CN115869534B - Implant 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 wire, and the electrode wire 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 spiral wound fixing component is combined with the inner sheath for conveying and puncturing, so that the implanted electrode is pushed into a nerve or other internal tissue implantation target point, the distal end of the electrode is fixed with a treated point, and the problems of poor fixing effect of the existing nerve stimulating electrode and dislocation in the clinical treatment process are solved.

Description

Implant electrode and peripheral nerve stimulation system thereof

Technical Field

The invention relates to the field of medical equipment, 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 electrically stimulating nerves. For example, acute and chronic pain has long been treatable by electrical stimulation, and painful nerve electrical stimulation systems include peripheral nerve treatments of implanted spinal nerve stimulators, non-implanted epidermal stimulation, and percutaneous implanted electrodes and external electrical stimulators; furthermore, sacral nerve stimulation can treat patients suffering from urinary incontinence; parkinsonism can treat the muscular stiffness and restore motor ability of a patient by electrode stimulation of the thalamus. Although these devices provide patients with pain relief and quality of life, these stimulation systems suffer from various drawbacks and deficiencies, as well as differences in patient anatomy, electrical stimulation energy deficiencies, including electrode displacement due to distal or proximal fixation failure, failure to cover the target site of pain or other functional nerves, etc., resulting in inadequate stimulation efficacy and ineffective suppression of the pain.

In order to ensure that the stimulation point of the electrode after implantation is fixed, a fixing mechanism is designed at the distal end of the electrode to keep mechanical fixation with the tissue of a human body, the fixing mechanism is designed according to the specificity of the implantation position, a plurality of instruments are not easy to design the fixing mechanism at the distal end of the anatomical position of the human body, and a near end fixing with a non-optimal fixing effect is needed, for example, the distal end of the electrode cannot be reasonably and effectively designed due to the anatomical specificity of the vertebra, so that all vertebra stimulation electrodes in the market at present adopt cylindrical electrodes which cannot be fixed, but a suture sheath is arranged on the near end electrode, and a doctor suture the electrode under the skin by using a suture mode. In summary, the reliability of the distal fixation of the electrode directly influences the effect of the electrical stimulation clinical treatment.

Patent US2010/0036454A1 discloses a distal winged fixation mechanism for a percutaneous implant electrode, which is similar in principle to the anchor of a ship and very similar to the distal winged anchor of a pacing electrode disclosed. The shape of the anchoring hook fixed at the distal end is derived from a plurality of similar designs, such as percutaneous implantation electrodes of Stimewave corporation in the United states, and the combination of a common vertebra stimulation electrode and a pacing wing electrode distal end fixing mechanism is adopted, so that 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 parts comprise eardrum nerves, visual nerves and the like, the implantation diameter is large, and the clinical application is unsuitable.

Patent US4026301 discloses a distal fixation mechanism of a pointed spiral, the principle of which is similar to a screw and also similar to the spiral shape of a pacing spiral electrode, but the fixation mechanism is different from a pacing electrode. Its disadvantages are complex construction, many components, large diameter required for implantation tool, and large trauma, and the design is directed to spinal bending nerve stimulation, so that it may not be suitable for use in other locations.

Among the percutaneous nerve stimulating products that have been marketed by SPR Therapeutics, inc. in the United states, the published electrode patent distal fixation mechanism is of the tight spiral hook type, and literature reports that in electrode pullout at the end of clinical short-term treatment, 5-20% of the product breaks at the electrode distal fixation due to insufficient strength of the spiral stainless steel cable, making some treatment centers refused to use SPR.

Therefore, it is necessary to provide a percutaneous implant electrode that is safe and reliable for the fixation mechanism and has 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, and a distal end fixing mechanism of the implanted electrode is safe and reliable.

In order to solve the technical problems, the invention provides an implantation electrode, which comprises an electrode head end and an electrode body, wherein the electrode head end comprises at least one stimulation 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 wire, and the electrode wire 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 spiral turns constituting the electrode body are sequentially arranged at a first pitch along an axial direction, and the second spiral turns constituting the fixing member are sequentially arranged at a second pitch along the axial direction, the second pitch being greater than the first pitch.

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

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

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

Preferably, the electrode tip includes a first stimulating electrode, the electrode body is formed by spirally winding an electrode wire, the first stimulating electrode is a tubular metal electrode, a metal wire forming the electrode wire extends distally to pass through an electrode tube of the metal electrode and then continues to extend and spirally wind to form the fixing component, and the metal wire is electrically connected with the metal electrode, or a distal end of the metal wire forming the electrode wire extends and then extends into a proximal end of an electrode tube of the first stimulating electrode and is electrically connected with the first stimulating electrode, and a proximal end of the fixing component extends into a distal end of the electrode tube of the first stimulating electrode and is connected with the first stimulating electrode.

Preferably, the electrode head end sequentially comprises a second stimulation electrode, a first stimulation electrode and a fixing part from the proximal end to the distal end, and the first stimulation electrode and the second stimulation electrode are arranged at intervals and insulated along the same axial direction; the electrode body is formed by spirally winding two electrode wires, and the two electrode wires are a first electrode wire and a second electrode wire respectively.

Preferably, the first stimulating electrode and the second stimulating electrode are tubular metal electrodes, the first electrode wire penetrates through the electrode tube of the second stimulating electrode in an insulating manner, the metal wire forming the first electrode wire extends distally to penetrate through the electrode tube of the first stimulating electrode and then continues to extend distally to be spirally wound to form the fixing component, the metal wire of the first electrode wire is electrically connected with the first stimulating electrode, and the metal wire at the distal end of the second electrode wire extends into the electrode tube of the second stimulating electrode and is electrically connected with the second stimulating electrode; or, the metal wire forming the second electrode wire extends to the distal end in the exposed state and is spirally and tightly wound to form the second stimulation electrode, the distal end of the first electrode wire penetrates through the cavity formed by the second stimulation electrode in a spiral mode in an insulating mode, the metal wire forming the first electrode wire extends to the distal end in the exposed state and is spirally and tightly wound to form the first stimulation electrode, and the metal wire at the distal end of the first stimulation electrode continues to extend to the distal end and is spirally wound to form the fixing part.

Preferably, an insulating buffer sleeve is sleeved outside the first electrode wire 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 layer is made of polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, and is extruded into a tube and then is applied to the periphery of the metal wire, or is sprayed onto the metal wire by a coating process.

The implanted electrode is a full-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 element combination capable of generating a stimulation function. .

In order to solve the technical problems, the invention also provides a peripheral nerve stimulation system which comprises the implantation 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 implantation 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.

Compared with the prior art, the invention has the following beneficial effects: according to the implanted electrode and the peripheral nerve stimulation system thereof, the spiral wound fixing component is arranged at the distal end of the implanted electrode, when the implanted electrode is conveyed to the vicinity of nerves or other treatment targets by the inner sheath, the position where the outer diameter of the distal spiral fixing component is equal to the inner diameter of the inner sheath is prevented from continuously moving towards the inside of the inner sheath, extrusion is generated between the outer diameter of the distal spiral fixing component and the pushing force of the inner sheath, and as a result, muscle tissue enters a spiral gap of the fixing component to fix the distal end of the electrode, so that the effect of fixing the electrode with a human body is achieved, and the problems of poor fixing effect of the existing nerve stimulation electrode and dislocation in the clinical treatment process are solved. The fixing mechanism of the far-end spiral structure is safe and reliable, and when the electric 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 exit human tissues atraumatically, the problems that the existing product fixing mechanism is easy to fatigue and the electrode is broken when pulled out are solved, and more effective treatment is provided for nerve regulation. Meanwhile, when the implanted electrode is a percutaneous implanted electrode, the electrode body of the percutaneous implanted electrode is spirally wound after being externally insulated by a metal wire to form an open spiral structure, and compared with the method that a closed insulating layer is formed on the whole periphery after the metal wire is spirally wound, the electrode body is more favorable for bearing the traction of muscle tissues in a 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, so that the wound of the human body is small and healed quickly, and the infection risk is reduced; the whole implanted electrode can be formed by integrally winding one or more metal wires with insulating layers, so that the risk of subsequent fracture breaking generated by a processing technology in the connection process of the conductor and the risk of connection separation caused by fatigue and abrasion in clinical use are reduced, and particularly, the tightly wound spiral electrode structure can increase the stimulation surface area of a human body and promote the stimulation current which can be borne.

Drawings

FIG. 1 is a schematic view showing the structure of a percutaneous implant electrode having a monopolar electrode according to a first embodiment of the present invention;

FIG. 2 is a schematic view of a percutaneous implant electrode having a monopolar electrode according to a second embodiment of the present invention;

FIG. 3 is a schematic view of a percutaneous implant electrode having bipolar electrodes according to a third embodiment of the invention;

FIG. 4 is a schematic view showing the structure of a percutaneous implant electrode having a bipolar electrode according to a fourth embodiment of the present invention;

fig. 5 (a), fig. 5 (b), fig. 5 (c) are schematic structural views of screw fixing parts with different lengths according to an embodiment of the present invention;

fig. 6 (a), 6 (b) and 6 (c) are schematic views illustrating assembly of screw fixing components with different lengths and inner sheaths according to an embodiment of the present invention;

fig. 7 (a), fig. 7 (b), and fig. 7 (c) are schematic diagrams illustrating bending of the fixing member after the electrode is implanted into a human body and the muscle tissue is extruded by the inner sheath and inserted into the spiral gap according to the embodiment of the present invention;

FIG. 8 is a schematic view of an embodiment of the present invention for percutaneous implantation of an electrode into and out of a body;

FIG. 9 is a schematic view of a fully implanted peripheral electrode according to another embodiment of the present invention;

FIG. 10 is a schematic diagram showing the overall structure 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 an excitation programmer;

Fig. 12 (a) is a schematic structural view of a stationary body surface electrode in an embodiment of the present invention, and fig. 12 (b) is a schematic structural view of a movable body surface electrode;

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 according to 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 differently distributing two electrode currents of an electrode combination and changing the total current direction;

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

In the figure:

1-subcutaneous tissue, 2-wound, 3-patient, 10-percutaneous implant electrode, 11-electrode head, 12-electrode body, 13-electrode tail, 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 control, 61-control key, 62-display screen, 63-hanging hole, 64-hand grip, 65-USB interface, 70-stationary 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 program generator, 111-first stimulation electrode, 112-second stimulation electrode, 113-fixed member, 114-insulated buffer sleeve, 115-third stimulation electrode, 121-fourth stimulation electrode, 121-second stimulation electrode, 121-wire, 121-wire conductor wire, 121-insulated wire; 1131-transition section, 200-inner sheath, 201-piercing knife edge.

Detailed Description

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

In order to more clearly describe the structural features of the present invention, the present invention employs "proximal", "distal", "axial" as the azimuth term, wherein "proximal" means the end near the operator; "distal" means the end remote from the operator, "electrode tip" means the electrode distal-most portion, and "axial" means the direction in which the electrode center axis is located or the direction parallel to the electrode center axis. The term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

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

The length of the spiral of the distal fixation member 113 in the axial direction is preferably 1.5mm-5mm, and this embodiment lists three different length designs that are suitable for use with different characteristics of the body tissue site. The axial length of the distal fixation member 113 shown in fig. 5 (a) is relatively short, and can be used for a relatively tight region of human tissue at the electrical stimulation target; the axial length of the distal fixation member 113 shown in fig. 5 (b) is slightly longer and can be used in a slightly loosened region of body tissue of the electrical stimulation target; the distal fixation member 113 shown in fig. 5 (c) has a longer axial length and can be used at a site where the body tissue of the electrical stimulation target is very loose. The skilled artisan can select a suitable length of the securing member 113 as desired.

Fig. 6 (a), 6 (b) and 6 (c) are partial schematic views of the percutaneous implant electrode with the fixing member 113 shown in fig. 5 (a), 5 (b) and 5 (c) combined with the inner sheath 200, respectively, and the percutaneous implant electrode 10 is used together with a delivery tool when being implanted into a body, wherein the delivery tool comprises an outer sheath (not shown) and the inner sheath 200, the percutaneous implant electrode 10 is combined with the inner sheath 200 before being implanted into a human body, the outer diameter D of the fixing member 113 is slightly larger than the inner diameter of the inner sheath 200 and slightly smaller than the inner diameter of the outer sheath, so that the fixing member 113 stays at the opening of the puncture blade 201 of the inner sheath 200 after the percutaneous implant electrode 10 is penetrated into the inner sheath 200, and can be implanted into a patient through the outer sheath after being combined with the inner sheath 200. The fixing member 113 forms a transition section 1131 with a diameter gradually increasing from the proximal end to the distal end to the maximum diameter (i.e., the outer diameter of the fixing member 113), 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 section 1131 is just larger than the inner diameter of the inner sheath 200, and the spiral of the fixing member 113 is inclined a little along the sharp penetration wall of the penetration blade 201 of the inner sheath 200, thus staying at the distal end port of the inner sheath 200. When the percutaneous implant electrode 10 is delivered from the inner sheath 200 to the vicinity of the nerve or other therapeutic target, the distal screw fixation member 113 having a diameter equal to the inner diameter of the inner sheath 200 is prevented from continuing to move toward the inside of the inner sheath 200 and is pressed against the pushing force of the inner sheath 200, so that the muscle tissue enters the screw gap to fix the distal end of the percutaneous implant electrode 10, thereby fixing the percutaneous implant electrode 10 to the human body.

The delivery process of the percutaneous implant electrode 10 into 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 finding the expected target point, puncturing the outer sheath and the test electrode assembly together to the expected target point, verifying whether stimulation is effective or not by an electronic stimulation system according to feedback of a patient, and if not, re-extracting the outer sheath and the test electrode assembly to re-find the target point.

Then, after the electrical stimulation test is completed, the test electrode is withdrawn from the outer sheath after being unlocked, 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, which is penetrated by the test electrode, is cut, so as to prepare for the implantation and fixation of the percutaneous implantation electrode 10.

Then, the percutaneous implant electrode 10 is inserted into the inner sheath 200 for assembly, the assembly of the percutaneous implant electrode 10 and the inner sheath 200 is inserted into the outer sheath which is left in the body, the distal end of the percutaneous implant electrode 10 will encounter the muscle which has been penetrated and folded by the test electrode before passing through the distal end of the outer sheath, and the half-circle penetrating blade 201 on the inner sheath 200 will continue to advance along the penetrating direction of the inner sheath, the length of which is shown in fig. 5 (a), 5 (b) and 5 (c), and the state of the fixing member 113 which is pressed and fixed by the muscle tissue of the human body after this direction is shown in fig. 7 (a), 7 (b) and 7 (c), respectively.

Fig. 7 (a) shows a design employing a shorter helix in the distal fixation member 113 when the target muscles are relatively tight, such as: the axial length of the fixing member 113 is 1.5mm, and the second pitch between the second spiral turns constituting the fixing member 113 is 0.5mm to 0.9mm. The inner sheath 200 with the percutaneous implant electrode 10 is first advanced smoothly through the inner sheath passage until the distal end of the percutaneous implant electrode 10 and the distal end of the inner sheath 200 pass beyond the distal end of the outer sheath, because the muscle that has been penetrated by the previous test electrode will naturally close, and the operator will encounter pressure from the opening of the muscle again in the body, because the distal designed half-turn penetration blade 201 of the inner sheath 200 is sharp, and it has the ability to penetrate the already closed muscle tissue and enter the muscle tissue together with the distal end of the percutaneous implant 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 will be squeezed but will not enter the inner sheath 200, so that the muscle will have to enter the gap between the second helical turns of the distal fixation member 113 under such squeezing, causing the percutaneous implant electrode 10 to be anchored there, so that the muscle tissue will be more firm between the helical gaps during healing, thus ensuring electrode stimulation targets throughout the treatment. If the target is a tight muscle, it is preferable to use a distal fixation member 113 of a relatively short axial length as shown in fig. 7 (a), and the operator can choose a fixation member 113 of a suitable length according to the target muscle condition to be stimulated during the operation.

As above, if the target muscle is not tight and 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 spiral turns constituting the fixing member 113 is 0.5-0.9mm. As the inner sheath 200 is advanced into the muscle with the percutaneous implant electrode 10, more of the spiral length can be incorporated into the muscle. In addition, in the process of squeezing the muscles, along with the squeezing direction and the action of force, the longer spiral can be squeezed to form bending as shown in fig. 7 (b), and the looser muscles firmly fix the electrode in the patient under the action of the lengthened spiral hooks, so that the electrode is not dislocated in the stimulation treatment process, and the electrical stimulation curative effect is maintained.

Similarly, if the target muscle is a more slightly relaxed site, a helical fixation element 113 of longer axial length as shown in fig. 7 (b) may be used, such as: the axial length of the fixing member 113 is 3-5mm or more, and the second pitch between the second spiral turns constituting the fixing member 113 is 0.5-0.9mm. When the inner sheath 200 is inserted into the muscle with the percutaneous implant electrode 10, the longer distal spiral is inserted into the muscle to be hooked as shown in fig. 7 (c), so that the gap between the second spiral turns is not only combined with the muscle during the extrusion process of the distal spiral and the muscle, but also the bent second spiral turns can capture the muscle tissue in a wider range, thereby achieving the effect of fixing the distal electrode at the target point to the greatest extent, ensuring that the electrode is not dislocated during the stimulation treatment, and maintaining the electrical stimulation treatment effect.

Finally, when the electrical stimulation treatment is finished or the electrode needs to be pulled out, the distal fixing member 113 of the percutaneous implantation electrode 10 provided in this embodiment is firmly combined with the muscle tissue due to the spiral structure, so that the first stimulation electrode 111 and the distal spiral fixing member 113 are difficult to be simply pulled out by the operator, and the following electrode withdrawal method may be adopted: if the screw of the fixing member 113 is of a right-handed (left-handed) design, when the percutaneous implant electrode 10 is withdrawn, the operator is required to pull the electrode lead 121 in the direction F to the outside of the body while pulling the finger force points a and B left-handed (right-handed) as shown in fig. 8, so that the muscle tissue screw-fixed at the distal end releases the screw space and the electrode lead 121 is smoothly withdrawn from the body. At the boundary between the body and the outside of the body, the L-line is shown in fig. 8, where the fixing member 113, the first stimulation electrode 111, and the electrode lead 121 of the distal end portion of the L-line are portions that enter the body, and the electrode lead 121 of the proximal end portion is a portion that is exposed to the outside of the body.

In the above embodiment of the percutaneous implant electrode 10, in another embodiment, please refer to fig. 9, the implant 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 number of the stimulation electrodes is specifically set according to the need, 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 implant electrode is provided with a fixing component 113 with a spiral structure, and when in use, the electrode tail end 13 is also fully implanted in a patient, and the electronic component combination is remotely controlled by an external electronic device through human tissue and air and transmits an electrical signal and energy, so as to realize the stimulation and treatment of a nerve by the peripheral stimulation system. Therefore, the present invention is not particularly limited in the type of the implanted electrode, and the fixing member 113 of a spiral structure may be provided to the tip of any implanted electrode.

Example 1

Referring to fig. 1, the percutaneous implant electrode 10 provided in this embodiment has an electrode with 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 wire 121, a first pitch between adjacent first spiral turns forming the electrode body 12 is preferably 0.30-0.48mm, the first stimulation electrode 111 is tightly wound in a distal direction by the wire 122 forming the electrode wire 121 in a bare state to form a spiral structure, the spiral turns forming the first stimulation electrode 111 are sequentially attached along an axial direction, that is, adjacent spiral turns are tightly attached to each other, the tightly wound first stimulation electrode 111 structure can increase a stimulation surface area of the percutaneous implant electrode 10, and the wire 122 at a distal end of the first stimulation electrode 111 continues to extend distally 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 in a stimulation position during the treatment of the patient (30-90) days or even longer, and to reduce dislocation of the first stimulation electrode 111, thereby improving the treatment effect. The electrode body 12 is also partially implanted in the patient, and the flexibility generated by arranging the electrode body 12 into a special pitch open spiral structure can overcome the stretching and twisting of muscles in the patient, and the open insulating spiral structure can reduce the diameter of the percutaneous electrode 10 to the greatest extent, so that the risk of wound infection is effectively reduced. The percutaneous implant electrode 10 of this structure can be integrally manufactured by integrally forming the insulating layer 123 at the insulation position outside the wire 122 through the coating process, so that the straight line is fine and has high strength, and then integrally winding the fixing member 113, the first stimulating electrode 111, the electrode body 12 and the electrode tail 13 by adopting the spiral winding process, thereby greatly reducing the risk of post-fracture breaking generated by the processing process in the connection process of the conductor and the risk of connection separation in clinical use.

Example 2

Referring to fig. 2, the percutaneous implant electrode 10 provided in this embodiment has an electrode with 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 implant electrode body, and has better electrical and in vivo corrosion resistance than a general wire; the electrode body 12 is formed by spirally winding an electrode wire 121 according to a first pitch, in an embodiment, a metal wire 122 forming the electrode wire 121 extends distally through an electrode tube of the metal electrode in a bare or insulated state and then continues to extend and is spirally wound according to a second pitch to form the fixing member 113, and the metal wire 122 is electrically connected with the metal electrode. In another embodiment, the distal end of the wire 122 forming the electrode lead 121 extends into the proximal end of the electrode tube of the metal electrode and is electrically connected to the first stimulating 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 different from the wire 122 according to the need, or may even be a non-metal insulating material, and whether the material of the fixing member 113 and the material of the first stimulating electrode 111 are the same according to the need of electrical stimulation, 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 stimulating electrode 111. The wire 122 establishes a reliable mechanical connection or both mechanical and electrical connection with the first stimulation electrode 111 by welding, crimping or other mechanical connection means. The press-holding mode refers to a connecting method that a part of one part is plugged into another part, and then the two parts are fixed by pressing the combined part. The press-and-hold manner in this embodiment means that the electrode wire 121 or the wire constituting the fixing member 113 is inserted into the electrode tube, and then the electrode tube is pressed so that a reliable electrical connection is established between the wire 122 and the electrode tube.

Example 3

Referring to fig. 3, the percutaneous implant electrode 10 provided in this embodiment has two electrodes, which is a dual-electrode structure, the electrode tip 11 sequentially includes, from the proximal end to the distal end, a second stimulation electrode 112, a first stimulation electrode 111, and a fixing member 113, where the first stimulation electrode 111 and the second stimulation electrode 112 are arranged in an insulating manner along the same axial direction at intervals, and the interval is preferably 10-15 mm; the electrode body 12 is formed by spirally winding two electrode wires 121 according to a first pitch, the two electrode wires 121 are a first electrode wire 1211 and a second electrode wire 1212, the first stimulating electrode 111 is connected with the adapter 20 through the first electrode wire 1211, the second stimulating electrode 112 is connected with the adapter 20 through the second electrode wire 1212, and any one electrode or any combination of two electrodes of the first stimulating electrode 111, the second stimulating electrode 112 and the body surface electrode 70 is used as a stimulating electrode or a return electrode, and the rest one or two electrodes form a stimulating loop. Thus, the three electrodes of the first stimulation electrode 111, the second stimulation electrode 112 and the body surface electrode may form six different stimulation paths comprising stimulation electrodes and return electrodes, and each stimulation path may act on different neural tissue, or six may act on the same electrode implantation condition. Moreover, in the case of a combination of two electrodes, by distributing the intensity of the current between the two electrodes, the overall flow direction of the current is controlled, reaching the effect of the virtual electrode, providing new possibilities for improving the stimulation effect. The implanted electrode 10 with the bipolar structure has larger stimulation range and more stimulation modes compared with the monopolar structure, increases the diversity of treatment, realizes different stimulation functions and stimulation effects, and is beneficial to improving the clinical treatment effect.

With continued reference to fig. 3, the first stimulating electrode 111 and the second stimulating electrode 112 are tubular metal electrodes, the metal electrodes may be platinum iridium electrodes, the first electrode lead 1211 passes through an electrode tube of the second stimulating electrode 112, the metal wire 122 forming the first electrode lead 1211 extends distally through the electrode tube of the first stimulating electrode 111, then continues to extend distally and is spirally wound to form the fixing member 113, the metal wire 122 is electrically connected with the first stimulating electrode 111, and the metal wire 122 at the distal end of the second electrode lead 1212 extends into an electrode tube of the second stimulating electrode 112 and is electrically connected with the second stimulating electrode 112; the metal wire 122 of the first electrode wire 1211 may be electrically connected to the first stimulating electrode 111 by welding in a bare or insulated state, or the first electrode wire 1211 with the insulating layer 123 may be connected to the first stimulating electrode 111 by crimping, and the insulating layer 123 is broken to electrically connect the metal wire 122 to the first stimulating electrode 111; similarly, the wire 122 of the second electrode lead 1212 may be electrically connected to the second stimulating electrode 112 by soldering in a bare or insulated state, or the second electrode lead 1212 with the insulating layer 123 may be connected to the first stimulating electrode 112 by crimping, and the insulating layer 123 may be crushed to electrically connect the wire 122 to the second stimulating electrode 112. Further, the first electrode wire 1211 between the first stimulating electrode 111 and the second stimulating electrode 112 is sleeved with an insulating buffer sleeve 114, so as to avoid short circuit between the first stimulating electrode 111 and the second stimulating electrode 112, and improve electrical safety.

Example 4

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

The embodiments of the monopolar electrode and the bipolar electrode are respectively given above, the invention does not limit the number of the stimulating electrodes, more stimulating electrodes, such as more than 3 (including 3), can be arranged for increasing the stimulation requirement of the human body, as long as the stimulating electrode at the proximal end can accommodate the corresponding electrode lead to pass through, and the invention specifically refers to the above embodiment for combining a plurality of stimulating electrodes.

The minimum diameter spinal stimulation electrode on the market at present is 1.27mm, and the puncture needle for implanting the electrode needs to be thicker than 14G (G is the BWG wire gauge specification of Bermingham, and the larger the "G" is, the thinner the outer diameter of the needle tube is). Such a thick penetration is more difficult to implant for the peripheral nerve, so the clinical requirement for the peripheral nerve is to design the percutaneous implant electrode 10 to be a smaller diameter of 0.70mm, which is a significant challenge and difficulty encountered in the design and manufacture of this size range. Within this diameter range of the percutaneous implant electrode 10, a delivery sheath of 18G may be designed based on the configuration of the syringe to effectively and smoothly deliver or implant the percutaneous implant electrode 10 around the painful nerve desired by the physician. Thus, designing two spiral electrode wires 121 with a limited cross-sectional area and being resistant to fatigue twisting and bending, and insulating between the two electrode wires 121 is also a great challenge. The electrode wire 121 provided in this embodiment selects a stainless steel wire or cable, the MP35N nonmagnetic nickel cobalt chromium molybdenum alloy wire or cable is wound to form an elastic slender spiral electrode wire 121, the cable is formed by hinging a plurality of strands of stainless steel wires, the fatigue resistance performance is better, and the elasticity and flexibility of the spiral electrode wire 121 can overcome stretching and extrusion of internal muscles. The material design of the insulating layer 123 of the two-strand electrode wire 121 is extruded into a tube by using a polymer material PU, PTFE or ETFE, and the tube is applied to the outer layer of the metal wire 122, or the polymer material PU, PTFE or ETFE is sprayed onto the metal wire 122 by using a coating process to form the insulating layer 123, so that insulation between the first electrode wire 1211 and the second electrode wire 1212 is ensured, and the insulating wall is ensured to be uniform in both extrusion and spraying processes, so that the insulating performance between the first electrode wire 1211 and the second electrode wire 1212 can be ensured in the implantation treatment process. The diameter of the wire 122 is preferably 0.1mm to 0.15mm, and the outer diameters of the first and second stimulating electrodes 111 and 112 are preferably 0.55mm to 0.70mm. Although the bipolar percutaneous implant electrode 10 is adopted in the peripheral nerve stimulation system provided in this embodiment, the first electrode wire 1211 and the second electrode wire 1212 are insulated and then wound into an open insulated spiral structure, and the percutaneous implant electrode 10 with the first and second stimulation electrodes 111 and 112 can be implanted into the body by using the implantation tool (puncture needle) with the same diameter and size as the existing similar products, so that the trauma is small, and more effective treatment can be provided for nerve regulation.

Referring to fig. 10, 11 a-11 c, 12a and 12b, the peripheral nerve stimulation system using the percutaneous implant electrode 10 provided by the present invention includes the percutaneous implant electrode 10, the adapter 20, the first cable 30, the stimulator 50, the remote controller 60 and the body surface electrode 70; the adaptor 20 is electrically connected to the proximal end of the percutaneous implant electrode 10, and further, the electrode wire 121 constituting the electrode body 12 may be linearly extended toward the proximal end to form the electrode tail 13. Specifically, the adaptor 20 is electrically connected with the wire 122 forming the electrode body 12, and the adaptor 20 can penetrate through the insulating layer 123 of the electrode wire 121 to establish a reliable connection with the wire 122 inside, and the connection position can be on the electrode body 12 or on the electrode tail end 13; in other embodiments, the wire 122 distal to the electrode tail 13 may be exposed and electrically connected to the adaptor 20. The adaptor 20 is electrically connected to the stimulator 50 through the first cable 30, and the stimulator 50 is used for transmitting electrical stimulation pulses; the body surface electrode is electrically connected to the stimulator 50 and forms a circuit with the percutaneous implant electrode 10. As shown in fig. 11a, in an embodiment, the body surface electrode is a fixed body surface electrode 70, the fixed body surface electrode 70 is fixed at the bottom of the stimulator 50, and is electrically connected to the stimulator 50 through a 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 to adhere the whole stimulator 50 to the skin of a human body, the first body surface electrode interface 71 is disposed on the first body surface patch 701 and is communicated with the hydrogel 702, and the hydrogel 702 is electrically conductive to form an electrically conductive layer. Meanwhile, an electrode interface is arranged on the stimulator 50, 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 adhered and fixed on the body surface of a patient through the hydrogel 702 on the surface of the stimulator, 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 electric 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 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 to attach the movable body surface electrode 80 to the skin of the human body, the second body surface electrode interface 81 is disposed on the second body surface patch 801 and is in communication with the hydrogel 802, the hydrogel 802 forms a conductive layer, in this embodiment, a third body surface patch 901 is further included, a third body surface electrode interface 91 is disposed on the third body surface patch 901, an adhesive 902 is coated on the third body surface patch 901, the adhesive 902 is a skin-friendly adhesive, the whole stimulator 50 is adhered to the skin of the human body by the adhesive 902, the patient or doctor can select to connect the movable body surface electrode 80 to the stimulator 50 by the second cable 72, specifically, one end of the second cable 72 is connected to the second body surface electrode interface 81, 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 connected to the stimulator 50 and the whole surface of the skin of the human body surface electrode 901, and the whole stimulator is electrically connected to the whole surface of the skin of the human body surface electrode 50 by the adhesive 902 and forms a mechanical circuit to form a stimulation circuit, and the stimulation circuit is electrically and can be electrically fixed to the whole surface of the stimulator 50 and can be electrically connected to the whole surface of the stimulator 50 via the whole surface patch and the surface of the stimulator. By the second cable 72 being led out, the movable body surface electrode 80 can be placed at any site where the patient needs stimulation, for example, at a site most sensitive to the stimulation, more effectively suppressing pain. Further, the multifunctional electric stimulation device further 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 and the second wiring port 41 are in matched detachable connection, 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 electric stimulation device is convenient to use. In other embodiments, the first cable 30 and the third cable 40 are non-detachable integral connections. Whether the cables are detachably connected or not is set according to the requirement, and the invention is not limited to the detachable connection.

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

With continued reference to fig. 11a, 11b and 11c, the patient selects the stimulation program and the stimulation intensity prescribed by the doctor through the remote controller 60, and 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 64, a control key 61, a display screen 62 and a hanging hole 63, where the hand grip 64 is preferably sized and shaped so that the patient can hold with one hand, and the control key 61 is disposed at the end of the hand grip 64, so as to facilitate the operation of the patient with one hand. The hanging hole 63 is disposed at the tail of the hand grip, and is hung for storage when the patient is not using the device, and the display screen 62 is disposed on the top surface of the hand grip 64, for displaying stimulation parameters and the like. The remote control 60 stores the stimulation program number and the stimulation intensity number, which correspond to the contents of the program table and the intensity table in the solidification memory of the stimulator 50, respectively. In another embodiment, as shown in fig. 6b, the remote controller 60 includes a hand holding portion 64, a control key 61 and a display screen 62, the hand holding portion 64 is preferably sized and shaped so that the patient can hold the remote controller with one hand, the control key 61 and the display screen 62 are both disposed on the top surface of the hand holding portion 64, so that the patient can remotely control the remote controller with one hand, and further, a USB interface 65 is disposed on the side surface of the hand holding portion 64, so that the remote controller 60 can be charged. Further, as shown in fig. 6c, the stimulator 50 may be controlled by the stimulation programmer 100, and the stimulation programmer 100 may be used to set stimulation parameters and stimulation programs for the stimulator 50 by installing a stimulation programming application on a 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 implant electrode 10 provided by the present invention, taking the movable body surface electrode 80 and the percutaneous implant electrode 10 as the double electrode structure as examples, in use, the percutaneous implant electrode 10 having the first stimulation electrode 111 and the second stimulation electrode 112 is implanted into the vicinity of 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 on the body surface of the patient 3, the movable body surface electrode 80 is placed on the place where the patient 3 needs to be stimulated through the second cable 72, during the treatment, the patient 3 selects the stimulation procedure and the stimulation intensity through the remote controller 60, and the target site is stimulated through the stimulator 50. In addition, the system includes a stimulation programmer 100 implemented by a tablet computer for a physician. During electrode implantation, the physician determines the integrity and function of the electrode by manipulating the control interface of the stimulation programmer 100. In another embodiment, the physician coordinates and determines the stimulation protocol (program) including waveform, modulation method and safe stimulation intensity range through the programming interface of the stimulation programmer 100 and solidifies these parameters into the stimulator 50, the patient selects a certain stimulation program and stimulation intensity by selecting a numbered form with the remote control 60, bluetooth communication transmits control information to the stimulator 50, the stimulator 50 generates a specific current pulse sequence according to the selected program, outputs to the target nerve tissue via one of the external lead, the adapter 20 and the implanted electrode, and composes a stimulation circuit via the other of the implanted electrodes or the designated body surface electrode.

Referring to fig. 14, the stimulator 50 is a three-channel bi-directional current pulse stimulator, and includes a controller 51 and a pulse generator 52, wherein the pulse generator 52 includes at least one pulse source 521, and the controller 51 controls the output amplitude, the current direction, the pulse width and/or the timing of the pulse source 521. The controller 51 is a microprocessor or a stimulator-specific control chip. In another embodiment, the three-channel pulse generator 52 is implemented with three independent bi-directional current pulse sources 521 as electrode drivers (drivers). Each pulse source 521 is capable of individually controlled generation of cathodic (N) and anodic (P) current pulses. One of the pulse sources 521 drives the body surface electrode 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 (index), i.e. either one or a combination of both electrodes can be used as the stimulation electrode (cathode) or the return electrode (anode), with the remaining one or both electrodes making up the stimulation return. Thus, three electrodes may form six different stimulation pathways consisting of stimulation electrodes and return electrodes, as shown in fig. 15 (a). Each stimulation channel may be active on a different nerve tissue or six possible stimulation options may be available under the same electrode implantation conditions. In contrast, as shown in fig. 15 (b), in the case of combining two electrodes, by distributing the Current intensity between the two electrodes, the overall Current flow (Current Steering) can be controlled to reach the effect of the virtual electrode, thereby providing a new possibility for improving the stimulation effect. When the stimulation occurs, the pulse source of the stimulating electrode and the pulse source of the return electrode form a "bridge" push-pull output mode, as shown in fig. 16 (a), and during the stimulating phase, current flows from the anode to the cathode, and during the balancing phase, the current is reversed, as shown in fig. 16 (b).

In summary, the present invention has at least the following advantages: 1. the distal end of the percutaneous implantation electrode is provided with a spiral wound fixing part, when the percutaneous implantation electrode is conveyed to the vicinity of nerves or other treatment targets by the inner sheath, the equal part of the outer diameter of the distal spiral fixing part and the inner diameter of the inner sheath is prevented from continuously moving to the inside of the inner sheath, extrusion is generated between the outer diameter of the distal spiral fixing part and the pushing force of the inner sheath, and as a result, muscle tissue enters a spiral gap of the fixing part to fix the distal end of the electrode, so that the electrode is fixed with a human body, and the problems of poor fixing effect of the current 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, and when the electric 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 exit human tissues atraumatically, the problems that the existing product fixing mechanism is easy to fatigue and the electrode is broken when pulled out are solved, and more effective treatment is provided for nerve regulation. 3. The electrode body of the percutaneous implantation electrode is wound after the external insulation of the metal wire to form an open type spiral structure, compared with the method that a closed type insulating layer is formed on the periphery after the spiral winding of the metal wire, the electrode body is more favorable for bearing the traction of muscle tissues in a body, and has better elasticity; 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 that the electrode has less trauma to human bodies, more effective treatment is provided for nerve regulation and control, and the risk of wound infection 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 caused by a processing technology in the connection process of the conductor and the risk of connection separation caused by fatigue and abrasion in clinical use are reduced. 5. The electrode body of the percutaneous implantation electrode is designed by superposing two tiny insulating metal wires in a spiral shape, a tubular or spiral bipolar electrode and a fixing part for fixing human tissues are formed at the far end of the percutaneous implantation electrode, and three electrodes consisting of the bipolar electrode and a body surface electrode can form six different stimulation passages consisting of a stimulation electrode and a return electrode, wherein each stimulation passage can play a role on different nerve 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, reaching the effect of the virtual electrode, providing new possibilities for improving the stimulation effect.

While the invention has been described with reference to the preferred embodiments, it is not intended to limit the invention thereto, and it is to be understood that the invention is not limited thereto but is capable of modification and development in any such manner as will be apparent to those skilled in the art.

Claims (13)

1. A percutaneous implant electrode for peripheral nerve stimulation, comprising an electrode tip and an electrode body, the electrode tip comprising at least one stimulation 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; the implanted electrode is matched with a conveying tool, the conveying tool comprises an outer sheath, a test electrode and an inner sheath, the outer diameter of the fixing part is larger than the inner diameter of the inner sheath, the outer diameter of the fixing part is smaller than the inner diameter of the outer sheath, when the implanted electrode is implanted, the assembly after the test electrode is inserted into the outer sheath punctures a stimulation target point, the test electrode is pulled out, the assembly after the percutaneous implanted electrode is inserted into the inner sheath passes through the outer sheath which is reserved in the body and is conveyed to the stimulation target point, the fixing part is prevented from moving towards the inside of the inner sheath, and extrusion is generated between the fixing part and pushing force of the inner sheath, so that muscle tissue enters a spiral gap of the fixing part, and the distal end of the electrode is fixed.

2. The implant electrode of claim 1, wherein the electrode body is helically wound from at least one electrode wire, the electrode wire comprising a wire and an insulating layer wrapped around the wire such that the electrode body is in an open insulated spiral configuration; or, the electrode body is a strand of metal wire cable wrapping the insulating layer.

3. The implant electrode of claim 2, wherein first turns constituting the electrode body are sequentially arranged at a first pitch along an axial direction, and second turns constituting the fixing member are sequentially arranged at a second pitch along the axial direction, 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 in the axial direction of 1.5mm to 5mm.

5. The implant electrode of claim 1, wherein the fixation member forms a transition section having a diameter that gradually increases from the proximal end to the distal end to a maximum diameter, and wherein the fixation member resides at a distal port of the inner sheath that no longer enters the inner sheath where an outer diameter of the transition section is equal to an inner diameter of the inner sheath when the implant electrode is inserted into the inner sheath.

6. The implant electrode of claim 2, wherein said electrode tip comprises a first stimulation electrode, said electrode body being helically wound from an electrode lead, said first stimulation electrode being helically tightly wound in a distal direction from said wire comprising said electrode lead in an exposed state, said wire distal to said first stimulation electrode continuing to be helically wound distally to form said securing means.

7. The implant electrode according to 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 a tubular metal electrode, a metal wire forming the electrode lead extends distally through an electrode tube of the metal electrode and then continues to extend and spirally wind to form the fixing component, and the metal wire is electrically connected with the metal electrode, or the distal end of the metal wire forming the electrode lead extends into a proximal end of the electrode tube of the first stimulation electrode and is electrically connected with the first stimulation electrode, and the proximal end of the fixing component extends into a distal end of the electrode tube of the first stimulation electrode and is connected with the first stimulation electrode.

8. The implant electrode according to claim 2, wherein the electrode tip comprises, in order from the proximal end to the distal end, a second stimulation electrode, a first stimulation electrode and a fixing member, the first stimulation electrode and the second stimulation electrode being arranged in an insulating manner at intervals along the same axial direction; the electrode body is formed by spirally winding two electrode wires, and the two electrode wires are a first electrode wire and a second electrode wire respectively.

9. The implant electrode according to claim 8, wherein the first stimulation electrode and the second stimulation electrode are tubular metal electrodes, the first electrode lead wire is insulated to pass through an electrode tube of the second stimulation electrode, the metal wire forming the first electrode lead wire extends distally through the electrode tube of the first stimulation electrode and then continues to extend distally and spiral to form the fixing part, the metal wire of the first electrode lead wire is electrically connected with the first stimulation electrode, and the metal wire of the distal end of the second electrode lead wire extends into the electrode tube of the second stimulation electrode and is electrically connected with the second stimulation electrode; or the metal wire forming the second electrode wire extends to the distal end in the exposed state and is spirally and tightly wound to form the second stimulation electrode, the distal end of the first electrode wire penetrates through the cavity formed by the spiral of the second stimulation electrode in an insulating manner, the metal wire forming the first electrode wire extends to the distal end in the exposed state and is spirally and tightly wound to form the first stimulation electrode, and the metal wire at the distal end of the first stimulation electrode continues to extend to the distal end and is spirally 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 316L stainless steel wire or MP35N non-magnetic nickel cobalt chromium molybdenum alloy wire; the insulating layer is made of polyurethane, polytetrafluoroethylene or ethylene-tetrafluoroethylene copolymer, and is extruded into a tube and then is applied to the periphery of the metal wire, or is sprayed onto the metal wire by a coating process.

12. The implant electrode of claim 1, wherein the implant electrode is a fully implanted peripheral electrode, the proximal end of the electrode body is provided with an electrode tail, and the electrode tail is wrapped with a combination of electronic components that can produce a stimulation function.

13. A peripheral nerve stimulation system comprising the implant electrode of any one of claims 2-11, 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 implantation 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.