Electrode sealing device

Abstract

The present invention relates to an electrode sealing device, comprising an electrode shell, a clamping block and a waterproof structure; the electrode shell has an axially extending inner hole, one end of the inner hole is open and the other end is blocked; the clamping block is arranged in the inner hole, the clamping block has an axially extending through hole, and the through hole is connected to the inner hole; the waterproof structure is arranged in the inner hole and is located on at least one side of the clamping block; wherein: the clamping block is configured to deform when it is subjected to an external force to allow the electrode to pass through the through hole and be inserted into the electrode shell; the clamping block is also configured to clamp the electrode through the through hole after the external force is released, so that the electrode is fixed relative to the electrode sealing device. The present invention can seal when the proximal end of the electrode is buried subcutaneously, and the electrode sealing device has a simple structure, convenient sealing operation, and good waterproof effect. At the same time, the size of the entire device is small and comfortable for patients to use.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an electrode sealing device. Background Art

[0002] Parkinson's disease is a common neurodegenerative disorder that is more common in the elderly, with an average age of onset around 60 years. The primary pathological change in Parkinson's disease is the degeneration and death of dopamine (DA) neurons in the substantia nigra of the midbrain, which leads to a significant decrease in DA content in the striatum, causing the disease. Parkinson's disease is characterized by resting tremor, bradykinesia, and postural and gait disturbances, which can have a significant impact on patients' daily lives.

[0003] With the development of modern medical technology, the use of electrodes to stimulate the subthalamic nucleus or the internal nucleus of the globus pallidus can effectively improve Parkinson's symptoms. The Deep Brain Stimulation (DBS) system used is as follows: Figure 1 As shown, it includes a pulse generator (usually abbreviated as IPG) 1, an extension wire 2, and an electrode 3. When the patient has symptoms such as resting tremor, posture and gait disorders on one side of the body (only the left or right side of the body), it is usually necessary to implant 1 pulse generator, 1 extension wire 2, and 1 electrode 3. If the patient's symptoms are bilateral, it is usually necessary to implant 1 pulse generator, 2 extension wires 2, and 2 electrodes 3, that is, Figure 1 As shown in the figure, electrode 3 is typically implanted approximately 10 cm into the brain, with the remainder buried subcutaneously. The other end is placed behind the ear and connected to a subcutaneous extension wire 2, which in turn is connected to a pulse generator 1. Pulse generator 1 generates an electrical signal, which is transmitted through subcutaneous extension wire 2 to electrode 3, ultimately reaching the target area in the brain.

[0004] During the operation, it is extremely important to confirm the target point in the brain. After implanting the electrode 3, a CT or MR scan is required to confirm whether the implantation position of the electrode 3 is correct. Before the scan, the proximal end of the electrode 3 (i.e., the end not implanted in the brain) needs to be sealed and protected, buried under the scalp, and then the scalp is sutured. Figure 2 As shown in Figures a to f:

[0005] First in Figure 2 In (a), the electrode protection cover 6 is put on the electrode 3; then Figure 2 In (b), the electrode cap 7 is placed on the proximal end of the electrode 3; Figure 2 In (c), the electrode cap 7 is locked using the set screw 8, e.g. Figure 2 As shown in (f), the electrode cap 7 is provided with a threaded fixing block 71 at the position indicated by the reference numeral 70, and the set screw 8 is locked with the threaded fixing block 71; Figure 2In (d), the electrode protection sleeve 6 is moved and placed on the electrode cap 7; finally, Figure 2 In (e), surgical thread 9 is used to tie up the two ends of the electrode protection sleeve 6 to protect and seal the electrode 3.

[0006] However, the above sealing operation has the following problems:

[0007] First, there are many parts and the operation is complicated, which prolongs the operation time to a certain extent;

[0008] Second, the electrode cap 7 is locked on the electrode 3 by the set screw 8. Since the set screw 8 is made of metal and has a high hardness, the electrode 3 may be damaged during the tightening process.

[0009] Third, a threaded fixing block 71 must be pre-buried in the electrode cap 7. Since the electrode cap 7 is made of a relatively soft material, the threaded fixing block 71 will usually rotate along with the set screw 8 during tightening, potentially damaging the electrode 3.

[0010] Fourth, it is necessary to use surgical thread 9 to tie the two ends of the electrode protective cover 6 for waterproofing. However, the effect of tying the thread depends entirely on human operation, which is highly subjective and the reliability of the tying thread is difficult to guarantee. For example, if the tying thread is too loose, it cannot play a sealing role, and if the tying thread is too tight, it may damage the electrode 3.

[0011] Therefore, it is necessary to provide a new electrode sealing device to reduce the number of parts, simplify the sealing operation, shorten the surgical operation time, while avoiding damage to the electrode and improving the waterproof effect. Summary of the Invention

[0012] The purpose of the present invention is to provide an electrode sealing device that simplifies the structure of the electrode sealing, simplifies the electrode sealing operation, shortens the surgical operation time, and avoids damage to the electrode during the operation. At the same time, the waterproof effect is good, and the entire device is small in size and comfortable for patients to use.

[0013] To achieve the above-mentioned objectives, the present invention provides an electrode sealing device comprising an electrode shell, a clamping block, and a waterproof structure; the electrode shell having an axially extending inner hole, one end of which is open and the other end is blocked; the clamping block is disposed in the inner hole, the clamping block having an axially extending through hole, the through hole communicating with the inner hole; the waterproof structure is disposed in the inner hole and is located on at least one side of the clamping block;

[0014] Wherein: the clamping block is configured to deform when it is subjected to an external force to allow the electrode to pass through the through hole and be inserted into the electrode shell; the clamping block is also configured to clamp the electrode through the through hole when the external force is released, so that the electrode is fixed relative to the electrode sealing device.

[0015] Optionally, the electrode shell includes a body, and a positioning portion is provided on the outer surface of the body corresponding to the clamping block; when the positioning portion is subjected to external force, the clamping block is deformed to increase the size of the through hole and allow the electrode to pass through the through hole.

[0016] Optionally, the clamping block is an elliptical cylinder, and the positioning portions are provided corresponding to both ends of the long axis of the elliptical cylinder; when the positioning portions are acted upon by external force, the short axis of the elliptical cylinder increases, thereby increasing the size of the through hole.

[0017] Optionally, the body of the electrode shell is cylindrical, and the positioning portion includes two first planes that are symmetrical about the axis of the electrode shell, and the two first planes are tangent to and parallel to the body.

[0018] Optionally, the outer surface of the body is further provided with a second plane, the second plane is adjacent to the two first planes, and the two first planes and one second plane are arranged around the axis of the electrode shell.

[0019] Optionally, the second plane is perpendicular to both of the first planes, and the second plane is flush with the outer surface of the body.

[0020] Optionally, the waterproof structure includes a first waterproof structure, which is arranged between the clamping block and the opening.

[0021] Optionally, the waterproof structure further includes a second waterproof structure and a third waterproof structure, the clamping block is arranged between the first waterproof structure and the second waterproof structure, and the second waterproof structure is arranged between the clamping block and the third waterproof structure.

[0022] Optionally, the waterproof structure is an annular protrusion formed on the inner surface of the inner hole, and the inner diameter of the annular protrusion is smaller than the diameter of the electrode.

[0023] Optionally, a protrusion or a groove is formed on the inner wall of the through hole.

[0024] Optionally, the electrode shell is connected to the clamping block through a secondary injection molding process.

[0025] Optionally, the length of the clamping block is smaller than the length of the inner hole, and the clamping block is arranged adjacent to the opening of the inner hole.

[0026] Optionally, the clamping block is made of stainless steel, polyetheretherketone or polyurethane, and the electrode shell is made of medical polymer material.

[0027] The electrode sealing device provided by the present invention has the following advantages:

[0028] First, the electrode sealing device of the present invention only requires an electrode shell and a clamping block, and the clamping block is arranged inside the electrode shell and fixes the electrode relative to the electrode sealing device by clamping. This has a simple structure, a small number of parts, and a simple electrode sealing operation, which can effectively shorten the surgical operation time.

[0029] Second, the electrode sealing device of the present invention does not require the use of set screws to lock the electrode cap on the electrode, thus avoiding damage to the electrode when locking the set screws in the prior art. In addition, the conventional electrode cap requires surgical thread to be tied at both ends of the electrode protective cover to ensure waterproofing. The reliability of the thread is difficult to ensure, and the electrode may be damaged if the thread is tied too tightly. The electrode sealing device of the present invention uses an internal waterproof structure for waterproofing, avoiding the influence of human factors during the sealing operation. Therefore, the waterproof reliability is good and damage to the electrode can be avoided.

[0030] Third, the electrode sealing device of the present invention is easy to process and can effectively reduce production costs and process costs. In particular, since the waterproof structure is arranged inside the electrode shell and is integrally formed with the electrode shell, the size of the electrode sealing device is reduced, and when the proximal end of the electrode is implanted subcutaneously, the patient is comfortable to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0032] Figure 1 This is a schematic diagram of the structure of the DBS system implanted in the skull when the patient's symptoms are bilateral in the prior art;

[0033] Figure 2 It is a schematic diagram of the principle of sealing operation on electrodes in the prior art;

[0034] Figure 3 2. It is a schematic structural diagram of the electrode shell of the electrode sealing device in a preferred embodiment of the present invention;

[0035] Figure 4 2. It is a schematic structural diagram of a clamping block of an electrode sealing device in a preferred embodiment of the present invention;

[0036] Figure 5 1 is a schematic diagram of the assembly of the electrode sealing device in a preferred embodiment of the present invention;

[0037] Figure 6 is a schematic diagram of the sealing operation of the electrode in a preferred embodiment of the present invention;

[0038] Figure 7 is a transverse cross-sectional view of a clamping block in a preferred embodiment of the present invention, wherein an arc-shaped protrusion is formed inside the clamping block;

[0039] Figure 8 is a transverse cross-sectional view of a clamping block in a preferred embodiment of the present invention, wherein a wave-shaped protrusion is formed inside the clamping block;

[0040] Figure 9 This is a schematic diagram of the principle of obtaining an electrode shell with a clamping block embedded therein by secondary injection molding in a preferred embodiment of the present invention.

[0041] The same or similar reference numerals in the drawings represent the same or similar components. DETAILED DESCRIPTION

[0042] The following describes the embodiments of the present invention through specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner. The illustrations only show components related to the present invention rather than being drawn according to the number, shape and size of components in actual implementation. The type, quantity and proportion of each component in actual implementation can be changed arbitrarily, and the component layout type may also be more complicated.

[0043] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0044] In order to make the objects, advantages and features of the present invention clearer, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. As used in this specification, the singular forms "one", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the meaning of "a plurality" generally includes two or more, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. The term "axial" generally refers to the direction parallel to the axis of the electrode cap, and "transverse" is generally the direction perpendicular to the axis.

[0045] In addition, in the following description, numerous specific details are provided to provide a more thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention can be practiced without one or more of these details. In other instances, certain technical features well known in the art are not described to avoid confusion with the present invention.

[0046] The embodiment of the present invention relates to an electrode cap. Figure 3 Schematic diagram of the structure of the electrode shell of the electrode sealing device in the preferred embodiment of the present invention. Figure 4 Schematic diagram of the structure of the clamping block of the electrode sealing device in the preferred embodiment of the present invention. Figure 5 1 is a schematic diagram of the assembly of the electrode sealing device in a preferred embodiment of the present invention.

[0047] like Figures 3 to 5 As shown, this embodiment relates to an electrode sealing device (or electrode cap), which can be used for DBS (deep brain stimulation) implantable extension wires, or other implantable extension wires, such as spinal nerve stimulation, vagus nerve stimulation, etc.

[0048] Specifically, the electrode sealing device includes an electrode shell 10 and a clamping block 20. The electrode shell 10 has an inner hole 11 extending axially, and one end of the inner hole 11 is open to allow the electrode 3 to be inserted (see Figure 6 ), and the other end is sealed for waterproofing. In other words, the inner hole 11 is configured as a blind hole. The clamping block 20 is fixed in the inner hole 11 of the electrode shell 10. The length (axial dimension) of the clamping block 20 is generally less than the length of the inner hole 11. The clamping block 20 is disposed in a portion of the inner hole 11, preferably adjacent to the opening of the inner hole 11. The clamping block 20 also has an axially extending through hole 21 that communicates with the inner hole 11.

[0049] The clamping block 20 is configured to be deformable, thereby changing the size of the through hole 21 (i.e., the minimum size of the through hole), facilitating the insertion of the electrode 3 and clamping the electrode 3 after the electrode 3 is inserted. More specifically, when the clamping block 20 is subjected to an external force, it deforms to allow the electrode 3 to pass through the through hole 21 and be inserted into the electrode shell 10; when the clamping block 20 is released from the external force, the electrode 3 can be clamped again through the through hole 21, so that the electrode 3 is fixed relative to the electrode sealing device. In addition, a waterproof structure is also provided in the inner hole 11 of the electrode shell 10, located on at least one side of the clamping block 20, which plays a waterproof role and prevents external liquids from entering the electrode shell 10 and affecting the electrode 3.

[0050] like Figure 4 As shown, the clamping block 20 is preferably an elliptical cylinder, that is, the cross-sectional shape of the clamping block 20 is an ellipse (i.e., an outer ellipse), and the cross-sectional shape of the through hole 21 is also an ellipse (i.e., an inner ellipse). The advantage of the elliptical shape is that it causes little damage to the electrode 3 during the clamping process, and it is easy to control the direction and size of the deformation, the clamping operation is convenient, the clamping effect is good, and the structure is simple and easy to process. In other embodiments, the clamping block 20 can also be other regular or irregular shapes. The present invention does not specifically limit the cross-sectional shape of the clamping block 20, especially the through hole 21.

[0051] Next, assuming that the clamping block 20 is an elliptical cylinder, the usage of the electrode sealing device of the present invention will be described in detail, but this should not be used as a limitation of the present invention.

[0052] First, as Figure 6 As shown in the middle figure (a), pressure can be manually applied to both sides of the electrode shell 10 (i.e., force F is applied on both sides), so that the clamping block 20 is under pressure. Figure 6 The elliptical deformation shown in Figure (b) is Figure 6 The circle or nearly circle shown in the middle figure (d); then Figure 6 As shown in the middle figure (c), the electrode 3 is inserted into the electrode shell 10. After the electrode 3 is inserted, Figure 6 As shown in the middle figure (d), at this time, the minor axis length of the elliptical through hole 21 is greater than the diameter of the electrode 3, so that the electrode 3 is in an unclamped state; finally, as shown in FIG. Figure 6 As shown in the middle figure (e), stop applying pressure and make the clamping block 20 return to the elliptical shape (as shown in the figure). Figure 6 (f) in the middle figure), thereby achieving the purpose of clamping the electrode 3. It should be noted that after the electrode 3 is inserted into the electrode shell 10, the waterproof structure can be deformed and interference fit with the electrode 3 to achieve a waterproof effect.

[0053] Therefore, the electrode sealing device of the present invention has a simple structure, a small number of parts (i.e., only the electrode shell 10 and the clamping block 20 are required), and the sealing operation is simple, which can effectively shorten the surgical operation time. Moreover, the electrode sealing device of the present invention does not need to use a set screw to lock the electrode cap on the electrode, thereby avoiding damage to the electrode when locking the set screw in the prior art. In addition, the traditional electrode cap needs to be waterproofed by tying the two ends of the electrode protective cover with surgical thread. The reliability of the tying thread is difficult to ensure, and the electrode may be damaged due to excessive tightening of the tying thread. The electrode sealing device of the present invention uses an internal waterproof structure for waterproofing, which avoids the influence of human factors during the sealing operation. Therefore, the waterproof reliability is good, and damage to the electrode can also be avoided. In addition, the electrode sealing device of the present invention is easy to process, which can effectively reduce production costs and process costs. In particular, the waterproof structure is arranged inside the electrode shell and is preferably integrally formed with the electrode shell, which reduces the size of the electrode sealing device, and is comfortable for patients to use when the proximal end of the electrode is implanted subcutaneously.

[0054] See Figure 5 The waterproof structure preferably includes a first waterproof structure 105, disposed between the clamping block 20 and the opening of the inner hole 11. In this embodiment, the first waterproof structure 105 is an annular protrusion that is configured to achieve an interference fit with the electrode 3 to achieve a waterproof effect. Furthermore, the waterproof structure also includes a second waterproof structure 106, with the clamping block 20 disposed between the first and second waterproof structures 105, 106. The provision of the second waterproof structure 106 achieves a dual waterproof effect, resulting in a better waterproof effect. Similar to the first waterproof structure 105, the second waterproof structure 106 is also an annular protrusion that is configured to achieve an interference fit with the electrode 3 to achieve a waterproof effect. Furthermore, the waterproof structure also includes a third waterproof structure 107, disposed between the clamping block 20 and the third waterproof structure 107, to further enhance the waterproof performance. Similarly, the third waterproof structure 107 is also an annular protrusion that is configured to achieve an interference fit with the electrode 3 to achieve a waterproof effect. In this embodiment, the number of waterproof structures is not limited to one, two, or three, and may be more than three. In addition, it should be noted that the electrode 3 is typically a circular electrode, and therefore the annular protrusion is also typically circular. Furthermore, the diameter of the electrode 3 is typically 1.3 mm, and correspondingly, the inner diameter of the annular protrusion is less than 1.3 mm, for example, the inner diameter of the annular protrusion can be selected to be 0.8 mm to 1.0 mm. Furthermore, the width of the annular protrusion along the axial direction of the electrode shell is preferably 0.4 mm to 0.6 mm, which is convenient for processing and easy insertion and removal of the electrode 3.

[0055] As mentioned above, the clamping block 20 is preferably an elliptical cylinder, and the long axis length of the inner ellipse where the through hole 21 is located is greater than the aperture of the inner hole of the electrode shell. For example, when the diameter of the electrode 3 is 1.3 mm, the long axis length of the inner ellipse can be selected from 2.5 mm to 4.5 mm, and the short axis length of the inner ellipse should be less than the diameter of the electrode, for example, it can be selected from 0.9 mm to 1.1 mm. The present invention does not impose any special restrictions on the thickness of the clamping block 20, as long as the clamping block 20 is easily deformable in the radial direction. In this embodiment, the thickness of the clamping block 20 is 0.6 mm to 1.0 mm, which is small in size and is conducive to reducing the size of the electrode cap.

[0056] Further reading Figure 3 The electrode shell 10 includes a main body 101, and a positioning portion is preferably provided on the outer surface of the main body 101 corresponding to the clamping block 20. During actual operation, the operator only needs to apply pressure on the positioning portion to deform the clamping block 20 and enlarge the size of the through hole 21 (that is, the minimum size becomes larger) to allow the electrode 3 to pass through the through hole 21. More specifically, the clamping block 20 is an elliptical cylinder, and the positioning portions are provided corresponding to the two ends of the long axis of the elliptical cylinder; when the positioning portion is subjected to pressure, the short axis of the elliptical cylinder increases and the size of the through hole 21 becomes larger. Here, the long axis of the elliptical cylinder refers to the long axis of the elliptical cylinder on the cross section of the elliptical cylinder.

[0057] Preferably, the main body 101 is cylindrical, and the positioning portion includes two first planes 103 arranged opposite to each other. The two first planes 103 are preferably tangent to the main body 101 and arranged parallel to each other (i.e., the two first planes 103 are symmetrical about the axis of the main body 101). In this way, the direction of the line connecting the tangent points of the two first planes 103 is the direction of the maximum dimension of the clamping block 20, that is, the direction of the major axis of the ellipse. In this way, the operator only needs to apply pressure on the two first planes 103 to ensure that the deformation of the clamping block 20 is in the direction of increasing the size of the through hole 21. Moreover, the distance between the two first planes 103 is also the same as the diameter of the main body 101, thereby avoiding increasing the size of the electrode sealing device and ensuring the comfort of the patient. For example, when the diameter of the electrode 3 is 1.3 mm, the diameter of the main body 101 is preferably 3.0 mm to 5.5 mm. Obviously, the size of the entire electrode sealing device is small, and thus the size buried under the patient's scalp is also small, which is comfortable for the patient to use. The axial length of the electrode shell 10 is set according to the length of the electrode 3 that needs to be sealed, and the present invention is not limited to this. For example, in this embodiment, the axial length of the body 101 can be selected to be 31 mm to 33 mm.

[0058] Furthermore, the outer surface of the body 101 is further provided with a second plane 102, and the second plane 102 is adjacent to the two first planes 103, and the two first planes 103 and one second plane 102 are arranged around the axis of the electrode shell, that is, arranged along the circumference of the body 101. Here, the second plane 102 is provided at the same time as the two first planes 103, which helps the operator to identify the force application point more quickly, facilitates the operator's hand to hold and operate the small-sized electrode cap, and is more convenient to insert the electrode 3 while applying pressure. Preferably, the second plane 102 is perpendicular to the two first planes 103, and the second plane 102 is flush with the outer surface of the body 101, which can not only ensure the strength of the entire device, but also avoid increasing the size of the device.

[0059] In this embodiment, the inner hole 11 of the electrode shell 10 is used to insert the electrode 3, which is clearance-matched with the electrode 3. For example, when the diameter of the electrode 3 is 1.3 mm, the inner diameter of the inner hole 11 can be 1.4 mm to 1.5 mm. This size is neither too small to affect the assembly of the electrode, nor too large to increase the size of the device. The shape of the inner hole 11 usually matches the shape of the electrode 3, and the present invention is not limited to this. In addition, the material of the electrode shell 10 is relatively soft to ensure the comfort of the patient's use. The material is usually a medical polymer material, including but not limited to polyurethane, silicone, etc. The clamping block 20 should have a certain hardness and a certain anti-fatigue property. The material can be a metal material or a non-metallic material, such as stainless steel, PEEK (polyetheretherketone) or polyurethane. Preferably, the electrode shell 10 and the clamping block 20 are integrally formed, for example, by injection molding or compression molding.

[0060] Furthermore, in order to make the electrode clamp more firmly, as Figure 7 As shown, a protrusion 22 may be formed on the inner wall of the through hole 21 of the clamping block 20. The shape of the protrusion 22 is preferably an arc-shaped protrusion, which can reduce the damage to the electrode 3 during the clamping process. The number and distribution of the protrusions 22 are not required and can be evenly distributed or unevenly distributed. The protrusions 22 can be distributed at intervals or as shown in FIG. Figure 8 Shown continuous distribution, promptly forms wavy protrusion 22.In other embodiments, protrusion 22 also can be sawtooth-shaped protrusion.In alternative embodiment, also can be provided with groove on the inwall of through hole 21, can increase the firmness of clamping equally.

[0061] Furthermore, the inventors took into consideration that it is somewhat difficult to position the clamping block 20 in the electrode shell 10. This is because, on the one hand, the clamping block 20 is small in size and difficult to assemble, and on the other hand, the connection strength between the clamping block 20 and the electrode shell 10 is difficult to ensure (for example, the connection between metal and polymer materials). For this reason, the present invention utilizes secondary injection molding to process the electrode shell 10 with the clamping block 20 inside.

[0062] Specifically, such as Figure 9 As shown, first, the clamping block 20 is pre-positioned in the mold cavity (not shown), and then the core rod 60 is inserted into the mold cavity for positioning, and the first injection molding is performed to obtain Figure 9 (a) shows the intermediate structure, and then the secondary injection molding is performed to allow the injection molding material to wrap the clamping block 20, and finally obtain Figure 9 The finished structure in (b), that is, the electrode shell 10 is obtained by secondary injection molding. The molding process ensures the connection strength between the electrode shell 10 and the clamping block 20, ensuring that the clamping block 20 is not easily detached or shifted. In addition, the shape of the core rod 60 matches the shape of the inner hole 11 of the electrode shell 10. For example, the core rod 60 is formed with an annular groove to form an annular protrusion.

[0063] The preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments. For example, in other embodiments, the second plane 102 can be eliminated. For another example, the positioning portion is not limited to the structural form of the first plane 103. It can also be a structure with an indicator mark or other shapes set on the outer surface of the main body 101 to indicate the force position of the clamping block. In addition, the diameter of the applicable electrode 3 is not limited to 1.3 mm, and the electrode sealing device of the present invention can also be used to seal and fix electrodes of other sizes, without limitation. In addition, the main body shape of the electrode shell includes but is not limited to a cylindrical shape. Here, considering the comfort of the patient during use, a cylindrical shape is preferred. Furthermore, the present invention does not limit the axial length of the clamping block. Under normal circumstances, the length of the clamping block should not be too short or too long. If it is too short, it is difficult to ensure the firmness of the clamping, and if it is too long, it is not easy to plug and unplug the electrode.

[0064] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the present invention.

Claims

1. An electrode sealing device, characterized in that: The invention comprises an electrode shell, a clamping block and a waterproof structure; the electrode shell has an axially extending inner hole, one end of which is open and the other end is blocked; the clamping block is arranged in the inner hole, and the clamping block has an axially extending through hole, which is connected to the inner hole; the waterproof structure is arranged in the inner hole and is located on at least one side of the clamping block; the electrode shell is wrapped around the outside of the clamping block by secondary injection molding and connected to the clamping block; The electrode shell includes a body, and a positioning portion is provided on the outer surface of the body corresponding to the clamping block; the clamping block is an elliptical cylinder, and the positioning portions are provided corresponding to the two ends of the major axis of the elliptical cylinder; when the positioning portion is subjected to an external force, the minor axis of the elliptical cylinder increases, thereby increasing the size of the through hole; the body of the electrode shell is cylindrical, and the positioning portion includes two first planes that are symmetrical about the axis of the electrode shell, the two first planes are tangent to and parallel to the body, and the direction of the line connecting the tangent points of the two first planes is the direction of the maximum dimension of the clamping block; the outer surface of the body is further provided with a second plane, the second plane is adjacent to the two first planes, and the two first planes and one second plane are arranged around the axis of the electrode shell; Wherein: the clamping block is configured to deform when it is subjected to an external force to allow the electrode to pass through the through hole and be inserted into the electrode shell; the clamping block is also configured to clamp the electrode through the through hole when the external force is released, so that the electrode is fixed relative to the electrode sealing device.

2. The electrode sealing device according to claim 1, characterized in that The second plane is perpendicular to both of the first planes, and the second plane is flush with the outer surface of the body.

3. The electrode sealing device according to claim 1, characterized in that The waterproof structure includes a first waterproof structure disposed between the clamping block and the opening.

4. The electrode sealing device according to claim 3, characterized in that The waterproof structure further includes a second waterproof structure and a third waterproof structure. The clamping block is arranged between the first waterproof structure and the second waterproof structure, and the second waterproof structure is arranged between the clamping block and the third waterproof structure.

5. The electrode sealing device according to claim 1, characterized in that: The waterproof structure is an annular protrusion formed on the inner surface of the inner hole, and the inner diameter of the annular protrusion is smaller than the diameter of the electrode.

6. The electrode sealing device according to claim 1, characterized in that A protrusion or a groove is formed on the inner wall of the through hole.

7. The electrode sealing device according to claim 1, characterized in that The length of the clamping block is smaller than the length of the inner hole, and the clamping block is disposed adjacent to the opening of the inner hole.

8. The electrode sealing device according to claim 1, characterized in that The material of the clamping block is stainless steel, polyetheretherketone or polyurethane, and the material of the electrode shell is medical polymer material.

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