Stimulation device

Abstract

The present application discloses a stimulation device. The stimulation device includes a puncture needle, a use electrode, an auxiliary electrode and a signal generator. The puncture needle includes a puncture needle through hole. The auxiliary electrode can pass through the puncture needle through hole, be implanted into the human body and connected to the signal generator, and the use electrode replaces the auxiliary electrode when the puncture position of the auxiliary implant end contact is the required position, is implanted into the human body and connected to the signal generator. As set up as above, since the use electrode can replace the auxiliary electrode, the implantation of the use electrode is simple and convenient, and the wound formed by the puncture of the puncture needle is small.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to stimulation devices. Background Art

[0002] Implantable neural electrical stimulation is a treatment method that excites, inhibits or regulates the conduction of the nervous system through electrical stimulation, thereby restoring or improving the functioning of the human body. This treatment method is increasingly being used. A stimulator is a medical device used for neural electrical stimulation, which includes electrodes. However, in actual use, it is inconvenient to implant electrodes into the human body, and the wound is large. Summary of the invention

[0003] The present application discloses a stimulator which can facilitate electrode implantation and has a small incision.

[0004] To achieve the above-mentioned purpose, the embodiment of the present application discloses a stimulation device. The stimulation device is used for nerve stimulation, and includes a puncture needle, a use electrode, an auxiliary electrode and a signal generator. The puncture needle includes a puncture needle through hole. The auxiliary electrode includes an auxiliary implant end, and the auxiliary implant end includes an auxiliary implant end contact. The auxiliary implant end passes through the puncture needle through hole and is implanted into the human body; the signal generator is connected to the auxiliary electrode, and a feedback signal of the auxiliary implant end contact is obtained through the auxiliary electrode, and whether the puncture position of the auxiliary implant end contact is the desired position is determined according to the feedback signal; the use electrode replaces the auxiliary electrode when the puncture position of the auxiliary implant end contact is the desired position, is implanted into the human body and connected to the signal generator. As set up as above, since the puncture needle is used to pierce the human body, and the use electrode replaces the auxiliary electrode when the puncture position of the auxiliary electrode is the desired position, the implantation of the use electrode is simple and convenient, and the wound formed by the puncture of the puncture needle is small.

[0005] Optionally, the gap between the puncture needle through hole and the auxiliary electrode or the working electrode is 0.05 to 1 mm, and / or the auxiliary electrode and the puncture needle are connected by a buckle, so that the auxiliary electrode and the puncture needle can be relatively fixed or separated. With this arrangement, since the gap is 0.05 mm to 1 mm, it is convenient to implant the auxiliary electrode, and it is also convenient to pull out the puncture needle and leave the working electrode in the human body when using the working electrode.

[0006] Optionally, the electrode used includes an implantation end, a connection end, and a guide wire, the implantation end includes at least two implantation end contacts and an anti-slip structure, and there is a height difference between the anti-slip structure and the implantation end contact in the radial direction of the electrode; the connection end includes a connection end contact, and the connection end contact and the implantation end contact are electrically connected through the corresponding guide wire. In this arrangement, due to the existence of the anti-slip structure, and the anti-slip structure can form a height difference with the implantation end contact in the radial direction of the neural stimulation electrode, so that after the implantation end of the neural stimulation electrode is implanted in the human body, the height difference can improve the displacement of the neural stimulation electrode. In addition, since there are at least two implantation end contacts, the efficiency of electrical stimulation is higher.

[0007] Optionally, the anti-slip structure includes an anti-slip arm, the anti-slip arm is inclined toward the connection end, and the height difference is formed between the free end of the anti-slip arm and the implant end contact. In this arrangement, since the anti-slip arm is inclined toward the connection end, the implant end will be hooked, which can better prevent the displacement of the nerve stimulation electrode.

[0008] Optionally, the implant end includes an implant end body, the anti-slip arm is folded back from the end of the implant end body toward the connecting end to form a hook shape with the implant end body, and all the implant end contacts are arranged on the implant end body; or, the implant end includes an implant end body, the anti-slip arm is folded back from the end of the implant end body toward the connecting end to form a hook shape with the implant end body, and the implant end contacts are respectively arranged on the anti-slip arm and the implant end body. With such an arrangement, the above two embodiments can prevent the displacement of the neural stimulation electrode. Compared with the two, in the case where the anti-slip structure includes the implant end contacts, there are more stimulation points and a better stimulation effect. Moreover, the anti-slip arm not only has the function of preventing displacement, but also includes implant end contacts, which indirectly simplifies the structure of the neural stimulation electrode.

[0009] Optionally, the anti-slip arm satisfies at least one of the following conditions: the length of the anti-slip arm extending from the inflection point is L1, 1mm≤L1≤50mm; the angle between the anti-slip arm and the implant end body is α, 30 degrees≤α≤60 degrees. In this way, the length L1 is within the above range, which not only makes it more difficult for the neural stimulation electrode to shift, but also facilitates implantation and removal of the electrode. Similarly, the angle α within the above range can also make it difficult for the neural stimulation electrode to shift and facilitate implantation, and also facilitate the removal of the electrode.

[0010] Optionally, the anti-detachment arm is in a straight line or an arc shape. In this way, the anti-detachment arm is in a straight line or an arc shape, which can be conveniently implanted and prevent the displacement of the nerve stimulation electrode, and is more convenient to remove the electrode.

[0011] Optionally, the implant end includes an implant end body provided with the implant end contact, the use electrode includes an anti-slip part, and the anti-slip part includes an anti-slip part body sleeved with the implant end body and the anti-slip structure connected to the anti-slip part body. In this arrangement, since the anti-slip part is sleeved on the implant end body as a separate component, more anti-slip structures can be formed on the anti-slip part, so as to better prevent the displacement of the nerve stimulation electrode.

[0012] Optionally, the anti-slip structure is an anti-slip arm extending from the anti-slip body to the connecting end, and the width between the anti-slip arm and the anti-slip body gradually increases along the length direction of the anti-slip body. In this way, because the width between the anti-slip arm and the anti-slip body gradually increases along the length direction of the anti-slip body, the anti-slip arm can better prevent the nerve stimulation electrode from being displaced.

[0013] Optionally, the anti-slip arm satisfies at least one of the following conditions: the length of the anti-slip arm extending from the anti-slip body is L2, 1mm≤L2≤10mm; the angle between the anti-slip arm and the anti-slip body is β, 30 degrees≤β≤60 degrees; there are at least two anti-slip arms and they are evenly arranged along the circumference of the anti-slip body. With such an arrangement, when any of the above conditions is met, the anti-slip part can have a good anti-slip effect and prevent the displacement of the neural stimulation electrode. For example, since the anti-slip arm is also folded back toward the connecting end, when there are at least two anti-slip arms and they are evenly arranged along the circumference of the anti-slip body, the anti-slip arms are distributed around the anti-slip body in the form of an umbrella, which has a good effect of preventing displacement and is more convenient for removing the electrode.

[0014] Optionally, the implant end contacts are respectively arranged on both sides of the anti-dropout member body, and / or the length of the implant end contact between the anti-dropout member body and the end of the implant end body is L3, 1mm≤L3≤30mm. With such arrangement, the above two embodiments can make the anti-dropout member not easy to be displaced or fall off, thereby ensuring that the neurostimulation electrode is not easy to be displaced or fall off.

[0015] Optionally, the implant end includes an implant end body, and the anti-slip structure extends from the implant end body to the outside of the implant end body or is recessed inside the implant end body, and forms a step structure with adjacent implant end contacts. As set up above, the anti-slip structure and the implant end body form a step to prevent the electrode from being displaced, and there is no need to deliberately set up an additional anti-slip structure (such as the aforementioned anti-slip member), and the structure of the electrode is simple.

[0016] Optionally, the implant end contacts are arranged at intervals on the implant end body to form a groove, the anti-slip structure is the groove, and / or the length of the anti-slip structure along the length direction of the implant end body is L4, 1mm≤L4≤30mm. In this arrangement, since the anti-slip structure is a groove formed by the implant end contacts, for the entire neural stimulation electrode, there is no need to set up additional related structures to form the anti-slip structure, and the structure of the electrode is simple. The length L4 is within the above range, which can better prevent the neural stimulation electrode from being displaced.

[0017] Optionally, the nerve stimulation electrode includes a tube body and a guide wire. The tube body includes a plurality of receiving holes that penetrate the tube body along the axial direction of the tube body, and the guide wires correspond to the receiving holes one by one, and are passed through the receiving holes and are filled with glue to fill the gap between the corresponding guide wires and the receiving holes. In this way, by passing the guide wires through the receiving holes, not only can the manufacturing process of the nerve stimulation electrode be simplified, but also each guide wire can be isolated from each other, and signal transmission will not be interfered with. Finally, the guide wire can be firmly fixed in the guide wire through the glue filling process.

[0018] Optionally, the electrodes used include implantation end contacts and connection end contacts, the number of the implantation end contacts is 1-64, and the number of the connection end contacts is 1-64. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is an exploded view of a stimulator of the present application when an auxiliary electrode is used;

[0020] Figure 2 is a cross-sectional view of a stimulator of the present application when an auxiliary electrode is used;

[0021] Figure 3 This is a cross-sectional view of the first electrode inserted into the puncture needle of the present application;

[0022] Figure 4 yes Figure 3 A partial enlarged view of part A;

[0023] Figure 5 yes Figure 3 A more detailed schematic diagram of a first use electrode is shown;

[0024] Figure 6 is a schematic diagram of the second electrode used in the present application;

[0025] Figure 7 yes Figure 6 A partial enlarged view of part B;

[0026] Figure 8is a schematic diagram of the third electrode used in the present application;

[0027] Fig. 9 yes Figure 8 A partial enlarged view of part C in the middle;

[0028] Fig.10 is a schematic diagram of the fourth electrode used in the present application;

[0029] Fig.11 yes Fig.10 A partial enlarged view of part D in the middle;

[0030] Fig.12 This is a cross-sectional view of an electrode used in the present application along the radial direction. DETAILED DESCRIPTION

[0031] Exemplary embodiments will be described in detail herein, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, the same numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present application. Instead, they are merely examples of devices consistent with some aspects of the present application as detailed in the appended claims.

[0032] The terms used in this application are only for the purpose of describing specific embodiments and are not intended to limit this application. Unless otherwise defined, the technical terms or scientific terms used in this application should be understood by people with ordinary skills in the field to which this application belongs. Similar words such as "one" or "one" used in this application specification and claims do not indicate a quantitative limitation, but indicate that there is at least one. Similar words such as "include" or "include" mean that the elements or objects appearing in front of "include" or "include" cover the elements or objects listed after "include" or "include" and their equivalents, and do not exclude other elements or objects. Similar words such as "connect" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Multiple" includes two, which is equivalent to at least two. The singular forms of "one", "said" and "the" used in this application specification and the attached claims are also intended to include plural forms, unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used in this article refers to and includes any or all possible combinations of one or more associated listed items.

[0033] See also Figures 1 to 4, the embodiment of the present application discloses a stimulator. The stimulator can be used for nerve stimulation, including using an electrode 1, a puncture needle 2, an auxiliary electrode 3 and a signal generator 4. The puncture needle 2 includes a puncture needle through hole 21. The auxiliary electrode 3 includes an auxiliary implant end 31, and the auxiliary implant end 31 includes an auxiliary implant end contact (not marked), and the auxiliary implant end 31 passes through the puncture needle through hole 21 and is implanted into a human body, such as a nerve 5. The signal generator 4 is connected to the auxiliary electrode 3, and a feedback signal of the auxiliary implant end contact is obtained through the auxiliary electrode 3, and whether the puncture position of the auxiliary implant end contact is the desired position is determined according to the feedback signal. How to obtain the feedback signal and determine the desired position can be adopted in any way, which will not be repeated. The using electrode 1 replaces the auxiliary electrode 3 when the puncture position of the auxiliary implant end contact is the desired position, is implanted into the human body and connected to the signal generator 4, so that the signal generator 4 can send a signal to perform relevant stimulation. The signal generator 4 is, for example, a pulse generator.

[0034] The method of replacing the auxiliary electrode 3 can be as follows: after confirming that the puncture position is the desired position, the puncture needle 2 remains on the human body, the auxiliary electrode 3 is separated from the signal generator 4, and the auxiliary electrode 3 is taken out from the puncture needle through hole 21 of the puncture needle 2. Then, the working electrode 1 is inserted through the puncture needle through hole 21 until the implantation end 11 of the working electrode 1 is implanted in the desired position. Finally, the puncture needle 2 is pulled out, and the puncture needle 2 moves along the working electrode 1 toward the signal generator 4 until it is separated from the working electrode 1. After separation, the working electrode 1 remains on the human body.

[0035] In the above embodiment, the electrode 1 and the auxiliary electrode 3 may be used to penetrate the puncture needle 2 in any manner, for example, through a motor and a corresponding motor module, etc.

[0036] As described above, since the puncture needle is used to pierce the human body, and the auxiliary electrode 3 is replaced by the working electrode 1 when the puncture position is the required position, the implantation of the working electrode 1 is simple and convenient, and the wound formed by the puncture needle 2 is small.

[0037] In some embodiments, the gap between the puncture needle through hole 21 and the auxiliary electrode 3 or the working electrode 1 is 0.05 to 1 mm, for example, 0.05 mm, 0.08 mm, 0.1 mm, 0.15 mm, 0.2 mm, 0.23 mm, 0.28 mm, 0.3 mm, 0.35 mm, 0.38 mm, 0.4 mm, 0.45 mm, 0.5 mm, 0.56 mm, 0.6 mm, 0.67 mm, 0.7 mm, 0.75 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.92 mm, 0.96 mm, 1 mm, etc. The gap is, for example, the difference between the diameter of the puncture needle through hole 21 and the diameter of the auxiliary electrode 3 or the working electrode 1. As described later, in the case where the electrode 1 includes an anti-detachment structure 112, the gap between the puncture needle through hole 21 and the electrode 1 refers to the radial distance between the inner wall of the puncture needle through hole 21 and the anti-detachment arm 1121. Figures 5 to 9 In the embodiment shown, it may be the difference between the diameter of the puncture needle through hole 21 and the diameter of the electrode 1, such as Fig. 9 and Fig.10 In this configuration, since the gap is 0.05 mm to 1 mm, it is convenient to implant the auxiliary electrode 3 and it is also convenient to pull out the puncture needle 2 and leave the working electrode 1 in the human body when the working electrode 1 is used.

[0038] In addition, in some embodiments, the auxiliary electrode 3 is connected to the puncture needle 2 by a buckle, so that the auxiliary electrode 3 can be relatively fixed or separated from the puncture needle 2. In this way, when the auxiliary electrode 3 needs to be replaced, the auxiliary electrode 3 can be relatively fixed to the puncture needle 2, and when it needs to be replaced, the auxiliary electrode 3 can be separated from the puncture needle 2, thereby making the auxiliary electrode 3 easy to disassemble and firmly fixed.

[0039] Please continue reading Figure 2 and Figure 1 , the signal generator 4 is attached to the human body surface 6, and the stimulator includes a handheld controller, which is wirelessly connected to the signal generator 4 to send a control signal to the signal generator 4. With such a configuration, it is convenient to operate the signal generator 4. The control signal is, for example, a signal related to adjusting the frequency, pulse, etc. of the signal generator 4.

[0040] See also Figures 5 to 11 Combined with Figure 4 and Figure 3In order to improve the problem of displacement of the electrode, the embodiment of the present application discloses a first electrode 1. The electrode 1 includes an implant end 11, a connecting end 12 and a guide wire 13. The implant end 11 includes at least two implant end contacts 111 and an anti-slip structure 112. Figures 5 to 11 The embodiment shown includes at least two implant end contacts 111, but the technician can understand that the implant end contact 111 can also be one. There is a height difference between the anti-slip structure 112 and the implant end contact 111 in the radial direction of the electrode 1. The connecting end 12 includes a connecting end contact 121, and the connecting end contact 121 and the implant end contact 111 are electrically connected through the corresponding guide wire 13. In this way, by the existence of the anti-slip structure 112, and the anti-slip structure 112 can form a height difference with the implant end contact 111 in the radial direction of the use electrode 1, so that after the implant end 11 of the use electrode 1 is implanted in the human body, the height difference can improve the displacement of the use electrode 1, for example, prevent the use electrode from being displaced. In addition, since there are at least two implant end contacts, the efficiency of electrical stimulation is higher.

[0041] As follows, several structures using electrodes are described in more detail with reference to the accompanying drawings.

[0042] See also Figure 5 Combined with Figure 3 and Figure 4 , Figure 5 The first embodiment of the electrode used in the present application is shown. In this embodiment, the anti-slip structure 112 includes an anti-slip arm 1121, the anti-slip arm 1121 is inclined toward the connection end 12, and the height difference is formed between the free end 1122 of the anti-slip arm 1121 and the implant end contact 111, such as Figure 5 As shown, the height difference is marked as H. In this arrangement, since the anti-slip arm 1121 is inclined toward the connecting end 12, and the height difference is formed between the free end 1122 of the anti-slip arm 1121 and the implant end contact 111, the implant end will be hooked, which can better prevent the displacement of the electrode. Based on the role of the anti-slip arm 1121, the technician can understand that the structure of the anti-slip arm 1121 can be any shape, not limited to a straight line as shown in the figure, and can be an arc, etc.

[0043] Please continue reading Figure 5In one embodiment, the implant end 11 includes an implant end body 113, and the anti-drop arm 1121 is folded back from the end of the implant end body 113 toward the connection end 12 to form a hook with the implant end body 113. The implant end body 113 can be considered as the part of the implant end 11 other than the anti-drop structure. All the implant end contacts 111 are arranged on the implant end body 113.

[0044] In another embodiment, the implant end 11 includes an implant end body 113. The anti-drop arm 1121 is bent back from the end of the implant end body 113 toward the connection end 12. The implant end contact 111 is respectively arranged on the anti-drop arm 1121 and the implant end body 113. That is to say, compared with the previous embodiment, the anti-drop arm 1121 is also provided with the implant end contact 111. Figure 5 , Figure 6 and Figure 7 As shown, an implantation end contact is provided on the free end 1122 of the anti-detachment arm 1121. In this case, the implantation end contact 111 on the anti-detachment arm 1121 is electrically connected to the implantation end contact on the implantation end body 113.

[0045] The other structures of the electrodes used in the implant end contact 111, which are respectively arranged on the anti-detachment arm 1121 and the implant end body 113, are described as follows: First, take the implant end contact 111 and the connection end contact 121 as an example, and weld the tail end of the guide wire 13 having the implant end contact 111 and the connection end contact 121, that is, weld the connection end contact 121 located at the connection end, so as to form a pair of contacts, which form an electrical conduction structure through the guide wire 13. Another implant end contact 111 and another connection end contact 121 are inserted and form an electrical conduction structure with the corresponding guide wire 13. The sealing part 114 is formed between the implant end contacts 111 and the connection end contacts 121, respectively, so that the implant end contacts 111 and the connection end contacts 121 are respectively formed in an electrically isolated state. On the basis of the above, a coating 115 is formed. The implant end 11 is bent toward the connecting end 12 to form the anti-detachment arm 1121. For the convenience of description, the part of the implant end 11 other than the anti-detachment structure 112 is referred to as the implant end body 113. Thus, the anti-detachment arm 1121 and the implant end body 113 form a hook shape, making the implant end 11 become a hook shape.

[0046] Compared with the above two embodiments, the difference lies in whether the implant end contact 111 is provided on the anti-detachment arm 1121. In the case where the anti-detachment structure 112 includes the implant end contact 111, there are more stimulation points and a better stimulation effect. Moreover, the anti-detachment arm 1121 not only has the function of preventing displacement, but also includes the implant end contact 111, which indirectly simplifies the structure of the electrode 1.

[0047] Please continue reading Figure 5 , the anti-slip arm 1121 satisfies at least one of the following conditions: the length of the anti-slip arm 1121 extending from the inflection point is L1, 1mm≤L1≤50mm, for example, 1mm, 3mm, 5mm, 8mm, 10mm, 13mm, 15mm, 18mm, 20mm, 22mm, 25mm, 28mm, 30mm, 33mm, 35mm, 38mm, 40mm, 43mm, 45mm, 48mm, 50mm, etc. Etc., when the anti-slip arm 1121 is arc-shaped, the length L1 is the arc length, and when the anti-slip arm 1121 is straight, the length L1 is the length of the straight line; the angle α between the anti-slip arm 1121 and the implant end body 113, α can be an acute angle, in some embodiments, 30 degrees ≤ α ≤ 60 degrees, and the value of α is, for example, 30, 32, 35, 38, 40, 43, 45, 50, 52, 55, 58, 60, etc. In this way, the length L1 is within the above range, not only the electrode 1 is less likely to be displaced, but also easy to implant. Similarly, the angle α within the above range can also make the electrode 1 less likely to be displaced and easier to implant, and it is also easier to remove the electrode 1. In some embodiments, not only the length of the anti-slip arm 1121 can be selected from the above range, but also the angle between the anti-slip arm 1121 and the implant end body 113 can be selected from the above range.

[0048] Please continue reading Figure 5 ,Although Figure 5 The anti-slip arm 1121 is shown as a straight line, but the technician can understand that in other embodiments, the anti-slip arm 1121 can also be in other shapes, such as an arc, as long as the anti-slip arm 1121 and the implant end body 113 form a hook shape to prevent the displacement of the electrode 1. In this way, the anti-slip arm 1121 is in a straight line or an arc shape, which can be easily implanted and prevent the displacement of the electrode.

[0049] like Figure 5 As shown, the anti-drop arm 1121 of the electrode 1 used in the first embodiment includes a guide wire that is folded back relative to the connecting end 12 . Figure 6 and Figure 7 A second electrode 1 is disclosed. The anti-drop arm 1121 of the second electrode 1 also includes an implantation end contact 111. The difference between this electrode 1 and the first electrode 1 is at least as follows: the anti-drop arm 1121 is arc-shaped, which makes it easier to remove the electrode 1.

[0050] Please continue reading Figure 6 and Figure 7In the second type of electrode, there are also sealing portions 114 between the implantation end contacts 111 and between the connection end contacts 121 to prevent electrical conduction between the corresponding two contacts. In addition, the electrode also includes a coating 115.

[0051] See also Figure 8 and Fig. 9 , the embodiment disclosed in the present application discloses a third type of electrode 1. Compared with the first two embodiments, the anti-slip part is an independent component and has the anti-slip structure 112. In this embodiment, for the convenience of description, the part of the implant end 11 other than the anti-slip part 10 is also referred to as the implant end body 113. The implant end 11 includes an implant end body 113 provided with the implant end contact 111. The electrode includes an anti-slip part 10, and the anti-slip part 10 includes an anti-slip part body 101 sleeved with the implant end body 113 and the anti-slip structure 112 connected to the anti-slip part body 101. The anti-slip structure 112 can be any structure as long as it can prevent the electrode from being displaced. In this embodiment, a height difference H is also formed between the free end 1122 of the anti-slip structure 112 and the implant end contact 111. In such a configuration, since the anti-slip component 10 is sleeved on the implant end body 113 as the separate component, more anti-slip structures can be formed on the anti-slip component 10, so as to better prevent the displacement of the electrode.

[0052] Please continue reading Figure 8 and Fig. 9 The anti-slip structure 112 is an anti-slip arm 1121 extending from the anti-slip body 101 to the connecting end 12, and the width between the anti-slip arm 1121 and the anti-slip body 101 gradually increases along the length direction of the anti-slip body 101. In this way, the anti-slip arm 1121 can better prevent the electrode 1 from being displaced.

[0053] Please continue reading Figure 8 and Fig. 9In the above embodiment, the anti-slip arm 1121 satisfies at least one of the following conditions: the length of the anti-slip arm 1121 extending from the anti-slip component body 101 is L2, 1mm≤L2≤10mm, for example, 1mm, 1.5mm, 2mm, 2.6mm, 3mm, 3.7mm, 4mm, 4.5mm, 5mm, 5.3mm, 5.8mm, 6mm, 6.2mm, 6.5mm, 6.9mm, 7mm, 7.3mm, 7.6mm, 8mm, 8.3mm, 8.7mm, 9mm, 9.4mm, 9.8mm, 10mm, etc.; the angle β between the anti-slip arm 1121 and the anti-slip component body 101. β can be an acute angle. In some embodiments, 30 degrees ≤ β ≤ 60 degrees. For example, the value of β is 30, 32, 35, 38, 40, 43, 45, 50, 52, 55, 58, 60, etc. The anti-slip arms 1121 are at least two and are evenly arranged along the circumference of the anti-slip body 101. In this way, under any of the above conditions, the anti-slip part 10 can have a good anti-slip effect, prevent the electrode 1 from being displaced, and facilitate the removal of the electrode 1. Of course, the technician can understand that the above conditions can also meet one of them. For example, only the anti-slip arms 1121 are set to multiple and evenly distributed around the circumference of the anti-slip body 101, and the angle between the anti-slip arms 1121 and the anti-slip body 101 can be a value within the value range of β, or it can not be a value within the value range.

[0054] Please continue reading Figure 8 and Fig. 9 , the position of the anti-dropout part 10 is not limited, it can be located at the implant end 11 and prevent the electrode 1 from being displaced. In one embodiment, the implant end contacts 111 are respectively provided on both sides of the anti-dropout part body 101. In this way, the implant end contacts 111 are respectively provided on both sides of the anti-dropout part 10, so that the anti-dropout part 10 is not easy to fall off or displaced, and correspondingly, the electrode in use is not easy to be displaced. In addition, in some embodiments, the length of the implant end contact 111 located between the anti-dropout part body 101 and the end of the implant end body 113 is L3, 1mm≤L3≤30mm, for example, 1mm, 3mm, 5mm, 8mm, 10mm, 13mm, 15mm, 18mm, 20mm, 22mm, 25mm, 28mm, 30mm, etc. Figure 8 and Fig. 9In the embodiment, there is an implant end contact 111 on each side of the anti-slip member 10. In other embodiments, the number of the implant end contacts 111 may exceed 2. Accordingly, there may be more than one implant end contact 111 between the anti-slip member body 101 and the end of the implant end body 113. In this case, the L3 refers to the sum of the lengths of all implant end contacts 111 between the anti-slip member body 101 and the end of the implant end body 113. In this way, the length L3 is within the above range, which can make the anti-slip member less likely to be displaced or fall off. The technician can understand that the implant end contacts 111 can be respectively set on both sides of the anti-slip member 10, and the length of the implant end contact 111 between the anti-slip member body 101 and the end of the implant end body 113 can be set to a value within the range of L3.

[0055] See also Fig.10 and Fig.11 , the embodiment of the present application discloses a fourth type of electrode 1. The structural difference between the electrode 1 and the other three electrodes 1 is that the anti-slip structure is different, so the same parts or locations are marked with the same mark. The relatively different structure of this electrode is described as follows: the implant end 11 includes an implant end body 113, and the anti-slip structure 112 extends from the implant end body 113 to the outside of the implant end body 113 or is recessed inside, and forms a step structure with the adjacent implant end contact 111. Fig.10 and Fig.11 In the figure, it is shown that the anti-slip structure 112 is recessed into the implant end body 113 to form a groove lower than the implant end contact 111. In this embodiment, the implant end 11 except the anti-slip structure 112 can be referred to as the implant end body 113. As set up as above, the anti-slip structure and the implant end body form a step to prevent the electrode from being displaced, and there is no need to deliberately set up an additional anti-slip structure (such as the aforementioned anti-slip member 10), and the structure of the electrode is simple.

[0056] Please continue reading Fig.10 and Fig.11In some embodiments, the implant end contacts 111 are arranged at intervals on the implant end body 113 to form a groove, and the anti-slip structure 112 is the groove. In this way, since the anti-slip structure 112 is formed by the implant end contacts 111, there is no need to set up additional related structures to form the anti-slip structure for the entire electrode, and the structure of the electrode is simple. The length of the anti-slip structure 112 along the length direction of the implant end body 113 is L4, 1mm≤L4≤30mm, for example, 1mm, 3mm, 5mm, 8mm, 10mm, 13mm, 15mm, 18mm, 20mm, 22mm, 25mm, 28mm, 30mm, etc. The depth of the depression of the anti-slip structure 112 or the height protruding from the implant end body 113 is selected according to the specific situation. In this way, the length L4 is within the above range, which can better prevent the displacement of the electrode. In some implementations, the anti-slip structure 112 may be configured as the groove and the length of the groove may be a value within the range of L4, or only one of them may be configured.

[0057] See also Fig.12 For any of the above-mentioned nerve stimulation electrodes 1, the nerve stimulation electrode 1 includes a tube body 14 and a guide wire 13, and the tube body 14 includes a plurality of receiving holes 141 that penetrate the tube body 14 along the axial direction of the tube body. The guide wires 13 correspond to the receiving holes 141 one by one, and are inserted into the receiving holes 141 and are filled with glue to fill the gap between the corresponding guide wires 13 and the receiving holes 141. Figure 8 As a schematic diagram, three receiving holes 141 are shown, and a guide wire 13 is inserted into each receiving hole 141. A glue layer 15 is formed between the guide wire 13 and the inner wall of the receiving hole 141. In this way, by inserting the guide wire 13 and the receiving hole 141, not only can the manufacturing process of the nerve stimulation electrode 1 be simplified, but also each guide wire 13 can be isolated from each other, and signal transmission will not be interfered. Finally, the guide wire 13 can be firmly fixed in the guide wire 13 through the glue injection process.

[0058] The numbers of implant end contacts and connection end contacts illustrated in the above various embodiments are not intended to limit the present application. In other embodiments of the present application, the number of implant end contacts is 1-64, and the number of connection end contacts is 1-64.

[0059] The above description is only a preferred implementation mode of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A stimulation device for nerve stimulation, characterized in that: The method comprises using an electrode (1), a puncture needle (2), an auxiliary electrode (3) and a signal generator (4), wherein: The puncture needle (2) comprises a puncture needle through hole (21); The auxiliary electrode (3) comprises an auxiliary implant end (31), the auxiliary implant end (31) comprises an auxiliary implant end contact, and the auxiliary implant end (31) passes through the puncture needle through hole (21) and is implanted into a human body; The signal generator (4) is connected to the auxiliary electrode (3), and a feedback signal of the auxiliary implant end contact is obtained through the auxiliary electrode (3), and whether the puncture position of the auxiliary implant end contact is the desired position is determined according to the feedback signal; The use electrode (1) replaces the auxiliary electrode (3) when the puncture position of the auxiliary implant end contact is at a desired position, is implanted into the human body and connected to the signal generator (4); The electrode comprises an implant end (11), a connection end (12) and a guide wire (13); the implant end (11) comprises at least two implant end contacts (111) and an anti-detachment structure (112); a height difference exists between the anti-detachment structure (112) and the implant end contact (111) in the radial direction of the electrode (1); the connection end (12) comprises a connection end contact (121); the connection end contact (121) and the implant end contact (111) are electrically connected via the corresponding guide wire (13); The anti-slip structure (112) comprises an anti-slip arm (1121), the anti-slip arm (1121) is inclined toward the connection end (12), and a height difference is formed between a free end (1122) of the anti-slip arm (1121) and the implant end contact (111); The implant end (11) comprises an implant end body (113), the anti-drop arm (1121) is folded back from the end of the implant end body (113) toward the connection end (12) to form a hook shape with the implant end body (113), and all the implant end contacts (111) are arranged on the implant end body (113); Alternatively, the implant end (11) comprises an implant end body (113), the anti-detachment arm (1121) is folded back from the end of the implant end body (113) toward the connecting end (12) to form a hook shape with the implant end body (113), and the implant end contact (111) is respectively arranged on the anti-detachment arm (1121) and the implant end body (113); the end of the implant end body and the connecting end respectively serve as the end of the electrode.

2. The stimulation device according to claim 1, characterized in that The gap between the puncture needle through hole and the auxiliary electrode or the working electrode is 0.05 to 1 mm, and / or the auxiliary electrode and the puncture needle are connected by a buckle, so that the auxiliary electrode and the puncture needle can be relatively fixed or separated.

3. The stimulation device according to claim 1, characterized in that The anti-slip arm (1121) satisfies at least one of the following conditions: the length of the anti-slip arm (1121) extending from the inflection point is L1, 1mm≤L1≤50mm; the angle between the anti-slip arm (1121) and the implant end body (113) is α, 30 degrees≤α≤60 degrees.

4. The stimulation device according to any one of claims 1 to 3, characterized in that The anti-drop arm (1121) is in a straight line or an arc shape.

5. The stimulation device according to any one of claims 1 to 3, characterized in that The electrode comprises a tube body (14) and a guide wire (13); the tube body (14) comprises a plurality of receiving holes (141) penetrating the tube body (14) along the axial direction of the tube body (14); the guide wires (13) correspond to the receiving holes (141) one by one, are passed through the receiving holes (141) and are filled with glue to fill the gap between the corresponding guide wires (13) and the receiving holes (141).

6. The stimulation device according to any one of claims 1 to 3, characterized in that: The electrodes used include implantation end contacts and connection end contacts, the number of the implantation end contacts is 1-64, and the number of the connection end contacts is 1-64.

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