An adjustable direction spinal cord stimulation device

Abstract

The utility model discloses a position adjustable spinal cord electric stimulation device relates to medical appliance technical field, including electric stimulation generator, electric stimulation connecting wire and base, and the base is made of soft film material, and it is provided with the symmetry of many electric stimulation units on left and right, and electric stimulation unit is connected with electric stimulation generator through electric stimulation connecting wire, forms the current conduction path, and the base both sides are equipped with the adjusting channel along the length direction, and there is direction adjusting line in the adjusting channel, and the direction adjusting line of one side can make the base front end to the same side offset, the adjusting line fixing device is buckle type, contains the buckle and the female buckle, and the female buckle has the adjusting line channel, and the buckle is longitudinally installed in the female buckle, and the adjusting line is fixed after buckling, and the female buckle outside has the fixed ear with fixed hole, and is fixed in the bony structure through the bone nail, and the electric stimulation connecting wire is fixed in the surrounding tissue through the fixing device, and the center line indication mark band is equipped in the base front end, realizes electrode accurate positioning and fixed.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to an adjustable spinal cord electrical stimulation device. Background Technology

[0002] The spinal cord is the neural tissue within the spinal column, serving as a relay station for transmitting signals from the brain to the 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 motor signals. The bony structures surrounding the spinal cord mainly include the vertebral bodies anteriorly and the laminae posteriorly. Spinal Cord Stimulation (SCS) is a neuromodulation technique used to treat chronic pain, suitable for patients with chronic pain who do not respond to traditional therapies. Its treatment principle is based on the gating theory proposed by Melzack and Wall in 1965, which blocks the transmission of pain signals through electrical stimulation. It involves implanting electrodes into the epidural space of the spinal canal, using electrical current to stimulate the spinal cord, blocking 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 US FDA for the treatment of lumbar spine surgery failure syndrome, chronic pain, complex regional pain syndrome, intractable angina pectoris, visceral abdominal pain, perineal pain, and limb pain caused by nerve damage. In the past 10 years, SCS has been gradually introduced into the management of chronic pain patients in China.

[0003] Spinal cord stimulation (SCS) comprises two main components: a pulse generator and electrodes, sometimes including extension leads. Current technology involves surgically placing stimulation electrodes on the surface of the spinal cord and connecting them to an electrical stimulation generator via leads. The generator is implanted subcutaneously, applying electrical stimulation signals of specific frequencies and intensities to achieve analgesia or promote motor recovery. For the treatment of chronic disorders of consciousness, electrodes are typically implanted in the epidural midline at the C2-C4 level of the spinal cord. Before and after spinal cord electrical stimulation, local brain glucose metabolism and cerebral blood flow significantly increase. Pulsed stimulation of the ascending reticular activating system originates enhances the activity of conscious impulses, improves neural conduction, and increases brain electrical activity.

[0004] Electrode arrays play a crucial role in spinal cord stimulation (SCS) therapy, delivering electrical currents to the spinal cord to block pain signals. Current electrode array technology involves surgeons manually placing the arrays on the spinal cord and controlling the flexible attachment arms to their final positions. However, manual placement of electrode arrays has several drawbacks: it is highly dependent on the surgeon's experience and skill, and different surgeons' techniques can lead to variations in treatment outcomes. Due to the surgeon's manual manipulation, it is difficult to precisely control the electrode placement, which may cause the array to deviate from the ideal stimulation area, affecting treatment effectiveness. Furthermore, due to the accuracy issues, surgeons may need to adjust the electrode array position multiple times to find the optimal pain control, a time-consuming process that prolongs surgery time, increases anesthesia and postoperative recovery time, and can also increase patient discomfort, especially when stillness is required during surgery. The increased surgical time and potential repetitive manipulation can also increase overall treatment costs. If the electrode array fails to achieve optimal placement during surgery, further adjustments may be necessary postoperatively, potentially involving additional medical interventions and costs.

[0005] In summary, manually placing electrode arrays by surgeons is prone to misalignment, requiring repeated adjustments and resulting in low placement efficiency, which affects the effectiveness and efficiency of treatment. Utility Model Content

[0006] To address the aforementioned issues where electrode deviation from the ideal stimulation area is easily caused by operational differences, affecting treatment efficacy, requiring multiple adjustments to position, prolonging surgery and anesthesia time, increasing patient discomfort and treatment costs, and potentially necessitating additional postoperative intervention, this invention provides an adjustable spinal cord electrical stimulation device.

[0007] The solution adopted by this utility model to solve its technical problem is: an adjustable spinal cord electrical stimulation device, 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 a soft membrane material, and multiple electrical stimulation units are symmetrically distributed on the left and right sides of the base. 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. Direction adjustment lines are provided in the adjustment channels. The front end of the direction adjustment line is fixed to 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 shifts to the same side. 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 male and a snap-on female. The snap-on female has an adjustment line channel extending through its slot, through which the direction adjustment line passes. The snap-on male slides longitudinally onto the snap-on female and is adapted to it. After the two are engaged, they provide a pressing and fixing effect on the direction adjustment line. The snap-on female has a fixing ear on its outer side, and a fixing hole extending through the fixing ear. The fixing hole cooperates with the bone screw to fix the adjustment line fixing device to the bony structure.

[0009] Furthermore, the female buckle has symmetrically arranged longitudinal guide holes, and the male buckle has symmetrically arranged guide posts matching the guide holes below it. The male buckle is longitudinally fitted into the guide holes through the guide posts.

[0010] Furthermore, the electrical stimulation connection wire is fixed to the surrounding tissue by an electrical stimulation connection wire fixing device to prevent the electrical stimulation connection wire from slipping.

[0011] Furthermore, a centerline indicator strip is provided at the front center of the base.

[0012] Compared with the prior art, the beneficial effects of this utility model are: This invention, by setting adjustment channels on both sides of the base and internal direction adjustment lines, allows for precise offset of the front end of the base to the same side during surgery by pulling on the adjustment line on one side. Combined with the reference positioning of the midline indicator band, it can accurately adjust the electrical stimulation unit to the target stimulation area, effectively avoiding the electrode offset problem caused by differences in doctor operation when traditionally placed manually. This ensures that the stimulation electric field accurately covers key areas such as the dorsal horn of the spinal cord, significantly improving the treatment effect. This device eliminates the need for repeated manual adjustment of electrode positions. Doctors can quickly calibrate the position by pulling the adjustment line externally, which significantly shortens the operation time, reduces the patient's anesthesia time and postoperative recovery period, and reduces the discomfort caused by repeated operation, thereby improving the safety of the operation and the patient's tolerance. The adjustment line fixation device adopts a snap-on structure. The length of the adjustment line can be firmly locked by the engagement of the male and female snaps. In addition, the fixation device is anchored to the bony 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. This avoids the risk of needing a second surgery to adjust the position after surgery due to displacement, and reduces additional medical costs. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the overall structure of this utility model; Figure 2 This is a three-dimensional structural diagram of the adjusting line fixing device of this utility model; Figure 3This is a cross-sectional structural diagram of the adjusting line fixing device of this utility model.

[0014] In the diagram: 1. Electrical stimulation generator; 2. Electrical stimulation connection cable; 3. Base; 4. Electrical stimulation unit; 5. Adjustment channel; 6. Direction adjustment cable; 7. Adjustment cable fixing device; 71. Snap-on female buckle; 72. Fixing ear; 73. Bone screw; 74. Fixing hole; 75. Adjustment cable channel; 76. Snap-on female buckle; 77. Guide post; 78. Guide hole; 8. Electrical stimulation connection cable fixing device; 9. Centerline indicator strip. Detailed Implementation

[0015] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0016] Please see Figure 1-3 This utility model provides a technical solution for an adjustable spinal cord electrical stimulation device: Example

[0017] according to Figure 1 As shown, this adjustable spinal cord electrical stimulation device is used to precisely locate the spinal cord stimulation area. Its core design lies in achieving precise control of the electrode position through a mechanical adjustment structure. The whole device includes three core components: an electrical stimulation generator 1, an electrical stimulation connecting line 2, and a base 3, as well as matching adjustment and fixation structures. The proximal end of the electrical stimulation connecting line 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 medical-grade silicone-polyurethane composite soft membrane material, molded into a long strip of flexible carrier, which has good biocompatibility and flexibility, and can conform to the physiological curvature of the spinal cord surface. The choice of soft membrane material not only reduces the pressure on the spinal cord tissue, but also provides a deformable basis for subsequent directional adjustment. When subjected to unilateral tension, the material can bend towards the force-bearing side to achieve front-end offset. Eight to ten electrical stimulation units 4, i.e., stimulation electrodes, are distributed symmetrically on the base 3. These electrical stimulation units 4 are connected to the electrical stimulation connecting line 2 to form a current conduction path.

[0018] An electrical stimulation connection wire fixing device 8 is fitted onto the electrical stimulation connection wire 2. The electrical stimulation connection wire fixing device 8 uses medical buckles or suture anchors to fix the electrical stimulation connection wire 2 to the surrounding soft tissue, preventing the base 3 or electrical stimulation unit 4 from shifting due to the pulling of the electrical stimulation connection wire or changes in body position, thus ensuring the continuity of current conduction.

[0019] To address the issue of insufficient positioning accuracy in traditional manual electrode placement, this design incorporates an adjustment channel 5 along the length of each side of the base 3. A direction adjustment line 6, made of high-strength, low-elasticity medical suture such as polyetheretherketone (PEEK), is threaded through each channel 5. The front end of the direction adjustment line 6 is fixedly connected to the front end of the adjustment channel 5, while the rear end extends out of the channel 5 and is free to move. When fine-tuning of the electrode array position is required during or after surgery, simply grasp one side of the direction adjustment line 6 and apply traction. Pulling on one side causes the front end of the base 3 to shift to the same side due to uneven force, thereby moving the electrical stimulation unit 4 closer to the target stimulation area, such as a specific segment of the spinal cord dorsal horn, achieving millimeter-level precision in position adjustment.

[0020] After orientation adjustment is completed, to maintain the stability of the adjusted position, orientation adjustment line 6 needs to be locked to keep the electrode array in the optimal stimulation target area. This scheme adopts the following... Figure 2 and Figure 3 The adjusting line fixing device 7 shown is a snap-fit ​​structure, specifically including a snap-fit ​​male buckle 76 and a snap-fit ​​female buckle 71. The snap-fit ​​female buckle 71 has a through-hole adjusting line channel 75 inside its slot, through which the directional adjusting line 6 passes. The snap-fit ​​male buckle 76 can slide longitudinally onto the snap-fit ​​female buckle 71. Specifically, the snap-fit ​​female buckle 71 has symmetrical longitudinal guide holes 78, and symmetrical guide posts 77 matching the guide holes 78 are arranged below the snap-fit ​​male buckle 76. The snap-fit ​​male buckle 76 is longitudinally fitted into the guide hole 78 via the guide posts 77. The cooperation between 77 and guide hole 78 provides guidance and anti-detachment effect for buckle 76; anti-slip texture is provided on the inner contact surface of both buckle 76 and buckle 71. When buckle 76 and buckle 71 are fastened, buckle 76 will press the direction adjustment line 6. The squeezing force and friction generated by the cooperation of buckle 76 and buckle 71 restrict the sliding of direction adjustment line 6, thereby fixing the length of direction adjustment line 6. At the same time, after buckle 76 and buckle 71 are fastened, their upper surfaces are flush, reducing local soft tissue irritation.

[0021] A fixing ear 72 is integrally formed on the outer side of the buckle 71. The fixing ear 72 has a fixing hole 74, which can be fixed to the bony structure of the spine, such as the lamina or spinous process, by means of bone nail 73, so as to avoid the electrode position shift due to tissue displacement and ensure long-term stimulation stability.

[0022] In practical use, the adjustable-direction spinal cord electrical stimulation device of this invention, taking the treatment of chronic consciousness disorders in the C2-C4 segment of the spinal cord as an example, has the following specific operating procedure: Preoperative preparation: The patient is placed in a prone position, and routine disinfection and draping are performed. The target stimulation segment of the spinal cord (C2-C4 epidural midline area) is determined by imaging localization. The surgical incision is marked, and an "I"-shaped incision of about 4 cm in length is made in the midline of the neck from C2 to C4. Device implantation: The skin, subcutaneous tissue and muscle layer are cut layer by layer, part of the spinous process is bitten off and the local lamina is removed to expose the epidural space. The base 3 is gently implanted into the predetermined area. The position of the base 3 is observed through X-ray fluoroscopy. The base 3 is initially adjusted to be centered to ensure that the electrical stimulation units 4 are symmetrically distributed on the dorsal side of the spinal cord. Connection line fixation: The electrical stimulation connection line 2 is run along the paravertebral tissue and sutured to the surrounding muscle tissue by the electrical stimulation connection line fixation device 8 to prevent the electrical stimulation connection line 2 from sliding after the operation and causing the base 3 to shift. Fine-tuning of direction: The alignment of the electrical stimulation unit 4 with the target stimulation area is confirmed by X-ray examination. If the electrical stimulation unit on the left deviates from the target area, the left directional adjustment line is pulled. At this time, the front end of the soft membrane base 3 will bend and shift to the left until the electrical stimulation unit 4 is aligned with the target area; if it deviates to the right, the right directional adjustment line is pulled to achieve the same adjustment. Fixed direction adjustment line: After confirming the position, slide the buckle 76 longitudinally along the buckle 71 and fasten it. Press the direction adjustment line 6 with the anti-slip texture to lock its length. Then, fix the adjustment line fixing device 7 to the bony structure of the adjacent vertebral lamina with bone nails 73 through the fixing hole 74 on the fixing ear 72 to firmly lock the adjusted position, avoid postoperative displacement, and ensure 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 under the skin, suture the surgical incision layer by layer, and apply a 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 the neuromodulation function. Example

[0023] Based on Example 1, such as Figure 1 As shown, a midline indicator strip 9 is located at the center of the front end of the base 3. This can be achieved using radiopaque lines or radioactive markers, allowing for quick confirmation of the initial centered position of the base 3 via X-ray fluoroscopy during or after surgery, providing a reference for subsequent adjustments. Fluoroscopy confirms that the marker strip coincides with the midsagittal line of the spine. If any deviation is detected, the position of the soft membranous base 3 can be immediately corrected using the aforementioned directional adjustment line 6, ensuring symmetrical coverage of the spinal cord's dorsal column by the stimulation electric field, improving stimulation efficiency and reducing side effects.

[0024] The above description is only a preferred embodiment of the present utility model and does not limit the present utility model. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A directionally adjustable spinal cord electrical stimulation device comprising an electrical stimulation generator (1), an electrical stimulation connecting line (2) and a base (3), characterized in that: The electric stimulation connecting line (2) is connected with the electric stimulation generator (1), the base (3) is made of soft film material, a plurality of electric stimulation units (4) are symmetrically distributed on the base (3), the electric stimulation units (4) are connected with the electric stimulation connecting line (2); the two sides of the base (3) are provided with adjusting channels (5) along the length direction, the direction adjusting lines (6) are arranged in the adjusting channels (5), the front end of the direction adjusting line (6) is fixed at the front end of the adjusting channel (5), the tail end of the direction adjusting line (6) is stretched out of the adjusting channel (5) and freely moves, when the direction adjusting line (6) on one side is pulled, the front end of the base (3) is offset to the same side, the adjusting line fixing device (7) is arranged on the direction adjusting line (6), which is used for adjusting the length and position of the direction adjusting line (6) and fixing the direction adjusting line (6) at the bony structure.

2. A directionally adjustable spinal cord stimulation device according to claim 1, characterized in that: The adjusting line fixing device (7) is a buckle type structure, including a buckle pin (76) and a buckle box (71), the adjusting line channel (75) is arranged in the buckle slot of the buckle box (71), the direction adjusting line (6) is arranged in the adjusting line channel (75), the buckle pin (76) is longitudinally slidably sleeved on the buckle box (71) and is matched with the buckle box (71), after the two are buckled, the direction adjusting line (6) is provided with the compression fixing effect, the buckle box (71) is provided with the fixing lug (72) on the outside, the fixing hole (74) is arranged in the fixing lug (72), the fixing hole (74) is matched with the bone nail (73), and the adjusting line fixing device (7) is fixed at the bony structure.

3. A directionally adjustable spinal cord stimulation device according to claim 2, wherein: The buckle box (71) is symmetrically provided with the guide hole (78) in the longitudinal direction, the guide column (77) matched with the guide hole (78) is symmetrically arranged below the buckle pin (76), and the buckle pin (76) is longitudinally sleeved in the guide hole (78) through the guide column (77).

4. A directionally adjustable spinal cord stimulation device according to claim 1, wherein: The electric stimulation connecting line (2) is fixed in the surrounding tissue through the electric stimulation connecting line fixing device (8), so that the electric stimulation connecting line (2) is prevented from sliding.

5. A directionally adjustable spinal cord stimulation device according to claim 1, wherein: The center of the front end of the base (3) is provided with the midline indicating mark belt (9).

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