Dorsal root ganglion stimulating electrode kit and use method thereof

Abstract

The invention relates to a dorsal root ganglion stimulating electrode, in particular to a dorsal root ganglion stimulating electrode kit and a using method thereof.The dorsal root ganglion stimulating electrode kit comprises a needle-shaped electrode, an elbow sleeve, a puncture needle, a puncture guide wire and a steel wire, and the dorsal root ganglion stimulating electrode kit is used in cooperation with a traditional surgical accessory puncture needle; and auxiliary implantation is carried out through the configured elbow sleeve, so that a lesion can be reached more accurately and quickly.

Description

Technical Field

[0001] The invention relates to a dorsal root ganglion stimulation electrode device, and in particular to a dorsal root ganglion stimulation electrode kit and a use method thereof. Background Art

[0002] The principle of spinal cord electrical stimulation therapy is mainly based on the gate control theory proposed by Melzak and Wall in 1965: electrical stimulation transmitted by electrodes implanted in the epidural space of the spinal cord blocks the transmission of pain signals from the spinal cord to the brain, making it impossible for pain signals to reach the cerebral cortex, thereby achieving the purpose of controlling pain or other diseases, such as Figure 1 shown.

[0003] As a neuromodulatory treatment method, spinal cord stimulation has the advantages of minimally invasive, adjustable, and few complications. It has become an effective method for long-term control of chronic pain. Clinical studies have shown that spinal cord stimulation can provide patients with satisfactory pain relief, improve their physical functions, and improve their quality of life, with better economic benefits than other therapies. Compared with chronic pain treatment methods such as drugs, nerve blocks / destruction, the most obvious advantage of spinal cord stimulation is its controllability and reversibility. Doctors or patients can adjust the programmable charger, and the stimulator outputs stimulation pulses with adjustable amplitude, pulse width, and frequency, which are transmitted to the spinal nerves through electrodes to achieve the best analgesic effect; if necessary, the stimulation electrodes can also be removed as a whole without causing significant effects on the patient's body. Through the method of neuromodulation, patients' demand for analgesics can also be reduced, alleviating the potential effects of a large number of drugs on body functions such as the liver and kidneys.

[0004] The dorsal root ganglion is a swelling nodule of the dorsal root of the spinal cord near the medial surface of each intervertebral foramen. It is composed of centripetal sensory fiber cells. It is responsible for receiving all nerve impulses from the body's receptors, including general somatic and visceral sensations, and transmitting them to the spinal cord through centripetal fibers.

[0005] Peripheral nerve damage affects the dorsal root ganglia, activating surrounding glial cells and releasing pro-inflammatory cytokines, which ultimately stimulate neurons to increase cell membrane excitability; the information is then transmitted to the dorsal horn of the spinal cord through the dorsal root ganglia, causing a series of neuronal changes to transmit the information.

[0006] Chronic pain treatment targeting the dorsal root ganglion includes transpleural injection of local anesthetics or steroids, dorsal rhizotomy, ganglionectomy, and conventional and pulsed radiofrequency treatment. It can also be achieved by open surgery or percutaneous puncture of electrodes under fluoroscopic guidance to reach the dorsal root ganglion and alter peripheral perception by modulating central nervous system pathways.

[0007] The dorsal root ganglion is an enlargement of the dorsal root enclosed in the dural sac when the dorsal root leaves the spine. Because the dorsal root ganglion is separated from the spinal cord by the dorsal root and its dendrites extend to the periphery, its nerves are thinner and shorter. In addition, the large contact size and thick electrode diameter of traditional spinal cord stimulation electrodes cannot meet the requirements of dorsal root ganglion stimulation.

[0008] In DRG stimulation, pain-paresthesia overlap is often achieved with high precision, probably because of the primary sensory neurons projecting to the painful area, whereas in conventional SCS, this target may require complex lead design and programming. DRG stimulation has the advantage of structural location and a target site that can be covered in each segment. The location of the DRG allows for a much lower threshold for electrical stimulation than conventional SCS, making it easier to target with neuromodulatory approaches.

[0009] The distribution of paresthesias with DRG stimulation remained constant over time and was largely independent of changes in body position. The stability of paresthesias is likely due to the fact that DRG stimulation is located within the bony enclosure of the intervertebral foramen, which helps to support the electrode in the desired position and ensures that the DRG and electrode are largely undisturbed by bending or movement of the highly mobile spine.

[0010] The cerebrospinal fluid (CSF) layer surrounding the DRG is another relevant factor in the stimulation environment; due to its thinness, its potential role as a current sink to disperse the electric field is limited. Therefore, DRG stimulation can be achieved at low amplitudes, requiring on average about 15% of the power output of conventional spinal cord stimulation. DRG stimulation has a relatively low resistance, thus consuming very little power, making it more suitable for stimulation.

[0011] Dorsal root ganglion stimulation can be used for pain that is relatively difficult to treat with traditional spinal cord stimulation, such as pelvic pain, PHN, groin pain, CRPS, pain after hip / knee replacement surgery, foot pain (such as pain caused by diabetic foot), etc.

[0012] Because the dendrites of the dorsal root ganglion extend to the periphery, the nerves are thinner and shorter, and the angles are complex, such as Figure 7 As shown in the schematic diagram of traditional spinal cord stimulation, in addition to the traditional surgical accessory puncture needle, an elbow cannula is required to assist in implantation. Summary of the invention

[0013] The present invention aims to solve the above-mentioned defects and provides a dorsal root ganglion stimulation electrode kit and a method of using the same.

[0014] In order to overcome the defects existing in the background technology, the technical solution adopted by the present invention to solve the technical problem is: the dorsal root ganglion stimulation electrode kit includes a needle electrode, an elbow cannula, a puncture needle, a puncture guide wire and a steel wire, the needle electrode includes a catheter, one end of the catheter is provided with a connecting ring 1, a connecting ring 2, a connecting ring 3, and a connecting ring 4, the other end of the catheter is provided with a platinum iridium ring 1, a platinum iridium ring 2, a platinum iridium ring 3 and a platinum iridium ring 4, and the middle section of the catheter is a spiral section; The elbow sleeve comprises a check valve, a sleeve and a T-valve for fixing the needle electrode, the sleeve is connected to one end of the T-valve, and the check valve is connected above the T-valve; The steel wire is placed in the needle-shaped electrode, the needle-shaped electrode penetrates into the sleeve of the elbow sleeve, and the sleeve of the elbow sleeve penetrates into the puncture needle.

[0015] According to another embodiment of the present invention, the spiral segment is further formed by synchronously winding four strands of guide wires, and the guide wire material is not limited to platinum-iridium-hartz alloy and nickel-cobalt alloy.

[0016] According to another embodiment of the present invention, it further includes that one end of each guide wire on the spiral segment is connected to the connecting ring, and the other end is connected to the platinum-iridium ring, including the first guide wire on the spiral segment having one end connected to connecting ring one, and the other end connected to platinum-iridium ring one, the second guide wire having one end connected to connecting ring two, and the other end connected to platinum-iridium ring two, the third guide wire having one end connected to connecting ring three, and the other end connected to platinum-iridium ring three, and the fourth guide wire having one end connected to connecting ring four, and the other end connected to platinum-iridium ring four.

[0017] According to another embodiment of the present invention, the surface of the puncture guide wire is further provided with an insulating coating, and the coating material is not limited to PFA, ETFE, PTFE, and PI.

[0018] According to another embodiment of the present invention, it further includes that the catheter on the needle-shaped electrode is made of polyurethane material, and its outer diameter is not limited to 1.0 mm, the material of connecting ring one, connecting ring two, connecting ring three, and connecting ring four is nickel-cobalt alloy, the material of platinum-iridium ring one, platinum-iridium ring two, platinum-iridium ring three, and platinum-iridium ring four is platinum-iridium alloy PtIr10, connecting ring one, connecting ring two, connecting ring three, and connecting ring four are injection molded, platinum-iridium ring one, platinum-iridium ring two, platinum-iridium ring three, and platinum-iridium ring four are forged or hot-melt molded, and the materials between connecting ring one, connecting ring two, connecting ring three, and connecting ring four are polyurethane materials.

[0019] According to another embodiment of the present invention, the material of the check valve is not limited to PC and TPU, the material of the T-type valve is not limited to PC and TPU, and the material of the sleeve is not limited to PEEK.

[0020] Methods of use for this dorsal root ganglion stimulation electrode kit include: The first step is to insert the puncture needle into the epidural space at a suitable angle under X-ray fluoroscopy, then rotate the needle tip to a suitable angle and remove the inner core of the puncture needle; Step 2: Insert the puncture guide wire through the outer core of the puncture needle, confirm that the puncture guide wire enters the epidural space, and then remove the puncture guide wire; Step 3: Insert the steel wire into the catheter of the needle electrode and extend it to the top; Step 4: insert the needle electrode into the elbow sleeve after the steel wire is inserted in the third step, so that the distal end of the needle electrode slightly protrudes from the distal end of the elbow sleeve, and tighten the T-valve so that the needle electrode cannot slide in the elbow sleeve; Step 5: Insert the cannula on the elbow cannula in step 4 into the puncture needle, adjust the angle of the cannula, and allow it to pass through the epidural space and enter the target intervertebral foramen. When the distal end of the cannula enters the target position, release the T-valve, push the needle electrode forward to enter the target hole, and confirm that the needle electrode is located at the dorsal root bone foramen through the lateral fluoroscopic film. Step 6: Take out the elbow casing; Step 7. Remove the outer core and steel wire of the puncture needle.

[0021] According to another embodiment of the present invention, the method further comprises pushing the needle electrode forward in the fifth step by slowly injecting sterile water or physiological saline through a check valve.

[0022] The beneficial effect of the present invention is that the dorsal root ganglion stimulation electrode kit is used in conjunction with a traditional surgical accessory puncture needle, and is implanted with an elbow cannula to more accurately and quickly reach the lesion. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present invention is further described below in conjunction with the accompanying drawings and embodiments.

[0024] Figure 1 It is a schematic diagram of the structure of the kit of the present invention; Figure 2 It is a schematic diagram of the structure of the needle-shaped electrode of the present invention; Figure 3 It is a structural schematic diagram of the elbow sleeve of the present invention; Figure 4 It is a schematic diagram of the structure of the puncture needle of the present invention; Figure 5 It is a schematic diagram of the structure of the needle-shaped electrode, elbow sleeve and steel wire of the present invention; Figure 6 It is a schematic diagram of the structure of the needle electrode, elbow sleeve, steel wire and puncture needle; Figure 7 is a schematic diagram of traditional spinal cord stimulation; Figure 8It is a structural schematic diagram of the relative angle adjustment between the elbow cannula and the puncture needle; Fig. 9 It is a schematic diagram of the structure of the target hole operation at the front end of the elbow casing; Fig.10 This is a schematic diagram of the needle electrode entering the dorsal root ganglion Fig.11 This is a schematic diagram of the needle electrode entering the dorsal root ganglion.

[0025] Among them: 1. needle electrode, 2. elbow cannula, 3. puncture needle, 4. puncture guide wire, 5. steel wire, 6. catheter, 7. connecting ring one, 8. connecting ring two, 9. connecting ring three, 10. connecting ring four, 11. platinum-iridium ring one, 12. platinum-iridium ring two, 13. platinum-iridium ring three, 14. platinum-iridium ring four, 15. spiral segment, 16. check valve, 17. T-type valve, 18. cannula, 19. inner core, 20. outer core. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] like Figure 1-4 The dorsal root ganglion stimulation electrode kit comprises a needle electrode 1, an elbow sleeve 2, a puncture needle 3, a puncture guide wire 4 and a steel wire 5. The needle electrode 1 comprises a catheter 6. One end of the catheter 6 is provided with a connecting ring 1 7, a connecting ring 2 8, a connecting ring 3 9, and a connecting ring 4 10. The other end of the catheter 6 is provided with a platinum iridium ring 1 11, a platinum iridium ring 2 12, a platinum iridium ring 3 13 and a platinum iridium ring 4 14. The middle section of the catheter 6 is a spiral section 15. The elbow sleeve 2 comprises a check valve 16, a sleeve 18 and a T-valve 17 for fixing the needle electrode 1. The sleeve 18 is connected to one end of the T-valve 17, and the check valve 16 is connected above the T-valve 17. The puncture needle 3 comprises an inner core 19 and an outer core 20. The inner core 19 is sleeved in the outer core 20.

[0028] The surface of the puncture guide wire 4 is provided with an insulating coating, and the coating material is not limited to PFA, ETFE, PTFE, and PI.

[0029] like Figure 5 , 6 As shown in , 8 , the assembly method is that the steel wire 5 is placed in the needle-shaped electrode 1 , the needle-shaped electrode 1 is inserted into the sleeve 18 of the elbow sleeve 2 , and the sleeve 18 of the elbow sleeve 2 is inserted into the puncture needle 3 .

[0030] like Figure 2As shown, the spiral section 15 on the needle-shaped electrode 1 is formed by synchronously winding four strands of guide wires, and the guide wire material is not limited to platinum-iridium-gold and nickel-cobalt alloy. One end of each guide wire on the spiral section 15 is connected to a connecting ring, and the other end is connected to a platinum-iridium ring, including the first strand of guide wire on the spiral section 15 is connected to a connecting ring 1 7 at one end and a platinum-iridium ring 1 11 at the other end, the second strand of guide wire is connected to a connecting ring 2 8 at one end and a platinum-iridium ring 2 12 at the other end, the third strand of guide wire is connected to a connecting ring 3 9 at one end and a platinum-iridium ring 3 13 at the other end, and the fourth strand of guide wire is connected to a connecting ring 4 10 at one end and a platinum-iridium ring 4 14 at the other end.

[0031] The catheter 6 on the needle electrode 1 is made of polyurethane material, and its outer diameter is not limited to 1.0 mm. The materials of connecting ring 1 7, connecting ring 2 8, connecting ring 3 9, and connecting ring 4 10 are nickel-cobalt alloy, and the materials of platinum-iridium ring 1 11, platinum-iridium ring 2 12, platinum-iridium ring 3 13, and platinum-iridium ring 4 14 are platinum-iridium alloy PtIr10. Connecting ring 1 7, connecting ring 2 8, connecting ring 3 9, and connecting ring 4 10 are injection molded, and platinum-iridium ring 1 11, platinum-iridium ring 2 12, platinum-iridium ring 3 13, and platinum-iridium ring 4 14 are forged or hot-melt molded. The materials between connecting ring 1 7, connecting ring 2 8, connecting ring 3 9, and connecting ring 4 10 are polyurethane materials.

[0032] like Figure 3 As shown, the material of the check valve 16 is not limited to PC and TPU, the material of the T-type valve 17 is not limited to PC and TPU, and the material of the sleeve 18 is not limited to PEEK.

[0033] Methods of use for this dorsal root ganglion stimulation electrode kit include: The first step is to insert the puncture needle 3 into the epidural space at a suitable angle under X-ray fluoroscopy, and then rotate the needle head of the puncture needle 3 to a suitable angle, and remove the inner core of the puncture needle 3, such as Fig. 9 As shown; Step 2: insert the puncture guide wire 4 through the outer core of the puncture needle 3, confirm that the puncture guide wire enters the epidural space, and then remove the puncture guide wire 4; Step 3: insert the steel wire 5 into the catheter of the needle electrode 1 and extend it to the top; Step 4: Insert the needle electrode 1 into the elbow sleeve 2 after the steel wire 5 is inserted in the third step, so that the distal end of the needle electrode 1 slightly protrudes from the distal end of the elbow sleeve 2, and tighten the T-type valve 17 so that the needle electrode 1 cannot slide in the elbow sleeve 2. Figure 5 As shown; Step 5: Insert the cannula on the elbow cannula 2 in step 4 into the puncture needle 3, adjust the angle of the cannula 18, and allow it to pass through the epidural space and enter the target intervertebral foramen. When the distal end of the cannula 18 enters the target position, release the T-valve 17, push the needle electrode 1 forward to enter the target hole, slowly inject sterile water or saline through the check valve to push it forward, and confirm that the needle electrode 1 is located at the dorsal root bone hole through the lateral perspective film. Fig. 9 , 10 , as shown in 11; Step 6: Take out the elbow sleeve 2; Step 7: Take out the outer core of the puncture needle 3 and the steel wire 5.

[0034] Through the above-mentioned method of use, the platinum-iridium ring of the needle electrode is placed on the affected part, the connecting ring of the needle electrode is connected to the extension wire and the spinal cord stimulator in sequence, and the platinum-iridium ring is in contact with the human body. The stimulation signal is sent out by the spinal cord stimulator, passes through the extension wire to the connecting ring, the spiral wire and the platinum-iridium ring, and then is transmitted to the body to achieve the purpose of treatment.

[0035] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A dorsal root ganglion stimulation electrode kit, comprising a needle electrode (1), an elbow cannula (2), a puncture needle (3), a puncture guide wire (4) and a steel wire (5), characterized in that: The needle-shaped electrode (1) comprises a catheter (6), one end of which is provided with a connecting ring 1 (7), a connecting ring 2 (8), a connecting ring 3 (9), and a connecting ring 4 (10), and the other end of the catheter (6) is provided with a platinum-iridium ring 1 (11), a platinum-iridium ring 2 (12), a platinum-iridium ring 3 (13), and a platinum-iridium ring 4 (14), and the middle section of the catheter (6) is a spiral section (15); The elbow sleeve (2) comprises a check valve (16), a sleeve (18) and a T-shaped valve (17) for fixing the needle-shaped electrode (1), the sleeve (18) being connected to one end of the T-shaped valve (17), and the check valve (16) being connected to the top of the T-shaped valve (17); The steel wire (5) is placed in the needle-shaped electrode (1), the needle-shaped electrode (1) is inserted into the sleeve (18) of the elbow sleeve (2), and the sleeve (18) of the elbow sleeve (2) is inserted into the puncture needle (3); The puncture needle (3) comprises an inner core (19) and an outer core (20), wherein the inner core (19) is sleeved inside the outer core (20).

2. A dorsal root ganglion stimulation electrode kit as claimed in claim 1, characterized in that: The spiral segment (15) is formed by synchronously winding four strands of guide wires, and the guide wire material is not limited to platinum-iridium-gold and nickel-cobalt alloy.

3. A dorsal root ganglion stimulation electrode kit as claimed in claim 1, characterized in that: One end of each guide wire on the spiral segment (15) is connected to a connecting ring, and the other end is connected to a platinum-iridium ring, including the first guide wire on the spiral segment (15) having one end connected to connecting ring one (7) and the other end connected to platinum-iridium ring one (11), the second guide wire having one end connected to connecting ring two (8) and the other end connected to platinum-iridium ring two (12), the third guide wire having one end connected to connecting ring three (9) and the other end connected to platinum-iridium ring three (13), and the fourth guide wire having one end connected to connecting ring four (10) and the other end connected to platinum-iridium ring four (14).

4. A dorsal root ganglion stimulation electrode kit as claimed in claim 1, characterized in that: The surface of the puncture guide wire (4) is provided with an insulating coating, and the coating material is not limited to PFA, ETFE, PTFE, and PI.

5. A dorsal root ganglion stimulation electrode kit as claimed in claim 1, characterized in that: The catheter (6) on the needle-shaped electrode (1) is made of polyurethane material, and its outer diameter is not limited to 1.0 mm. The materials of the connecting ring 1 (7), the connecting ring 2 (8), the connecting ring 3 (9), and the connecting ring 4 (10) are nickel-cobalt alloy. The materials of the platinum-iridium ring 1 (11), the platinum-iridium ring 2 (12), the platinum-iridium ring 3 (13), and the platinum-iridium ring 4 (14) are platinum-iridium alloy PtIr10. The connecting ring 1 (7), the connecting ring 2 (8), the connecting ring 3 (9), and the connecting ring 4 (10) are injection molded. The platinum-iridium ring 1 (11), the platinum-iridium ring 2 (12), the platinum-iridium ring 3 (13), and the platinum-iridium ring 4 (14) are forged or hot-melt molded. The connecting ring 1 (7), the connecting ring 2 (8), the connecting ring 3 (9), and the connecting ring 4 (10) are made of polyurethane material.

6. A dorsal root ganglion stimulation electrode kit as claimed in claim 1, characterized in that: The material of the check valve (16) is not limited to PC or TPU, the material of the T-type valve (17) is not limited to PC or TPU, and the material of the sleeve (18) is not limited to PEEK.

7. The method for using the dorsal root ganglion stimulation electrode kit according to claim 1, characterized in that: The method of use includes: The first step is to insert the puncture needle (3) into the epidural space at a suitable angle under X-ray fluoroscopy, then rotate the needle head of the puncture needle (3) to a suitable angle, and remove the inner core of the puncture needle (3); Step 2: insert the puncture guide wire (4) through the outer core of the puncture needle (3), confirm that the puncture guide wire enters the epidural space, and then remove the puncture guide wire (4); Step 3: insert the steel wire (5) into the catheter of the needle-shaped electrode (1) and extend it to the top end; Step 4: insert the needle electrode (1) into the elbow sleeve (2) after the steel wire (5) is inserted in the step 3, so that the distal end of the needle electrode (1) slightly protrudes from the distal end of the elbow sleeve (2), and tighten the T-shaped valve (17) so that the needle electrode (1) cannot slide in the elbow sleeve (2); Step 5: insert the cannula on the elbow cannula (2) in step 4 into the puncture needle (3), adjust the angle of the cannula (18) so that it passes through the epidural space and enters the target intervertebral foramen. When the distal end of the cannula (18) enters the target position, release the T-valve (17), push the needle electrode (1) forward to enter the target hole, and confirm that the needle electrode (1) is located at the dorsal root bone foramen through a lateral fluoroscopic film. Step 6: Take out the elbow sleeve (2); Step 7: Remove the outer core and steel wire (5) of the puncture needle (3).

8. The method for using the dorsal root ganglion stimulation electrode kit according to claim 7, characterized in that: In the fifth step, the needle electrode (1) is pushed forward by slowly injecting sterile water or physiological saline through the check valve.

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