WO2012108108A1

WO2012108108A1 - Lead assembly, electrical stimulation device, and lead

Info

Publication number: WO2012108108A1
Application number: PCT/JP2011/079772
Authority: WO
Inventors: 美仁福井; 政弘小野田
Original assignee: テルモ株式会社
Priority date: 2011-02-08
Filing date: 2011-12-22
Publication date: 2012-08-16
Also published as: JP2012161496A

Abstract

A lead assembly includes a lead that is implanted in a living body and a lead manipulator with a long shape that moves the lead in order to adjust the implantation location. The lead comprises the following: a first lumen that communicates from the base end to a predetermined position; a second lumen that communicates from that predetermined position to the tip and has a smaller diameter than the first lumen; and a lead main body on which is formed a locking unit at the boundary between the first lumen and the second lumen. The lead manipulator comprises the following: a manipulation unit with a long shape that can penetrate the second lumen; and a lock-engaging unit that connects to the manipulation unit and comes into contact with the locking unit in a state where the manipulation unit has passed through the first lumen in order to penetrate the second lumen.

Description

Lead assembly, electrical stimulator and lead

The present invention relates to a lead assembly, an electrical stimulation device using the lead assembly, and a lead constituting the lead assembly, and more particularly to a lead assembly, an electrical stimulation device, and a lead used by being implanted in a living body.

At present, pain is alleviated by electrical stimulation of nerves when it is not effective in conventional drug therapy, nerve block therapy or surgical therapy, or when the treatment cannot be continued due to side effects. Electrical stimulation therapy is effective. 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 trial period of 24 hours to several weeks is usually set up to confirm the effectiveness of pain relief by electrical stimulation. In the trial period, the electrode lead is generally punctured from the back side and the stimulation electrode is placed in the epidural space outside the spinal dura covering the spinal cord, and then the electrode lead is connected to an external stimulation device. The degree of pain relief can be examined under various stimulation patterns. Then, when a predetermined effect is recognized during the trial period, the main implantation is performed.

When performing this implantation, the electrode lead placed during the trial period is removed, and then a new electrode lead stimulation electrode is placed again in the epidural space, and the electrode lead passes through the subcutaneous tunnel to the waist and abdomen. Or led to the chest. The electrode lead is then connected to the stimulator and implanted subcutaneously.

During the trial period of spinal cord stimulation, the electrode leads are connected to an external stimulator, which can reduce the risk of infection, the patient's activity limitation, or the limitation of this activity. There was a problem of affecting the effectiveness judgment.

In order to solve this problem, a leadless micro stimulator having electrodes at both ends of the housing has been considered (see Patent Document 1). This micro stimulator is configured to be completely implanted in a living body in a state where the provided electrode is arranged near the nerve. This makes it possible to reduce the risk of infection and minimize the restriction of patient activity.

US Pat. No. 5,193,539

By the way, when changing the intensity of stimulation by the micro stimulator described in Patent Document 1, a programmer that communicates with the micro stimulator by an electromagnetic coupling method is used. However, in the electromagnetic coupling type communication, the coil of the micro stimulator and the coil of the programmer must be close to each other. Therefore, in the case of spinal nerve stimulation therapy that requires the microstimulator to be placed in the epidural space, the programmer must be placed on the back to communicate with the microstimulator. The operation of such a programmer may be difficult for some patients, and some patients feel the operation very troublesome.

In this regard, if only the coil part (configuration for receiving electromagnetic waves from the programmer) can be placed under the skin of the abdomen or the body side, with at least the position of the electrodes of the microstimulator, the communication with the microstimulator is performed. Can be operated within the reach of the programmer.

Here, in order to arrange the coil part under the skin of the abdomen or the body side, for example, the coil part is built in the lead, and this lead is extended from the back part (or waist) to the body side (or the abdomen via the body side). A method of implanting the living body so as to guide it is conceivable. However, since the skin from the back (or lower back) to the body side (or the abdomen via the body side) is extremely curved, implanting the lead under the skin like that is a normal stylet, guide wire, etc. Even if was used, it was difficult.

The present invention has been made in view of such a point, and an object thereof is to provide a lead assembly, an electrical stimulation device, and a lead that can be easily implanted into a curved subcutaneous skin.

In order to solve the above-mentioned problems, a lead assembly according to the present invention includes a lead implanted in a living body and a long-shaped lead operation body that moves the lead to adjust the implantation position.
The lead is locked to a first lumen that communicates from the base end to a predetermined position, a second lumen that communicates from the predetermined position to the tip and has a smaller diameter than the first lumen, and a boundary between the first lumen and the second lumen A lead body having a portion formed thereon.
The lead operating body has an elongated operating portion that can be inserted into the second lumen, and is continuous with the operating portion. When the operating portion is inserted into the second lumen through the first lumen, A to-be-engaged locked portion.

According to the above-described configuration of the present invention, in a state where the lead operating body is inserted from the opening at the base end of the lead and the locking portion and the locked portion are in contact with each other, at least one of the operating portion from the tip of the lead The part protrudes. When the protruding portion is pulled, the locking portion is pushed by the locked portion, and the lead moves.

According to the present invention, since the lead can be implanted (the lead is moved in the living body) by pulling the operating portion protruding from the tip of the lead, the lead is bent during the implantation and advanced into the living body. Can be prevented from becoming difficult. As a result, there is an effect that the lead can be easily implanted into, for example, an extremely curved subcutaneous tunnel.

It is a perspective view showing the whole electrical stimulation device concerning an embodiment of the present invention. FIG. 2A is a schematic diagram showing a cross section in the axial direction near the tip of the second lead according to the embodiment of the present invention. FIG. 2B is a schematic diagram showing the second lead with the guide wire inserted. It is a block diagram which shows the function of the stimulation circuit which concerns on embodiment of this invention, and a programmer. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body. It is explanatory drawing for demonstrating the procedure which implants the electrical stimulation apparatus which concerns on embodiment of this invention in the biological body.

Hereinafter, embodiments for carrying out the present invention will be described. 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 suitable 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 procedure.
<Example Embodiment>
1. 1. Configuration of electrical stimulation device 2. Functions of the stimulation circuit 3. Programmer functions Implanting procedure of electrical stimulation device <Modification>

<Example Embodiment>
Examples of embodiments of the present invention will be described with reference to FIGS.
[1. Configuration of electrical stimulation device]
FIG. 1 is a perspective view showing an entire electrical stimulation apparatus according to an embodiment of the present invention.

The electrical stimulation device 101 is configured to be implanted in a living body, and stimulates nerves and muscles such as the spinal cord in the living body with an electrical stimulation signal (hereinafter referred to as “electrical stimulation signal”). The electrical stimulation device 101 includes a first lead 102 for stimulating nerves, a stimulation device 103 for supplying an electrical stimulation signal to the first lead 102, and a second lead for controlling the operation of the stimulation device 103. 104 (lead). The electrical stimulation device 101 further includes a guide wire 130 (lead operating body) for implanting the second lead 104 into the living body.

First, the first lead 102 will be described.
The first lead 102 includes four stimulation electrodes 105 for stimulating nerves and the like, and a body 106 that fixes each stimulation electrode 105 so as to be exposed to the living body when the first lead 102 is disposed in the living body. With. Here, the number of stimulation electrodes 105 is four, but this is only an example, and the number of stimulation electrodes 105 can be arbitrarily set.

The stimulation electrode 105 is made of a conductive and biocompatible material such as platinum or a platinum alloy (for example, platinum 90% / iridium 10% alloy), and is formed in a hollow, substantially cylindrical shape. ing. For example, when the nerve of the spinal cord is stimulated, the first lead 102 is implanted in the epidural space where the distance between the spinal dura mater and the spinal column is about 5 mm. The outer diameter of is preferably about 1 to 3 mm. Further, the inner diameter of the stimulation electrode 105 needs to be set larger than the diameter of a stylet lumen 109 described later. This is to prevent the stimulation electrode 105 from blocking the stylet lumen 109.

4 ends of four conducting wires 205 (see FIG. 3) are connected to the four stimulation electrodes 105, respectively. The other ends of the four conductive wires 205 are connected to a stimulation circuit 117 of the stimulation apparatus 103 described later. Thereby, each stimulation electrode 105 and the stimulation circuit 117 are electrically connected. The four conductive wires 205 are completely embedded in the body 106.

The body 106 is made of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, and has a substantially cylindrical shape. In the body 106, a hole having a circular opening shape that opens to the proximal end 108 and communicates to the vicinity of the distal end 107 is formed in the axial direction. This hole is a stylet lumen 109 for inserting the stylet 150. The diameter of the stylet lumen 109 needs to be approximately equal to or slightly larger than the diameter of the stylet 150.

Since the stylet lumen 109 is formed on the first lead 102, the stylet 150 can be used when the first lead 102 is implanted in the living body. As a result, the first lead 102 can be more easily implanted in the living body, and the accuracy of the placement of the stimulation electrode 105 in the living body can be further improved.

Also, the outer diameter of the body 106 is substantially equal to the outer diameter of the stimulation electrode 105 so that the stimulation electrode 105 is exposed. By the way, when the first lead 102 is implanted in the epidural space, in order for the stimulation electrode 105 to be stably disposed, a part of the first lead 102 is equal to at least the three vertebral bodies in the spine in the epidural space. It must be longer than the length. Therefore, the axial length of the body 106 is longer than the length equal to the three vertebral bodies in the spine plus 15 cm. The length of 15 cm here is an average length from the puncture site of the back skin to the epidural space, and an extra length for tearing the slit of the epidural needle described later near the proximal end 108. Equivalent to the sum.

Next, the second lead 104 will be described with reference to FIG. 2 in addition to FIG.
FIG. 2 is an explanatory view showing the vicinity of the tip of the second lead 104 according to the embodiment of the present invention.
FIG. 2A is a schematic diagram showing a cross section of the second lead 104 in the axial direction, and FIG. 2B is a schematic diagram showing the second lead 104 in a state where the guide wire 130 is completely inserted.

Like the body 106 of the first lead 102, the body 110 (lead body) of the second lead 104 is made of a flexible and biocompatible material such as a resin material such as silicone or polyurethane. It is formed in a substantially cylindrical shape.

The axial length of the body 110 is, for example, about 1/4 of the abdominal circumference of the patient when the second lead 104 is disposed in the living body so as to be guided from the waist (or back) to the body side. It is preferable that However, when the second lead 104 is arranged so as to be guided from the waist to the abdomen through the body side, the length of the body 110 in the axial direction needs to be about ½ of the abdominal circumference of the patient.

Further, in order to facilitate the insertion of the second lead 104 into the living body, the vicinity of the tip 112 of the body 110 is formed in a tapered shape as shown in FIG. The body 110 penetrates from the distal end 112 to the proximal end 113 and has a through-hole having a circular opening shape. This through hole is a guide wire lumen 114 for penetrating the guide wire 130.

As shown in FIGS. 2A and 2B, the guide wire lumen 114 includes a first lumen 114a and a second lumen 114b having a diameter smaller than the diameter of the first lumen 114a. The first lumen 114a is formed from the base end 113 of the body 110 to a predetermined position near the distal end 112, and the second lumen 114b is formed from the predetermined position to the distal end 112.

Further, in the body 110, a portion forming a boundary between the first lumen 114 a and the second lumen 114 b corresponds to the locking portion 202, and the coil portion 111 is embedded on the tip 112 side from the locking portion 202. ing. Since the portion where the coil portion 111 is embedded is thicker than the other portions, the entire coil portion 111 can be reliably incorporated in the body 110. Thereby, when the 2nd lead 104 is implanted, it can prevent that the coil part 111 contacts a biological body. In addition, when the second lead 104 is implanted into the living body so that the second lead 104 is guided from the waist to the body side (or the abdomen through the body side), the coil portion 111 is placed under the skin where human hands reach such as the body side and the abdomen. can do.

Further, a fixing mechanism 115 that holds the position of the second lead 104 when the second lead 104 is implanted in the living body is provided near the tip 112 of the body 110. The fixing mechanism 115 includes a plurality of branch portions 115 a protruding from the outer peripheral surface of the body 110. The branch part 115a is made of the same material as the body 110 and is formed in a substantially rod shape, and one end face thereof is rounded. The other end face is joined to the body 110.

These branch portions 115 a are arranged at equiangular intervals along the circumferential direction of the outer peripheral surface of the body 110, and are inclined toward the base end 113 side with respect to the axis of the body 110. Accordingly, when the body 110 is pulled toward the proximal end 113, the branch portion 115a is prevented from being caught by a living tissue and the position of the distal end 112 is prevented from being shifted. In addition, as a joining method of the branch part 115a to the body 110, for example, a method by fusion (thermal fusion, high-frequency fusion, ultrasonic fusion, etc.), a method by adhesion (adhesion with an adhesive or a solvent), or the like. Can be mentioned.

As shown in FIGS. 2A and 2B, the coil unit 111 is a circuit including, for example, a coil in which an electric wire is spirally wound, and a stimulation device 103 to be described later via a conductive wire 204 (see FIG. 3). The stimulation circuit 117 is electrically connected. The conducting wire 204 is completely embedded in the body 110.

Next, the stimulation apparatus 103 will be described.
The stimulation device 103 includes a housing 116 and a stimulation circuit 117 housed and fixed in the housing 116.
The casing 116 is made of a material such as a relatively hard and biocompatible metal or resin, such as titanium or epoxy, or ceramic, and is formed in a substantially rectangular parallelepiped shape. The casing 116 has through

holes

118a and 118b with circular openings.

The diameter of one through hole 118a is substantially equal to the outer diameter of the body 106 of the first lead 102, and the portion from the base end 108 of the body 106 to a predetermined position is inserted and fixed in the through hole 118a. As a result, the stylet lumen 109 that opens to the base end 108 of the body 106 can be exposed from one side surface of the housing 116, and the stylet 150 can be inserted into the stylet lumen 109.

Further, the diameter of the other through hole 118b is substantially equal to the outer diameter of the body 110 of the second lead 104, and a portion from the base end 113 of the body 110 to a predetermined position is inserted and fixed in the through hole 118b. Thereby, the guide wire lumen 114 opened to the base end 113 of the body 110 can be exposed from the other side surface of the housing 116, and the guide wire 130 can be inserted into the guide wire lumen 114.

The stimulation circuit 117 is a circuit in which a small part such as a custom IC is mounted on a circuit board, and generates an electrical stimulation signal. The stimulation circuit 117 is electrically connected to four conductors 205 (see FIG. 3) embedded in the body 106 so as to supply the generated electrical stimulation signal to each stimulation electrode 105 independently. ing. In addition, the stimulation circuit 117 is electrically connected to the coil unit 111 via the conductive wire 204 (see FIG. 3). The functional configuration of the stimulation circuit 117 will be described later with reference to FIG.

Next, the guide wire 130 will be described.
The guide wire 130 has an elongated shape and is made of a metal wire such as a superelastic alloy or stainless steel as a core. A resin coating or the like can be provided on the surface of the core as necessary. As shown in FIG. 1, the guide wire 130 is inserted into the guide wire lumen 114 from the distal end through an opening formed in the base end 113, and penetrates into the second lead 104 as shown in FIG. 2B. Used in the state. Therefore, the length of the guide wire 130 in the axial direction must be sufficiently longer than the length of the second lead 104 in the axial direction.

The guide wire 130 is provided with a first operation portion 131 (operation portion), a locked portion 132, and a second operation portion 133 in order from the distal end side.

The first operation part 131 is formed in a substantially cylindrical shape. As shown in FIG. 2B, the diameter of the first operation portion 131 is substantially equal to or smaller than the diameter of the second lumen 114b, and the first operation portion 131 has the first lumen 114a. Of course, it is possible to pass through the second lumen 114b. A scale 203 indicating the length of the first operation unit 131 in the axial direction is formed on the surface of the first operation unit 131.

The locked portion 132 is formed in a substantially cylindrical shape having the same axis as the first operation portion 131. The locked portion 132 can be formed, for example, by welding a pipe-shaped metal member on the core. The diameter of the locked portion 132 is larger than the diameter of the second lumen 114b and equal to or less than the diameter of the first lumen 114a, and the locked portion 132 can pass only the first lumen 114a. As a result, as shown in FIG. 2B, the locked portion 132 is in contact with the locking portion 202 when the first operating portion 131 is completely inserted into the second lumen 114b. .

The second operation part 133 is formed in a substantially cylindrical shape having the same axis as the locked part 132. In the example shown in FIG. 1 and FIG. 2B, the diameter of the second operation portion 133 is substantially equal to or smaller than the diameter of the second lumen 114b as in the first operation portion 131. However, the second operation unit 133 only needs to be configured to be able to pass through the first lumen 114a, and the diameter of the second operation unit 133 only needs to be approximately equal to or smaller than the diameter of the first lumen 114a. That is, the length of extension of the locked portion 132 may be increased, and the locked portion 132 may also serve as the second operation portion 133.

Next, a functional configuration of the programmer 350 for sending the instruction to the stimulation circuit 117 and the stimulation circuit 117 to the coil unit 111 will be described with reference to FIG.
FIG. 3 is a block diagram illustrating functions of the stimulation circuit and the programmer according to the embodiment of the present invention.

[2. Function of stimulation circuit]
First, the functional configuration of the stimulation circuit 117 will be described.
The stimulation circuit 117 includes a rechargeable battery 303, a charging unit 304, a communication unit 305, a control unit 306, a stimulation parameter setting unit 307, an electrode configuration setting unit 308, an oscillation unit 309, and a stimulation electrode switch unit 310. Is provided.

The rechargeable battery 303 is a rechargeable battery such as a lithium ion battery. The rechargeable battery 303 supplies the accumulated power to each block constituting the stimulation circuit 117.

The coil unit 111 built in the second lead 104 is a resonance circuit composed of, for example, a coil and a capacitor. When the rechargeable battery 303 is charged, the coil unit 111 receives a charging electromagnetic wave transmitted from a programmer 350 described later. Then, an alternating current generated from the coil unit 111 with this reception is output to the charging unit 304. The coil unit 111 receives an electromagnetic wave on which predetermined information is transmitted, which is transmitted from the programmer 350, and the received electromagnetic wave is output from the coil unit 111 to the communication unit 305.

The charging unit 304 has a built-in rectifier circuit, converts the alternating current output from the coil unit 111 into a direct current, and acquires power. Then, the rechargeable battery 303 is charged with the acquired power.

The communication unit 305 demodulates the electromagnetic wave received by the coil unit 111 and extracts information carried on the electromagnetic wave. The extracted information is output to the control unit 306.

The control unit 306 is a microcomputer, for example, and controls each block of the stimulation circuit 117. The control unit 306 stores information input from the communication unit 305. However, when information is already stored, this information is replaced with newly input information and stored. Therefore, the control unit 306 stores the latest information input from the communication unit 305.

Here, the information stored in the control unit 306 is stimulation parameters and electrode configuration information.
The stimulation parameter is information regarding the stimulation intensity of the electrical stimulation signal, and is information indicating the value of the pulse voltage, pulse current, pulse width, or frequency that determines the stimulation intensity of the electrical stimulation signal. Is output.

The electrode configuration information is information related to the electrode configuration, and information for changing the polarity of the electrical stimulation signal and information for causing the stimulation electrode switch unit 310 to select the stimulation electrode 105 that outputs the electrical stimulation signal. And is output to the electrode configuration setting unit 308.

The stimulation parameter setting unit 307 generates a stimulation intensity change signal for changing the stimulation intensity of the electrical stimulation signal generated by the oscillation unit 309 based on the input stimulation parameter.

The electrode configuration setting unit 308 generates an electrode configuration selection signal for selecting the stimulation electrode 105 that outputs the electrical stimulation signal generated by the oscillation unit 309 based on the input electrode configuration information. Note that the stimulation intensity change signal output from the stimulation parameter setting unit 307 is output to the oscillation unit 309, and the electrode configuration selection signal output from the electrode configuration setting unit 308 is output to the stimulation electrode switch unit 310.

The oscillation unit 309 generates an electrical stimulation signal based on the stimulation intensity change signal input from the stimulation parameter setting unit 307 and outputs the electrical stimulation signal to the stimulation electrode switch unit 310.

The stimulation electrode switch unit 310 determines the stimulation electrode 105 that outputs the electrical stimulation signal input from the oscillation unit 309 based on the electrode configuration selection signal input from the electrode configuration setting unit 308.

[3. Programmer function]
Next, a functional configuration of the programmer 350 will be described.
The programmer 350 is an example of an external device used from outside the body, and performs communication and the like with the electrical stimulation device 101 implanted in the living body. The programmer 350 includes a power supply unit 351, a control unit 352, a communication unit 353, and a coil unit 354.

The power supply unit 351 supplies the accumulated power to each block constituting the programmer 350. For the power supply unit 351, for example, a primary battery or a rechargeable battery is used.

The control unit 352 includes, for example, a microcomputer, and controls the communication unit 353 based on an operation of a user such as a doctor. This operation is performed, for example, by operating an operation unit (not shown) provided in the programmer 350.

When there is a power supply instruction from the user, the communication unit 353 generates a power supply electromagnetic wave based on the control of the control unit 352. Then, the generated electromagnetic wave for power supply is transmitted to the coil unit 111 of the electrical stimulation apparatus 101 via the coil unit 354.

In addition, when there is an instruction to change the stimulation intensity or the like of the electrical stimulation signal from the user, the communication unit 353 generates an electromagnetic wave on which stimulation parameters and electrode configuration information are placed based on the control of the control unit 352. . Then, the generated electromagnetic wave is transmitted to the coil unit 111 of the electrical stimulation apparatus 101 via the coil unit 354.

The coil unit 354 may be any coil that can transmit electromagnetic waves to the electrical stimulation device 101, and may be, for example, a wire wound in a circular shape or a spiral shape.

[4. Procedure for implanting electrical stimulator]
Next, a procedure for implanting the electrical stimulation device 101 when electrical stimulation of spinal nerves is performed from the epidural space will be described with reference to FIGS.
4 to 6 are longitudinal sectional views of the human body showing the vicinity of the back, and FIGS. 7 to 10 are explanatory views of the human body viewed from the back side.

First, the doctor determines a target spinal cord stimulation site in advance based on the patient's pain distribution. Then, as shown in FIG. 4, a split or epidural needle 406 with a slit is inserted from the patient's back side into the epidural space 405 under fluoroscopy. The position where the epidural needle 406 is inserted into the epidural space 405 is generally selected to be three or more vertebral bodies in the spine 403 from the target stimulation site.

Next, the stylet 150 is completely inserted into the stylet lumen 109 (see FIG. 1) formed on the first lead 102. Then, as shown in FIG. 5, the tip 107 of the first lead 102 into which the stylet 150 is inserted is passed through the epidural needle 406, and the first lead 102 is inserted into the living body 404. Then, the first lead 102 is inserted into the epidural space 405 by pushing the proximal end 150 a of the stylet 150 in the axial direction.

Subsequently, the proximal end 150a of the stylet 150 is further pushed in the axial direction, the first lead 102 is directed upward into the epidural space 405, and the stimulation electrode 105 of the first lead 102 is brought close to the target stimulation site. Position.

Then, the first lead 102 is inserted into and removed from the living body 404 and the stimulation electrode 105 is moved little by little, and the programmer 350 is operated to perform nerve stimulation. At this time, in the stimulation apparatus 103, an electrical stimulation signal having a predetermined stimulation intensity is generated based on the operation of the doctor, and the generated electrical stimulation signal is output to the stimulation electrode 105, and the position of the stimulation electrode 105 is determined. Neural stimulation of the part close to Then, the doctor determines the optimal position of the stimulation electrode 105 while listening to the patient's response to the nerve stimulation.

Here, as shown in FIG. 6, the doctor holds the first lead 102 and the stylet 150 so that the stimulation electrode 105 does not move from the determined optimal position, and the stylet lumen of the first lead 102. With the stylet 150 passing through 109, the epidural needle 406 is removed from the living body 404. Then, the slit portion (not shown) of the epidural needle 406 is torn, and the epidural needle 406 is removed from the surface of the first lead 102. At this time, a part of the body 106 protruding from the body (hereinafter referred to as “protruding portion”) corresponds to an excessive portion for removing the epidural needle 406 from the living body 404 described with reference to FIG.

Subsequently, as shown in FIG. 7, a small incision 408 is formed at the insertion site of the first lead 102 on the back side, and the stylet 150 is taken out from the stylet lumen 109 of the first lead 102. Then, the body 106 of the first lead 102 is sewn to the tissue exposed by the small incision 408 with a thread (not shown) and fixed. Thereby, it is possible to prevent the determined position of the stimulation electrode 105 from shifting.

Subsequently, the doctor makes a small incision 410 on the body side. Then, a subcutaneous tunnel (not shown) that penetrates the small incision 408 and the small incision 410 is formed in the living body 404 using a tunneling tool (not shown).

After the above processing is completed, the doctor holds the second operation unit 133 (see FIG. 1) of the guide wire 130 and the first operation unit 131 is formed at the proximal end 113 of the second lead 104. The first lumen 114a is inserted through the opening. At this time, the doctor holds the second lead 104 with the hand that does not have the guide wire 130 so that the second lead 104 does not move.

And when a doctor pushes the 2nd operation part 133 to the axial direction, the 1st operation part 131 will advance in the 1st lumen 114a, and will be inserted in the 2nd lumen 114b. When the second operating portion 133 is further pushed in the axial direction, the locked portion 132 comes into contact with the locking portion 202 and the movement of the guide wire 130 is stopped as shown in FIG. At this time, the first operation unit 131 protrudes from the tip 112 of the second lead 104.

Subsequently, the doctor inserts the first operation unit 131 protruding from the tip 112 of the second lead 104 into a subcutaneous tunnel (not shown) through an opening formed in the small incision 408. And the 1st operation part 131 is pushed to the axial direction. As a result, the first operation unit 131 advances through the subcutaneous tunnel (not shown), and the tip of the first operation unit 131 protrudes from the small incision 410 as shown in FIG.

Subsequently, the doctor grasps the tip of the first operation unit 131 and pulls it in the direction from the small incision 410 toward the outside of the body (for example, the direction indicated by the white arrow in FIG. 8). Then, the locking portion 202 (see FIG. 2B) of the second lead 104 is pushed by the locked portion 132 of the guide wire 130. As a result, the second lead 104 is moved together with the guide wire 130 in the direction indicated by the white arrow in FIG. 8, and the second lead 104 is moved from the distal end 112 through the opening formed in the small incision 408 to the subcutaneous tunnel ( (Not shown).

Then, when the doctor further pulls the first operation unit 131 in the direction indicated by the white arrow in FIG. 8, the second lead 104 advances through the subcutaneous tunnel as shown in FIG. At this time, the doctor can know the implantation position of the second lead 104 by checking the scale 203 (see FIG. 2) of the first operation unit 131.

Then, when the doctor confirms that the second lead 104 has been implanted at an appropriate position, the second operation portion of the guide wire is supported while supporting the second lead 104 so that the implantation position of the second lead 104 does not change. By pulling 133, the guide wire 130 is taken out from the guide wire lumen 114 of the second lead 104. Then, the body 110 of the second lead 104 is sewn and fixed to the tissue exposed by the small incision 408 with a thread (not shown). Then, the body portions protruding from the small incision 408 of the first and

second leads

102 and 104 are bundled, and implanted under the small incision 408 together with the stimulator 103.

Subsequently, a suture hole (not shown) formed in the casing 116 (see FIG. 1) of the stimulation device 103 so that the electrical stimulation device 101 is fixed in a state of being completely implanted in the living body 404. ) Is threaded (not shown), and the stimulator 103 is sewn to the tissue of the living body 404. Then, as shown in FIG. 10, the

small incisions

408 and 410 are respectively sutured with the suture thread 409. This treatment is intended to prevent the stimulating device 103 from moving within the living body 404 or prevent an infection from being caused from the insertion port of the electrical stimulating device 101.

As described above, according to the embodiment of the present invention, by pulling the first operation portion 131 of the guide wire 130 while the guide wire 130 is completely penetrated into the second lead 104, the second lead 104. Can be implanted in vivo. Since the second lead 104 is implanted by pulling the guide wire 130, it is possible to prevent the second lead 104 from being bent during the implantation and difficult to advance into the living body. As a result, there is an effect that the second lead 104 can be easily implanted in, for example, an extremely curved subcutaneous tunnel.

In the embodiment described above, the first and

second leads

102 and 104 and the stimulation device 103 are described as the electrical stimulation device 101. However, the electrical stimulation device 101 including the programmer 350 is further described. As a broad concept. Further, a structure constituted by the second lead 104 and the guide wire 130 corresponds to a lead assembly.

<Modification>
In the above-described embodiment, a connector for detachably connecting various leads (the first lead 102 or the second lead 104) and the stimulation device 103 may be provided in the various leads and the stimulation device 103. In this case, when the various leads and the stimulation device 103 are connected by the respective connectors, the stimulation electrode 105 or the coil unit 111 and the stimulation circuit 117 are electrically connected. Thereby, various leads can be implanted separately, and the difficulty of implantation can be reduced.

Further, in this case, since only the first lead 102 can be implanted, the epidural needle 406 (see FIG. 6) used for implantation of the first lead 102 is removed from the first lead 102 without tearing. be able to. As a result, it is not necessary to provide an extra portion in the body 106 (see FIG. 1) for tearing the epidural needle 406, and the axial length of the body 106 can be shortened.

In addition, as described above, the epidural needle 406 used for implantation of the first lead 102 can be removed from the first lead 102 without tearing, so that the epidural needle 406 used for implantation is used. Needless to say, it does not have to be divided or slitted.

In the embodiment and the modification described above, the electrical stimulation device 101 includes the coil part 111 in the second lead 104. However, a part other than the coil part 111 may be included. For example, a reed switch that can switch on / off the stimulation circuit from outside the body may be used. Further, a guide wire lumen 114 such as the second lead 104 may be formed on the first lead 102.

4 to 10, an example in which the second lead 104 is implanted in the living body so as to be guided from the waist (back) to the body side has been described. Similarly, the second lead 104 is passed from the waist to the body side through the abdomen. It can also be implanted in the living body so as to guide it. Furthermore, the electrical stimulation apparatus 101 can be implanted in other places in the living body by the same procedure.

DESCRIPTION OF SYMBOLS 101 ... Electrical stimulation apparatus, 102 ... 1st lead, 103 ... Stimulation apparatus, 104 ... 2nd lead, 105 ... Stimulation electrode, 106, 110 ... Body, 109 ... Lumen for stylet, 111 ... Coil part, 114 ... Guide wire 114a ... first lumen, 114b ... second lumen, 115 ... fixing mechanism, 116 ... housing, 117 ... stimulation circuit, 130 ... guide wire, 131 ... first operation part, 132 ... locked part, 133 2nd operation unit, 150 ... stylet, 202 ... locking unit, 303 ... rechargeable battery, 304 ... charging unit, 305 ... communication unit, 306 ... control unit, 307 ... stimulation parameter setting unit, 308 ... electrode configuration setting unit 309: Oscillating unit 310 ... Stimulation electrode switch unit 350 350 Programmer 351 Power supply unit 352 Control unit 353 Communication unit 354 Coil , 403 ... spine, 404 ... biological, 405 ... epidural space, 406 ... epidural needle, 408, 410 ... small incision, 409 ... suture

Claims

A lead assembly including a lead to be implanted in a living body, and a long-shaped lead operating body that moves the lead to adjust the implantation position,
The lead is
A first lumen communicating from the proximal end to a predetermined position, a second lumen communicating from the predetermined position to the distal end and having a smaller diameter than the first lumen, and locked to a boundary between the first lumen and the second lumen A lead body formed with a portion,
The lead operating body is:
An elongated operating portion that can penetrate into the second lumen;
A lead assembly comprising: a locked portion that is continuous with the operating portion, and is in contact with the locking portion in a state where the operating portion is inserted into the second lumen through the first lumen. .
In a state where the locking portion and the locked portion are in contact, at least a part of the operation portion protrudes from the tip of the lead main body through the second lumen, and when the protruding portion is pulled, The lead assembly according to claim 1, wherein a stop portion is pushed by the locked portion, and the lead is moved together with the lead operation body.
The lead assembly according to claim 1 or 2, wherein the lead is provided with a fixing mechanism for fixing the lead in a living body.
The lead assembly according to any one of claims 1 to 3, wherein the operation portion has a scale indicating an axial length thereof.
A stimulation device having a stimulation circuit for generating a stimulation signal, a lead connected to the stimulation device and placed in the living body, and a long lead operation body for adjusting the implantation position by moving the lead An electrical stimulator comprising:
The lead is
A first lumen communicating from the proximal end to a predetermined position, a second lumen communicating from the predetermined position to the distal end and having a smaller diameter than the first lumen, and locked to a boundary between the first lumen and the second lumen A lead body formed with a portion,
The lead operating body is:
An elongated operating portion that can penetrate into the second lumen;
An electrical stimulation device comprising: a locked portion that is continuous with the operating portion, and is in contact with the locking portion in a state where the operating portion is inserted into the second lumen through the first lumen. .
The electrical stimulation apparatus according to claim 5, wherein the lead includes a stimulation electrode that stimulates nerves and / or muscles in a living body when the stimulation signal is applied.
The electrical stimulation apparatus according to claim 5, wherein the lead includes a switch that switches on / off operation of the stimulation circuit.
The electrical stimulation device according to claim 5, wherein the lead includes a coil unit that performs power supply and / or communication with the stimulation circuit according to electromagnetic waves oscillated from an external device.
A lead implanted in a living body,
A first lumen communicating from the proximal end to a predetermined position, a second lumen communicating from the predetermined position to the distal end and having a smaller diameter than the first lumen, and locked to a boundary between the first lumen and the second lumen A lead comprising a lead body formed with a portion.