Subcutaneous tunnel tool and use method

Abstract

The invention relates to a subcutaneous tunnel tool and a use method, belongs to the technical field of medical instruments, and provides the subcutaneous tunnel tool for solving the problems in the prior art. A tunnel cavity is formed in the hollow pipe, and the detachable handle is connected to one end of the hollow pipe; one end of the puncture line is a blunt head, and the other end of the puncture line is connected with the detachable handle through the tunnel cavity; at least two limiting grooves are formed in one end of the carrying wire, and the other end of the carrying wire penetrates through the tunnel cavity to be connected with the detachable handle. At least two extension wires are arranged, and one end of each extension wire is embedded in the corresponding limiting groove and connected with the corresponding carrying wire. The end portion of the extension wire can be a single-row connector or a double-row connector, the extension wire is connected with the carrying wire and can penetrate out of the end portion of the hollow pipe along with the detachable handle and the carrying wire, the extension wire is located in the hollow pipe all the time when penetrating out, and therefore a notch cannot be enlarged, namely the damage to a human body caused by the incision is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a subcutaneous implant tool and its usage method, and also relates to a tunneling tool for an extension wire of deep brain stimulation and its usage method. Background Art

[0002] With the development of medical technology, in some surgical procedures, medical devices are implanted into the human body to achieve the purpose of treatment or detection. Implantable nerve stimulation systems generally include implantable cortical stimulation (CNS), implantable spinal cord stimulation (SCS), implantable vagus nerve stimulation (VNS), deep brain stimulation system (DBS), cardiac pacemaker, etc. Usually, the DBS electrode is connected to the implantable nerve stimulator through the extension of the extension wire. During the surgical procedure, surgical supporting tools are required to create a subcutaneous channel for the extension wire and bury the extension wire subcutaneously to connect it to the stimulating electrode and the implantable nerve stimulator.

[0003] The existing patent application CN118576290A relates to a subcutaneous implant tool, which includes a puncture rod, a puncture head, and a wire-carrying assembly. The wire-carrying assembly includes a wire-carrying member and a protective sleeve. At least part of the wire-carrying member and the connection head of the extension wire connected thereto are disposed in the protective sleeve, and the puncture rod pulls the extension wire through the wire-carrying assembly. The protective sleeve can effectively protect the extension wire, and the surface of the protective sleeve is smooth, which can cover the concave-convex structure formed after the connection of the wire-carrying member and the extension wire. When the wire-carrying assembly passes through the subcutaneous tissue, the resistance is small, and the blood vessels are not easily scratched, avoiding large subcutaneous bleeding.

[0004] The existing patent application CN112354078A relates to a tunneling tool and kit for an extension wire of deep brain stimulation, belonging to the technical field of medical devices, including: 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, and 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.

[0005] The current operation method for creating a subcutaneous tunnel is a puncture rod with a pointed puncture head. The puncture rod penetrates through the subcutaneous tissue with the puncture head and then replaces it with a wire carrier for fixing the extension wire, and the puncture rod is pulled back, so as to unidirectionally pull the extension wire to move under the skin.

[0006] An extension wire is connected to a single electrode using a single-row connector. The single-row connector is small in size, and the size of the subcutaneous tunnel is relatively small, resulting in less subcutaneous damage to the patient. To achieve the purpose of reducing the resistance when the wire-carrying component passes through the subcutaneous tissue, preventing blood vessels from being scratched, and avoiding large subcutaneous bleeding, the number of protective parts is increased, which enlarges the patient's wound surface and also increases the complexity of the doctor's operation during the surgery.

[0007] With the development of medical technology, more and more electrodes need to be implanted. Currently, many medical device manufacturers use a horizontal double-row connector on an extension wire to connect to two electrodes. The size of the double-row connector is twice as large as that of the previous single-row connector. If the original subcutaneous tunnel tools and surgical methods are still used, the subcutaneous damage area to the patient will also double, causing greater tissue damage to the patient, increasing the risk of infection, and seriously affecting the postoperative recovery.

[0008] Therefore, it is necessary to improve the existing structure and operation method to effectively accommodate extension wires of different sizes and solve the problems faced during the current surgery. Summary of the Invention

[0009] In view of the problems existing in the prior art, the present invention provides a subcutaneous implantation tool and a usage method for creating a subcutaneous tunnel and pulling an extension wire in the subcutaneous tunnel to a predetermined position, enabling the pulse generator of the implantable nerve stimulation system to be connected to the stimulation electrode through the extension wire.

[0010] By using a detachable handle to achieve bidirectional pulling, it can ensure that the trauma diameter of the extension wire of the double-row connector is the same as that of the extension wire of the single-row connector, without adding protective parts, and can also protect the extension wire during pulling.

[0011] A subcutaneous tunnel tool includes:

[0012] A detachable handle;

[0013] A hollow tube, with a tunnel cavity formed inside the hollow tube, and the detachable handle is connected to one end of the hollow tube;

[0014] A puncture wire, one end of which is a blunt head and can be positioned at the end of the hollow tube as the piercing end of the hollow tube, and the other end is connected to the detachable handle via the tunnel cavity;

[0015] A wire carrier, with at least two limiting grooves provided at one end of the wire carrier, and the other end of the wire carrier passes through the tunnel cavity and is connected to the detachable handle, and can be pulled by the detachable handle;

[0016] There are at least two extension wires. One end of each extension wire is embedded in the limiting groove and connected to the carrier wire, so that by pulling the detachable handle, the carrier wire can be driven, and then one end of the extension wire can pass through the end of the hollow tube.

[0017] The other end of the extension wire can be a single-row connector or a double-row connector. The extension wire is connected to the carrier wire. Compared with the fixed handle disclosed in the prior art, the handle provided by the present invention is detachable. Therefore, when the other end of the extension wire is a double-row connector, the detachable handle can be installed and fixed at one end of the hollow tube close to the human chest, and the end of the extension wire can follow the detachable handle and the carrier wire to pass through the end of the hollow tube. The extension wire is always inside the hollow tube when passing through, and the single-row or double-row connector at the other end of the extension wire is always located outside the hollow tube, that is, behind the human ear. Therefore, it will not cause the incision to expand, that is, it will not increase the harm to the human body.

[0018] Further, connection interfaces are provided at both ends of the hollow tube, and the detachable handle is provided with a locking screw. The detachable handle and the hollow tube form a detachable connection through the cooperation of the locking screw and the connection interface.

[0019] Further, the connection interface includes an adjacent circular through-hole and a handle guiding groove. The detachable handle is inserted at the handle guiding groove, and the locking screw cooperates with the circular through-hole to achieve the connection. The locking screw is inserted or screwed at the circular through-hole to achieve the detachable connection between the detachable handle and the hollow tube.

[0020] Further, guide ribs are provided inside the detachable handle, and the guide ribs can cooperate with the handle guiding groove to form a limiting mechanism. The cooperation between the guide ribs and the handle guiding groove can realize the preliminary positioning of the detachable handle and the hollow tube, and facilitate the quick cooperation between the locking screw and the circular through-hole.

[0021] Further, the outer diameter of the carrier wire is smaller than the inner diameter of the hollow tube, so as to reduce the friction when the carrier wire passes through the tunnel cavity.

[0022] Further, a convex portion is provided at the end of the extension wire, and the convex portion is embedded in the limiting groove, and the depth of the limiting groove is not less than the width of the convex portion.

[0023] Further, the outer diameter of the carrier wire is smaller than the inner diameter of the hollow tube, so that the end of the carrier wire provided with the limiting groove can be arranged inside the hollow tube, providing a good protection effect for the extension wire and avoiding damage to the extension wire during pulling.

[0024] Further, a limiting opening is formed at the end of the limiting groove.

[0025] Further, a clamping groove is provided inside the detachable handle, and the clamping groove is used for limiting the puncture wire or the wire carrier. A clamping end is provided at the end of the puncture wire or the wire carrier, and can be clamped at the clamping groove to form a reliable connection.

[0026] A method for using a subcutaneous tunnel tool, comprising:

[0027] S1, connecting the detachable handle (1), the hollow tube (2), and the puncture wire (3) in sequence to complete the assembly;

[0028] S2, passing the hollow tube (2) from the first incision to the second incision, and then removing the puncture wire (3); wherein, the first incision is located behind the human ear, and the second incision is located at the human chest;

[0029] S3, removing the detachable handle (1) from the first incision, and then installing and connecting it to the other end of the hollow tube (2), that is, the detachable handle (1) is located at the second incision;

[0030] Or without removing the detachable handle (1), that is, the detachable handle (1) is located at the first incision;

[0031] S4, clamping the protruding parts (6-1) at the ends of at least two extension wires (6) in the limiting grooves (4-2) of the wire carrier (4);

[0032] S5, connecting one end of the wire carrier (4) to the detachable handle (1);

[0033] S6, pulling the detachable handle (1) until the wire carrier (4) is exposed, and removing the detachable handle (1) and the hollow tube (2).

[0034] Compared with the prior art, the beneficial effects of the present invention are:

[0035] 1. By swapping the two ends of the detachable handle for use, two-way pulling of the extension wire can be achieved, providing different methods for using the subcutaneous tunnel tool.

[0036] 2. It has good adaptability and can be well compatible with new and old extension wire subcutaneous tunneling schemes.

[0037] 3. If the other end of the extension wire is a double-row connector, it is fixed to the end of the hollow tube near the human chest using the detachable handle. When the detachable handle pulls one end of the extension wire, the double-row connector at the other end is always located behind the human ear and does not enter the hollow tube, thus not increasing the trauma diameter of the patient's subcutaneous tunnel, having small resistance, not increasing significant bleeding, and being beneficial for postoperative healing.

[0038] 4. The extended wire connected in a single row or the extended wire connected in a double row can extend into the interior of the hollow tube, providing good protection for one end of the extended wire during pulling. Description of the Drawings

[0039] Figure 1 It is a schematic diagram of the overall structure of the subcutaneous tunneling tool;

[0040] Figure 2 It is a schematic diagram of the assembly structure of Embodiment 1;

[0041] Figure 3 It is a schematic diagram of the internal structure of the detachable handle;

[0042] Figure 4 It is a schematic diagram of the assembly of the extended wire, the wire carrier, and the extended wire in Embodiment 1;

[0043] Figure 5 It is a schematic diagram of the connection between the wire carrier and the extended wire in Embodiment 1;

[0044] Figure 6 It is a schematic diagram of the assembly of the extended wire, the wire carrier, and the extended wire in Embodiment 2;

[0045] Figure 7 It is a schematic diagram of the assembly of the extended wire, the wire carrier, and the extended wire in Embodiment 3;

[0046] Figure 8 It is a schematic diagram of the operation process in Embodiment 1;

[0047] Figure 9 It is a schematic diagram of the operation process in Embodiment 2;

[0048] Figure 10 It is a schematic diagram of the operation process in Embodiment 3;

[0049] In the figure: 1 is a detachable handle; 1-1 is a locking screw; 1-2 is a guiding rib; 1-3 is a clamping groove; 2 is a hollow tube; 2-1 is a circular through-hole; 2-2 is a handle guiding groove; 3 is a puncture wire; 3-1 is a blunt head; 4 is a wire carrier; 4-1 is a buckle; 4-2 is a limiting groove; 4-3 is a clamping groove; 5 is a tunnel cavity; 6 is an extended wire; 6-1 is a convex part. Detailed Embodiments

[0050] Embodiment 1

[0051] The subcutaneous tunneling tool of this embodiment, as Figures 1 to 5 shown, includes:

[0052] A detachable handle 1;

[0053] A hollow tube 2, a tunnel cavity 5 is formed inside the hollow tube 2, and the detachable handle 1 is connected to one end of the hollow tube 2;

[0054] A puncture wire 3, one end of which is a blunt head 3-1, can be positioned at the end of the hollow tube 2 and serves as the piercing end of the hollow tube 2, and the other end is connected to the detachable handle 1 via the tunnel cavity 5;

[0055] A wire carrier 4, one end of the wire carrier 4 is provided with two limiting grooves 4-2, the other end of the wire carrier 4 passes through the tunnel cavity 5 and is connected to the detachable handle 1, and can be pulled by the detachable handle 1; the two limiting grooves 4-2 have a first depth and a second depth, wherein the first depth is greater than the second depth, and the first depths and second depths of the two limiting grooves 4-2 on different sides are arranged in an alternating manner.

[0056] There are two extension wires 6. One end of each extension wire 6 is embedded in the limiting groove 4-2 and is connected to the wire carrier 4, so that by pulling the detachable handle 1, the wire carrier 4 can be driven, and further one end of the extension wire 6 can be drawn out from the end of the hollow tube 2. In this embodiment, the other end of the adopted extension wire 6 has a double-row connector, one end is provided with a convex portion 6-1, the convex portion 6-1 is embedded in the limiting groove 4-2, and the depth of the limiting groove 4-2 is not less than the width of the convex portion 6-1. The convex portions 6-1 of the two extension wires 6 are arranged at the first depth of the limiting groove 4-2. Since the first depths and second depths of the two limiting grooves 4-2 are arranged in an alternating manner, as Figure 4 and Figure 5 shown, the ends of the two extension wires 6 are arranged in a staggered manner and are not symmetrically arranged on both sides of the wire carrier 4. In addition, limiting steps are formed inside the limiting grooves with different depths, effectively preventing the extension wires 6 from coming out.

[0057] The outer diameter of the wire carrier 4 is smaller than the inner diameter of the hollow tube 2, so that the end of the wire carrier 4 provided with the limiting groove 4-2 can be arranged inside the hollow tube 2, providing good protection for the extension wires 6 and avoiding damage to the extension wires 6 during pulling.

[0058] A limiting opening 4-3 is formed at the end of the limiting groove 4-2 to prevent the extension wire 6 from coming out of the limiting groove 4-2.

[0059] Both ends of the hollow tube 2 are provided with connection interfaces, the detachable handle 1 is provided with a locking screw 1-1, and the detachable handle 1 and the hollow tube 2 form a detachable connection through the cooperation of the locking screw 1-1 and the connection interface.

[0060] The connection interface includes a circular through-hole 2-1 and a handle guiding groove 2-2 arranged adjacent to each other. The detachable handle 1 is inserted at the handle guiding groove 2-2, and the locking screw 1-1 is engaged with the circular through-hole 2-1 to achieve connection. The locking screw 1-1 is inserted or screwed at the circular through-hole 2-1 to achieve the detachable connection between the detachable handle 1 and the hollow tube 2.

[0061] The detachable handle 1 is provided with a guiding rib 1-2, and the guiding rib 1-2 can cooperate with the handle guiding groove 2-2 to form a limiting mechanism. The guiding rib 1-2 and the handle guiding groove 2-2 cooperate to achieve the preliminary positioning of the detachable handle 1 and the hollow tube 2, facilitating the quick cooperation between the locking screw 1-1 and the circular through-hole 2-1.

[0062] The detachable handle 1 is provided with a clamping groove 1-3, and the clamping groove 1-3 is used to limit the puncture wire 3 or the wire carrier 4. The end of the puncture wire 3 or the wire carrier 4 is provided with a clamping end, which can be clamped at the clamping groove 1-3 to form a reliable connection.

[0063] The usage method of the subcutaneous tunnel tool in this embodiment is as Figure 8 shown and includes:

[0064] Connect the detachable handle 1, the hollow tube 2, and the puncture wire 3 in sequence to complete the assembly; as shown in (a) of Figure 8 , pass the hollow tube 2 from the first incision (behind the ear) to the second incision (below the collarbone), that is, install the detachable handle 1, the hollow tube 2, and the puncture wire 3 from top to bottom. At this time, the detachable handle 1 is located at the first incision behind the ear, the puncture wire 3 is located at the second incision below the collarbone, and the hollow tube 2 is located in the subcutaneous tunnel between the first incision 7 behind the ear and the second skin incision 8 below the collarbone. Then disconnect the end of the puncture wire 3 from the clamping groove 1-3 of the detachable handle 1 and draw out the puncture wire 3 from the hollow tube 2. Next, loosen the locking screw 1-1 of the detachable handle 1 and pull out the detachable handle 1 to disconnect it from the hollow tube 2. As shown in (b) of Figure 8 , install the detachable handle 1 again at the end of the second incision 8 of the hollow tube 2 located below the collarbone, install it along the handle guiding groove 2-2 of the hollow tube 2, and tighten the locking screw 1-1. Place the two double-row connector extension wires in the two limiting grooves 4-2 of the wire carrier 4 respectively, and snap the protruding parts 6-1 at the ends of the two extension wires 6 into the limiting grooves 4-2 of the wire carrier 4; the other end of the extension wire 6 is a double-row connector. Connect one end of the wire carrier 4 to the detachable handle 1; pull the detachable handle 1 downward from top to bottom until the wire carrier 4 is exposed, as shown in (c) of Figure 8 , remove the detachable handle 1 and the hollow tube 2.

[0065] Embodiment 2

[0066] The difference between this embodiment and Embodiment 1 is that: as Figure 6 shown, the other end of the extension wire 6 is a single-row connector. At this time, the two single-row connector extension wires can be respectively connected to two electrodes and a nerve stimulator. As Figure 9 shown in (a) of Figure 9 , the detachable handle 1, the hollow tube 2 and the puncture wire 3 are installed from top to bottom. As

[0067] shown in (b) and (c) of

[0068] , it can be known that in this embodiment, after the detachable handle 1 is removed, it is installed on the other side of the hollow tube 2, and the moving direction of the extension wire 6 is from top to bottom. Figure 7 shown, the single-row connector at the other end of the extension wire 6 is embedded in the limit groove. As Figure 10 shown in (a) of Figure 10 , the detachable handle 1, the hollow tube 2 and the puncture wire 3 are installed from top to bottom. As

[0069] Bidirectional pulling is realized through the detachable handle, which can not only be used in cooperation with the extension wire of the single-row connector, but also be used in cooperation with the extension wire of the double-row connector. And when tunneling under the skin, it can ensure that the trauma diameter of the extension wire of the double-row connector is the same as that of the extension wire of the single-row connector. Moreover, without adding protective parts, it can also protect the extension wire during pulling.

[0070] The subcutaneous tunneling tool provided by the present invention, a tunneling tool and kit for the extension wire of deep brain stimulation, has the advantages of small overall diameter after the extension wire is connected to the wire carrier and being convenient for wire leading.

Claims

1. A subcutaneous tunnel tool, characterized in that Comprising: A detachable handle (1); A hollow tube (2), a tunnel cavity (5) is formed inside the hollow tube (2), and the detachable handle (1) is connected to one end of the hollow tube (2); A puncture wire (3), one end of which is a blunt head and can be positioned at the end of the hollow tube (2) as the piercing end of the hollow tube (2), and the other end is connected to the detachable handle (1) via the tunnel cavity (5); A wire carrier (4), at least two limiting grooves (4-2) are provided at one end of the wire carrier (4), and the other end of the wire carrier (4) passes through the tunnel cavity (5) and is connected to the detachable handle (1), and can be pulled by the detachable handle (1); At least two extension wires (6) are provided. One end of the extension wire (6) is embedded in the limiting groove (4-2) and connected to the wire carrier (4), so that by pulling the detachable handle (1), the wire carrier (4) is driven to pass through the tunnel cavity (5), and further one end of the extension wire (6) passes out from the end of the hollow tube (2).

2. The subcutaneous tunnel tool according to claim 1, wherein, Both ends of the hollow tube (2) are provided with connection interfaces, the detachable handle (1) is provided with a locking screw (1-1), and the detachable handle (1) and the hollow tube (2) form a detachable connection through the cooperation of the locking screw (1-1) and the connection interface.

3. The subcutaneous tunnel tool according to claim 2, wherein, The connection interface includes an adjacent circular through hole (2-1) and a handle guide groove (2-2). The detachable handle (1) is inserted at the handle guide groove (2-2), and the locking screw (1-1) cooperates with the circular through hole (2-1) to achieve connection.

4. The subcutaneous tunneling tool according to claim 2, characterized in that, A guide rib (1-2) is provided inside the detachable handle (1), and the guide rib (1-2) can cooperate with the handle guide groove (2-2) to form a limiting mechanism.

5. The subcutaneous tunneling tool according to claim 1, characterized in that, The outer diameter of the wire carrier (4) is smaller than the inner diameter of the hollow tube (2).

6. The subcutaneous tunneling tool according to claim 1, wherein, A convex portion (6-1) is provided at the end of the extension wire (6), and the convex portion (6-1) is embedded in the limiting groove (4-2), and the depth of the limiting groove (4-2) is not less than the width of the convex portion (6-1).

7. The subcutaneous tunnel tool according to claim 5, wherein The outer diameter of the wire carrier (4) is smaller than the inner diameter of the hollow tube (2) so that the end of the wire carrier (4) provided with the limiting groove (4-2) can be arranged inside the hollow tube (2).

8. The subcutaneous tunneling tool according to claim 5 or 6 or 7, characterized in that, A limiting opening (4-3) is formed at the end of the limiting groove (4-2).

9. The subcutaneous tunnel tool according to claim 5, wherein A clamping groove (1-3) is provided inside the detachable handle (1), and the clamping groove (1-3) is used for limiting the puncture wire (3) or the wire carrier (4).

10. A method for using a subcutaneous tunneling tool, characterized in that, Comprising: S1, connecting the detachable handle (1), the hollow tube (2), and the puncture wire (3) in sequence to complete the assembly; S2, passing the hollow tube (2) from the first incision to the second incision, and then removing the puncture wire (3); wherein, the first incision is located behind the human ear, and the second incision is located at the human chest; S3, removing the detachable handle (1) from the first incision, and then installing and connecting it to the other end of the hollow tube (2), that is, the detachable handle (1) is located at the second incision; Or not removing the detachable handle (1), that is, the detachable handle (1) is located at the first incision; S4, snap the protrusions (6-1) at the ends of at least two extension wires (6) into the limiting grooves (4-2) of the carrier wire (4); S5, connect one end of the carrier wire (4) to the detachable handle (1); S6, pull the detachable handle (1) until the carrier wire (4) is exposed, and remove the detachable handle (1) and the hollow tube (2).

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