Electrode arrangement for subcutaneous implantation

Abstract

The invention belongs to the technical field of medical experimental instruments, and provides an electrode device for subcutaneous implantation, comprising: an electrode comprising a cylinder structure and a barb structure arranged at one end of the cylinder structure; one end of the wire is connected with the cylinder structure; and the interface is connected to the other end of the wire. The section width of the electrode can be increased through the cylinder structure, the electrode can be stably implanted subcutaneously, and electrode displacement or damage caused by animal activity or tissue growth can be reduced. The barb structure enables the electrode to be better fixed subcutaneously, so that the electrode can be accurately positioned, the accuracy of an experimental result and the repeatability of an experiment are improved, and the complexity of surgical operation is also reduced.

Description

Technical Field

[0001] The invention belongs to the technical field of medical experimental instruments, and in particular relates to an electrode device for subcutaneous implantation. Background Art

[0002] Neural electrodes are widely used in the field of neural stimulation. For example, skin-attached neural electrodes are often used in various medical and health fields such as human health monitoring, pain management, rehabilitation therapy, and neural function regulation.

[0003] Especially in advanced applications such as temporally coherent electric field stimulation, there is an increasing demand for animal implanted electrodes. These experiments are designed to verify the biological efficacy and safety of human electrodes through animal models. Among them, the implantation of neural electrodes in small animals, especially small simulated experimental animals such as mice, faces significant challenges. Due to the small size of these animals, surgical implantation of neural electrodes is usually difficult to operate, and it is difficult to reduce the physical damage and physiological interference of surgical wounds to animals.

[0004] In the related prior art, in animal experiments, non-invasive skin-attached electrodes can also be used, such as microwire or microneedle electrodes. Although it is relatively easy to record neural signals, it faces many challenges when conducting electrical stimulation. Especially in animal transcranial electrical stimulation experiments, due to the small size of the animals and the weak skull, it is difficult to achieve stable fixation using traditional fixation methods such as skull nails. This difficulty in fixation not only increases the complexity of the surgical operation, but may also lead to inaccurate electrode position, affecting the accuracy and repeatability of the experimental results. Summary of the invention

[0005] In view of this, the present invention provides an electrode device for subcutaneous implantation to solve the problems existing in the prior art.

[0006] On the one hand, the present invention provides an electrode device for subcutaneous implantation, comprising: an electrode, comprising a cylindrical structure and a barb structure, wherein the barb structure is arranged at one end of the cylindrical structure; a wire, one end of which is connected to the cylindrical structure; and an interface, which is connected to the other end of the wire.

[0007] The beneficial effect is that the cylindrical structure can increase the cross-sectional width of the electrode compared to the long strip electrodes in the prior art, which helps to stably implant the electrode under the skin and reduce electrode displacement or damage caused by animal activities or tissue growth. The barb structure is arranged at one end of the cylindrical structure. During the experiment, the barb structure first contacts the skin of the animal, making it easier to insert the electrode under the skin in the wound. Due to the presence of the barb structure, the electrode can be better fixed under the skin, so that the electrode can be accurately positioned, which improves the accuracy of the experimental results and the repeatability of the experiment, and also reduces the complexity of the surgical operation. By increasing the cross-sectional width of the electrode and using a high-density electronic interface to fix it in a stable position such as the skull, the present invention effectively overcomes the problems of unstable electrode fixation and inaccurate position in the existing scheme, and improves the accuracy and repeatability of the experiment.

[0008] As an optional embodiment, the barb structure includes: a connecting portion connected to one end of the cylindrical structure; a sharp portion, one end of which is connected to the connecting portion, and the other end of the sharp portion gradually narrows in a direction away from the connecting portion.

[0009] The beneficial effect is that the projection of the connecting portion on the circular surface of the cylindrical structure is smaller than the area of ​​the circular surface of the cylindrical structure, so that there is a gap between the cylindrical structure and the barb structure. The sharp portion gradually narrows from the end connected to the connecting portion to the end away from the connecting portion, so that the tip of the sharp portion can be inserted under the wound skin first, and as the sharp portion continues to extend, the sharp portion guides the cylindrical structure to be inserted.

[0010] As an optional embodiment, the plurality of sharp portions are arranged in a circumferential direction in sequence, a gap is formed between two adjacent sharp portions, and the outer contours of the plurality of sharp portions at least constitute a part of the outer contour of a cone.

[0011] The beneficial effect is that at least part of the outer contour of each sharp portion is an inverted cone-shaped outer contour, so that multiple sharp portions can form an inverted cone-shaped structure, and there is a gap between two adjacent sharp portions. After the barb structure is inserted subcutaneously, some surrounding tissues can be filled in the gap, thereby hindering the movement of the sharp portion, that is, limiting the displacement of the electrode.

[0012] As an optional embodiment, the barb structure is formed by cutting triangular blocks at intervals on the outer circumference of the inverted cone structure.

[0013] The beneficial effects are that the operation process of forming the barb structure is simplified, and when the electrode is taken out, the plane formed by cutting the triangular block can reduce the resistance of the tissue to the electrode.

[0014] As an optional implementation manner, the edge of the electrode is a smooth edge.

[0015] The beneficial effect is that the smooth edge design of the electrode reduces damage to tissues and reduces the risk of rejection, which is particularly important for long-term implantation of the electrode.

[0016] As an optional implementation manner, the outer surface of the electrode is gold-plated.

[0017] The beneficial effect is that the outer surface of the electrode is gold-plated to enhance the conductivity of the electrode and increase the contact area of ​​the electrode. The gold-plated layer not only provides excellent conductivity, but also is suitable for long-term implantation due to its biocompatibility and corrosion resistance.

[0018] As an optional implementation manner, the wire is welded to the electrode to form a welding layer.

[0019] The beneficial effect is that the electrode and the wire are connected by welding, which ensures the stability of the structure connecting the wire and the electrode and improves the conductivity of the wire. This connection method not only improves the reliability of the electrode, but also reduces the complexity of maintenance.

[0020] As an optional implementation, the welding layer is covered with a cement encapsulation layer, and the cement encapsulation layer also covers the end surface of the electrode away from the barb structure.

[0021] The beneficial effect is that the back of the electrode is encapsulated with cement, which not only prevents leakage, but also effectively reduces corrosion damage and extends the service life of the electrode.

[0022] As an optional implementation, the electrode is provided with a central hole, and the end of the wire is inserted into the central hole.

[0023] The beneficial effect is that the end of the wire is inserted into the central hole so that one end of the wire can extend into the interior of the electrode, and then the welded end is welded in the central hole, so that the connection structure of the wire is more secure.

[0024] As an optional implementation, the end of the electrode away from the barb structure is suitable for being fixed to the skin incision through a sealing layer.

[0025] The beneficial effect is that by using tissue glue to seal the back of the electrode, it not only prevents the electrode from direct contact with the surrounding tissue and reduces tissue reaction, but also enhances the overall structural stability of the electrode. This is in stark contrast to the problem of easy detachment or tissue damage in existing solutions, improving animal welfare and the sustainability of experiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 This is a schematic diagram of the main structure of an electrode of an electrode device for subcutaneous implantation according to an embodiment of the present invention;

[0028] Figure 2 It is a schematic diagram of the top view of the electrode of the electrode device for subcutaneous implantation according to an embodiment of the present invention;

[0029] Figure 3 It is a schematic side view of the structure of an electrode of an electrode device for subcutaneous implantation according to an embodiment of the present invention;

[0030] Figure 4 It is a structural schematic diagram of the electrode device for subcutaneous implantation in use according to an embodiment of the present invention.

[0031] Description of reference numerals:

[0032] 10. Electrode device for subcutaneous implantation;

[0033] 100. Electrode;

[0034] 110. Cylindrical structure;

[0035] 1101, center hole;

[0036] 120. Barb structure;

[0037] 121, connecting part;

[0038] 122, sharp part;

[0039] 200, wire;

[0040] 300. Interface. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0042] In the related existing technologies, some adopt the method of attaching electrodes on the skin surface. Attaching electrodes on the skin surface also needs to take into account the need to shave the animal's hair, but the residual hair will still affect the impedance of the contact between the animal skin and the electrode, which is not conducive to simulating human body electrodes.

[0043] Therefore, we are faced with the challenge of designing and manufacturing micro-neural electrodes that can generate strong enough current while minimizing damage to biological tissues, and at the same time facilitate implantation and long-term fixation in animals. This requires not only innovations in electrode materials and designs, but also precise implantation techniques and careful biocompatibility assessments to ensure the validity of the experiment and animal welfare.

[0044] In addition, for tissues that often move and deform, such as muscles, small or long electrodes are prone to fall off during animal activities. Therefore, designing an electrode that can be stably fixed while minimizing damage to animals has become an important research topic.

[0045] In this case, it is necessary to explore new electrode materials and designs to improve their stability and biocompatibility in animals. This can reduce interference with animal activities and damage to tissues. At the same time, it is also necessary to develop more convenient and minimally invasive surgical techniques to reduce damage during implantation and improve the positioning accuracy of electrodes. In addition, the comfort and welfare of animals must be taken into account when designing experiments to ensure that discomfort and pain to animals are minimized during the experiment.

[0046] Combine the following Figures 1 to 4 , describing an embodiment of the present invention.

[0047] like Figure 1 and Figure 4 As shown, according to an embodiment of the present invention, a subcutaneously implanted electrode device 10 is provided, and the subcutaneously implanted electrode device 10 includes an electrode 100, a wire 200 and an interface 300, the electrode 100 includes a cylindrical structure 110 and a barb structure 120, the barb structure 120 is arranged at one end of the cylindrical structure 110, one end of the wire 200 is connected to the cylindrical structure 110, and the interface 300 is connected to the other end of the wire 200.

[0048] Understandably, if Figure 1 and Figure 2 As shown, compared with the elongated electrode 100 in the prior art, the cylindrical structure 110 can increase the cross-sectional width of the electrode 100, which helps to stably implant the electrode 100 subcutaneously and reduce displacement or damage of the electrode 100 caused by animal activities or tissue growth.

[0049] The barb structure 120 is arranged at one end of the cylindrical structure 110. During the experiment, a wound is made on the skin of the animal, and the barb structure 120 first contacts the skin of the animal, and then is inserted under the skin through the wound. Compared with the cylindrical structure 110, the barb structure 120 has a smaller cross-sectional area, that is, the area perpendicular to the insertion direction, making it easier for the electrode 100 to be inserted under the skin in the wound. It can also be understood that the barb structure 120 can also play a guiding role for the cylindrical structure 110, and can better guide the cylindrical structure 110 to enter under the skin.

[0050] Since there is a gap between the barb structure 120 and the cylindrical structure 110, when the electrode 100 is installed in place, the gap will be filled with surrounding tissue, thereby preventing the movement of the electrode 100. Due to the presence of the barb structure 120, the electrode 100 can be better fixed under the skin, so that the electrode 100 can be accurately positioned, which improves the accuracy of the experimental results and the repeatability of the experiment, and also reduces the complexity of the surgical operation.

[0051] Therefore, the design of the electrode 100 of the present invention takes into account the problem of small size and weak skull of the animal. By increasing the cross-sectional width of the electrode 100 and using a high-density electronic interface to fix it to a stable position such as the skull, the present invention effectively overcomes the problem of unstable fixation and inaccurate position of the electrode 100 in the existing solution, and improves the accuracy and repeatability of the experiment.

[0052] In another embodiment, Figure 1 and Figure 3 As shown, the barb structure 120 includes a connecting portion 121 and a sharp portion 122 . The connecting portion 121 is connected to one end of the cylindrical structure 110 , one end of the sharp portion 122 is connected to the connecting portion 121 , and the other end of the sharp portion 122 gradually narrows in a direction away from the connecting portion 121 .

[0053] It can be understood that the projection of the connecting portion 121 on the circular surface of the cylindrical structure 110 is smaller than the area of ​​the circular surface of the cylindrical structure 110, so that there is a gap between the cylindrical structure 110 and the barb structure 120. The sharp portion 122 gradually narrows from the end connected to the connecting portion 121 to the end away from the connecting portion 121, so that the tip of the sharp portion 122 can be inserted under the wound skin first, and as the sharp portion 122 continues to extend, the sharp portion 122 guides the cylindrical structure 110 to be inserted.

[0054] The sharp portion 122 and the connecting portion 121 may be integrally provided, or the cylindrical structure 110 , the connecting portion 121 and the sharp portion 122 may be integrally provided.

[0055] In another embodiment, the plurality of sharp portions 122 are arranged in a circular pattern in sequence, a gap is formed between two adjacent sharp portions 122 , and the outer contours of the plurality of sharp portions 122 at least constitute a portion of the outer contour of a cone.

[0056] It can be understood that at least part of the outer contour of each sharp portion 122 is an inverted cone-shaped outer contour, so that multiple sharp portions 122 can form an inverted cone-shaped structure, and there is a gap between two adjacent sharp portions 122. After the barb structure 120 is inserted subcutaneously, some surrounding tissues can be filled in the gap, thereby hindering the movement of the sharp portion 122, that is, limiting the displacement of the electrode 100.

[0057] Specifically, the barb structure 120 is formed by cutting triangular pieces at intervals from the outer circumference of an inverted cone-shaped structure.

[0058] It can be understood that the inverted cone structure can be cut into four or three triangular pieces, for example, without specific limitation herein, so as to form a sharp portion 122 having both an arcuate surface and a flat surface. The arcuate surface of the sharp portion 122 can facilitate the insertion of the sharp portion 122 into the subcutaneous tissue, and the flat surface of the sharp portion 122 is arranged in the notch, so that the electrode 100 can reduce resistance when being taken out.

[0059] In another embodiment, the outer surface of the electrode 100 is gold plated.

[0060] The outer surface of the electrode 100 may be formed with a gold-plated layer, for example, the gold-plated layer is a gold-plated copper sheet, and the use of the gold-plated copper sheet as the main material can enhance the conductivity of the electrode 100 and increase the contact area of ​​the electrode 100. The gold-plated layer not only provides excellent conductivity, but also is suitable for long-term implantation due to its biocompatibility and corrosion resistance.

[0061] The electrode 100 is made of a gold-plated copper sheet, which greatly improves the stability and durability of the electrode 100 compared with the microwire or microneedle electrode 100 commonly used in existing solutions.

[0062] In another embodiment, the edge of the electrode 100 is a smooth edge.

[0063] It can be understood that the smooth edge design of the electrode 100 reduces damage to tissues and reduces the risk of rejection, which is particularly important for long-term implantation of the electrode 100.

[0064] In another embodiment, the wire 200 is welded to the electrode 100 to form a welding layer. The electrode 100 and the wire 200 are connected by welding, which ensures the stability of the structure of the connection between the wire 200 and the electrode 100 and improves the conductivity of the wire 200. This connection method not only improves the reliability of the electrode 100, but also reduces the complexity of maintenance.

[0065] Among them, Figure 1 and Figure 3 As shown, the electrode 100 is provided with a central hole 1101, and the end of the wire 200 is inserted into the central hole 1101, so that one end of the wire 200 can extend into the interior of the electrode 100, and then the welded end is welded in the central hole 1101, so that the connection structure of the wire 200 is more secure. The central hole 1101 can be a blind hole.

[0066] The welding layer is covered with a cement encapsulation layer, and the cement encapsulation layer also covers the end surface of the electrode 100 away from the barb structure 120 .

[0067] It can be understood that the back of the electrode 100 is encapsulated with dental cement, which not only prevents leakage, but also effectively reduces corrosion damage and prolongs the service life of the electrode 100.

[0068] In another embodiment, the end of the electrode 100 away from the barb structure 120 is suitable for being fixed to the skin incision through a sealing layer.

[0069] Understandably, tissue glue is used to seal the implant wound, which not only makes it difficult for the electrode 100 to fall off, but also accelerates wound healing and ensures the stability and safety of the electrode 100 at the designated location. This design is particularly suitable for locations that frequently deform, such as near muscles or joints, where the electrode 100 can adapt to the deformation of these locations, reducing discomfort to the animal.

[0070] By using tissue glue to seal the back of the electrode 100, it not only prevents the electrode 100 from direct contact with the surrounding tissue and reduces tissue reaction, but also enhances the overall structural stability of the electrode 100. This is in sharp contrast to the problem of easy falling off or causing tissue damage in the existing solution, and improves the welfare of animals and the sustainability of experiments.

[0071] The electrode device 10 for subcutaneous implantation of the present invention can achieve nerve excitation or inhibition through low-frequency stimulation, and reduce pain through high-frequency stimulation. This versatility makes the electrode device 10 for subcutaneous implantation of the present invention not only suitable for basic neuroscience research, but also suitable for the treatment and management of clinical neurological diseases, while the existing solutions are relatively limited in application in this regard.

[0072] In addition, if Figure 4As shown, the interface 300 in the present application adopts a high-density interface, that is, the interface is provided with multiple connection points, and by increasing the connection points of the interface 300, the connection point density is high, so that it can perform multi-channel recording and stimulation on small-volume animals. This feature enables the electrode 100 to perform well when performing complex or multi-parameter experiments.

[0073] The wire 200 is made of microwires, and the soft and fine characteristics of the microwires ensure the naturalness of animal activities and reduce interference with animal behavior.

[0074] When the electrode device 10 for subcutaneous implantation in the present application is used, first, a small incision is made through the skin to form a wound, and then a relatively large-sized electrode 100 can be implanted. This method greatly reduces the trauma of surgery to animals.

[0075] The electrode device 10 for subcutaneous implantation provided by the present invention can be used to achieve long-term nerve stimulation by subcutaneous implantation, can be used for animal verification of nerve stimulation methods such as vagus nerve stimulation, and can also be used for long-term nerve electrical stimulation regulation of specific acupuncture points or muscle tissues of animals.

[0076] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. An electrode device for subcutaneous implantation, characterized in that: include: An electrode (100) comprises a cylindrical structure (110) and a barb structure (120), wherein the barb structure (120) is arranged at one end of the cylindrical structure (110); A wire (200), one end of which is connected to the cylindrical structure (110); The interface (300) is connected to the other end of the wire (200).

2. The electrode device for subcutaneous implantation according to claim 1, characterized in that: The barb structure (120) comprises: A connecting portion (121) connected to one end of the cylindrical structure (110); One end of the sharp portion (122) is connected to the connecting portion (121), and the other end of the sharp portion (122) gradually narrows in a direction away from the connecting portion (121).

3. The electrode device for subcutaneous implantation according to claim 2, characterized in that: The plurality of sharp portions (122) are arranged in a circular pattern in sequence, a gap is formed between two adjacent sharp portions (122), and the outer contours of the plurality of sharp portions (122) at least constitute a part of the outer contour of a cone.

4. The electrode device for subcutaneous implantation according to any one of claims 1 to 3, characterized in that: The barb structure (120) is formed by cutting triangular blocks at intervals on the outer circumference of an inverted cone structure.

5. The electrode device for subcutaneous implantation according to any one of claims 1 to 3, characterized in that: The edge of the electrode (100) is a smooth edge.

6. The electrode device for subcutaneous implantation according to any one of claims 1 to 3, characterized in that: The outer surface of the electrode (100) is gold-plated.

7. The electrode device for subcutaneous implantation according to any one of claims 1 to 3, characterized in that: The wire (200) and the electrode (100) are welded to form a welding layer.

8. The electrode device for subcutaneous implantation according to claim 7, characterized in that: The welding layer is covered with a cement encapsulation layer, and the cement encapsulation layer also covers the end surface of the electrode (100) away from the barb structure (120).

9. The electrode device for subcutaneous implantation according to claim 7, characterized in that: The electrode (100) is provided with a central hole (1101), and one end of the wire (200) is inserted into the central hole (1101).

10. The electrode device for subcutaneous implantation according to any one of claims 1 to 3, characterized in that: The end of the electrode (100) away from the barb structure (120) is suitable for being fixed to the skin incision through a sealing glue layer.

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