Identification assembly of directional electrode and stimulation system

Abstract

The invention belongs to the technical field of medical instruments, and discloses an identification assembly of a directional electrode and a stimulation system. The directional electrode comprises a connecting section, a stimulating section and a middle section for connecting the stimulating section and the connecting section; the identification assembly of the direction electrode is used for identifying the orientation of the direction electrode and comprises an identification device. The identification device comprises a guide wire, the guide wire is provided with an inserting end, the inserting end penetrates through the connecting section and the middle section and is fixedly connected with the stimulation section so that the guide wire and the stimulation section can synchronously rotate, the side, away from the inserting end, of the guide wire is provided with an identification section, the identification section is provided with an identification structure, and the identification structure can identify the orientation of the direction electrode. In this way, the orientation of the directional electrode can be obtained in real time through changes of the identification structure, it is ensured that the directional electrode can accurately face the designated direction when implanted, the treatment effect is improved, the possibility that the directional electrode needs to be implanted again is reduced, the program control testing time of the directional electrode is shortened, gaps borne by buffering are reduced, and the comfort level of a patient in an operation is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a marking component of a directional electrode and a stimulation system. Background Art

[0002] The directional electrode is a stimulation structure used in deep brain electrical stimulation, which is mainly used in scenarios where the location of the nucleus is asymmetric with the stimulation contact.

[0003] In the prior art, the stimulation segment of the directional electrode is provided with a plurality of stimulation contacts and a developing structure. When implanted, the developing structure is developed by X-ray to form a radiographic image to determine the orientation of the stimulation piece of the directional electrode.

[0004] However, this judgment method can only be performed after the directional electrode is implanted in the patient's body. If the orientation of the directional electrode is inaccurate after implantation, not only will the treatment effect be deteriorated, but if the orientation deviation of the directional electrode is too large, it will need to be re-implanted, which will extend the programming test time of the directional electrode, bring higher risks to the patient, and the patient's surgical comfort will also be deteriorated. Summary of the invention

[0005] The purpose of the present invention is to provide an identification component and a stimulation system for a directional electrode, which solves the problem in the prior art that it is difficult to detect the direction of the directional electrode in time when the directional electrode is implanted. If the direction of the directional electrode is inaccurate, not only will the treatment effect be deteriorated, but re-implantation may also be required, resulting in an extended programming test time for the directional electrode, a higher risk for the patient, and poor surgical comfort.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides a direction electrode identification component for identifying the direction of the direction electrode, wherein the direction electrode comprises a connection segment, an intermediate segment and a stimulation segment connected in sequence for connecting to an extension wire or a stimulator; the direction electrode identification component comprises:

[0008] A guide wire having a plug-in end, the plug-in end passing through the connecting section and the middle section and fixedly connected to the stimulation section so that the guide wire can rotate synchronously with the stimulation section, and the guide wire has an identification section on a side away from the plug-in end, the identification section has an identification structure, and the identification structure can identify the orientation of the directional electrode.

[0009] Optionally, the stimulation segment insulating spacer ring is provided with a plurality of the stimulation pieces, and the identification structure corresponds to at least one of the stimulation pieces.

[0010] Optionally, the stimulation segment has a slot, and the plug-in end of the guide wire is provided with a first limit block, and the first limit block is plugged into the slot to limit the rotation of the guide wire.

[0011] Optionally, the stimulation section has an insert block, and the insert end of the guide wire is provided with an insert notch, and the insert notch is plugged into and matched with the insert block to limit the self-rotation of the guide wire.

[0012] Optionally, one end of the guide wire away from the plug end extends out of the connecting section, and the identification structure is an identification portion, which is arranged at the end of the guide wire extending out of the connecting section.

[0013] Optionally, the identification structure is an identification piece, and the identification piece is arranged on the guide wire and can rotate synchronously with the guide wire.

[0014] Optionally, the identification structure further includes:

[0015] At least one identification hole, the identification hole is opened through the identification member;

[0016] Or, at least one identification groove, the identification groove is opened on the surface of the identification member;

[0017] Or, at least one identification protrusion, the identification protrusion is convexly arranged on the surface of the identification member;

[0018] Or, at least one identification coating, wherein the identification coating is located on the surface of the identification element.

[0019] Optionally, one end of the guide wire away from the plug-in end extends out of the connecting section and is clamped and fixed to the identification piece.

[0020] In a second aspect, the present invention provides a stimulation system comprising:

[0021] Stimulator;

[0022] a directional electrode, one end of which is implanted in the patient's body and the other end of which is electrically connected to the stimulator;

[0023] The identification component of the direction electrode as described in the second aspect is used to identify the direction of the direction electrode.

[0024] Optionally, the stimulation system further comprises:

[0025] An extension wire is provided, through which the stimulator is electrically connected to the direction electrode.

[0026] Beneficial effects of the present invention:

[0027] On the one hand, after the guide wire is inserted from the connecting section and passes through the middle section, it forms a fixed connection with the stimulation section, ensuring that the guide wire and the stimulation section can rotate synchronously, and the identification structure set in the identification section will also rotate, so that the direction of the directional electrode can be determined according to the identification structure. In this way, when the identification device is applied to the directional electrode, the medical staff can judge the implantation angle of the directional electrode in real time by observing the identification structure, and then the direction of the directional electrode can be obtained. When the directional electrode rotates, the identification structure rotates synchronously, and the direction of the directional electrode can be obtained in real time through the change of the identification structure, ensuring that the directional electrode can be accurately implanted in the specified direction, so as to improve the treatment effect, reduce the possibility of the directional electrode needing to be re-implanted, shorten the directional electrode program-controlled test time, reduce the gap borne by the buffer, and improve the patient's comfort during surgery.

[0028] Secondly, when the stimulation system is in use, the directional electrode can determine the orientation of the stimulation piece in real time during implantation, thereby ensuring that the directional electrode can accurately point to the specified direction after implantation, so that the therapeutic effect of the stimulation system can reach the expected effect, and also reduce the possibility of the need to re-implant the directional electrode, thereby reducing the time of programmed testing of the stimulation system, effectively reducing the risk borne by the patient and improving the patient's surgical comfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a structural schematic diagram of the plugging state of the stimulation segment of the directional electrode and the guide wire in the first embodiment of the present invention;

[0030] Figure 2 It is a structural schematic diagram of the plug-in end and the connecting section of the guide wire of the marking device in the first embodiment of the present invention;

[0031] Figure 3 is a schematic structural diagram of a guide wire of a marking device in Embodiment 1 of the present invention;

[0032] Figure 4 is a schematic structural diagram of a stimulation segment of a directional electrode in Embodiment 1 of the present invention;

[0033] Figure 5 is a schematic structural diagram of an identification member of an identification device in Embodiment 1 of the present invention;

[0034] Figure 6 is a schematic structural diagram of the plug-in end of the guide wire of the marking device in the second embodiment of the present invention;

[0035] Figure 7 It is a schematic diagram of the structure of the stimulation segment of the directional electrode in the second embodiment of the present invention.

[0036] In the figure:

[0037] 1. Guide wire; 21. First limiting block; 22. Second limiting block; 221. Insertion notch; 3. Identification piece; 4. Stimulation segment; 41. Slot; 43. Stimulation sheet; 44. Insert block; 45. Socket; 5. Identification hole; 6. Identification slot. DETAILED DESCRIPTION

[0038] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0039] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" 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 a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. 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] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0041] In the description of this embodiment, the terms "upper", "lower", "left", "right" and other directions or positional relationships are based on the directions or positional relationships shown in the drawings, and are only for the convenience of description and simplification of operation, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operate in a specific direction, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0042] The embodiment of the invention discloses a marking component of a direction electrode and a stimulation system.

[0043] Embodiment 1

[0044] Reference Figures 1 to 3The identification component of the direction electrode is used to identify the direction of the direction electrode. The direction electrode includes a connecting segment, an intermediate segment and a stimulation segment 4 which are connected in sequence and are used to connect to an extension wire or a stimulator; the identification component of the direction electrode includes a guide wire 1, the guide wire 1 has a plug-in end, the plug-in end passes through the connecting segment and the intermediate segment and is fixedly connected to the stimulation segment 4 so that the guide wire 1 can rotate synchronously with the stimulation segment 4, and the guide wire 1 has an identification segment on the side away from the plug-in end, the identification segment has an identification structure, and the identification structure can identify the direction of the direction electrode.

[0045] Specifically, the directional electrode is divided into a connecting section, an intermediate section and a stimulation section 4 in sequence along its axial direction. The stimulation section 4 is implanted in the user's body, and the connecting section is used to form an electrical connection with the stimulator. The plug-in end of the guide wire 1 is inserted from the connecting section and passes through the intermediate section to form a fixed connection with the stimulation section 4. The fixed connection can be formed by plug-in matching, or by bonding and the like. During plug-in matching, the plug-in structure can form a planar fit, thereby ensuring that the guide wire 1 and the stimulation section 4 rotate synchronously. The end of the guide wire 1 away from the plug-in end extends out of the directional electrode and forms an identification section. The surface of the identification section is provided with an identification structure. The identification structure can be a hole, a groove, a protrusion, a color coating or any other suitable means, or a combination of multiple means can be used. The present invention does not make specific limitations on this, and it is only necessary that the identification structure can facilitate medical staff to quickly identify the direction of the directional electrode.

[0046] After the guide wire 1 is inserted from the connecting section and passes through the middle section, it forms a fixed connection with the stimulation section 4, ensuring that the guide wire 1 and the stimulation section 4 can rotate synchronously, and the identification structure set in the identification section will also rotate, so that the direction of the directional electrode can be determined according to the identification structure. In this way, when the identification device is applied to the directional electrode, the medical staff can judge the implantation angle of the directional electrode in real time by observing the identification structure, and then the direction of the directional electrode can be obtained. When the directional electrode rotates, the identification structure rotates synchronously, and the direction of the directional electrode can be obtained in real time through the change of the identification structure, ensuring that the directional electrode can be accurately implanted in the specified direction, so as to improve the treatment effect, reduce the possibility of the directional electrode needing to be re-implanted, shorten the directional electrode program-controlled test time, reduce the gap borne by the buffer, and improve the patient's comfort during surgery.

[0047] Optionally, the insulating spacer ring of the stimulation segment 4 is provided with a plurality of stimulation pieces 43 , and the identification structure corresponds to at least one stimulation piece 43 .

[0048] Specifically, the stimulation pieces 43 can be arranged in multiple groups at intervals along the axial direction of the stimulation section 4, and each group of insulating spacers is provided with three stimulation pieces 43, and the identification structure can correspond to any stimulation piece 43, so the orientation of the stimulation piece 43 can be determined by the identification structure. Since the spacing arrangement between adjacent stimulation pieces 43 is known, when the orientation of the stimulation piece 43 is known, the orientation of other stimulation pieces 43 can be determined synchronously. In other embodiments, the identification structure can correspond to multiple stimulation pieces 43 at the same time to further reduce the difficulty of identification. The specific corresponding method can be designed according to the actual needs and difficulty of orientation identification, and this application does not limit this.

[0049] Optionally, the stimulation section 4 has a slot 41, and the plug-in end of the guide wire 1 is provided with a first limit block 21. The first limit block 21 is plugged into the slot 41 to limit the self-rotation of the guide wire 1.

[0050] Specifically, the first limit block 21 can be in a cubic shape to form a first limit plane on its side, and the shape of the slot 41 can be adapted to the shape of the first limit block 21. The shape of the first limit block 21 can be disc-shaped, or can be in a rectangular parallelepiped shape, a cube shape, or a triangular prism shape. The specific shape of the first limit block 21 can be formed as long as the first limit plane is formed and the first limit plane is ensured to fit the side wall of the slot 41, and the present invention does not limit this.

[0051] By plugging the first limit block 21 into the slot 41, the first limit plane fits against the side wall of the slot 41 to form a limit. When the stimulation segment 4 rotates, the side wall of the slot 41 can squeeze the limit plane, thereby driving the guide wire 1 to rotate synchronously through the limit block.

[0052] Reference Figure 4 Optionally, the stimulation segment 4 has a plug hole 45 for inserting the guide wire 1 , and the plug hole 45 is opened on the bottom wall of the slot 41 .

[0053] Optionally, one end of the guide wire 1 away from the plug-in end extends out of the connecting section, and the identification structure is an identification portion, which is arranged at the end of the guide wire 1 extending out of the connecting section.

[0054] Specifically, the identification part can be a structure such as a slot or a block structure, which is directly arranged at the position where the guide wire 1 extends out of the connecting section. At this time, the orientation of the directional electrode can be realized by directly observing the identification part on the guide wire 1.

[0055] Reference Figure 5 Optionally, the identification structure is an identification member 3. The identification member 3 is arranged on the guide wire 1 and can rotate synchronously with the guide wire 1.

[0056] Specifically, the identification member 3 may be columnar, a section of the guide wire 1 away from the plug end is inserted into the identification member 3, and the guide wire 1 is fixedly connected to the identification member 3, and the fixed connection may be achieved by plugging, clamping or bonding, etc., to ensure that the identification member 3 can rotate synchronously with the guide wire 1. A slot, a protrusion or a coating or other structures may be provided on the identification member 3 for direction identification.

[0057] By setting the columnar identification member 3, on the one hand, sufficient space can be provided to set the corresponding structure for identification to improve the recognition of the direction. On the other hand, the identification member 3 is fixedly connected to the guide wire 1 to ensure that the identification member 3 and the guide wire 1 can rotate synchronously.

[0058] Optionally, the identification structure includes at least one identification hole 5. The identification hole 5 is formed through the identification member 3, and different identification holes 5 have different shapes.

[0059] Specifically, the identification member 3 may be cylindrical, and a plurality of identification holes 5 may be provided on the identification member 3. The plurality of identification holes 5 may be distributed at intervals along the axial direction of the identification member 3. The shape of the identification hole 5 may be cylindrical or square columnar. Only one identification hole 5 of each shape may be provided, or multiple identification holes 5 of the same shape may be provided. The sizes of the plurality of identification holes 5 of the same shape may be different, so that each identification hole 5 is unique. The shape, size, and number of the specific identification holes 5 may be designed according to the actual identification requirements, and the present invention does not limit this.

[0060] Optionally, the identification structure includes at least one identification groove 6. The identification groove 6 is formed on the surface of the identification member 3, and different identification grooves 6 have different shapes.

[0061] Specifically, a plurality of identification grooves 6 are spaced apart along the circumferential and axial directions of the identification member 3 . The shape of the identification grooves 6 may be cylindrical or prismatic, etc. The layout of specific shapes and sizes may refer to the shapes and sizes of the identification holes 5 , which will not be elaborated herein.

[0062] Optionally, the identification structure includes at least one identification protrusion (not shown in the figure). The identification protrusion is convexly arranged on the surface of the identification member 3, and different identification protrusions have different shapes.

[0063] Specifically, a marking protrusion is formed on the surface of the identification part 3. The marking protrusion can be regular, such as cylindrical or prismatic, or can be other irregular shapes, text shapes, or pattern shapes. The heights of the marking protrusions can also be different, so that the differences between the marking protrusions are more obvious and easier to identify.

[0064] Optionally, the identification structure includes at least one identification coating (not shown in the figure). The identification coating is located on the surface of the identification element 3.

[0065] Specifically, the marking coating can be a color coating, and the colors of the multiple marking coatings are different. The marking coating can also form special words, patterns or shapes to increase recognition.

[0066] It should be understood that among the identification groove 6, the identification hole 5, the identification protrusion and the identification coating, four of them can be set on the identification member 3 at the same time, and the four of them can be arranged in a specific order so that the identification member 3 can present a different combination of identification structures every time it rotates a certain angle, thereby improving recognition. It is also possible to set only one, two or three of the four, and the specific combination and arrangement method can be designed according to the actual identification requirements, and there is no limitation on this.

[0067] Reference Figure 3 and Figure 4 Optionally, the identification member 3 may be in the shape of a sleeve to form a sleeve connection with the connecting section of the directional electrode. The identification member 3 may also be an arc-shaped sheet, on which a clamp ring is provided, and the clamp ring and the arc-shaped sheet form a space for inserting the connecting section of the directional electrode, and the clamp ring just corresponds to the contact point of the connecting section, and each contact point is provided with a clamp ring.

[0068] Optionally, one end of the guide wire 1 away from the plug-in end extends out of the connecting section and is clamped and fixed to the identification member 3 .

[0069] Specifically, a section of the guide wire 1 away from the plug-in end can be bent and fixed with the identification piece 3 in a snap-fitting manner, and a structure such as glue or an insertion rod can be provided at the snap-fitting portion to lock the guide wire 1 and the identification piece 3 together, so that the two form a stable fixed connection through a simple structure, ensuring that the two can rotate synchronously.

[0070] The stimulation system includes a stimulator, a directional electrode, an identification component of the directional electrode in the above embodiment, and an extension wire. One end of the directional electrode is implanted in the patient's body, and the other end is electrically connected to the stimulator or the extension wire. The identification component is used to identify the direction of the directional electrode.

[0071] When the stimulation system is in use, the directional electrode can determine the orientation of the stimulation piece 43 in real time during implantation, thereby ensuring that the directional electrode can accurately point to the specified direction after implantation, so that the therapeutic effect of the stimulation system reaches the expected level and the possibility of the directional electrode needing to be re-implanted is reduced, thereby reducing the time for programmed testing of the stimulation system, effectively reducing the risk borne by the patient and improving the patient's surgical comfort.

[0072] Embodiment 2

[0073] On the basis of the first embodiment, the difference between this embodiment and the first embodiment lies in the different connection structures between the guide wire 1 and the stimulation segment 4 .

[0074] Reference Figure 6 and Figure 7Optionally, the stimulation section 4 has an inserting block 44. The inserting end of the guide wire 1 is provided with an inserting notch 221, and the inserting notch 221 is inserted and matched with the inserting block 44 to limit the self-rotation of the guide wire 1.

[0075] Specifically, the plug block 44 can be formed on the stimulation segment 4 by embedding or integrally forming, and the plug block 44 can be in a cubic shape, such as a cuboid. The plug-in end of the guide wire 1 can be provided with a second limit block 22 with a cross-sectional area larger than the guide wire 1. The second limit block 22 can be in a disc shape, and a plug-in notch 221 is provided on the side of the second limit block 22 away from the guide wire 1. The plug-in notch 221 is adapted to the plug block 44, and the side wall of the plug-in notch 221 can be used as a second limit plane. It should be understood that the shapes of the plug block 44 and the plug-in notch 221 are not limited to the shapes in the above examples, as long as the two can form a plane fitting limit so that the guide wire 1 can rotate synchronously with the stimulation segment 4.

[0076] By plugging the plug block 44 into the plug-in notch 221 , the second limiting plane fits against the side wall of the plug block 44 to form a limit. When the stimulation segment 4 rotates, the side wall of the plug block 44 can squeeze the limiting plane, thereby driving the guide wire 1 to rotate synchronously through the second limiting block 22 .

[0077] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, various obvious changes, readjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A direction electrode identification component, characterized in that: Used to mark the direction of a directional electrode, the directional electrode comprises a connecting segment, an intermediate segment and a stimulating segment (4) which are connected in sequence and are used to connect to an extension wire or a stimulator; the marking component of the directional electrode comprises: A guide wire (1), the guide wire (1) having a plug-in end, the plug-in end passing through the connecting section and the middle section and fixedly connected to the stimulation section (4) so ​​that the guide wire (1) can rotate synchronously with the stimulation section (4), the guide wire (1) having an identification section on a side away from the plug-in end, the identification section having an identification structure, and the identification structure can identify the orientation of the directional electrode.

2. The direction electrode identification component according to claim 1, characterized in that: The insulating spacer ring of the stimulation section (4) is provided with a plurality of stimulation pieces (43), and the identification structure corresponds to at least one of the stimulation pieces (43).

3. The direction electrode identification component according to claim 1, characterized in that: The stimulation section (4) has a slot (41), and the plug-in end of the guide wire (1) is provided with a first limit block (21), and the first limit block is plugged into the slot (41) to limit the self-rotation of the guide wire (1).

4. The direction electrode identification component according to claim 1, characterized in that: The stimulation section (4) has an insert block (44), and the insert end of the guide wire (1) is provided with an insert notch (221), and the insert notch (221) is inserted and matched with the insert block (44) to limit the self-rotation of the guide wire (1).

5. The direction electrode identification component according to any one of claims 1 to 4, characterized in that: One end of the guide wire (1) away from the plug-in end extends out of the connecting section, and the identification structure is an identification portion, which is arranged on the end of the guide wire (1) extending out of the connecting section.

6. The direction electrode identification component according to any one of claims 1 to 4, characterized in that: The identification structure is an identification piece (3), and the identification piece (3) is arranged on the guide wire (1) and can rotate synchronously with the guide wire (1).

7. The direction electrode identification component according to claim 6, characterized in that: The identification structure also includes: at least one identification hole (5), the identification hole (5) being formed through the identification member (3); Or, at least one identification groove (6), wherein the identification groove (6) is provided on the surface of the identification element (3); Or, at least one identification protrusion, the identification protrusion being convexly arranged on the surface of the identification member (3); Or, at least one marking coating, wherein the marking coating is located on the surface of the marking element (3).

8. The direction electrode identification component according to claim 6, characterized in that: One end of the guide wire (1) away from the plug-in end extends out of the connecting section and is clamped and fixed with the identification piece (3).

9. A stimulation system, characterized in that include: Stimulator; a directional electrode, one end of which is implanted in the patient's body and the other end of which is electrically connected to the stimulator; The identification component of the directional electrode according to any one of claims 1 to 8, wherein the identification component is used to identify the orientation of the directional electrode.

10. The stimulation system according to claim 9, characterized in that The stimulation system further comprises: An extension wire is provided, through which the stimulator is electrically connected to the direction electrode.

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