Implantable nerve stimulation electrode and adapter, implantation system and stimulation system thereof

Abstract

The utility model discloses an implantable nerve stimulation electrode and an implantation system and a stimulation system thereof. The stimulation electrode comprises a far-end electrode, an outer sleeve and an electrode body, the electrode body is formed by spirally winding n electrode wires, and each electrode wire comprises a metal wire and an insulating layer wrapping the metal wire, so that the electrode body is of an insulating spiral structure; the outer sleeve is sleeved outside the far end of the electrode body, the near end of the electrode body is exposed, a far end port of the outer sleeve is sealed by a first sealing element, and a near end port of the outer sleeve is sealed by a second sealing element; the far-end electrodes are arranged on the outer sleeve in a sleeving mode, the number of the far-end electrodes is n, the n far-end electrodes are electrically connected with the far ends of the n electrode wires respectively, and n is a positive integer larger than or equal to 1. And the far end part of the electrode body is sleeved with the outer sleeve, so that the fatigue resistance is improved, meanwhile, the stress of the electrode body is small, the reliability is improved, and the safety is further improved. The near-end part of the electrode body is an exposed spiral electrode body, so that the wound on the human body is small, the healing is fast, and the infection risk is reduced.

Description

Technical Field

[0001] The utility model relates to the field of medical instruments, in particular to an implantable nerve stimulation electrode. Background Art

[0002] At present, people have learned that many diseases can be treated by electrical stimulation of nerves. For example, acute and chronic pain can be treated by electrical stimulation for a long time. Pain nerve electrical stimulation systems include implantable spinal nerve stimulators, non-implantable epidermal stimulation, and peripheral nerve treatment with percutaneous implanted electrodes and external electrical stimulators; sacral nerve stimulation can treat patients with incontinence; Parkinson's patients can use electrodes to stimulate the thalamus to treat patients' muscle stiffness and restore mobility. Although these devices relieve patients' pain and improve their quality of life, these stimulation systems have various defects and shortcomings.

[0003] Patent US2010 / 0036454A1 discloses a wing-shaped fixation mechanism at the distal end of a percutaneously implanted electrode, and its principle is similar to that of a ship's anchor hook, which is very similar to the disclosed wing-shaped anchor hook at the distal end of a pacing electrode. This distally fixed anchor hook shape has led to many similar designs, such as the percutaneously implanted electrode of StimWave, a US company, which uses a combination of an ordinary spinal stimulation electrode and a pacing wing-shaped electrode distal fixation mechanism. The disadvantage is that the implant diameter is large (1.3mm). In the case of peripheral nerve stimulation, including sensory and motor nerves, and other parts of the nerves, including the tympanic nerves, optic nerves, etc., the larger the implant diameter, the greater the trauma, and it is not suitable for clinical application.

[0004] Patent US4026301A discloses a distal fixation mechanism with a tip spiral, which is similar in principle to a screw and also similar in shape to the spiral shape of a pacing spiral electrode, but the fixation mechanism is different from that of a pacing electrode. Its disadvantages are that it is complex in structure, has many components, requires a large diameter for the implantation tool, and is also very traumatic. In addition, this design is for spinal curvature nerve stimulation, so it is not suitable for use in other parts.

[0005] In the transcutaneous nerve stimulation product that has been launched by SPR Therapeutics in the United States, the distal fixation mechanism of the electrode is disclosed to be a tight spiral hook type. Literature reports that when the electrode is removed at the end of clinical short-term treatment, the spiral stainless steel cable is not strong enough, causing 5-20% breakage at the distal fixation of the electrode, causing some treatment centers to refuse to use this SPR product.

[0006] Therefore, it is necessary to provide an implantable neural stimulation electrode that can increase the electrode stimulation area while reducing the force on the electrode body, improving reliability and safety, causing less trauma to the human body and healing faster, and reducing the risk of infection. Utility Model Content

[0007] The technical problem to be solved by the utility model is to provide an implantable neural stimulation electrode, which can increase the electrode stimulation area, reduce the force on the electrode body, improve reliability and safety, cause little trauma to the human body and heal quickly, reduce the risk of infection and ensure good stimulation effect.

[0008] In order to solve the above technical problems, the utility model provides an implantable neural stimulation electrode, including a distal electrode, an outer sleeve and an electrode body; the electrode body is formed by spirally winding n electrode wires, and the electrode wires include metal wires and an insulating layer wrapped around the metal wires, so that the electrode body has an insulating spiral structure; the outer sleeve is sleeved on the distal end of the electrode body, and the proximal end of the electrode body is exposed, the distal port of the outer sleeve is sealed by a first seal, and the proximal port of the outer sleeve is sealed by a second seal; the distal electrode is sleeved on the outer sleeve, the number of the distal electrodes is n, and the n distal electrodes are respectively electrically connected to the distal ends of the n electrode wires, and n is a positive integer greater than or equal to 1.

[0009] Preferably, the first seal and the second seal are both made of biocompatible glue; the distal electrode is a tubular electrode made of stainless steel or platinum-containing alloy or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy.

[0010] Preferably, the electrode body is formed by coaxially and side-by-side equal-diameter spiral winding of n electrode wires, the material of the metal wire is a platinum-containing alloy, stainless steel or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy; the insulating material used in the insulating layer is a copolymer of ethylene and tetrafluoroethylene, polyurethane or polytetrafluoroethylene, the insulating material is extruded into a tube shape and then applied to the periphery of the metal wire, or the insulating material is sprayed onto the metal wire using a coating process.

[0011] Preferably, a fixing mechanism is provided at the distal end of the outer sleeve, and the fixing mechanism is formed by spirally winding a metal wire. The fixing mechanism includes a fixing portion and a connecting portion, and the fixing portion is located outside the outer sleeve, and the connecting portion extends into the outer sleeve and is connected to the outer sleeve or the electrode body; or, the connecting portion is connected to a distal electrode close to the fixing mechanism.

[0012] Preferably, after being spirally wound, the electrode body has a channel for allowing a guide wire to pass through and supporting the guide wire.

[0013] In order to solve the above technical problems, the utility model provides an implantation system, including a puncture sheath, a guide wire and an implantable neural stimulation electrode, wherein the guide wire penetrates into the channel of the stimulation electrode, the distal end of the guide wire presses against the distal end of the stimulation electrode, and the maximum outer diameter of the stimulation electrode is smaller than the inner diameter of the puncture sheath, so that the guide wire and the stimulation electrode are combined and inserted into the puncture sheath and implanted into the body.

[0014] In order to solve the above technical problems, the utility model provides an implantation system, including an outer sheath, an inner sheath and an implantable neural stimulation electrode, wherein the maximum outer diameter of the fixing mechanism is greater than the inner diameter of the inner sheath, so that after the stimulation electrode penetrates the inner sheath, the fixing mechanism is clamped at the distal port of the inner sheath; the maximum outer diameter of the fixing mechanism is smaller than the inner diameter of the outer sheath, so that after the stimulation electrode and the inner sheath are combined, they are implanted into the body through the outer sheath.

[0015] In order to solve the above technical problems, the utility model also provides an adapter, including a first shell, a second shell, a base and a cable, the first shell and the second shell are respectively detachably connected to the base, a connecting piece is arranged on the base in the first shell, the cable is placed in the second shell and electrically connected to the connecting piece, a spring sheet with a blade is arranged on the connecting piece, the spring sheet and the connecting piece are both made of conductive material, when the electrode wire with an insulating layer is placed on the blade and the first shell is buckled on the base, the blade cuts through the insulating layer of the electrode wire, so that the electrode wire is electrically connected to the cable through the spring sheet and the connecting piece.

[0016] Preferably, the first shell and the second shell are movably connected via a hinge, a first slot is provided on the end side of the first shell, a first protrusion is correspondingly provided on the end side of the base, and the first slot is engaged with the first protrusion; second slots are provided on both sides of the second shell, second protrusions are correspondingly provided on both sides of the base, and the second slot is engaged with the second protrusion.

[0017] Preferably, the number of the spring clips is four, namely the first spring clip, the second spring clip, the third spring clip and the fourth spring clip, the first spring clip has a beveled first blade, the second spring clip has a beveled second blade, the third spring clip has a beveled third blade, and the fourth spring clip has a beveled fourth blade, the first spring clip and the second spring clip are arranged on one side of the connecting piece, the first blade and the second blade form a V-shaped concave angle relative to each other, the third spring clip and the fourth spring clip are arranged on the other side of the connecting piece, the third blade and the fourth blade form a V-shaped concave angle relative to each other, a buckle is arranged in the first shell, the position of the buckle corresponds to the V-shaped concave angle, and through holes for the electrode wire to pass through are correspondingly formed on both sides of the first shell and the base, the position of the through hole corresponds to the position of the V-shaped concave angle, so that the electrode wire is placed at the V-shaped concave angle after passing through the through hole.

[0018] In order to solve the above technical problems, the utility model also provides a stimulation electrode system, including a stimulation electrode, an adapter and a stimulator, the proximal end of each electrode wire of the stimulation electrode is placed on the blade of the shrapnel in the adapter, and after covering the first shell, the blade cuts through the insulation layer of the electrode wire, the electrode wire and the cable of the adapter are electrically connected, and the proximal end of the cable is electrically connected to the stimulator.

[0019] Compared with the prior art, the utility model has the following beneficial effects: the utility model provides an implantable neural stimulation electrode and its implantation system and stimulation system, wherein an outer sleeve is sleeved on the distal electrode body, and the distal electrode is sleeved on the outside of the outer sleeve. Compared with the structure without an outer sleeve, the outer diameter of the distal electrode is larger, the electrode stimulation area is larger, and the stimulation effect is better. The proximal end of the outer sleeve is an exposed electrode body. During the implantation process of the stimulation electrode, the distal part of the stimulation electrode with the outer sleeve is implanted into the human body, and the outer sleeve can protect this part of the electrode body. After the distal end of the stimulation electrode is subjected to force, the force is evenly distributed outside the outer sleeve, so that the distal electrode body is subjected to less force, which improves the fatigue resistance of the electrode body. The ports on both sides of the outer sleeve are sealed to ensure that no body fluids enter the outer sleeve, thereby avoiding the stimulation electrode in the body. During the long-term implantation process, the body fluid will have an adverse effect on the distal electrode body. The electrode body is safer and more reliable. After the electrode is implanted, there is only the electrode body at the skin wound. The electrode body is a spiral structure. The size of the wound is the outer diameter of the electrode wire, not the outer diameter of the outer sleeve. Compared with the structure in which the outer sleeve is set outside the electrode body, the wound on the patient's body surface can be greatly reduced, reducing the risk of infection in the patient. In particular, a spirally wound fixing mechanism is set at the distal end of the stimulation electrode. When the stimulation electrode is delivered to the vicinity of the nerve or other treatment targets, the muscle tissue enters the spiral gap of the fixing mechanism to fix the distal end of the electrode, which plays a role in fixing the electrode to the human body, solving the current problem of poor fixation of nerve stimulation electrodes and dislocation or displacement during clinical treatment. The fixing mechanism of the distal spiral structure is safe and reliable. When the electrical stimulation treatment is over or the stimulation electrode needs to be pulled out, the distal spiral fixing mechanism can make the operator operate easily and smoothly, so that the entire stimulation electrode can be withdrawn from the human tissue without trauma, overcoming the problem that the fixing mechanism of existing products is easy to fatigue and the electrode will break when pulled out, providing more effective treatment for nerve regulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic diagram of the structure of the stimulation electrode in the first embodiment of the utility model;

[0021] Figure 2 This is a schematic diagram of the assembly of the electrode body and the outer sleeve in the first embodiment of the utility model;

[0022] Figure 3 This is a schematic diagram of the structure of the stimulation electrode in the second embodiment of the utility model;

[0023] Figure 4 (a) Figure 4 (b) Figure 4 (c) is a schematic diagram of the structure of the spiral fixing mechanism of different lengths in the second embodiment of the utility model;

[0024] Figure 5a This is a schematic diagram of the assembly of the guide wire and the stimulation electrode in the embodiment of the utility model. Figure 5b This is a schematic diagram of the structure of the implantation system in the embodiment of the utility model;

[0025] Figure 6 This is a structural schematic diagram of an implantation system in another embodiment of the utility model;

[0026] Figure 7 for Figure 6 A partial enlarged schematic diagram of point A in the middle

[0027] Figure 8 This is a schematic diagram of the internal structure of the adapter in the embodiment of the utility model;

[0028] Fig. 9 This is a schematic diagram of the overall structure of the adapter in the embodiment of the utility model;

[0029] Fig.10 This is a schematic diagram of a state in which the first housing of the adapter in the embodiment of the utility model is opened and the electrode wire is placed therein;

[0030] Fig.11 This is a schematic diagram of the structure of the electrode wire being installed into the adapter in the embodiment of the utility model;

[0031] Fig.12a This is a schematic diagram of the structure of a single adapter in an embodiment of the utility model. Figure 12b This is a schematic diagram of the structure of a double adapter in an embodiment of the utility model;

[0032] Fig.13 It is a schematic diagram of the structure of the neural electrical stimulation system in an embodiment of the utility model.

[0033] In the figure:

[0034] 1-stimulation electrode, 11-fixing mechanism, 111-fixing part, 12-distal electrode, 121-first distal electrode, 122-second distal electrode, 13-electrode body, 131-electrode wire, 14-outer sleeve, 15-seal, 151-first seal, 152-second seal, 16-channel, 2-adapter, 21-first shell, 211-press buckle, 212-first protrusion, 213-first slot, 22-second shell, 221-hinge, 222-second protrusion, 223-second slot, 23-base, 231-positioning column, 232-spring, 24-cable, 25-through hole, 241-connecting plate, 2320-blade, 2321-first spring, 2322-second spring, 2323-third spring, 2324-fourth spring, 3, 5-puncture sheath, 31-puncture sheath tube, 32-puncture sheath handle, 4-guide wire, 41-guide wire handle, 51-inner sheath, 52-outer sheath, 6-stimulator. DETAILED DESCRIPTION

[0035] The utility model is further described below in conjunction with the accompanying drawings and embodiments.

[0036] In order to more clearly describe the structural features of the present invention, the present invention uses "proximal end", "distal end" and "axial end" as directional words, wherein "proximal end" refers to the end close to the operator; "distal end" refers to the end far from the operator, and "axial end" refers to the direction of the central axis of the stimulation electrode or the direction parallel to it. The term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0037] See also Figure 1 and Figure 2The stimulation electrode 1 provided in this embodiment includes a distal electrode 12, an outer sleeve 14 and an electrode body 13; the electrode body 13 is formed by spirally winding n electrode wires 131, and the electrode wire 131 includes a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body 13 is an insulating spiral structure; the outer sleeve 14 is sleeved on the distal part of the electrode body 13, and the proximal part of the electrode body 13 is exposed, and both side ports of the outer sleeve are sealed with a seal 15 to ensure that no body fluid enters the outer sleeve 14. Specifically, the distal port of the outer sleeve 14 is sealed by a first seal 151, and the proximal port of the outer sleeve 14 is sealed by a second seal 152, and the material of the seal 15 is biocompatible glue, such as silicone; the number of the distal electrodes 12 is n, and the n distal electrodes 12 are respectively electrically connected to the distal ends of the n electrode wires 131, n is a positive integer greater than or equal to 1, and n is preferably 2-12, and more preferably 2 or 4. The distal electrode 12 is a stimulation end, which stimulates the target point. Preferably, the distal electrode 12 is a tubular electrode made of stainless steel or a platinum-containing alloy or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy. The length of a single distal electrode 12 and the spacing between two adjacent distal electrodes 12 can be selected in a variety of ways for different diseases. The distal electrode 12 at the proximal end is a connecting end. After the electrode wire 131 is inserted into the adapter 2, the adapter 2 is connected to the stimulator 6 used in conjunction with it through the cable 24.

[0038] The function of the electrode body 13 is to conduct current. In a specific embodiment, the electrode body 13 is formed by coaxially parallel equal-diameter spiral winding of n electrode wires 131. Each electrode wire 131 includes a metal wire and an insulating layer. The insulating layer is wrapped around the metal wire to ensure that the electrodes are not connected to each other and cause abnormal stimulation. The metal wire can be a platinum-iridium alloy wire, a stainless steel wire or an MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy wire. The insulating material used in the insulating layer is a copolymer of ethylene and tetrafluoroethylene, polyurethane or polytetrafluoroethylene. The insulating material is extruded into a tube and then applied to the periphery of the metal wire, or the insulating layer is The material is sprayed onto the metal wire using a coating process; n distal electrodes 12 are respectively electrically connected to the distal ends of n electrode wires 131, where n is 2 in this embodiment, and the two distal electrodes 12 are respectively: a first distal electrode 121 and a second distal electrode 122, the first distal electrode 121 is sleeved at the distal end of the outer sleeve 14, and the second distal electrode 122 is sleeved at the proximal end of the outer sleeve 14, and the electrode body 13 of this embodiment is composed of two electrode wires 131, wherein the distal end of one electrode wire 131 is connected to the first distal electrode 121, and the distal end of the other electrode wire 131 is connected to the second distal electrode 122.

[0039] The outer sleeve 14 is made of a biocompatible material such as PU (polyurethane), and can be implanted in the human body for a short or long term, while providing protection for the electrode body 13 implanted in the body. The stimulation electrode 1 with the outer sleeve 14 is partially implanted in the human body, and the outer sleeve 14 can protect the electrode body 13 of this part. After the distal end of the stimulation electrode 1 is subjected to force, the force is evenly distributed outside the outer sleeve 14, so that the electrode body 13 is subjected to less force, thereby improving the fatigue resistance of the electrode body 13. The axial ports on both sides of the outer sleeve 14 are sealed to ensure that no body fluids enter the outer sleeve 14, thereby avoiding the body fluids from causing adverse effects on the distal electrode body 13 during the long-term implantation of the stimulation electrode 1 in the body, thereby making the electrode body 13 safer and more reliable.

[0040] The proximal end of the outer sleeve 14 is the exposed electrode body 13. When the stimulation electrode 1 is implanted in the human body, the distal end thereof with the outer sleeve 14 portion and part of the electrode body 13 is implanted in the body. Therefore, the wound on the human body surface is located at the exposed electrode body 13. The size of the wound is the outer diameter of the n electrode wires 131 constituting the electrode body 13 in a straightened state after being combined, rather than the outer diameter of the outer sleeve 14 or the outer diameter of the spiral structure of the electrode body 13. This greatly reduces the size of the wound and reduces the risk of infection for patients.

[0041] The distal end of the electrode wire 131 constituting the electrode body 13 passes through the outer sleeve 14 and is electrically connected to the corresponding distal electrode 12, the proximal end of the electrode wire 131 is electrically connected to the adapter 2, and the gap between adjacent distal electrodes 12 is filled with biological glue, which can prevent the conduction between each distal electrode 12. In other embodiments, an insulating ring is provided between two adjacent distal electrodes 12, and the insulating ring can be connected to the distal electrode 12 by gluing. By controlling the axial length of the insulating ring, the spacing between adjacent distal electrodes 12 can be controlled, and the insulating ring can prevent the conduction between each distal electrode 12.

[0042] In the first embodiment, please also refer to Figure 1 , Figure 2 , Figure 5a and Figure 5b , the distal end of the outer sleeve 14 is in a closed state, without an additional fixing mechanism 11. During implantation, the stimulation electrode 1 is inserted through the guide wire 4, which can support the front end of the stimulation electrode 1, and then the guide wire 4 with the stimulation electrode 1 is inserted into the puncture sheath 3. After the puncture sheath 3 punctures the target stimulation position, the puncture sheath 3 is pulled out, and the guide wire 4 is supported to keep the electrode position unchanged. After the puncture sheath 3 is pulled out, the guide wire 4 is pulled out to complete the implantation of the stimulation electrode 1. Therefore, the inner diameter of the spiral structure of the electrode body 13 is larger than the outer diameter of the guide wire 4, which satisfies the smooth passage of the guide wire 4. A channel 16 for the guide wire 4 to pass through and support the guide wire 4 is formed inside the spiral structure of the electrode body 13.

[0043] In the second embodiment, if Figure 3and Figure 4 As shown, the distal end of the outer sleeve 14 is provided with a fixing mechanism 11, which is a spiral structure formed by spiral winding of a metal wire. The fixing mechanism 11 can be formed by spiral winding of the same metal wire as the electrode wire 131, or other metal materials can be selected as needed, and even non-metallic insulating materials can be selected; for example, stainless steel can be used for short-term percutaneous implantation, which is low in cost; but platinum-iridium alloy is generally used for long-term implantation, and the mass ratio of platinum-iridium is 80 / 20 or 90 / 10. Specifically, the fixing mechanism 11 includes a fixing portion 111 and a connecting portion, the diameter of the connecting portion is smaller than the diameter of the fixing portion 111, and in one embodiment, the connecting portion of the fixing mechanism 11 is welded to the first distal electrode 121 at the farthest end. Further, the fixing mechanism 11 can be connected to the first distal electrode 121 by a connecting ring, which is a metal ring sleeved on the outside of the outer sleeve 14. The connecting ring can release electrical signals simultaneously with the first distal electrode 121, increase the electrical energy and coverage of the first distal electrode 121, and is also a mechanical means for firmly connecting the spiral fixing mechanism 11. If the electrical signal of the stimulation system does not need to be increased, the surface of the spiral fixing mechanism 11 can be insulated and connected to the first distal electrode 121 with silicone, ETFE (ethylene-tetrafluoroethylene copolymer), parylene coating or other polymer materials; when the stimulation electrode 1 is used in a stimulation system with feedback, the surface of the spiral fixing mechanism 11 needs to be coated with TiN (titanium nitride) to increase the sensing surface area. In other embodiments, the connecting portion of the fixing mechanism 11 extends into the outer sleeve 14 and is fixedly connected to the outer sleeve 14 by gluing or other means, or the connecting portion of the fixing mechanism 11 extends into the outer sleeve 14 and is welded to the electrode body 13.

[0044] The fixing part 111 is located at the farthest end of the stimulation electrode 1 and plays a role in fixing it in the human body.

[0045] The spiral coils constituting the fixing portion 111 are arranged in sequence along the axial direction at a predetermined pitch, and the pitch is preferably 0.5 mm to 0.9 mm. The pitch referred to in this embodiment refers to the axial distance between two corresponding points on two adjacent spiral coils, such as Figure 4 The axial length of the spiral of the distal fixing portion 111 is preferably 1.5 mm to 5 mm. This embodiment lists three different length designs, which are suitable for different characteristics of human tissue parts. Figure 4 The distal fixing portion 111 shown in (a) has a shorter axial length and can be used for electrical stimulation of a relatively dense part of the human body tissue at the target point; Figure 4 The distal fixing portion 111 shown in (b) has a slightly longer axial length and can be used for electrically stimulating a target area where the human tissue is slightly loose; Figure 4The distal fixing portion 111 shown in (c) has a longer axial length and can be used for very loose human tissue at the target of electrical stimulation. A person skilled in the art can select a fixing portion 111 of a suitable length as required.

[0046] Figure 4 (a) shows a design in which the spiral of the distal fixing part 111 is shorter when the target muscle is relatively tight, for example, the axial length of the fixing part 111 is 1.5 mm, and the pitch between the spiral turns constituting the fixing part 111 is 0.5 mm-0.9 mm. Figure 4 The distal fixing portion 111 with a shorter axial length as shown in (a) is more suitable. The operator can select a fixing portion 111 of a suitable length according to the target muscle to be stimulated.

[0047] If the target muscle is not tight and slightly loose, you can use Figure 4 (b) shows a slightly longer axial length of the distal spiral fixing portion 111, for example, the axial length of the fixing portion 111 is 2.25-3.00 mm, and the pitch between the spiral turns constituting the fixing portion 111 is 0.5-0.9 mm. When the inner sheath 51 with the stimulation electrode 1 enters the muscle, more spiral length can be combined with the muscle.

[0048] Similarly, if the target muscle is a more loose part, you can use Figure 4 (c) shows a spiral fixing portion 111 with a longer axial length, for example, the axial length of the fixing portion 111 is 3-5 mm or longer, and the second pitch between the second spiral turns constituting the fixing portion 111 is 0.5-0.9 mm.

[0049] When the electrical stimulation treatment is finished or the electrode needs to be removed, the distal fixing portion 111 of the stimulation electrode 1 provided in this embodiment is firmly combined with the muscle tissue due to its spiral structure, and the following electrode withdrawal method can be adopted: if the spiral of the fixing portion 111 is a right-handed (left-handed) design, when removing the stimulation electrode 1, the stimulation electrode 1 is pulled out of the body while being rotated left-handed (right-handed), so that the muscle tissue fixed by the distal spiral can release the spiral spacing and the stimulation electrode 1 can be smoothly removed from the body.

[0050] See also Figure 1 and Figure 5a and Figure 5bThis embodiment provides an implantation system, including a puncture sheath 3, a guide wire 4 and the stimulation electrode 1 in the first embodiment or the second embodiment. The puncture sheath 3 includes a puncture sheath tube 31 and a puncture sheath handle 32. The puncture sheath handle 32 is used to manipulate and control the puncture sheath tube 31 to enter or withdraw from the patient's body. The guide wire 4 penetrates into the channel 16 of the stimulation electrode 1. The distal end of the guide wire 4 supports the distal end of the stimulation electrode 1. The maximum outer diameter of the stimulation electrode 1 is smaller than the inner diameter of the puncture sheath tube 31, so that the guide wire 4 and the stimulation electrode 1 are combined and inserted into the puncture sheath tube 31 and implanted into the body. The guide wire 4 is a shaped steel wire, which can support the soft stimulation electrode 1 to play a rigid role and help the stimulation electrode 1 to be implanted in place. Preferably, a guide wire handle 41 is provided at the proximal end of the guide wire 4 to facilitate manipulation of the guide wire 4. When in use, the guide wire handle 41 is operated to allow the guide wire 4 to carry the stimulation electrode 1 into the puncture sheath 31, and the puncture sheath handle 32 is operated to allow the puncture sheath 31 to be inserted into the human body. After the puncture sheath 31 is punctured to the target stimulation position, a sufficient distance is left between the proximal end of the puncture sheath 31 and the distal end of the guide wire handle 41, so that when the puncture sheath 31 is completely pulled out, the guide wire 4 still supports the distal end of the stimulation electrode 1 without moving. After the puncture sheath 31 is completely pulled out, the guide wire 4 is pulled out of the puncture sheath 3, so that the distal end of the stimulation electrode 1 is fixed in the human tissue, and the implantation operation of the stimulation electrode 1 is completed. After the electrode is implanted, the stimulation electrode 1 is electrically connected to the adapter 2 through the electrode wire 131, and the adapter 2 is electrically connected to the stimulator 6 through the cable 24 to perform electrical stimulation. In this embodiment, through the cooperation of the guide wire 4, when the stimulation electrode 1 is implanted in the human body, the inner sheath 51 is not required, and only the puncture sheath 31 (equivalent to the outer sheath 52) and the guide wire 4 are required. For the stimulation electrode 1 in the second embodiment, the diameter of the spiral fixing mechanism 11 is equal to or smaller than the outer diameter of the distal electrode 12 and the outer sleeve 14, wherein the outer diameters of the distal electrode 12 and the outer sleeve 14 are substantially the same, so that the space can be fully utilized and the diameter of the implantation tool (puncture sheath 31) can be saved. During use, the guide wire 4 is inserted into the distal electrode 12, and the guide wire 4 can support the distal end of the stimulation electrode 1. Then the guide wire 4 carries the stimulation electrode 1 into the puncture sheath 31. After the puncture sheath 31 punctures the target stimulation position, the puncture sheath 31 is pulled out, and the guide wire 4 is supported to keep the position of the stimulation electrode 1 unchanged. After the puncture sheath 31 is pulled out, the guide wire 4 is pulled out to complete the implantation operation of the stimulation electrode 1. After the stimulation electrode 1 is implanted, the stimulation electrode 1 is electrically connected to the adapter 2 through the electrode wire 131, and the adapter 2 is electrically connected to the stimulator 6 through the cable 24 to perform electrical stimulation.In the aforementioned method, the stimulation electrode 1 with the guide wire 4 cannot be exposed at the distal end of the puncture sheath 31, otherwise during the puncture process, the spiral fixing portion 111 will damage the human tissue and destroy the spiral structure, resulting in failure to play a fixing role. This problem can be solved by setting a limiting portion at the proximal end of the puncture sheath 31, or by using a solid needle and the puncture sheath 31 to puncture near the expected nerve first, and then inserting the stimulation electrode 1 with the guide wire 4 after pulling out the solid needle. The guide wire 4 gently pushes the distal spiral fixing portion 111 against the human tissue. After the test is successful, the distal spiral fixing portion 111 is squeezed into the human tissue and fixed by force through the guide wire 4, and the implantation is successful. In another embodiment, the puncture sheath 31 and the test needle are combined for puncture. After the test implantation point is successfully tested, the test needle is removed, and the stimulation electrode 1 with the guide wire 4 is inserted into the puncture sheath 31 until the distal end of the stimulation electrode 1 contacts the human tissue. The puncture sheath 31 uses force to squeeze the distal spiral fixing portion 111 into the human tissue to fix it, and the puncture sheath 31 is pulled out to complete the implantation. This method has an additional test needle.

[0051] Please also see Figure 3 , Figure 6 and Figure 7 This embodiment provides another implantation system, which uses an inner and outer sheath to implant the stimulation electrode 1 into the body, specifically, including a puncture sheath 5 and Figure 2In the stimulation electrode 1 in the second embodiment shown, the puncture sheath 5 includes an inner sheath 51 and an outer sheath 52, and a fixing mechanism 11 is arranged at the distal end of the stimulation electrode 1. The maximum diameter D of the fixing portion 111 of the fixing mechanism 11 is slightly larger than the inner diameter of the inner sheath 51, and the outer diameter of the distal electrode 12 is smaller than the inner diameter of the inner sheath 51, so that when the stimulation electrode 1 is inserted into the inner sheath 51, the fixing mechanism 11 is clamped at the distal end port of the inner sheath 51. At the same time, the maximum diameter D of the fixing portion 111 is slightly smaller than the inner diameter of the outer sheath 52. When implanted, the inner sheath 51 assembly equipped with the stimulation electrode 1 can be inserted into the proximal end of the outer sheath 52 and pushed forward until it can no longer move forward. When the distal end of the stimulation electrode 1 is pushed out of the distal end of the outer sheath 52, the distal fixing mechanism 11 of the stimulation electrode 1 is squeezed by the human tissue and will be bent and combined with the human tissue to be fixed. After the stimulation electrode 1 is fixed, the outer sheath 52 and the inner sheath 51 are locked together by a locking mechanism and pulled out from the body. Since the inner sheath 51 and the stimulation electrode 1 have a relatively loose gap fit, when the inner sheath 51 and the outer sheath 52 are pulled out together, the stimulation electrode 1 will remain in the human tissue and the implantation is completed. When used specifically, in one embodiment, first, the test electrode and the outer sheath 52 are assembled and punctured into the vicinity of the expected implantation point of the human nerve, and the stimulation position is tested by the test electrode. After the test is successful, the test electrode is pulled out; then, the inner sheath 51 assembly equipped with the stimulation electrode 1 is installed into the outer sheath 52, so that the distal end of the stimulation electrode 1 is fixed in the human tissue; finally, the inner sheath 51 and the outer sheath 52 are pulled out together, and the stimulation electrode 1 is left in the body. After the electrode is implanted, the stimulation electrode 1 is electrically connected to the adapter 2 through the electrode wire 131, and the adapter 2 is electrically connected to the stimulator 6 through the cable 24 to perform electrical stimulation.

[0052] Please also see Figure 8 , Fig. 9 and Fig.10The present embodiment provides an adapter, including a first shell 21, a second shell 22, a base 23 and a cable 24. The first shell 21 and the second shell 22 are respectively detachably matched and connected to the base 23. A first card slot 213 is provided on the end side of the first shell 21, and a first protrusion 212 is correspondingly provided on the end side of the base 23. When the first shell 21 is buckled to the base 23, the first card slot 213 is engaged with the first protrusion 212, so that the first shell 21 and the base 23 are buckled and connected. When the first shell 21 is opened, the first card slot 213 and the first protrusion 212 are released from the buckle connection; second card slots 223 are provided on both sides of the second shell 22, and second protrusions 222 are correspondingly provided on both sides of the base 23. The second card slot 223 is engaged with the second protrusion 222, so that the second shell 22 and the base 23 are buckled and connected. When the second card slot 223 and the second protrusion 222 are released from the buckle connection, the second shell 22 can be disassembled and separated from the base 23. The first shell 21 and the second shell 22 are movably connected by a hinge 221. Preferably, the first shell 21, the second shell 22 and the hinge 221 are an integrated structure. A connecting piece 241 is provided on the base 23 in the first shell 21. The cable 24 is placed in the second shell 22 through an interface on the second shell 22 and is electrically connected to the connecting piece 241. The connecting piece 241 and the cable 24 are respectively fixed to the base 23 by two or more positioning columns 231. A spring piece 232 with a blade 2320 is provided on the connecting piece 241. Both the spring piece 232 and the connecting piece 241 are made of conductive material. There are four spring pieces 232, namely the first spring piece 2321, the second spring piece 2322, the third spring piece 2323 and the fourth spring piece 2324. The first spring piece 2321 has a The first spring piece 2321 and the second spring piece 2322 have a beveled second spring piece 2322, the third spring piece 2323 has a beveled third spring piece, and the fourth spring piece 2324 has a beveled fourth spring piece. The first spring piece 2321 and the second spring piece 2322 are arranged on one side of the connecting piece 241, and the first blade and the second blade form a V-shaped concave angle relative to each other. The third spring piece 2323 and the fourth spring piece 2324 are arranged on the other side of the connecting piece 241, and the third blade and the fourth blade form a V-shaped concave angle relative to each other. A buckle 211 is arranged in the first shell 21, and the position of the buckle 211 corresponds to the V-shaped concave angle.

[0053] See also Fig.11A through hole 25 for the electrode wire 131 to pass through is formed on both sides of the first shell 21 and the base 23. The position of the through hole 25 corresponds to the position of the V-shaped concave angle, so that the electrode wire 131 passes through the through hole 25 and is placed at the V-shaped concave angle. When the electrode wire 131 with an insulating layer is placed at the blade 2320 and the first shell 21 is buckled on the base 23, the buckle 211 in the first shell 21 presses the electrode wire 131 to the blade 232, and the blade 232 cuts through the insulating layer of the electrode wire 131, so that the electrode wire 131 is electrically connected to the cable 24 through the spring piece 232 and the connecting piece 241.

[0054] The present embodiment provides an adapter 2 and a distal electrode 12 for cooperation, that is, n distal electrodes need to be connected to n adapters 2 through electrode wires 131 one by one, as shown in 12a for a single adapter 2. Figure 12b Two adapters 2 are shown, which are arranged specifically according to the number of distal electrodes 12 .

[0055] See also Fig.13 This embodiment provides a neural electrical stimulation system, including a stimulator 6, an adapter 2 and a stimulation electrode 1. The number of adapters 2 is the same as the number of distal electrodes 12 and the number of electrode wires 131, which are all n. That is, each distal electrode 12 is electrically connected to an adapter 2 through an electrode wire 131, and each adapter 2 is electrically connected to the stimulator 6 through a cable 24. The stimulator 6 is sealed by a metal shell to form an electronic cavity, and a power supply and a circuit main board are arranged in the electronic cavity. The circuit main board is connected to the adapter 2 through a cable 24. A current pulse generator is arranged on the circuit main board. The current pulse output channel of the current pulse generator is transmitted to the distal electrode 12 through the adapter 2 to realize the electrical pulse stimulation function; the metal shell is used as a loop electrode of the current pulse.

[0056] In summary, the utility model has at least the following advantages: 1. The electrode body outside the proximal end of the outer sleeve is exposed and has an open spiral structure, which reduces the size of the patient's skin wound and reduces the risk of infection for the patient. The ports on both sides of the outer sleeve are sealed with biocompatible glue to prevent the entry of body fluids and improve safety. 2. The outer sleeve is sleeved outside the electrode body, and the distal electrode is sleeved outside the outer sleeve. Compared with the structure without an outer sleeve, the outer diameter of the distal electrode is larger, the area of ​​electrode stimulation is larger, and the stimulation effect is better. 3. During the implantation process of the stimulating electrode, the part with the outer sleeve is implanted into the human body. The outer sleeve can protect this part of the electrode body. After the distal end of the stimulating electrode is subjected to force, it is evenly distributed outside the outer sleeve, so that the force on the distal electrode body is small, which improves the fatigue resistance of the electrode body. 4. A spirally wound fixing mechanism is set at the distal end of the stimulation electrode, which is safe and reliable. When the stimulation electrode is delivered to the vicinity of the nerve or other treatment targets, the muscle tissue enters the spiral gap of the fixing mechanism to fix the distal end of the electrode, which plays a role in fixing the electrode to the human body, solving the current problems of poor fixation of nerve stimulation electrodes and dislocation or displacement during clinical treatment, avoiding the occurrence of adverse events such as electrode dislocation or displacement, and has positive significance for sacral nerve stimulation systems or other peripheral nerve stimulation surgeries. When the electrical stimulation treatment is over or the stimulation electrode needs to be pulled out, the distal spiral fixing mechanism enables the operator to operate easily and smoothly, allowing the entire stimulation electrode to be non-traumatically withdrawn from the human tissue, overcoming the problem of easy fatigue of the fixing mechanism of existing products and the breakage of the electrode when it is pulled out, providing more effective treatment for nerve regulation.

[0057] Although the present invention has been disclosed as above with preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art may make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be based on the definition of the claims.

Claims

1. An implantable neural stimulation electrode, characterized in that: It includes a distal electrode, an outer sleeve and an electrode body; The electrode body is formed by spirally winding n electrode wires, wherein the electrode wires include metal wires and an insulating layer wrapped outside the metal wires, so that the electrode body has an insulating spiral structure; The outer sleeve is sleeved outside the distal end of the electrode body, the proximal end of the electrode body is exposed, the distal end port of the outer sleeve is sealed by a first sealing member, and the proximal end port of the outer sleeve is sealed by a second sealing member; The distal electrode is sleeved on the outer sleeve, the number of the distal electrodes is n, and the n distal electrodes are respectively electrically connected to the distal ends of the n electrode wires, and n is a positive integer greater than or equal to 1.

2. The implantable neural stimulation electrode according to claim 1, characterized in that: The first seal and the second seal are both made of biocompatible glue; the distal electrode is a tubular electrode made of stainless steel or platinum-containing alloy or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy.

3. The implantable neural stimulation electrode according to claim 1, characterized in that: The electrode body is formed by coaxially and side-by-side equal-diameter spiral winding of n electrode conductors; the material of the metal wire is a platinum-containing alloy, stainless steel or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy; the insulating material used in the insulating layer is a copolymer of ethylene and tetrafluoroethylene, polyurethane or polytetrafluoroethylene; the insulating material is extruded into a tube shape and then applied to the periphery of the metal wire, or the insulating material is sprayed onto the metal wire using a coating process.

4. The implantable neural stimulation electrode according to claim 1, characterized in that: A fixing mechanism is provided at the distal end of the outer sleeve, and the fixing mechanism is formed by spirally winding a metal wire. The fixing mechanism includes a fixing portion and a connecting portion. The fixing portion is located outside the outer sleeve, and the connecting portion extends into the outer sleeve and is connected to the outer sleeve or the electrode body; or, the connecting portion is connected to a distal electrode close to the fixing mechanism.

5. The implantable neural stimulation electrode according to any one of claims 1 to 4, characterized in that: After being spirally wound, the electrode body has a channel for a guide wire to pass through and support the guide wire.

6. An implant system, characterized in that: It comprises a puncture sheath, a guide wire and the implantable neural stimulation electrode according to any one of claims 1 to 5, wherein the guide wire penetrates into the channel of the stimulation electrode, the distal end of the guide wire presses against the distal end of the stimulation electrode, and the maximum outer diameter of the stimulation electrode is smaller than the inner diameter of the puncture sheath, so that the guide wire and the stimulation electrode are combined and inserted into the puncture sheath and implanted into the body.

7. An implant system, characterized in that: It comprises an outer sheath, an inner sheath and the implantable neural stimulation electrode as claimed in claim 4, wherein the maximum outer diameter of the fixing mechanism is greater than the inner diameter of the inner sheath, so that after the stimulation electrode penetrates the inner sheath, the fixing mechanism is clamped at the distal port of the inner sheath; the maximum outer diameter of the fixing mechanism is smaller than the inner diameter of the outer sheath, so that after the stimulation electrode and the inner sheath are combined, they are implanted into the body through the outer sheath.

8. An adapter for an implantable neural stimulation electrode according to any one of claims 1 to 5, characterized in that: It includes a first shell, a second shell, a base and a cable, the first shell and the second shell are respectively detachably connected to the base, a connecting piece is arranged on the base in the first shell, the cable is placed in the second shell and is electrically connected to the connecting piece, a spring piece with a blade is arranged on the connecting piece, the spring piece and the connecting piece are both made of conductive material, when the electrode wire with an insulating layer is placed on the blade and the first shell is buckled on the base, the blade cuts through the insulating layer of the electrode wire, so that the electrode wire is electrically connected to the cable through the spring piece and the connecting piece.

9. The adapter according to claim 8, characterized in that: The first shell and the second shell are movably connected via a hinge, a first slot is provided on the end side of the first shell, a first protrusion is correspondingly provided on the end side of the base, and the first slot is engaged with the first protrusion; second slots are provided on both sides of the second shell, second protrusions are correspondingly provided on both sides of the base, and the second slot is engaged with the second protrusion.

10. The adapter according to claim 8, characterized in that: There are four spring clips, namely the first spring clip, the second spring clip, the third spring clip and the fourth spring clip. The first spring clip has a first beveled blade, the second spring clip has a second beveled blade, the third spring clip has a third beveled blade, and the fourth spring clip has a fourth beveled blade. The first spring clip and the second spring clip are arranged on one side of the connecting piece, and the first blade and the second blade form a V-shaped concave angle relative to each other. The third spring clip and the fourth spring clip are arranged on the other side of the connecting piece, and the third blade and the fourth blade form a V-shaped concave angle relative to each other. A buckle is arranged in the first shell, and the position of the buckle corresponds to the V-shaped concave angle. Through holes for the electrode wire to pass through are correspondingly formed on both sides of the first shell and the base, and the position of the through hole corresponds to the position of the V-shaped concave angle, so that the electrode wire is placed at the V-shaped concave angle after passing through the through hole.

11. An implantable neural stimulation electrode system, characterized in that: It comprises the stimulation electrode as described in any one of claims 1 to 5, n adapters as described in any one of claims 8 to 10, and a stimulator, wherein the proximal end of each electrode wire of the stimulation electrode is placed on the blade of the shrapnel in one of the adapters, and after the first shell is covered, the blade cuts through the insulation layer of the electrode wire, the electrode wire is electrically connected to the cable of the adapter, and the proximal end of the cable is electrically connected to the stimulator.

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