An extension wire tunneling tool and kit for deep brain stimulation

Abstract

The present invention relates to a tunneling tool and kit for an extension wire for deep brain stimulation, belonging to the technical field of medical devices, and comprising: a puncture rod, a puncture head, and a wire carrier; the puncture rod has a connection end, and the puncture head can be installed at the connection end of the puncture rod; the wire carrier includes a connecting rod, one end of the wire carrier can be connected to the connection end of the puncture rod, the connecting rod can be inserted into the connection head of the extension wire, and the connecting rod is fixed by radial tightening with a screw. The tunneling tool and kit for the extension wire for deep brain stimulation provided by the present invention have the advantages that the overall diameter is small after the extension wire is connected to the wire carrier, and it is convenient for wire leading.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a tunneling tool for an extension wire for deep brain stimulation and a kit including the tool. Background Art

[0002] Deep brain stimulation systems can be used for the treatment of diseases such as Parkinson's disease, essential tremor, dystonia, and obsessive-compulsive disorder. The implanted part of the deep brain stimulation system in the body includes an electrode, an extension wire, and a pulse generator. An electric pulse is generated by the pulse generator, reaches the electrode through the extension wire, and is released into the corresponding nucleus in the brain to inhibit abnormal nerve signals, thereby achieving the effect of controlling movement disorder diseases such as Parkinson's disease.

[0003] Currently, when implanting the extension wire under the skin, the extension wire needs to be connected to a wire carrier. The wire carrier is wrapped around the outside of the connection head of the extension wire, and the wire carrier pulls the extension wire through two incisions on the skin under the guidance of a puncture rod.

[0004] Regarding the above related technologies, the inventor believes that the wire carrier is wrapped around the outside of the connection head of the extension wire, resulting in an increase in the overall diameter of the two, increasing the wire leading resistance and the difficulty of leading the wire. Summary of the Invention

[0005] In order to improve the problem of large wire leading resistance caused by the increase in the overall diameter when the extension wire is connected to the wire carrier in the related technologies, the present invention provides a tunneling tool for an extension wire for deep brain stimulation and a kit.

[0006] In a first aspect, a tunneling tool for an extension wire for deep brain stimulation provided by the present invention adopts the following technical solution:

[0007] A tunneling tool for an extension wire for deep brain stimulation includes:

[0008] A puncture rod, a puncture head, and a wire carrier;

[0009] The puncture rod has a connection end, and the puncture head can be installed at the connection end of the puncture rod;

[0010] The wire carrier includes a connecting rod. One end of the wire carrier can be connected to the connection end of the puncture rod. The connecting rod can be inserted into the connection head of the extension wire, and the connecting rod is radially tightened and fixed by a screw.

[0011] By adopting the above technical solution, the connecting rod of the wire carrier can be inserted into the connection head of the extension wire, thereby reducing the overall diameter when the wire carrier is connected to the extension wire and reducing the wire leading resistance.

[0012] Optionally, the number of the connecting rods included in the wire carrier is one or two.

[0013] By adopting the above technical solution, it is possible to select a corresponding wire carrier for different numbers of extension wires, thereby ensuring the minimum overall diameter when the extension wires are connected to the wire carrier.

[0014] Optionally, when the number of connecting rods of the wire carrier is two, the difference in length between the two connecting rods is greater than or equal to the length of the connection head of the extension wire.

[0015] By adopting the above technical solution, when the number of extension wires is two, it is possible to stagger the connection heads of the two extension wires, thereby reducing the overall diameter when the extension wires are connected to the wire carrier.

[0016] Optionally, a limiting block is provided on the longer connecting rod of the wire carrier.

[0017] By adopting the above technical solution, it is convenient to stagger the connection of the connection head of the extension wire with the connecting rod.

[0018] Optionally, the puncture rod is a solid rod-like structure.

[0019] By adopting the above technical solution, the diameter of the puncture rod is reduced, which helps to reduce the pain of the patient.

[0020] Optionally, the wire carrier is made of a metal material.

[0021] By adopting the above technical solution, the wire carrier has high structural strength, a smooth surface, and is convenient for leading the wire.

[0022] In a second aspect, a tunneling tool kit for an extension wire for deep brain stimulation provided by the present invention adopts the following technical solution:

[0023] A tunneling tool kit for an extension wire for deep brain stimulation, comprising the aforementioned tunneling tool for an extension wire, and further comprising: an extension wire;

[0024] The connection head of the extension wire includes a plurality of locking components arranged along the axial direction of the connection head, and the connecting rod of the wire carrier can be inserted into the locking components and locked by the locking components.

[0025] By adopting the above technical solution, the connecting rod can be inserted into the locking components and locked, which not only reduces the overall diameter when the connection head of the extension wire is connected to the wire carrier, but also prevents the connection head from falling off the wire carrier during the wire leading process.

[0026] Optionally, the locking component includes a locking member, and a fixing hole is provided in the middle of the locking member, and the connecting rod can be inserted into the fixing hole;

[0027] A screw is provided on the upper part of the locking member, and the screw can lock the connecting rod inserted into the fixing hole.

[0028] By adopting the above technical solution, the locking assembly can lock the connecting rod to prevent the connecting rod from falling off from the connector.

[0029] Optionally, the outer diameter of the connecting rod is equal to the inner diameter of the fixing hole.

[0030] By adopting the above technical solution, the connecting rod will not shake in the fixing hole, thereby improving the stability of the connection between the connecting rod and the connector.

[0031] Optionally, the locking force of each locking assembly on the connecting rod is the same.

[0032] By adopting the above technical solution, the connecting rod can be firmly connected to the connector, and the connector and the connecting rod can be prevented from being damaged.

[0033] In summary, the present invention includes at least one of the following beneficial technical effects:

[0034] 1. The connecting rod of the wire carrier can be inserted into the connector of the extension wire, thereby reducing the overall diameter when the extension wire is connected to the wire carrier. This not only helps the smooth progress of the wire leading process, but also reduces the pain of the patient;

[0035] 2. When the number of extension wires is two, by staggering the connectors of the extension wires, the overall diameter of the connection between the wire carrier and the extension wires in the case of multiple extension wires can be reduced, and the wire leading resistance can be reduced;

[0036] 3. The wire carrier is made of a metal material, and the connector of the extension wire locks and connects the connecting rod of the wire carrier, which can prevent the wire carrier from breaking and the wire carrier and the extension wire from falling off during the wire leading process. Description of the Drawings

[0037] Figure 1 It is a schematic diagram of the connection relationship between the puncture rod and the puncture head in the embodiment of the present invention;

[0038] Figure 2 It is a schematic diagram of the connection relationship between the puncture rod, the wire carrier and the extension wire in the embodiment of the present invention;

[0039] Figure 3 It is a schematic diagram of the structure of the wire carrier with one connecting rod;

[0040] Figure 4 It is a schematic diagram of the structure of the wire carrier with two connecting rods;

[0041] Figure 5 It is Figure 4Schematic diagram of the connection relationship between the shown wire carrier and the extension wire;

[0042] Figure 6 It is a schematic cross-sectional view of the extension wire connector at the locking assembly;

[0043] Figure 7 It is a schematic diagram of the extension wire lead path.

[0044] Explanation of reference numerals: 1, puncture rod; 11, handle; 2, puncture head; 3, wire carrier; 31, connecting rod; 311, limit block; 32, connecting column; 4, extension wire; 41, connector; 411, locking assembly; 412, protective layer; 413, operation hole; 4111, locking member; 4112, fixing hole; 4113, screw; 5, first skin incision; 6, second skin incision. Detailed implementation manners

[0045] The following further elaborates on the present invention in conjunction with the attached Figures 1-7 drawings.

[0046] Referring to Figure 1 and Figure 2 In an embodiment of the present invention, a tunneling tool for an extension wire for deep brain stimulation is disclosed, which includes a puncture rod 1, a puncture head 2, and a wire carrier 3. Among them, the puncture rod 1 is a solid rod-shaped structure, thereby reducing the diameter of the puncture rod 1 and being able to reduce the resistance during the wire leading process of the extension wire 4. The puncture rod 1 and the puncture head 2 are made of metal materials. One end of the puncture rod 1 is a connection end for connecting with the puncture head 2 and the wire carrier 3, and the other end of the puncture rod 1 is provided with a handle 11, and the setting of the handle 11 makes the puncture process easy to operate. One end of the extension wire 4 connected to the wire carrier 3 is provided with a connector 41; the wire carrier 3 includes a connecting rod 31, which can be inserted into the connector 41 and is fixed by radial tightening with a screw 4113; the other end of the wire carrier 3 can be connected to the connection end of the puncture rod 1. By inserting the connecting rod 31 into the connector 41 of the extension wire 4 and firmly connecting the connecting rod 31 and the connector 41, the overall diameter at the connection between the wire carrier 3 and the extension wire 4 is reduced, which helps to reduce the resistance during the wire leading process of the extension wire 4 and can also reduce the pain of the patient.

[0047] Specifically, the puncture rod 1 can be connected to the puncture head 2 and the wire carrier 3 in various ways such as snap connection or threaded connection, and those skilled in the art can choose according to needs.

[0048] Referring to Figure 3, the wire carrier 3 includes a connecting rod 31 and a connecting column 32. The wire carrier 3 can be made of a metal material, such as medical stainless steel. Compared with polymer materials, the outer surface of the wire carrier 3 made of metal material in the present invention is smoother, which can effectively prevent scratching of subcutaneous capillaries during the wire leading process. When the number of extension wires 4 is one, the connecting column 32 can be set to a cylindrical shape, and one end of the connecting column 32 can be connected to the connecting end of the puncture rod 1 in a mating manner. The connecting rod 31 is arranged at the other end of the connecting column 32 and the number is one. The connecting rod 31 can be inserted into the connector 41 of the extension wire 4 and connected to the connector 41.

[0049] During deep brain stimulation, according to the number of electrodes, the number of extension wires 4 used will also be different. When the number of extension wires 4 is two, it is necessary to lead the wires through the same wire carrier 3. Refer to Figure 4 and Figure 5 , the connecting column 32 of the wire carrier 3 can be set to a flat column shape, the outer surface of the connecting column 32 is a smooth curved surface, and the cross-sectional area of one end of the connecting column 32 is larger than that of the other end. The end of the connecting column 32 with a smaller cross-sectional area is used to connect to the puncture rod 1, and two connecting rods 31 are arranged at the end of the connecting column 32 with a larger cross-sectional area, and each of the two connecting rods 31 is connected to an extension wire 4. At this time, in order to avoid the situation where the overall diameter is too large caused by the juxtaposition of the connectors 41 on the two extension wires 4, the two connecting rods 31 on the same end face of the connecting column 32 are set to different lengths, and the difference in their lengths is greater than or equal to the length of the connector 41 of the extension wire 4. Thus, the two connectors 41 can be staggered in position, reducing the overall diameter when the connector 41 is connected to the wire carrier 3.

[0050] Refer to Figure 4 , when two extension wires 4 need to be connected to the same wire carrier 3, in order to facilitate the positioning of the extension wires 4, a limit block 311 can be provided on the longer connecting rod 31. The limit block 311 can be integrally formed with the corresponding connecting rod 31 or sleeved on the connecting rod 31. By providing the limit block 311 and making the limit block 311 located at an appropriate position, when installing the extension wire 4 on the longer connecting rod 31, the connector 41 abuts against the limit block 311; correspondingly, when installing the extension wire 4 on the shorter connecting rod 31, the connector 41 can abut against the connecting column 32. Thus, the cumbersome steps of installing the extension wires 4 on the two connecting rods 31 and further adjusting their relative positions are avoided.

[0051] To avoid damage to the extension wire 4 and the connecting rod 31 caused by excessive locking force of the screw 4113, and at the same time reduce the occurrence of the connecting rod 31 falling off from the connector 41 due to too small locking force, the screw 4113 can be tightened by a torque screwdriver. At this time, the locking force of each screw 4113 on the connecting rod 31 is the same. It is easy to understand that during the process of connecting and locking the connector 41 and the connecting rod 31, at least 2 screws 4113 need to be tightened to ensure the connection effect.

[0052] In a preferred embodiment, the connecting rod 31 is made of a metal material, and the properties of the metal material should at least meet that the elastic limit M is between 600 - 1100 MPa and the Young's modulus E is between 100 - 130 GPa. Preferably, the rigidity of the screw 4113 is better than that of the connecting rod. The connecting rod 31 is radially tightened and fixed by the screw 4113, and the friction coefficient between the connecting rod 31 and the screw 4113 is at least 0.4. Since a torque screwdriver is used in the present invention, the tightening torque of the screw 4113 can be set to a fixed value, and the range can be 0.2 - 0.3 Kgf·cm. According to the torque calculation formula T = KFD, where K is the tightening torque coefficient, the value of the tightening torque coefficient K is selected as 0.12 according to the precision machining non-lubricated screw, and D is the screw diameter.

[0053] When the screw 4113 is tightened onto the connecting rod 31, the connecting rod 31 will undergo radial deformation. At this time, the contact surface between the screw 4113 and the connecting rod 31 can be approximated as an ellipse, then the contact surface area S between the screw 4113 and the connecting rod 31 is S = π * a * b. In this formula, b is the length of the major semi-axis of the contact surface, which is equal to the screw radius; a is the length of the minor semi-axis of the contact surface and increases as the connecting rod is squeezed.

[0054] In the present invention, the diameter of the connecting rod 31 is L and the radial deformation due to extrusion is ΔL. The above a and S can be expressed as:

[0055] a = [(L / 2) 2 - (L / 2 - ΔL) 2 ] 1 / 2

[0056] S = π * b * [(L / 2) 2 - (L / 2 - ΔL) 2 ] 1 / 2

[0057] When the screw 4113 is tightened, the radial stress of the connecting rod 31 is balanced, which can be approximately expressed as:

[0058] (T / K / D) / [π * b * [(L / 2) 2 - (L / 2 - ΔL) 2 ] 1 / 2 = E * ΔL / L

[0059] Since the materials selected for the present invention can meet the balance conditions at the maximum torque, when the tightening torque is 0.3 Kgf·cm, T = 0.0294 N·m. At this time, ΔL≈(0.001521 * L / E 2 / b 4 ) 1 / 3 。

[0060] Similarly, the elastic limit M of the material of the connecting rod 31 can also meet: M > E * ΔL / L, that is

[0061] M > (0.001521 * L -2 * E * b -4 ) 1 / 3

[0062] In this embodiment, it should at least meet:

[0063] 600 * 10 6 > (0.001521 * L -2 * 100 * 10 9 * b -4 ) 1 / 3

[0064] L * D 2 > 4.76 * 10 -9

[0065] At the same time, the friction force between the screw 4113 and the connecting rod 31 should meet:

[0066] μ * (T / K / D) > 30 N

[0067] In this embodiment, it should at least meet:

[0068] 0.4 * 0.0196 / 0.12 / D > 30

[0069] D < 0.0021

[0070] The above are the relational expressions that the diameter of the connecting rod 31 and the diameter of the screw 4113 need to meet in the present invention and this embodiment, where the units of L and D are meters (m).

[0071] Preferably, the diameter D of the used screw 4113 is 1.5 - 2 mm, then the diameter L of the connecting rod 31 is at least 1.2 mm.

[0072] Thus, since the diameter of the connecting rod is small, the size of the connector 41 can be correspondingly reduced, thereby reducing the overall diameter when the connecting rod 31 is connected to the connector 41.

[0073] An embodiment of the present invention also discloses a tunneling tool kit for an extension wire for deep brain stimulation, which includes the aforementioned extension wire tunneling tool and also includes an extension wire 4.

[0074] Referring to Figure 5 , the connector 41 of the extension wire 4 is provided at one end of the extension wire 4. A plurality of locking components 411 are arranged axially along the connector 41 within the connector 41.

[0075] Referring to Figure 6 , the locking component 411 includes a locking member 4111. A fixing hole 4112 for inserting the connecting rod 31 is provided in the middle of the locking member 4111. The axes of the fixing holes 4112 of the plurality of locking members 4111 coincide. The outer diameter of the connecting rod 31 is equal to the inner diameter of the fixing hole 4112, so that the connecting rod 31 can be stably inserted into the fixing hole 4112, reducing the shaking of the connecting rod 31.

[0076] The locking member 4111 is made of a metallic material. Each locking member 4111 is electrically connected to the pulse generator through a branch wire. It is easy to understand that when performing deep brain stimulation, multiple electrodes are used, and multiple electrodes need to be connected to the pulse generator through wires. Therefore, multiple branch wires can be arranged in the same extension wire 4, and each branch wire is electrically connected to a locking member 4111. For example, an extension wire 4 can include 4 branch wires. Correspondingly, 4 locking members 4111 need to be provided on the connector 41. When 4 electrodes are needed for treatment, a wire carrier 3 with one connecting rod 31 can be used for wire leading; when 8 electrodes are needed for treatment, two extension wires 4 need to be provided, and a wire carrier 3 with two connecting rods 31 can be used for wire leading.

[0077] A screw 4113 is provided on the upper part of the locking member 4111, and the screw 4113 is in threaded cooperation with the locking member 4111. By rotating the screw to press down, the connecting rod 31 inserted into the fixing hole 4112 can be locked, thereby preventing the connecting rod 31 from falling out of the fixing hole 4112 during the wire leading process.

[0078] Referring to Figure 6 , the outside of the locking component 411 is covered with a protective layer 412. An operation hole 413 is provided in the upper part of the protective layer 412, and the operation hole 413 corresponds to the position of the screw 4113, facilitating the tightening operation of the screw 4113. The protective layer 412 can be made of a soft organic polymer insulating material. Thus, the protective layer 412 is not only insulating and corrosion-resistant, but also its softness can reduce the discomfort of the patient.

[0079] Referring to Figure 7 , a method for using an extension wire tunneling tool and kit for deep brain stimulation provided by the present invention is as follows:

[0080] First, install the puncture head 2 on the connection end of the puncture rod 1, and then puncture from the first skin incision 5 to the second skin incision 6 through the skin, so that the puncture head 2 penetrates through the second skin incision 6. Among them, the first skin incision 5 is located behind the ear, and the second skin incision 6 is located below the collarbone.

[0081] Then, remove the puncture head 2 from the connection end of the puncture rod 1 and install the wire carrier 3 on the connection end of the puncture rod 1. Then, insert the connecting rod 31 of the wire carrier 3 into the connector 41 of the extension wire 4, and use a torque screwdriver to tighten the screw 4113 to lock the connecting rod 31. Pull the puncture rod 1 to drive the extension wire 4 to move out along the second skin incision 6 to the first skin incision 5.

[0082] Finally, loosen the screw 4113 with a screwdriver to separate the wire carrier 3 from the connector 41, and then connect the connector 41 with the connector of the electrode to complete the connection process of the extension wire 4 and the electrode.

[0083] The tunneling tool and kit for the extension wire used in deep brain stimulation provided by the present invention connect the connecting rod 31 provided at one end of the wire carrier 3 with the connector 41 of the extension wire 4, reducing the overall diameter when the extension wire 4 is connected to the wire carrier 3. The overall maximum diameter is the outer diameter of the wire carrier 3, thereby reducing the resistance of the lead wire and reducing the pain of the patient at the same time.

[0084] The above is the preferred embodiment of the present invention. It does not limit the protection scope of the present invention accordingly. Therefore, all equivalent changes made according to the structure, shape, and principle of the present invention should be covered within the protection scope of the present invention.

Claims

1. An extension wire tunneling tool kit for deep brain stimulation, characterized in that, Including an extended wire tunneling tool, comprising: a puncture rod (1), a puncture head (2), and a wire carrier (3); The puncture rod (1) has a connection end, and the puncture head (2) can be mounted on the connection end of the puncture rod (1); The wire carrier (3) includes a connecting rod (31). One end of the wire carrier (3) can be connected to the connection end of the puncture rod (1). The connecting rod (31) can be inserted into the connection head (41) of the extended wire (4), and the connecting rod (31) is fixed radially by a screw (4113); It further includes: an extended wire (4); The connection head (41) of the extended wire (4) includes a plurality of locking components (411) arranged axially along the connection head (41). The connecting rod (31) of the wire carrier (3) can be inserted into the locking component (411) and locked by the locking component (411); The locking component (411) includes a locking piece (4111). A fixing hole (4112) is provided in the middle of the locking piece (4111). The connecting rod (31) can be inserted into the fixing hole (4112); A screw (4113) is provided on the upper part of the locking piece (4111). The screw (4113) can lock the connecting rod (31) inserted into the fixing hole (4112); The connecting rod (31) is made of a metal material. The elastic limit M of this metal material is between 600 - 1100 MPa, and the Young's modulus E is between 100 - 130 GPa; The friction coefficient μ between the connecting rod (31) and the screw (4113) is at least 0.4; The tightening torque T of the screw (4113) ranges from 0.2 - 0.3 Kgf·cm; When the screw (4113) is tightened onto the connecting rod (31), the connecting rod (31) will undergo radial deformation. The diameter of the connecting rod (31) is L, and the radially squeezed deformation is ΔL; When the screw (4113) is tightened, the radial stress of the connecting rod (31) is balanced, expressed as: (T / K / D) / [π*b*[(L / 2) 2 -(L / 2 - ΔL) 2 1 / 2 =E*ΔL / L;​ K is the tightening moment coefficient, D is the screw diameter; b is the major semi - axis length of the contact surface, equal to the screw radius; The elastic limit M of the material of the connecting rod (31) satisfies: M > E * ΔL / L; Meanwhile, the friction force between the screw (4113) and the connecting rod (31) should satisfy: μ * (T / K / D) > 30 N; The units of L and D are meters.

2. The tunneling tool kit for an extension wire according to claim 1, characterized in that The number of the connecting rods (31) included in the wire carrier (3) is one or two.

3. The tunnel - making tool kit for an extension wire according to claim 2, characterized in that, When the number of the connecting rods (31) of the wire carrier (3) is two, the difference in the lengths of the two connecting rods (31) is greater than or equal to the length of the connection head (41) of the extended wire (4).

4. The tunneling tool kit for an extension wire according to claim 3, characterized in that A limit block (311) is provided on the longer connecting rod (31) of the wire carrier (3).

5. The tunneling tool kit for an extension wire according to any one of claims 1-4, characterized in that, The puncture rod (1) is a solid rod - like structure.

6. The tunneling tool kit for the extension wire according to any one of claims 1-4, characterized in that, The wire carrier (3) is made of a metal material.

7. The tunneling tool kit for an extension wire according to claim 1, characterized in that, The outer diameter of the connecting rod (31) is equal to the inner diameter of the fixing hole (4112).

8. The tunneling tool kit for the extension wire according to claim 1, characterized in that, The locking force of each locking component (411) on the connecting rod (31) is the same.

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