Miniature implantable spinal cord stimulator

Abstract

A miniature implantable spinal cord stimulator, comprising an electrode, a stimulator body and a control system, wherein the electrode, the stimulator body and the control system operate in cooperation, the electrode and the stimulator body are integrally connected to each other without any extension lead, the stimulator body is implanted beneath a spinous process of a spine, and the upper end of the stimulator body is flush with other spinous processes of the spine; and the control system comprises: a main controller unit, a radio frequency unit, a channel decoding unit, a transmitter unit, a power divider / 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 the miniature implantable spinal cord stimulator in combination with spinal cord decompression surgery and spinal fixation surgery in an early stage after a spinal cord injury, the stimulator, having a small size and short electrode leads, avoids post-operative protrusion of an implant, and a golden window period after the spinal cord injury can thus be effectively utilized, so as to create favorable conditions for the rehabilitation of the spinal cord injury and improve rehabilitation outcomes.

Description

A miniature implantable spinal cord nerve stimulator Technical Field

[0001] This invention relates to the field of neurostimulation technology, specifically a miniature implantable spinal cord nerve stimulator. Background Technology

[0002] Spinal cord injury (SCI) refers to damage to the neural structures within the spinal canal (including the spinal cord, nerve roots, and cauda equina) caused by various factors, resulting in sensory, motor, reflex, and bowel and bladder dysfunction at or below the level of injury. Studies show that there are currently 3.74 million SCI patients in China, with approximately 90,000 new cases each year.

[0003] Spinal cord injury is extremely dangerous. If limb function rehabilitation is not effectively promoted, it can lead to life-threatening complications such as respiratory problems, pressure sores, urinary tract infections, and kidney failure. Urinary tract complications are the most serious among spinal cord injury patients; 74% of patients experience urinary incontinence within three months, and each patient experiences an average of 10 urinary tract complications per year. Within five years of injury, the incidence of upper urinary tract injury increases rapidly, reaching 30 times that of the general population. Primary caregivers of spinal cord injury patients often bear a heavy physical, psychological, and financial burden, affecting their health and consequently reducing their quality of life.

[0004] Conventional treatment plans for spinal cord injury neurorepair mainly include surgical decompression at the injury site, nerve bridging, neuromodulation, and cell therapy. In specific applications of neuromodulation, 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 nerve stimulators cannot be placed simultaneously during combined spinal fixation surgery. Instead, the spinal fixation surgery and spinal nerve stimulator implantation surgery are performed separately. At the same time, the spinal nerve stimulator is implanted in the subcutaneous tissue above the buttock, resulting in a noticeable protrusion of the implant on the body surface. Furthermore, the electrode leads are long and easily subject to traction and displacement.

[0006] In summary, in order to alleviate the pain burden of patients with spinal cord injuries and achieve the greatest clinical benefit with minimal surgical trauma, this invention proposes a miniature implantable spinal cord nerve stimulator. Summary of the Invention

[0007] The purpose of this invention is to provide a miniature implantable spinal cord stimulator to solve the problems mentioned in the background art.

[0008] To achieve the above objectives, the present invention provides the following technical solution: a miniature implantable spinal cord nerve stimulator, comprising electrodes, a stimulator body, and a control system; the electrodes, stimulator body, and control system operate in coordination, the electrodes and stimulator body are integrated and connected without extension wires, the stimulator body is submerged below the spinous process of the spine, the upper end line is flush with the other spinous processes of the spine, and there is no depression or implant protrusion on the posterior view of the spine after surgery; by implanting the spinal cord nerve stimulator simultaneously with spinal fixation surgery, the treatment window for the rehabilitation of damaged spinal cord nerves is moved forward, and then the repair of damaged spinal cord and nerves is promoted through ultra-low dose stimulation, thereby improving the prognosis;

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

[0010] The main controller unit, encapsulated inside the stimulator body, 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 transmit and receive radio frequency information, energy, and encoding.

[0012] The channel decoding unit corresponds one-to-one with the radio frequency unit and is a dual-channel parallel structure, including a channel 1 decoding unit and a channel 2 decoding unit. The radio frequency signal after being filtered 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 decoding efficiency and decoding accuracy, and improve signal transmission quality.

[0013] The transmitter unit is used to transmit radio frequency coded signals to the outside.

[0014] The power divider / combiner unit is used for power combining and power distribution of radio frequency signals;

[0015] The main power supply unit is used to generate the potential required by the neurostimulator and adaptively adjusts the system power supply according to the load power.

[0016] Energy storage unit, used to store energy and supply it to the main power supply unit;

[0017] The electrical stimulation unit is used to generate specific spinal cord electrical stimulation signals according to the control of the master controller unit;

[0018] The electrode includes an array electrode unit, which is integrated with the stimulator body without extension lines or connecting lines, 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 control the electrical stimulation output of the master controller in a closed loop according to the different posture characteristics.

[0020] Compared with the prior art, the beneficial effects of the present invention are: it can be combined with spinal cord decompression and spinal fixation surgery in the early stage of spinal cord injury to implant a miniature spinal cord nerve stimulator; the miniature spinal cord nerve stimulator is small in size and the electrode leads are short enough that the stimulator is sunk into the spinous process of the spinal cord injury site, and the stimulator is firmly fixed to the spinal fixation frame, eliminating the risk of displacement. At the same time, there is no implant protrusion on the body surface after surgery, creating favorable conditions for spinal cord injury rehabilitation. Attached Figure Description

[0021] Figure 1 is a system block diagram of a miniature implantable spinal cord stimulator.

[0022] Figure 2 shows a side view of a miniature implantable spinal cord stimulator after implantation.

[0023] Figure 3 shows a post-implantation view of a miniature implantable spinal cord stimulator.

[0024] Figure 4 shows a rear view of a miniature implantable spinal cord stimulator and paddle array electrodes after implantation.

[0025] Figure 5 shows a rear view of a miniature implantable spinal cord stimulator and a dual-column co-directional array electrode after implantation.

[0026] Figure 6 shows a rear view of a miniature implantable spinal nerve stimulator and its dual-column anisotropic electrodes after implantation.

[0027] Among them: main controller unit 10, radio frequency 1 unit 201, radio frequency 2 unit 202, channel 1 decoding unit 301, channel 2 decoding unit 302, transmitter unit 40, power divider / synthesizer unit 50, main power supply unit 60, energy storage unit 70, electrical stimulation unit 80, array electrode unit 90, and attitude recognition unit 100. Detailed Implementation

[0028] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0029] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0030] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

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

[0032] Please refer to Figures 1-6. A miniature implantable spinal cord nerve stimulator includes electrodes, a stimulator body, and a control system. The electrodes, stimulator body, and control system work together. The electrodes and stimulator body are integrated and connected without extension wires. The stimulator body is sunk below the spinous process of the spine, and the upper end line is flush with the other spinous processes of the spine. There is no depression or implant protrusion on the posterior view of the spine after surgery. By implanting the spinal cord nerve stimulator during spinal fixation surgery, the treatment window for the rehabilitation of damaged spinal cord nerves is moved forward. Then, through ultra-low dose stimulation, the repair of damaged spinal cord and nerves is promoted, and the prognosis is improved.

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

[0034] The main controller unit 10 is encapsulated inside the stimulator body and is used for dual-channel parallel decoding, encoding settings of the transmitter, and control of other peripheral units.

[0035] The radio frequency unit is used to transmit and receive radio frequency information, energy, and encoding.

[0036] The channel decoding unit corresponds one-to-one with the radio frequency unit 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 being filtered 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 decoding efficiency and decoding accuracy, and improve signal transmission quality.

[0037] Transmitter unit 40 is used to transmit radio frequency coded signals to the outside;

[0038] The power divider / combiner unit 50 is used for power combining and power distribution of radio frequency signals;

[0039] The main power supply unit 60 is used to generate the potential required by the neurostimulator and adaptively adjusts the system power supply according to the load power.

[0040] Energy storage unit 70 is 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 specific spinal cord electrical stimulation signals according to the control of the main controller unit 10.

[0042] The electrode includes an array electrode unit 90, which is integrated with the stimulator body and has no extension line or connecting line. It is used to transmit the electrical pulses generated by the electrical stimulation unit 80 to a specific electrode site.

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

[0044] In this embodiment of the invention, the stimulator body includes a stimulator shell, and four arc-shaped bendable fixing ears are provided on the stimulator shell, which are used to fix the stimulator body to the spinal support during the spinal fixation surgery, thereby avoiding the secondary implantation required in traditional surgery.

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

[0046] Transmitter unit 40 is configured with carrier modulation format, transmit power, RF unit parallel or serial transmission interval, and redundancy check.

[0047] The power divider / combiner unit 50 serves two purposes: firstly, it receives radio frequency (RF) signals from the outside and combines the power based on the RF energy received from RF unit 1 201 and RF unit 202, using a portion of the energy directly as the main power supply and transmitting the other portion in parallel to the energy storage unit 70 for energy storage; secondly, it distributes the RF signals transmitted by the transmitter unit 40 according to the transmitter characteristics, wherein the distribution ratio is related to the RF transmission quality of RF unit 1 201, RF unit 202, and channel 1 decoder 301 and channel 2 decoder 302.

[0048] In a preferred embodiment of the present invention, the main power supply unit 60 switches to a high-voltage, 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 part of the electrical energy comes from the external energy obtained by the combiner.

[0049] In a preferred embodiment of the present invention, the energy storage unit 70 is used to store energy and provide the energy to the main power supply unit 60. It receives external radio frequency energy obtained by the combiner. The energy storage unit 70 has an adaptive current sampling function, which 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 monopolar pulses, bipolar pulses, and mixed monopolar and bipolar pulses, etc., and the electrical stimulation signal can be output synchronously or asynchronously in multiple channels according to the polarity of the array electrodes and the number of channels.

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

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

[0053] As a preferred embodiment of the present invention, the posture recognition unit 100 includes a multi-axis acceleration sensor integrated in the main controller 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, used to sense and monitor pressure changes near the spine, spinal canal, and spinous process.

[0055] The preferred embodiments of this patent have been described in detail above. However, this patent is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of this patent.

Claims

1. A micro-implantable spinal neurostimulator, comprising: It includes electrodes, a stimulator body, and a control system; the electrodes, stimulator body, and control system work together; the electrodes and stimulator body are integrated and connected without extension wires; the stimulator body is submerged below the spinous process of the spine, and the upper end line is flush with the other spinous processes of the spine. The control system includes: a main controller unit (10), a radio frequency unit, a channel decoding unit, a transmitter unit (40), a power divider / synthesizer unit (50), a main power supply unit (60), an energy storage unit (70), an electrical stimulation unit (80), an array electrode unit (90), and an attitude recognition unit (100). The main controller unit (10) is encapsulated inside the stimulator body and is used for dual-channel parallel decoding processing, encoding settings of the transmitter, and control of other peripheral units; the radio frequency unit is used for transmitting and receiving radio frequency information, energy, and encoding; the channel decoding unit corresponds one-to-one with the radio frequency unit 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; The transmitter unit (40) is used to send radio frequency encoded signals to the outside; the power divider / synthesizer unit (50) is used to combine and distribute the power of the radio frequency signals; the main power supply unit (60) is used to generate the potential required by the nerve stimulator; the energy storage unit (70) is used to store energy and provide energy to the main power supply unit (60); the electrical stimulation unit (80) is used to generate specific spinal cord electrical stimulation signals according to the control of the main controller unit (10); the electrodes include an array electrode unit (90), which is integrated with the stimulator body and has no extension line or connecting line, and is used to transmit the electrical pulses generated by the electrical stimulation unit (80) to specific electrode sites; The posture recognition unit (100) is used to recognize changes in the patient's body position and to control the electrical stimulation output of the master controller in a closed loop according to the different posture characteristics.

2. The micro-implantable spinal neurostimulator of claim 1, wherein, The stimulator body includes a stimulator shell, which has four arc-shaped bendable fixing ears for fixing the stimulator body to the spinal support during spinal fixation surgery.

3. The micro-implantable spinal neurostimulator of claim 2, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The main controller unit (10) is configured as a multi-core processor for parallel computing. The radio frequency unit is configured as a dual-antenna design structure, distributed on the left and right sides of the spinal nerve stimulator, and configured as a micro-curved surface structure. The curved surface can fit the human vertebral arch. The radio frequency unit is divided into radio frequency 1 unit (201) and radio frequency 2 unit (202). Each radio frequency unit consists of an electric / magnetic field tuner unit, a filter unit, an integrator unit, and an isolation unit, used to receive radio frequency information and radio frequency energy from the outside, and to transmit the radio frequency code generated by the main controller unit to the external space field.

4. The micro-implantable spinal neurostimulator of claim 3, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The transmitter unit (40) is configured with carrier modulation format, transmission power, RF unit parallel or serial transmission interval, and redundancy check.

5. The micro-implantable spinal neurostimulator of claim 4, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The power divider / combiner unit (50) is used to receive radio frequency signals from the outside, combine the power according to the amount of radio frequency energy received from the radio frequency (1) unit (201) and the radio frequency (2) unit (202), and use a part of the energy directly as the main power supply, while the other part of the energy is transmitted in parallel to the energy storage unit (70) for energy storage; on the other hand, it is used to distribute the power of the radio frequency signals transmitted by the transmitter unit (40) according to the characteristics of the transmitter.

6. The micro-implantable spinal neurostimulator of claim 5, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. During the operation of the transmitter unit (40), the main power supply unit (60) switches to a high-voltage, high-current mode, and during the operation of the combiner, the main power supply switches to a low-current mode.

7. The micro-implantable spinal neurostimulator of claim 6, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The energy storage unit (70) is used to store energy and provide the energy to the main power supply unit (60) for use, and to receive external radio frequency energy acquired by the combiner.

8. The micro-implantable spinal neurostimulator of claim 7, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The array electrode unit (90) is divided into a double-row multi-contact columnar electrode, a double-row multi-contact arc surface electrode, and a planar paddle electrode.

9. The micro-implantable spinal neurostimulator of claim 7, wherein the at least one electrode is configured to stimulate the spinal cord at a location between the C7 and T1 vertebrae. The array electrode unit (90) is equipped with micromechanical pressure sensors to sense and monitor pressure changes at the electrode implantation site.

10. The micro-implantable spinal neurostimulator of claim 9, wherein, The posture recognition unit (100) includes a multi-axis acceleration sensor integrated in the main controller unit (10), which is used to identify changes in the patient's body position. It also includes a micro pressure sensor integrated in the array electrode unit (90) for sensing and monitoring pressure changes near the spine, spinal canal and spinous process.

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