Implanted electrode and peripheral nerve stimulation system and implantation system thereof

Abstract

The invention discloses an implanted electrode and a peripheral nerve stimulation system and implantation system thereof.The implanted electrode can be completely implanted into the body of a patient in a percutaneous mode, the implanted electrode comprises a fixing mechanism, a stimulation electrode, an electrode body and a propelling disc from the far end to the near end, and the electrode body comprises a metal wire and an insulating layer wrapping the metal wire; the stimulating electrode is electrically connected with the electrode body, the propelling disc is electrically connected with the electrode body, and the propelling disc is formed by coiling a metal wire; the implantation electrode and the implantation tool are used in a matched mode, the implantation tool comprises an outer sheath and a propelling needle, the outer sheath comprises an outer sheath tube and a first handle which are connected with each other, the propelling needle comprises a third handle and a second needle body which are connected with each other, the outer diameter of a propelling disc is larger than the inner diameter of the outer sheath tube, and the outer diameters of other portions, except the propelling disc, of the implantation electrode are all smaller than the inner diameter of the outer sheath tube. After the implanted electrode is inserted into the outer sheath, the second needle body pushes the propelling disc towards the far end direction, so that the propelling disc deforms, and the implanted electrode penetrates through the outer sheath tube to be conveyed to a stimulation target spot.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an implanted electrode and a peripheral nerve stimulation system and an implanted system thereof. Background Art

[0002] People have learned that many diseases can be treated by electrical nerve stimulation. For example, acute and chronic pain can be treated by electrical stimulation. Common methods of treating pain by electrical nerve stimulation include implantable spinal nerve stimulators, non-implantable epidermal stimulation, and peripheral nerve therapy with percutaneous implanted electrodes and external electrical stimulators. These stimulation methods often implant electrodes into the target nerve site, with the distal end of the electrode wire close to the nerve and the proximal end connected to an internal or external pulse transmitter.

[0003] Among them, the external pulse transmitter requires the distal end of the electrode wire to be implanted near the target nerve first, and the proximal end must be exposed outside the body and connected to the adapter before being connected to the pulse transmitter. Since the electrode wire is partially exposed outside the body, it is easy to get infected at the electrode implantation site, and it cannot be implanted in the human body for a long time. Patients need to be implanted multiple times for long-term treatment; the proximal end of the percutaneous electrode wire, the connecting wire and the connector need to be worn under the clothes, which is bloated and cumbersome. In addition, patients often have a poor acceptance of this method, which is not conducive to product promotion. Secondly, pulse transmitters implanted in the body are often expensive, and patients will be under great economic pressure when using them.

[0004] Based on the applicant's existing patents CN115869534B and CN113426011A for implantable electrodes and peripheral nerve stimulation systems, the proximal end of the implantable electrode must be exposed outside the body and connected to the adapter before being connected to the pulse transmitter. Therefore, it is necessary to modify the structure and surgical method of the implantable electrode and the working principle of the pulse transmitter to achieve complete implantation of the electrode, remote communication between the implantable electrode and the external pulse transmitter, and electrical stimulation of the target nerve without the need to wear the proximal end wire of the electrode under the clothes. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide an implantable electrode and its neural electrical stimulation system and implantation system, which can implant all electrodes and permanently implant them subcutaneously, have a low risk of postoperative infection, and can be used for a long time.

[0006] In order to solve the above technical problems, the present invention provides an implantable electrode, which can be fully implanted into a patient's body percutaneously. The implantable electrode includes a fixing mechanism, a stimulation electrode, an electrode body and a propulsion disk from the distal end to the proximal end. The electrode body includes a metal wire and an insulating layer wrapped outside the metal wire. The stimulation electrode is electrically connected to the electrode body, and the propulsion disk is electrically connected to the electrode body. The propulsion disk is formed by winding the metal wire. The implantable electrode is used in conjunction with an implantation tool. The implantation tool includes an outer sheath and a propulsion needle. The outer sheath includes an outer sheath tube and a first handle connected to each other. The propulsion needle includes a third handle and a second needle body connected to each other. The outer diameter of the propulsion disk is greater than the inner diameter of the outer sheath tube. The outer diameter of the implantable electrode except the propulsion disk is smaller than the inner diameter of the outer sheath tube. After the implantable electrode is inserted into the outer sheath, the second needle body pushes the propulsion disk toward the distal end, causing the propulsion disk to deform and allowing the implantable electrode to pass through the outer sheath tube and be transported to the stimulation target.

[0007] Preferably, the electrode body is formed by spirally winding an electrode wire, and the electrode wire includes a metal wire and an insulating layer wrapped around the metal wire, so that the electrode body presents an open insulating spiral structure, and the metal wire of the electrode wire is wound toward the distal end to form the spiral stimulation electrode and the spiral fixing mechanism in sequence, and the metal wire of the electrode wire is wound toward the proximal end to form the propulsion disk.

[0008] Preferably, the outer diameter of the fixing mechanism is larger than the outer diameter of the stimulation electrode, and the pitch of the fixing mechanism is larger than the pitch of the stimulation electrode.

[0009] Preferably, the propulsion disk is in a spiral shape winding in the circumferential direction or in a spiral shape winding in the axial direction.

[0010] Preferably, the conductive material of the electrode 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, and 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] In order to solve the above technical problems, the present invention also provides an implantation tool for percutaneously implanting the above implantable electrode into the body, comprising an outer sheath, a test electrode needle and a push needle; the outer sheath comprises the outer sheath tube and the first handle connected to each other, the first handle has a guide cavity, and the guide cavity is connected to the outer sheath tube; the test electrode needle comprises a second handle and a first needle body connected to each other, the axial length of the first needle body is greater than the axial length of the outer sheath tube, the first needle body is inserted into the outer sheath tube through the guide cavity, the distal end of the first needle body is exposed to the outer sheath tube, the second handle is detachably connected to the first handle, the first needle body is made of conductive material, the proximal end of the first needle body is connected to the stimulator through a cable, the distal end of the first needle body exposed to the outer sheath tube forms a stimulation part, and the first needle body and the outer sheath tube are insulated; the push needle comprises the third handle and the second needle body connected to each other, the axial length of the second needle body is greater than or equal to the axial length of the outer sheath tube, the second needle body can pass through the guide cavity into the outer sheath tube to push the implantable electrode out of the outer sheath tube.

[0012] Preferably, a card slot is provided on the first handle, a first connecting portion is provided on the second handle, a first boss is provided on the first connecting portion, and when the first connecting portion is inserted into the guide cavity, the first boss is placed in the card slot, so that the first handle is snap-connected with the second handle, or / and, a second connecting portion is provided on the third handle, a second boss is provided on the second connecting portion, and when the second connecting portion is inserted into the guide cavity, the second boss is placed in the card slot, so that the first handle is snap-connected with the third handle.

[0013] Preferably, the slot is a waist-shaped hole, and the first boss and the second boss are both made of elastic material.

[0014] Preferably, a first corrugation is arranged outside the first handle, or / and a second corrugation is arranged outside the second handle, or / and a third corrugation is arranged outside the third handle.

[0015] Preferably, color markings are evenly spaced along the axial direction of the outer sheath tube, the distal end of the outer sheath tube is flat, the outer sheath tube is coated with an insulating coating, or / and, the distal end of the test electrode needle is pointed, or / and, the distal end of the push needle is flat, and the second needle body is a solid rod.

[0016] In order to solve the above technical problems, the present invention also provides an implantation system, including the above-mentioned implantation electrode and the above-mentioned implantation tool. During implantation, after the test electrode needle is inserted into the assembly behind the outer sheath and punctures the stimulation target, the test electrode needle is pulled out, and the outer sheath is left in the human body to form an implantation channel. The implantation electrode is inserted into the outer sheath, and the advancement needle is inserted into the outer sheath to push the implantation electrode in the distal direction, and at the same time, the outer sheath is withdrawn in the proximal direction to deliver the implantation electrode to the stimulation target.

[0017] In order to solve the above technical problems, the present invention also provides a peripheral nerve stimulation system, including a stimulator, a surface patch electrode and the above-mentioned implanted electrode; the stimulator is used to send electrical stimulation pulses, the surface patch electrode is electrically connected to the stimulator, and is inductively coupled with the implanted electrode to form a stimulation circuit.

[0018] The stimulator is provided with two electrode interfaces, and the body surface patch electrode is correspondingly provided with two first body surface electrode interfaces. The back of the first body surface electrode interface is correspondingly provided with a first sensing contact. The two electrode interfaces are connected to the two first body surface electrode interfaces, and the two first sensing contacts are respectively positive and negative poles. The two ends of the implanted electrode are respectively located within the coverage range of the two first sensing contacts, and induction forms a stimulation circuit.

[0019] Preferably, the stimulator is provided with two electrode interfaces and a plug, and the body surface patch electrode is correspondingly provided with two first body surface electrode interfaces and one second body surface electrode interface, the two electrode interfaces are respectively connected to the two first body surface electrode interfaces, the second body surface electrode interface is electrically connected to the plug through a connecting cable, a first sensing contact is correspondingly arranged on the back side of the first body surface electrode interface, and a second sensing contact is correspondingly arranged on the back side of the second body surface electrode interface, and the two ends of the implanted electrode are respectively located within the coverage range of the two first sensing contacts and the second sensing contact, so as to form a stimulation circuit by induction.

[0020] Preferably, the stimulator is provided with two electrode interfaces, the body surface patch electrode is provided with two first body surface electrode interfaces and one second sensing contact, the first sensing contact is correspondingly arranged on the back side of the first body surface electrode interface, the two first sensing contacts are respectively positive and negative poles, the two electrode interfaces are respectively connected to the two first body surface electrode interfaces, the first sensing contact, the second sensing contact and the first body surface electrode interface close to the second sensing contact are electrically connected inside the body surface patch electrode by a connecting wire, the second sensing contact is arranged on the side that fits the skin, and the two ends of the implanted electrode are respectively located within the coverage range of the first sensing contact and the second sensing contact, so as to form a stimulation circuit by induction.

[0021] Compared with the prior art, the present invention has the following beneficial effects: the implantable electrode and its peripheral nerve stimulation system and implantation system provided by the present invention are formed by winding a metal wire at the proximal end of the implantable electrode. By setting a corresponding implantation tool, the implantable electrode is completely implanted into the patient's body, and the pulse transmitter, i.e., the stimulator, is placed outside the body. After the stimulator is electrically connected to the surface patch electrode, it senses with the implanted electrode to form a stimulation circuit, thereby achieving the effect of electrically stimulating the target nerve. The implantable electrode is permanently implanted, with a low risk of postoperative infection, and can be used for a long time, thereby solving the shortcomings of easy infection at the percutaneous implantation site and only short-term treatment. Moreover, there is no need to set up an adapter and its fixing device and connecting cables, thereby simplifying the entire system device, solving the problems of conventional percutaneous implantable electrodes having bulky external equipment, low patient acceptance of the proximal end of the implanted electrode exposed outside the body, and high cost of pulse transmitters implanted in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1a , Figure 1b Schematic diagrams of the structures of implanted electrodes in two different embodiments of the present invention;

[0023] Figure 2 Schematic diagram of the structure of the outer sheath in an embodiment of the present invention;

[0024] Figure 3 Schematic diagram of the structure of the test electrode needle in the embodiment of the present invention;

[0025] Figure 4 This is a schematic diagram of the structure of the push pin in an embodiment of the present invention;

[0026] Figure 5 It is a stimulation schematic diagram of the entire stimulation system after the implanted electrode is implanted into the human body in the second embodiment of the present invention;

[0027] Figure 6a , Figure 6b is a schematic diagram of the structure of a stimulator in an embodiment of the present invention;

[0028] Figure 7a is a schematic structural diagram of a body surface patch electrode in a first embodiment of the present invention, Figure 7b is a schematic structural diagram of a body surface patch electrode in a second embodiment of the present invention;

[0029] Figure 8 It is a schematic diagram of the connection between the stimulator and the body surface patch electrode in the first embodiment of the present invention;

[0030] Fig. 9 It is a schematic diagram of a stimulation system after the implanted electrode is implanted into a human body in the first embodiment of the present invention;

[0031] Fig.10 It is a schematic diagram of a stimulation system after the implanted electrode is implanted into a human body in the third embodiment of the present invention;

[0032] Fig.11a is a schematic structural diagram of a body surface patch electrode in a third embodiment of the present invention, Fig.11b for Fig.11a Schematic diagram of the internal circuit connection of the body surface patch electrode;

[0033] Fig.12 A schematic diagram of an outer sheath and a test electrode needle assembly puncturing into a body to search for a target point in an embodiment of the present invention;

[0034] Fig.13 A perspective schematic diagram of an implanted electrode inserted into an outer sheath according to an embodiment of the present invention;

[0035] Fig.14 This is a schematic diagram of a push needle entering an outer sheath to push an implanted electrode into the body in an embodiment of the present invention;

[0036] Fig.15 for Figure 1a Schematic diagram of the implanted electrode after the propulsion disk is deformed under the action of the propulsion needle and the outer sheath;

[0037] Fig.16 for Figure 1b Schematic diagram of the implanted electrode pushing disc inside the outer sheath;

[0038] Fig.17 for Figure 1b Schematic diagram of the pusher disk of the implanted electrode after stretching.

[0039] In the figure:

[0040] 1-implanted electrode, 11-fixing mechanism, 12-stimulating electrode, 13-electrode body, 131-metal wire, 132-insulating layer, 14-pushing disk, 2-outer sheath, 21-first handle, 211-guiding cavity, 212-slot, 213-first corrugation, 22-outer sheath tube, 221-color mark, 3-test electrode needle, 31-second handle, 310-first connecting part, 311-first boss, 312-second corrugation, 32-first needle body, 321 -stimulation part, 9, 33-connecting cable, 4-push needle, 41-third handle, 410-second connecting part, 411-second boss, 412-third corrugation, 42-second needle body, 5-stimulator, 51-indicator light, 52-plug, 53-switch button, 54-electrode interface, 6-body surface patch electrode, 61-first body surface electrode interface, 62-second body surface electrode interface, 63-second sensing contact, 7-skin, 8-target nerve, 10-connecting line. DETAILED DESCRIPTION

[0041] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0042] In order to more clearly describe the structural features of the present invention, the present invention uses "proximal", "distal" and "axial" as directional words, wherein "proximal" refers to the end close to the operator; "distal" refers to the end far away from the operator, "axial" refers to the direction of the central axis of the implanted electrode or the direction parallel to the central axis of the implanted electrode, and "circumferential" refers to the direction of the implanted electrode along the circumference. The term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise. The orientation or position relationship indicated by the terms "center", "upper", "lower", "front", "back", "left", "right", etc. is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention. In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0043] See also Figure 1a and Figure 1b The implantable electrode 1 provided in this embodiment can be fully implanted into the patient's body through the skin. The implantable electrode 1 includes a fixing mechanism 11, a stimulating electrode 12, an electrode body 13 and a propulsion disk 14 from the distal end to the proximal end. The electrode body 13 is used to conduct current. The electrode body 13 includes a metal wire 131 and an insulating layer 132 wrapped outside the metal wire 131. The insulating layer 132 can prevent the external conduction of the electrode body 13. The stimulating electrode 12 is electrically connected to the electrode body 13. The propulsion disk 14 is electrically connected to the electrode body 13. The propulsion disk 14 is formed by winding the metal wire 131. The implantable electrode 1 and the body surface patch electrode 6 connected to the external stimulator 5 form a stimulation circuit by induction, supplying power to the implantable electrode 1 and providing a stimulation signal, so that the stimulating electrode 12 discharges to treat the target nerve. The fixing mechanism 11 is inserted into the muscle tissue to fix the implantable electrode 1 in the body; the implantable electrode 1 and the implantation tool are used together, please refer to Figure 2 and Figure 5 The implantation tool comprises an outer sheath 2 and a propulsion needle 4. The outer sheath 2 comprises an outer sheath tube 22 and a first handle 21 connected to each other. The propulsion needle 4 comprises a third handle 41 and a second needle body 42 connected to each other. The outer diameter of the propulsion disk 14 is equal to or greater than the inner diameter of the outer sheath tube 22. The outer diameters of the implanted electrode 1 except the propulsion disk 14 are all smaller than the inner diameter of the outer sheath tube 22. After the implanted electrode 1 is inserted into the outer sheath 2, the propulsion needle 4 pushes the propulsion disk 14 in the distal direction, and the outer sheath 2 is withdrawn in the proximal direction, so that the propulsion disk 14 is deformed and the implanted electrode 1 is transported to the stimulation target, i.e., the target nerve 8, through the outer sheath tube 22.

[0044] In a preferred embodiment, if Figure 1a and Figure 1bAs shown, the electrode body 13 is formed by spirally winding an electrode wire, and the electrode wire includes a metal wire 131 and an insulating layer 132 wrapped around the metal wire 131, so that the electrode body 13 is an open insulating spiral structure. The spiral structure can effectively enhance the fatigue resistance of the implanted electrode 1 in the body. The metal wire 131 of the electrode wire is wound toward the distal end to form a spiral stimulation electrode 12 and a spiral fixing mechanism 11 in sequence, and the metal wire 131 of the electrode wire is wound toward the proximal end to form a propulsion disk 14. Preferably, the outer diameter of the fixing mechanism 11 is greater than the outer diameter of the stimulation electrode 12, and the pitch of the fixing mechanism 11 is greater than the pitch of the stimulation electrode 12. The metal wire 131 changes diameter at the distal end, so that the fixing mechanism 11 is easy to fix the target nerve position in the body; the stimulation electrode 12 is tightly wound by the metal wire 131, that is, two adjacent spiral coils are close together, which can effectively increase the stimulation area and enhance the fatigue performance of the implanted electrode 1 in the body. The fixing mechanism 11 wound into a spiral structure of the metal wire 131 not only fixes the implanted electrode 1 in the body, but also plays the role of discharge treatment of the target nerve. The spiral coils constituting the fixing mechanism 11 are arranged in sequence along the axial direction according to a predetermined pitch, preferably 0.5mm-0.9mm. The pitch referred to in this embodiment refers to the axial distance between two corresponding points on two adjacent spiral coils. The axial length of the spiral of the distal fixing mechanism 11 is preferably 1.5mm-5mm. When the axial length of the distal fixing mechanism 11 is shorter, it can be used for relatively tight parts of human tissue at the target of electrical stimulation; when the axial length of the distal fixing mechanism 11 is slightly longer, it can be used for slightly loose parts of human tissue at the target of electrical stimulation; when the axial length of the distal fixing mechanism 11 is longer, it can be used for very loose parts of human tissue at the target of electrical stimulation. Those skilled in the art can select a fixing mechanism 11 of appropriate length as needed. During muscle compression, the spiral fixing mechanism 11 will be squeezed to form a bend as the direction and force of compression act, so that the muscle, under the action of the spiral hook, firmly fixes the implanted electrode 1 in the patient's body, so that the electrode does not dislocate during the stimulation treatment, and the therapeutic effect of electrical stimulation is maintained.

[0045] The metal wire 131 of the electrode conductor can be composed of a single metal wire, or a plurality of metal wires, i.e., a metal cable, such as 4, 6, 8, 12, 19 strands, etc. The plurality of metal wires are twisted into one strand and then wound into a wire such as Figure 1a and Figure 1b The metal wire 131 shown in the figure has better flexibility than a single-strand metal wire. The conductive material of the electrode wire is a platinum alloy, stainless steel or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy; the insulating material used in the insulating layer 132 is a copolymer of ethylene and tetrafluoroethylene (ETFE), polyimide (PI) or polytetrafluoroethylene (PTFE), and the insulating material is extruded into a tube and then applied to the periphery of the metal wire 131, or the insulating material is sprayed onto the metal wire 131 using a coating process.

[0046] In other embodiments, the fixing mechanism 11 may be a metal hook shape or other shapes, the stimulation electrode 12 may be a tubular electrode or an electrode of other shapes, the stimulation electrode 12 may be a single electrode or multiple electrodes, and the stimulator 5 may be provided with corresponding connection channels according to the number of stimulation electrodes 12. The present invention does not impose any special restrictions on this, and technicians in this field may set it according to needs.

[0047] The shape of the propulsion disk 14 can be a spiral shape that winds around the circumference, such as Figure 1a As shown, or in the shape of a paper clip wound axially, as Figure 1b The shape of the propulsion disk 14 can be various curved and coiled shapes as long as the area can be increased, and its purpose is to increase the contact area with the propulsion needle 4 and to increase the coverage area after deformation.

[0048] See also Figure 2 , Figure 3 and Figure 4 The present embodiment provides an implantation tool for percutaneously implanting an implant electrode 1 into a body, comprising an outer sheath 2, a test electrode needle 3 and a push needle 4, wherein the outer sheath 2 comprises an outer sheath tube 22 and a first handle 21 connected to each other, wherein the first handle 21 has a guide cavity 211 therein, and the guide cavity 211 is communicated with the outer sheath tube 22; the test electrode needle 3 comprises a second handle 31 and a first needle body 32 connected to each other, wherein the axial length of the first needle body 32 is greater than the axial length of the outer sheath tube 22, the first needle body 32 is inserted into the outer sheath tube 22 via the guide cavity 211, and the distal end of the first needle body 32 is exposed outside the outer sheath tube 22, and the second handle 31 It is detachably connected to the first handle 21, the first needle body 32 is made of conductive material, the proximal end of the first needle body 32 is connected to the stimulator 5 through a cable 33, the distal end of the first needle body 32 exposed outside the outer sheath 22 forms a stimulation part 321, and the first needle body 32 and the outer sheath 22 are insulated; the push needle 4 includes a third handle 41 and a second needle body 42 that are connected to each other, the axial length of the second needle body 42 is greater than or equal to the axial length of the outer sheath 22, and the second needle body 42 can pass through the guide cavity 211 into the outer sheath 22 to push the implanted electrode 1 out of the outer sheath 22 and transport it to the stimulation target.

[0049] Furthermore, a slot 212 is provided on the first handle 21, a first connecting portion 310 is provided on the second handle 31, a first boss 311 is provided on the first connecting portion 310, and when the first connecting portion 310 is inserted into the guide cavity 211, the first boss 311 is placed in the slot 212, so that the first handle 21 and the second handle 31 are snap-connected, and the outer sheath 2 and the test electrode needle 3 are combined together, or / and, a second connecting portion 410 is provided on the third handle 41, and a second boss 411 is provided on the second connecting portion 410, as the second needle body 42 is pushed forward, when the second connecting portion 410 is inserted into the guide cavity 211, the second boss 411 is placed in the slot 212, so that the first handle 21 and the third handle 41 are snap-connected, and after the first handle 21 and the third handle 41 are snap-connected, it can be judged that the second needle body 42 has completely entered the outer sheath tube 22, completing the pushing of the implanted electrode 1. Preferably, the slot 212 is a waist-shaped hole, and the first boss 311 and the second boss 411 are made of elastic material. The first handle 21 is provided with a first corrugation 213, the second handle 31 is provided with a second corrugation 312, and the third handle 41 is provided with a third corrugation 412 to increase the friction when holding.

[0050] Preferably, color markings 221 are evenly spaced along the axial direction of the outer sheath 22, which can give the doctor a rough judgment of the implantation depth during the operation. The distal end of the outer sheath 22 is a flat head, and the outer sheath 22 is coated with an insulating coating to insulate the outer sheath 22 when the test electrode needle 3 is energized. The stimulation point is only the needle tip of the test electrode needle 3, that is, the stimulation part 321. The inner diameter of the outer sheath 22 is slightly larger than the outer diameter of the first needle body 32 of the test electrode needle 3 and the second needle body 42 of the propulsion needle 4. If the inner diameter of the outer sheath 22 is too large, it will cause muscle tissue to be stuck in the outer sheath 22. The distal end of the test electrode needle 3 is a pointed head, and the distal end of the propulsion needle 4 is a flat head. The second needle body 42 is a solid rod to enhance the propulsion force of the implanted electrode 1 in the outer sheath 2 forward.

[0051] During implantation, the test electrode needle 3 is inserted into the outer sheath 2, and the assembly is punctured and penetrated into the human body by the needle tip at the distal end of the test electrode needle 3. The test electrode needle 3 is electrically connected to the external stimulator 5 through the connecting cable 33, and the external stimulator 5 sends an electrical signal to stimulate the target nerve to determine whether the implantation position is accurate. After puncturing the stimulation target, the test electrode needle 3 is pulled out, and the outer sheath 2 is left in the human body to form an implantation channel for the implanted electrode 1. The implanted electrode 1 is inserted into the outer sheath 2 left in the body, and the thrust needle 4 is inserted into the outer sheath 2 and pushes it in the distal direction while withdrawing the outer sheath 2 in the proximal direction to deliver the implanted electrode 1 to the stimulation target.

[0052] See also Figure 5This embodiment provides a peripheral nerve stimulation system, including a stimulator 5, a surface patch electrode 6 and an implanted electrode 1; the stimulator 5 is used to send electrical stimulation pulses and provide pulse signals, and the surface patch electrode 6 is electrically connected to the stimulator 5. When in use, after the surface patch electrode 6 and the stimulator 5 are connected as one, the surface patch electrode 6 is attached to the skin 7 through a hydrogel, and induction with the implanted electrode 1 forms a stimulation circuit, so that the implanted electrode 1 stimulates and treats the target nerve according to the signal sent by the stimulator. The stimulator 5 includes a controller and a pulse generator, and the pulse generator includes a pulse source. The controller controls the output amplitude, current direction, pulse width and / or timing of the pulse source, and the implanted electrode 1 stimulates and treats the target nerve after receiving the pulse signal.

[0053] In the first embodiment, if Figure 6a and Figure 6b As shown, the stimulator 5 is provided with two electrode interfaces 54, a plug 52, an indicator light 51 and a switch button 53. Figure 7a As shown, the body surface patch electrode 6 is correspondingly provided with two first body surface electrode interfaces 61 and one second body surface electrode interface 62, and the back sides of the first body surface electrode interface 61 and the second body surface electrode interface 62 (i.e., the side of the body surface patch electrode 6 that contacts the skin 7) are correspondingly provided with a first sensing contact, and the back side of the second body surface electrode interface is correspondingly provided with a second sensing contact (not shown in the figure, but can be referred to Fig.11b The second sensing contact 63 in the stimulator 5 is provided, and the two electrode interfaces 54 are respectively connected to the two first body surface electrode interfaces 61 (mechanically and electrically connected at the same time), and the connection method can be a snap connection, so that the stimulator 5 and the body surface patch electrode 6 are combined into one, and the second body surface electrode interface 62 is connected to the plug 52 through the connecting cable 9, such as Fig. 9 As shown, after the body surface patch electrode 6 is attached to the patient's skin 7, the two ends of the implanted electrode 1 are respectively located within the coverage range of the two first sensing contacts and the second sensing contact, and a stimulation circuit is formed by induction. The length of the body surface patch electrode 6 can be set as needed, so as to adapt to implanted electrodes 1 of various lengths and inclinations, that is, as long as the first sensing contact and the second sensing contact can cover the top of the two ends of the implanted electrode 1 to form a stimulation circuit by induction.

[0054] In the second embodiment, if Figure 6b As shown, the stimulator 5 is provided with two electrode interfaces 54, such as Figure 7b As shown, the body surface patch electrode 6 is provided with two first body surface electrode interfaces 61, and the back of the first body surface electrode interface 61 is provided with a first sensing contact, and the two electrode interfaces 54 are connected to the two first body surface electrode interfaces 61 respectively, as shown in FIG. Figure 5As shown; compared with the first embodiment, the internal circuit structure of the stimulator 5 needs to be modified so that the two first sensing contacts are respectively positive and negative poles, and the treatment is achieved without using an external connecting cable. After the body surface patch electrode 6 is attached to the patient's skin 7, the two ends of the implanted electrode 1 are respectively located within the coverage range of the two first sensing contacts, and a stimulation loop is formed by induction. Since the size of the stimulator 5 should not be too large, the distance between the two first body surface electrode interfaces 61 is relatively short. The body surface patch electrode 6 in this embodiment is suitable for the implanted electrode 1 to have a smaller inclination angle relative to the vertical line of the skin 7 at the implantation site after being implanted into the human body, that is, the distance between the distal end and the proximal end of the implanted electrode 1 in the direction parallel to the skin 7 is relatively short, so that the two ends of the implanted electrode 1 are respectively located within the coverage range of the two first sensing contacts, and a stimulation loop is formed by induction.

[0055] In the third embodiment, if Figure 6b As shown, the stimulator 5 is provided with two electrode interfaces 54, and the internal circuit structure of the stimulator 5 is the same as that of the second embodiment. Fig.11a and Fig.11b As shown, the arrangement of the two first body surface electrode interfaces 61 is the same as that of the first embodiment. The difference from the body surface patch electrode 6 in the first embodiment is that the internal circuit of the body surface patch electrode 6 needs to be modified. The body surface patch electrode 6 is provided with two first body surface electrode interfaces 61 and a second sensing contact 63. The first sensing contacts are correspondingly arranged on the backs of the two first body surface electrode interfaces 61. The two first sensing contacts are respectively positive and negative poles. The second sensing contact 63 and the first body surface electrode interface 61 close to the second sensing contact 63 are electrically connected inside the body surface patch electrode 6 with a connecting line 10. The two electrode interfaces 54 are connected to the two first body surface electrode interfaces 61 respectively. The first sensing contact and the second sensing contact 63 are arranged on the side that fits the skin 7. Because the second sensing contact 63 does not need to be directly connected to the stimulator 5, the second body surface electrode interface 62 can be cancelled, and the part stimulated with the skin 7, i.e., the second sensing contact 63, is retained. After the surface patch electrode 6 is attached to the patient's skin 7, the two ends of the implanted electrode 1 are respectively located within the coverage of the first sensing contact 61 and the second sensing contact 63, and a stimulation circuit is formed by induction. Compared with the first embodiment, the stimulator 5 and the surface patch electrode 6 provided in this embodiment are not entangled by external connecting cables, and there is no need to plug and connect the connecting cables. The appearance is simpler and the use is more convenient. When the implanted electrode 1 spans a long (far) distance in the body, the stimulator 5 transmits signals and energy to the implanted electrode 1. The length between the second sensing contact 63 of the surface patch electrode 6 and the first surface electrode interface 61 can be of various lengths to cover most of the situations where the implanted electrode 1 is implanted in the human body.

[0056] When used specifically, taking the body surface patch electrode 6 in the first embodiment as an example, first, Fig.12As shown, the assembly of the test electrode needle 3 and the outer sheath 2 is inserted into the skin 7, puncturing into the vicinity of the implantation point of the target nerve 8 of the human body, and at the same time, the stimulator 5 and the surface patch electrode 6 of the first embodiment are attached to a suitable position, perpendicular to the proximal end of the intended implanted electrode 1 as shown in FIG. Fig. 9 As shown, the connecting cable 33 at the proximal end of the test electrode needle 3 is connected to the stimulator 5, and the position of the test electrode needle 3 is continuously adjusted to find the best stimulation point. After the test is completed, the test electrode needle 3 is disconnected from the stimulator 5, and the test electrode needle 3 is rotated to unlock the buckles of the first handle 21 of the outer sheath 2 and the second handle 31 of the test electrode needle 3, and the test electrode needle 3 is pulled out from the outer sheath 2. Then, as shown in FIG. Fig.14 As shown, the implant electrode 1 is placed in the outer sheath 2. Since the outer diameter of the propulsion disk 14 is greater than or equal to the inner diameter of the outer sheath tube 22, the rear propulsion disk 14 of the implant electrode 1 is suspended in the guide cavity 211 of the first handle 21 of the outer sheath 2 or at the proximal end of the outer sheath tube 22, and is stuck there. When the propulsion needle 4 is not pushed forward, the implant electrode 1 will not extend out of the outer sheath tube 22. Fig.13 Then, with the help of the imaging device, the implanted electrode 1 is pushed into the target nerve 8 using the push needle 4, and the push needle 4 is pushed forward, while the outer sheath 2 is withdrawn in the proximal direction at a uniform speed. Fig. 9 As shown, a section between the two first surface electrode interfaces 61 of the surface patch electrode 6 senses the proximal metal wire (propulsion disk 14) of the implanted electrode 1, and a second surface electrode interface 62 of the surface patch electrode 6 senses the distal stimulation electrode 12, completing the transmission of electrical pulses to achieve the purpose of stimulation therapy.

[0057] use Figure 1a When the electrode 1 is implanted, the vortex-shaped propulsion disk 14 is squeezed and deformed into a spiral shape under the action of the propulsion needle 4 and the inner wall of the outer sheath tube 22, as shown in FIG. Fig.15 The implanted electrode 1 used is replaced with Figure 1b When the electrode is implanted as shown, the state of the paper clip-shaped propulsion disk 14 during the puncture process is as follows Fig.16 As shown, the propulsion disk 14 is slightly tilted during the propulsion process until it is completely inserted into the body. After the implanted electrode 1 enters the body, the doctor can use surgical tools to operate the propulsion disk 14 of the implanted electrode 1 in the body, stretch the propulsion disk 14, and expand the coverage area of ​​the propulsion disk 14 so that the sensing range with the surface patch electrode 6 is wider. The stretched propulsion disk 14 is as shown in FIG. Fig.17 shown.

[0058] In summary, the implantable electrode and its peripheral nerve stimulation system and implantation system provided by the present invention are formed by winding a metal wire at the proximal end of the implantable electrode. By setting a corresponding implantation tool, the implantable electrode is completely implanted into the patient's body, and the pulse transmitter, i.e., the stimulator, is placed outside the body. After the stimulator is electrically connected to the surface patch electrode, it senses with the implanted electrode to form a stimulation circuit, thereby achieving the effect of electrically stimulating the target nerve. The implantable electrode is permanently implanted, with a low risk of postoperative infection, and can be used for a long time, thereby solving the shortcomings of easy infection at the percutaneous implantation site and only short-term treatment. Moreover, there is no need to set up an adapter and its fixing device and connecting cables, thereby simplifying the entire system device, solving the problems of conventional percutaneous implantable electrodes having bulky external equipment, low patient acceptance of the proximal end of the implanted electrode exposed outside the body, and high cost of pulse transmitters implanted in the body.

[0059] 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 electrode, characterized in that: The implantable electrode can be fully implanted percutaneously into the patient's body. The implantable electrode includes a fixing mechanism, a stimulation electrode, an electrode body and a propulsion disk from the distal end to the proximal end. The electrode body includes a metal wire and an insulating layer wrapped outside the metal wire. The stimulation electrode is electrically connected to the electrode body, and the propulsion disk is electrically connected to the electrode body. The propulsion disk is formed by winding the metal wire. The implantable electrode is used in conjunction with an implantation tool. The implantation tool includes an outer sheath and a propulsion needle. The outer sheath includes an outer sheath tube and a first handle connected to each other. The propulsion needle includes a third handle and a second needle body connected to each other. The outer diameter of the propulsion disk is greater than the inner diameter of the outer sheath tube. The outer diameter of the implantable electrode except the propulsion disk is smaller than the inner diameter of the outer sheath tube. After the implantable electrode is inserted into the outer sheath, the second needle body pushes the propulsion disk toward the distal direction, causing the propulsion disk to deform and allowing the implantable electrode to pass through the outer sheath tube and be transported to the stimulation target.

2. The implantable electrode as described in claim 1, wherein the electrode body is formed by spirally winding an electrode wire, and the electrode wire includes a metal wire and an insulating layer wrapped around the metal wire, so that the electrode body presents an open insulating spiral structure, and the metal wire of the electrode wire is wound toward the distal end to form the spiral stimulation electrode and the spiral fixing mechanism in sequence, and the metal wire of the electrode wire is wound toward the proximal end to form the propulsion disk.

3. The implantable electrode according to claim 2, characterized in that The outer diameter of the fixing mechanism is greater than the outer diameter of the stimulation electrode, and the pitch of the fixing mechanism is greater than the pitch of the stimulation electrode.

4. The implantable electrode according to claim 1, wherein: The propulsion disc is in a spiral shape winding in the circumferential direction or in a loop shape winding in the axial direction.

5. The implantable electrode according to claim 2, characterized in that The conductive material of the electrode 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.

6. An implantation tool for percutaneously implanting the implant electrode according to any one of claims 1 to 5 into a body, characterized in that: Includes outer sheath, test electrode needle and push needle, The outer sheath comprises the outer sheath tube and the first handle connected to each other, the first handle has a guide cavity therein, and the guide cavity is communicated with the outer sheath tube; The test electrode needle comprises a second handle and a first needle body connected to each other, the axial length of the first needle body is greater than the axial length of the outer sheath tube, the first needle body is inserted into the outer sheath tube via the guide cavity, the distal end of the first needle body is exposed outside the outer sheath tube, the second handle is detachably connected to the first handle, the first needle body is made of a conductive material, the proximal end of the first needle body is connected to the stimulator through a cable, the distal end of the first needle body exposed outside the outer sheath tube forms a stimulation part, and the first needle body and the outer sheath tube are insulated; The push needle includes the third handle and the second needle body connected to each other, the axial length of the second needle body is greater than or equal to the axial length of the outer sheath, and the second needle body can pass through the guide cavity into the outer sheath to push the implanted electrode out of the outer sheath.

7. The implantation tool according to claim 6, characterized in that The first handle is provided with a slot, the second handle is provided with a first connecting portion, the first connecting portion is provided with a first boss, when the first connecting portion is inserted into the guide cavity, the first boss is placed in the slot, so that the first handle and the second handle are snap-connected, or / and, the third handle is provided with a second connecting portion, the second connecting portion is provided with a second boss, when the second connecting portion is inserted into the guide cavity, the second boss is placed in the slot, so that the first handle and the third handle are snap-connected.

8. The implantation tool according to claim 7, characterized in that The clamping slot is a waist-shaped hole, and the first boss and the second boss are both made of elastic material.

9. The implantation tool according to claim 7, characterized in that The first handle is provided with a first corrugation outside, or / and, the second handle is provided with a second corrugation outside, or / and, the third handle is provided with a third corrugation outside.

10. The implantation tool according to claim 7, characterized in that Colored marks are evenly spaced along the axial direction of the outer sheath tube, the distal end of the outer sheath tube is flat, the outer sheath tube is coated with an insulating coating, or / and, the distal end of the test electrode needle is pointed, or / and, the distal end of the push needle is flat, and the second needle body is a solid rod.

11. An implant system, characterized in that: The implantable electrode comprises the implantable electrode as claimed in any one of claims 1 to 5 and the implantable tool as claimed in any one of claims 6 to 10. During implantation, after the assembly after the test electrode needle is inserted into the outer sheath punctures the stimulation target, the test electrode needle is pulled out, and the outer sheath is left in the human body to form an implantation channel. The implantable electrode is inserted into the outer sheath, and the push needle is inserted into the outer sheath to push the implantable electrode in the distal direction, and the outer sheath is withdrawn in the proximal direction at the same time to deliver the implantable electrode to the stimulation target.

12. A peripheral nerve stimulation system, characterized in that: It comprises a stimulator, a body surface patch electrode and the implanted electrode according to any one of claims 1 to 5; the stimulator is used to send electrical stimulation pulses, the body surface patch electrode is electrically connected to the stimulator, and is induced by the implanted electrode to form a stimulation circuit.

13. The peripheral nerve stimulation system according to claim 12, characterized in that: The stimulator is provided with two electrode interfaces, and the body surface patch electrode is correspondingly provided with two first body surface electrode interfaces. The back of the first body surface electrode interface is correspondingly provided with a first sensing contact. The two electrode interfaces are connected to the two first body surface electrode interfaces, and the two first sensing contacts are respectively positive and negative poles. The two ends of the implanted electrode are respectively located within the coverage range of the two first sensing contacts, and induction forms a stimulation circuit.

14. The peripheral nerve stimulation system according to claim 12, characterized in that: The stimulator is provided with two electrode interfaces and a plug, and the body surface patch electrode is correspondingly provided with two first body surface electrode interfaces and one second body surface electrode interface, the two electrode interfaces are respectively connected to the two first body surface electrode interfaces, the second body surface electrode interface is electrically connected to the plug through a connecting cable, a first sensing contact is correspondingly provided on the back side of the first body surface electrode interface, and a second sensing contact is correspondingly provided on the back side of the second body surface electrode interface, and the two ends of the implanted electrode are respectively located within the coverage range of the two first sensing contacts and the second sensing contact, so as to form a stimulation circuit by induction.

15. The peripheral nerve stimulation system according to claim 12, characterized in that: The stimulator is provided with two electrode interfaces, and the body surface patch electrode is provided with two first body surface electrode interfaces and one second sensing contact. The first sensing contact is correspondingly arranged on the back side of the first body surface electrode interface, and the two first sensing contacts are respectively positive and negative poles. The two electrode interfaces are respectively connected to the two first body surface electrode interfaces, and the second sensing contact and the first body surface electrode interface close to the second sensing contact are electrically connected inside the body surface patch electrode by a connecting wire. The first sensing contact and the second sensing contact are arranged on the side that fits the skin, and the two ends of the implanted electrode are respectively located within the coverage range of the first sensing contact and the second sensing contact, so as to form a stimulation circuit by induction.

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