WO2014061162A1

WO2014061162A1 - Connection mechanism for electrical stimulus device

Info

Publication number: WO2014061162A1
Application number: PCT/JP2012/077161
Authority: WO
Inventors: 美仁福井
Original assignee: テルモ株式会社
Priority date: 2012-10-19
Filing date: 2012-10-19
Publication date: 2014-04-24

Abstract

To make it possible to implant an electrical stimulus device (1) in a living body (30) in an appropriate manner. Accordingly, a connection mechanism (60) for an electrical stimulus device pertaining to the present invention is configured to be provided with a core body (62) and a connector (61). One end of the core body (62) is inserted into a shaft center part (14a) of an extension (14) embedded in a stimulus device (4). The connector (61) has a first end part to which the base end of an insertion tool (55) is connected, and a second end part to which the end part of the extension (14) is connected. The core body (62) is inserted into or connected to the connector (61).

Description

Electrical stimulator connection mechanism

The present invention relates to a connection mechanism for an electrical stimulation device that is used when an electrical stimulation device used for electrical stimulation therapy for electrically stimulating a living body is implanted in a living body with minimal invasiveness.

Conventionally, in the treatment of pain, when there is no effect on drug therapy, nerve block therapy, or surgical therapy, or when the treatment cannot be continued due to side effects, etc., there is an electrical stimulation therapy that alleviates pain by electrically stimulating the nerve. Has an effect. Spinal cord electrical stimulation therapy, which is one type of electrical stimulation therapy, is a stimulation therapy that electrically stimulates the spinal cord in order to relieve pain transmitted to the brain through the spinal cord.

In spinal cord electrical stimulation therapy, a test stimulus (hereinafter referred to as “test stimulus”) is usually performed to confirm the effectiveness of pain relief by electrical stimulation. In the test stimulation, a stimulation electrode lead which is an electrode lead having a stimulation electrode for electrically stimulating the spinal cord at its distal end is inserted into the epidural space outside the spinal dura which covers the spinal cord by puncture from the back. Then, the stimulation electrode lead is connected to an external electrical stimulation device, and the degree of pain relief is examined under various stimulation patterns.

When a predetermined effect is recognized by this test stimulus, an electrical stimulation device is implanted (hereinafter referred to as “main implantation”). FIG. 32 is a schematic diagram schematically illustrating a procedure for implanting the electrical stimulation device during main implantation. In FIG. 32, the extension electrode 300, which is an electrode lead that relays the stimulation electrode lead 100 and the stimulation device 200, has the stimulation electrode 101 of the stimulation electrode lead 100 inserted into the epidural space 31 of the living body 30. It is a figure which shows the state inserted through the inside.

Four stimulation electrodes 101 are provided at one end of the stimulation electrode lead 100, and four terminal electrodes 102 corresponding to the stimulation electrode 101 are provided at the other end. Each electrode of the stimulation electrode 101 and each electrode of the terminal electrode 102 are electrically connected by a lead wire (not shown).

The extension 300 is provided with a connector 301 that accommodates the terminal electrode 102 of the stimulation electrode lead 100 at one end and a terminal electrode 302 at the other end. The terminal electrode 302 is accommodated in the connector 202 of the stimulation apparatus 200. Inside the connector 301, four contact electrodes (not shown) that are electrically connected to each other when the terminal electrode 102 of the stimulation electrode lead 100 is accommodated are provided. The contact electrode and the terminal electrode 302 are electrically connected by a conducting wire (not shown).

The stimulation apparatus 200 includes a housing 201 and a connector 202 that houses the terminal electrode 302 of the extension 300.

In this implantation, an incision is first made in the insertion portion of the stimulation electrode lead 100 into the living body 30, and an incision B11 is provided. Next, an incision is made in a planned implantation site of the stimulation apparatus 200, for example, the lumbar region, and a space equivalent to the stimulation apparatus 200 is subcutaneously formed by blunt dissection from the incision B12Ｂ generated by the incision. Pocket B13 is provided. Then, a tunneling tool is inserted from the cut opening B12 toward the cut opening B11. As a tunneling tool, it is common to use a tunneler which is composed of an elongated rod and a cylindrical sheath having a central portion as a lumen, and the sheath is attached to cover the rod.

Subsequently, the rod is pulled out from the tunneler inserted between the incision B11 and the incision B12, and the sheath is left under the skin. Then, after the distal end portion of the extension 300, that is, the end portion on the side where the terminal electrode 302 is provided is pushed from the sheath end portion on the cut opening B11 side and guided to the sheath end portion on the cut opening B12 side, the sheath Is pulled out from the side of the incision B12, whereby the stimulation electrode lead 100 is inserted into the subcutaneous tunnel B10.

Patent Document 1 describes a tunneling tool that can attach an electrode lead to the tip of a rod. In the tunneling tool described in Patent Document 1, an electrode lead is attached to the tip of a rod of a tunneling tool inserted subcutaneously, the rod is pulled to pull the electrode lead into the sheath, then the sheath is torn, and the sheath is removed from the living body. By removing it, the electrode lead can be inserted through the subcutaneous tunnel.

After inserting the stimulation electrode lead 100 into the subcutaneous tunnel B10, the terminal electrode 102 of the stimulation electrode lead 100 is accommodated in the connector 301 of the extension 300 on the side of the incision B11. In addition, the terminal electrode 302 of the extension 300 on the side of the incision B12 is accommodated in the connector 202 of the stimulation apparatus 200. Then, in a state where the stimulation electrode lead 100 inserted into the epidural space 31 and the stimulation device 200 are connected via the extension 300, the stimulation device 200 is implanted in the subcutaneous pocket B13 provided in the waist. .

US Pat. No. 7,218,970

By the way, according to the tunneling tool described in Patent Document 1, when the electrode lead is inserted into the subcutaneous tunnel, the electrode lead is passed through the sheath of the tunneling tool, that is, the lumen portion. For this reason, it is necessary to provide the tunneling tool with a lumen through which the electrode lead passes. However, since the diameter of the tunneling tool itself that is provided with the lumen is also increased, the invasion of the patient's living body is increased accordingly.

In addition, if the end of the electrode lead that is different from the end inserted through the tunneling tool is integrated with the stimulator, the stimulator can be pulled into the living body only by the force that pulls the electrode lead. Is considered difficult. In such a case, the stimulating device can be accommodated in the subcutaneous pocket in the living body by pushing the stimulating device into the living body by hand. However, by applying a force in the direction of pushing the stimulator into the living body, the electrode lead connected to the stimulator bends (kinks) in the subcutaneous tunnel, and the coating covering the electrode lead is broken. There is a possibility that the conducting wire passing through the inside of the electrode lead may be disconnected.

The present invention has been made in view of such a point, and an object thereof is to enable appropriate implantation of an electrical stimulation device into a living body.

The connection mechanism for an electrical stimulation device according to the present invention has a configuration including a core and a connection portion, and the configuration and function of each configuration portion are as follows. The core-like body has stimulation electrodes implanted in the living body to electrically stimulate nerves or muscles, or electrodes provided corresponding to the stimulation electrodes at both ends, and one end of both ends is It is inserted into the axial center portion of an electrode lead embedded in a stimulation device that generates an electrical stimulation signal to be applied to the stimulation electrode. The connecting portion has a first end to which the proximal end of the insertion tool inserted through the living body is connected and a second end to which the end of the electrode lead is connected, and the core is inserted. Or connected.

With this configuration, since the insertion tool and the electrode lead are connected via the connection portion, it is not necessary to provide a lumen portion for inserting the electrode lead in the axial center portion of the insertion tool. Thereby, since the diameter of an insertion tool can be made small, formation of a subcutaneous tunnel can be performed minimally invasively. In addition, since the core body is inserted into the through hole of the electrode lead, the rigidity of the electrode lead is increased, so that a force in the direction of pushing into the living body is applied to the stimulation device formed integrally with the electrode lead. Even in this case, the electrode lead is not bent in the living body.

According to the connection mechanism for an electrical stimulation device of the present invention, the stimulation device can be appropriately implanted in the living body.

It is a perspective view which shows the schematic structural example of each part of the electrical stimulation apparatus which concerns on the 1st Example of this invention. FIG. 1A is a perspective view illustrating a configuration example of a stimulation electrode lead, an auxiliary lead, and a stimulation device. FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead is connected to the stimulation electrode lead. It is the schematic which shows the structural example of the connection mechanism which concerns on the 1st Example of this invention. It is the schematic which shows the structural example of the connection mechanism which concerns on the 1st Example of this invention. It is a block diagram which shows the example of an internal structure of the stimulating device which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 1 to the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 2 to the biological body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 3 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 4 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 5 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 6 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 7 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 8 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 9 in the biological body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 10 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 11 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 12 in the living body of the electric stimulator which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 13 in the living body of the electric stimulator which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 14 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 15 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 16 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 17 and the procedure 18 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. FIG. 21A is an explanatory view showing a state of an operation of attaching the tip portion of the extension to the insertion rod. FIG. 21B is a configuration diagram of a connection mechanism that connects the insertion rod and the extension. It is explanatory drawing which shows the implantation procedure 18 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 19 in the biological body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 20 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 21 in the biological body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 22 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 23 in the biological body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 24 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is explanatory drawing which shows the implantation procedure 25 in the living body of the electrical stimulation apparatus which concerns on the 1st Example of this invention. It is a schematic diagram which shows the schematic structural example of the extension, the bending prevention rod, the connection part, and the insertion rod based on the 2nd Example of this invention. It is a schematic diagram which shows the schematic structural example of an extension, a bending prevention rod, an electrode protection part, a connection part, and an insertion rod based on the 3rd Example of this invention. It is explanatory drawing which shows schematically the implantation procedure to the biological body of the conventional electrical stimulation apparatus.

Embodiments for carrying out the present invention will be described below. The embodiments described below are preferable specific examples of the present invention. Therefore, various technically preferable limitations are attached. However, the scope of the present invention is not limited to these embodiments unless otherwise specified in the following description. For example, the numerical conditions of each parameter given in the following description are only preferred examples, and the dimensions, shapes, and arrangement relationships in the drawings used for the description are also schematic. The description will be made in the following order.
1. 1st Embodiment (example in which an insertion tool is fixed to a connection part)
1-1. Configuration of electrical stimulation device 1-2. Configuration of connection mechanism between insertion tool and extension 1-3. Circuit configuration of stimulation circuit 1-4. 1. Implanting method of electrical stimulator Second embodiment (an example in which an insertion tool is fixed to a bending prevention rod)
3. 3rd Embodiment (example in which an insertion tool is engaged with a connection part)

[1. First Embodiment]
[1-1. Configuration of electrical stimulation device]
An example of the first embodiment of the present invention will be described with reference to the accompanying drawings. First, the mechanical configuration of the electrical stimulation device 1 according to the first embodiment will be described.
FIG. 1 is a perspective view showing a schematic configuration example of each part constituting the electrical stimulation apparatus 1 according to the first embodiment of the present invention. FIG. 1A is a perspective view illustrating a configuration example of the stimulation electrode lead 2, the auxiliary lead 3, and the stimulation device 4. FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead 3 is connected to the stimulation electrode lead 2.

The electrical stimulation device 1 stimulates nerves and / or muscles in a living body with electrical stimulation signals (hereinafter referred to as “electrical stimulation signals”). In spinal cord electrical stimulation therapy, the nerves of the spinal cord are stimulated. Is. As shown in FIG. 1A, the electrical stimulation device 1 is a stimulation electrode lead 2 that is implanted in a living body and is an electrode lead used to guide an electrical stimulation signal to a nerve and / or muscle and stimulate it. And an auxiliary lead 3 connected to the stimulation electrode lead 2 and a stimulation device 4 for supplying an electrical stimulation signal to the stimulation electrode lead 2.

The auxiliary lead 3 is used by being connected to the stimulation electrode lead 2 at the time of the test stimulation when the stimulation electrode lead 2 is implanted into the living body, and is removed from the stimulation electrode lead 2 after the completion of the test stimulation. The stimulation device 4 includes a housing 13 and an extension 14 that is an electrode lead that relays between the stimulation device 4 and the stimulation electrode lead 2. An end of the extension 14 is embedded in the housing 13 and is formed integrally with the housing 13. The “connecting mechanism for an electrical stimulation device” of the present invention plays a role of connecting the insertion tool used when the extension 14 is implanted into a living body and the extension 14 as an electrode lead. First, a configuration example of the stimulation electrode lead 2 and the auxiliary lead 3 will be described with reference to FIG. 1, and thereafter, the “connection mechanism for an electrical stimulation device” of the present invention will be described with reference to FIG. 2 and FIG. .

As shown in FIG. 1A, the stimulation electrode lead 2 is configured as a substantially cylindrical elongated body, and at one end thereof, four stimulation electrodes 5 for stimulating spinal nerves are provided. The other end is provided with a connector 7 to which a terminal electrode 8 of the auxiliary lead 3 described later or a terminal electrode 15 of the stimulating device 4 is connected.

In the following description, the end portion of the stimulation electrode lead 2 that is disposed at a position close to the stimulation device 4 in a state where the stimulation device 4 is connected to the stimulation electrode lead 2 is referred to as a proximal end and is far away. The end on the side disposed at the position is referred to as the distal end. That is, the end on the side where the stimulation electrode 5 is provided is the distal end, and the end on the side where the connector 7 is provided is the proximal end.

The stimulation electrode 5 is made of a material having conductivity and biocompatibility, such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy), and is hollow. It is formed in a substantially cylindrical shape. In this example, the number of stimulation electrodes 5 is four, but this number is merely an example, and the number of stimulation electrodes 5 can be arbitrarily set.

A body 6 as a lead portion is provided between the four stimulation electrodes 5 of the stimulation electrode lead 2. The body 6 is fixed so that each of the four stimulation electrodes 5 is exposed to the living body when the stimulation electrode lead 2 is disposed in the living body. The body 6 is made of a flexible and biocompatible material, for example, a long body formed of a resin material such as silicone or polyurethane in a substantially cylindrical shape. It is preferable that it is 3 mm.

In the body 6 configured as an elongated body, a substantially cylindrical hole (shown in the figure) that opens at the proximal end serving as a connection portion with the connector 7 and communicates through the hollow portion of the stimulation electrode 5 to the vicinity of the distal end. Is omitted in the axial direction. This hole (lumen) is a hole into which a stylet for pushing the stimulation electrode lead 2 and maintaining the shape of the stimulation electrode lead 2 is inserted while the stimulation electrode 5 is inserted into the living body. Represented as “stylet lumen”. The structure of the stylet lumen will be described later with reference to FIG.

The connector 7 is formed of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, in a hollow and substantially cylindrical shape, and has a contact electrode (not shown) therein. The contact electrode and the stimulation electrode 5 are electrically connected by a conducting wire (not shown), and the conducting wire is completely embedded in the body 6. As described above, the terminal electrode 8 of the auxiliary lead 3 or the terminal electrode 15 of the stimulation device 4 is inserted into the hollow portion of the connector 7. A groove 7 a as a connection mechanism with the auxiliary lead 3 is provided at the proximal end of the connector 7. The outer shape of the connector 7 is preferably 3 to 9 mm.

Next, the configuration of the auxiliary lead 3 will be described with reference to FIG. 1A. The auxiliary lead 3 is configured as a substantially cylindrical long body, and at one end thereof, four terminal electrodes 8 corresponding to the respective stimulation electrodes 5 of the stimulation electrode lead 2 are provided. At the other end, four terminal electrodes 9 corresponding to the respective stimulation electrodes 5 of the stimulation electrode lead 2 are provided. The terminal electrode 8 and the terminal electrode 9 are made of a conductive and biocompatible material such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, 90% platinum / 10% iridium alloy). And is held by a body 10 made of an elongated body formed in a substantially cylindrical shape. The electrodes of the terminal electrode 8 and the terminal electrode 9 are electrically connected by conductive wires (not shown) that are completely embedded in the body 10. The same material as the terminal electrode 8 and the terminal electrode 9 can be used as the material of the conductive wire, and the material of the body 10 is a flexible and biocompatible material such as silicone or polyurethane. Resin material is used.

The terminal electrode 8 is inserted into the connector 7 of the stimulation electrode lead 2, and an external stimulation device (not shown) that generates an electrical stimulation signal for test stimulation is connected to the terminal electrode 9. In the following description, the end portion of the auxiliary lead 3 on the side close to the extracorporeal stimulation device in a state in which the extracorporeal stimulation device is connected to the terminal electrode 9 is referred to as a proximal end, and the far end is located. The end on the side where it is arranged is called the distal end. That is, the end of the stimulation electrode lead 2 on the side where the terminal electrode 8 accommodated in the connector 7 is provided is the distal end, and the end on the side where the terminal electrode 9 to which the extracorporeal stimulation device is connected is close. It becomes the end.

Also, an engaging member 11 is provided near the center of the body 10 in the axial direction as a connection mechanism with the connector 7 of the stimulation electrode lead 2. The engaging member 11 is formed on the circumference of the body 10 so as to protrude from the body 10, and a claw portion (not shown) that engages with the groove portion 7 a of the connector 7 of the stimulation electrode lead 2 is formed at a tip portion thereof. ) Is formed. The material of the engaging member 11 is not limited to silicone or polyurethane, and any material may be used as long as it is flexible and biocompatible. Further, the auxiliary lead 3 is provided with a stylet lumen (not shown) penetrating from the proximal end to the distal end. That is, as shown in FIG. 1B, when the auxiliary lead 3 is connected to the stimulation electrode lead 2, the stylet lumen communicates from the proximal end of the auxiliary lead 3 to the vicinity of the distal end of the stimulation electrode lead 2. It will be.

Next, the configuration of the stimulation device 4 will be described again with reference to FIG. 1A. The stimulation device 4 includes a housing 13 and an extension 14. Inside the housing 13, a stimulation circuit 12 that generates an electrical stimulation signal and applies the generated electrical stimulation signal to the stimulation electrode 5 is provided. The housing 13 is made of a relatively hard and biocompatible metal or resin, such as titanium or epoxy, and has a substantially rectangular parallelepiped shape.

The extension 14 is formed in a substantially cylindrical shape, and a lumen portion 14a indicated by a broken line is provided in an axial center portion thereof. The extension 14 is made of a flexible and biocompatible material, for example, a long body formed of a resin material such as silicone or polyurethane in a substantially cylindrical shape. It is preferable that it is 3 mm. A terminal electrode 15 corresponding to the stimulation electrode 5 is provided at the end (distal end) of the extension 14 accommodated in the connector 7 of the stimulation electrode lead 2. Further, an extension fixing portion 17 is provided at the distal end portion of the extension 14. The extension fixing portion 17 is formed as a screw receiver, and a tip portion of the fixing screw comes into contact therewith. The fixing screw is used when the extension 14 is fixed to the connector 7 of the stimulation electrode lead 2 or a connecting portion 61 (see FIG. 2) described later. As a material of the extension fixing part 17, for example, relatively hard stainless steel having biocompatibility is used.

The terminal electrode 15 has a substantially cylindrical shape in which a material such as stainless steel, an MP35N alloy, platinum, or a platinum alloy (for example, platinum 90% / iridium 10% alloy) is hollow. And is held by a body 16 made of an elongated body formed in a substantially cylindrical shape. The terminal electrode 15 is connected to the stimulation circuit 12 inside the housing 13 by a lead wire (not shown) embedded in the body 16, and the proximal end of the extension 14 is embedded in the housing 13 of the stimulation device 4. Thus, the extension 14 and the housing 13 are integrally formed.

That is, the stimulation device 4 according to the present embodiment does not have the connector 202 like the conventional stimulation device 200 described with reference to FIG. Therefore, the stimulation device 4 according to the present embodiment can be made smaller than the conventional stimulation device.

The stimulation circuit 12 is a circuit in which a small component such as a custom IC is mounted on a circuit board. The stimulation circuit 12 generates an electrical stimulation signal and performs control to apply the generated electrical stimulation signal to the stimulation electrode 5. In order to independently supply the electrical stimulation signal generated by the stimulation circuit 12 to each stimulation electrode 5, the stimulation circuit 12 and each electrode of the terminal electrode 15 associated with the stimulation electrode 5 are connected to the body of the extension 14. 16 are electrically connected by conductive wires (not shown) embedded therein. As the conductor material, the same material as the terminal electrode 15 can be used. The electrical configuration of the stimulation circuit 12 will be described later with reference to FIG.

[1-2. Configuration of the connection mechanism between the insertion tool and the extension]
Subsequently, referring to FIG. 2, a configuration of a connection mechanism 60 that connects the extension rod 14 of the insertion tool and the extension 14 used when implanting the extension 14 and the stimulation device 4 into a subcutaneous pocket or a subcutaneous tunnel. An example will be described. The connection mechanism 60 includes a connection portion 61 that connects the insertion rod 55 and the extension 14, a bending prevention rod 62 that is used as a core for increasing the rigidity of the extension 14, and an electrode protection cover 63.

The connecting portion 61 is a mechanism for connecting the proximal end portion of the insertion rod 55 and the distal end portion (distal end) of the extension 14. For example, the connection portion 61 has a substantially cylindrical shape having a diameter slightly larger than the diameter of the insertion rod 55. Shaped. As the material of the connecting portion 61, a resin or metal that is biocompatible and relatively hard, such as epoxy or stainless steel, is used. The connecting portion 61 is formed with an insertion rod accommodating portion 61a (an insertion tool accommodating portion) which is a recess for accommodating the insertion rod 55 at the distal end (first end portion), and a proximal end (second end portion). ), An extension accommodating portion 61b (electrode lead accommodating portion), which is a recess for accommodating the tip end portion of the extension 14, is formed. A taper is provided on the outer peripheral portion of the portion where the insertion rod accommodating portion 61a is formed. As a result, the end portion of the connecting portion 61 connected to the proximal end portion of the insertion rod 55 may become difficult to pull by pulling on the dermis layer or subcutaneous tissue of the skin during traction, or may damage the dermis layer or subcutaneous tissue of the skin. Can be prevented. That is, it becomes easy to perform traction and can be performed with minimal invasiveness. An end portion of the bending prevention rod 62 is connected to the bottom portion 61c which is a concave portion of the extension accommodating portion 61b. The attachment position and the angle of the bending prevention rod 62 to the bottom 61 c are the angle at which the bending prevention rod 62 is parallel to the axial direction of the connection 61 at the position of the bottom 61 c that is the axial center of the connection 61.

The bending prevention rod 62 is a rod for preventing the extension 14 from being bent in the subcutaneous pocket or the subcutaneous tunnel, and is used by being inserted into the lumen portion 14 a provided in the extension 14. As a material of the bending prevention rod 62, for example, a relatively hard stainless steel having biocompatibility is used. When the insertion rod 55 to which the distal end portion of the extension 14 is connected is pulled to pass the extension 14 through the subcutaneous tunnel, the casing 13 of the stimulator 4 following the extension 14 is implanted into the subcutaneous pocket from outside the body. It is necessary to push the housing 13 into the subcutaneous pocket. Since the extension 14 is formed of a flexible material as described above, there is a possibility that the extension 14 is bent in the subcutaneous pocket or the subcutaneous tunnel by applying the pushing force. By passing the anti-bending rod 62 over the entire length of the extension 14, the rigidity of the extension 14 increases, so that the extension 14 is bent in the subcutaneous pocket or the subcutaneous tunnel even when a force to be pushed into the housing 13 is applied. Disappears.

Therefore, the length of the bending prevention rod 62 needs to be at least equal to or longer than the total length of the extension 14. In the present embodiment, as shown in FIG. 2, the stimulating device 4 is provided with a concave receiving portion 13a for accommodating the end portion of the bending preventing rod 62, and the distal end portion of the extension 14 is provided on the receiving portion 13a. The end portion of the bending prevention rod 62 inserted from above is accommodated. For this reason, the length of the bending preventing rod 62 is a length obtained by adding the total length L1 of the extension 14 and the length L2 of the receiving portion 13a in the depth direction. As a material for the receiving portion 13a, a resin or metal that is biocompatible and relatively hard, such as epoxy or stainless steel, is used.

With this configuration, when the distal end portion of the bending prevention rod 62 is inserted into the lumen portion 14a from the distal end of the extension 14 and reaches the receiving portion 13a of the stimulating device 4, the distal end portion of the extension 14 becomes the extension. It contacts the bottom 61c of the housing 61b. That is, as shown in FIG. 3, the bending prevention rod 62 is pushed by pushing the bending prevention rod 62 into the lumen portion 14 a until the distal end portion of the extension 14 is accommodated in the extension accommodation portion 61 b of the connection portion 61. The extension 14 is inserted through the entire length.

Returning to FIG. 2, the description will be continued. On the side surfaces of the insertion rod accommodating portion 61a and the extension accommodating portion 61b, a screw hole 61d (first fixing portion) and a screw hole 61e (first fixing portion) in the direction perpendicular to the axial direction, respectively. 2 fixed portions). The screw hole 61e is a hole that opens to the extension fixing portion 17 when the distal end portion of the extension 14 is accommodated in the extension accommodating portion 61b. The insertion rod 55 is fixed to the connection portion 61 by screwing (inserting) the screw 61f2 into the screw hole 61d in a state where the proximal end of the insertion rod 55 is accommodated in the insertion rod accommodation portion 61a. In addition, the extension 14 is fixed to the connecting portion 61 by screwing the screw 61f1 into the screw hole 61e in a state where the distal end portion of the extension 14 is accommodated in the extension accommodating portion 61b.

The electrode protection cover 63 is connected to the second end portion on the proximal end side of the connection portion 61. The electrode protection cover 63 has a cylindrical shape with a hollow center, and plays a role of protecting the terminal electrode 15 provided at the distal end portion of the extension 14. The length of the electrode protection cover 63 in the radial direction is equal to the diameter of the connection portion 61. As a result, when the connection portion 61 and the electrode protection cover 63 are pulled subcutaneously, the end portion of the electrode protection cover 63 connected to the connection portion 61 is caught on the dermis layer or the subcutaneous tissue of the skin. It can be prevented that it becomes difficult to tow and damage to the dermis layer and subcutaneous tissue of the skin. The length of the electrode protection cover 63 in the axial direction is equal to or longer than the length of the region where the terminal electrode 15 is formed at the tip of the extension 14. Thereby, when the tip end portion of the extension 14 is accommodated in the extension accommodating portion 61 b of the connection portion 61, the terminal electrode 15 of the extension 14 is covered with the electrode protection cover 63. In other words, the electrode protective cover 63 can prevent body fluid or the like from adhering to the terminal electrode 15. The electrode protection cover 63 is made of, for example, a flexible and biocompatible material, for example, a resin material such as silicone.

[1-3. Circuit configuration of stimulation circuit]
Next, the electrical configuration of the stimulation circuit 12 housed in the stimulation apparatus 4 will be described with reference to FIG. FIG. 4 is a functional block diagram showing the electrical configuration of the stimulation circuit 12 according to the first embodiment of the present invention and the terminal electrode 15 of the extension 14 connected to the stimulation circuit 12.

The stimulation circuit 12 includes a coil unit 21, a charging unit 22, a rechargeable battery 23, a communication unit 24, a control unit 25, a stimulation parameter setting unit 26, an oscillation unit 27, an electrode configuration setting unit 28, a switch Part 29.

The coil unit 21 is a resonance circuit composed of, for example, a coil and a capacitor. When the rechargeable battery 23 is charged, the coil unit 21 receives an electromagnetic wave for charging transmitted from an external controller (not shown). Then, an alternating current generated from the coil unit 21 with this reception is output to the charging unit 22. The coil unit 21 receives an electromagnetic wave on which predetermined information is transmitted, which is transmitted from an external controller (not shown), and the received electromagnetic wave is output from the coil unit 21 to the communication unit 24.

The charging unit 22 has a built-in rectifier circuit, converts the alternating current output from the coil unit 21 into a direct current, and acquires power. Then, the rechargeable battery 23 is charged with the acquired power. The rechargeable battery 23 is a rechargeable battery such as a lithium ion battery. Although not shown in FIG. 4, the rechargeable battery 23 supplies the accumulated power to each block constituting the stimulation circuit 12.

The communication unit 24 demodulates the electromagnetic wave received by the coil unit 21 and extracts information carried on the electromagnetic wave. Then, the extracted information is output to the stimulation parameter setting unit 26 and the electrode configuration setting unit 28 via the control unit 25. The information output to the stimulation parameter setting unit 26 is information regarding the stimulation intensity of the electrical stimulation signal (hereinafter referred to as “stimulation parameter”), and the information output to the electrode configuration setting unit 28 is information regarding the electrode configuration ( Hereinafter, this is referred to as “electrode configuration information”.

The stimulation intensity of the electrical stimulation signal is determined by the pulse voltage, pulse current, pulse width, or frequency of the electrical stimulation signal, and values such as the pulse voltage are set as stimulation parameters. The electrode configuration information includes information for changing the polarity of the electrical stimulation signal and information for causing the switch unit 29 to select the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal. Signal.

The stimulation parameter setting unit 26 generates a stimulation intensity change signal for changing the stimulation intensity of the electrical stimulation signal generated by the oscillation unit 27 based on the stimulation parameter input from the communication unit 24. The oscillating unit 27 generates an electrical stimulation signal based on the stimulation intensity change signal input from the stimulation parameter setting unit 26, and outputs the generated electrical stimulation signal to the switch unit 29.

The electrode configuration setting unit 28 is an electrode for selecting the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal generated by the oscillation unit 27 based on the electrode configuration information input from the communication unit 24. A configuration selection signal is generated. The stimulation intensity change signal output from the stimulation parameter setting unit 26 is output to the oscillation unit 27, and the electrode configuration selection signal output from the electrode configuration setting unit 28 is output to the switch unit 29.

The switch unit 29 determines the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal input from the oscillation unit 27 based on the electrode configuration selection signal input from the electrode configuration setting unit 28. For example, a microcomputer or the like is used as the control unit 25, and the control unit 25 controls each block of the stimulation circuit 12.

[1-3. Implanting method of electrical stimulation device]
Next, an example of a method for implanting the stimulation electrode lead 2 and the stimulation device 4 when the nerve stimulation of the spinal cord is performed from the epidural space using the electrical stimulation device 1 will be described with reference to FIGS. The description will be given with reference. 5 to 29 are explanatory views of the human body as seen from the back side.

(Procedure 1)
First, the doctor determines a target spinal stimulation site in advance based on the distribution of pain of the patient. In general, the stimulation electrode lead 2 is inserted from the target stimulation site from the lower position of three or more vertebral bodies of the spine. As shown in FIG. 5, local anesthesia is performed with a syringe 32 on the skin and subcutaneous tissue where the stimulation electrode lead 2 is to be inserted.
(Procedure 2)
Subsequently, as shown in FIG. 6, the doctor inserts an epidural needle 33 having a hollow center with a split type or a slit into a place where the stimulation electrode lead 2 is to be inserted, under X-ray fluoroscopy. Puncture from the side and insert the tip into the epidural space 31.

(Procedure 3)
Next, as shown in FIG. 7, the doctor inserts the stylet 34 into the stylet lumen of the auxiliary lead 3 attached to the stimulation electrode lead 2, and the tip portion thereof is the distal end of the stimulation electrode lead 2. Make it reach the vicinity. Thereby, the shape of the stimulation electrode lead 2 and the auxiliary lead 3 is deformed into a substantially linear shape.

Then, the tip of the stimulation electrode lead 2 through which the stylet 34 is inserted is passed through the hollow portion of the epidural needle 33, and the stimulation electrode lead 2 is inserted into the living body 30. After the stimulation electrode lead 2 is inserted into the epidural needle 33, the stimulation electrode lead 2 is inserted into the epidural space 31 by pushing the stylet 34 in the axial direction from the proximal end. Subsequently, the doctor further pushes the proximal end of the stylet 34 in the axial direction so that the position of the stimulation electrode lead 2 in the epidural space 31 is raised, and the stimulation electrode 5 of the stimulation electrode lead 2 is targeted. It is located near the stimulation site.

(Procedure 4)
Next, as shown in FIG. 8, the doctor slightly pulls out the stylet 34 inserted into the stimulation electrode lead 2 and the auxiliary lead 3 to hollow out the portion of the stimulation electrode lead 2 where the stimulation electrode 5 is provided. To.
(Procedure 5)
In this state, as shown in FIG. 9, an external stimulation device 35 for test stimulation is connected to the portion of the terminal electrode 9 exposed from the auxiliary lead 3, and the test stimulation is performed.

The extracorporeal stimulation device 35 connects, for example, a housing 35a having a stimulation circuit (not shown) therein, a clip portion 35b that is held with the terminal electrode 9 of the auxiliary lead 3 interposed therebetween, and a clip portion 35b and the housing 35a. It consists of a lead part 35c. The clip portion 35b has a contact electrode (not shown) on the inner side thereof, and this contact electrode is connected to a stimulation circuit inside the housing 35a by a lead wire (not shown) embedded in the lead portion 35c. The clip portion 35 b connects the terminal electrode 9 and the contact electrode by sandwiching the terminal electrode 9 of the auxiliary lead 3, whereby the stimulation electrode 5 is connected to the stimulation circuit of the extracorporeal stimulation device 35. The stimulation circuit in the housing 35a selects the stimulation electrode 5 that emits an electrical stimulation signal based on an instruction input by an indicator 35d such as a stylus pen on the operation surface of the housing 35a, the voltage of the electrical stimulation signal, Adjust frequency, pulse width, etc. The electrical stimulation signal thus adjusted is output to the stimulation electrode 5, thereby stimulating a portion of the nerve close to the position of the stimulation electrode 5.

This test stimulation is performed in a state where the terminal electrode 9 of the auxiliary lead 3 is sandwiched by the clip portion 35b of the extracorporeal stimulation device 35. Then, the doctor determines the optimum position of the stimulation electrode 5, the voltage, frequency, pulse width, etc. of the electrical stimulation signal while listening to the response to the nerve stimulation from the patient.

(Procedure 6)
Next, after removing the clip part 35b of the extracorporeal stimulation device 35 from the terminal electrode 9 of the auxiliary lead 3, the doctor makes a small incision around the puncture hole of the epidural needle 33 as shown in FIG.
(Procedure 7)
Thereafter, as shown in FIG. 11, the stylet 34 is removed from the auxiliary lead 3 and the stimulation electrode lead 2 while holding the stimulation electrode lead 2 and the auxiliary lead 3 so that the stimulation electrode 5 does not move from the determined optimum position. Then, the auxiliary lead 3 is removed from the stimulation electrode lead 2.
(Procedure 8)
Then, as shown in FIG. 12, while holding the stimulation electrode lead 2 so that the stimulation electrode 5 does not move from the determined optimum position, the entire epidural needle 33 is removed from the living body 30, and the slit portion is torn. The epidural needle 33 is removed from the surface of the stimulation electrode lead 2.

(Procedure 9)
Subsequently, as shown in FIG. 13, the doctor places a subcutaneous tissue at a predetermined position of the waist where the stimulation device 4 is planned to be implanted and a position where a subcutaneous tunnel is to be formed from the stimulation device 4 to the small incision portion of the back. Next, local anesthesia is performed using the syringe 32.
(Procedure 10)
Then, as shown in FIG. 14, a small incision is made at the planned implantation position of the lumbar stimulation device 4.

(Procedure 11)
Next, as shown in FIG. 15, the doctor inserts the insertion rod 55 into the small incision portion provided in the waist using the insertion tool 50 for forming the subcutaneous tunnel, and pushes it to the small incision portion on the back. To form a subcutaneous tunnel. As the insertion tool 50, for example, a pressing tool wire fixing part 51, a gripping part 52, a pressing tool wire fastening part 53, a pressing tool wire 54, an insertion rod 55, a pressing tool 56, and an insertion rod receiving part 57. Use what has.

The insertion rod 55 inserted under the skin is made of, for example, a comparatively hard and biocompatible stainless steel as a long body, and has a diameter of about 2 mm, for example. The distal end portion of the insertion rod 55 inserted into the living body 30 has a conical shape, and the other end of the insertion rod 55 is fixed to a pusher wire fixing portion 51 formed in a substantially cylindrical shape. At a predetermined position in the axial direction of the insertion rod 55, a grip portion 52 formed in a substantially cylindrical shape, which is a portion possessed by a doctor when the insertion rod 55 is pushed forward, is provided. It is attached to the insertion rod 55 in such a form that it can be moved and fixed at an arbitrary position in the axial direction of 55. As a material for the pusher wire fixing portion 51 and the grip portion 52, for example, a relatively hard resin having biocompatibility such as epoxy is used.

The pusher 56 is a mechanism for pressing the distal end portion of the insertion rod 55 from the body surface, and is formed as a plate-like substantially rectangular parallelepiped. A pusher wire 54 having a length substantially the same as the length of the insertion rod 55 is connected to the end of the pusher 56. The other end of the pusher wire 54 is fixed to the pusher wire fixing part 51, and the middle part of the pusher wire 54 is passed through the hollow part of the pusher wire fastening part 53 provided in the grip part 52. As a material of the pusher 56, for example, a relatively hard resin having biocompatibility such as epoxy is used, and for the pusher wire 54, a flexible material having biocompatibility such as polypropylene is used.

Since the diameter of the insertion rod 55 is very thin, the insertion rod 55 bends when a force that pushes subcutaneously is applied, and sometimes the distal end portion of the insertion rod 55 is caught on the dermis layer on the body surface side than the subcutaneous tissue and does not advance further. Sometimes. By pushing the insertion rod 55 under the skin while pressing the position of the distal end portion of the insertion rod 55 from the body surface with the pusher 56, the distal end portion of the insertion rod 55 is not scratched by the dermis layer. It becomes easy to proceed under the skin.

The insertion rod receiving portion 57 provided on the pusher 56 is formed in a protruding shape with respect to the pusher 56, and a recess is formed near the center thereof. The material of the insertion rod receiving portion 57 can be the same as that of the pusher 56.
(Procedure 12)
As shown in FIG. 16, when the distal end portion of the insertion rod 55 approaches the small incision portion of the back, the doctor turns the pusher 56 upside down and presses the insertion rod receiving portion 57 into the small incision. . Then, the insertion rod 55 is pushed forward so that the distal end portion of the insertion rod 55 fits into the recess of the insertion rod receiving portion 57.

By performing such an operation, the distal end portion of the insertion rod 55 is accommodated in the recess of the insertion rod receiving portion 57 at the small incision portion of the back. As a result, when the distal end of the insertion rod 55 protrudes from the subcutaneous tissue to the body surface or passes through the small incision portion, the distal end of the insertion rod 55 may inadvertently damage the doctor's hand or the patient's tissue. Can be prevented.

(Procedure 13)
Next, as shown in FIG. 17, the doctor once removes the pusher wire fixing portion 51 and the grip portion 52 from the insertion rod 55, attaches the stimulator sizer 58 to the insertion rod 55, and then grips the insertion rod 55 again. The part 52 (in the figure, the state which has removed the pressing tool wire fastening part 53) is attached. The stimulator sizer 58 is a subcutaneous pocket type taking mechanism for forming a subcutaneous pocket in which the housing 13 of the stimulator 4 is implanted. The stimulator sizer 58 is made of, for example, a relatively hard resin having biocompatibility such as an epoxy resin as a material. The stimulator sizer 58 is configured to have almost the same shape as the housing 13 of the stimulator 4 and is inserted into a small incision portion. In order to facilitate insertion under the skin, the distal end portion has a conical shape or a tapered shape.

(Procedure 14)
As shown in FIG. 18, the stimulating device sizer 58 is pushed subcutaneously through the small incision in the waist by pushing the insertion rod 55 attached with the stimulating device sizer 58 subcutaneously in the direction of the small incision on the back.
(Procedure 15)
Then, as shown in FIG. 19, the insertion rod 55 is pulled out in the direction opposite to the insertion direction, and the stimulator sizer 58 is taken out of the skin, whereby a subcutaneous pocket is formed at the position where the stimulator sizer 58 has been inserted. .
(Procedure 16)
After the subcutaneous pocket for the stimulating device 4 is formed, the doctor removes the stimulating device sizer 58 and the grip portion 52 from the insertion rod 55 as shown in FIG.

(Procedure 17)
Next, the doctor pulls the extension 14 and the housing 13 of the stimulator 4 from the place where the subcutaneous pocket is formed in the waist toward the small incision portion on the back. In order to perform the traction, first, the distal end portion of the extension 14 of the stimulation device 4 is attached to the proximal end portion of the insertion rod 55 inserted through the subcutaneous tunnel as shown in FIG. 21A. In order to perform this operation, first, the connection portion 61 of the connection mechanism 60 is attached to the tip portion of the extension 14. That is, as shown in FIG. 21B, the doctor inserts the bending prevention rod 62 into the lumen portion 14 a of the extension 14 so that the distal end portion reaches the receiving portion 13 a of the casing 13 of the stimulation device 4. And the extension 14 and the connection part 61 are connected by screwing the screw 61f1 in the screw hole 61e of the extension accommodation part 61b in which the front-end | tip part of the extension 14 was accommodated.

(Procedure 18)
Thereafter, as shown in FIG. 22, the doctor connects the connection portion 61 to which the extension 14 is attached to the proximal end portion of the insertion rod 55. That is, the connecting portion 61 is attached to the insertion rod 55 by accommodating the proximal end of the insertion rod 55 in the insertion rod accommodation portion 61a of the connection portion 61 and screwing the screw 61f2 into the screw hole 61d.

(Procedure 19)
Subsequently, as shown in FIG. 23, the doctor attaches the grip portion 52 to the distal end portion of the insertion rod 55 exposed from the small incision portion of the back, and pulls the insertion rod 55 out of the living body 30 while holding the grip portion 52. Pull in the direction.
(Procedure 20)
Then, the insertion rod 55 is continuously pulled until the distal end portion of the extension 14 comes out from the small incision portion on the back. As a result, as shown in FIG. 24, the extension 14 is inserted through the subcutaneous tunnel.
(Procedure 21)
Then, when the casing 13 of the stimulator 4 pulled together with the extension 14 reaches the small incision portion of the waist, the doctor pushes the casing 13 into the subcutaneous pocket while pulling the extension 14. FIG. 25 is a diagram illustrating a state in which the housing 13 of the stimulation device 4 is accommodated in the subcutaneous pocket.

(Procedure 22)
After the housing 13 of the stimulating device 4 is accommodated in the subcutaneous pocket, the doctor removes the insertion rod 55 from the connection mechanism 60 connected to the extension 14, and further, as shown in FIG. The fixing with the connection mechanism 60 is removed, and the bending prevention rod 62 inserted into the inner cavity portion 14a of the extension 14 is pulled out.

(Procedure 23)
Next, as shown in FIG. 27, the doctor inserts a finger or forceps (not shown) subcutaneously from a small incision portion on the back to make a blunt incision to form a subcutaneous pocket.
(Procedure 24)
Then, as shown in FIG. 28, the distal end portion of the extension 14 is inserted into the connector 7 of the stimulation electrode lead 2 and the extension fixing portion 17 is fixed to the connector 7 with a screw using a hexagon wrench or the like. Is stored in the formed subcutaneous pocket on the back.
(Procedure 25)
Finally, as shown in FIG. 29, the doctor sutures the small incision portion of the subcutaneous pocket on the back and the small incision portion of the subcutaneous pocket on the waist.

According to the connection mechanism 60 that connects the insertion rod 55 and the extension 14 according to the first embodiment described above, the distal end portion of the extension 14 is connected to the proximal end portion of the insertion rod 55. Accordingly, by pulling the insertion rod 55 to which the extension 14 is connected, the extension 14 can be passed through the subcutaneous tunnel. Therefore, it is not necessary to provide a through-hole for passing the extension 14 in the insertion rod 55, and the diameter of the insertion rod 55 can be reduced. Therefore, invasion of the patient's living body 30 can be reduced.

In addition, the connection mechanism 60 according to the present embodiment has a mechanism for accommodating and fixing the insertion rod 55 and the extension 14, and the end of the bending prevention rod 62 is provided at the bottom 61 c of the extension accommodating portion 61 b in which the extension 14 is accommodated. Are connected. For this reason, the bending prevention rod 62 is inserted into the inner cavity portion 14a of the extension 14 by accommodating the distal end portion of the extension 14 in the extension accommodating portion 61b. As a result, the extension 14 has a predetermined rigidity. Therefore, even when the housing 13 of the stimulating device 4 is pushed into the living body 30 by the doctor, the extension 14 connected to the housing 13 remains in the subcutaneous pocket or subcutaneous tunnel. It won't be bent. Therefore, it is possible to prevent the body 16 of the extension 14 from being broken and the body fluid from invading or the conducting wire (not shown) passing through the extension 14 from being broken due to this bending.

Further, according to the connection mechanism 60 according to the present embodiment, the tip portion of the extension 14 is accommodated in the extension accommodating portion 61b of the connection mechanism 60, so that the portion where the terminal electrode 15 of the extension 14 is provided is electrode protection. Covered by a cover 63. As a result, when the extension 14 connected to the insertion rod 55 via the connection portion 61 is pulled through the subcutaneous tunnel by the insertion rod 55, body fluid or the like may adhere to the terminal electrode 15 of the extension 14. Disappear.

[2. Second Embodiment]
Next, a connection mechanism according to a second embodiment of the present invention will be described with reference to FIG. FIG. 30 is a schematic diagram showing the extension 14, the bending prevention rod 62A, the connection portion 61A, and the insertion rod 55A that constitute the connection mechanism according to the present embodiment. In the present embodiment, as shown in FIGS. 30A and 30B, the bending prevention rod 62A is made independent from the connecting portion 61A. Further, the extension 14 and the connecting portion 61A are connected by the female screw portion 17Aa provided in the extension fixing portion 17A and the male screw portion 61Ab provided in the connecting portion 61A. The extension fixing portion 17A side may be a male screw and the connection portion 61A side may be a female screw. When configured in this way, the electrode lead connector needs to be shaped so that it can be fixed by the extension fixing portion 17A. 30A shows a state in which the extension 14, the bending prevention rod 62A, the connecting portion 61A, and the insertion rod 55A are not connected, and FIG. 30B shows a state in which these are connected. In FIG. 30, portions corresponding to those in FIG. 2 are denoted by the same reference numerals, and redundant description is omitted.

A stopper 62Aa is provided at a predetermined position in the axial direction of the bending prevention rod 62A. The stopper 62 </ b> Aa has a substantially cylindrical shape, and the length of the diameter is longer than the diameter of the lumen portion 14 a provided in the extension 14. The extension fixing portion 17A at the distal end portion of the extension 14 has a cylindrical shape like the extension 14, and an internal thread portion 17Aa is formed therein. A stopper accommodating portion 17Ab that accommodates the stopper 62Aa is provided continuously to the female screw portion 17Aa at the center of the tip of the female screw portion 17Aa. The shape of the stopper accommodating portion 17Ab is such that the stopper 62Aa can rotate within the stopper accommodating portion 17Ab when the anti-bending rod 62A inserted into the lumen portion 14a of the extension 14 rotates in the circumferential direction. The shape is slightly larger than the outer shape.

The position of the stopper 62Aa in the axial direction of the bending prevention rod 62A is determined when the stopper 62Aa is accommodated in the stopper accommodating portion 17Ab when the bending preventing rod 62A is inserted into the lumen 14a provided in the extension 14. Thus, the distal end portion of the bending prevention rod 62 </ b> A is set to a position where it reaches the receiving portion 13 a (see FIG. 2) of the housing 13 of the stimulation device 4. That is, the length L3 from the end portion on the side inserted into the extension 14 to the formation position of the stopper 62Aa is set from the bottom position of the receiving portion 13a of the stimulating device 4 to the distal end of the body 16 connected to the extension fixing portion 17A. The length is equal to the length L4 up to the portion. With this configuration, the doctor inserts the anti-bending rod 62A into the lumen 14a in the extension 14 until the stopper 62Aa is accommodated in the stopper accommodating portion 17Ab. Can be inserted through to the end. More specifically, the bottom portion of the receiving portion 13a of the casing 13 of the stimulating device 4 can be reached.

The connection portion 61A has a head portion 61Aa to which the electrode protection cover 63 is fixed, an electrode protection cover 63, and a male screw portion 61Ab formed integrally with the head portion 61Aa. The male screw portion 61Ab is attached to the head portion 61Aa so that the screw tip faces in the direction in which the electrode protection cover 63 is attached. A through hole 61Ac into which the bending prevention rod 62A is inserted is provided in both the head 61Aa and the male screw portion 61Ab.

In the present embodiment, the bending prevention rod 62A is connected to the insertion rod 55A. The insertion rod 55A has a bending prevention rod accommodating portion 55Aa in which the bending prevention rod 62A is accommodated, and a screw hole 55Ab. The bending prevention rod accommodating portion 55Aa is formed as a concave shaft hole, and the diameter thereof is set to be substantially the same as or slightly larger than the diameter of the bending prevention rod 62A. The length of the shaft hole in the depth direction is such that the bending prevention rod 62A is inserted into the inner cavity portion 14a of the extension 14 and the connection portion 61A is attached to the extension fixing portion 17A, and protrudes from the end of the connection portion 61A. The bending prevention rod 62A has a length substantially the same as the length of the bending prevention rod 62A. The screw hole 55Ab is formed in a direction perpendicular to the axial direction of the insertion rod 55A from the circumferential portion of the insertion rod 55A toward the bending prevention rod housing portion 55Aa.

In the procedure 17 of “Electrical stimulation device implantation method”, the bending prevention rod 62A is first inserted into the lumen 14a of the extension 14 by the doctor. Subsequently, the bending prevention rod 62A protruding from the distal end portion of the extension 14 is passed through the through hole 61Ac of the connection portion 61A, and the male screw portion 61Ab of the connection portion 61A is screwed into the female screw portion 17Aa of the extension fixing portion 17A. A connecting portion 61A is attached to the extension fixing portion 17A. In the next procedure 18, the bending prevention rod 62A protruding from the end of the connection portion 61A is inserted into the bending prevention rod housing portion 55Aa of the insertion rod 55A, and the screw 55Ac is screwed into the screw hole 55Ab. Accordingly, as shown in FIG. 30B, the extension 14 to which the connecting portion 61A is attached is connected to the insertion rod 55A.

In step 22, the doctor first loosens the screw 55Ac inserted into the screw hole 55Ab of the insertion rod 55A, and removes the bending prevention rod 62A from the bending prevention rod housing portion 55Aa of the insertion rod 55A. Removed. And the connection part 61A is removed from the extension fixing | fixed part 17A because the connection part 61A rotates in the direction opposite to the time of screwing. Subsequently, the bending prevention rod 62A inserted through the lumen portion 14a of the extension 14 is pulled out from the lumen portion 14a. Further, the connection portion 61A, the bending prevention rod 62A, and the insertion rod 55A are rotated by rotating the connection portion 61A in the direction opposite to that when screwing without loosening the screw 55Ac inserted into the screw hole 55Ab of the insertion rod 55A. Can be removed from the extension 14 as a whole.

Also in the second embodiment described above, an effect equivalent to the effect obtained in the first embodiment can be obtained. In the present embodiment, even if the insertion rod 55A rotates in the circumferential direction, the bending prevention rod 62A fixed to the insertion rod 55A is circular at the lumen portion 14a of the extension 14 to which the connection portion 61A is connected. Can rotate in the circumferential direction. That is, even when the insertion rod 55A is twisted in the circumferential direction during towing, the torsion is not transmitted to the extension 14, and the extension 14 is not left in the subcutaneous tunnel while the torsional stress is applied. Accordingly, it is possible to prevent the body 16 of the extension 14 from being broken due to torsional stress and intrusion of bodily fluids, or disconnection of a lead wire (not shown) passed through the extension 14.

[3. Third Embodiment]
Next, a connection mechanism according to a third embodiment of the present invention will be described with reference to FIG. FIG. 31 is a schematic diagram showing the extension 14, the bending prevention rod 62A, the electrode protection part 63A, the connection part 61B, and the insertion rod 55B that constitute the connection mechanism according to the present embodiment. Also in the present embodiment, as shown in FIGS. 31A and 31B, the bending prevention rod 62A is made independent from the connecting portion 61B. In the present embodiment, the connection portion 61B is engaged with the insertion rod 55B, and the electrode protection cover 63 is independent from the connection portion 61B. FIG. 31A shows a state in which the extension fixing portion 17A, the bending prevention rod 62A, the electrode protection portion 63A, and the insertion rod 55B engaged with the connection portion 61B are not connected, and FIG. Indicates the state that has been performed. In FIG. 31, portions corresponding to those in FIGS. 2 and 30 are denoted by the same reference numerals, and redundant description is omitted.

This embodiment is different from the second embodiment described above in that the male screw portion inserted into the female screw portion 17Aa provided in the extension fixing portion 17A is provided in the connection portion 61B engaged with the insertion rod 55B. Is a point. Similar to the second embodiment, the insertion rod 55B is provided with a bending prevention rod housing portion 55Aa. The base end portion of the insertion rod 55B is provided with a groove portion 55Ba at a position that is a predetermined length from the end portion, and a connecting portion 61B described later is engaged therewith. The diameter of the outer periphery of the portion from the end of the insertion rod 55B on the side where the groove 55Ba is formed to the groove 55Ba is smaller than the diameter of the outer periphery from the groove 55Ba to the tip of the insertion rod 55B.

The connecting portion 61B has a head portion 61Ba and a male screw portion 61Bb formed integrally with the head portion 61Ba, and is engaged with the insertion rod 55B in a form rotatable in the circumferential direction. A retaining projection 61Ba1 is provided at the base portion of the head 61Ba, and the retaining projection 61Ba1 is engaged with the groove portion 55Ba so as to be rotatable in the circumferential direction. Each of the head 61Ba and the male screw portion 61Bb is provided with a through hole 61Bc through which the bending prevention rod 62A is inserted. The electrode protection part 63A has an electrode protection cover 63Aa and an electrode cover fixing part 63Ab for fixing the electrode protection cover 63Aa, and is fixed by being sandwiched between the extension 14 and the connection part 61B.

In the procedure 17 of “Electrical stimulation device implantation method”, the bending prevention rod 62A is first inserted into the lumen 14a of the extension 14 by the doctor. Subsequently, the electrode protection portion 63A is passed through the bending prevention rod 62A protruding from the tip end portion of the extension 14, and further passed through the through hole 61Bc of the connection portion 61B. Then, the doctor rotates the circumferential portion of the connection portion 61B where the retaining protrusion 61Ba1 is formed, so that the male screw portion 61Bb of the connection portion 61B is screwed into the female screw portion 17Aa of the extension fixing portion 17A. At this time, as shown in FIG. 31B, the electrode protection part 63A is fixed by being sandwiched between the extension 14 and the connection part 61B, and the bending prevention rod 62A is housed in the bending prevention rod housing part 55Aa. Thereby, since the insertion rod 55B is connected to the extension 14 by the engagement with the connection portion 61B, the procedure 18 is omitted.

In step 22, the doctor first connects the circumferential portion of the position where the retaining protrusion 61Ba1 is formed in the direction opposite to that when screwing, so that the female screw portion 17Aa of the extension fixing portion 17A is connected. The male thread portion 61Bb of the portion 61B is removed, and the connection portion 61B and the insertion rod 55B engaged therewith are removed from the extension 14. Subsequently, the electrode protection part 63A is removed from the extension 14, and the bending prevention rod 62A inserted through the lumen 14a of the extension 14 is pulled out from the lumen 14a of the extension 14.

Also in the third embodiment described above, an effect equivalent to the effect obtained in the first embodiment can be obtained. In the present embodiment, the extension 14 can be easily attached to and removed from the insertion rod 55B by simply rotating the portion where the retaining protrusion 61Ba1 is formed. Further, since the insertion rod 55B and the connection portion 61B are connected by engagement, even if the insertion rod 55B rotates in the circumferential direction, the rotation is transmitted to the connection portion 61B and the extension 14 connected thereto. Absent. That is, even if the insertion rod 55B is twisted in the circumferential direction during towing, the torsion is not transmitted to the extension 14, and the extension 14 is not left in the subcutaneous tunnel while the torsional stress is applied. Accordingly, it is possible to prevent the body 16 of the extension 14 from being broken due to torsional stress and intrusion of bodily fluids, or disconnection of a lead wire (not shown) passed through the extension 14.

In each of the above-described embodiments, the extension 14 and the insertion rod 55 are connected as an example, but the present invention is not limited to this. For example, when the stimulation electrode lead 2 having the stimulation electrode 5 is formed integrally with the housing 13 of the stimulation apparatus 4, the stimulation electrode lead 2 may be connected to the insertion rod 55. In this case, a mechanism similar to the extension fixing portion 17 may be provided at the distal end portion of the stimulation electrode lead 2.

DESCRIPTION OF SYMBOLS 1 ... Electrical stimulation apparatus, 2 ... Stimulation electrode lead, 3 ... Auxiliary lead, 4 ... Stimulation apparatus, 5 ... Stimulation electrode, 12 ... Stimulation circuit, 13 ... Housing, 13a ... Receiving part, 14 ... Extension, 14a ... Through-hole , 15 ... Terminal electrode, 17, 17A ... Extension fixing part, 17Ab ... Stopper housing part, 55, 55A, 55B ... Inserting rod, 55Aa ... Bending prevention rod housing part, 60 ... Connection mechanism, 61, 61A, 61B ... Connection part , 61a ... insertion rod accommodating portion, 61b ... extension accommodating portion, 62, 62A ... anti-bending rod, 62Aa ... stopper, 63 ... electrode protection cover

Claims

A shaft of an electrode lead having an electrode made of a flexible elongated body, one end of which is inseparably integrated with a stimulator that generates an electrical stimulation signal, and the other end of which is applied with the electrical stimulation signal A core that is inserted into the heart,
A first end to which a proximal end of an insertion tool inserted through the living body is connected; and a second end to which an end of the electrode lead is connected, and the core is inserted or connected. A connection mechanism for an electrical stimulation device comprising a connected portion.
The core-like body inserted into the axial center portion of the electrode lead is fixed so as to be unable to move in the axial direction by connecting the second end portion of the connection portion and the end portion of the electrode lead. Item 2. The electrical stimulator connection mechanism according to Item 1.
The connection mechanism for an electrical stimulation device according to claim 2, wherein when the core body becomes immovable in the axial direction, the core body is inserted over the entire length of the electrode lead in the axial direction.
The receiving part in which the edge part of the said core body is accommodated in the said stimulation apparatus is formed, and the said core body is penetrated to the full length of the axial direction of the said electrode lead, and the said receiving part depth. Connection mechanism for electrical stimulator.
The connection mechanism for an electrical stimulation device according to any one of claims 1 to 4, further comprising an electrode protection cover that is formed in a cylindrical hole shape that covers a portion where the electrode is formed, and is formed at a second end portion of the connection portion.
The electrical stimulation according to claim 2, wherein the insertion tool is rotatable in a circumferential direction with respect to the connection portion in a state where a proximal end of the insertion device is connected to the first end portion of the connection portion. Device connection mechanism.
The electrical stimulation device according to claim 6, wherein a proximal end of the insertion tool is engaged with a first end of the connection part so that the insertion tool can be rotated in a circumferential direction with respect to the connection part. Connection mechanism.
A core body accommodating portion that accommodates an end portion of the core body inserted into the connection portion is formed at a proximal end of the insertion tool, and the end portion of the core body is fixed by the core body accommodating portion. The connection mechanism for an electrical stimulation device according to claim 6.
The electrode protection fixing part which fixes the said electrode protection cover is provided, and this electrode protection part is pinched | interposed and fixed between the edge part of the said electrode lead, and the said connection part. Connection mechanism for electrical stimulator.