Fixing structure

Abstract

The utility model belongs to the technical field of medical instruments, and discloses a fixing structure. The fixing structure is used for fixing a connecting part between an implantable extension wire and an electrode wire, and comprises a fixing piece and a fastening piece. Specifically, the fixing piece is arranged on the connecting part, a plurality of through holes are formed in the fixing piece, and the fixing piece can deform; and the fastening piece can penetrate through the fixing piece to be connected with the implantation part, so that the fixing piece deforms and compresses the connection part. According to the utility model, the fixing piece with the multi-through-hole structure can apply pressure to the connecting part in a surface extrusion manner, so that the problem that the pressure intensity of the fixing piece with the multi-through-hole structure to the connecting part is smaller because the structure of a fixing plate is fixed in a point extrusion manner in the prior art is avoided; therefore, the extrusion force on the welding spot and the guide wire at the connection part can be reduced, the conduction stability of the implantable extension wire and the electrode wire is improved, the treatment effect is ensured, and the treatment feeling of a patient is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a fixing structure. Background Art

[0002] An implantable deep brain stimulator (DBS), also known as a brain pacemaker, is an advanced medical device used to treat various neurological diseases. It specifically includes a pulse generator, a stimulating electrode, and an implantable extension wire. Among them, the pulse generator is the core component of the deep brain stimulator. It can generate electrical pulse signals and transmit these signals to specific areas of the brain through the electrode wire and the implantable extension wire. The pulse generator has multiple control programs and can independently program the stimulation parameters of each channel, such as polarity, voltage, current, pulse width, and frequency, etc., to provide refined treatment options for patients. The stimulating electrode contacts can directly stimulate the nerve nuclei in the deep brain, thereby changing the propagation status of the brain internal loop. The implantable extension wire is used to connect the pulse generator and the stimulating electrode to ensure that the electrical pulse signals can be accurately and stably transmitted to the target area.

[0003] The implantable extension wire and the electrode wire need to be connected by welding to ensure the stable electrical connection between the two. Usually, the welding part of the implantable extension wire and the electrode wire needs to be implanted at the position of the temporal bone behind the ear. To prevent the displacement of the welding part resulting in an open circuit, it is necessary to fix the welding part to protect the multiple solder joints on the welding part.

[0004] In the prior art, multiple long and straight fixing plates are used to cover the welding part in a direction perpendicular to the extension direction of the implantable extension wire or the electrode wire, and the two ends of the fixing plate are connected to the implanting part by screws to achieve the fixation of the welding part. However, the fixing plate usually has a relatively large thickness and high stiffness. When the fixing plate is fixed, a relatively large force is often required to bend the fixing plate. This fixing process generates a relatively large extrusion force on the solder joints of the welding part, resulting in damage to the solder joints or deformation of the wire inside the wire due to excessive extrusion force, leading to conduction failure or unstable conduction state, losing or reducing the treatment effect. Summary of the Utility Model

[0005] The purpose of the utility model is to provide a fixing structure for fixing the connection part between the implantable extension wire and the electrode wire, reducing the extrusion force on the solder joints and wire filaments of the connection part, thereby improving the stability of the conduction between the implantable extension wire and the electrode wire, ensuring the treatment effect, and enhancing the treatment experience of patients.

[0006] To achieve the above object, the utility model adopts the following technical solutions:

[0007] A fixing structure for fixing the connection part between an implantable extension lead and an electrode lead, comprising:

[0008] A fixing member disposed on the connection part, the fixing member being provided with a plurality of through holes, and the fixing member being deformable;

[0009] A fastening member that can pass through the fixing member and connect to the implantation site, so that the fixing member deforms and compresses the connection part.

[0010] As an alternative embodiment of the fixing structure, the fixing member is a plate-shaped member with a planar structure.

[0011] As an alternative embodiment of the fixing structure, the fixing member is a plate-shaped member with an arched structure, and the connection part is located in the arched groove formed by the fixing member.

[0012] As an alternative embodiment of the fixing structure, in a direction perpendicular to the length of the implantable extension lead or the electrode lead, the plurality of through holes are arranged at intervals in sequence.

[0013] As an alternative embodiment of the fixing structure, in the direction of the length of the implantable extension lead or the electrode lead, the plurality of through holes are distributed in multiple columns.

[0014] As an alternative embodiment of the fixing structure, the through holes are arranged in an array on the fixing member.

[0015] As an alternative embodiment of the fixing structure, the through holes are arranged in a single column or a double column on the fixing member, and the plurality of fixing members are arranged at intervals in sequence in the direction of the length of the implantable extension lead or the electrode lead.

[0016] As an alternative embodiment of the fixing structure, the fixing member is made of titanium alloy.

[0017] As an alternative embodiment of the fixing structure, the through holes are round holes or oval holes.

[0018] As an alternative embodiment of the fixing structure, the fastening member can pass through the through holes and connect to the implantation site.

[0019] Beneficial effects:

[0020] In the present utility model, by forming a plurality of through holes in the fixing member, the whole fixing member can be formed into a net structure. By using the through holes to remove a part of the material on the fixing member, the stiffness of the whole fixing member is reduced, and the fixing member is more easily deformed. When the fixing member is fixedly connected to the implantation site through a fastener, due to the low stiffness and easy deformation of the fixing member, the fastener can be fixed on the implantation site with a smaller operating force. At the same time, the fixing member with a net structure can apply pressure to the connection part in a surface extrusion manner, avoiding the situation in the prior art where the structure of the fixing plate is fixed by point extrusion. The fixing member with a net structure has a smaller pressure on the connection part, and thus can reduce the extrusion force on the solder joints and wire guides at the connection part, thereby improving the stability of the conduction between the implantable extension lead and the electrode lead, ensuring the treatment effect, and improving the treatment experience of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of the fixing structure when fixedly connecting the connection part provided by an embodiment of the present utility model;

[0022] Figure 2 is Figure 1 a partial enlarged view at A;

[0023] Figure 3 is a schematic structural diagram of the fixing structure when hiding the outer sleeve of the connection part provided by an embodiment of the present utility model;

[0024] Figure 4 is Figure 1 a partial enlarged view at B.

[0025] In the figure:

[0026] 100, implantable extension lead; 200, electrode lead; 300, connection part; 310, solder joint;

[0027] 1, fixing member; 11, through hole; 2, fastener. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] The present utility model will be further described in detail below with reference to the drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present utility model, rather than limiting the present utility model. Additionally, it should be noted that for the sake of description, only parts related to the present utility model are shown in the drawings, rather than all the structures.

[0029] In the description of the present utility model, unless otherwise clearly defined and limited, the terms "connected", "connected to", and "fixed" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0030] In the present utility model, unless otherwise clearly defined and limited, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through other features therebetween. Moreover, the first feature being "above", "over", and "on top of" the second feature includes the first feature being directly above and obliquely above the second feature, or merely indicating that the horizontal height of the first feature is higher than that of the second feature. The first feature being "below", "beneath", and "underneath" the second feature includes the first feature being directly below and obliquely below the second feature, or merely indicating that the horizontal height of the first feature is lower than that of the second feature.

[0031] In the description of this embodiment, the orientation or positional relationships such as "above", "below", "right", etc. are based on the orientation or positional relationship shown in the drawings. It is only for the convenience of description and simplifying the operation, rather than indicating or implying that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0032] The following briefly explains the technical field and related terms of the embodiments of the present application.

[0033] Implantable medical systems include implantable nerve electrical stimulation systems, implantable cardiac electrical stimulation systems (also known as cardiac pacemakers), implantable drug delivery systems (Implantable Drug Delivery System, abbreviated as IDDS), and lead adapter systems, etc. Implantable nerve electrical stimulation systems are, for example, deep brain stimulation systems (Deep Brain Stimulation, abbreviated as DBS), implantable cerebral cortex stimulation systems (Cortical Nerve Stimulation, abbreviated as CNS), implantable spinal cord stimulation systems (Spinal Cord Stimulation, abbreviated as SCS), implantable sacral nerve stimulation systems (Sacral Nerve Stimulation, abbreviated as SNS), implantable vagus nerve stimulation systems (Vagus Nerve Stimulation, abbreviated as VNS), etc.

[0034] The implantable nerve electrical stimulation system includes a stimulator (i.e., implantable nerve stimulator) implanted in the patient's body and a programming device arranged outside the patient's body. That is to say, the stimulator is a medical device, or rather, the medical device includes the stimulator. The relevant neuromodulation technology mainly implants electrodes at specific parts (i.e., target points) of the tissues of the organism through stereotactic surgery, and sends electrical pulses to the target points through the electrodes to regulate the electrical activities and functions of the corresponding nerve structures and networks, thereby improving symptoms and relieving pain.

[0035] Please refer to the appendix Figure 1 - appendix Figure 4 In this embodiment, a fixing structure is involved. This fixing structure is used to fix the connection part 300 between the implantable extension lead 100 and the electrode lead 200. The fixing structure includes a fixing member 1 and a fastening member 2. Specifically, the fixing member 1 is arranged on the connection part 300. The fixing member 1 is provided with a plurality of through holes 11, and the fixing member 1 can be deformed; the fastening member 2 can pass through the fixing member 1 and be connected to the implanting part, so that the fixing member 1 is deformed and presses the connection part 300 tightly.

[0036] In this embodiment, the wires inside the implantable extension lead 100 and the wires inside the electrode lead 200 are usually connected by welding. The connection part 300 is the complete area of the welded part of the two wires, which includes part of the wires and the solder joint 310.

[0037] In this embodiment, by forming a plurality of through holes 11 in the fixing member 1, the fixing member 1 can be integrally formed into a mesh structure. By using the through holes 11 to remove a part of the material on the fixing member 1, the stiffness of the entire fixing member 1 is reduced, making the fixing member 1 easier to deform. When the fixing member 1 is fixedly connected to the implantation site through the fastener 2, due to the low stiffness and easy deformation of the fixing member 1, the fastener 2 can be fixed to the implantation site with a smaller operating force. At the same time, the fixing member 1 with a mesh structure can apply pressure to the connection part 300 in a surface extrusion manner, avoiding the situation in the prior art where the fixing of the fixing plate is carried out in a point extrusion manner. The fixing member 1 with a mesh structure has a smaller pressure on the connection part 300, thereby being able to reduce the extrusion force on the solder joints 310 and the guide wires of the connection part 300, improving the conduction stability between the implantable extension wire 100 and the electrode wire 200, ensuring the treatment effect, and enhancing the patient's treatment experience.

[0038] In this embodiment, the fixing member 1 can adopt an integral structure to ensure that one fixing member 1 can completely cover the connection part 300, thereby reducing the number of fasteners 2. Exemplarily, four fasteners 2 are respectively arranged near the four right angles of the fixing member 1 and connected to the implantation site to ensure the fixing reliability of the fixing member 1.

[0039] Optionally, the fixing member 1 is a plate-shaped member with a planar structure.

[0040] In one implementation manner of this embodiment, the structure of the fixing member 1 is flat. Those skilled in the art can understand that on the premise of ensuring the stable fixing of the connection part 300, the thickness of the fixing member 1 can be reduced as much as possible to reduce the stiffness of the entire fixing member 1 and improve the deformation ability.

[0041] Optionally, the fixing member 1 is a plate-shaped member with an arched structure, and the connection part 300 is located in the arched groove formed by the fixing member 1.

[0042] In one implementation manner of this embodiment, during the connection and fixing, by making the fixing member 1 have an arched structure, it can be ensured that after the fixing member 1 covers the connection part 300 and before being fixedly connected by the fastener 2, the amount of deformation of the fixing member 1 caused by the connection action of the fastener 2 is appropriately reduced. Therefore, compared with the flat fixing member 1, the arched fixing member 1 can be appropriately increased in thickness.

[0043] Optionally, in the direction perpendicular to the length of the implantable extension wire 100 or the length of the electrode wire 200, the plurality of through holes 11 are arranged at intervals in sequence.

[0044] In this embodiment, along the height from the connection part 300 to the implantation part position, it is higher in the middle and lower on both sides. In fact, the deformation trend of the fixing member 1 should be the same as this trend to ensure stable deformation of the fixing member 1 and avoid random deformation. Therefore, the fixed fixing member 1 should also be higher in the middle and lower on both sides. By arranging a plurality of through holes 11 along the direction perpendicular to the length of the implantable extension wire 100 or the electrode wire 200, compared with the random arrangement, the deformation of the fixing member 1 can conveniently occur according to the above trend, thus avoiding other random deformations on the fixing member 1 and improving the fixing stability.

[0045] In this embodiment, the distance between adjacent through holes 11 can be the same or different.

[0046] Further, in the direction of the length of the implantable extension wire 100 or the electrode wire 200, a plurality of through holes 11 are arranged in multiple columns.

[0047] On the basis of arranging a plurality of through holes 11 along the direction perpendicular to the length of the implantable extension wire 100 or the electrode wire 200, by continuously increasing the number of columns of the through holes 11 along the direction of the length of the implantable extension wire 100 or the electrode wire 200, the deformation trend of the integrated fixing member 1 can be made consistent everywhere, and the fixing stability can be improved.

[0048] In this embodiment, the distance between the through holes 11 in adjacent columns can be the same or different.

[0049] Optionally, the through holes 11 are arranged in an array on the fixing member 1.

[0050] In this embodiment, the through holes 11 can also be arranged on the fixing member 1 in an array. Compared with the random arrangement, the array arrangement is easier to process, thus ensuring the cost. Of course, those skilled in the art can adjust the specific array scheme considering the fixing stability and cost, and this embodiment does not make specific limitations.

[0051] Optionally, the through holes 11 are arranged in a single column or a double column on the fixing member 1, and a plurality of fixing members 1 are arranged at intervals in the direction of the length of the implantable extension wire 100 or the electrode wire 200.

[0052] Of course, for the fixation of the same connection part 300, the method of using a plurality of fixing members 1 can also be adopted to improve the fixing stability. The width of the fixing member 1 can be appropriately adjusted to meet the length requirements of different connection parts 300. For a connection part 300 with a smaller length, a fixing member 1 with a single column or a double column distribution of through holes 11 can be used. For a connection part 300 with a larger length, a fixing member 1 with a multi-column distribution of through holes 11 or a plurality of fixing members 1 with a single column of through holes 11 can be used, so as to improve the adaptability.

[0053] Optionally, the inner wall of the through-hole 11 is an arc surface.

[0054] In this embodiment, at the position of the through-hole 11 of the fixing member 1, a certain stress will be borne on the inner wall of the through-hole 11. By machining the inner wall into an arc surface, for example, a round hole or an oval hole can be used, which can avoid the problem of stress concentration caused by the sharp corner structure of the inner wall. The arc surface of the through-hole 11 can improve the stability and service life of the fixing member 1.

[0055] Optionally, the fixing member 1 is made of titanium alloy.

[0056] Titanium alloy has good biocompatibility with human tissues, can minimize biological reactions, and reduce the risk of rejection and infection after implantation.

[0057] Optionally, the fastener 2 can pass through the through-hole 11 and be connected to the implantation site.

[0058] In this embodiment, the fastener 2 can be connected to the implantation site by means of the through-holes 11 near the four right-angle positions. Specifically, the through-holes 11 are round holes, and the fastener 2 is a conventional threaded fastener. The fastener 2 passes through the through-hole 11 and is threadedly connected to the surface of the implantation site to realize the connection and fixation of the fixing member 1.

[0059] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limiting the implementation manners of the present invention. For those of ordinary skill in the art, various obvious changes, re-adjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to enumerate all the implementation manners here. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the claims of the present invention.

Claims

1. A fixing structure for fixing a connection portion (300) between an implantable extension lead (100) and an electrode lead (200), characterized in that: include: A fixing member (1) is arranged on the connecting portion (300), the fixing member (1) is provided with a plurality of through holes (11), and the fixing member (1) can be deformed; A fastener (2) can pass through the fixing member (1) and connect to the implantation site, so that the fixing member (1) is deformed and the connection site (300) is compressed.

2. The fixing structure according to claim 1, characterized in that: The fixing member (1) is a plate-shaped member with a planar structure.

3. The fixing structure according to claim 1, characterized in that: The fixing member (1) is a plate-shaped member with an arched structure, and the connecting portion (300) is located in an arched groove formed by the fixing member (1).

4. The fixing structure according to claim 1, characterized in that: In a direction perpendicular to the length of the implantable extension lead (100) or the length of the electrode lead (200), the plurality of through holes (11) are arranged in sequence and spaced apart.

5. The fixing structure according to claim 4, characterized in that: In the direction of the length of the implantable extension lead (100) or the length of the electrode lead (200), the plurality of through holes (11) are distributed in a plurality of rows.

6. The fixing structure according to claim 1, characterized in that: The through holes (11) are distributed in an array on the fixing member (1).

7. The fixing structure according to claim 1, characterized in that: The through holes (11) are distributed in a single row or in double rows on the fixing member (1), and a plurality of the fixing members (1) are arranged in sequence and at intervals along the length of the implantable extension lead (100) or the length of the electrode lead (200).

8. The fixing structure according to claim 1, characterized in that: The fixing piece (1) is made of titanium alloy.

9. The fixing structure according to claim 8, characterized in that: The through hole (11) is a circular hole or an elliptical hole.

10. The fixing structure according to any one of claims 1 to 9, characterized in that: The fastener (2) can pass through the through hole (11) and be connected to the implantation site.

Images