Implantable electrode lead and nerve stimulation system

Abstract

The utility model discloses an implantable electrode lead and a nerve stimulation system, and the implantable electrode lead comprises an implantation section implanted in a skull, a connection section connected with the implantation section, and a flexible supporting member. The flexible supporting piece is installed in the connecting section and supports the connecting section in the radial direction of the implantable electrode wire so as to prevent the connecting section from being pressed and deformed, and the flexible supporting piece and the connecting section can be bent synchronously. The implantable electrode lead and the nerve stimulation system are used for preventing the guide wire element from being pressed and deformed, and the service life of the implantable electrode lead is prolonged.

Description

TECHNICAL FIELD

[0001] The utility model relates to implantable electrode lead technical field especially, it relates to a kind of implantable electrode lead and nerve stimulation system. BACKGROUND

[0002] Electrode lead is a kind of medical instrument for implanting into patient's body to treat patient by the way of applying electric stimulation.Electrode lead generally includes implant segment for implanting into target area and connecting segment connected with implant segment.Electrode lead implant segment is used to apply electric stimulation to target area to treat patient.In deep brain electric stimulation, the target area is located in patient's skull, and implant segment is implanted into skull, and connecting segment extends from the top of skull to connect with external extension lead.

[0003] In related technology, electrode lead includes spiral guide wire, spiral guide wire is generally set to hollow structure to improve the fatigue resistance of lead, and spiral guide wire part is located in connecting segment.In the process of connecting connecting segment with extension lead, clamping tool is used to clamp connecting segment, so that connecting segment is extended to extension lead and electrically connected with extension lead.Spiral guide wire in connecting segment is deformed under pressure when clamping connecting segment.The connecting position of connecting segment and extension lead is generally located below temporal bone of skull and above sternum clavicle, which is the most severe part of electrode lead under bending or torsion working condition.As spiral guide wire is easily deformed when clamping connecting segment, it can cause spiral guide wire to sharply reduce fatigue resistance when electrode lead is bent or twisted, thereby reducing the service life of electrode lead. UTILITY MODEL CONTENTS

[0004] The utility model aims at providing a kind of implantable electrode lead and nerve stimulation system, for preventing connecting segment from being deformed under pressure, to protect the internal components of connecting segment, improve the service life of implantable electrode lead.

[0005] The utility model aims at the following technical scheme realization:

[0006] An implantable electrode lead, comprising:

[0007] Implant segment implanted into skull;

[0008] Connecting segment connected with implant segment;

[0009] Flexible support, installed in the connecting segment and supports the connecting segment along the radial direction of the implantable electrode lead, to prevent the connecting segment from being deformed under pressure, and the flexible support can be bent synchronously with the connecting segment.

[0010] Preferably, a guide wire element is further included, the guide wire element is spirally wound and distributed to form a containing channel, the flexible support is accommodated in the containing channel, and the flexible support supports the guide wire element to prevent the guide wire element from being deformed under pressure.

[0011] The guide wire element is partially arranged in the implanting section and partially arranged in the connecting section.

[0012] Preferably, a guide wire element and a sleeve are further included, the guide wire element is spirally wound on the outside of the sleeve, and the flexible support is arranged in the sleeve.

[0013] Preferably, the flexible support is a support column made of polyurethane, nylon or silicone rubber, and the flexible support is a solid or hollow structure.

[0014] Alternatively, the flexible support is a woven mesh structure.

[0015] Preferably, the implantable electrode lead wire includes an outer tube arranged outside the guide wire element, the guide wire element and the outer tube are arranged with a spacing therebetween to form a spacing cavity, the spacing cavity is arranged with the flexible support, and the flexible support is a woven mesh structure.

[0016] Preferably, the guide wire element includes a plurality of layers of spiral guide wires, and the plurality of layers of spiral guide wires are arranged in a stacked manner along the radial direction of the implantable electrode lead wire.

[0017] Preferably, the flexible support is accommodated in the connecting section, and the flexible support does not exceed the connecting section.

[0018] Preferably, the flexible support is arranged with a limiting portion, the implantable electrode lead wire is arranged with a cooperating portion cooperating with the limiting portion, and the cooperating portion cooperates with the limiting portion to limit the movement of the flexible support relative to the implantable electrode lead wire along the extension direction of the implantable electrode lead wire.

[0019] Preferably, one end of the flexible support is arranged with a guide portion for guiding when the flexible support is installed in the connecting section.

[0020] A neural stimulation system, comprising:

[0021] a stimulator;

[0022] The implantable electrode lead wire of any one of the above, one end of which is implanted in a patient's body, and the other end of which is electrically connected to the stimulator.

[0023] Preferably, the neural stimulation system further comprises:

[0024] an extension lead wire through which the stimulator is electrically connected with the implantable electrode lead wire.

[0025] Compared with the prior art, the utility model has at least the following beneficial effects:

[0026] By setting the flexible support in the connecting section, the flexible support can support the connecting section in the radial direction, when the connecting section is pressed and tends to deform towards the inside, the flexible support can support to prevent the connecting section from being deformed, eliminate or reduce the deformation degree of the connecting section, protect the components in the connecting section, and further improve the service life of the implantable electrode lead wire; and the flexible support can be bent synchronously with the connecting section to ensure that the connecting section has a certain bending flexibility in the axial direction, facilitating the extension of the connecting section along the required path. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 is a partial structure schematic view of the implantable electrode lead wire of the utility model embodiment;

[0028] Figure 2 is a partial sectional view of the implantable electrode lead wire of the utility model embodiment;

[0029] Figure 3 is still another partial sectional view of the implantable electrode lead wire of the utility model embodiment;

[0030] Figure 4 is a structure schematic view of the flexible support of the utility model embodiment;

[0031] Figure 5 is a structure schematic view of the implantable electrode lead wire when implanted into the skull of a patient.

[0032] In the figure: 1, implantable electrode lead wire; 11, implanting section; 111, stimulating end; 112, split electrode; 113, electrode sheet; 12, connecting section; 121, second end; 122, connecting end; 123, connecting contact; 13, guide wire element; 131, accommodating channel; 132, sleeve; 14, outer tube; 15, interval cavity; 16, matching part; 2, flexible support; 21, first end; 22, limiting part; 23, guide part; 200, stimulator; 300, electrode lock; 400, extension lead wire; 500, temporal bone; 600, clavicle. DETAILED DESCRIPTION

[0033] Example implementations will now be described more fully with reference to the accompanying drawings. Example implementations may, however, be implemented in many different forms and should not be construed as limited to the implementations set forth herein; rather, these implementations are provided so that this disclosure will be thorough and complete, and fully convey the inventive aspects of the example implementations to those skilled in the art. Like reference numerals refer to like elements throughout the figures, and descriptions of the same elements will not be repeated.

[0034] The words expressing position and direction described in the present application are illustrated by taking the drawings as an example, but changes can also be made according to needs, and the changes made are all included in the protection scope of the present application.

[0035] As shown in Figure 1 and Figure 2 The present application provides an implantable electrode lead 1, which comprises an implant segment 11, a connecting segment 12 and a flexible support 2.

[0036] The implant segment 11 is used for implanting inside the skull of a patient and for generating electrical stimulation to treat the patient. Specifically, the implant segment 11 comprises a stimulation end 111, and the stimulation end 111 comprises at least one segment electrode 112, and each segment electrode 112 comprises one or more electrode segments 113, and when the segment electrode 112 comprises a plurality of electrode segments 113, the plurality of electrode segments 113 are insulatively and spacedly distributed along the circumference of the implantable electrode lead 1. Wherein, when a plurality of segment electrodes 112 are provided, the plurality of segment electrodes 112 are spacedly distributed along the extension direction of the implantable electrode lead 1. Each electrode segment 113 can serve as a stimulation contact to apply electrical stimulation to the patient.

[0037] One end of the connecting segment 12 is connected with the implant segment 11, for example, integrally connected with the implant segment 11, and the other end extends to be connected with an external component. Specifically, the implantable electrode lead 1 is of a whole structure, and the part of the implantable electrode lead 1 used for implanting inside the skull of a patient forms the implant segment 11, while the part outside the skull of the patient forms the connecting segment 12. The connecting segment 12 comprises a connecting end 122, and the connecting end 122 comprises at least one connecting contact 123, and the connecting contact 123 is electrically connected with the external component to realize the connection between the connecting segment 12 and the external component. Wherein, the external component is a component independent of the electrode lead, for example, the external component is an extension lead or a stimulator.

[0038] The implantable electrode lead 1 can include an outer tube 14 and a wire element 13 inside the outer tube 14. The surface of the outer tube 14 forms the electrode pads 113 and the connection contacts 123. The wire element 13 can be a helical wire formed by winding a plurality of wires, and the wire element 13 is hollow inside. The outer tube 14 is partially located in the implant segment 11 and partially located in the connection segment 12. The wire element 13 is partially located in the implant segment 11 and partially located in the connection segment 12. The wires in the wire element 13 are used to electrically connect the electrode pads 113 and the connection contacts 123, so that the electrode pads 113 can be electrically connected to external components through the connection contacts 123.

[0039] The flexible support 2 is installed in the connection segment 12 and supports the connection segment 12 in the radial direction of the implantable electrode lead 1 to prevent the connection segment 12 from being deformed towards the inside of the connection segment 12 due to compression and causing the wire element 13 located in the connection segment 12 to be deformed. The radial direction of the implantable electrode lead 1 is perpendicular to the axis of the implantable electrode lead 1, and the radial direction of the implantable electrode lead 1 passes through the central axis of the implantable electrode lead 1. The flexible support 2 can support components in the connection segment 12 to support the connection segment 12, for example, the flexible support 2 directly supports the wire element 13 in the connection segment 12; or the flexible support 2 can support the outer tube 14 located in the connection segment 12.

[0040] The flexible support 2 can be arranged only in the connection segment 12 and not beyond the connection segment 12, i.e. the flexible support 2 does not extend into the implant segment 11. Specifically, the flexible support 2 includes a first end 21 adjacent to the implant segment 11, and the connection segment 12 includes a second end 121 connected to the implant segment 11. Referring to Figure 2 , the first end 21 of the flexible support 2 can be parallel to the second end 121 of the connection segment 12, at this time the first end 21 of the flexible support 2 is flush with one end of the connection segment 12 adjacent to the implant segment 11 and does not extend into the implant segment 11; or the first end 21 of the flexible support 2 can be recessed from the second end 121 of the connection segment 12, at this time the first end 21 of the flexible support 2 is spaced apart from the implant segment 11. In other embodiments, the flexible support 2 can also extend into the implant segment 11. As a preferred embodiment, the flexible support 2 is arranged only in the connection segment 12 and used to support the connection segment 12.

[0041] The flexible support 2 is soft and bendable, so that after the flexible support 2 is installed in the connecting section 12, the connecting section 12 can keep a certain bending softness in the axial direction, and the connecting section 12 can bend synchronously with the flexible support 2, so that the connecting section 12 can extend along a desired extension path. In addition, the flexible support 2 has a certain strength in the radial direction, so that the flexible support 2 can support the connecting section 12 in the radial direction to prevent the connecting section 12 from deforming the lead wire element 13 located in the connecting section 12 due to clamping or other reasons. The radial direction of the flexible support 2 corresponds to the radial direction of the implantable electrode lead wire 1.

[0042] In the implantation process of the implantable electrode lead wire, a tungsten wire or other support structure can be first implanted in the implantable electrode lead wire 1 to ensure the straightness of the implantable electrode lead wire 1 and increase the strength of the implantable electrode lead wire 1. After the implantation section 11 of the implantable electrode lead wire 1 is implanted at a target position in the patient's body, the tungsten wire is removed, the flexible support 2 is installed in the connecting section 12 of the implantable electrode lead wire 1, and then a clamping tool is used to clamp the connecting section 12 to pull the connecting section 12 to connect with an external component. When clamping the connecting section 12, the flexible support 2 supports the connecting section 12 in the radial direction to prevent the lead wire element 13 in the connecting section 12 from being extruded and deformed due to the clamping force. After the connecting section 12 is connected with the external component, even if the connection position of the connecting section 12 and the external component is located at the most unfavorable position of the electrode lead wire under bending or torsion working conditions, since the lead wire element 13 will not or substantially not be deformed during clamping, and the flexible support 2 keeps supporting the connecting section 12 in the radial direction, the decrease of the fatigue resistance of the lead wire element 13 under bending or torsion of the implantable electrode lead wire can be effectively reduced, and the service life of the lead wire element 13 and the implantable electrode lead wire can be improved. In the use process of the implantable electrode lead wire, the flexible support 2 can be kept in the connecting section 12.

[0043] In some specific embodiments, the lead wire element 13 is formed by spirally winding a plurality of lead wires, and the lead wire element 13 surrounds a receiving channel 131 for receiving the flexible support 2. The flexible support 2 is received in the receiving channel 131, so that the flexible support 2 can be used to apply a radial support force to the lead wire element 13, thereby preventing the lead wire element 13 from being extruded and deformed.

[0044] Referring to Figure 3 In yet some specific embodiments, a sleeve 132 can be arranged inside the lead wire element 13, and the lead wire element 13 is spirally wound outside the sleeve 132. The sleeve 132 is hollow inside and forms a receiving channel 131 for receiving the flexible support 2. The flexible support 2 is installed in the sleeve 132 and indirectly supports the lead wire element 13 through the sleeve 132.

[0045] The accommodation channel 131 can be used as a mounting position of the tungsten wire, i.e., the tungsten wire is inserted into the accommodation channel 131 to support the lead wire 1 of the implantable electrode, and after the implantation of the implantation section 11 is completed and the tungsten wire is pulled out, the flexible support 2 is mounted in the accommodation channel 131 to support the connecting section 12.

[0046] The flexible support 2 can be pre-prepared and then inserted into the accommodation channel 131. The flexible support 2 can be gap-fitted with the wall forming the accommodation channel 131 to facilitate the installation of the flexible support 2, or the flexible support 2 can be the same size as the accommodation channel 131, so that the flexible support 2 can be fitted with the wall forming the accommodation channel 131, and the support effect of the flexible support 2 on the guide wire element 13 is improved.

[0047] In some embodiments, the flexible support 2 can also not be arranged in the guide wire element 13, but arranged outside the guide wire element 13 and inside the outer tube 14. Specifically, the guide wire element 13 and the outer tube 14 are arranged with a spacing and form a spacing cavity 15, part of the spacing cavity 15 is located in the connecting section 12, and the flexible support 2 is arranged in the part of the spacing cavity 15 located in the connecting section 12. The flexible support 2 prevents the outer tube 14 from deforming and thereby protects the guide wire element 13.

[0048] In some embodiments, the flexible support 2 can be a support column made of polyurethane, nylon, or silicone rubber, etc. so that the flexible support 2 can be bent and have a certain strength in the radial direction to meet the support requirements of the guide wire element 13 in the connecting section 12. The flexible support 2 can be arranged as a solid or hollow structure. For example, when the flexible support 2 is made of a material with better softness, the flexible support 2 can be arranged as a solid structure to ensure the support effect of the flexible support 2; when the flexible support 2 is made of a material with poor softness, the flexible support 2 can be arranged as a hollow structure to prevent the flexible support 2 from greatly affecting the bending softness of the connecting section 12. According to the needs, for example, when it is necessary to reduce the weight or material of the flexible support 2, the flexible support 2 can also be arranged as a hollow structure or a partially hollow structure while meeting the required support requirements.

[0049] In some embodiments, the flexible support 2 can also be a braided mesh structure. The flexible support 2 in the braided mesh structure can be bent and have a certain strength in the radial direction, and can provide support while not affecting or substantially affecting the overall softness of the implantable electrode lead 1 to meet the support requirements of the connecting section 12. The flexible support 2 in the braided mesh structure can be arranged in the accommodation channel 131 formed in the guide wire element 13, or can be arranged in the spacing cavity 15 between the outer tube 14 and the guide wire element 13.

[0050] With reference to Figure 2 In some embodiments, an end of the flexible support 2 away from the implanting section 11 can be provided with a limiting portion 22, and the implantable electrode lead 1 is provided with a cooperating portion 16 cooperating with the limiting portion 22. When the flexible support 2 is installed on the connecting section 12 of the implantable electrode lead 1, the limiting portion 22 of the flexible support 2 cooperates with the cooperating portion 16 of the implantable electrode lead 1 to limit the movement of the flexible support 2 relative to the implantable electrode lead 1 in the extension direction of the implantable electrode lead 1, thereby preventing the flexible support 2 from further extending into the implanting section 11 and ensuring the accurate installation position of the flexible support 2. The limiting portion 22 can be a head portion formed by the flexible support 2 and having a larger radial cross section, and the cooperating portion 16 is a groove arranged to cooperate with the limiting portion 22. When the limiting portion 22 cooperates with the cooperating portion 16, the limiting portion 22 abuts against the wall forming the cooperating portion 16 to limit the movement of the flexible support 2 relative to the implantable electrode lead 1 in the extension direction of the implantable electrode lead 1.

[0051] In addition, with reference to Figures 2 to 4 , an end of the flexible support 2 adjacent to the implanting section 11 can be provided with a guide portion 23. When the flexible support 2 is installed in the connecting section 12, the guide portion 23 of the flexible support 2 first contacts the connecting section 12, so that the guide portion 23 can guide the installation of the flexible support 2 in the connecting section 12, and the guide portion 23 can prevent the flexible support 2 from scratching the implantable electrode lead 1 when inserted. The guide portion 23 can be a smooth chamfer arranged at the first end 21 of the flexible support 2.

[0052] In some embodiments, the guide wire element 13 can include a plurality of layers of spiral guide wires, each layer of spiral guide wire being formed by a plurality of guide wires spirally wound, and the plurality of layers of spiral guide wires being arranged in the radial direction of the implantable electrode lead 1 in sequence. By arranging the guide wire element 13 as a plurality of layers of spiral guide wires, the strength of the guide wire element 13 can be increased, thereby effectively reducing the degree of deformation of the guide wire element 13 under compression.

[0053] In some embodiments, the space between the guide wire element 13 and the outer tube 14 forms a space cavity 15, which can be filled with a flexible filler. The flexible filler can support the outer tube 14 to reduce the deformation of the outer tube 14 when it is squeezed. The flexible filler can be a flexible material, such as a glue of an insulating material. The glue is filled in the space cavity 15 to support the outer tube 14, and can not affect or substantially affect the overall flexibility of the implantable electrode lead 1 while providing support. In addition, the flexible filler can fix the relative position of the guide wire element 13 and the outer tube 14.

[0054] With reference to Figure 5 The utility model further provides a nerve stimulation system, including stimulator 200, electrode lock 300 and above-mentioned implantable electrode lead 1. The implantable electrode lead 1 is implanted in the inside of the skull of patient. The electrode lock 300 is arranged at the top of the skull of patient and the electrode lock 300 is used to lock the junction of implantation section 11 and connecting section 12 to fix the implantable electrode lead 1. The connecting section 12 extends from the side of implantation section 11 adjacent to the skull to the temporal bone 500 and further extends to the temporal bone 500 and clavicle 600 to be directly electrically connected with stimulator 200. Alternatively, the nerve stimulation system further includes extension lead 400, and the connecting section 12 is connected with the extension lead 400 and is electrically connected with stimulator 200 through the extension lead 400, so that stimulator 200 can apply electric signal to the stimulation contact in the implantable electrode lead 1 through the extension lead 400 to control the implantable electrode lead 1 to apply electric stimulation to the patient.

[0055] Although the embodiments of the utility model have been shown and described above, it should be understood that the above-mentioned embodiments are exemplary and cannot be understood as limiting the utility model. Those skilled in the art can change, modify, replace and transform the above-mentioned embodiments within the scope of the utility model without departing from the principles and purposes of the utility model. All these changes should be within the protection scope of the utility model claim.

Claims

1. An implantable electrode lead, comprising: The implantable electrode lead (1) comprises: an implant segment (11) implanted in the skull; a connecting segment (12) connected to the implant segment (11); a flexible support (2) installed in the connecting segment (12) and supporting the connecting segment (12) in the radial direction of the implantable electrode lead (1) to prevent the connecting segment (12) from being compressed and deformed, the flexible support (2) being capable of bending synchronously with the connecting segment (12).

2. The implantable electrode lead of claim 1, wherein, The implantable electrode lead (1) further comprises a guide wire element (13) spirally wound and surrounding a receiving channel (131), the flexible support (2) being received in the receiving channel (131) and supporting the guide wire element (13) to prevent the guide wire element (13) from being compressed and deformed. The guide wire element (13) is partially arranged in the implant segment (11) and partially arranged in the connecting segment (12).

3. The implantable electrode lead of claim 1, wherein, The implantable electrode lead (1) further comprises a guide wire element (13) spirally wound on the outside of a sleeve (132) and a flexible support (2) arranged in the sleeve (132).

4. The implantable electrode lead of either of claims 2 or 3, wherein, The flexible support (2) is a support column made of polyurethane, nylon or silicone rubber, and is of a solid or hollow structure. Alternatively, the flexible support (2) is a woven mesh structure.

5. The implantable electrode lead of claim 1, wherein, The implantable electrode lead (1) comprises a guide wire element (13) and an outer tube (14) arranged on the outside of the guide wire element (13), the guide wire element (13) and the outer tube (14) being spaced apart and forming a spacing cavity (15), the spacing cavity (15) being provided with the flexible support (2), and the flexible support (2) being a woven mesh structure.

6. The implantable electrode lead of claim 5, wherein, The guide wire element (13) comprises multiple layers of spiral guide wires arranged in the radial direction of the implantable electrode lead (1) in sequence.

7. The implantable electrode lead of claim 1, wherein, The flexible support (2) is received in the connecting segment (12) and does not protrude beyond the connecting segment (12).

8. The implantable electrode lead of claim 1, wherein, The flexible support (2) is provided with a limiting portion (22), and the implantable electrode lead (1) is provided with a cooperating portion (16) cooperating with the limiting portion (22), the cooperating portion (16) cooperating with the limiting portion (22) to limit the movement of the flexible support (2) relative to the implantable electrode lead (1) in the extension direction of the implantable electrode lead (1).

9. The implantable electrode lead of claim 1, wherein, One end of the flexible support (2) is provided with a guide portion (23) for guiding when the flexible support (2) is installed in the connecting segment (12).

10. A neural stimulation system, comprising: The implantable electrode lead (1) comprises: a stimulator; The implantable electrode lead according to any one of claims 1 to 9 is implanted in the body of a patient at one end and electrically connected to the stimulator at the other end.

11. The neurostimulation system of claim 10, wherein, The neural stimulation system further comprises an extension lead, the stimulator being electrically connected to the implantable electrode lead through the extension lead.

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