CN115869534A - Implanted electrode and peripheral nerve stimulation system thereof - Google Patents

Abstract

The invention discloses an implanted electrode and a peripheral nerve stimulation system thereof, wherein the implanted electrode comprises an electrode head end and an electrode body, and the electrode head end comprises at least one electrode and a fixing part; the electrode body is formed by spirally winding at least one electrode lead, and the electrode lead comprises a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body is in an open type insulating spiral structure; the fixing part is of a spiral structure and is arranged at the far end of the electrode, and the outer diameter of the fixing part is larger than the diameter of the electrode body. The fixing component which is spirally wound is combined with the inner sheath for conveying and puncturing, so that the implanted electrode is pushed to enter nerves or other in-vivo tissues to implant a target point, and the far end of the electrode is fixed with a treated point, thereby solving the problems of poor fixing effect and dislocation in the clinical treatment process of the existing nerve stimulation electrode.

Description

Implanted electrode and peripheral nerve stimulation system thereof

Technical Field

The invention relates to the field of medical instruments, in particular to an implanted electrode and a peripheral nerve stimulation system thereof.

Background

It is now known that many diseases can be treated by electrical stimulation of nerves. For example, acute and chronic pain can be treated by electrical stimulation, which has been used for a long time, and pain nerve electrical stimulation systems include peripheral nerve treatments of implanted spinal nerve stimulators, non-implanted epidermal stimulation and percutaneously implanted electrodes and external electrical stimulators; moreover, sacral nerve stimulation can treat the patients with incontinence of urine and feces; the Parkinson's disease people can treat muscular stiffness and recover mobility of patients by stimulating thalamus through electrodes. Although these devices provide patients with relief and improved quality of life, these stimulation systems have various drawbacks and deficiencies, as well as anatomical differences in patients, insufficient energy for electrical stimulation, including electrode displacement due to failure of distal fixation or proximal fixation, failure of electrical stimulation to cover the target of pain or other functional nerves, etc., resulting in failure to adequately deliver the stimulation effect and failure to effectively suppress the pain.

In order to ensure that the stimulation point of the electrode is fixed after being implanted, a fixing mechanism is designed at the far end of the electrode to be mechanically fixed with the tissue of a human body, the fixing mechanism is designed according to the particularity of the implanted part, and for some instruments, because the far end of the anatomical position of the human body is not easy to design the fixing mechanism, the near end fixing with the fixing effect which is not optimal needs to be adopted, for example, the spine stimulation electrode cannot be reasonably and effectively designed due to the anatomical particularity of the spine, so that all spine stimulation electrodes in the market currently adopt cylindrical electrodes which cannot be fixed, but a suture sheath is arranged on the near end electrode, and a doctor suture the electrode subcutaneously and fix the electrode in a suture mode. In conclusion, the reliability of the distal fixation of the electrodes directly affects the effectiveness of the clinical treatment by electrical stimulation.

Patent US2010/0036454A1 discloses a fastening mechanism in which the distal end of a percutaneous implanted electrode is winged, the principle of which is similar to that of a boat-shaped anchor, and very similar to the distal winged anchor of the disclosed pacing electrode. The shape of the distal fixation anchor derives many similar designs, such as the percutaneous implantation electrode of StimWave in America, the combination of the common spine stimulation electrode and the pacing wing electrode distal fixation mechanism is adopted, the defect is that the implantation diameter is large (1.3 mm), the peripheral nerve stimulation comprises sensory and motor nerves, the nerves at other positions comprise the auricular nerve, the optic nerve and the like, the implantation diameter is large, the trauma is large, and the clinical application is not suitable.

Patent US4026301 discloses a distal fixation mechanism for tip screws that has a similar principle to screws and a similar spiral shape to that of pacing spiral electrodes, but the fixation mechanism is different from that of pacing electrodes. Its disadvantages are complex construction, many components, large diameter required for the implantation tool, large trauma, and the design is directed to spinal curvature nerve stimulation, so it is not suitable for use in other locations.

In the percutaneous nerve stimulation product already marketed by the company SPR Therapeutics in the United states, the patent discloses that the electrode distal fixing mechanism is a tight spiral hook type, and the document reports that in the process of extracting the electrode at the end of the clinical short-term treatment, the spiral stainless steel cable is not strong enough to cause 5-20% of the electrode distal fixing part to be broken, so that some treatment centers refuse to use the product of SPR.

Therefore, there is a need for a percutaneous implant electrode with a secure fixation mechanism and a small implant diameter.

Disclosure of Invention

The invention aims to solve the technical problem of providing an implanted electrode and a peripheral nerve stimulation system thereof, wherein a far-end fixing mechanism of the implanted electrode is safe and reliable.

In order to solve the technical problem, the invention provides an implant electrode, which comprises an electrode head end and an electrode body, wherein the electrode head end comprises at least one stimulating electrode and a fixing part; the fixing part is of a spiral structure and is arranged at the far end of the implanted electrode, and the outer diameter of the fixing part is larger than that of the electrode body.

Preferably, the electrode body is formed by spirally winding at least one electrode lead, and the electrode lead comprises a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body is in an open type insulating spiral structure; or the electrode body is a strand of metal wire cable wrapping the insulating layer.

Preferably, the first coils constituting the electrode body are sequentially arranged in the axial direction at a first pitch, and the second coils constituting the fixing member are sequentially arranged in the axial direction at a second pitch, the second pitch being greater than the first pitch.

Preferably, the diameter of the wire is 0.1mm to 0.15mm, the first pitch is 0.30mm to 0.48mm, the diameter of the electrode body is 0.55mm to 0.70mm, the second pitch is 0.5mm to 0.9mm, and the length of the fixing part in the axial direction is 1.5mm to 5mm.

Preferably, the implant electrode is used with a delivery tool, the delivery tool includes an outer sheath and an inner sheath, the outer diameter of the fixing component is larger than the inner diameter of the inner sheath and smaller than the inner diameter of the outer sheath, the fixing component forms a transition section with a diameter gradually increasing to the maximum diameter from the proximal end to the distal end, and when the percutaneous implant electrode is inserted into the inner sheath, the fixing component stays at the position where the outer diameter of the transition section is equal to the inner diameter of the inner sheath at the distal end port of the inner sheath and does not enter the inner sheath any more.

Preferably, the electrode tip includes a first stimulation electrode, the electrode body is formed by spirally winding an electrode lead, the first stimulation electrode is formed by spirally and tightly winding the metal wire forming the electrode lead in a distal direction in an exposed state, and the metal wire at the distal end of the first stimulation electrode is continuously spirally wound in the distal direction to form the fixing component.

Preferably, the electrode head end includes a first stimulation electrode, the electrode body is formed by a spiral winding of electrode wire, first stimulation electrode is tubular metal electrode, and the wire that constitutes electrode wire extends to the distal end and continues to extend behind metal electrode's the electrode tube and spiral winding forms fixed part, just the wire with the metal electrode electricity is connected, or, constitute the distal end of electrode wire extends after stretching into the proximal end of first stimulation electrode's electrode tube and with first stimulation electrode electricity is connected, the proximal end of fixed part stretch into the distal end of first stimulation electrode's electrode tube and with first stimulation electrode is connected.

Preferably, the electrode tip comprises a second stimulation electrode, a first stimulation electrode and a fixing component in sequence from the proximal end to the distal end, and the first stimulation electrode and the second stimulation electrode are arranged at intervals and in an insulating manner along the same axial direction; the electrode body is formed by spirally winding two electrode leads, wherein the two electrode leads are respectively a first electrode lead and a second electrode lead.

Preferably, the first stimulation electrode and the second stimulation electrode are both tubular metal electrodes, the first electrode lead passes through the electrode tube of the second stimulation electrode in an insulated manner, the metal wire forming the first electrode lead extends through the electrode tube of the first stimulation electrode towards the far end and then continues to extend towards the far end to form the fixing part in a spiral winding manner, the metal wire of the first electrode lead is electrically connected with the first stimulation electrode, and the metal wire at the far end of the second electrode lead extends into the electrode tube of the second stimulation electrode and is electrically connected with the second stimulation electrode; or the wire forming the second electrode lead extends to the far end in an exposed state and is spirally and tightly wound to form the second stimulation electrode, the far end of the first electrode lead is insulated and penetrates through a cavity formed by the second stimulation electrode in a spiral shape, the wire forming the first electrode lead extends to the far end in an exposed state and is spirally and tightly wound to form the first stimulation electrode, and the wire at the far end of the first stimulation electrode continuously extends to the far end and is spirally and tightly wound to form the fixing part.

Preferably, an insulating buffer sleeve is sleeved outside the first electrode lead between the first stimulation electrode and the second stimulation electrode.

Preferably, the metal wire is a 316L stainless steel wire or an MP35N nonmagnetic nickel-cobalt-chromium-molybdenum alloy wire; the insulating material adopted by the insulating layer is polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, and the insulating material is extruded into a pipe shape and then is pasted on the periphery of the metal wire, or the insulating material is sprayed on the metal wire by a coating process.

The implantation electrode is a full-implantation peripheral electrode, the near end of the electrode body is provided with an electrode tail end, and the electrode tail end is wrapped with an electronic element combination capable of generating a stimulation function. .

In order to solve the technical problem, the invention also provides a peripheral nerve stimulation system, which comprises the implant electrode, an adapter, a first cable, a stimulator and a body surface electrode; the implant electrode is percutaneously insertable into a patient; the adaptor is electrically connected with the proximal end of the implanted electrode, the adaptor is electrically connected with the stimulator through the first cable, and the stimulator is used for sending an electric stimulation pulse; the body surface electrode is electrically connected with the stimulator and forms a stimulation loop with the implanted electrode through stimulated human tissue.

Compared with the prior art, the invention has the following beneficial effects: according to the implant electrode and the peripheral nerve stimulation system thereof, the spirally wound fixing part is arranged at the far end of the implant electrode, when the implant electrode is conveyed to the position near a nerve or other treatment targets by the inner sheath, the part, with the outer diameter equal to the inner diameter of the inner sheath, of the far-end spiral fixing part is prevented from continuously moving towards the inner part of the inner sheath, and is extruded with the pushing force of the inner sheath, so that muscle tissues enter the spiral gap of the fixing part to fix the far end of the electrode, the effect of fixing the electrode and a human body is achieved, and the problems of poor fixing effect and dislocation in the clinical treatment process of the existing nerve stimulation electrode are solved. The fixing mechanism of the far-end spiral structure is safe and reliable, when the electrical stimulation treatment is finished or the implanted electrode needs to be pulled out, the far-end spiral fixing mechanism can enable an operator to easily and smoothly operate, so that the whole implanted electrode can be withdrawn from human tissues without wound, the problems that the fixing mechanism of the existing product is easy to fatigue and the electrode can be broken when being pulled out are solved, and more effective treatment is provided for nerve regulation and control. Meanwhile, when the implanted electrode is a percutaneous implanted electrode, the electrode body of the percutaneous implanted electrode is in an open spiral structure formed by insulating a metal wire and then spirally winding the metal wire, and compared with a closed insulating layer formed on the periphery of the whole body after the metal wire is spirally wound, the electrode body is more favorable for bearing the traction of muscle tissues 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 and the thickness of a wrapped insulating layer, so that the wound on a human body is small and healed quickly, and the infection risk is reduced; and the whole implanted electrode can be formed by integrally winding one or more metal wires with insulating layers, so that the subsequent fracture risk generated by a processing process in the connection process of the conductor and the risk of connection and separation caused by fatigue wear in clinical use are reduced, particularly, the tightly wound spiral electrode structure can increase the stimulation surface area to a human body and promote bearable stimulation current.

Drawings

FIG. 1 is a schematic view of a first embodiment of a percutaneous implant electrode having a monopolar electrode in accordance with the present invention;

FIG. 2 is a schematic view of a second embodiment of a percutaneous implant electrode having a monopolar electrode in accordance with the present invention;

FIG. 3 is a schematic structural view of a percutaneous implant electrode having a bipolar electrode in a third embodiment of the invention;

FIG. 4 is a schematic structural view of a fourth embodiment of a percutaneous implant electrode having a bipolar electrode in accordance with the present invention;

FIGS. 5 (a), 5 (b), and 5 (c) are schematic structural views of screw fixing members of different lengths according to embodiments of the present invention;

fig. 6 (a), 6 (b) and 6 (c) are schematic assembly diagrams of the spiral fixing part and the inner sheath with different lengths in the embodiment of the invention;

7 (a), 7 (b) and 7 (c) are schematic bending diagrams of the fixing component after the electrode is implanted into a human body and muscle tissues are pressed by the inner sheath to be embedded into the spiral gaps in the embodiment of the invention;

FIG. 8 is a schematic illustration of a percutaneously implantable electrode implanted and withdrawn from a body in accordance with an embodiment of the present invention;

FIG. 9 is a schematic view of a fully implanted peripheral electrode in accordance with another embodiment of the present invention;

FIG. 10 is a schematic diagram of the overall configuration of a peripheral nerve stimulation system according to an embodiment of the present invention;

fig. 11 (a) and 11 (b) are schematic structural diagrams of a remote controller according to an embodiment of the present invention, and fig. 11 (c) is a schematic diagram of a stimulus controller;

FIG. 12 (a) is a schematic structural diagram of a fixed body surface electrode and FIG. 12 (b) is a schematic structural diagram of a movable body surface electrode in the embodiment of the present invention;

FIG. 13 is a schematic diagram of a patient using a peripheral nerve stimulation system in accordance with an embodiment of the present invention;

FIG. 14 is a schematic circuit diagram of a stimulator in accordance with an embodiment of the present invention;

fig. 15 (a) is a schematic diagram of six possible stimulation paths of three electrodes, and fig. 15 (b) is a schematic diagram of a virtual electrode formed by different distribution of two electrode currents of an electrode combination and change of the direction of the total current;

fig. 16 (a) is a schematic view of a stimulation circuit formed by the stimulation electrode and the circuit electrode, and fig. 16 (b) is a schematic view of the operation principle of the bidirectional current pulse source.

In the figure:

1-subcutaneous tissue, 2-wound, 3-patient, 10-percutaneous implanted electrode, 11-electrode head end, 12-electrode body, 13-electrode tail end, 30-first cable, 31-first wiring port, 40-third cable, 41-second wiring port, 50-stimulator, 51-controller, 52-pulse generator, 521-pulse source, 53-third wiring port, 60-remote controller, 61-control key, 62-display screen, 63-hanging hole, 64-hand holding part, 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 programming controller, 111-first stimulation electrode, 112-second stimulation electrode, 113-fixed electrode, 115-third body surface electrode interface, 114-insulation sheath component, 114-insulation layer, stimulation wire, 122-first stimulation electrode, 121-second stimulation wire, and fourth wire stimulation wire; 1131-transition section, 200-inner sheath, 201-piercing blade.

Detailed Description

The invention is further described below with reference to the figures and examples.

In order to describe the structural features of the present invention more clearly, the present invention adopts "proximal", "distal" and "axial" as directional terms, wherein "proximal" means the end close to the operator; "distal" refers to the end away from the operator, "electrode tip" refers to the most distal portion of the electrode, and "axial" refers to the direction in which the central axis of the electrode lies or is parallel to the central axis of the electrode. The term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

Referring to fig. 1 to 4, an implanted electrode is an example of a percutaneous implanted electrode, and the percutaneous implanted electrode 10 provided in this embodiment includes an electrode tip 11 and an electrode body 12, where the electrode tip 11 includes at least one electrode and a fixing part 113, the electrode body 12 is formed by spirally winding at least one electrode lead 121, the electrode lead 121 includes a metal wire 122 and an insulating layer 123, and the metal wire 122 is wrapped by the insulating layer 123, so that the electrode body 12 is in an open insulating spiral structure, and first spiral coils constituting the electrode body 12 are sequentially arranged along an axial direction at a first pitch, which is beneficial for the electrode body 12 to bear the traction of muscle tissue in a body, and has better elasticity, the size of the first pitch is designed as required, and is preferably 0.30 to 0.48mm, and the diameter of the electrode body 12 is preferably 0.55mm to 0.70mm. The fixing part 113 is also of a spiral structure and is disposed at the distal end of the first stimulation electrode 111, and the outer diameter of the fixing part 113 is larger than the diameter of the electrode body 12, that is, the outer diameter of the fixing part 113 is the maximum diameter thereof, so that the fixing part 113 is clamped at the distal end port of the inner sheath when the fixing part is matched with the inner sheath for delivering the implant electrode. Preferably, the second spiral turns constituting the fixing member 113 are arranged in sequence along the axial direction at a second pitch, which is greater than the first pitch, preferably 0.5mm to 0.9mm, and the pitch in this embodiment refers to the axial distance between two corresponding points on two adjacent spiral turns, as shown by s in fig. 5 c. In other embodiments, the electrode body 12 may also be a wire cable wrapped with an insulating layer, i.e., a plurality of wires wrapped with an insulating layer around the outer periphery of the wire cable.

The length of the helix of the distal end securing member 113 in the axial direction is preferably 1.5mm to 5mm, and three different length designs are shown in this embodiment, suitable for use in different characteristic human tissue sites. The axial length of the distal fixing member 113 shown in fig. 5 (a) is short, and can be used for electrically stimulating a portion where human tissues at a target point are relatively compact; the distal fixing member 113 shown in fig. 5 (b) has a slightly longer axial length, and can be used to electrically stimulate a slightly loose portion of the body tissue at the target site; the distal anchoring member 113 shown in fig. 5 (c) has a longer axial length and can be used to electrically stimulate a very loose portion of the body tissue at the target site. The skilled person can select a suitable length of the fixing member 113 as required.

Fig. 6 (a), fig. 6 (b) and fig. 6 (c) are partial schematic views of the percutaneous implantation electrode having the fixing component 113 shown in fig. 5 (a), fig. 5 (b) and fig. 5 (c) combined with the inner sheath 200, and the percutaneous implantation electrode 10 is used with a delivery tool when being implanted into a body, the delivery tool includes an outer sheath (not shown) and an inner sheath 200, before being implanted into a human body, the percutaneous implantation electrode 10 is combined with the inner sheath 200, an outer diameter D of the fixing component 113 is slightly larger than an inner diameter of the inner sheath 200 and slightly smaller than an inner diameter of the outer sheath, so that the fixing component 113 stays at an opening of the puncture blade 201 of the inner sheath 200 after the percutaneous implantation electrode 10 penetrates through the inner sheath 200, and can penetrate through the outer sheath to be implanted into the patient after being combined with the inner sheath 200. The fixing member 113 forms a transition 1131 with a diameter gradually increasing to a maximum diameter (i.e. the outer diameter of the fixing member 113) from the proximal end to the distal end, when the percutaneous implant electrode 10 is inserted into the inner sheath 200, the fixing member 113 stops entering the inner sheath 200 when the diameter of the transition 1131 of the fixing member 113 is just larger than the inner diameter of the inner sheath 200, and the spiral of the fixing member 113 inclines slightly along the sharp puncture wall of the puncture blade 201 of the inner sheath 200, so as to stop at the distal end port of the inner sheath 200. When the percutaneous implantation electrode 10 is delivered to the vicinity of a nerve or other treatment targets by the inner sheath 200, the part of the distal spiral fixing part 113, which has the same diameter as the inner diameter of the inner sheath 200, is prevented from moving further into the inner sheath 200 and is squeezed by the pushing force of the inner sheath 200, so that muscle tissues enter the spiral gap to fix the distal end of the percutaneous implantation electrode 10, thereby fixing the percutaneous implantation electrode 10 with the human body.

The delivery process for implanting the percutaneous implant electrode 10 in the body is as follows:

first, the test electrode is inserted into the sheath for assembly and locking. Searching a nerve stimulation target point under ultrasound, after searching an expected target point, puncturing the sheath and the test electrode assembly to the expected target point together, verifying whether stimulation is effective or not by the electronic stimulation system according to the feedback of a patient, and if not, pulling out the sheath and the test electrode assembly again to search the target point again.

Then, after the electrical stimulation test is effective, the test electrode is unlocked and then withdrawn from the outer sheath, the outer sheath is left in the body to reserve the stimulation target, and the part of the muscle of the distal end of the outer sheath penetrated by the test electrode is cut to prepare for the implantation and fixation of the percutaneous implantation electrode 10.

Then, the percutaneous implantation electrode 10 is inserted into the inner sheath 200 for assembly, the assembly of the percutaneous implantation electrode 10 and the inner sheath 200 is inserted into the outer sheath left in the body, the distal end of the percutaneous implantation electrode 10 passes through the distal end of the outer sheath and meets the muscle which is punctured and folded by the previous test electrode, the half-circle puncture blade 201 on the inner sheath 200 continues to advance along the puncture direction of the inner and outer sheaths, and the fixing part 113 with the length as shown in fig. 5 (a), 5 (b) and 5 (c) is respectively shown in fig. 7 (a), 7 (b) and 7 (c) after being pressed and fixed by the muscle tissue of the human body in the direction.

Fig. 7 (a) shows the use of a shorter spiral design in the distal fixation member 113 when the target muscle is relatively tight, such as: the axial length of the fixing member 113 is 1.5mm, and the second pitch between the second helical turns constituting the fixing member 113 is 0.5mm to 0.9mm. The inner sheath 200 with the percutaneously implanted electrode 10 attached thereto is first inserted into the inner channel of the outer sheath and advanced smoothly until the distal end of the percutaneously implanted electrode 10 and the distal end of the inner sheath 200 are beyond the distal end of the outer sheath, because the muscle that has been previously penetrated by the test electrode is naturally closed, and then the surgeon is exposed to pressure from the body muscle to reopen, because the half-turn piercing blade 201 of the distal end design of the inner sheath 200 is sharp, and it is capable of piercing the closed muscle tissue and additionally enters the muscle tissue with the distal end of the percutaneously implanted electrode 10, because the outer diameter of the distal helical fixation member 113 is larger than the inner diameter of the inner sheath 200, so that the distal helical fixation member 113 is compressed but does not enter the inner sheath 200, and thus the muscle has to come to rest in the gap between the second helical turns of the distal fixation member 113, and the percutaneously implanted electrode 10 is fixed thereto, so that the muscle tissue is more firmly held in the helical gap during the healing process, thus ensuring stimulation of the electrode target site throughout the treatment. If the target site is a tight muscle, it is preferable to use the distal fixing member 113 having a short axial length as shown in FIG. 7 (a), and the operator can select a suitable length of the fixing member 113 according to the condition of the target muscle to be stimulated.

As above, if the target muscle is not tight and is slightly loose, a distal helical fixation member 113 having a slightly longer axial length as shown in fig. 7 (b) may be used, such as: the axial length of the fixing member 113 is 2.25-3.00mm, and the second pitch between the second coils constituting the fixing member 113 is 0.5-0.9mm. More helical length can be incorporated into the muscle when the inner sheath 200 is brought into the muscle with the percutaneously implanted electrode 10 attached. In addition, in the process of muscle extrusion, along with the extrusion direction and the force action, the longer spiral can be extruded to form a curve as shown in fig. 7 (b), and the loose muscle enables the electrode to be firmly fixed in the body of a patient under the action of the lengthened spiral hook, so that the electrode is not dislocated in the stimulation treatment process, and the electrical stimulation curative effect is kept.

Similarly, if the target muscle is a more relaxed region, a helical fixation member 113 having a longer axial length as shown in fig. 7 (b) may be used, such as: the fixing member 113 has an axial length of 3-5mm or more, and a second pitch between second helical turns constituting the fixing member 113 is 0.5-0.9mm. When the inner sheath 200 is inserted into the muscle with the percutaneously implanted electrode 10, the longer distal end coil is hooked into the muscle as shown in fig. 7 (c), so that the gap between the second spiral loops is not only combined with the muscle during the pressing process of the distal end coil and the muscle, but also the bent second spiral loops can capture the muscle tissue in a larger range, so that the effect of fixing the distal end electrode at the target point to the maximum extent is achieved, the electrode is not dislocated during the stimulation treatment process, and the electrical stimulation treatment effect is maintained.

Finally, when the electrical stimulation treatment is finished or the electrode needs to be pulled out, the distal fixing part 113 of the percutaneous implant electrode 10 provided in this embodiment is firmly combined with the muscle tissue because of the spiral structure, so that it becomes difficult to simply pull out the first stimulation electrode 111 and the distal spiral fixing part 113 directly from the operator, and the following electrode withdrawing method can be adopted: if the spiral of the fixing member 113 is designed to be right-handed (left-handed), when the percutaneous implant electrode 10 is pulled out, the operator needs to pull the electrode lead 121 outward in the direction of F along the left-handed (right-handed) edge of the finger force points A and B as shown in FIG. 8, so that the muscle tissue fixed by the spiral at the distal end is released between the spiral pitches to allow the electrode lead 121 to be pulled out of the body smoothly. In fig. 8, line L is shown at the limit inside and outside the body, the fixing part 113, the first stimulation electrode 111 and the electrode lead 121 facing the distal end part of the line L are parts entering the body, and the electrode lead 121 facing the proximal end of the line L is a part exposed outside the body.

In another embodiment, please refer to fig. 9, the implanted electrode may also be a fully implanted peripheral electrode, the proximal end of the electrode body 12 is provided with an electrode tail end 13, the electrode tail end 13 is wrapped with an electronic component combination capable of generating a stimulation function, the electrode head end 11 includes at least one stimulation electrode, the number of the stimulation electrodes may be 1-8, and the stimulation electrodes are specifically set as required, fig. 9 shows 4 stimulation electrodes, which are respectively a first stimulation electrode 111, a second stimulation electrode 112, a third stimulation electrode 115 and a fourth stimulation electrode 116, the distal end of the implanted electrode is provided with a fixing component 113 of a spiral structure, when in use, the electrode tail end 13 is also fully implanted into the patient, and the electronic component combination is mechanically remotely controlled by an external electronic device through human tissue and air and transmits electrical signals and energy, so as to realize stimulation and treatment of the peripheral stimulation system on nerves. Therefore, the present invention is not limited to the type of the implanted electrode, and any electrode tip implanted in the body may be provided with the fixing member 113 having a spiral structure.

Example 1

Referring to fig. 1, the percutaneous implantation electrode 10 provided in this embodiment has an electrode, which is a monopolar electrode structure, the electrode tip 11 includes a first stimulation electrode 111 and a fixing member 113, the electrode body 12 is formed by spirally winding an electrode lead 121, a first pitch between adjacent first spiral coils forming the electrode body 12 is preferably 0.30-0.48mm, the first stimulation electrode 111 is formed by tightly winding the metal wire 122 forming the electrode lead 121 in a bare state in a distal direction, the tight winding means that the spiral coils forming the first stimulation electrode 111 are sequentially attached along an axial direction, that is, adjacent spiral coils are tightly wound, the tightly wound first stimulation electrode 111 structure can increase a stimulation surface area of the percutaneous implantation electrode 10, and the metal wire 122 at the distal end of the first stimulation electrode 111 continuously extends to the distal end and is spirally wound according to a second pitch to form the fixing member 113. The fixing member 113 is provided to maintain the first stimulation electrode 111 at a stimulation position during the treatment of the patient (30-90) days or more, and to reduce dislocation of the first stimulation electrode 111 to improve the treatment effect. The electrode body 12 is also partially implanted into the patient, the flexibility of the electrode body 12 due to the special pitch open helical structure can overcome the tension and distortion of the muscle in the patient, and the open insulating helical structure can reduce the diameter of the percutaneous electrode 10 to the utmost extent, thereby effectively reducing the risk of wound infection. The percutaneous implantation electrode 10 with the structure can be integrally processed and manufactured, the insulating layer 123 is formed at the required insulating position outside the metal wire 122 through the coating processing technology, so that the straight diameter is small and has high strength, and then the fixing part 113, the first stimulation electrode 111, the electrode body 12 and the electrode tail end 13 are integrally wound by adopting the spiral winding technology, so that the subsequent fracture risk generated by the processing technology in the connection process of the electric conductor and the connection separation risk in clinical use are greatly reduced.

Example 2

Referring to fig. 2, the percutaneous implantation electrode 10 provided in this embodiment has an electrode in a monopolar electrode structure, the electrode tip 11 includes a first stimulation electrode 111 and a fixing member 113, the first stimulation electrode 111 is a tubular metal electrode, the metal electrode may be a platinum iridium electrode, and the platinum iridium electrode is a good implantation electrode body and has better electrical and in vivo corrosion resistance than a common wire; the electrode body 12 is formed by spirally winding an electrode lead 121 according to a first pitch, in an embodiment, a metal wire 122 forming the electrode lead 121 extends through an electrode tube of the metal electrode to a distal end in an exposed or insulated state, and then continues to extend and spirally winds according to a second pitch to form the fixing part 113, and the metal wire 122 is electrically connected with the metal electrode. In another embodiment, the distal end of the wire 122 constituting the electrode lead 121 extends to extend into the proximal end of the metal electrode after the electrode tube and is electrically connected to the first stimulation electrode 111, the fixing member 113 is formed by spirally winding another wire or other materials, the material of the fixing member 113 may be the same as the wire 122, or may be selected from materials different from the wire 122 according to needs, or may even be selected from non-metallic insulating materials, whether the materials of the fixing member 113 and the first stimulation electrode 111 are the same or not is selected according to the electrical stimulation needs, and the proximal end of the fixing member 113 extends into the distal end of the electrode tube of the metal electrode and is connected to the first stimulation electrode 111. The wire 122 establishes a reliable mechanical connection or a simultaneous mechanical and electrical connection with the first stimulation electrode 111 by welding, crimping or other mechanical connection means. The press-holding manner is a connection method in which a part of one part is inserted into another part and then the combined part is pressed to fix the two parts. The crimping manner in this embodiment means that the electrode lead 121 or the wire constituting the fixing member 113 is inserted into the electrode tube and then the electrode tube is pressed so that the wire 122 and the electrode tube are electrically connected with each other with reliability.

Example 3

Referring to fig. 3, the percutaneous implantation electrode 10 provided in this embodiment has two electrodes, and is a dual-electrode structure, the electrode tip 11 sequentially includes a second stimulation electrode 112, a first stimulation electrode 111, and a fixing part 113 from a proximal end to a distal end, the first stimulation electrode 111 and the second stimulation electrode 112 are arranged at an interval along the same axial direction, and the interval distance is preferably 10-15 mm; the electrode body 12 is formed by spirally winding two electrode leads 121 according to a first pitch, the two electrode leads 121 are a first electrode lead 1211 and a second electrode lead 1212 respectively, the first stimulation electrode 111 is connected with the adaptor 20 through the first electrode lead 1211, the second stimulation electrode 112 is connected with the adaptor 20 through the second electrode lead 1212, any one or any two of the first stimulation electrode 111, the second stimulation electrode 112 and the body surface electrode 70 is used as a stimulation electrode or a loop electrode, and the rest one or two electrodes form a stimulation loop. Therefore, the three electrodes of the first stimulation electrode 111, the second stimulation electrode 112 and the body surface electrode can form six different stimulation paths consisting of the stimulation electrode and the return electrode, and each stimulation path can act on different nerve tissues, or under the same electrode implantation condition, six stimulation effects can be achieved. Moreover, in the case of the combination of two electrodes, the overall flow direction of the current is controlled by distributing the current intensity between the two electrodes, and the effect of reaching the virtual electrode is achieved, thereby providing new possibility for improving the stimulation effect. Compared with a monopolar structure, the implanted electrode 10 with the bipolar structure has a larger stimulation range and more stimulation modes, increases the treatment diversity, realizes different stimulation functions and stimulation effects, and is favorable for improving the clinical treatment effect.

With reference to fig. 3, the first stimulation electrode 111 and the second stimulation electrode 112 are both tubular metal electrodes, the metal electrodes may be platinum iridium electrodes, the first electrode lead 1211 passes through the electrode tube of the second stimulation electrode 112, the wire 122 constituting the first electrode lead 1211 extends distally through the electrode tube of the first stimulation electrode 111 and then continues to extend distally and spirally winds to form the fixing component 113, the wire 122 is electrically connected to the first stimulation electrode 111, and the wire 122 at the distal end of the second electrode lead 1212 extends into the electrode tube of the second stimulation electrode 112 and is electrically connected to the second stimulation electrode 112; the wire 122 of the first electrode lead 1211 can be electrically connected with the first stimulation electrode 111 in an exposed or insulated state by welding, or the first electrode lead 1211 with the insulating layer 123 can be connected with the first stimulation electrode 111 by pressing and holding, so that the insulating layer 123 is broken to electrically connect the wire 122 with the first stimulation electrode 111; similarly, the wire 122 of the second electrode lead 1212 may be electrically connected to the second stimulation electrode 112 by welding in an exposed or insulated state, or the second electrode lead 1212 with the insulating layer 123 may be connected to the first stimulation electrode 112 by pressing and holding, and the insulating layer 123 may be broken to electrically connect the wire 122 to the second stimulation electrode 112. Further, an insulating buffer sleeve 114 is sleeved outside the first electrode lead 1211 between the first stimulation electrode 111 and the second stimulation electrode 112, so as to prevent a short circuit from occurring between the first stimulation electrode 111 and the second stimulation electrode 112, and improve electrical safety.

Example 4

Referring to fig. 4, the percutaneous implantation electrode 10 provided in this embodiment has two electrodes, which are bipolar electrode structures, and is different from the structure of the first stimulation electrode 111 and the second stimulation electrode 112 in embodiment 3, in this embodiment, the second stimulation electrode 112 is formed by extending the wire 122 constituting the second electrode lead 1212 to the distal end in an exposed state and spirally and tightly winding, in the first stimulation electrode 111 in this embodiment, after the distal end of the first electrode lead 1211 passes through the cavity spirally formed by the second stimulation electrode 112, the wire 122 constituting the first electrode lead 1211 is formed by extending the wire 122 to the distal end in an exposed state and spirally and tightly winding, and the wire 122 at the distal end of the first stimulation electrode 111 continues to extend to the distal end and spirally and tightly winds according to a second pitch to form the fixing component 113. The percutaneous implantation electrode 10 with the structure is formed by winding two metal wires 122 with insulating layers 123, and two electrode leads 121 are wound into a whole along the same central axis in a staggered manner. The first stimulation electrode 111 is formed by tightly winding the metal wire 122 with the insulating layer removed or directly exposed at the distal end of the first electrode lead 1211, the second stimulation electrode 112 is formed by tightly winding the metal wire 122 with the insulating layer 123 removed or directly exposed at the second electrode lead 1212 on the first electrode lead 1211 with the insulating layer 123, and the second stimulation electrode 112 is wound on the insulating layer 123 of the first electrode lead 1211, so that the second stimulation electrode 112 is not electrically connected with the first stimulation electrode 111. The first stimulation electrode 111 and the second stimulation electrode 112 can respectively perform independent electrical stimulation functions, and the treatment diversity is greatly enriched.

The embodiments of the monopolar electrode and the bipolar electrode are respectively given above, the number of the stimulation electrodes is not limited in the present invention, and in order to increase the stimulation requirement of the human body, more stimulation electrodes may be provided, for example, more than 3 (including 3), as long as the proximal stimulation electrode can accommodate the corresponding electrode lead to pass through, and a plurality of stimulation electrode combinations are performed with specific reference to the above embodiments.

The minimum diameter of the spinal stimulation electrode in the current market is 1.27mm, and a puncture needle for implanting the electrode needs to be thicker than 14G (G is the BWG gauge specification of Bermingham, the larger the G is, the thinner the outer diameter of the needle tube is). Such a coarse penetration is more difficult for peripheral nerve implantation, so that the clinical requirement for peripheral nerve implantation is to design the percutaneous electrode 10 to be 0.70mm with a finer diameter, and the design and manufacture of this size range is challenging. Within this diameter range of the percutaneously implantable electrode 10, an 18G delivery sheath can be designed based on the configuration of the syringe to effectively and smoothly deliver or implant the percutaneously implantable electrode 10 around the pain nerve desired by the physician. Therefore, the two strands of spiral electrode leads 121 are designed in a limited cross-sectional area and resistant to fatigue distortion and bending, and insulation between the two strands of electrode leads 121 is also a great challenge. The electrode lead 121 provided by the embodiment selects stainless steel wires or cables, the MP35N nonmagnetic nickel-cobalt-chromium-molybdenum alloy wires or cables are wound to form the elastic slender spiral electrode lead 121, the cable is formed by twisting a plurality of strands of stainless steel wires, so that the cable has better fatigue resistance, and the elasticity and flexibility of the spiral electrode lead 121 can overcome the tension and extrusion of muscles in a body. The insulating layer 123 of the two strands of electrode leads 121 is made of polymer material PU, PTFE or ETFE, and is extruded into a tube shape and then applied to the outer layer of the metal wire 122, or the polymer material PU, PTFE or ETFE is sprayed on the metal wire 122 by a coating process to form the insulating layer 123, so as to ensure the insulation between the first electrode lead 1211 and the second electrode lead 1212, and the insulating property between the first electrode lead 1211 and the second electrode lead 1212 can be ensured by ensuring the uniformity of the insulating wall in both the extrusion and spraying processes. The diameter of the wire 122 is preferably 0.1mm to 0.15mm, and the outer diameters of the first and second stimulation electrodes 111 and 112 are preferably 0.55mm to 0.70mm. Although the bipolar percutaneous implantation electrode 10 is adopted in the peripheral nerve stimulation system provided by the embodiment, because the first stimulation electrode 111 and the second stimulation electrode 112 are coaxially arranged at equal intervals and in equal diameter, and the first electrode lead 1211 and the second electrode lead 1212 are insulated and then wound into an open type insulated spiral structure, the percutaneous implantation electrode 10 with the first stimulation electrode 111 and the second stimulation electrode 112 can be implanted into the body by using an implantation tool (puncture needle) which is the same in diameter and size as the existing similar product, so that the trauma is also small, and more effective treatment can be provided for nerve regulation.

Referring to fig. 10, fig. 11a to fig. 11c, fig. 12a and fig. 12b, the peripheral nerve stimulation system using the percutaneously implanted electrode 10 according to the present invention includes a percutaneously implanted electrode 10, an adapter 20, a first cable 30, a stimulator 50, a remote controller 60 and a body surface electrode 70; the adapter 20 is electrically connected to the proximal end of the percutaneous implant electrode 10, and further, the electrode lead 121 constituting the electrode body 12 may be linearly extended proximally to form the electrode tail 13. Specifically, the adaptor 20 is electrically connected to the wire 122 constituting the electrode body 12, and the adaptor 20 can penetrate through the insulating layer 123 of the electrode lead 121 and then establish a reliable connection with the inner wire 122, and the connection position can be on the electrode body 12 or on the electrode tail end 13; in other embodiments, the wire 122 at the distal end of the electrode tail 13 may be exposed and electrically connected to the adapter 20. The adaptor 20 is electrically connected with the stimulator 50 through the first cable 30, and the stimulator 50 is used for sending electric stimulation pulses; the body surface electrodes are electrically connected to the stimulator 50 and form a circuit with the percutaneously implanted electrodes 10. As shown in FIG. 11a, in one embodiment, the body surface electrodes are fixed body surface electrodes 70, the fixed body surface electrodes 70 are fixed to the bottom of the stimulator 50 and electrically connected to the stimulator 50 through the first body surface electrode interface 71. Specifically, the fixed body surface electrodes 70 are 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 to adhere the whole stimulator 50 to the skin of the human body, the first body surface electrode interface 71 is disposed on the first body surface patch 701 and is in communication with the hydrogel 702, and the hydrogel 702 is electrically conductive to form a conductive layer. Meanwhile, the stimulator 50 is provided with an electrode interface, 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 are integrated, then the whole stimulator 50 is pasted and fixed on the body surface of a patient through hydrogel 702 on the surface of the first body surface patch, and the stimulator 50, the percutaneous implantation electrode 10 and the hydrogel 702 form a loop in the human body to form a path for realizing electrical stimulation. Alternatively, in another embodiment, as shown in FIG. 11b, the body surface electrode is a movable body surface electrode 80, the movable body surface electrode 80 comprises 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 to attach the movable body surface electrode 80 to the skin of the human body, the second body surface electrode interface 81 is arranged on the second body surface patch 801 and is communicated with the hydrogel 802, the hydrogel 802 forms a conductive layer, in this embodiment, the third body surface patch 901 is further provided with a third body surface electrode interface 91, the third body surface patch 901 is coated with an adhesive 902, the adhesive 902 is a skin-friendly adhesive and is non-conductive, the whole stimulator 50 is adhered to the skin of the human body through the adhesive 902, the patient or doctor can choose to connect the movable body surface electrode 80 with the stimulator 50 through the second cable 72, specifically, one end of the second cable 72 is connected with the second body surface electrode interface 81, the other end of the second cable 72 is connected with the third body surface electrode interface 91, the third body surface electrode interface 91 is electrically and mechanically connected with the electrode interface on the stimulator 50, so that the third body surface patch 901 and the stimulator 50 are integrated, then the whole stimulator 50 is pasted and fixed on the body surface of the patient through the viscose 902 on the surface of the stimulator, the stimulator 50, the percutaneous implantation electrode 10 and the hydrogel 802 form a loop in the human body, a path for realizing electrical stimulation is formed, and the position of the movable body surface electrode 80 can be freely moved, so that the electrical performance is optimal. With the second cable 72 being led out, the movable body surface electrode 80 can be placed anywhere the patient needs stimulation, for example, at the most sensitive to stimulation, more effectively suppressing pain. Further, the multifunctional stimulator also comprises a third cable 40, the first cable 30 is detachably connected with the third cable 40, the third cable 40 is detachably connected with the stimulator 50, specifically, the proximal end of the first cable 30 is provided with a first wiring port 31, the distal end of the third cable 40 is provided with a second wiring port 41, the first wiring port 31 is detachably connected with the second wiring port 41 in a matching way, the proximal end of the third cable 40 is provided with a third wiring port 53, and the third wiring port 53 is detachably connected with the stimulator 50, so that the multifunctional stimulator is convenient to use. In other embodiments, the first cable 30 and the third cable 40 are integrally connected in a non-detachable manner. Whether the cables are detachably connected or not is set according to needs, and the invention is not limited to this.

The specific working process and principle are as follows: after the tiny micro percutaneous implantation electrode 10 is implanted near a peripheral nerve with pain suppression, the tiny micro percutaneous implantation electrode is exposed to the epidermis from the human tissue, the near end of the percutaneous implantation electrode 10 is connected to the stimulator 50 through the micro adapter 20, the stimulator 50 forms a loop with the percutaneous implantation electrode 10 through the body surface electrode 70, the stimulator 50 sends an electric stimulation pulse required by treatment, and therefore the purpose of nerve regulation is achieved, and the stimulation pulse can be controlled and selected through the remote controller 60 to have different stimulation parameters, such as pulse width, frequency, amplitude and the like. The percutaneous implantation electrode 10 is a bipolar electrode structure, and can further improve the clinical treatment effect of the current monopolar electrode stimulation.

With continued reference to fig. 11a, 11b and 11c, the patient selects the stimulation program and stimulation intensity prescribed by the doctor through the remote controller 60, the remote controller 60 is connected with the stimulator 50 in a wireless communication manner, specifically, in one embodiment, as shown in fig. 6a, the remote controller 60 includes a hand grip portion 64, a control key 61, a display 62 and a hanging hole 63, the hand grip portion 64 is preferably sized and shaped to be held by one hand of the patient, and the control key 61 is disposed at the end of the hand grip portion 64 to facilitate the operation of the patient by one hand. The hanging hole 63 is arranged at the tail part of the hand holding part and is hung and stored when the patient does not use the hanging hole, and the display screen 62 is arranged on the top surface of the hand holding part 64 and is used for displaying stimulation parameters and the like. The remote controller 60 stores a stimulation program ordinal number and a stimulation intensity ordinal number, which correspond to the contents of the solidified memory odometer and the intensity meter of the stimulator 50, respectively. In another embodiment, as shown in fig. 6b, the remote controller 60 includes a grip portion 64, a control key 61 and a display 62, the grip portion 64 is preferably sized and shaped to be held by a single hand of a patient, the control key 61 and the display 62 are both disposed on the top surface of the grip portion 64 for the single-hand remote control operation of the patient, and further, a USB interface 65 is disposed on the side surface of the grip portion 64 for charging the remote controller 60. Further, as shown in fig. 6c, the stimulator 50 may be controlled by the stimulation programmer 100, and the stimulation programmer 100 sets the stimulation parameters and the stimulation program for the stimulator 50 by installing the stimulation programming application on the mobile terminal, which may be a mobile phone, a tablet computer, or the like.

Referring to fig. 13, in the peripheral nerve stimulation system using the percutaneous implantation electrode 10 provided by the present invention, taking the movable body surface electrode 80 and the percutaneous implantation electrode 10 as a two-electrode structure as an example, when in use, the percutaneous implantation electrode 10 having the first stimulation electrode 111 and the second stimulation electrode 112 is percutaneously implanted near a 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 on the body surface of the patient 3, the movable body surface electrode 80 is placed on the position of the patient 3 to be stimulated by the second cable 72, during the treatment, the patient 3 selects the stimulation program and the stimulation intensity by the remote controller 60, and the stimulation treatment is performed on the target position by the stimulator 50. In addition, the system includes a stimulation programmer 100 implemented as a tablet computer by the physician. During electrode implantation, the physician determines the integrity and function of the electrode by manipulating the control interface of stimulation programmer 100. In another embodiment, the physician can debug and determine the stimulation protocol (program) including waveform, modulation method and safe stimulation intensity range through the programming interface of the stimulation programmer 100 and consolidate these parameters into the stimulator 50, the patient can select a certain stimulation program and stimulation intensity by selecting the number format using the remote controller 60, the bluetooth communication will transmit control information to the stimulator 50, the stimulator 50 will generate a specific current pulse sequence according to the selected program, output to the target nerve tissue via the external lead, the adapter 20 and one of the implanted electrodes, and form a stimulation circuit via the other of the implanted electrodes or the designated body surface electrodes.

Referring to fig. 14, the stimulator 50 is a three-channel bidirectional current pulse stimulator, and includes a controller 51 and a pulse generator 52, the pulse generator 52 includes at least one pulse source 521, and the controller 51 controls the output amplitude, current direction, pulse width and/or timing of the pulse source 521. The controller 51 is a microprocessor or a control chip dedicated to the stimulator. In another embodiment, three channel pulse generator 52 is implemented as an electrode Driver (Driver) by three independent bi-directional current pulse sources 521. Each pulse source 521 is individually controllable to generate a cathodic (N) and anodic (P) current pulse. One of the pulse sources 521 drives the body surface electrodes 70 or 80, and the other two drive the two implanted first and second stimulation electrodes 111 and 112, respectively. In this embodiment, the output function and performance of each channel is equivalent (inductive), i.e. any one or combination of two electrodes can be used as the stimulation electrode (cathode) or the return electrode (anode), and the remaining one or two electrodes make up the stimulation return. Thus, three electrodes can form six different stimulation pathways consisting of stimulation and return electrodes, as shown in fig. 15 (a). Each stimulation channel may be active on a different nerve tissue, or there are six possible stimulation options under the same electrode implantation conditions. In addition, as shown in fig. 15 (b), in the case of a combination of two electrodes, by distributing the Current intensity between the two electrodes, the total Current direction (Current Steering) can be controlled to reach the effect of the virtual electrode, thereby providing a new possibility of improving the stimulation effect. When stimulation occurs, the pulse source of the stimulation electrode and the pulse source of the return electrode form a 'bridge' push-pull output mode, as shown in fig. 16 (a), and in the stimulation phase time, current flows from the anode to the cathode, and in the equilibrium phase, the current is reversed, as shown in fig. 16 (b).

In summary, the present invention has at least the following advantages: 1. the fixing part which is spirally wound is arranged at the far end of the percutaneous implantation electrode, when the percutaneous implantation electrode is conveyed to the position near the nerve or other treatment targets by the inner sheath, the part where the outer diameter of the far-end spiral fixing part is equal to the inner diameter of the inner sheath is prevented from continuously moving towards the inner sheath, and extrusion is generated between the outer diameter of the far-end spiral fixing part and the pushing force of the inner sheath, so that muscle tissues enter the spiral gap of the fixing part to fix the far end of the electrode, the electrode and a human body are fixed, and the problems of poor fixing effect of the existing nerve stimulation electrode and dislocation in the clinical treatment process are solved. 2. The fixing mechanism of the far-end spiral structure is safe and reliable, when the electrical stimulation treatment is finished or the implanted electrode needs to be pulled out, the far-end spiral fixing mechanism can enable an operator to easily and smoothly operate, so that the whole implanted electrode can be withdrawn from human tissues without wound, the problems that the fixing mechanism of the existing product is easy to fatigue and the electrode can be broken when being pulled out are solved, and more effective treatment is provided for nerve regulation. 3. The electrode body of the percutaneous implanted electrode is insulated outside the metal wire and then wound to form an open spiral structure, compared with a closed insulating layer formed on the periphery after the metal wire is wound in a spiral mode, the open spiral structure is more beneficial to bearing the traction of muscle tissues in a body and has better elasticity; and the diameter of the percutaneous part of the electrode body can be reduced to the diameter of the metal wire and the thickness of the wrapped insulating layer, so that the wound on a human body is small, more effective treatment is provided for nerve regulation and control, and the wound infection risk is reduced. 4. The percutaneous implantation electrode is formed by integrally winding one or two metal wires with insulating layers, so that the risk of subsequent fracture generated by a processing process in the connection process of the electric conductor and the risk of connection and separation caused by fatigue abrasion in clinical use are reduced. 5. The electrode body of the percutaneous implantation electrode is designed by overlapping and spirally forming two extremely small strands of insulating metal wires, a tubular or spiral bipolar electrode and a fixing component for fixing human tissues are formed at the far end of the percutaneous implantation electrode, three electrodes consisting of the bipolar electrode and a body surface electrode can form six different stimulation channels consisting of stimulation electrodes and loop electrodes, and each stimulation channel can play a role in different nervous tissues. Moreover, in the case of the 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 possibility for improving the stimulation effect.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (13)

1. An implant electrode comprising an electrode tip and an electrode body, the electrode tip comprising at least one stimulating electrode and a fixation component; the fixing part is of a spiral structure and is arranged at the far end of the implanted electrode, and the outer diameter of the fixing part is larger than that of the electrode body.

2. The implant electrode of claim 1, wherein the implant electrode is a percutaneous implant electrode, the electrode body is formed by spirally winding at least one electrode lead, the electrode lead comprises a metal wire and an insulating layer wrapped outside the metal wire, so that the electrode body is in an open insulating spiral structure; or the electrode body is a strand of metal wire cable wrapped with an insulating layer.

3. The implant electrode of claim 2, wherein a first coil constituting the electrode body is sequentially arranged in an axial direction at a first pitch, and a second coil constituting the fixing member is sequentially arranged in an axial direction at a second pitch, the second pitch being greater than the first pitch.

4. An implant electrode according to claim 3, wherein the wire has a diameter of 0.1mm to 0.15mm, the first pitch is 0.30mm to 0.48mm, the electrode body has a diameter of 0.55mm to 0.70mm, the second pitch is 0.5mm to 0.9mm, and the fixing member has a length of 1.5mm to 5mm in the axial direction.

5. The implant electrode of claim 1, wherein the implant electrode is used with a delivery tool comprising an outer sheath and an inner sheath, the fixation member having an outer diameter greater than an inner diameter of the inner sheath and less than an inner diameter of the outer sheath; the fixing component forms a transition section with the diameter gradually increased to the maximum diameter from the proximal end to the distal end, and when the implant electrode is inserted into the inner sheath, the fixing component stays at the distal end port of the inner sheath at the position where the outer diameter of the transition section is equal to the inner diameter of the inner sheath and does not enter the inner sheath any more.

6. The implant electrode of claim 2, wherein the electrode tip comprises a first stimulation electrode, the electrode body is formed by spirally winding an electrode lead, the first stimulation electrode is formed by spirally and tightly winding the metal wire forming the electrode lead in a distal direction in an exposed state, and the metal wire at the distal end of the first stimulation electrode is continuously spirally wound in the distal direction to form the fixing component.

7. The implant electrode of claim 2, wherein the electrode tip comprises a first stimulation electrode, the electrode body is formed by spirally winding an electrode wire, the first stimulation electrode is a tubular metal electrode, a wire forming the electrode wire extends through the electrode tube of the metal electrode towards the distal end and then continues to extend and spirally winds to form the fixing member, and the wire is electrically connected to the metal electrode, or the distal end of the wire forming the electrode wire extends to extend into the proximal end of the electrode tube of the first stimulation electrode and is electrically connected to the first stimulation electrode, and the proximal end of the fixing member extends into the distal end of the electrode tube of the first stimulation electrode and is connected to the first stimulation electrode.

8. The implant electrode according to claim 2, wherein the electrode tip comprises a second stimulation electrode, a first stimulation electrode and a fixing component in sequence from the proximal end to the distal end, and the first stimulation electrode and the second stimulation electrode are arranged at intervals and in an insulated mode along the same axial direction; the electrode body is formed by spirally winding two electrode leads, wherein the two electrode leads are respectively a first electrode lead and a second electrode lead.

9. The implant electrode of claim 8, wherein the first stimulation electrode and the second stimulation electrode are both tubular metal electrodes, the first electrode lead is insulated and passes through the electrode tube of the second stimulation electrode, the wire forming the first electrode lead extends distally through the electrode tube of the first stimulation electrode and then continues to extend helically to form the fixing part, the wire of the first electrode lead is electrically connected with the first stimulation electrode, and the wire of the distal end of the second electrode lead extends into the electrode tube of the second stimulation electrode and is electrically connected with the second stimulation electrode; or the wire forming the second electrode lead extends to the far end in an exposed state and is spirally and tightly wound to form the second stimulation electrode, the far end of the first electrode lead penetrates through a cavity formed by the second stimulation electrode in a spiral mode in an insulated mode, the wire forming the first electrode lead extends to the far end in an exposed state and is spirally and tightly wound to form the first stimulation electrode, and the wire at the far end of the first stimulation electrode continuously extends to the far end and is spirally and tightly wound to form the fixing part.

10. The implant electrode of claim 9, wherein the first electrode lead between the first stimulation electrode and the second stimulation electrode is sheathed with an insulating buffer sheath.

11. The implant electrode of claim 2, wherein the wire is a 316L stainless steel wire or an MP35N nonmagnetic nickel cobalt chromium molybdenum alloy wire; the insulating material adopted by the insulating layer is polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, and the insulating material is extruded into a pipe shape and then is pasted on the periphery of the metal wire, or the insulating material is sprayed on the metal wire by a coating process.

12. The implant electrode according to claim 2, wherein the implant electrode is a fully implanted peripheral electrode, the proximal end of the electrode body is provided with an electrode tail end, and the electrode tail end is wrapped with an electronic component combination capable of generating a stimulation function.

13. A peripheral nerve stimulation system comprising the implant electrode of any of claims 2-11, the adaptor, the first cable, the stimulator, and the body surface electrode;

the implant electrode is percutaneously insertable into a patient;

the adaptor is electrically connected with the proximal end of the implanted electrode, the adaptor is electrically connected with the stimulator through the first cable, and the stimulator is used for sending electric stimulation pulses;

the body surface electrode is electrically connected with the stimulator and forms a stimulation loop with the implanted electrode through stimulated human tissue.

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