Spinal cord electrical stimulation device with adjustable direction
Through the adjustable spinal cord electrical stimulation device, the adjustment channel and the snap-on fixing device are used to achieve precise positioning and stable fixation of the electrodes, solving the problem of position deviation caused by manual placement of the electrode array, improving treatment efficiency and safety, and reducing surgical and treatment costs.
Patent Information
- Application Number
- CN202511017204.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-23
- Publication Date
- 2025-09-16
AI Technical Summary
In existing technologies, manual placement of electrode arrays relies on the surgeon's experience, resulting in deviations from the ideal stimulation area, affecting treatment efficacy and requiring multiple adjustments, which prolongs surgery time, increases patient discomfort, and increases treatment costs.
A spinal cord stimulation device with adjustable direction is used. The adjustment channels and direction adjustment lines on both sides of the base, combined with a snap-on fixing device, can achieve precise positioning and stable fixation of the electrodes. Millimeter-level precision adjustment is achieved by externally pulling the adjustment line to ensure that the electrode array is located in the optimal stimulation area.
It improves the accuracy of electrode placement, shortens operation time, reduces the patient's anesthesia time and postoperative recovery period, reduces discomfort and additional medical costs, and ensures the stability and safety of treatment effects.
Smart Images
Figure CN120643835A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a spinal cord electrical stimulation device with adjustable direction. Background Art
[0002] The spinal cord is the neural tissue within the spine, serving as a relay station for transmitting signals between the brain and peripheral limbs and organs. It is divided into ventral (anterior) and dorsal (posterior) regions, with the dorsal region (posterior horn) regulating sensory signals and the ventral region (anterior horn) regulating movement. The bony structures surrounding the spinal cord primarily consist of the vertebral bodies in the front and the lamina in the back. Spinal cord stimulation (SCS) is a neuromodulatory technology used to treat chronic pain. It is suitable for patients with chronic pain who have not responded to traditional therapies. The treatment principle is based on the gate control theory proposed by Melzack and Wall in 1965. It blocks the transmission of pain signals through electrical stimulation. Electrodes are implanted in the epidural space of the spinal canal, stimulating the spinal cord with electrical current to block the transmission of pain signals to the brain, thereby controlling pain. Numerous studies have confirmed that SCS is safe and effective in treating chronic pain. SCS has been approved by the U.S. FDA for the treatment of failed lumbar surgery syndrome, chronic pain, complex regional pain syndrome, intractable angina, visceral abdominal pain, perineal pain, and limb pain caused by nerve damage. In the past decade, SCS has gradually been introduced into the management of chronic pain patients in China.
[0003] SCS consists of two main components: a pulse generator and electrodes, and sometimes also includes extension wires. The existing technology is to place stimulation electrodes on the surface of the spinal cord in a surgical manner, and connect the electrodes to the electrical stimulation generator through wires. The electrical stimulation generator is implanted subcutaneously and applies electrical stimulation signals of a specific frequency and intensity to achieve the purpose of analgesia or promote motor recovery. For the treatment of chronic disorders of consciousness, electrodes are usually implanted in the epidural midline at the level of C2-C4 of the spinal cord. After spinal cord electrical stimulation, the local glucose metabolism rate and cerebral blood flow in the anterior and posterior brain are significantly increased. The pulse stimulation of the starting part of the ascending reticular activating system enhances the activity of conscious impulses, improves the state of nerve conduction, and increases brain electrical activity.
[0004] Electrode arrays play a crucial role in spinal cord stimulation (SCS) therapy, delivering electrical current to stimulate the spinal cord and thereby blocking pain signals. Existing electrode arrays are manually placed on the spinal cord by surgeons, using flexible attachment arms to maintain their final position. However, manual placement of electrode arrays has several drawbacks: Manual placement is highly dependent on the surgeon's experience and skill, leading to variability in treatment effectiveness. Manual manipulation makes it difficult to precisely control electrode placement, potentially causing the array to deviate from the ideal stimulation area, affecting treatment effectiveness. Furthermore, due to positioning accuracy issues, the surgeon may need to repeatedly adjust the electrode array position to achieve optimal pain control. This process is time-consuming, extending surgery time, anesthesia duration, and postoperative recovery time. Repeated adjustments to electrode position can also increase patient discomfort, especially if patients are required to remain still during surgery. Manual placement of electrode arrays can also increase overall treatment costs due to the increased surgical time and potential for repeated manipulations. If the electrode array is not optimally positioned during surgery, further adjustments may be required postoperatively, potentially involving additional medical intervention and costs.
[0005] In summary, manual placement of the electrode array by surgeons is prone to positional deviation, requiring repeated adjustments to the position of the electrode array, resulting in low efficiency in placing the electrode array and affecting the effectiveness and efficiency of treatment. Summary of the Invention
[0006] In order to address the above-mentioned problem that electrodes may easily deviate from the ideal stimulation area due to operational differences, affecting the treatment effect, requiring multiple position adjustments, prolonging surgery and anesthesia time, increasing patient discomfort and treatment costs, and may even require additional postoperative intervention, the present invention provides a spinal cord stimulation device with adjustable direction, which enables the stimulation electrodes to be accurately placed in the correct position, thereby improving the accuracy of placing the stimulation electrodes in the correct position.
[0007] The solution adopted by the present invention to solve its technical problems is: a spinal cord electrical stimulation device with adjustable direction, including an electrical stimulation generator, an electrical stimulation connecting line and a base, the electrical stimulation connecting line is connected to the electrical stimulation generator, the base is made of soft membrane material, and multiple electrical stimulation units are symmetrically distributed on the left and right of the base, and the electrical stimulation units are connected to the electrical stimulation connecting line; adjustment channels are provided on both sides of the base along the length direction, and direction adjustment lines are provided in the adjustment channels, the front end of the direction adjustment line is fixed at the front end of the base, and the tail end extends out of the adjustment channel and moves freely. When the direction adjustment line on one side is pulled, the front end of the base is offset to the same side, and an adjustment line fixing device is provided on the direction adjustment line for adjusting the length and position of the direction adjustment line and fixing the direction adjustment line to the bony structure.
[0008] Furthermore, the adjustment line fixing device is a snap-on structure, including a snap-on buckle and a snap-on mother buckle. An adjustment line channel is opened in the card slot of the snap-on mother buckle, and the direction adjustment line passes through the adjustment line channel. The snap-on buckle is longitudinally slid onto the snap-on mother buckle and adapted to the snap-on mother buckle. After the two are fastened together, a compression and fixing effect is provided for the direction adjustment line. A fixing ear is provided on the outer side of the snap-on mother buckle, and a fixing hole is opened on the fixing ear. The fixing hole cooperates with the bone screw to fix the adjustment line fixing device to the bone structure.
[0009] Furthermore, longitudinal guide holes are symmetrically opened on the female buckle, and guide posts matching the guide holes are symmetrically arranged below the male buckle, and the male buckle is longitudinally inserted into the guide hole through the guide posts.
[0010] Furthermore, the electrical stimulation connecting wire is fixed to the surrounding tissue by an electrical stimulation connecting wire fixing device to prevent the electrical stimulation connecting wire from sliding.
[0011] Furthermore, a center line indicator strip is provided at the front center of the base.
[0012] The beneficial effects of the present invention are as follows: Through the adjustment channels on both sides of the base and the internal direction adjustment wire, the present invention can achieve precise offset of the front end of the base to the same side by pulling the unilateral adjustment wire during surgery. Combined with the reference positioning of the midline indicator tape, the electrical stimulation unit can be accurately adjusted to the target stimulation area, effectively avoiding the electrode offset problem caused by doctor operation differences during traditional manual placement, ensuring that the stimulation electric field accurately covers key areas such as the dorsal horn of the spinal cord, and significantly improving the treatment effect. The device eliminates the need for repeated manual adjustments to the electrode position. Doctors can quickly calibrate the position by pulling the adjustment wire externally, significantly shortening surgery time, reducing the patient's anesthesia duration and postoperative recovery period. It also reduces the discomfort caused by repeated manipulations, improving surgical safety and patient tolerance. The adjustment wire fixing device adopts a snap-on structure. The length of the adjustment wire can be firmly locked by fastening the sub-buckle and the main buckle. The fixing device is then anchored to the bone structure with bone screws. It can effectively resist the tension caused by tissue displacement or changes in body position, ensuring that the electrode is in the optimal stimulation position for a long time, avoiding the risk of secondary surgery due to position displacement after surgery, and reducing additional medical costs. BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 It is a schematic diagram of the three-dimensional structure of the adjusting wire fixing device of the present invention; Figure 3 It is a schematic cross-sectional structure diagram of the adjustment line fixing device of the present invention.
[0014] In the figure: 1. Electric stimulation generator; 2. Electric stimulation connecting line; 3. Base; 4. Electric stimulation unit; 5. Adjustment channel; 6. Direction adjustment line; 7. Adjustment line fixing device; 71. Snap buckle; 72. Fixing ear; 73. Bone screw; 74. Fixing hole; 75. Adjustment line channel; 76. Snap buckle; 77. Guide column; 78. Guide hole; 8. Electric stimulation connecting line fixing device; 9. Center line indicator tape. DETAILED DESCRIPTION
[0015] The present invention will be further described below with reference to the accompanying drawings and examples.
[0016] See also Figure 1-3 The present invention provides a technical solution for a spinal cord electrical stimulation device with adjustable direction: Example
[0017] according to Figure 1 As shown, this direction-adjustable spinal cord electrical stimulation device is used to precisely locate the spinal cord stimulation area. Its core design is to achieve precise control of the electrode position through a mechanical adjustment structure. The device comprises three core components: an electrical stimulation generator 1, an electrical stimulation cable 2, and a base 3, as well as a supporting adjustment and fixation structure. The proximal end of the electrical stimulation cable 2 is connected to the electrical stimulation generator 1, and the distal end is led to the dorsal side of the spinal cord through a subcutaneous tunnel. The base 3 is made of a medical-grade silicone-polyurethane composite soft membrane material, molded into a long, flexible carrier with good biocompatibility and flexibility, which can conform to the physiological curvature of the spinal cord surface. The choice of soft membrane material not only reduces compression on the spinal cord tissue but also provides a deformable foundation for subsequent directional adjustment. When subjected to unilateral tension, the material can bend toward the side receiving the force, achieving front-end offset. Eight to ten electrical stimulation units 4, or stimulation electrodes, are distributed symmetrically on the base 3. These electrical stimulation units 4 are connected to the electrical stimulation cable 2 to form a current conduction path.
[0018] An electric stimulation connection line fixing device 8 is provided on the electric stimulation connection line 2. The electric stimulation connection line fixing device 8 adopts a medical buckle or suture anchor, which can fix the electric stimulation connection line 2 to the surrounding soft tissue to avoid displacement of the base 3 or the electric stimulation unit 4 due to traction of the electric stimulation connection line or changes in body position, thereby ensuring the continuity of current conduction.
[0019] In order to solve the problem of insufficient positioning accuracy during traditional manual electrode placement, this solution provides an adjustment channel 5 on each side of the base 3 along the length direction. A direction adjustment line 6 is passed through the adjustment channel 5. The direction adjustment line 6 is made of high-strength, low-elasticity medical suture, such as polyetheretherketone. The front end of the direction adjustment line 6 is fixedly connected to the front end of the adjustment channel 5, and the tail end passes through the adjustment channel 5 and can move freely. When the position of the electrode array needs to be fine-tuned during or after surgery, it is only necessary to grasp the direction adjustment line 6 on one side and apply traction. When pulling the direction adjustment line 6 on one side, the front end of the base 3 will deviate to the same side due to uneven force, thereby driving the electrical stimulation unit 4 to approach the target stimulation area, such as a specific segment of the dorsal horn of the spinal cord, to achieve millimeter-level precision position adjustment.
[0020] After the direction adjustment is completed, in order to maintain the stable position after adjustment, the direction adjustment line 6 needs to be locked to keep the electrode array in the optimal stimulation target area. This solution adopts the following method: Figure 2 and Figure 3 The adjustment line fixing device 7 shown is a snap-on structure design, specifically including a snap-on buckle 76 and a snap-on mother buckle 71. The snap-on mother buckle 71 has a slot inside which is provided with an adjustment line channel 75, through which the direction adjustment line 6 passes. The snap-on buckle 76 can be slidably sleeved on the snap-on mother buckle 71 in the longitudinal direction. Specifically, the snap-on mother buckle 71 has longitudinal guide holes 78 symmetrically provided thereon, and guide posts 77 matching the guide holes 78 are symmetrically provided below the snap-on buckle 76. The snap-on buckle 76 is longitudinally sleeved in the guide holes 78 through the guide posts 77. The cooperation between 77 and the guide hole 78 can provide guidance and anti-falling effect for the buckle buckle 76; the inner contact surfaces of both the buckle buckle 76 and the buckle mother buckle 71 are provided with anti-slip grooves. When the buckle buckle 76 is fastened with the buckle mother buckle 71, the buckle buckle 76 will press the direction adjustment line 6. The extrusion force and friction force generated by the cooperation between the buckle buckle 76 and the buckle mother buckle 71 limit the sliding of the direction adjustment line 6, thereby fixing the length of the direction adjustment line 6. At the same time, after the buckle buckle 76 is fastened with the buckle mother buckle 71, the upper surfaces of the two are flush, reducing local soft tissue irritation.
[0021] A fixing ear 72 is integrally formed on the outer side of the buckle female buckle 71, and a fixing hole 74 is opened on the fixing ear 72. The adjustment wire fixing device 7 can be fixed to the bony structure of the spine such as the vertebral plate or spinous process through a bone screw 73 to avoid electrode position deviation due to tissue displacement and ensure long-term stimulation stability.
[0022] In specific use, the present invention provides a direction-adjustable spinal cord electrical stimulation device. Taking the treatment of chronic consciousness disorders in the spinal cord C2-C4 segment as an example, the specific operation process is as follows: Preoperative preparation: The patient is placed in the prone position, routine disinfection and draping are performed, and the target spinal cord stimulation segment (C2-C4 epidural midline area) is determined by imaging. The surgical incision is marked, and an "I"-shaped incision approximately 4 cm long is made in the midline of the neck between C2 and C4. Device implantation: Cut the skin, subcutaneous tissue, and muscle layer layer by layer, bite off part of the spinous process and remove the local lamina to expose the epidural space, and gently implant the base 3 into the predetermined area. Observe the position of the base 3 through X-ray fluoroscopy, and make preliminary adjustments to center the base 3 and ensure that the electrical stimulation units 4 are symmetrically distributed on the dorsal side of the spinal cord. Connecting wire fixation: The electrical stimulation connecting wire 2 is routed along the paravertebral tissue and sutured to the surrounding muscle tissue through the electrical stimulation connecting wire fixing device 8 to prevent the electrical stimulation connecting wire 2 from sliding after surgery and causing displacement of the base 3; Fine-tuning the direction: X-ray examination is used to confirm the alignment between the electrical stimulation unit 4 and the target stimulation area. If the left electrical stimulation unit deviates from the target area, pull the left direction adjustment line. At this time, the front end of the soft membrane base 3 will bend and deviate to the left until the electrical stimulation unit 4 is aligned with the target area. If it deviates to the right, pull the right direction adjustment line to achieve the right deviation adjustment in the same way. Fixing the direction adjustment line: After the position is confirmed, slide the buckle buckle 76 longitudinally along the buckle mother buckle 71 and buckle it, pressing the direction adjustment line 6 with the anti-slip groove to lock its length; then use the fixing hole 74 on the fixing ear 72 to fix the adjustment line fixing device 7 to the bone structure of the adjacent vertebral plate with the bone screw 73, firmly locking the adjusted position to avoid postoperative displacement and ensure the long-term stability of the adjusted position; Postoperative connection and stimulation: Connect the electrical stimulation connection line 2 to the electrical stimulation generator 1 implanted subcutaneously, suture the surgical incision layer by layer, and apply an electric current of a specific frequency and intensity through the electrical stimulation generator 1 after the operation. The electrical stimulation unit 4 transmits the current to the target area of the spinal cord to achieve neural regulation function. Example
[0023] Based on the first embodiment, Figure 1 As shown, a midline indicator band 9 is provided at the front center of the base 3. A radiographic marker or radioactive marking strip can be used here to quickly confirm the initial centering of the base 3 during or after surgery using X-ray fluoroscopy, providing a reference for subsequent adjustments. Fluoroscopic confirmation of the marker band's alignment with the midsagittal line of the spine is used. If deviation is detected, the position of the soft membranous base 3 can be immediately corrected using the aforementioned direction adjustment lines 6, ensuring symmetrical coverage of the dorsal columns of the spinal cord by the stimulation field, improving stimulation efficiency, and minimizing secondary stimulation.
[0024] The above description is only a preferred embodiment of the present invention and does not limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention should be included in the scope of protection of the present invention.
Claims
1. A spinal cord electrical stimulation device with adjustable direction, comprising an electrical stimulation generator (1), an electrical stimulation connecting line (2) and a base (3), characterized in that: The electric stimulation connection line (2) is connected to the electric stimulation generator (1), the base (3) is made of a soft membrane material, and a plurality of electric stimulation units (4) are symmetrically distributed on the left and right sides of the base (3), and the electric stimulation units (4) are connected to the electric stimulation connection line (2); adjustment channels (5) are opened on both sides of the base (3) along the length direction, and a direction adjustment line (6) is arranged in the adjustment channel (5), the front end of the direction adjustment line (6) is fixed to the front end of the adjustment channel (5), and the tail end extends out of the adjustment channel (5) and moves freely. When the direction adjustment line (6) on one side is pulled, the front end of the base (3) deviates to the same side, and an adjustment line fixing device (7) is provided on the direction adjustment line (6) for adjusting the length and position of the direction adjustment line (6) and fixing the direction adjustment line (6) to the bone structure.
2. The direction-adjustable spinal cord electrical stimulation device according to claim 1, characterized in that: The adjustment line fixing device (7) is a snap-on structure, comprising a snap-on sub-button (76) and a snap-on mother buckle (71); an adjustment line channel (75) is provided in the card slot of the snap-on mother buckle (71); the direction adjustment line (6) is provided in the adjustment line channel (75); the snap-on sub-button (76) is longitudinally slidably mounted on the snap-on mother buckle (71) and is adapted to the snap-on mother buckle (71); after the two are fastened together, a compression and fixing effect is provided for the direction adjustment line (6); a fixing ear (72) is provided on the outer side of the snap-on mother buckle (71); a fixing hole (74) is provided on the fixing ear (72); the fixing hole (74) cooperates with the bone screw (73) to fix the adjustment line fixing device (7) to the bone structure.
3. The direction-adjustable spinal cord electrical stimulation device according to claim 2, characterized in that: A longitudinal guide hole (78) is symmetrically provided on the buckle mother buckle (71), and a guide column (77) matching the guide hole (78) is symmetrically provided below the buckle sub-buckle (76), and the buckle sub-buckle (76) is longitudinally sleeved in the guide hole (78) via the guide column (77).
4. The direction-adjustable spinal cord electrical stimulation device according to claim 1, characterized in that: The electrical stimulation connection line (2) is fixed to the surrounding tissue by an electrical stimulation connection line fixing device (8), thereby preventing the electrical stimulation connection line (2) from sliding.
5. The direction-adjustable spinal cord electrical stimulation device according to claim 1, characterized in that: A centerline indicating marking band (9) is provided at the front center of the base (3).