Electrode contacts, cortical electrodes and implantable medical devices

Abstract

The present invention relates to the field of medical devices, and provides an electrode contact, a cortical electrode and an implantable medical device. The electrode contact comprises a main body and a fixing part. The fixing part is fixed in a substrate as the outer edge of the main body. The fixing part is provided with an opening so that a metal wire can extend from the opening to a concave cavity. Compared with the metal wire being routed from above the electrode contact, the space occupied by the metal wire in the thickness direction of the substrate is reduced, which helps to reduce the overall thickness of the substrate. The metal wire is welded and fixed in the concave cavity, and the concave cavity can accommodate the welding point, thereby avoiding causing an increase in the thickness of the substrate. Part of the substrate can also be filled in the concave cavity to improve the connection strength between the substrate and the electrode contact.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an electrode contact, a cortical electrode and an implantable medical device. Background Art

[0002] Previous studies have shown that there are characteristic abnormal EEG activities before epileptic seizures, which can be used to predict abnormal seizures. Implanting cortical electrodes to monitor the cerebral cortex area, sense and record abnormal brain signals, can provide a basis for the diagnosis and treatment of epilepsy and related diseases. In the base of the cortical electrode, the wire is fixed and passed above the electrode contact, occupying a certain thickness of the base. In addition, the thickness of the outer insulation layer of the wire needs to be guaranteed, resulting in a large base thickness, which is not conducive to implantation in the human body. Summary of the invention

[0003] In view of this, in order to solve the problem that the existing connection method between the wire and the electrode contact leads to a large substrate thickness, which is not conducive to implantation in the human body, the present invention provides an electrode contact, a cortical electrode and an implantable medical device.

[0004] A first aspect of the present invention provides an electrode contact, comprising: a main body having a bottom wall and a side wall connected to the bottom wall; and

[0005] A fixing portion connected to an end of the side wall away from the bottom wall and protruding from an outer wall surface of the side wall;

[0006] The side wall and the bottom wall are combined to form a concave cavity, and the fixing portion is provided with an opening for routing a metal wire, and the opening is connected to the concave cavity.

[0007] Furthermore, the fixing portion is arranged around the cavity, and a plurality of openings are arranged and evenly distributed around the cavity.

[0008] Furthermore, the side walls are combined to form a hollow cylindrical structure, the fixing portion is annular and coaxial with the hollow cylindrical structure, and the opening passes through the fixing portion axially and radially respectively.

[0009] Furthermore, the shape of the bottom wall in the thickness direction is circular, and its diameter is D1. The width of the outer wall surface of the fixing portion protruding from the side wall is W1, and then 0.2D1≤W1≤0.5D1.

[0010] Furthermore, the diameter of the cavity is D2, and the width of the inner wall surface of the fixing portion protruding from the side wall is W2, then 0.2D2≤W2≤0.25D2.

[0011] Furthermore, the bottom wall, the side walls, and the side walls and the fixing portion are formed by integral processing.

[0012] A second aspect of the present invention provides a cortical electrode, characterized in that it comprises a substrate and the above-mentioned electrode contact;

[0013] The substrate is mounted with at least one electrode contact.

[0014] Furthermore, it also includes a metal wire, which passes through the opening and is welded to the electrode contact in the cavity, and a portion of the substrate is filled in the cavity.

[0015] Furthermore, the substrate is provided with more than two electrode contacts, and the distance between two adjacent electrode contacts is 1 mm-15 mm.

[0016] A third aspect of the present invention provides an implantable medical device comprising the above-mentioned cortical electrode.

[0017] The present invention provides an electrode contact, which includes a main body and a fixing part. The fixing part is fixed in a substrate as the outer edge of the main body. The fixing part is provided with an opening so that a metal wire can extend from the opening to a concave cavity. Compared with the existing metal wire being routed from above the electrode contact, the space occupied by the metal wire in the thickness direction of the substrate is reduced, which is beneficial to reducing the overall thickness of the substrate. The metal wire is welded and fixed in the concave cavity, and the concave cavity can accommodate welding points, thereby avoiding the increase in substrate thickness caused by the welding points. Part of the substrate can also be filled in the concave cavity to improve the connection strength between the substrate and the electrode contact. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only 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 ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0019] Figure 1 It is a schematic diagram of an electrode contact having an opening in an embodiment of the present invention.

[0020] Figure 2 Schematic diagram of an electrode contact having two openings in an embodiment of the present invention.

[0021] Figure 3 Schematic diagram of an electrode contact having four openings in an embodiment of the present invention.

[0022] Figure 4 Schematic diagram of the connection between electrode contacts and metal wires in an embodiment of the present invention.

[0023] Figure 5 Schematic diagram of another embodiment of the present invention showing the connection between the electrode contact and the metal wire.

[0024] Figure 6 It is a schematic diagram of another electrode contact having an opening in an embodiment of the present invention.

[0025] Figure 7 Embodiment of the present invention Figure 6 Schematic diagram of the relationship between W1 and D1, and W2 and D2 of electrode contacts.

[0026] Figure 8 Schematic diagram of the electrode contact fixing hole in the embodiment of the present invention.

[0027] Fig. 9 Schematic diagram of a cortical electrode in an embodiment of the present invention.

[0028] Fig.10 Schematic diagram of a cortical electrode having two rows of electrode contacts in an embodiment of the present invention.

[0029] Fig.11 2 is another schematic diagram of a cortical electrode having two rows of electrode contacts in an embodiment of the present invention.

[0030] Fig.12 Schematic diagram of a cortical electrode having two branch pipe sections in an embodiment of the present invention.

[0031] Fig.13 Schematic diagram of the local structure of the cortical electrode in the embodiment of the present invention.

[0032] Description of reference numerals:

[0033] 11. Electrode contact; 12. Base; 13. Metal wire; 14. Protection tube; 141. Branch pipe section; 15. Connection contact; 16. Insulation part;

[0034] 111, main body; 1111, bottom wall; 1112, side wall; 112, fixing part; 1121-fixing hole; 113, concave cavity; 114, opening. DETAILED DESCRIPTION

[0035] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the detailed description of the present invention below, some specific details are described in detail. It is possible for a person skilled in the art to fully understand the present invention without the description of these details. In order to avoid confusing the essence of the present invention, known methods, processes, flows, components and circuits are not described in detail.

[0036] In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

[0037] Unless the context clearly requires otherwise, the words "include", "comprising" and similar words throughout the application should be interpreted as including rather than exclusive or exhaustive; that is, the meaning is "including but not limited to".

[0038] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0039] Unless otherwise clearly defined and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0040] For ease of explanation, spatially relative terms such as "inside", "outside", "below", "below", "lower", "above", "upper", etc. are used herein to describe the relationship of one element or feature illustrated in the figures to another element or feature. It will be understood that spatially relative terms may be intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. For example, if the device in the figure is turned over, the elements described as being "below" or "below" other elements or features will then be positioned as being "above" the other elements or features. Thus, the example term "below" can include both the orientations of above and below. The device may be oriented in other ways, and the spatially relative descriptors used herein should be interpreted accordingly.

[0041] In order to solve the problem that the existing connection method between the wire and the electrode contact leads to an increase in the thickness of the substrate, which is not conducive to implantation in the human body, the present invention provides an electrode contact, a cortical electrode and an implantable medical device. The cortical electrode includes an electrode contact and a substrate, the substrate is equipped with the electrode contact, and the implantable medical device includes the cortical electrode.

[0042] Figure 1 It is a schematic diagram of an electrode contact having an opening in an embodiment of the present invention.

[0043] like Figure 1As shown, the electrode contact includes a main body 111 and a fixing part 112. The main body 111 is used to contact the human cerebral cortex, collect and receive weak EEG signals, and transmit the collected and received weak EEG signals to the stimulator through a metal wire. The pulses emitted by the stimulator can also be transmitted to the cerebral cortex. The main body 111 has a bottom wall 1111 and a side wall 1112 connected to the bottom wall 1111. After the electrode contact is installed on the base, part of the side wall 1112 and the bottom wall 1111 are located outside the base. The fixing part 112 is connected to the end of the side wall 1112 away from the bottom wall 1111, and protrudes from the outer wall surface of the side wall 1112 to form a "outer edge", "flanged edge" and other similar structures. The fixing part 112 is located in the base. The fixing part 112 improves the stability of the connection between the electrode contact and the base, and prevents the electrode contact from escaping from the base.

[0044] After the side wall 1112 is connected to the bottom wall 1111, the space enclosed by the side wall 1112 forms a cavity 113 of the main body 111. The metal wire is welded and fixed in the cavity 113. The cavity 113 can accommodate the welding point, thereby avoiding increasing the thickness of the substrate. Part of the substrate can also be filled in the cavity 113 to improve the connection strength between the substrate and the electrode contact.

[0045] In the present invention, the metal wire and the electrode contact are welded by resistance welding or laser welding.

[0046] The fixing portion 112 is provided with an opening 114 connected to the concave cavity 113, so that the metal wire extends to the concave cavity 113 through the opening 114. Compared with the existing wire passing over the contact, the present invention reduces the space occupied by the wire in the thickness direction of the substrate. When the opening 114 can completely accommodate the metal wire, the influence of the superposition of the wire and the electrode contact on the thickness of the substrate can be eliminated, thereby reducing the thickness requirement of the substrate, which is conducive to implantation in the human body. In the direction perpendicular to the bottom wall 1111, the opening 114 can be rectangular, trapezoidal, etc. In some other embodiments, the opening 114 has a certain width (capable of placing the wire) and extends from the outside of the fixing portion 112 to the concave cavity 113, and its shape can be set by a person skilled in the art according to needs. The shape of the opening 114 illustrated in the accompanying drawings of the present invention is rectangular.

[0047] The side walls 1112 of the main body 111 are enclosed to form a hollow cylindrical structure, the concave cavity 113 is cylindrical, the fixing part 112 is arranged around the concave cavity 113, the fixing part 112 is annular and coaxial with the hollow cylindrical structure, and the opening 114 is arranged to penetrate the fixing part 112 in the axial direction and radial direction of the fixing part 112. In the present invention, the fixing part 112 and the side walls 1112, and the side walls 1112 and the bottom wall 1111 can be formed by integral processing, and the electrode contacts can be made of metal conductive materials as a whole, and formed by multiple stamping processes, or can be cut as a whole. A chamfered surface is set on the outer side of the connection between the bottom wall 1111 and the side wall 1112 to prevent the electrode contacts from scratching the cerebral cortex.

[0048] The material of the electrode contact can be nickel-chromium alloy, titanium alloy, platinum-iridium alloy or medical stainless steel, preferably titanium alloy.

[0049] Figure 2 Schematic diagram of an electrode contact having two openings 114 in an embodiment of the present invention. Figure 3 Schematic diagram of an electrode contact having four openings 114 in an embodiment of the present invention. Figure 4 Schematic diagram of the connection between electrode contacts and metal wires in an embodiment of the present invention. Figure 5 Schematic diagram of another embodiment of the present invention showing the connection between the electrode contact and the metal wire.

[0050] like Figure 2 As shown, two openings 114 are provided, and the two openings 114 are located on a straight line passing through the center of the fixing portion 112. Figure 4 The metal wire 13 enters the cavity 113 from one of the two openings 114 , extends into the cavity 113 and is welded to the main body 111 . Preferably, the metal wire 13 extends to the center of the cavity 113 and is welded to the main body 111 .

[0051] Figure 5 Two wires are shown in the example, but there may be more wires in practice. The two openings 114 may also be used for wires of other electrode contacts to pass through. It is understandable that the wires passing through the openings 114 have an insulating layer. One of the metal wires 13 extends into the cavity 113 and is welded to the main body 111, and the remaining wires enter the cavity 113 from one opening and then extend from the other opening, thereby reducing the space occupied by the metal wires in the thickness direction of the substrate when passing over the electrode contacts.

[0052] Figure 3There are four middle openings 114, which are evenly distributed around the fixing portion 112, and the metal wire can enter the cavity 113 from four directions. In the cortical electrode scheme with multiple contacts densely distributed, the electrode contacts of the four openings 114 facilitate the distribution of the metal wires in the matrix, so that the metal wires can be placed in the openings 114 when passing through the electrode contacts from multiple directions, thereby reducing the occupation of the metal wires by the thickness of the matrix.

[0053] Figure 6 FIG. 1 is a schematic diagram of another electrode contact having an opening 114 in an embodiment of the present invention.

[0054] like Figure 6 As shown, the side wall 1112 and the bottom wall 1111 form a cylindrical cavity 113, the fixing portion 112 is annular, the fixing portion 112 is fixed to the end of the side wall 1112 away from the bottom wall 1111, and the inner ring diameter of the fixing portion 112 is smaller than the diameter of the cavity 113. It can be understood that the fixing portion 112 protrudes from the inner wall surface of the side wall 1112, and the fixing portion 112 blocks part of the port of the cavity 113 in the circumferential direction. After the substrate is partially filled into the cavity 113, the contour of the substrate in the cavity 113 is larger than the inner ring contour of the fixing portion 112, and the substrate in the cavity 113 is not easy to fall out, thereby ensuring the stability of the connection between the electrode contact and the substrate.

[0055] Figure 7 Embodiment of the present invention Figure 6 Schematic diagram of the relationship between W1 and D1, and W2 and D2 of electrode contacts.

[0056] like Figure 6 , 7 The shape of the bottom wall 1111 in the thickness direction is circular, the diameter of the bottom wall 1111 is D1, the width of the outer wall surface of the fixing portion 112 protruding from the side wall 1112 is W1, and the relationship between D1 and W1 is: 0.2D1≤W1≤0.5D1. The width dimension of the fixing portion 112 is proportional to the bottom wall dimension of the main body 111 to ensure the coordination of the overall dimension of the electrode contact. If the dimension W1 is too small, the connection strength between the electrode contact and the substrate is weak, and it cannot effectively prevent the electrode contact from shaking or falling out. If the dimension W1 is too large, the distance between the bottom walls 1111 of the two adjacent contacts is too large, and the number of electrode contacts set on the substrate of the same size is reduced, resulting in poor EEG signal collection effect.

[0057] The electrode contact of the present invention is used for implantation in the human body, and the overall size is required to be miniaturized. The size range of D2 is between 4mm and 10mm. The width of the inner wall surface of the fixing portion 112 protruding from the side wall 1112 is W2. In order to achieve the welding of the metal wire in the cavity and the smooth injection of the substrate into the cavity 113, the relationship between D2 and W2 is set to: 0.2D2≤W2≤0.25D2. If W2 is too small, the ability of the fixing portion 112 to restrict the substrate from escaping from the cavity 113 is weak. If W2 is too large, it is not conducive to filling the substrate into the cavity 113.

[0058] In some other embodiments, Figure 6 , 7 The fixing portion 112 may also be provided with a plurality of openings 114 communicating with the concave cavity 113 , and the openings 114 penetrate the fixing portion 112 in the axial and radial directions. The matching between the metal wire and the openings 114 is consistent with the above, and will not be described in detail.

[0059] Figure 8 Schematic diagram of the electrode contact fixing hole in the embodiment of the present invention.

[0060] In the embodiment of the present invention, the fixing portion 112 may further include a fixing hole 1121. Figure 8 As shown, taking the example of an opening 114 in the fixing portion 112, a portion of the fixing portion 112 protruding from the outer wall of the main body 111 is provided with a plurality of axially penetrating fixing holes 1121, and the plurality of fixing holes 1121 are evenly distributed along the circumferential direction of the fixing portion 112, and the opening 114 is located between two fixing holes 1121, and the fixing holes 1121 are used to connect with the substrate to improve the connection strength between the electrode contacts and the substrate.

[0061] Fig. 9 Schematic diagram of a cortical electrode in an embodiment of the present invention. Fig.10 Schematic diagram of a cortical electrode having two rows of electrode contacts in an embodiment of the present invention. Fig.11 2 is another schematic diagram of a cortical electrode having two rows of electrode contacts in an embodiment of the present invention. Fig.12 Schematic diagram of a cortical electrode having two branch pipe sections in an embodiment of the present invention. Fig.13 Schematic diagram of the local structure of the cortical electrode in the embodiment of the present invention.

[0062] like Figure 9-13The cortical electrode provided by the present invention includes a substrate 12, a metal wire 13 and the above-mentioned electrode contact. The main body of the electrode contact 11 is used to contact the human cerebral cortex and collect and receive brain electrical signals. The axial depth of the opening 114 of the electrode contact is greater than the diameter of the metal wire 13, so that the opening 114 can completely accommodate the metal wire 13. The cortical electrode also includes a functional end, an extension section and a connecting end. The substrate 12 is located at the functional end, and the substrate 12 is installed with at least one electrode contact 11. Generally, the substrate 12 is installed with more than two electrode contacts 11, and the spacing between two adjacent electrode contacts 11 is between 1mm and 15mm.

[0063] The substrate 12 is in the form of a sheet, generally a rectangle, but may also be circular, elliptical, trapezoidal, etc. When the lesion area or monitoring area of ​​the brain is large, the substrate 12 may be processed into a rectangular sheet with a larger area, and the electrode contacts 11 may also be arranged in two or more rows as required. When the cortical area to be monitored is small, the substrate 12 may be processed into a long strip, and the electrode contacts 11 may be arranged in a row, arranged along the length direction of the substrate 12, and each electrode contact 11 is provided with two openings 114, the openings 114 face the arrangement direction of the electrode contacts 11, so that the metal wire 13 can be placed in the opening 114 when passing over the electrode contact 11, thereby reducing the space occupied by the metal wire 13 in the thickness direction of the substrate 12.

[0064] The substrate 12 is made of implantable materials such as polyurethane, silicone rubber, polytetrafluoroethylene, or PDMS, and the metal wire 13 is connected to the electrode contact at the connection end. The extension section includes a protective tube 14, the metal wire 13 is assembled into the protective tube 14, and the electrode contact at the functional end is connected to the metal wire 13. The substrate is formed by molding, injection molding, and other process methods to complete the production of the cortical electrode. The order of production of the cortical electrode can be adjusted.

[0065] The connection end includes an insulating portion 16 and a connection contact 15 mounted on the insulating portion 16, and the connection contact 15 is connected to a metal wire 13 led out of the protection tube 14. The connection end is used to connect to the stimulator, and adjacent connection contacts 15 are insulated by the insulating portion 16.

[0066] When the electrode contacts 11 of the present invention are arranged in multiple rows, each row of electrode contacts 11 may be provided with a corresponding protective tube 14. Fig.11 The electrode contacts 11 are arranged in two rows, and two protection tubes 14 are arranged, forming two connection ends.

[0067] The protection tube 14 may also be provided with two or more branch pipe sections 141, and the metal wires 13 connected to different electrode contacts 11 may be grouped according to the requirements, and each group of metal wires 13 may be led out from different branch pipe sections 141. Fig.12The electrode contacts 11 are arranged in a row, the substrate 12 is connected to a protection tube 14, and the protection tube 14 is provided with two branch pipe sections 141 to form two connection ends.

[0068] The protection tube 14 is made of polymer materials, such as polyurethane, silicone rubber or other materials. Fig.13 In the embodiment, the protection tube 14 is designed as a flat structure. Since a portion of the protection tube 14 is fixed in the substrate 12 , the flat structure can further reduce the thickness of the substrate 12 .

[0069] In the present invention, a mounting groove is provided on one side of the substrate 12 for contacting the cortex, and the mounting groove is engaged with the electrode contact. The mounting groove is slightly smaller than the electrode contact, so that the electrode contact can be squeezed by the substrate 12. The cross-sectional shape of the mounting groove in the thickness direction of the substrate 12 is approximately "T"-shaped, and a fixing column can be provided on the surface of the mounting groove for cooperating with the fixing portion 112, and the fixing column is used to cooperate with the fixing hole 1121 of the electrode contact. A mesh reinforcement member can be laid in the substrate 12, so a reinforcement member can be provided in the substrate 12 corresponding to the fixing portion 112, or the laying density of the reinforcement member can be increased, that is, the rigidity of the substrate 12 around the fixing portion 112 is focused on, thereby preventing the electrode contact 11 from coming out of the substrate 12.

[0070] The present invention also provides an implantable medical device, which includes a stimulator, deep brain electrodes and cortical electrodes. The deep brain electrodes and cortical electrodes are respectively connected to the stimulator. The deep brain electrodes can monitor deep brain electrical signals and output stimulation currents, and the cortical electrodes can monitor electrical signals in the cerebral cortex and output stimulation currents.

[0071] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An electrode contact, characterized in that: include: A main body (111) comprising a bottom wall (1111) and a side wall (1112) connected to the bottom wall (1111); and A fixing portion (112), connected to an end of the side wall (1112) away from the bottom wall (1111) and protruding from an outer wall surface of the side wall (1112); The side wall (1112) and the bottom wall (1111) are combined to form a concave cavity (113); the fixing portion (112) is provided with an opening (114) for routing a metal wire; and the opening (114) is connected to the concave cavity (113).

2. The electrode contact according to claim 1, characterized in that: The fixing portion (112) is arranged around the concave cavity (113), and a plurality of openings (114) are arranged and evenly distributed around the circumference of the concave cavity (113).

3. The electrode contact according to claim 1, characterized in that: The side walls (1112) are enclosed to form a hollow cylindrical structure, the fixing portion (112) is annular and coaxial with the hollow cylindrical structure, and the opening (114) penetrates the fixing portion (112) in the axial direction and the radial direction respectively.

4. The electrode contact according to claim 3, characterized in that: The shape of the bottom wall (1111) in the thickness direction is circular, and its diameter is D1. The width of the outer wall surface of the fixing portion (112) protruding from the side wall (1112) is W1, and then 0.2D1≤W1≤0.5D1.

5. The electrode contact according to claim 3, characterized in that: The diameter of the concave cavity (113) is D2, and the width of the inner wall surface of the fixing portion (112) protruding from the side wall (1112) is W2, then 0.2D2≤W2≤0.25D2.

6. The electrode contact according to claim 1, characterized in that: The bottom wall (1111), the side wall (1112), and the side wall (1112) and the fixing portion (112) are formed by integral processing.

7. A cortical electrode, characterized in that: It comprises a substrate and an electrode contact according to any one of claims 1 to 6; The substrate is mounted with at least one electrode contact.

8. The cortical electrode according to claim 7, characterized in that: It also includes a metal wire, which passes through the opening (114) and is welded to the electrode contact in the cavity (113), and a portion of the matrix is ​​filled in the cavity (113).

9. The cortical electrode according to claim 7, characterized in that: The substrate is provided with more than two electrode contacts, and the distance between two adjacent electrode contacts is 1 mm to 15 mm.

10. An implantable medical device, characterized in that: The invention comprises the cortical electrode as described in any one of claims 7 to 9.

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