A peripheral nerve stimulation system

Abstract

The present invention discloses a peripheral nerve stimulation system, comprising an implanted electrode, an adapter, a first cable, a stimulator and a body surface electrode; the implanted electrode can be percutaneously inserted into a patient's body, the implanted electrode includes an electrode tip and an electrode body from the distal end to the proximal end, the electrode tip includes at least one electrode, the electrode body is formed by spirally winding at least one electrode wire, the electrode wire includes a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body is an open insulating spiral structure; the adapter is electrically connected to the proximal end of the implanted electrode, the adapter is electrically connected to the stimulator through the first cable, and the stimulator is used to send electrical stimulation pulses; the body surface electrode can be directly connected to the stimulator or connected to the stimulator through a second cable, and forms a stimulation circuit with the implanted electrode. The peripheral nerve stimulation system provided by the present invention can effectively suppress pain and improve clinical treatment effects.

Description

Technical Field

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

[0002] As we all know, pain is a disease that is difficult to cure for humans, and the pain mechanism is extremely complex. Electrical stimulation therapy has a long history, including implantable spinal nerve stimulators, non-implantable epidermal stimulation, and peripheral nerve therapy with percutaneous implanted electrodes and external electrical stimulators. Although these devices relieve pain for patients and improve their quality of life, these stimulation systems have various defects and deficiencies, as well as differences in the patient's anatomical structure, insufficient electrical stimulation energy (including electrode displacement), and electrical stimulation that cannot cover the target of the pain nerve, which leads to the inability to effectively suppress the patient's pain.

[0003] Patent documents with patent numbers US4556051 applied for in 1985 and US5830151 applied for in 1998 disclosed treatment methods and equipment for peripheral nerve electrical stimulation. Although peripheral nerve electrical stimulation treatment has a long history, it is not widely used in practice because the effectiveness of electrical stimulation provided by surface electrodes is poor and the electrical stimulator is relatively large and inconvenient to wear.

[0004] The transcutaneous stimulation system disclosed in the patent document with publication number US20180056066A1 generates a loop between the implanted electrode and the epidermal electrode to achieve the effect of nerve electrical stimulation. However, the epidermal electrode in this system can only be placed below the stimulator. If it is on the surface of the human body where the stimulator is not convenient to place, the surface electrode cannot be realized, which reduces the range of placement of the surface electrode, and may not reach the optimal path of stimulation, resulting in limited effect of the patient's treatment of nerve pain. The most important thing is that the above patent has only a single implanted electrode, which can only achieve unipolar stimulation of the peripheral nerve implant electrode and stimulation of a single path. The effect of peripheral nerve stimulation is affected by the relative position of the stimulating electrode and the target nerve. Only when the target nerve is located in the stimulation path can the stimulation effect be produced. Similarly, if the electrode and the target nerve are close, the stimulation current is easy to cover the target nerve, which is easy to produce a better effect, otherwise, it is difficult to have an effect. Therefore, the stimulation effect of a single electrode is easily affected by the implantation position. Even if the electrode is in place during implantation, the implanted electrode may shift over time. In addition, a single implanted electrode cannot perform bipolar or multipolar stimulation in the body. All of the above affect the effectiveness of a single implanted electrode system in stimulating nerves and treating pain.

[0005] Currently, many doctors use spinal stimulation electrodes implanted into peripheral nerves for pain treatment. However, the electrodes for spinal nerve stimulation are made by spirally winding a metal wire and then setting a closed insulating layer around it. The diameter is generally thicker, between 1.3mm and 1.4mm. Therefore, the outer diameter of the needle tube of the puncture needle that needs to implant the electrode into the body is also relatively thick, which makes it difficult to implant the peripheral nerves, causes great trauma to the patient, and increases the risk of infection. The clinical demand for peripheral nerves is to design the implantable electrode to a smaller diameter of 0.70mm. The design and manufacture of implantable electrodes in this size range are very challenging and difficult. How to design a spiral electrode wire with a limited cross-sectional area and be resistant to fatigue, twisting and bending, and the insulation between the spiral electrode wires is also a big challenge.

[0006] In addition, the transcutaneous stimulation system disclosed in the patent document with publication number US20180056066A1 has a stimulation output of a square wave current pulse with fixed amplitude and frequency. After the doctor selects the stimulation program, these parameters are fixed. The pulse waveform template is the smallest stimulation unit, which consists of a stimulation phase pulse and a balance phase pulse, referred to as a stimulation pulse. Studies have shown that different nerve fibers have different response spectra to stimulation, and the spectrum of the stimulation pulse also affects the propagation distance of the stimulation current. For example, a slowly rising pulse current can affect deeper nerves. The effect of the sparse wave pulse sequence output alternately at low and high frequencies is better than that of a single frequency, etc. The stimulator of the above patent and most of the existing stimulators can only output a single frequency square wave voltage or current stimulation pulse waveform with a fixed rising edge, lacking the possibility of selecting the target nerve, and thus having corresponding limitations on suppressing pain. Moreover, stimulation with constant amplitude and frequency can easily cause fatigue and desensitization in the nervous system, thereby affecting the therapeutic effect. Summary of the invention

[0007] The technical problem to be solved by the present invention is to provide a peripheral nerve stimulation system that can effectively inhibit pain and improve clinical treatment effects.

[0008] In order to solve the above technical problems, the present invention provides a peripheral nerve stimulation system, including an implanted electrode, an adapter, a first cable, a stimulator and a surface electrode; the implanted electrode can be percutaneously inserted into the patient's body, and the implanted electrode includes an electrode tip and an electrode body from the distal end to the proximal end, the electrode tip includes at least one electrode, and the electrode body is formed by spirally winding at least one electrode wire, the electrode wire includes a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body is an open insulating spiral structure; the adapter is electrically connected to the proximal end of the implanted electrode, the adapter is electrically connected to the stimulator through the first cable, and the stimulator is used to send electrical stimulation pulses; the surface electrode is electrically connected to the stimulator, and forms a stimulation circuit with the implanted electrode through the stimulated human tissue.

[0009] Preferably, the electrode tip includes a first electrode and a fixing hook, the electrode body is formed by spirally winding an electrode wire, the spiral coils constituting the electrode body are arranged in sequence along the axial direction at a predetermined pitch, the first electrode is formed by spirally winding the metal wire constituting the electrode wire in a bare state toward the distal direction, and the metal wire at the distal end of the first electrode continues to extend toward the distal end and bends to form the fixing hook.

[0010] Preferably, the pitch between two adjacent turns of the first electrode in the 2-3 turns at the distal end is greater than the pitch at other locations.

[0011] Preferably, the electrode tip includes a first electrode and a fixing hook, the first electrode is a tubular metal electrode, the electrode body is formed by spirally winding an electrode wire, the spiral coils constituting the electrode body are arranged in sequence along the axial direction at a predetermined pitch, the metal wire constituting the electrode wire extends to the distal end in a bare state, passes through the electrode tube of the metal electrode, and then continues to extend and bend to form the fixing hook, and the metal wire is electrically connected to the metal electrode.

[0012] Preferably, the electrode tip includes a first electrode and a fixing hook, the first electrode is a tubular metal electrode, the electrode body is formed by spirally winding an electrode wire, the spiral turns constituting the electrode body are arranged in sequence along the axial direction at a predetermined pitch, the distal end of the metal wire constituting the electrode wire extends into the proximal end of the electrode tube of the first electrode and is electrically connected to the first electrode, the fixing hook is made of metal wire, the proximal end of the fixing hook extends into the distal end of the electrode tube of the first electrode and is connected to the first electrode.

[0013] Preferably, the electrode tip includes a second electrode, a first electrode and a fixing hook from the proximal end to the distal end, and the first electrode and the second electrode are arranged insulated and spaced apart along the same axial direction; the electrode body is formed by spirally winding two electrode wires, and the two electrode wires are respectively a first electrode wire and a second electrode wire, and the spiral turns constituting the electrode body are arranged in sequence along the axial direction according to a predetermined pitch, the first electrode is connected to the adapter through the first electrode wire, and the second electrode is connected to the adapter through the second electrode wire, and any one of the first electrode, the second electrode and the body surface electrode or a combination of any two electrodes can be used as a stimulation electrode or a loop electrode, and form a stimulation loop with the remaining one or two electrodes through the stimulated human tissue.

[0014] Preferably, both the first electrode and the second electrode are tubular metal electrodes, the first electrode wire is insulated and passes through the electrode tube of the second electrode, the metal wire constituting the first electrode wire extends distally through the electrode tube of the first electrode and then continues to extend distally and bends to form the fixing hook, and the metal wire of the first electrode wire is electrically connected to the first electrode, and the exposed metal wire at the distal end of the second electrode wire extends into the electrode tube of the second electrode and is electrically connected to the second electrode; or, the metal wire constituting the second electrode wire is extended distally in a bare state and spirally wound to form the second electrode, the distal end of the first electrode wire is insulated and passes through the cavity formed by the spiral of the second electrode, the metal wire constituting the first electrode wire is extended distally in a bare state and spirally wound to form the first electrode, and the metal wire at the distal end of the first electrode continues to extend distally and bends to form the fixing hook.

[0015] Preferably, an insulating buffer sleeve is provided on the outer sheath of the first electrode wire between the first electrode and the second electrode.

[0016] Preferably, the bending angle of the fixing hook is 20-60 degrees.

[0017] Preferably, the diameter of the metal wire is 0.1 mm-0.15 mm, and the outer diameter of the first electrode and / or the second electrode is 0.55 mm-0.70 mm.

[0018] Preferably, the metal wire is 316L stainless steel wire or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy wire; the insulating material used in the insulating layer is polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, 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.

[0019] Preferably, the exposed metal wire is connected to the first electrode or the second electrode by welding or crimping.

[0020] Preferably, it also includes a mounting seat, the adapter is installed on the mounting seat, the mounting seat includes a main body and a base, the main body is arranged on the base, the main body is an arched hollow structure, the bottom surface of the base is provided with skin-friendly glue, and the mounting seat can be adhered to the periphery of the patient's wound through the skin-friendly glue.

[0021] Preferably, the base and the top of the main body are both annular and coaxially arranged, the outer diameter of the top of the main body is smaller than the outer diameter of the base, and a plurality of arch bars are connected between the top and the base.

[0022] Preferably, the number of the arch strips is 5-8, the adapter is arranged on a base between two adjacent arch strips, and the remaining arch strips are evenly spaced along the circumferential direction.

[0023] Preferably, a first guide rail, a second guide rail and a first buckle are provided on the base, a first side wing and a second side wing are correspondingly provided on both sides of the bottom of the adapter, the first side wing is inserted into the first guide rail, the second side wing is inserted into the second guide rail, and the base and the adapter are fixed by the first buckle.

[0024] Preferably, the adapter comprises a first shell and a second shell that are matched and detachably connected, a first channel and a second channel are arranged in the second shell, a first spring sheet and a second spring sheet are arranged opposite to each other in the first channel, a third spring sheet and a fourth spring sheet are arranged opposite to each other in the second channel, the first spring sheet has a first beveled blade, the second spring sheet has a second beveled blade, the third spring sheet has a third beveled blade, the fourth spring sheet has a fourth beveled blade, the first blade and the second blade form a V-shaped concave angle relative to each other, the third blade and the fourth blade form a V-shaped concave angle relative to each other, the first electrode wire is inserted into the first channel and placed At the V-shaped concave angle formed by the first blade and the second blade, the second electrode wire is inserted into the second channel and placed at the V-shaped concave angle formed by the third blade and the fourth blade. When the first shell is buckled on the second shell, the first blade and the second blade cooperate to cut through the insulation layer of the first electrode wire, and the third blade and the fourth blade cooperate to cut through the insulation layer of the second electrode wire, so that the first electrode wire, the second electrode wire and the adapter are electrically connected; an interface is set on the second shell, and the first cable passes through the interface to be connected to the first channel and the second channel respectively.

[0025] Preferably, the body surface electrode is a fixed body surface electrode, the fixed body surface electrode is arranged at the bottom of the stimulator, and the fixed body surface electrode is directly electrically connected to the stimulator.

[0026] Preferably, the body surface electrode is a movable body surface electrode, and the movable body surface electrode is electrically connected to the stimulator via a second cable.

[0027] Preferably, a remote controller for patients is included, the remote controller is connected to the stimulator via Bluetooth communication, and the remote controller stores stimulation program numbers and stimulation intensity numbers, which respectively correspond to the contents of the program table and intensity table in the solidified memory of the stimulator.

[0028] Preferably, the remote control includes a grip, a control key, a display screen and a hanging hole, the control key is arranged at the end of the grip, the hanging hole is arranged at the tail of the grip, and the display screen is arranged on the top surface of the grip; or, the remote control includes a grip, a control key, a display screen and a charging port, the control key and the display screen are arranged on the top surface of the grip, and the charging port is arranged on the side of the grip.

[0029] Preferably, a stimulation programmer implemented by a tablet computer is included, and the clinician sets or adjusts the stimulation parameters, stimulation program of the stimulator and diagnoses the condition of the implanted electrodes for the patient through the programming interface of the stimulation programmer during the implantation operation and during clinical diagnosis and treatment.

[0030] Compared with the prior art, the present invention has the following beneficial effects: in the peripheral nerve stimulation system provided by the present invention, the electrode body of the implanted electrode is insulated outside the metal wire and then spirally wound to form an open spiral structure. Compared with the metal wire spirally wound and then formed into a closed insulating layer on the whole periphery, it is more conducive to the electrode body to withstand the traction of the muscle tissue in the body and has better elasticity; due to the open spiral structure of the electrode body, the diameter of the percutaneous part of the electrode body can be reduced to the diameter of a single metal wire plus the thickness of the wrapped insulating layer (0.20mm-0.30mm), rather than the diameter formed by the overall wrapping of the insulating layer after spiraling (0.50-0.70mm), which causes less trauma to the human body and heals quickly, reducing the risk of infection; and it can be formed by integrally winding one or two metal wires with an insulating layer, reducing the risk of subsequent breakage caused by the processing technology during the connection of the conductor and the risk of connection separation due to fatigue wear during clinical use, especially the tightly wound spiral electrode structure can increase the stimulation surface area of ​​the human body and improve the bearable stimulation current. In particular, the electrode body of the implanted electrode is designed by superimposed spiral molding with two extremely fine insulated metal wires, and a cylindrical or superimposed spiral double electrode structure and a structure fixed to human tissue are formed at the distal end of the implanted electrode. The three electrodes consisting of the double electrodes in the body and the surface electrodes can form six different stimulation pathways consisting of stimulation electrodes and loop electrodes, and each stimulation pathway may act on different neural tissues. Moreover, in the case of a combination of two electrodes, by distributing the current intensity between the two electrodes, the overall flow direction of the current is controlled to reach the effect of the virtual electrode, providing new possibilities for improving the stimulation effect. In addition, the surface electrode can not only be directly placed at the bottom of the stimulator, but also be connected to the electrode interface at the bottom of the stimulator through a cable, so that it can be placed at any part of the patient that needs stimulation, such as a part that is particularly sensitive to stimulation. In particular, between the implanted electrode and the stimulator, a micro adapter is provided to protect the implanted electrode from skin wounds, and transmit stimulation signals, so that the patient can reduce the chance of accidental wound injury and infection during treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of the overall structure of a peripheral nerve stimulation system in an embodiment of the present invention;

[0032] Figure 2a , Figure 2b is a schematic diagram of the structure of a remote controller in an embodiment of the present invention, Figure 2c is a schematic diagram of the stimulation programmer;

[0033] Figure 3a is a schematic diagram of the structure of a fixed body surface electrode in an embodiment of the present invention, Figure 3b It is a schematic diagram of the structure of the movable body surface electrode;

[0034] Figure 4a , Figure 4b It is a schematic structural diagram of an implant electrode having a monopolar electrode in a first embodiment of the present invention;

[0035] Figure 5 is a schematic structural diagram of an implant electrode having a monopolar electrode in a second embodiment of the present invention;

[0036] Figure 6 It is a schematic structural diagram of an implant electrode having bipolar electrodes in a third embodiment of the present invention;

[0037] Figure 7 It is a schematic structural diagram of an implant electrode having a bipolar electrode in a fourth embodiment of the present invention;

[0038] Figure 8a is a schematic diagram of the overall structure of the adapter installed on the mounting base in the embodiment of the present invention, Figure 8b for Figure 4a Schematic diagram of the decomposition of Figure 8c is a schematic diagram of the overall structure of the adapter; Figure 8d is a schematic diagram of the structure of the second shell, Figure 8e It is a schematic diagram of the overall structure of the mounting base;

[0039] Fig. 9 A schematic diagram of a patient using a peripheral nerve stimulation system according to an embodiment of the present invention;

[0040] Fig.10 is a circuit diagram of a stimulator in an embodiment of the present invention;

[0041] Fig.11 (a) is a schematic diagram of six possible stimulation paths for three electrodes. Fig.11 (b) is a schematic diagram of a virtual electrode formed by distributing the current of the two electrodes of the electrode combination differently and changing the direction of the total current;

[0042] Fig.12 (a) is a schematic diagram of the stimulation circuit formed by the stimulation electrode and the loop electrode. Fig.12 (b) is a schematic diagram of the working principle of the bidirectional current pulse source;

[0043] Fig.13 It is a circuit diagram of a stimulator using a single unidirectional current pulse source in another embodiment of the present invention;

[0044] Fig.14 (a) is a schematic diagram of the measurement circuit structure of a stimulator in an embodiment of the present invention; Fig.14 (b) is a schematic diagram of the neural response signal measurement process in an embodiment of the present invention;

[0045] Fig.15 Schematic diagram of five stimulation pulse waveform templates in an embodiment of the present invention;

[0046] FIG16(a) is a schematic diagram of a constant frequency and constant amplitude continuous stimulation mode and an intermittent stimulation mode in an embodiment of the present invention; FIG16(b) is a schematic diagram of a dual frequency pulse continuous stimulation mode and an intermittent stimulation mode in an embodiment of the present invention;

[0047] Fig.17 A schematic diagram of a simulated amplitude modulation stimulation mode in an embodiment of the present invention, wherein the modulation modes include sine wave, triangle wave and sawtooth wave modulation;

[0048] Fig.18 It is a schematic diagram of a simulated frequency modulation stimulation mode in an embodiment of the present invention, wherein the modulation modes include sine wave, triangle wave and sawtooth wave modulation;

[0049] Fig.19 Schematic diagram of a key-shift modulation stimulation mode in an embodiment of the present invention, wherein the modulation modes include amplitude shift keying, frequency shift keying, and a combination of amplitude shift and frequency shift keying;

[0050] Fig. 20 It is a structural schematic diagram of a method for realizing stimulation modulation by a stimulation controller in an embodiment of the present invention;

[0051] Fig.21 A schematic diagram of a flow chart of patient debugging settings for implementing a stimulation prescription in an embodiment of the present invention;

[0052] Fig. 22 Schematic diagram of the programming interface of the stimulation programmer used by doctors in an embodiment of the present invention.

[0053] In the figure:

[0054] 1-subcutaneous tissue, 2-wound, 3-patient, 10-implanted electrode, 11-electrode head, 12-electrode body, 13-electrode tail, 20-adapter, 21-mounting seat, 211-base, 212-main body, 2121-top, 2122-arch bar, 30-first cable, 31-first wiring port, 40-third cable, 41-second wiring port, 50-stimulator, 51-stimulation controller, 52-pulse generator, 521-pulse source, 53-third wiring port Cable port, 60-remote control, 61-control key, 62-display screen, 63-hanging hole, 64-hand grip, 65-USB interface, 70-fixed body surface electrode, 701-first body surface patch, 801-second body surface patch, 702, 802-hydrogel, 71-first body surface electrode interface, 72-second cable, 80-movable body surface electrode, 81-second body surface electrode interface, 91-third body surface electrode interface, 901-third body surface patch, 902-adhesive, 100- Stimulation programmer, 111-first electrode, 112-second electrode, 113-fixing hook, 114-insulating buffer sleeve, 121-electrode wire, 122-metal wire, 123-insulating layer, 1131-bending portion, 1132-straight portion, 1211-first electrode wire, 1212-second electrode wire, 2111-first guide rail, 2112-second guide rail, 2113-limiting member, 2114-first buckle, 201-first shell, 202-second shell, 203 -first channel, 204-second channel, 205-through hole, 2021-first side wing, 2022-second side wing, 2031-first spring clip, 2032-second spring clip, 2033-first blade, 2034-second blade, 2041-third spring clip, 2042-fourth spring clip, 2043-third blade, 2044-fourth blade, 2023-interface, 2024-first protrusion, 2025-second protrusion, 2011-first slot, 2012-second slot. DETAILED DESCRIPTION

[0055] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0056] 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 away from the operator, "electrode tip end" refers to the most distal part of the electrode, and "axial end" refers to the direction where the central axis of the electrode is located or the direction parallel to the central axis of the electrode. The term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0057] See also Figure 1 , Figure 2a-2c , Figure 3a and Figure 3b The peripheral nerve stimulation system provided in this embodiment includes an implanted electrode 10, an adapter 20, a first cable 30, a stimulator 50, a remote control 60 and a surface electrode; the implanted electrode 10 can be percutaneously inserted into the patient's body, and the implanted electrode 10 includes an electrode tip 11 and an electrode body 12 from the distal end to the proximal end, the electrode tip 11 includes at least one electrode, and the electrode body 12 is formed by spirally winding at least one electrode wire 121, the electrode wire 121 includes a metal wire 122 and an insulating layer 123, and the metal wire 122 is wrapped with the insulating layer 123, so that the electrode body 12 is an open insulating spiral structure, and the spiral coils constituting the electrode body 12 are arranged in sequence along the axial direction according to a predetermined pitch, which is beneficial for the electrode body 12 to withstand the traction of the muscle tissue in the body and has better elasticity. The pitch size is specially designed according to needs, preferably 0.38-0.48mm. The metal wire 122 is preferably 316L stainless steel wire or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy wire; the insulating material of the insulating layer 123 is preferably polyurethane (PU), polytetrafluoroethylene (PTFE) or ethylene-tetrafluoroethylene copolymer (ETFE), and the insulating material is extruded into a tube shape and then applied to the periphery of the metal wire 122, or the insulating material is sprayed onto the metal wire 122 using a coating process. The metal wire 122 can be an extremely fine metal wire, and the diameter of the metal wire is preferably 0.1mm-0.15mm. The diameter of the prepared percutaneous implantable electrode is 0.55mm-0.70mm, which can meet the clinical needs of peripheral nerve stimulation. Therefore, compared with the prior art in which the metal wire is spirally twisted to form a closed insulating structure around the entire spiral structure, due to the open spiral structure of the electrode body 12, the diameter of the percutaneous part of the electrode body 12 is reduced to the diameter of a single metal wire plus the thickness of the wrapped insulating layer (0.20mm-0.30mm) after the skin wound is contracted and squeezed, rather than the diameter formed after spiraling (0.50-0.70mm), which causes less trauma to the patient and heals faster, reduces the risk of wound infection, and provides more effective treatment for neuroregulation.

[0058] Please continue to see Figure 1, the adapter 20 is electrically connected to the proximal end of the implanted electrode 10, and further, the electrode wire 121 constituting the electrode body 12 can be extended straightly to the proximal end to form the electrode tail end 13. The adapter 20 is electrically connected to the metal wire 122 constituting the electrode body 12, and the adapter 20 can penetrate the insulating layer 123 of the electrode wire 121 to establish a reliable connection with the internal metal wire 122. The connection position can be on the electrode body 12 or at the electrode tail end 13; in other embodiments, the metal wire 122 at the distal end of the electrode tail end 13 can also be exposed and electrically connected to the adapter 20. The adapter 20 is electrically connected to the stimulator 50 through the first cable 30, and the stimulator 50 is used to send electrical stimulation pulses; the surface electrode is electrically connected to the stimulator 50 and forms a loop with the implanted electrode 10. Figure 3a As shown, in one embodiment, the body surface electrode is a fixed body surface electrode 70, which is fixed at the bottom of the stimulator 50 and is electrically connected to the stimulator 50 through the first body surface electrode interface 71. Specifically, the fixed body surface electrode 70 is composed of a first body surface patch 701, a hydrogel 702 and a first body surface electrode interface 71. One side of the first body surface patch 701 is connected to the stimulator 50. The hydrogel 702 is coated on the first body surface patch 701 so that the entire stimulator 50 can be adhered to the human skin. The first body surface electrode interface 71 is arranged on the first body surface patch 701 and is connected to the hydrogel 702. The hydrogel 702 can conduct electricity to form a conductive layer. At the same time, the stimulator 50 is provided with an electrode interface, and the fixed body surface electrode 70 and the stimulator 50 are electrically and mechanically connected through the body surface electrode interface 71 and the electrode interface on the stimulator 50, so that the first body surface patch 701 and the stimulator 50 become one, and then the entire stimulator 50 is attached and fixed to the patient's body surface through the hydrogel 702 on its surface. The stimulator 50, the implanted electrode 10 and the hydrogel 702 form a loop in the human body, forming a path for achieving electrical stimulation. Optionally, in another embodiment, as Figure 3bAs shown, the body surface electrode is a movable body surface electrode 80, and the movable body surface electrode 80 includes a second body surface patch 801, a second body surface electrode interface 81 and a hydrogel 802. The hydrogel 802 is coated on the second body surface patch 801, and the movable body surface electrode 80 can be attached to the human skin. The second body surface electrode interface 81 is arranged on the second body surface patch 801 and is connected to the hydrogel 802. The hydrogel 802 forms a conductive layer. In this embodiment, a third body surface patch 901 is also included. The third body surface patch 901 is provided with a third body surface electrode interface 91. The third body surface patch 901 is coated with adhesive 902. The adhesive 902 is a skin-friendly adhesive and is not conductive. The entire stimulator 50 is adhered to the human skin through the adhesive 902. On the skin, the patient or doctor can choose to connect the movable body surface electrode 80 to the stimulator 50 through the second cable 72. Specifically, one end of the second cable 72 is connected to the second body surface electrode interface 81, and the other end of the second cable 72 is connected to the third body surface electrode interface 91. The third body surface electrode interface 91 is electrically and mechanically connected to the electrode interface on the stimulator 50, so that the third body surface patch 901 and the stimulator 50 are integrated, and then the entire stimulator 50 is attached and fixed to the patient's body surface through the adhesive 902 on its surface. The stimulator 50, the implanted electrode 10 and the hydrogel 802 form a loop in the human body, forming a path for realizing electrical stimulation, and the position of the movable body surface electrode 80 can be moved at will to optimize the electrical performance. Through the lead-out second cable 72, the movable body surface electrode 80 can be placed at any part of the patient that needs stimulation, such as the part that is most sensitive to stimulation, to more effectively suppress pain. Further, the third cable 40 is also included, the first cable 30 and the third cable 40 are detachably connected, and the third cable 40 and the stimulator 50 are detachably connected. Specifically, the proximal end of the first cable 30 has a first wiring port 31, and the distal end of the third cable 40 has a second wiring port 41, and the first wiring port 31 and the second wiring port 41 match and are detachably connected, and the proximal end of the third cable 40 has a third wiring port 53, and the third wiring port 53 is detachably connected to the stimulator 50 for convenient use. In other embodiments, the first cable 30 and the third cable 40 are non-detachably connected in one piece. Whether the cables are detachably connected is set as needed, and the present invention does not limit this.

[0059] The specific working process and principle of the peripheral nerve stimulation system described in the present invention are as follows: after the distal end of the tiny micro-implanted electrode 10 is implanted near the peripheral nerve related to pain suppression, the proximal end of the implanted electrode 10 exposed outside the human epidermis is connected to the stimulator 50 through the micro-adapter 20. The stimulator 50 forms a loop with the implanted electrode 10 through the fixed body surface electrode 70 or the movable body surface electrode 80. The stimulator 50 sends the electrical stimulation pulses required for treatment, thereby achieving the purpose of nerve regulation. The stimulation pulses can be controlled by the remote controller 60 to select different pre-set stimulation parameters, such as pulse width, frequency and amplitude. The implanted electrode 10 is a bipolar electrode, which can further improve the clinical treatment effect achieved by the current monopolar electrode stimulation.

[0060] Please continue to see Figure 2a , Figure 2b and Figure 2c The patient selects the stimulation program and stimulation intensity prescribed by the doctor through the remote controller 60, and the remote controller 60 is wirelessly connected to the stimulator 50. Specifically, in one embodiment, Figure 2a As shown, the remote controller 60 includes a grip portion 64, a control key 61, a display screen 62 and a hanging hole 63. The size and shape of the grip portion 64 are preferably such that the patient can hold it with one hand. The control key 61 is disposed at the end of the grip portion 64 to facilitate one-handed operation by the patient. The hanging hole 63 is disposed at the tail of the grip portion, and is hung and stored when the patient is not in use. The display screen 62 is disposed on the top surface of the grip portion 64 to display stimulation parameters, etc. The remote controller 60 stores stimulation program numbers and stimulation intensity numbers, which respectively correspond to the contents of the program table and intensity table in the solidified memory of the stimulator 50. In another embodiment, as Figure 2b As shown, the remote controller 60 includes a grip portion 64, a control key 61 and a display screen 62. The size and shape of the grip portion 64 are preferably such that the patient can hold it with one hand. The control key 61 and the display screen 62 are both arranged on the top surface of the grip portion 64, so that the patient can operate the remote controller with one hand. Furthermore, a USB port 65 is arranged on the side of the grip portion 64, so that the remote controller 60 can be charged. Figure 2c As shown, the stimulator 50 can be controlled by the stimulation programmer 100. The stimulation programmer 100 is used to set stimulation parameters and stimulation programs for the stimulator 50 by installing a stimulation programming application on a mobile terminal. The mobile terminal can be a mobile phone, a tablet computer, etc.

[0061] See also Figure 4aIn one embodiment, the implanted electrode 10 has one electrode, which is a monopolar electrode structure. The electrode tip 11 includes a first electrode 111 and a fixing hook 113. The electrode body 12 is formed by spirally winding an electrode wire 121. The spacing between adjacent spiral turns constituting the electrode body 12 is preferably 0.35-0.45 mm. The first electrode 111 is formed by tightly winding the metal wire 122 constituting the electrode wire 121 in a bare state toward the distal direction to form a spiral structure. The spiral turns constituting the first electrode 111 are all sequentially fitted along the axial direction. The tightly wound first electrode 111 structure can increase the stimulation surface area of ​​the implanted electrode 10. The metal wire 122 at the distal end of the first electrode 111 continues to extend linearly toward the distal end and bends to form the fixing hook 113. The bending angle α formed between the bending portion 1131 and the straight portion 1132 of the fixing hook 113 is 10° to 60°, preferably 20° to 60°. The fixing hook 113 is provided to enable the first electrode 111 to maintain the stimulation position during the patient's (30-90) days or even longer treatment, reduce the dislocation of the first electrode 111 and thus improve the treatment effect. The electrode body 12 will also be implanted into the patient's body. The flexibility generated by setting the electrode body 12 into a special pitch open spiral structure can overcome the muscle stretching and twisting in the patient's body. The open insulating spiral structure can reduce the diameter of the percutaneous electrode 10 to the extreme, effectively reducing the risk of wound infection. The implanted electrode 10 of this structure can be integrally processed as a whole. An insulating layer 123 is formed at the place where insulation is required outside the metal wire 122 through a coating process, so that the diameter is small and has high strength. Then, the electrode head 11, the electrode body 12 and the electrode tail 13 are integrally wound using a spiral winding process, which greatly reduces the risk of subsequent breakage caused by the processing technology during the connection of the conductor and the risk of connection separation during clinical use.

[0062] Furthermore, if Figure 4b As shown, in this embodiment, the pitch between adjacent spiral turns within 2-3 turns at the distal end of the first electrode 111 is greater than the pitch at other places. Figure 4a The structure shown is similar, but a large pitch transition zone of 1-2 turns is added between the first electrode 111 and the fixing hook 113, which can reduce the stress concentration at this position, thereby improving the overall tensile strength of the fixing hook 113.

[0063] See also Figure 5In another embodiment, the implantable electrode 10 has one electrode, which is a monopolar electrode structure. The electrode head 11 includes a first electrode 111 and a fixing hook 113. The first electrode 111 is a tubular metal electrode. The metal electrode can be a platinum-iridium electrode. The platinum-iridium electrode is a good implantable electrode body with better electrical and in vivo corrosion resistance than ordinary metal wires. The electrode body 12 is formed by spirally winding an electrode wire 121. In one embodiment, the metal wire 122 constituting the electrode wire 121 extends to the distal end in a bare state through the electrode tube of the metal electrode and then continues to extend and bend to form the fixing hook 113, and the metal wire 122 is electrically connected to the metal electrode. This structure directly uses a tubular metal electrode as the first electrode 111, and there is no need to perform a winding process with high consistency requirements on the first electrode 111. The processing technology is relatively simple, and the tubular structure of the first electrode 111 has a stronger tensile strength structure than the spiral structure. In another embodiment, the distal end of the metal wire 122 constituting the electrode conductor 121 extends into the proximal end of the electrode tube of the metal electrode and is electrically connected to the first electrode 111. The fixing hook 113 is made of another metal wire or other material. The material of the fixing hook 113 can be the same as that of the metal wire 122, or a material different from that of the metal wire 122 can be selected as needed, and even a non-metallic insulating material can be selected. Whether the fixing hook 113 and the first electrode 111 are selected according to the electrical stimulation requirements, the proximal end of the fixing hook 113 extends into the distal end of the electrode tube of the metal electrode and is connected to the first electrode 111. This structure can more flexibly change the material and structure of the fixing hook 113, thereby achieving a better fixing effect. The metal wire 122 establishes a reliable mechanical connection or a mechanical and electrical connection with the first electrode 111 by welding, crimping or other mechanical connection methods. The crimping method refers to a connection method in which a part of one part is inserted into another part, and then the two are fixed by squeezing the combined part. The crimping method in this embodiment means inserting the bare metal wire 122 of the electrode conductor 121 or the metal wire constituting the fixing hook 113 into the electrode tube, and then squeezing the electrode tube to establish a reliable electrical connection between the metal wire 122 and the electrode tube.

[0064] See also Figure 6 and Figure 7In another embodiment, the implanted electrode 10 has two electrodes and is a dual-electrode structure. The electrode head 11 includes a second electrode 112, a first electrode 111 and a fixing hook 113 from the proximal end to the distal end. The first electrode 111 and the second electrode 112 are insulated and spaced apart along the same axial direction, and the spacing distance is preferably 10-15 mm; the electrode body 12 is formed by spirally winding two electrode wires 121, and the two electrode wires 121 are respectively a first electrode wire 1211 and a second electrode wire 1212. The first electrode 111 is connected to the adapter 20 through the first electrode wire 1211, and the second electrode 112 is connected to the adapter 20 through the second electrode wire 1212. Any one of the first electrode 111, the second electrode 112 and the body surface electrode 70 or a combination of any two electrodes serves as a stimulation electrode or a loop electrode, and forms a stimulation loop with the remaining one or two electrodes. Therefore, the three electrodes of the first electrode 111, the second electrode 112 and the body surface electrode can form six different stimulation pathways consisting of stimulation electrodes and loop electrodes, and each stimulation pathway may act on different neural tissues, or in other words, under the same electrode implantation conditions, there are six possible stimulation effects. Moreover, in the case of a combination of two electrodes, by distributing the current intensity between the two electrodes and controlling the overall flow direction of the current, the effect of reaching the virtual electrode provides new possibilities for improving the stimulation effect. Compared with the monopolar structure, the implanted electrode 10 of the bipolar structure has a larger stimulation range and more stimulation methods, which increases the diversity of treatment, realizes different stimulation functions and stimulation effects, and is conducive to improving the clinical treatment effect.

[0065] Please continue to see Figure 6 In one specific embodiment, the first electrode 111 and the second electrode 112 are both tubular metal electrodes, and the metal electrode can be a platinum-iridium electrode. The first electrode wire 1211 passes through the electrode tube of the second electrode 112. The metal wire 122 constituting the first electrode wire 1211 extends distally through the electrode tube of the first electrode 111 in a bare state, and then continues to extend distally and bends to form the fixing hook 113. The exposed metal wire 122 is electrically connected to the first electrode 111, and the exposed metal wire 122 at the distal end of the second electrode wire 1212 extends into the electrode tube of the second electrode 112 and is electrically connected to the second electrode 112. Furthermore, an insulating buffer sleeve 114 is provided on the outer jacket of the first electrode wire 1211 between the first electrode 111 and the second electrode 112 to avoid a short circuit between the first electrode 111 and the second electrode 112, thereby improving electrical safety. In another specific embodiment, see Figure 7The second electrode 112 is formed by the metal wire 122 constituting the second electrode wire 1212 extending to the distal end in a bare state and spirally winding, the distal end of the first electrode wire 1211 passes through the cavity formed by the spiral of the second electrode 112, the metal wire 122 constituting the first electrode wire 1211 extends to the distal end in a bare state and spirally winding to form the first electrode 111, and the metal wire 122 at the distal end of the first electrode 111 continues to extend to the distal end and bends to form the fixing hook 113. The implant electrode 10 of this structure is formed by winding two metal wires 122 with insulating layers 123, and the two electrode wires 121 are staggered and wound as a whole along the same central axis. The first electrode 111 is a metal wire 122 tightly wound after the insulation layer is removed from the distal end of the first electrode wire 1211 or directly exposed, and the second electrode 112 is a metal wire 122 tightly wound on the first electrode wire 1211 with the insulation layer 123 after the insulation layer 123 is removed from the second electrode wire 1212 or directly exposed. Since the second electrode 112 is wound on the insulation layer 123 of the first electrode wire 1211, the second electrode 112 is not electrically connected to the first electrode 111. The first electrode 111 and the second electrode 112 can perform independent electrical stimulation functions, which greatly enriches the diversity of treatment.

[0066] The smallest diameter of spinal stimulation electrodes on the market is 1.27mm, and the puncture needle for implanting the electrode needs to be a relatively thick 14G (G is the Birmingham BWG wire gauge specification, and the larger the "G", the thinner the outer diameter of the needle tube). Such a thick puncture needle is difficult to implant into peripheral nerves, so the clinical demand for peripheral nerves is to design the implant electrode 10 to have a smaller diameter of 0.70mm. The challenges and difficulties encountered in the design and manufacture of this size range are very large. Within this diameter range of the implant electrode 10, an 18G needle tube can be designed based on the structure of the syringe to effectively and smoothly deliver or implant the implant electrode 10 around the painful nerve desired by the doctor. Therefore, it is also a great challenge to design two spiral electrode wires 121 with a limited cross-sectional area and to resist fatigue twisting and bending, and the insulation between the two electrode wires 121 is also a great challenge. The electrode conductor 121 provided in this embodiment is a stainless steel wire or cable. The MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy wire or cable is wound to form an elastic, slender spiral electrode conductor 121. The cable is formed by twisting multiple strands of stainless steel wire, which can have better fatigue resistance. The elasticity and flexibility of the spiral electrode conductor 121 can overcome the stretching and squeezing of muscles in the body. The material design of the insulating layer 123 of the two-strand electrode conductor 121 uses polymer materials PU, PTFE or ETFE to extrude into a tube shape and apply it to the outer layer of the metal wire 122, or the above-mentioned polymer materials PU, PTFE or ETFE are sprayed onto the metal wire 122 by a coating process to form an insulating layer 123 to ensure the insulation between the first electrode conductor 1211 and the second electrode conductor 1212. Whether it is an extrusion or spraying process, it is necessary to ensure that the insulating wall is uniform to ensure the insulation performance between the first electrode conductor 1211 and the second electrode conductor 1212 during implantation treatment. The diameter of the metal wire 122 is preferably 0.1mm-0.15mm, and the outer diameters of the first electrode 111 and the second electrode 112 are preferably 0.55mm-0.70mm. Although the peripheral nerve stimulation system provided in this embodiment uses a bipolar implant electrode 10, since the first electrode 111 and the second electrode 112 are coaxially spaced and arranged with equal diameters, the first electrode wire 1211 and the second electrode wire 1212 are insulated and then wound into an open insulating spiral structure, the implant electrode 10 having the first electrode 111 and the second electrode 112 can be implanted into the body using an implantation tool (puncture needle) of the same diameter size as existing similar products, which also achieves less trauma but can provide more effective treatment for nerve regulation.

[0067] Please continue to see Figure 6The distal ends of the first electrode wire 1211 and the second electrode wire 1212 are both exposed metal wires 122. The metal wire 122 at the distal end of the second electrode wire 1212 is connected to the second electrode 112 by welding or crimping, and the metal wire 122 at the distal end of the first electrode wire 1211 is connected to the first electrode 111 by welding or crimping.

[0068] See also Figure 8a to Figure 8e In a specific embodiment, the adapter 20 is installed on the mounting seat 21. The mounting seat 21 includes a main body 212 and a base 211. The main body 212 is arranged on the base 211. The main body 212 is an arched hollow structure. The bottom surface of the base 211 is provided with skin-friendly glue. The mounting seat 21 can be attached to the periphery of the patient's wound through the skin-friendly glue to provide certain protection, and the hollow structure of the main body 212 can ensure the ventilation effect near the wound and reduce the infection probability of the wound. Furthermore, the bottom surface of the base 211 is provided with a release paper with skin-friendly glue. When in use, the mounting seat 21 can be attached to the wound by tearing off the release paper. Figure 1 On the skin around the wound 2 shown, the outer contours of the base 211 and the top 2121 of the main body 212 are both circular, hollow in the middle and coaxially arranged, the outer diameter of the top 2121 of the main body 212 is smaller than the outer diameter of the base 211, and a plurality of arch bars 2122 are connected between the top 2121 and the base 211; the number of the arch bars 2122 is preferably 5-8, the adapter 20 is installed on the base 211 between two adjacent arch bars 2122, and the remaining plurality of arch bars 2122 are equally spaced along the circumferential direction.

[0069] Please continue to see Figure 8bIn a specific embodiment, the base 211 is provided with a first guide rail 2111, a second guide rail 2112 and a first buckle 2114, and the first side wing 2021 and the second side wing 2022 are correspondingly provided on both sides of the bottom of the adapter 20, and the first side wing 2021 and the second side wing 2022 are respectively inserted into the first guide rail 2111 and the second guide rail 2112, and fixed by the first buckle 2114. Further, the base 211 is provided with a stopper 2113, which is used to block the adapter 20 and prevent the adapter 20 from sliding out of the base 211 after being inserted into the first guide rail 2111 and the second guide rail 2112. The adapter 20 includes a first shell 201 and a second shell 202 that are matched and detachably connected. Specifically, the first shell 201 and the second shell 202 can be buckled and connected by providing a matching second protrusion 2025 and a second slot 2012 on the end sides of the first shell 201 and the second shell 202. The second housing 202 is provided with a first channel 203 and a second channel 204, the first channel 203 is provided with a first spring piece 2031 and a second spring piece 2032, the second channel 204 is provided with a third spring piece 2041 and a fourth spring piece 2042, the first spring piece 2031, the second spring piece 2032, the third spring piece 2041 and the fourth spring piece 2042 are all fixed on the second housing 202. In a specific embodiment, the first spring piece 2031 has a first beveled blade 2033, the second spring piece 2032 has a second beveled blade 2034, the third spring piece 2041 has two third beveled blades 2043, the fourth spring piece 2042 has a fourth beveled blade 2044, the first blade 2033 and The second blade 2034 forms a V-shaped concave angle relative to each other, the third blade 2043 and the fourth blade 2044 form a V-shaped concave angle relative to each other, and a through hole 205 is set on the second shell 202 corresponding to the first channel 203 and the second channel 204. The first electrode wire 1211 penetrates the first channel 203 and is placed at the V-shaped concave angle formed by the first blade 2033 and the second blade 2034. The second electrode wire 1212 penetrates the second channel 204 and is placed at the V-shaped concave angle formed by the third blade 2043 and the fourth blade 2044. The number of the first blade 2033, the second blade 2034, the third blade 2043 and the fourth blade 2044 is preferably 2, and those skilled in the art can design it according to actual needs. The second shell 202 is provided with an interface 2023, and the first cable 30 passes through the interface 2023 to connect with the first channel 203 and the second channel 204 respectively. During installation, the first shell 201 is opened, the first cable 30 is inserted from the interface 2023, welded to the first channel 203 and the second channel 204 respectively, and then fixed at the interface 2023. It can be fixed by dispensing glue or other methods, and the present invention does not impose any special restrictions on this.Then, the first shell 201 is buckled onto the second shell 202, so that the buckles on the first shell 201 and the second shell 202 are in an open state. After the implanted electrode 10 passes through the patient's wound 2, the first electrode wire 1211 of the electrode tail end 13 is placed in the V-shaped concave angle formed by the first blade 2033 and the second blade 2034, and the second electrode wire 1212 is placed in the V-shaped concave angle formed by the third blade 2043 and the fourth blade 2044, and the buckles on both sides of the first shell 201 and the second shell 202 are buckled respectively, and the buckles are the first protrusion 2024 and the first groove 2011. The matching structure of the adapter 20 is shown in FIG. 2 . When the adapter 20 is fastened, the buckles on both sides are mainly used to press the first electrode wire 1211 to the gap between the first blade 2033 and the second blade 2034, and to press the second electrode wire 1212 to the gap between the third blade 2043 and the fourth blade 2044. The sharp first blade 2033 and the second blade 2034, the third blade 2043 and the fourth blade 2044 can just cut through the insulating layer 123 of the first electrode wire 1211 and the second electrode wire 1212 to establish a reliable electrical connection. At the same time, the buckles on both sides fix the first shell 201 and the second shell 202. Next, slide the first side wing 2021 and the second side wing 2022 at the bottom of the adapter 20 into the first guide rail 2111 and the second guide rail 2112 on the mounting seat 21, limit the adapter 20 by the stopper 2113, and fix the adapter 20 by the first buckle 2114.

[0070] For the implantable electrode 10 with a single electrode structure, only one electrode wire 121 is connected to the adapter 20. The electrode wire 121 at the electrode tail end 13 is placed in any one of the first channel 203 and the second channel 204, and the other channel is left vacant. Its specific usage is the same as that of the implantable electrode 10 with a dual electrode structure and will not be repeated here.

[0071] Therefore, the adapter 20 installed on the mounting base 21 can allow the implanted electrode 10 led out from the wound 2 to be reliably connected to the external stimulator 50, and connect the signal of the implanted electrode 10 to the stimulator 50. The entire structure provides protection for the implanted electrode 10 exposed to the skin wound, while allowing the implanted electrode 10 to stably and reliably conduct the stimulator signal.

[0072] See also Fig. 9The peripheral nerve stimulation system of the present invention takes the movable body surface electrode 80 as an example. When in use, the implant electrode 10 having the first electrode 111 and the second electrode 112 is percutaneously implanted near the target nerve in the body of the patient 3, the adapter 20 is placed on the skin of the patient 3, the stimulator 50 is fixed to the body surface of the patient 3, and the movable body surface electrode 80 is placed at the place where the patient 3 needs stimulation through the second cable 72. During the treatment process, the patient 3 selects the stimulation program and stimulation intensity through the remote control 60, and the stimulator 50 stimulates the target part for treatment. In addition, the system also includes a stimulation programmer 100 implemented by the doctor using a tablet computer. During the electrode implantation process, the doctor determines the integrity and function of the electrode by operating the control interface of the stimulation programmer 100. In another embodiment, the doctor debugs and determines the stimulation plan (program) through the programming interface of the stimulation programmer 100, including the waveform, modulation method and safe stimulation intensity range, and fixes these parameters into the stimulator 50. The patient uses the remote control 60 to select a stimulation program and stimulation intensity by selecting a number. The Bluetooth communication transmits the control information to the stimulator 50. The stimulator 50 generates a specific current pulse sequence according to the selected program, which is output to the target neural tissue through the external wire, the adapter 20 and one of the implanted electrodes, and forms a stimulation circuit through another electrode in the implanted electrode or a designated surface electrode.

[0073] See also Fig.10 , the stimulator 50 is a three-channel bidirectional current pulse stimulator, including a stimulation controller 51 and a pulse generator 52, the pulse generator 52 includes at least one pulse source 521, and the stimulation controller 51 controls the output amplitude, current direction, pulse width and / or timing of the pulse source 521. The stimulation controller 51 is a microprocessor or a stimulator-specific control chip. In another embodiment, the three-channel pulse generator 52 is implemented by three independent bidirectional current pulse sources 521 as electrode drivers (Driver). Each pulse source 521 can be individually controlled to generate cathode (N) and anode (P) current pulses. One of the pulse sources 521 drives the body surface electrode 70, and the remaining two drive the two implanted first electrodes 111 and the second electrode 112 respectively. In this embodiment, the output function and performance of each channel are equivalent (Indifferent), that is, any electrode or a combination of two electrodes can be used as a stimulation electrode (cathode) or a loop electrode (anode), and form a stimulation loop with the remaining one or two electrodes. Therefore, the three electrodes can form six different stimulation pathways consisting of stimulation electrodes and loop electrodes, such as Fig.11 As shown in a. Each stimulation pathway may act on different neural tissues, or in other words, under the same electrode implantation conditions, there are six possible stimulation options. Fig.11As shown in Figure b, in the case of a two-electrode combination, by distributing the current intensity between the two electrodes, the overall direction of the current (Current Steering) can be controlled to achieve the effect of the virtual electrode, thereby providing new possibilities for improving the stimulation effect. When stimulation occurs, the pulse source of the stimulation electrode and the pulse source of the loop electrode form a "bridge" push-pull output mode, such as Fig.12 As shown in a, during the stimulation phase, the current flows from the anode to the cathode, and in the equilibrium phase, the current reverses, as shown in Fig.12 As shown in b.

[0074] See also Fig.13 In another embodiment, the stimulator 50 includes a single unidirectional current pulse source. In this embodiment, three stimulation channels share a unidirectional current pulse source driver, and the stimulation pulse output by the driver is distributed to one or more designated electrodes by an output switching switch, that is, the stimulation pulse output by the current pulse source is distributed to the body surface electrode 70 or 80, the first electrode 111 and / or the second electrode 112 through the output switching switch. The switching of the stimulation phase and the equilibrium phase direction of the current pulse is also achieved by the output switching switch. This design can also achieve six stimulation circuits through electrode combinations, such as Fig.11 a. However, this design cannot achieve Fig.11 b shows a controllable virtual electrode. This design can reduce circuit power consumption and circuit components.

[0075] In any of the above embodiments, the stimulator can measure the impedance of the implanted electrode by outputting a fixed small current pulse and simultaneously monitoring the voltage of the implanted electrode to determine the integrity of the implanted electrode. At the same time, the structure of the dual implanted electrodes also facilitates the detection of the response signal of the nerve to the stimulation pulse. Fig.14 In the embodiment shown in FIG. 1 , the neural signal detection circuit uses the stimulation electrode as the detection electrode and the non-stimulation electrode as the reference electrode or the signal ground. The neural signal detection process is reflected in the following example. Fig.14 In the implementation scheme of b, first, the stimulator outputs a current pulse to stimulate the target nerve tissue, and at the same time closes the nerve signal detection channel to avoid blocking the high-gain amplifier. After the stimulation pulse is completed, a charge release cycle is immediately added to release the residual charge left on the output capacitor by the stimulation pulse through the short-circuit switch to reduce interference such as DC drift of the electrode potential. After the charge release cycle is over, the nerve signal detection channel is opened to record the response signal formed by the action potential of the nerve caused by the stimulation. All the timing of the signal detection process is set according to the signal conduction characteristics of the target nerve to achieve the best recording effect. The recorded nerve response signal can be used for clinical diagnosis, and can also be used as stimulation feedback to adjust the stimulation intensity.

[0076] See also Fig.15 In addition to the default square wave stimulation pulse, the stimulation system provided by the present invention adds four new current stimulation pulse waveform templates, namely trapezoidal, sinewave, asymmetric and passively balanced. Each waveform module starts with a stimulation phase pulse with an amplitude of A1 and a width of tx, followed by a balance phase pulse with an amplitude of A2 and a width of tz responsible for charge neutralization. An adjustable inter-wave delay ty is set between the two-phase pulses. If the balance phase is set to a current pulse for rapid neutralization, it is an active balanced stimulation. Regardless of the waveform template used, the safety of the stimulation requires that the charges of the stimulation phase and the balance phase are equal, that is, Q1=Q2, where Q1 and Q2 are the integrals of the current pulse waveform within the pulse width, that is At the same time, the maximum stimulation intensity of the monophasic pulse is also restricted by the Shannon Criteria. That is, K = Log (D * Q) ≤ 1.85. Where D is the current density of the monophasic pulse, milliamperes per square centimeter, which is related to the electrode surface area, and Q is the monophasic stimulation charge, which is related to the current amplitude and pulse width. The latest research shows that for peripheral nerve stimulation, the K value can exceed 1.85, but this limit can be adjusted through the software of the stimulator. The equilibrium phase can also use short-circuit discharge instead of current pulses, that is, passive balanced stimulation. Passive balanced stimulation can save the stimulation current of the equilibrium phase, but the required discharge time is long and it is not suitable for high-frequency stimulation. If the stimulation phase and the equilibrium phase use the same pulse form, it is symmetrical stimulation. Conversely, if different pulse forms are used, it is asymmetrical stimulation. In asymmetrical stimulation, the charges of the two stimulation phases may be unbalanced, but the sum of the charges of the stimulation pulse and the equilibrium pulse should be balanced within a certain time interval. The default values ​​of each parameter of the stimulation pulse waveform are adjusted to the optimal default values ​​through clinical trials, but doctors can further adjust them through the stimulation programmer according to the patient's response to the stimulation.

[0077] Both trapezoidal waves and sine waves have slow rising and falling edges, which reduce the high-frequency components of the stimulation pulse. Reported clinical studies have shown that stimulation or electric field changes with high-frequency components can easily excite (activate) nerves close to the electrode, while low-frequency stimulation allows the electric field changes caused by stimulation to travel farther, thus being effective on nerves that are far from the electrode. After the electrode is implanted, its position is fixed, and thus the relative position of the electrode and each nerve tissue is also fixed. Trapezoidal waves and sine waves provide us with the possibility of stimulating the target nerve in a targeted and selective manner after the electrode is implanted.

[0078] In addition to providing a variety of stimulation waveforms, the stimulator also provides a variety of stimulation modes, that is, dynamically modulating the amplitude or frequency of the stimulation pulse sequence in different ways, and arranging the stimulation program to output the modulated pulse sequence (called a stimulation module) continuously or intermittently at a specified time, in a specified manner, and within a specified intensity range. Examples of the stimulation modes provided by the present invention include:

[0079] 1. Constant frequency and amplitude stimulation mode: The stimulator outputs continuous stimulation pulses to the designated electrodes according to the selected stimulation pulse waveform, frequency and amplitude, such as Fig.16a The stimulation program selects continuous output or intermittent output mode and specifies the pulse frequency and the upper and lower limits of the adjustable amplitude. The patient can adjust the stimulation intensity, that is, the amplitude between the upper and lower limits of the stimulation pulse, according to the effect he feels. When using intermittent output, the patient can also choose to slowly increase or decrease the amplitude (Ramp-up and Ramp-down) to increase or decrease the stimulation intensity smoothly and increase comfort. In addition, this stimulation mode also includes dual-frequency stimulation sequences, such as Fig.16b Dual-frequency stimulation adds a slow interference frequency to the main frequency and can be used in some special stimulation cases.

[0080] 2. Analog (continuous) modulation stimulation mode: The stimulator continuously modulates the amplitude or frequency of the selected stimulation pulse waveform using different analog methods, such as Fig.17 and Fig.18 As shown. Analog modulation methods include sine wave modulation, triangle wave modulation and sawtooth wave modulation. This mode adds a modulation frequency to the basic stimulation element, which is called interference frequency. Interference frequency may have a certain stimulation effect on specific symptoms. However, the main purpose of this stimulation mode is to reduce or even eliminate the rapid disappearance of the therapeutic effect caused by nerve sensory desensitization (habituation) and fatigue (fatigue) caused by extracellular electrical stimulation of nerve cells (extracellular stimulation). The control parameters of the analog modulation mode include the modulation period, the average amplitude value or the average frequency value, and the modulation depth percentage, which can determine the maximum and minimum values ​​of the amplitude or frequency.

[0081] 3. Key shift modulation stimulation mode: The stimulator performs two-level jump switching of amplitude or frequency of the selected stimulation pulse waveform or both amplitude shift keying (Amplitude Shift Keying) and frequency shift keying (Frequency Shift Keying) at specified intervals, such as Fig.19As shown. Research on the principle of transcutaneous electrical stimulation analgesia shows that the analgesic effect of interactive stimulation with low frequency and high current and high frequency and low current is better than stimulation with a single frequency or two frequencies at the same time at different stimulation points. The adjustment parameters of key-shift stimulation include high amplitude and low amplitude, high frequency and low frequency, modulation frequency, and modulation duty cycle, that is, the proportion of high value time in the modulation cycle.

[0082] See also Fig. 20 In one embodiment of the stimulator circuit, the stimulation waveform and the modulation stimulation mode functions of the stimulator are mainly implemented by a stimulation controller. The stimulation controller includes a waveform generator, a clock reference, a voltage reference, a digital-to-analog converter, and an amplitude and frequency modulator.

[0083] See also Fig.21 The neurostimulation system provides a patient-specific stimulation plan, or "stimulation prescription". Each patient's stimulator has a specific stimulation plan, including the appropriate stimulation waveform, stimulation program, and effective range of stimulation intensity. The stimulation plan is implemented through the "patient fitting" process. Patient fitting is performed in a hospital or clinic, and the required settings are as follows: Fig.21 As shown. The doctor uses the programming interface (Clinician App) of the doctor's stimulation programmer to select parameters such as stimulation electrodes, stimulation waveforms, stimulation modes and stimulation intensity, and directly controls the stimulator to stimulate. The doctor evaluates the selected stimulation parameters through the patient's feedback to determine the stimulation electrodes or electrode combinations, stimulation modes, stimulation programs and the corresponding effective stimulation intensity range suitable for the patient. The result of the patient's debugging is a stimulation prescription suitable for the patient, which is sintered in the solidification memory of the stimulator in the form of a table. The patient selects the corresponding table directory number in the memory of the stimulator through the remote control, including the stimulation program and stimulation intensity. Fig. 22 An embodiment of a programming interface for a physician-use stimulation programmer.

[0084] In summary, the present invention has at least the following advantages: 1. The monopolar or bipolar electrode is implanted with an implantation tool with a smaller diameter than the puncture sheath of similar products, and the diameter of the percutaneous part of the electrode body can be reduced to the diameter of the metal wire plus the thickness of the wrapped insulating layer, so as to minimize trauma and provide more effective treatment for neuromodulation; 2. The dual implanted electrodes combined with the novel surface electrode arrangement can arbitrarily select the stimulation circuit, increase the stimulation range, and improve the effectiveness of treatment; 3. More effective neuromodulation is provided through novel stimulation waveforms and pulse modulation methods; 4. A novel wound protection structure is provided, and the tiny electrodes are connected to the stimulator through cables at the same time, thereby reducing the chance of accidental wound injuries and infections during treatment; 5. The movable surface electrodes can increase the stimulation range and make neuromodulation more effective.

[0085] 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. A peripheral nerve stimulation system, characterized in that: It includes an implanted electrode, an adapter, a first cable, a stimulator and a body surface electrode; The implantable electrode can be percutaneously inserted into a patient's body, and the implantable electrode includes an electrode tip and an electrode body from the distal end to the proximal end, the electrode tip includes at least one electrode, and the electrode body is formed by spirally winding at least one electrode wire, the electrode wire includes a metal wire and an insulating layer wrapped outside the metal wire, the diameter of the metal wire is 0.1mm-0.15mm, so that the electrode body is an open insulating spiral structure, and the spiral turns constituting the electrode body are arranged in sequence along the axial direction according to a predetermined pitch, and the pitch size is 0.38mm-0.48mm, so that the diameter of the percutaneous part of the electrode body is the diameter of the metal wire plus the thickness of the wrapped insulating layer, which is 0.20mm-0.30mm; The adapter is electrically connected to the proximal end of the implanted electrode, the adapter is electrically connected to the stimulator via the first cable, and the stimulator is used to send electrical stimulation pulses; The body surface electrode is electrically connected to the stimulator and forms a stimulation circuit with the implanted electrode through the stimulated human tissue.

2. The peripheral nerve stimulation system according to claim 1, characterized in that: The electrode tip includes a first electrode and a fixing hook. The electrode body is formed by spirally winding an electrode wire. The spiral coils constituting the electrode body are arranged in sequence along the axial direction at a predetermined pitch. The first electrode is formed by spirally winding the metal wire constituting the electrode wire in a bare state toward the distal direction. The metal wire at the distal end of the first electrode continues to extend toward the distal end and bends to form the fixing hook.

3. The peripheral nerve stimulation system according to claim 2, characterized in that: The pitch between two adjacent turns in the 2-3 turns of the first electrode located at the distal end is greater than the pitch at other locations.

4. The peripheral nerve stimulation system according to claim 1, characterized in that: The electrode tip includes a first electrode and a fixing hook, the first electrode is a tubular metal electrode, the electrode body is formed by spirally winding an electrode wire, the spiral coils constituting the electrode body are arranged in sequence along the axial direction according to a predetermined pitch, the metal wire constituting the electrode wire extends to the distal end in a bare state, passes through the electrode tube of the metal electrode, and then continues to extend and bend to form the fixing hook, and the metal wire is electrically connected to the metal electrode.

5. The peripheral nerve stimulation system according to claim 1, characterized in that: The electrode tip includes a first electrode and a fixing hook, the first electrode is a tubular metal electrode, the electrode body is formed by spirally winding an electrode wire, the spiral coils constituting the electrode body are arranged in sequence along the axial direction according to a predetermined pitch, the distal end of the metal wire constituting the electrode wire extends into the proximal end of the electrode tube of the first electrode and is electrically connected to the first electrode, the fixing hook is made of metal wire, the proximal end of the fixing hook extends into the distal end of the electrode tube of the first electrode and is connected to the first electrode.

6. The peripheral nerve stimulation system according to claim 1, characterized in that: The electrode tip includes, from the proximal end to the distal end, a second electrode, a first electrode and a fixing hook, wherein the first electrode and the second electrode are arranged insulated and spaced apart along the same axial direction; the electrode body is formed by spirally winding two electrode wires, wherein the two electrode wires are respectively a first electrode wire and a second electrode wire, and the spiral coils constituting the electrode body are arranged in sequence along the axial direction at a predetermined pitch, the first electrode is connected to the adapter via the first electrode wire, and the second electrode is connected to the adapter via the second electrode wire, and any one of the first electrode, the second electrode and the body surface electrode or a combination of any two electrodes can be used as a stimulation electrode or a loop electrode, and form a stimulation loop with the remaining one or two electrodes through the stimulated human tissue.

7. The peripheral nerve stimulation system according to claim 6, characterized in that: The first electrode and the second electrode are both tubular metal electrodes, the first electrode wire is insulated and passes through the electrode tube of the second electrode, the metal wire constituting the first electrode wire extends to the distal end through the electrode tube of the first electrode and then continues to extend to the distal end and bends to form the fixing hook, and the metal wire of the first electrode wire is electrically connected to the first electrode, and the exposed metal wire at the distal end of the second electrode wire extends into the electrode tube of the second electrode and is electrically connected to the second electrode; or, the metal wire constituting the second electrode wire is extended to the distal end in a bare state and spirally wound to form the second electrode, the distal end of the first electrode wire is insulated and passes through the cavity formed by the spiral of the second electrode, the metal wire constituting the first electrode wire is extended to the distal end in a bare state and spirally wound to form the first electrode, and the metal wire at the distal end of the first electrode continues to extend to the distal end and bends to form the fixing hook.

8. The peripheral nerve stimulation system according to claim 7, characterized in that: An insulating buffer sleeve is disposed on the outer sheath of the first electrode wire between the first electrode and the second electrode.

9. The peripheral nerve stimulation system according to any one of claims 2 to 8, characterized in that: The bending angle of the fixing hook is 20-60 degrees.

10. The peripheral nerve stimulation system according to claim 6, characterized in that: The outer diameter of the first electrode and / or the second electrode is 0.55 mm-0.70 mm.

11. The peripheral nerve stimulation system according to claim 1, characterized in that: The metal wire is 316L stainless steel wire or MP35N non-magnetic nickel-cobalt-chromium-molybdenum alloy wire; the insulating material used in the insulating layer is polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, 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.

12. The peripheral nerve stimulation system according to claim 7, characterized in that: The exposed metal wire is connected to the first electrode or the second electrode by welding or crimping.

13. The peripheral nerve stimulation system according to claim 1, characterized in that: It also includes a mounting seat, the adapter is installed on the mounting seat, the mounting seat includes a main body and a base, the main body is arranged on the base, the main body is an arched hollow structure, the bottom surface of the base is provided with skin-friendly glue, and the mounting seat can be adhered to the periphery of the patient's wound through the skin-friendly glue.

14. The peripheral nerve stimulation system according to claim 13, characterized in that: The base and the top of the main body are both annular and coaxially arranged. The outer diameter of the top of the main body is smaller than the outer diameter of the base. A plurality of arch bars are connected between the top and the base.

15. The peripheral nerve stimulation system according to claim 14, characterized in that: The number of the arch strips is 5-8, the adapter is arranged on a base between two adjacent arch strips, and the remaining arch strips are evenly spaced along the circumference.

16. The peripheral nerve stimulation system according to claim 13, characterized in that: A first guide rail, a second guide rail and a first buckle are arranged on the base, a first side wing and a second side wing are correspondingly arranged on both sides of the bottom of the adapter, the first side wing is inserted into the first guide rail, the second side wing is inserted into the second guide rail, and the base and the adapter are fixed by the first buckle.

17. The peripheral nerve stimulation system according to claim 6, characterized in that: The adapter comprises a first shell and a second shell that are matched and detachably connected, a first channel and a second channel are arranged in the second shell, a first spring sheet and a second spring sheet are arranged opposite to each other in the first channel, a third spring sheet and a fourth spring sheet are arranged opposite to each other in the second channel, the first spring sheet has a first beveled blade, the second spring sheet has a second beveled blade, the third spring sheet has a third beveled blade, the fourth spring sheet has a fourth beveled blade, the first blade and the second blade form a V-shaped concave angle relative to each other, the third blade and the fourth blade form a V-shaped concave angle relative to each other, the first electrode wire is inserted into the first channel and placed in the At the V-shaped concave angle formed by the first blade and the second blade, the second electrode wire is inserted into the second channel and placed at the V-shaped concave angle formed by the third blade and the fourth blade. When the first shell is buckled on the second shell, the first blade and the second blade cooperate to cut through the insulation layer of the first electrode wire, and the third blade and the fourth blade cooperate to cut through the insulation layer of the second electrode wire, so that the first electrode wire, the second electrode wire and the adapter are electrically connected; an interface is set on the second shell, and the first cable passes through the interface to be connected to the first channel and the second channel respectively.

18. The peripheral nerve stimulation system according to claim 1, wherein: The body surface electrode is a fixed body surface electrode, which is arranged at the bottom of the stimulator and is directly electrically connected to the stimulator.

19. The peripheral nerve stimulation system according to claim 1, characterized in that: The body surface electrode is a movable body surface electrode, which is electrically connected to the stimulator via a second cable, and the movable body surface electrode can be placed at a desired part of the human body.

20. The peripheral nerve stimulation system according to claim 1, wherein: It includes a remote controller for patients, which is connected to the stimulator via Bluetooth communication. The remote controller stores stimulation program numbers and stimulation intensity numbers, which correspond to the contents of the program table and intensity table in the solidified memory of the stimulator.

21. The peripheral nerve stimulation system according to claim 20, characterized in that: The remote control includes a grip, a control key, a display screen and a hanging hole, wherein the control key is arranged at the end of the grip, the hanging hole is arranged at the tail of the grip, and the display screen is arranged on the top surface of the grip; or, the remote control includes a grip, a control key, a display screen and a charging port, wherein the control key and the display screen are arranged on the top surface of the grip, and the charging port is arranged on the side of the grip.

22. The peripheral nerve stimulation system according to claim 1, characterized in that: It includes a stimulation programmer implemented by a tablet computer. Clinicians use the programming interface of the stimulation programmer to set or adjust the stimulation parameters and stimulation program of the stimulator and diagnose the condition of the implanted electrodes for the patient during the implantation operation and during clinical diagnosis and treatment.

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