancy check;

[0047] The power splitter / combiner unit 50 is used, on the one hand, to receive RF signals from the outside, and to combine the power according to the amount of RF energy received from the RF 1 unit 201 and the RF 2 unit 202, and to use a part of the energy directly as the main power supply, and to transmit the other part of the energy in parallel to the energy storage unit 70 for energy storage; on the other hand, it is used to distribute the power of the RF signal transmitted by the transmitter unit 40 according to the transmitter characteristics; wherein the distribution ratio is related to the RF transmission quality of the RF 1 unit 201, the RF 2 unit 202 and the channel 1 decoding 301, and the channel 2 decoding 302.

[0048] As a preferred embodiment of the present invention, the main power supply unit 60 switches to a high-voltage and high-current mode during the operation of the transmitter unit 40, and switches to a low-current mode during the operation of the combiner. The remaining electrical energy comes from external energy obtained by the combiner.

[0049] As a preferred embodiment of the present invention, the energy storage unit 70 is used to store energy and provide energy to the main power supply unit 60 for use, and receives external RF energy obtained by the combiner. The energy storage unit 70 has an adaptive current sampling function, and adaptively sets the energy storage charging current according to the power allocated by the combiner. The energy storage unit 70 has a zero-voltage protection function to prevent irreversible loss of the energy storage medium.

[0050] As a preferred embodiment of the present invention, the electrical stimulation unit 80 can generate unipolar pulses, bipolar pulses, unipolar and bipolar mixed pulses, etc. According to the polarity and number of channels of the array electrodes, the electrical stimulation signals can be output synchronously or asynchronously in multiple channels.

[0051] As a preferred embodiment of the present invention, the array electrode unit 90 is divided into double-row multi-contact columnar electrodes, double-row multi-contact arc surface electrodes, and planar paddle electrodes;

[0052] Specifically, micromechanical pressure sensors are distributed in the array electrode unit 90, which can sense and monitor the pressure changes at the electrode implantation site, and are used to determine the displacement of the electrode, the spine and spinal canal pressure at the implantation site, etc. At the same time, they can identify the chest rise and fall of the implantee, and adaptively adjust the stimulation electrode site and stimulation intensity to meet the limb movement needs.

[0053] As a preferred embodiment of the present invention, the posture recognition unit 100 includes a multi-axis acceleration sensor integrated in the main control unit 10, and uses the multi-axis acceleration sensor to recognize changes in the patient's body position;

[0054] It also includes a micro pressure sensor integrated in the array electrode unit 90 for sensing and monitoring the pressure changes near the spine, spinal canal, and spinous process.

[0055] The above describes in detail the preferred implementation of this patent, but this patent is not limited to the above implementation. Various changes can be made within the knowledge scope of ordinary technicians in this field without departing from the purpose of this patent.

Claims

1. A miniature implantable spinal cord neurostimulator, characterized in that: It includes electrodes, a stimulator body, and a control system; the electrodes, the stimulator body, and the control system cooperate to operate, the electrodes are integrally connected with the stimulator body without an extension wire, the stimulator body is sunk below the spinous process of the spine, and the upper end line is flush with the remaining spinous processes of the spine; The control system comprises: a main controller unit (10), a radio frequency unit, a channel decoding unit, a transmitter unit (40), a power splitter / combiner unit (50), a main power supply unit (60), an energy storage unit (70), an electrical stimulation unit (80), an array electrode unit (90), and a posture recognition unit (100); A main controller unit (10) is encapsulated inside the stimulator body and is used for dual-channel parallel decoding processing, encoding setting of the transmitter and control of other peripheral units; a radio frequency unit is used for transmitting and receiving radio frequency information, energy and encoding; a channel decoding unit corresponds to the radio frequency unit one by one and is a dual-channel parallel structure, including a channel 1 decoding unit (301) and a channel 2 decoding unit (302); the radio frequency signal after filtering processing in the radio frequency unit is sent to the channel 1 decoding unit (301) and the channel 2 decoding unit (302) for synchronous decoding; A transmitter unit (40) is used to send a radio frequency coded signal to the outside; a power splitter / combiner unit (50) is used to combine and distribute the radio frequency signal; a main power supply unit (60) is used to generate a potential required by the nerve stimulator; an energy storage unit (70) is used to store energy and provide the energy to the main power supply unit (60); an electrical stimulation unit (80) is used to generate a specific spinal cord electrical stimulation signal according to the control of the main control unit (10); the electrode includes an array electrode unit (90), the array electrode unit (90) is integrated with the stimulator body, has no extension line or connection line, and is used to transmit the electrical pulse generated by the electrical stimulation unit (80) to a specific electrode site; The posture recognition unit (100) is used to recognize changes in the patient's body position and to close-loop control the electrical stimulation output of the main controller according to different body position and posture characteristics.

2. A miniature implantable spinal cord neurostimulator according to claim 1, characterized in that: The stimulator body includes a stimulator shell, and the stimulator shell is provided with four arc-shaped bendable fixing ears for fixing the stimulator body on the spinal support during the implementation of spinal fixation.

3. A miniature implantable spinal cord neurostimulator according to claim 2, characterized in that: The main controller unit (10) is configured as a multi-core structure processor for parallel computing. The radio frequency unit is configured as a dual antenna design structure, which is distributed on the left and right sides of the spinal cord nerve stimulator and is configured as a micro-curved surface structure, and the curved surface can fit the human vertebral lamina. The radio frequency unit is divided into a radio frequency 1 unit (201) and a radio frequency 2 unit (202). Each radio frequency unit is composed of an electric / magnetic field tuner unit, a filter unit, an integrator unit, and an isolation unit, and is used to receive radio frequency information and radio frequency energy from the outside, and transmit the radio frequency code generated by the main controller unit to the external space field.

4. A miniature implantable spinal cord neurostimulator according to claim 3, characterized in that: The transmitter unit (40) is configured with carrier modulation format, transmission power, radio frequency unit parallel transmission or serial transmission interval, and redundancy check.

5. A miniature implantable spinal cord neurostimulator according to claim 4, characterized in that: The power splitter / combiner unit (50) is used, on the one hand, to receive radio frequency signals from the outside, to combine power according to the radio frequency energy received from the radio frequency (1) unit (201) and the radio frequency (2) unit (202), and to use a portion of the energy directly as the main power supply, while transmitting the other portion of the energy in parallel to the energy storage unit (70) for energy storage; and on the other hand, to distribute the power of the radio frequency signal transmitted by the transmitter unit (40) according to the transmitter characteristics.

6. A miniature implantable spinal cord neurostimulator according to claim 5, characterized in that: The main power supply unit (60) switches to a high-voltage and high-current mode when the transmitter unit (40) is in operation, and switches to a low-current mode when the combiner is in operation.

7. A miniature implantable spinal cord neurostimulator according to claim 6, characterized in that: The energy storage unit (70) is used to store energy and provide the energy to the main power supply unit (60) for use, and receives external radio frequency energy obtained by the combiner.

8. A miniature implantable spinal cord neurostimulator according to claim 7, characterized in that: The array electrode unit (90) is divided into double-row multi-contact columnar electrodes, double-row multi-contact arc surface electrodes, and planar paddle electrodes.

9. A miniature implantable spinal cord neurostimulator according to claim 7, characterized in that: Micromechanical pressure sensors are distributed in the array electrode unit (90) to sense and monitor pressure changes at the electrode implantation site.

10. A miniature implantable spinal cord neurostimulator according to claim 9, characterized in that: The posture recognition unit (100) comprises a multi-axis acceleration sensor integrated in the main control unit (10), and utilizes the multi-axis acceleration sensor to recognize changes in the patient's body position; Also included is a micro pressure sensor integrated in the array electrode unit (90) for sensing and monitoring pressure changes in the spine, spinal canal, and vicinity of the spinous process.

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