JP2015080500A - Electrostimulator - Google Patents

Abstract

PROBLEM TO BE SOLVED: To ensure that surplus parts of electrode leads 2A and 2B connected to an electrostimulator in series can be housed.SOLUTION: An insertion terminal 4A of an insertion part 3B included in the electrode lead 2B is connected to a connector terminal 8A of a housing part 7A included in the electrode lead 2A so that the electrode leads 2A and 2B are connected in series. A portion of a lead part 6A of the electrode lead 2A and a portion of a lead part 6B of the electrode lead 2B are wound around a bobbin 10a. A bobbin cover 10b is bent, covers the portions of the lead parts 6A and 6B wound around the bobbin 10a, and fixes the portions of the lead parts 6A and 6B so as not to loosen from the bobbin 10a.

Description

  The present invention relates to an electrical stimulation device used for electrical stimulation therapy for electrically stimulating a living body, and more particularly to an electrical stimulation device that can be implanted in a living body with minimal invasiveness.

  Conventionally, when a pain treatment using pharmacotherapy or the like does not show a useful effect, or when the treatment cannot be continued due to side effects, etc., an electric stimulation therapy that alleviates pain by electrically stimulating nerves is effective. I give it. Spinal cord electrical stimulation therapy, one of the electrical stimulation therapies, uses the SCS (Spinal Cord Stimulation) system to electrically stimulate the nerves of the spinal cord in order to relieve the pain transmitted to the brain through the spinal cord. . The SCS system includes an electrode lead having a stimulation electrode for electrically stimulating a living body, and a stimulation device (IPG: Implantable Pulse Generator) for supplying an electrical stimulation signal (hereinafter referred to as “electric stimulation signal”) to the stimulation electrode. An electrical stimulation device is included. In spinal cord electrostimulation therapy, an electrode lead is guided to the epidural space in the space behind the spinal dura covering the spinal cord, and the spinal cord level through which nerves involved in the patient's pain pass is stimulated with a stimulation electrode. By doing this, a painful sensation called paresthesia is caused in the pain region to relieve pain.

  However, in spinal cord electrostimulation therapy, it is difficult to place the stimulation electrode so that the paresthesia coincides with the pain region, and the patient may feel uncomfortable when paresthesia occurs in the painless region. In addition, it is difficult to stimulate nerves that are far from the epidural space and pass through a deep region of the spinal cord, for example, it is difficult to relieve back pain. On the other hand, in recent years, peripheral nerve stimulation has been performed by locally implanting an electrode lead of the SCS system under the maximum pain area of the pain area and electrically stimulating the peripheral nerve endings of the maximum pain area to locally induce painesia. Therapeutic therapy (PNFS: Peripheral Nerve Field Stimulation) is being applied clinically.

  As an electrode lead implanted in a living body, for example, one disclosed in Patent Document 1 is known. The biostimulation technique disclosed in Patent Document 1 allows a change in effective stimulation area by arranging a plurality of electrodes on a lead to be implanted in a living body and controlling the polarity of each electrode by a program. According to the biostimulation technique disclosed in Patent Literature 1, even after the lead of the biostimulation apparatus is implanted in the living body, the effective stimulation area is changed to enable adjustment of the stimulation site (area).

US Pat. No. 6,473,653

  However, since the conventional electrode lead used in the SCS system is provided with the stimulation electrode only at the tip portion thereof, it is effective only for pain in a narrow region where the stimulation electrode is disposed. Therefore, in order to alleviate a wide range of pain, multiple electrode leads are implanted subcutaneously, and a plurality of stimulation devices for supplying electrical stimulation signals to the stimulation electrodes provided on the multiple electrode leads are subcutaneously used. Although it is necessary to implant, the implantation technique becomes complicated and the invasion to the living body is large. In addition, since the tip portion of the electrode lead is placed in the pain area, it may become a mechanical stimulus, causing ulcers and erythema in the pain area, which may further exacerbate the condition. In addition, when a patient has sensory abnormalities (allodynia) in which microstimulation that is not normally felt as pain is recognized as painful, it is difficult to place the stimulation electrode directly in the pain region. Patent Document 1 discloses a technique (Fig. 14) that can change the effective stimulation area within the area occupied by a plurality of electrodes arranged on the lead. Is limited.

  In view of this, it has been studied to implant a plurality of stimulation devices that subcutaneously implant a plurality of electrode leads and supply electrical stimulation signals to stimulation electrodes provided on the plurality of electrode leads. Since the pain area varies depending on the patient's age, sex, and symptoms, it can be considered that if the lead part of the electrode lead is lengthened, the electrode lead can be implanted subcutaneously corresponding to the pain area of various shapes . However, a lead wire for supplying the electrical stimulation signal received from the stimulation circuit to the stimulation electrode is wired inside the lead portion, and the remaining portion of the lead portion cannot be easily cut. For this reason, the remaining part of the lead part is implanted into the living body. A living tissue is likely to adhere to the surplus portion of the lead portion that has been implanted in the living body with time. For this reason, when the pain region changes and the position of the stimulation electrode must be adjusted, the biological tissue attached to the lead portion must be peeled off, and the invasiveness to the living body is large and complicated procedures are required. Along with this, the biological tissue and the lead part may be damaged.

  The present invention has been made in view of such a situation, and an object of the present invention is to alleviate pain by implanting a surplus portion of a lead portion of an electrode lead into a living body.

The electrical stimulation apparatus according to the present invention includes a connection lead in which a plurality of electrode leads on which stimulation electrodes are arranged are connected in series, and a stimulation apparatus having a stimulation circuit that outputs an electrical stimulation signal.
The lead portion has flexibility, and a conducting wire is wired inside. The first terminal portion is provided at one end of the lead portion. A storage part is provided in the other end of a lead part, and the remainder part of a lead part is stored. The stimulation electrode is provided between the first terminal portion and the storage portion, and is electrically connected to the first terminal portion by a conductive wire, and the living body is electrically connected by an electrical stimulation signal supplied from the first terminal portion. stimulate. And the remainder part of a lead part is accommodated in an accommodating part.

  According to the present invention, since the surplus portion of the lead portion is stored in the storage portion well, it is possible to prevent living tissue from adhering to the surplus portion of the lead portion implanted subcutaneously. And a pain area | region can be electrically stimulated by the stimulation electrode provided between the 1st terminal part of the lead | read | reed part and the accommodating part, and pain can be relieved.

It is a perspective view showing an example of schematic structure of an electrode lead which constitutes an electric stimulator concerning one embodiment of the present invention, and a stimulator. It is a perspective view which shows the example of schematic structure of the electrode lead connected in series which concerns on one Embodiment of this invention. FIG. 2A is a perspective view illustrating a schematic configuration example of one electrode lead. FIG. 2B is a perspective view showing a schematic configuration example of a connecting lead in which three electrode leads are connected in series. FIG. 2C is a perspective view illustrating a state in which the lead portion is stored in the storage portion. It is sectional drawing of the axial direction which shows the schematic internal structural example of the electrode lead which concerns on one Embodiment of this invention. FIG. 3A is a cross-sectional view showing a state where a bobbin and a bobbin cover are separated before connection of two electrode leads. FIG. 3B is a cross-sectional view showing a state where the bobbin and the bobbin cover are combined after the connection of the two electrode leads. It is sectional drawing which shows the detailed structure of the bobbin which concerns on one Embodiment of this invention. 4A is a cross-sectional view of the bobbin taken along line AA ′ of FIG. 3A. 4B is a cross-sectional view of the bobbin taken along line BB ′ of FIG. 3A. It is an axial sectional view showing an example of an internal configuration of three electrode leads constituting a connecting lead according to an embodiment of the present invention. It is a block diagram which shows the internal structural example of the lead IC chip and electrode IC chip which concern on one Embodiment of this invention. It is a functional block diagram which shows the electric constitution of the stimulation circuit which concerns on one Embodiment of this invention. It is explanatory drawing which shows the data structural example of the control power supply signal supplied to the electrode lead which concerns on one Embodiment of this invention. It is explanatory drawing which shows the procedure which implants the conventional electrode lead under the skin of a biological body. FIG. 9A is an explanatory diagram showing an electrode lead implantation procedure 1. FIG. 9B is an explanatory diagram illustrating an electrode lead implantation procedure 2. FIG. 9C is an explanatory diagram showing an electrode lead implantation procedure 3. FIG. 9D is an explanatory view showing an electrode lead implantation procedure 4. It is explanatory drawing which shows the procedures 1-4 which implant the electrode lead which concerns on one Embodiment of this invention to the subcutaneous body of a biological body. 10A shows Procedure 1, FIG. 10B shows Procedure 2, FIG. 10C shows Procedure 3, and FIG. 10D shows Procedure 4. It is explanatory drawing which shows the procedures 5-8 which implant the electrode lead which concerns on one Embodiment of this invention to the subcutaneous body of a biological body. 11E shows procedure 5, FIG. 11F shows procedure 6, FIG. 11G shows procedure 7, and FIG. 11H shows procedure 8. It is explanatory drawing which shows the procedures 9-12 which implant the electrode lead which concerns on one Embodiment of this invention to the subcutaneous body of a biological body. 12I shows the procedure 9, FIG. 12J shows the procedure 10, FIG. 12K shows the procedure 11, and FIG. 12L shows the procedure 12. It is explanatory drawing which shows the procedures 13-16 which implant the electrode lead which concerns on one Embodiment of this invention under the living body. 13M shows the procedure 13, FIG. 13N shows the procedure 14, FIG. 13O shows the procedure 15, and FIG. 13P shows the procedure 16. It is explanatory drawing which shows the procedures 17 and 18 which implant the electrode lead which concerns on one Embodiment of this invention under the living body. FIG. 14Q shows procedure 17 and FIG. 14R shows procedure 18. It is explanatory drawing which shows the state which implanted the electrical stimulation apparatus which concerns on one Embodiment of this invention to the subcutaneous body of the biological body.

Embodiments for carrying out the present invention will be described below. The embodiments described below are preferred 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. In the present specification and drawings, components having substantially the same function or configuration are denoted by the same reference numerals, and redundant description is omitted.
The description will be made in the following order.
1. 1. Embodiment 1-1. Overall configuration of electrical stimulation apparatus 1-2. Configuration of electrode lead 1-3. Internal structure of electrode lead 1-4. Internal configuration of lead IC chip 1-5. Internal configuration of electrode IC chip 1-6. Management of stimulation electrodes in each electrode lead 1-7. Circuit configuration of stimulation circuit 1-8. Data structure of control power signal 1-9. 1. Electrode lead implantation method Modified example

<1. One Embodiment>
[1-1. Overall configuration of electrical stimulation device]
First, a mechanical configuration example of the electrical stimulation device 1 according to an embodiment of the present invention will be described with reference to FIGS. 1 and 2.
FIG. 1 is a perspective view showing a schematic configuration example of electrode leads 2A to 2C constituting an electrical stimulation device 1 and a stimulation device 20 according to an embodiment of the present invention.
FIG. 2 is a perspective view illustrating a schematic configuration example of the connected electrode leads 2A to 2C. FIG. 2A is a perspective view illustrating a schematic configuration example of one electrode lead 2A. FIG. 2B is a perspective view showing a schematic configuration example of a connecting lead 2 in which three electrode leads 2A to 2C are connected in series. FIG. 2C is a perspective view showing a state in which the lead portions 6A and 6B are stored in the storage portion 7A.

  The electrical stimulation device 1 is a device used for electrical stimulation of nerves or muscles. The electrical stimulation device 1 stimulates nerves or muscles in the living body by supplying electrical stimulation signals to the stimulation electrodes 5A to 5C of the electrode leads 2A to 2C implanted in the living body. The electrical stimulation device 1 is implanted in a living body and supplies electrical stimulation signals to the electrode leads 2A to 2C and the stimulation electrodes 5A to 5C used to stimulate the electrical stimulation signal by guiding it to nerves or muscles. And a stimulating device 20 for performing. In the following description, the electrical stimulation apparatus 1 that can be used for peripheral nerve stimulation therapy (PNFS) that electrically stimulates nerves under the skin will be described as an example.

  Here, in a state in which the electrode leads 2A to 2C connected in series are connected to the stimulating device 20, the end portions of the electrode leads 2A to 2C on the side arranged at positions close to the stimulating device 20 are used. The “proximal end” will be referred to as the “distal end” for each end on the side far from the stimulator 20. That is, in the electrode leads 2A to 2C, the end on the side where the storage portions 7A to 7C are provided is the distal end, and the end on the side where the insertion portions 3A to 3C are provided is the proximal end.

First, the configuration of the electrode lead 2A will be described with reference to FIGS. 1 and 2A.
The electrode lead 2A has a lead portion 6A configured as a long body having flexibility. At the proximal end of the lead portion 6A, an insertion portion 3A to be inserted into the connector 22 of the stimulation device 20 is provided. A storage portion 7A into which the insertion portion 3B of the electrode lead 2B is inserted is provided at the distal end of the lead portion 6A. The insertion portion 3A of the electrode lead 2A is provided with three insertion terminals 4A (first terminal portions).

  The electrode lead 2A includes two stimulation electrodes provided between the insertion portion 3A at the proximal end (one end) of the lead portion 6A and the storage portion 7A at the distal end (the other end) of the lead portion 6A. 5A. The stimulation electrode 5A is electrically connected to the insertion terminal 4A and a conductive wire 9 (see FIG. 5 described later), and electrically stimulates nerves in the living body by an electrical stimulation signal supplied from the insertion terminal 4A. The lead portion 6A fixes the stimulation electrode 5A so that the two stimulation electrodes 5A come into contact with the living body when the electrode lead 2A is implanted in the living body. The insertion terminal 4 </ b> A and the stimulation electrode 5 </ b> A are formed along the outer peripheral direction of the lead portion 6 </ b> A, and are arranged at a certain interval in the axial direction.

  7 A of storage parts wind up and accommodate the surplus part of the distal end side of 6 A of lead parts. As shown in FIG. 2A, the storage portion 7A includes a separable bobbin 10a and a bobbin cover 10b. The combined bobbin 10a and bobbin cover 10b can be freely rotated independently. A part of the lead part 6A and a part of the lead part 6B are wound around the bobbin 10a and the bobbin cover 10b and covered with the bent bobbin cover 10b, thereby being stored in the storage part 7A.

  The bobbin 10a has a cylindrical shaft portion 7d (an example of a first shaft portion). At both ends of the shaft portion 7d, a collar portion 7a (an example of a first collar portion) and a collar portion 7b (an example of a second collar portion) that are circular and have the same diameter are provided as an example. The two collar portions 7a and 7b, the shaft portion 7d, and the distal end of the lead portion 6A are integrally formed.

  The collar portion 7b is provided with a connector terminal 8A. The connector terminal 8A is provided with the same number of three terminals as the insertion terminal 4A. And the connector terminal 8A and the insertion terminal 4A are electrically connected by the conducting wire 9 (refer FIG. 5 mentioned later) embedded and wired inside the lead part 6A. The insertion portion 3B of the electrode lead 2B is inserted into the opening 7f of the storage portion 7A shown in FIG. 2A, and the connector terminal 8A and the insertion terminal 4B of the insertion portion 3B are electrically connected inside the storage portion 7A. The

  The bobbin cover 10b has a cylindrical shaft portion 7e (an example of a second shaft portion). One end of the shaft portion 7e is provided with a collar portion 7c (an example of a third collar portion) that is circular and has a diameter larger than that of the collar portions 7a and 7b. As shown in FIG. 2A, the collar portion 7c and the shaft portion 7e are integrally formed.

  As shown in FIG. 2C, in a state where the shaft portion 7d and the shaft portion 7e are combined, a surplus portion of the lead portion 6A is wound around the shaft portion 7d between the facing flange portions 7a and 7b. A surplus portion of the lead portion 6B is wound around the shaft portion 7e between the opposing flange portions 7b and 7c. In this way, the storage portion 7A is stored separately by winding the surplus portion of the lead portion 6A and the surplus portion of the lead portion 6B around the shaft portions 7d and 7e, respectively. The shaft portions 7d and 7e may be formed in other shapes such as a polygonal column shape and an elliptic column shape.

  The collar portion 7c is cut at an equal interval (for example, an interval of 90 degrees). The notch is formed by combining the bobbin 10a with the bobbin cover 10b and winding the surplus portions of the lead portions 6A and 6B around the shaft portions 7d and 7e, respectively. It is provided to facilitate passage of the portions 6A and 6B. When the collar portion 7c is bent, the lead portion wound around the bobbin 10a is fixed so as not to loosen and come off. The collar portion 7c is made of a resin material such as silicone or polyurethane having flexibility and biocompatibility.

  The electrode lead 2B is provided with four stimulation electrodes 5B in the lead portion 6B, which is different from the electrode lead 2A. The other electrode lead 2B has an insertion portion 3B, an insertion terminal 4B, a lead portion 6B, a storage portion 7B, and a connector terminal 8B. The electrode lead 2A has an insertion portion 3A, an insertion terminal 4A, a lead portion 6A, and a storage portion 7A. And the same as the connector terminal 8A.

  The electrode lead 2C has the same function and configuration as the electrode lead 2A. That is, the insertion part 3C, the insertion terminal 4C, the stimulation electrode 5C, the lead part 6C, the storage part 7C, and the connector terminal 8C of the electrode lead 2C are the insertion part 3A, the insertion terminal 4A, and the stimulation electrode 5A of the electrode lead 2A, respectively. The lead portion 6A, the storage portion 7A, and the connector terminal 8A are the same.

  Then, at least two electrode leads are connected in series by connection of an insertion terminal and a receiving terminal provided on each electrode lead. In the present embodiment, as shown in FIG. 2B, an example in which three electrode leads 2A to 2C are sequentially connected is shown. As shown in FIG. 1, the insertion portion 3B of the electrode lead 2B is inserted into the storage portion 7A of the electrode lead 2A, and the storage portion 7A and the insertion portion 3B are fixed, thereby connecting the connector terminal 8A and the insertion terminal 4B. The Further, the insertion portion 3C of the electrode lead 2C is inserted into the storage portion 7B of the electrode lead 2B, and the storage portion 7B and the insertion portion 3C are fixed, whereby the connector terminal 8B and the insertion terminal 4C are connected. In the following description, the electrode leads 2 </ b> A to 2 </ b> C connected in series are referred to as connection leads 2.

Next, the configuration of the stimulation apparatus 20 will be described with reference to FIG. 1 again.
The stimulation device 20 includes a housing 21 and a connector 22 protruding from the housing 21. A stimulation circuit 30 that supplies electrical stimulation signals to the stimulation electrodes 5A to 5C of the electrode leads 2A to 2C is provided inside the housing 21.

  The casing 21 is formed in a substantially rectangular parallelepiped shape using a relatively hard and biocompatible metal or resin, for example, a material such as titanium or epoxy. The housing 21 is provided with a connector 22 into which the insertion part 3A of the electrode lead 2A is inserted. The connector terminal 23 in the connector 22 is electrically connected to the stimulation circuit 30 in the housing 21.

  The stimulation circuit 30 is a circuit in which a small component such as a custom IC is mounted on a circuit board, and generates an electrical stimulation signal by power supplied from a power supply unit. And the stimulation circuit 30 performs control which supplies the produced | generated electrical stimulation signal independently with respect to each electrode of the stimulation electrodes 5A-5C. The electrical configuration of the stimulation circuit 30 will be described later (FIG. 7).

  The insertion terminals 4A to 4C and the stimulation electrodes 5A to 5C described above are both formed in a substantially annular shape and are embedded and held in the outer peripheral surfaces of the lead portions 6A to 6C. Moreover, the conductive wire 9 wired in the insertion terminals 4A to 4C, the stimulation electrodes 5A to 5C, the connector terminals 8A to 8C, and the lead portions 6A to 6C is made of a conductive and biocompatible material. . Examples of this material include stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy).

  The lead portions 6A to 6C are made of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, and the outer diameter is 1 to 1 so as to be minimally invasive at the time of implantation. It is preferable that it is about 3 mm. The storage portions 7A to 7C are made of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane. However, the material used for the storage portions 7A to 7C is not limited to the resin material, and may be any material as long as it is flexible and biocompatible.

[1-2. Configuration of electrode lead]
Next, with reference to FIG. 3 and FIG. 4, details of the configuration when connecting the electrode leads 2A and 2B will be described.
FIG. 3 is an axial cross-sectional view showing a schematic internal configuration example of the distal end of the electrode lead 2A and the proximal end of the electrode lead 2B. FIG. 3A is a cross-sectional view showing a state where the bobbin 10a and the bobbin cover 10b are separated before the two electrode leads 2A and 2B are connected. FIG. 3B is a cross-sectional view showing a state where the bobbin 10a and the bobbin cover 10b are combined after the two electrode leads 2A and 2B are connected. 3 omits the description of the conducting wire 9, and the storage portion 7A includes a portion 7m in which the lead portion 6A is integrally connected to the shaft portion 7d (see FIG. 4A described later), a connector terminal 8A, Is developed on a plane.
FIG. 4 is a cross-sectional view showing a detailed configuration of the bobbin 10a. 4A is a cross-sectional view of the bobbin 10a taken along line AA 'of FIG. 3A. FIG. 4B is a cross-sectional view of the bobbin 10a taken along line BB ′ of FIG. 3A.
In the following description, the side (the right side in FIG. 3) where the lead portion 6A of the electrode lead 2A extends from the storage portion 7A in the storage portion 7A is referred to as the proximal end, and the insertion portion 3B of the electrode lead 2B is inserted. The side (left side of FIG. 3) is called the distal end.

As shown in FIG. 3A, the storage portion 7A of the electrode lead 2A is separated into a bobbin 10a and a bobbin cover 10b.
As shown in FIG. 4A, the portion 7m in which the distal end of the lead portion 6A of the electrode lead 2A is integrally connected to the shaft portion 7d cannot be moved from the shaft portion 7d. As described above, the lead wire 9 (see FIG. 5 described later) in the lead portion 6A is wired in the shaft portion 7d and connected to the connector terminal 8A. The portion 7n other than the distal end of the lead portion 6A is wound around the shaft portion 7d as a surplus portion of the lead portion 6A.

  As shown in FIG. 3A, a part of the lower surface of the collar portion 7b protrudes, and an opening 7f having an inner diameter substantially the same as the outer diameter of the insertion portion 3B of the electrode lead 2B is formed in the protruding portion. In addition, an accommodating portion 7g, which is a substantially cylindrical space having the same inner diameter as the opening 7f, is formed in the protruding portion from the opening 7f toward the proximal end. As shown in FIG. 4B, the accommodating portion 7g is provided at a position symmetrical to the position where the lead portion 6A is connected with respect to the rotation center of the bobbin 10a. As shown in FIG. 3A again, the insertion portion 3B of the electrode lead 2B is accommodated in the accommodation portion 7g. On the inner peripheral surface of the accommodating portion 7g, three connector terminals 8A are provided along the axial direction of the accommodating portion 7g. The arrangement of each terminal of the connector terminal 8A corresponds to the arrangement of each terminal of the insertion terminal 4B provided in the insertion part 3B accommodated in the accommodation part 7g.

  The connector terminal 8A is configured by a garter spring which is a coiled metal spring as an example of a fixing mechanism, and slightly protrudes inward with respect to the inner periphery of the opening 7f. Further, the insertion terminal 4B of the electrode lead 2B is formed as a recess that matches the inner peripheral portion of the garter spring. Accordingly, the housing portion 7g fixes the insertion portion 3B by tightening the garter spring with respect to the insertion terminal 4B of the insertion portion 3B inserted into the inner peripheral portion of the garter spring. For this reason, the insertion part 3B of the electrode lead 2B is difficult to come off from the accommodating part 7g of the collar part 7b.

  A fixing screw hole 7h is formed near the distal end of the accommodating portion 7g in a direction orthogonal to the axial direction of the accommodating portion 7g. By the fixing screw 7i screwed into the fixing screw hole 7h, the vicinity of the distal end of the insertion portion 3B is fixed to the accommodating portion 7g. In the vicinity of the insertion portion 3B with which the tip of the fixing screw 7i comes into contact, a fixing portion (not shown) is formed in a substantially annular shape and is embedded and held in the outer peripheral surface. Thereby, the electrode lead 2B is firmly connected to the electrode lead 2A. The fixing screw 7i and the fixing portion are made of a relatively hard and biocompatible material such as stainless steel.

  A receiving portion 7j is formed on the lower surface of the bobbin 10a and in the vicinity of the center of the collar portion 7b. On the other hand, a protruding portion 7k protruding upward from the shaft portion 7e is formed on the upper surface of the bobbin cover 10b and in the vicinity of the center of the shaft portion 7e. The protrusion 7k has a substantially conical shape. The receiving portion 7j is formed as a space in which the protruding portion 7k is fitted when the bobbin cover 10b is combined with the bobbin 10a. However, since the contact surfaces of the receiving portion 7j and the protruding portion 7k are not fixed to each other, even if the bobbin 10a and the bobbin cover 10b are combined, the bobbin 10a and the bobbin cover 10b slide with each other and become independent. And can be freely rotated.

[1-3. Internal structure of electrode lead]
Next, the details of the electrode leads 2A to 2C constituting the connecting lead 2 will be described with reference to FIG.
FIG. 5 is a cross-sectional view in the axial direction showing an internal configuration example of the electrode leads 2A to 2C. In FIG. 5, the description of the bobbin cover 10b provided in the storage portions 7A to 7C is omitted.

  As described above, a total of eight stimulation electrodes 5A to 5C are provided on the connection lead 2 in which the electrode leads 2A to 2C are connected in series. A symbol corresponding to an electrode ID (electrode number) from the proximal end to the distal end corresponding to the arrangement of the stimulation electrodes provided on the electrode lead for each of the electrode leads 2A to 2C constituting the connection lead 2 Are attached in order, and each electrode ID is shown in FIG. Below, electrode ID is used as information (electrode identification information) for identifying a stimulation electrode. The electrode identification information may be characters, symbols, or a combination thereof in addition to a number (number). Here, the electrode IDs of the stimulation electrodes provided in each of the electrode leads 2A to 2C have a predetermined regularity corresponding to the arrangement of the stimulation electrodes, and are attached in order from a predetermined value. In the present embodiment, numbers starting from “0” and incremented by 1 are assigned as electrode IDs to a plurality of stimulation electrodes provided in one electrode lead.

First, an example of the internal configuration of the electrode lead 2A will be described.
In the electrode lead 2 </ b> A, three plug terminals 4 </ b> A arranged from the proximal end to the distal end and three connector terminals 8 </ b> A arranged from the proximal end to the distal end are connected by a conductor 9. Electrical connection is made in order from the proximal end to the distal end.

  In the following description, terminal numbers “0” to “2” are assigned in order from the proximal end to the distal end of the individual terminals constituting the insertion terminal 4A, and the individual terminals constituting the connector terminal 8A are provided. Terminal numbers “0” to “2” are assigned in order from the proximal end to the distal end. Further, the conductors connected to the terminals having the terminal numbers “0” to “2” of the plug-in terminal 4A are collectively referred to as a conductor 9 without particular distinction. In addition, the conducting wire 9 is wired so as to bypass the receiving portion 7j provided on the bobbin 10a.

  In the electrode lead 2A, an electrode IC chip 50 (an example of an electrode control unit) is provided at a position corresponding to the stimulation electrode 5A having the electrode ID “0” inside the lead portion 6A. The electrode IC chip 50 controls the supply of electrical stimulation signals to the stimulation electrode 5A, and the same number of electrode IC chips 50 as the number of stimulation electrodes 5A are provided corresponding to the stimulation electrode 5A. Details of the electrode IC chip 50 will be described later (see FIG. 6). The electrode IC chip 50 is electrically connected to the stimulation electrode 5A having the electrode ID “0”, the three insertion terminals 4A having the terminal numbers “0” to “2”, and the terminal numbers “0” to “2”. Each of the three conductors 9 that connect the three connector terminals 8A is electrically connected.

  Furthermore, the electrode IC chip 50 having the same specification is also provided at a position corresponding to the stimulation electrode 5A having the electrode ID “1” inside the lead portion 6A. The electrode IC chip 50 corresponding to the stimulation electrode 5A having the electrode ID “1” is also the stimulation electrode having the electrode ID “1” in the same manner as the electrode IC chip 50 corresponding to the stimulation electrode 5A having the electrode ID “0”. 5A and the three conductors 9 are electrically connected.

  In the electrode lead 2A, a lead IC chip 40 (an example of a lead control unit) is provided inside the insertion portion 3A. The lead IC chip 40 is connected to the insertion terminal 4 </ b> A having the terminal number “0” and the electrode IC chip 50 corresponding to the electrode IDs “0” and “1” via the conductor 9. The lead IC chip 40 controls the operation of the electrode IC chip 50 provided corresponding to each stimulation electrode 5A, and one lead IC chip 40 is provided for one electrode lead. The lead IC chip 40 has a function of identifying an electrode lead as will be described later, and controls the operation of each electrode IC chip 50 when the electrode lead 2A is designated from the stimulator 20. Details of the lead IC chip 40 will be described later (see FIG. 6).

  With the above-described configuration, the electrical stimulation signal supplied from the stimulation device 20 to the insertion terminal 4A having the terminal numbers “1” and “2” of the electrode lead 2A, for example, passes through the conductor 9, and the electrode ID is “0”. , “1” is supplied to the electrode IC chip 50 corresponding to the stimulation electrode 5A. Then, based on the control of the lead IC chip 40 and the electrode IC chip 50 connected to the insertion terminal 4A having the terminal number “0”, an electrical stimulation signal is supplied to the stimulation electrode 5A, and the stimulation electrode 5A electrically stimulates the living body. To do.

Next, an example of the internal configuration of the electrode lead 2B will be described.
In the electrode lead 2B, like the electrode lead 2A, the insertion terminals 4B having terminal numbers “0” to “2” arranged from the proximal end to the distal end, and the proximal end to the distal end are arranged. The arranged connector terminals 8B having terminal numbers “0” to “2” are electrically connected in order from the proximal end to the distal end by the conducting wire 9.

  In the electrode lead 2B, the electrode IC chip 50 is provided at a position corresponding to the stimulation electrode 5B having the electrode ID “0” in the lead portion 6B. The electrode IC chip 50 is electrically connected to the stimulation electrode 5B having the electrode ID “0”, the three insertion terminals 4B having the terminal numbers “0” to “2”, and the terminal numbers “0” to “2”. Each of the three conductors 9 that connect the three connector terminals 8B is electrically connected. Furthermore, the electrode IC chip 50 having the same specification is also provided at positions corresponding to the three stimulation electrodes 5B having the electrode IDs “1” to “3” inside the lead portion 6B. The electrode IC chips 50 corresponding to the stimulation electrodes 5B having the electrode IDs “1” to “3” are also electrically connected to the stimulation electrodes 5B and the three conductors 9 corresponding to the electrode IDs.

  Also in the electrode lead 2B, a lead IC chip 40 is provided inside the insertion portion 3B, as in the electrode lead 2A. The lead IC chip 40 is connected to each of the insertion terminal 4B having the terminal number “0” and each of the electrode IC chips 50 corresponding to the electrode IDs “0” to “3” via the conductive wires 9.

Next, an example of the internal configuration of the electrode lead 2C will be described.
The electrode lead 2C has the same two stimulation electrodes 5C as the electrode lead 2A. Therefore, the internal configuration of the electrode lead 2C is the same as that of the electrode lead 2A. That is, in the electrode lead 2 </ b> C, the electrode IC chip 50 is provided at a position corresponding to the stimulation electrode 5 </ b> C having the electrode ID “0” or “1” in the lead portion 6 </ b> C. Each electrode IC chip 50 is electrically connected to the stimulation electrode 5C corresponding to the electrode ID, and has three insertion terminals 4C having terminal numbers “0” to “2” and terminal numbers “0” to “2”. Each of the three conducting wires 9 that connect the three connector terminals 8C is electrically connected.

  Also in the electrode lead 2C, a lead IC chip 40 is provided inside the insertion portion 3C, similarly to the electrode lead 2A. The lead IC chip 40 is connected to the insertion terminal 4 </ b> C having the terminal number “0” and the electrode IC chip 50 corresponding to the electrode IDs “0” and “1” via the conductor 9.

  By connecting the electrode leads 2A to 2C in series in this way, the eight stimulation electrodes 5A to 5C to which the electrode IDs are attached are connected to the terminals of the electrode lead 2A via the corresponding electrode IC chip 50 and the conducting wire 9. Each is electrically connected to a predetermined insertion terminal 4A among the numbers "0" to "2". For this reason, it is possible to supply an electrical stimulation signal from the stimulation device 20 to the stimulation electrodes 5A to 5C via a predetermined terminal of the insertion terminal 4A. Then, the lead IC chip 40 provided on the electrode lead designated by the stimulating device 20 controls the operation of the electrode IC chip 50 corresponding to each of the stimulation electrodes 5A to 5C, so that the electrical from the stimulation electrode of the corresponding electrode lead. A stimulation signal is output to the nerve in the living body, and the pain site can be electrically stimulated.

[1-4. Internal structure of lead IC chip]
Next, with reference to FIG. 6, the internal configuration of the electrode leads 2 </ b> A to 2 </ b> C constituting the connection lead 2 will be described more specifically. Hereinafter, the lead IC chip 40 and the electrode IC chip 50 of the electrode lead 2A will be described as an example.
FIG. 6 is a block diagram illustrating an internal configuration example of the lead IC chip 40 and the electrode IC chip 50 of the electrode lead 2A. In FIG. 6, the stimulation electrode 5A with the electrode ID “0” is represented as “stimulation electrode 5A (0)”, and the stimulation electrode 5A with the electrode ID “1” is represented as “stimulation electrode 5A (1)”.

First, an example of the internal configuration of the lead IC chip 40 will be described.
The lead IC chip 40 provided in the insertion part 3A of the electrode lead 2A includes a lead IC chip power supply part 41, a lead IC chip control part 42, a lead ID storage part 43 (an example of a lead identification information storage part), and The electrode number storage unit 44 and the gate unit 45 are provided.

  Electrical stimulation to the nerve is performed by applying an electrical stimulation signal (stimulation pulse signal and reference potential signal) between at least two stimulation electrodes. That is, a stimulation pulse signal is applied to at least one stimulation electrode, and a reference potential signal is applied to at least one stimulation electrode.

  The stimulation pulse line L1 is connected to the terminal having the terminal number “2” of the insertion terminal 4A of the insertion portion 3A, the reference potential line L2 is connected to the terminal having the terminal number “1” of the insertion terminal 4A, and the terminal 4A A control power supply line L3 is connected to the terminal having the terminal number “0”.

The stimulation pulse line L1 is a line that transmits a stimulation pulse signal constituting an electrical stimulation signal. Hereinafter, the stimulation pulse signal may be simply referred to as “stimulation pulse”. Here, the stimulation pulse line L1 is connected to the insertion terminal 4A having the terminal number “2”.
The reference potential line L2 is a line that transmits a reference potential signal constituting an electrical stimulation signal. Here, the reference potential line L2 is connected to the insertion terminal 4A having the terminal number “1”. The reference potential is the same as the reference potential in each part of the lead IC chip 40 and the electrode IC chip 50.
The control power supply line L3 is a line through which a serial signal including a control signal and a power supply signal is transmitted between the stimulation device 20 and the lead IC chip 40, and between the stimulation device 20 and the electrode IC chip 50. Here, the control power supply line L3 is connected to the insertion terminal 4A having the terminal number “0”. The control signal is a signal including information for setting electrical stimulation in the lead IC chip 40 and the electrode IC chip 50. The power supply signal is a burst wave signal (burst signal) supplied to each power supply unit of the lead IC chip 40 and the electrode IC chip 50. Hereinafter, the serial signal including the control signal and the power signal is referred to as “control power signal”. The control power line L3 also transmits a response signal output from the electrode IC chip 50 or the lead IC chip 40.

The insertion terminal 4A with the terminal number “2” arranged in the insertion part 3A includes a connector terminal 8A with a terminal number “2” and a switch part 54 of the electrode IC chip 50 provided corresponding to each stimulation electrode 5A. Is electrically connected.
The insertion terminal 4A having the terminal number “1” is electrically connected to the connector terminal 8A having the terminal number “1” and the switch section 54 of each electrode IC chip 50, and the lead IC chip power supply section 41 and the electrode IC. It is connected to a terminal (not shown) of the chip power supply unit 51 and becomes a reference potential for obtaining power from a power supply signal supplied to each power supply unit. Each switch unit 54 is electrically connected to the corresponding stimulation electrode 5A (0), 5A (1).
The insertion terminal 4A having the terminal number “0” includes the connector terminal 8A having the terminal number “0”, the lead IC chip power supply unit 41, the lead IC chip control unit 42, the gate unit 45, and the electrode IC chip power supply unit 51. Electrically connected. Further, the insertion terminal 4A having the terminal number “0” is connected to each of the electrode IC chip control units 52 of the electrode IC chip 50 provided corresponding to each stimulation electrode 5A via the gate portion 45 of the lead IC chip 40. Electrically connected.

  The lead IC chip power supply unit 41 has a built-in rectifier circuit (not shown), and rectifies the power supply signal included in the control power supply signal supplied from the insertion terminal 4A having the terminal number “0” to obtain power. The lead IC chip power supply unit 41 supplies the acquired power to each block in the lead IC chip 40.

  The lead IC chip control unit 42 performs predetermined control based on a control signal included in the control power supply signal supplied from the insertion terminal 4A having the terminal number “0”. That is, the lead IC chip control unit 42 includes the lead ID (lead number) included in the control signal in the control power signal and the lead ID assigned to the electrode lead 2A stored in the lead ID storage unit 43. It is determined whether or not they match. When the lead ID included in the control signal matches the lead ID of the lead IC chip 40, the lead IC chip control unit 42 turns on the gate unit 45 and supplies the control power signal to the stimulation electrode 5A side. . As the lead IC chip controller 42, for example, an arithmetic control device such as a custom IC or a microcomputer can be used.

  The lead ID storage unit 43 stores a lead ID that can uniquely identify the electrode lead 2 </ b> A assigned by the stimulation device 20. A non-volatile memory is used for the read ID storage unit 43. Below, lead ID is used as information (lead identification information) for identifying an electrode lead (lead part). The lead identification information may be characters, symbols, or a combination thereof in addition to a number (number).

  The number-of-electrodes storage unit 44 stores the number of stimulation electrodes 5A arranged on the electrode lead 2A. In the example of FIG. 6, information that the number of stimulation electrodes 5A is two is stored in the number-of-electrodes storage unit 44. Has been. The process of storing the number of electrodes in the electrode number storage unit 44 is performed at the stage where the electrode lead 2A is manufactured as an example. In the present embodiment, the electrode IDs of the stimulation electrodes 5A to 5C of the electrode leads 2A to 2C are converted into relative values by uniquely identifying the electrode leads 2A to 2C using the lead ID. A non-volatile memory is used for the electrode number storage unit 44.

  The gate unit 45 is an example of a switching unit, and based on the gate signal output from the lead IC chip control unit 42, the insertion terminal 4A having the terminal number “0” and the electrode IC chip 50 corresponding to each stimulation electrode 5A. The electrode IC chip control unit 52 is turned on (ON). When no gate signal is input, the gate unit 45 is in an off state. When the gate unit 45 is on, the control power supply signal input from the insertion terminal 4A with the terminal number “0” is applied to each electrode IC chip 50 corresponding to the stimulation electrodes 5A (0) and 5A (1) of the electrode lead 2A. It is supplied to the electrode IC chip controller 52. The gate unit 45 is configured by using a switching element such as an FET (Field Effect Transistor) as an example.

[1-5. Internal structure of electrode IC chip]
Next, an internal configuration example of the electrode IC chip 50 will be described. Here, as the electrode IC chip 50, an electrode IC chip 50 corresponding to the stimulation electrode 5A (0) will be described as an example.

  As shown in FIG. 6, the electrode IC chip 50 corresponding to the stimulation electrode 5A (0) includes an electrode IC chip power supply unit 51, an electrode IC chip control unit 52, an electrode ID storage unit 53 (an electrode identification information storage unit). An example) and a switch unit 54.

  The electrode IC chip power supply unit 51 has the same function as the lead IC chip power supply unit 41. That is, the electrode IC chip power supply unit 51 has a built-in rectifier circuit (not shown), rectifies the power supply signal included in the control power supply signal supplied from the insertion terminal 4A having the terminal number “0”, and acquires power, The acquired power is supplied to each block in the electrode IC chip 50.

  The electrode IC chip control unit 52 controls the connection of the switch unit 54 based on a control signal included in the control power signal supplied from the insertion terminal 4 </ b> A having the terminal number “0” via the gate unit 45.

  That is, the electrode IC chip control unit 52 matches the electrode ID included in the control signal in the control power supply signal with the electrode ID assigned to the stimulation electrode 5A (0) stored in the electrode ID storage unit 53. Judge whether to do. When the electrode ID included in the control signal matches the electrode ID of the electrode IC chip 50, the electrode IC chip control unit 52 switches the connection of the switch unit 54 based on the selection signal included in the control signal. . For the electrode IC chip controller 52, for example, an arithmetic control device such as a custom IC or a microcomputer can be used.

  The electrode ID storage unit 53 stores, for example, an electrode ID (electrode identification information) that can identify the stimulation electrode 5A (0) provided on the electrode lead 2A when the electrode lead 2A is manufactured. A non-volatile memory is used for the electrode ID storage unit 53.

  The switch unit 54 switches the internal switch based on the selection signal output from the electrode IC chip control unit 52. That is, the switch unit 54 switches a line connected to the stimulation electrode 5A (0) and switches an electrical stimulation signal supplied to the stimulation electrode 5A (0). As a form for supplying a signal to the stimulation electrode 5A (0), a form for supplying the stimulation pulse by connecting the stimulation electrode 5A (0) and the stimulation pulse line L1, and a reference potential signal for connecting to the reference potential line L2 are supplied. As well as an unconnected configuration that does not supply any signal. The switch unit 54 is configured using a switch element such as an FET (field effect transistor). Note that the switch unit 54 maintains the state of the switched internal switch until the next selection signal is received after the internal switch is switched by the selection signal.

The electrode IC chip 50 corresponding to the stimulation electrode 5A (0) has been described above as an example, but the same applies to the electrode IC chip 50 corresponding to the stimulation electrode 5A (1). The internal configuration examples of the lead IC chip 40 and the electrode IC chips 50 of the electrode lead 2A are the same for the electrode leads 2B and 2C. When the electrode leads 2A to 2C are connected, the stimulation pulse supplied to the insertion terminal 4A with the terminal number “2” of the electrode lead 2A is an electrode IC corresponding to each stimulation electrode of the electrode leads 2B and 2C through the conductor 9. It is also supplied to the switch unit 54 in the chip 50.
Further, the reference potential signal supplied to the insertion terminal 4A having the terminal number “1” of the electrode lead 2A is also supplied to the switch section 54 in each electrode IC chip 50 of the electrode leads 2B and 2C through the lead wire 9.
Further, the control power signal supplied to the insertion terminal 4A having the terminal number “0” of the electrode lead 2A is supplied to the lead IC chip power supply unit 41 in the lead IC chip 40 of the electrode leads 2B and 2C and in each electrode IC chip 50. The electrode IC chip power supply unit 51 is also supplied. Further, the control power signal supplied to the electrode lead 2A is also supplied to the electrode IC chip control unit 52 in each electrode IC chip 50 via the gate portions 45 of the electrode leads 2B and 2C.

[1-6. Management of stimulation electrodes in each electrode lead]
As described above, in the electrode lead 2A, the number of stimulation electrodes 5A is two, and the electrode ID of the stimulation electrode 5A is “0” and “1” in order from the proximal end to the distal end. Such assignment of the electrode ID is performed in the same manner for the other electrode leads 2B and 2C, and the electrode ID of the electrode lead 2B is “0”, “1”, “2” in order from the proximal end to the distal end. The electrode ID of the electrode lead 2C is set to “0” and “1” in order from the proximal end to the distal end. As described above, the electrode ID of the stimulation electrode 5A included in the electrode lead 2A has a value that overlaps with the electrode ID of the stimulation electrode included in the other electrode leads 2B and 2C.

  In the present embodiment described above, the electrode IDs of the stimulation electrodes 5A to 5C of the electrode leads 2A to 2C can be converted into relative values by uniquely identifying the electrode leads 2A to 2C using the lead ID. That is, the stimulation electrodes 5A to 5C can be specified by combining the lead ID and the electrode ID regardless of the connection order of the electrode leads 2A to 2C. Therefore, it is not necessary to assign the electrode ID to the stimulation electrodes 5A to 5C in the order of connection of the three electrode leads 2A to 2C, and the management of the stimulation electrodes 5A to 5C is facilitated.

  In addition, according to the present embodiment, the electrode ID of the stimulation electrode provided on the electrode lead can be converted into a relative value, so that a large number of electrode leads can be connected. And about the connection lead which connected many electrode leads, electrode ID of the stimulation electrode of each electrode lead can be managed easily.

  Moreover, in this embodiment, since the number of conducting wires 9 can be made smaller than the number of stimulation electrodes 5A to 5C provided on the electrode leads 2A to 2C, the lead portion even if the electrode leads 2A to 2C are connected. Each diameter of 6A-6C can be suppressed small. Therefore, it is possible to form a minimally invasive connection lead.

  Further, the lead IC chip 40 of each electrode lead identifies the electrode lead using the lead ID, and the control power signal is supplied only to the electrode IC chip control unit in the corresponding electrode lead, so that power saving can be achieved. .

  The above-described lead IC chip 40 is provided at an arbitrary position inside the insertion portion 3A. However, the lead IC chip 40 may be provided inside the lead portion 6A at an arbitrary position, and one of the electrode IC chips 50 is the lead IC chip 40. You may have a function.

[1-7. Circuit configuration of stimulation circuit]
Next, the electrical configuration of the stimulation circuit 30 housed in the stimulation apparatus 20 will be described with reference to FIG.
FIG. 7 is a functional block diagram showing an electrical configuration of the stimulation circuit 30.

The stimulation circuit 30 includes a coil unit 61, a charging unit 62, a rechargeable battery 63, a communication unit 64, a control unit 65 (an example of a main control unit), a stimulation parameter setting unit 66, and a stimulation output oscillation unit 67. A control parameter setting unit 68, a control output oscillation unit 69, and a power supply unit 70.
The stimulation circuit 30 designates the electrode leads 2A to 2C and the stimulation electrodes 5A to 5C in the electrode leads 2A to 2C using the above-described lead ID and electrode ID, and electrically stimulates the stimulation electrodes in the designated electrode lead. The signal is supplied.

  The coil unit 61 is a resonance circuit composed of, for example, a coil and a capacitor. When the rechargeable battery 63 is charged, the coil unit 61 receives a charging electromagnetic wave transmitted from the controller 60 arranged outside the body. Then, an alternating current generated from the coil unit 61 with the reception of the electromagnetic wave is output to the charging unit 62. In addition, the coil unit 61 receives an electromagnetic wave carrying predetermined information transmitted from a controller 60 disposed outside the body, and an alternating current (alternating current signal) corresponding to the received electromagnetic wave is transmitted from the coil unit 61 to the communication unit. 64.

  The charging unit 62 incorporates a rectifier circuit (not shown), converts the alternating current output from the coil unit 61 into a direct current, and acquires power. Then, the rechargeable battery 63 is charged with the acquired power. The rechargeable battery 63 is a rechargeable secondary battery such as a lithium ion battery. The rechargeable battery 63 supplies the accumulated power to each block constituting the stimulation circuit 30.

  The communication unit 64 demodulates the AC signal output from the coil unit 61 and extracts information contained in the AC signal. Then, the extracted information is output to the stimulation parameter setting unit 66 and the control parameter setting unit 68 via the control unit 65. The information output to the stimulation parameter setting unit 66 is information regarding the stimulation intensity of the electrical stimulation signal. The information output to the control parameter setting unit 68 is information related to the configuration of the connecting lead 2 (electrode configuration information) and information related to the electrical stimulation signal applied to the stimulation electrode (connection information).

  The stimulation intensity of the electrical stimulation signal is determined by the pulse voltage, pulse current, pulse width, or frequency of the stimulation pulse that constitutes the electrical stimulation signal, and values such as the pulse voltage are set as stimulation parameters. Is done. In addition, the lead IDs of the electrode leads 2A to 2C that output electrical stimulation signals, the electrode ID information (electrode configuration information) of the stimulation electrodes in the corresponding electrode leads, and the polarity of the electrical stimulation signals applied to the corresponding stimulation electrodes are changed. Information (connection information) to be set is set as a control parameter.

  The stimulation parameter setting unit 66 sets a stimulation parameter based on information related to the stimulation intensity of the electrical stimulation signal input from the control unit 65, and based on this stimulation parameter, for example, the electrical generated by the stimulation output oscillation unit 67 A stimulus intensity change signal for changing the stimulus intensity of the stimulus signal is generated.

  The stimulus output oscillating unit 67 generates a stimulation pulse that constitutes an electrical stimulation signal based on a stimulation intensity change signal input from the stimulation parameter setting unit 66, for example, and the generated stimulation pulse is applied to the stimulation pulse line L1 of the connector 22. Output to the connected terminal.

  The control parameter setting unit 68 sets control parameters based on the electrode configuration information and connection information input from the control unit 65.

  The control output oscillating unit 69 generates a control power signal that is a serial signal based on the control parameter, setting command, or read command input from the control parameter setting unit 68, and uses the generated control power signal as a control power line of the connector 22. Output to the terminal connected to L3. A power signal (burst signal) based on the power supplied from the power supply unit 70 is added to the generated control power signal. A terminal (not shown) connected to the reference potential of the power supply unit 70 is connected to a terminal connected to the reference potential line L <b> 2 of the connector 22.

  For example, a microcomputer or the like is used as the control unit 65. The control unit 65 controls each block of the stimulation circuit 30. In addition, the control unit 65 stores information related to the configuration of the connection lead 2 including the electrode leads 2 </ b> A to 2 </ b> C in the memory 35 a inside the control unit 65. Information regarding the configuration of the connection lead 2 includes the lead IDs of the electrode leads 2A to 2C, the order of connection (order of lead ID), and the number of stimulation electrodes of each electrode lead. For example, the storage of the information related to the configuration of the connection lead 2 is performed at the timing of performing the initial processing after the connection lead 2 is connected to the connector 22 of the stimulation apparatus 20. The doctor inputs the lead ID written on the packaging material of each of the electrode leads 2A to 2C to the controller 60 in the order of connection of the electrode leads 2A to 2C, and communicates with the stimulator to connect the leads. 2 is stored in the memory 35 a inside the control unit 65.

  In addition, the stimulation circuit 30 includes a response signal receiving unit (not shown) connected to the control power supply line L3. The response signal receiving unit has a function of receiving response signals (serial signals) output from the electrode leads 2 </ b> A to 2 </ b> C via the connector 22 and transmitting them to the control unit 65.

[1-8. Data structure of control power signal]
Here, the data structure of the control power signal transmitted to the control power line L3 will be described with reference to FIG.
FIG. 8 shows an example of the data structure of a control power signal for setting connection information in the electrode IC chip 50. The control power supply signal includes ID information (electrode configuration information) including the lead ID of the electrode lead and the electrode ID of the stimulation electrode in the electrode lead corresponding to the lead ID, and setting information of the stimulation electrode corresponding to the electrode ID. A control signal 72 consisting of (connection information) is included. Subsequent to the control signal 72, a power supply signal 73, which is a burst signal composed of repeated rectangular waves, is added. The control output oscillating unit 69 adds a low level start signal 71 to the heads of the control signal 72 and the power supply signal 73 and transmits it to the control power supply line L3. The lead IC chip 40 recognizes that the control signal has been transmitted by detecting the start signal 71.

[1-9. Electrode lead implantation method]
Next, a conventional electrode lead implantation method and an electrode lead implantation method according to the present embodiment will be described.

<Conventional electrode lead implantation method>
First, a conventional electrode lead implantation method for performing peripheral nerve stimulation therapy by applying the SCS system will be described.
FIG. 9 is an explanatory diagram showing a procedure for implanting the conventional electrode lead 104 under the skin of the living body 100. FIG. 9A to FIG. 9D are explanatory views showing implantation steps 1 to 4 of the electrode lead 104.

(Procedure 1)
The doctor identifies the maximum pain site 102 in the pain region 101 in the patient's living body 100 through examination (FIG. 9A).
(Procedure 2)
Next, the doctor punctures the hollow puncture needle 103 subcutaneously from a position away from the identified maximum pain site 102 and advances until the needle tip of the puncture needle 103 reaches the specified maximum pain site 102 (FIG. 9B). .
(Procedure 3)
Next, the doctor inserts the electrode lead 104 used in the SCS system into the hollow portion of the puncture needle 103 (FIG. 9C). Since the stimulation electrode 106 shown in FIG. 9D is provided at one end of the electrode lead 104, the electrode lead 104 is inserted so that the stimulation electrode 106 coincides with the maximum pain site 102.
(Procedure 4)
Thereafter, the doctor removes the puncture needle 103 from the living body 100 and removes the puncture needle 103 from the electrode lead 104 while the electrode lead 104 is implanted in the living body 100. Then, the insertion terminal 105 of the electrode lead 104 is connected to an external stimulation device (not shown), and various patterns of electrical stimulation signals are supplied from the external stimulation device to the stimulation electrode 106 of the electrode lead 104 to alleviate pain. The position of the stimulation electrode 106 suitable for the maximum pain site 102 and the parameters of the electrical stimulation signal are adjusted and determined. Finally, the doctor connects the insertion terminal 105 of the electrode lead 104 to the stimulation device 107 (FIG. 9D), and implants the stimulation device 107 together with the electrode lead 104 subcutaneously in the living body.

  In such a conventional electrode lead 104, only the vicinity of the maximum pain region 102 is electrically stimulated, and the entire pain region 101 cannot be electrically stimulated. Further, when the position of the maximum pain site 102 has changed, electrical stimulation cannot be applied following the changed maximum pain site 102 by a method other than reimplanting the electrode lead 104. Further, with one electrode lead 104, electrical stimulation can be applied only to one location. Furthermore, in order to apply electrical stimulation to the pain region 101 over a wide range by the stimulation device 107, it is necessary to supply an electrical stimulation signal with a strong voltage to the stimulation electrode 106, which may cause discomfort associated with stimulation. It was. In addition, by placing the stimulation electrode 106 on the maximum pain site 102, the end of the electrode lead 104 becomes a mechanical stimulus in the maximum pain site 102, and ulcers and erythema are likely to occur, which may further worsen the condition. there were.

<Implantation method of electrode lead according to this embodiment>
Next, a procedure for implanting the electrode leads 2A and 2B according to the present embodiment under the skin of the living body 80 will be described with reference to FIGS. In this description, the procedure for implanting the electrode lead 2C is omitted.
10-14 is explanatory drawing which shows the procedure which implants electrode lead 2A, 2B which concerns on the example of this embodiment under the living body 80 subcutaneously. 10A to 10D show steps 1 to 4, FIGS. 11E to 11H show steps 5 to 8, FIGS. 12I to 12L show steps 9 to 12, and FIGS. 13M to 13P show steps 13 to 16. FIG. 14Q and FIG. 14R are explanatory diagrams showing procedures 17 and 18.
FIG. 15 is an explanatory diagram showing a state where the electrical stimulation device 1 according to the present embodiment is implanted under the skin of a living body.

(Procedure 1)
The doctor identifies the pain area 81 and the maximum pain site 82 in the patient's living body 80 by examination. Next, based on the specified pain region 81, puncture positions 83a to 83c for puncturing the pulling wire 84 under the skin are determined. Then, the doctor draws a cross mark indicating the determined puncture positions 83a to 83c on the surface of the living body 80 using a marking pen (not shown) (FIG. 10A). Puncture positions 83a to 83c are indicated by points where two straight lines forming a drawn cross intersect. The puncture positions 83a to 83c are determined at positions where the stimulation electrode 5A of the electrode lead 2A implanted subcutaneously is disposed at the lower end of the pain region 81 and the stimulation electrode 5B of the electrode lead 2B crosses the maximum pain site 82. Is done.

(Procedure 2)
Next, the doctor inserts the tip of the pulling wire 84 from the determined puncture position 83a, pushes the pulling wire 84 into the subcutaneous tissue of the living body 80, and then pushes the tip of the pulling wire 84 from the puncture position 83b to the body surface. (FIG. 10B). Since a puncture needle (not shown) is formed at the tip of the pulling wire 84, it is possible to push the pulling wire 84 subcutaneously by puncturing the puncture needle subcutaneously from the puncture position 83a.

(Procedure 3)
Next, the doctor connects the distal end of the insertion portion 3A of the electrode lead 2A to the connection portion 85 provided at the proximal end of the pulling wire 84, and then the distal end of the pulling wire 84 protruding from the puncture position 83b to the body surface. Is pulled (FIG. 10C). Then, the doctor pulls the pulling wire 84 until the insertion part 3A of the electrode lead 2A comes out of the body surface from the puncture position 83b. When the connecting portion 85 of the pulling wire 84 is drawn subcutaneously, the insertion portion 3A of the electrode lead 2A is drawn subcutaneously according to the movement of the connecting portion 85, and the electrode lead 2A moves in the subcutaneous. Then, the stimulation electrode 5 </ b> A of the electrode lead 2 </ b> A is disposed at the lower end of the pain region 81.

(Procedure 4)
Next, the doctor removes the insertion portion 3A of the electrode lead 2A taken out from the body surface from the connection portion 85 of the pulling wire 84 (FIG. 10D).

(Procedure 5)
Next, the doctor forms a small incision 86a at the puncture position 83a. This small incision 86a is made to provide a space for implanting the storage portion 7A under the skin (FIG. 11E).
(Procedure 6)
Next, the doctor inserts the tip of the pulling wire 84 from the puncture position 83c toward the small incision 86a formed in the procedure 5, pushes the pulling wire 84 into the subcutaneous tissue of the living body 80, and then the small incision 86a. The tip of the pulling wire 84 is taken out from the body surface (FIG. 11F).

(Procedure 7)
Next, the doctor connects the insertion portion 3B of the electrode lead 2B to the connection portion 85 provided at the proximal end of the pulling wire 84 (FIG. 11G).
(Procedure 8)
Next, the doctor pulls the pulling wire 84 that is brought out from the small incision 86a to the body surface (FIG. 11H). Then, the doctor pulls the pulling wire 84 until the insertion portion 3B of the electrode lead 2B comes out from the small incision 86a to the body surface. When the connecting portion 85 of the pulling wire 84 is drawn subcutaneously, the insertion portion 3B of the electrode lead 2B is drawn subcutaneously according to the movement of the connecting portion 85, and the electrode lead 2B moves inside the subcutaneous. Then, the stimulation electrode 5B of the electrode lead 2B is disposed at the maximum pain site 82. In addition, the electrode leads 2A and 2B are aligned so that the stimulation electrodes 5A and 5B are appropriately arranged with respect to the pain region 81. Then, the storage portion 7A of the electrode lead 2A and the insertion portion 3B of the electrode lead 2B are arranged close to each other so that the electrode leads 2A and 2B can be easily connected in series. Thereafter, the doctor removes the insertion portion 3 </ b> B of the electrode lead 2 </ b> B extended from the body surface from the connection portion 85 of the pulling wire 84.
The number of electrodes provided on the electrode leads 2A and 2B implanted subcutaneously is six, but the number of electrodes may be seven or more or less than six.

(Procedure 9)
Next, the doctor wraps the remainder of the lead portion 6A exposed on the body surface of the lead portion 6A of the electrode lead 2A around the shaft portion 7d of the bobbin 10a (FIG. 12I).
(Procedure 10)
Next, as shown in FIG. 3 described above, the doctor inserts the insertion part 3B of the electrode lead 2B into the opening 7f provided in the bobbin 10a. Then, the fixing screw 7i is screwed into the fixing screw hole 7h, and the insertion portion 3B is fixed to the opening 7f (FIG. 12J). Thereby, electrode lead 2A, 2B is connected in series.

(Procedure 11)
Next, the doctor combines the bobbin 10a and the bobbin cover 10b (FIG. 12K).
(Procedure 12)
Next, the doctor winds the remainder of the lead portion 6B exposed on the body surface of the lead portion 6B of the electrode lead 2B around the shaft portion 7e of the bobbin 10a (FIG. 12L).

(Procedure 13)
Next, the doctor bends the collar portion 7c and covers the bobbin 10a with the bent portion of the collar portion 7c (FIG. 13M). At this time, the lead portions 6A and 6B of the electrode leads 2A and 2B wound around the bobbin 10a are covered by the bent portion of the collar portion 7c. For this reason, the lead portions 6A and 6B are less likely to loosen from the bobbin 10a.

(Procedure 14)
Next, the doctor inserts a waterproof protector 87 into the opening 7f provided in the storage portion 7B of the electrode lead 2B (FIG. 13N). In this example, since the insertion portion 3C of the electrode lead 2C is not inserted into the storage portion 7B, the connector terminal 8B may be corroded when body fluid enters the opening 7f. For this reason, a protector 87 having the same thickness as the insertion portion 3C and the same length as the depth of the accommodating portion 7g is inserted into the opening portion 7f to prevent entry of body fluid. The protector 87 inserted into the opening 7f is fixed to the opening 7f by screwing a fixing screw 7i into a fixing screw hole 7h provided in the bobbin 10a of the storage portion 7B.

(Procedure 15)
Next, the doctor winds the remainder of the lead portion 6B exposed on the body surface of the lead portion 6B around the bobbin 10a of the storage portion 7B by the same procedure as the above-described procedures 9 to 13. And the collar part 7c of the accommodating part 7B is bent, and the bobbin 10a is covered with the bending part of the collar part 7c (FIG. 13O).
(Procedure 16)
Next, the doctor forms a small incision 86c at the puncture position 83c. The small incision 86c is made to provide a space for implanting the storage portion 7B under the skin (FIG. 13P).

(Procedure 17)
Next, the doctor implants the storage portion 7A into the small incision 86a and sutures the small incision 86a. Similarly, the doctor implants the storage portion 7B into the small incision 86c and sutures the small incision 86c (FIG. 14Q).
(Procedure 18)
Next, the doctor inserts the insertion portion 3A of the electrode lead 2A protruding from the puncture position 83b into the body surface into the connector 22 of the stimulation device 20 (FIG. 14R). Then, various patterns of stimulation are performed from the stimulation device 20 to adjust and determine the positions of the electrode leads 2A and 2B suitable for pain relief, parameters of the electrical stimulation signal, and the like.

(Procedure 19)
Next, the doctor creates a subcutaneous pocket for implanting the stimulation device 20 in the waist or abdomen of the patient, implants the stimulation device 20 in the created subcutaneous pocket, and completes implantation of the electrical stimulation device 1. (FIG. 15).

(Procedure 20)
Next, the doctor inputs the lead IDs of the electrode leads 2A and 2B written on the packaging of the electrode leads 2A and 2B to the controller 60 in the order of connection, and communicates with the stimulation device 20 to connect the electrode leads 2A and 2B. Obtain the number of each stimulation electrode. At this time, the control unit 65 of the stimulation device 20 reads the number of electrodes stored in the electrode number storage unit 44 of the lead IC chip 40 of the electrode leads 2A and 2B based on the lead ID received from the controller 60, and uses this value. It transmits to the controller 60. On the operation screen of the controller 60, the configuration of the stimulation electrodes 5A and 5B of the connection lead 2 is graphically displayed based on the information on the number of electrodes obtained from the stimulation device 20. On this operation screen, the doctor designates a stimulation electrode to which an electrical stimulation signal is applied, that is, a stimulation electrode to which a stimulation pulse is applied and a stimulation electrode to which a reference potential is applied, and sends a setting command to the stimulation apparatus 20. Thus, desired electrical stimulation can be performed.

  The electrode lead 2C can be connected to the electrode lead 2B and implanted subcutaneously by the same procedure as that for connecting the electrode lead 2B to the electrode lead 2A. In this case, the electrode leads 2A to 2C are connected in series, and furthermore, a wide range of pain regions 81 can be electrically stimulated by the eight stimulation electrodes 5A to 5C.

  According to the electrical stimulation apparatus 1 according to this embodiment described above, the electrode leads 2A to 2C are implanted under the skin of the living body 80, and peripheral nerve stimulation therapy is performed using the plurality of stimulation electrodes 5A to 5C. Thereby, it becomes possible to give electrical stimulation to the pain area | region 81 by the stimulation electrodes 5A-5C arrange | positioned in the pain area | region 81 of wider range than before. For this reason, electrical stimulation can be performed over the entire pain region 81 to alleviate pain.

  The surplus portions of the lead portions 6A to 6C of the electrode leads 2A to 2C that are exposed from the living body 80 to the body surface are respectively stored in the storage portions 7A to 7C, and the lead portions 6A to 6A are implanted under the skin of the living body 80. Biological tissue is less likely to get entangled in the remainder of 6C. For this reason, even if it is electrode lead 2A-2C implanted once subcutaneously, it is easy to unwind lead parts 6A-6C from storage parts 7A-7C again, and to perform position adjustment of stimulation electrodes 5A-5C.

  The storage portions 7A to 7C can be separated into a bobbin 10a and a bobbin cover 10b, respectively. For example, the insertion portion 3B of the electrode lead 2B inserted into the housing portion 7g provided on the bobbin 10a of the electrode lead 2A can be reliably fixed using the fixing screw 7i. For this reason, even when the storage portion 7A is implanted under the skin of the living body 80, the insertion portion 3B does not fall out of the storage portion 7g, and the pain region 81 can be electrically stimulated safely.

  In addition, the electrical stimulation device 1 can implant all of the stimulation device 20 and the electrode leads 2A to 2C subcutaneously with respect to the SCS system in which the electrode lead is implanted in the epidural space. Therefore, implantation can be performed by a very minimally invasive technique, and the burden on the patient's living body 80 is small. Also, troubles such as epidural hematoma, nerve damage, and dural puncture that occur when an electrode lead is implanted into the epidural space in the SCS system can be avoided.

  In addition, the doctor can easily change the positions of the stimulation electrodes 5A to 5C while holding both ends of the electrode leads 2A to 2C by implanting the electrode leads 2A to 2C under the skin of the living body 80 in a straight state. For this reason, it is easy for the doctor to determine the implantation positions of the stimulation electrodes 5A to 5C, and the operation time can be shortened compared to the SCS system. Further, portions where the electrode leads 2A to 2C are exposed from the living body 80 are housed in the housing portions 7A to 7C and implanted subcutaneously. For this reason, even if a patient changes a body position, since the part by which electrode lead 2A-2C was put together follows a patient's motion, position shift of stimulation electrodes 5A-5C can be suppressed.

  Conventionally, in order to implant a plurality of electrode leads, it is necessary to use a stimulator having a multi-connector or a distributor called a splitter. It had to be routed from the device to the pain area, which was a very complicated task during implantation. However, in the electrode leads 2A to 2C connected in series according to the present embodiment, the single electrode lead 2A may be routed from the stimulating device 20 to the pain region, and the burden of implantation can be reduced.

  Further, in the conventional SCS system, since the electrode lead is implanted in the epidural space under fluoroscopy, a long time is required for the operation. However, since the electrode leads 2A to 2C according to the present embodiment are implanted subcutaneously, an operation can be performed without requiring X-ray fluoroscopy, and there is no fear of radiation exposure to the patient.

<2. Modification>
Various modifications can be envisaged for the present invention.
For example, the combination of the number of electrodes constituting the stimulation electrodes 5A to 5C is a combination of two, four, and two electrodes, but these numbers are merely examples, and have other numbers. A stimulation electrode may be combined. For example, the number of electrodes constituting the stimulation electrodes 5A to 5C may be the same or different from each other. Further, the number of electrode leads used in the electrical stimulation device 1 is not limited to two or three, and may be appropriately increased or decreased to one or four or more. Moreover, you may make it different, without making the space | interval of the stimulation electrode arrange | positioned for every electrode lead constant.

  The storage portions 7A to 7C are provided at the distal ends of the electrode leads 2A to 2C, but may be provided at the proximal ends of the electrode leads 2A to 2C. In the case of such a configuration, the lead IC chip 40 is disposed inside the storage portions 7A to 7C. As a result, an electrical stimulation signal having an appropriate stimulation intensity can be supplied to the stimulation electrodes 5A to 5C by the lead IC chip 40 disposed closer to the proximal end side than the stimulation electrodes 5A to 5C.

  In the above-described embodiment, the lead IC chip 40 of each electrode lead is identified by using the lead ID, but an electrode lead that does not have the lead IC chip 40 may be used. . In this case, a stimulation circuit having the same function as that of the stimulation circuit 30 grasps the position of each stimulation electrode provided on the electrode leads connected in series, and generates an electrical stimulation signal having an appropriate stimulation intensity. Output to. Even with such an electrode lead, a storage portion similar to the storage portions 7A to 7C described above can be provided, and the remainder of the lead portion can be stored in the storage portion.

  Alternatively, the remainder of the lead portions 6A to 6C may be wound around the storage portions 7A to 7C and the collar portion 7c may be bent, and then the whole may be bonded with an adhesive. Moreover, the surplus part of lead part 6A-6C can also be fixed to storage part 7A-7C with the swelling agent apply | coated to the outer peripheral surface of the collar parts 7a-7c. If such storage portions 7A to 7C are placed on the living body 80, the swelling agent absorbs the body fluid to increase the volume of the swelling agent, and covers the lead portions 6A to 6C stored in the storage portions 7A to 7C. . And it becomes difficult to loosen lead part 6A-6C from storage part 7A-7C. Moreover, since the unevenness | corrugation arises in the surface where a swelling agent contacts the biological body 80, accommodating part 7A-7C implanted in the biological body 80 becomes difficult to move from an implantation position.

  Further, the interval of the cuts provided in the collar portion 7c may be more or less than the 90 degree interval. Further, the intervals between the cuts may not be equal.

  Further, by providing a projection or the like on the outer edge portion of the collar portion 7c, when the collar portion 7c is bent, the projection portion fits into a notch portion or the like provided on the outer edge portion of the collar portion 7a. May be. Thereby, it can prevent that a bodily fluid etc. penetrate | invade from the clearance gap produced when the bent collar part 7c opened.

  Further, the stimulation device 20 is provided with the connector 22 protruding from the housing 21, but the connector 22 is housed inside the housing 21 to eliminate the portion protruding from the housing 21, thereby reducing the size of the stimulation device 20. Also good.

  Further, although the stimulation device 20 and the electrode lead 2A are configured to be connected via the connector 22, they may be configured to be connected via an extension lead that does not have a stimulation electrode.

  Moreover, you may comprise so that the stimulation electrode 5A which expanded the space | interval of an electrode may be arrange | positioned at 6 A of lead parts. Thereby, for example, the living body 80 can be electrically stimulated with only one electrode lead 2A that is bent between the electrodes of the stimulation electrode 5A and implanted subcutaneously.

  Further, although the electrode leads 2A to 2C are implanted in the living body 80 in a substantially Z-shaped pattern as shown in FIG. 14, the electrode leads 2A to 2C may be implanted in other patterns. For example, various patterns such as a substantially square shape, a substantially W shape, and a substantially M shape can be used. Further, not only the electrode leads 2A, 2B, and 2C are connected in series, but also the electrode leads 2B, 2A, and 2C may be connected in series, for example.

  In the above-described embodiment, since the lead IC chip 40 is built in the insertion portions 3A to 3C of the electrode leads 2A to 2C, the insertion portions 3A to 3C side of the electrode leads 2A to 2C become the proximal end, and the storage portion The 7A-7C side is configured to be the distal end. However, after the lead IC chip 40 is built in the accommodating portions 7A to 7C of the electrode leads 2A to 2C, the insertion portions 3A to 3C are arranged on the distal end side of the electrode leads 2A to 2C, and the proximal end side is arranged. It is good also as a structure which has arrange | positioned storage part 7A-7C.

  Further, the present invention is not limited to the above-described embodiments, and various other application examples and modifications may be taken without departing from the gist of the present invention described in the claims.

  DESCRIPTION OF SYMBOLS 1 ... Electrical stimulator, 2A-2C ... Electrode lead, 3A-3C ... Insertion part, 4A-4C ... Insertion terminal, 5A-5C ... Stimulation electrode, 6A-6C ... Lead part, 7A-7C ... Storage part, 8A- 8C ... Connector terminal, 9 ... Lead wire, 10a ... Bobbin, 10b ... Bobbin cover, 20 ... Stimulator, 30 ... Stimulus circuit

Claims (7)

A lead portion that is flexible and has a lead wire disposed therein; a first terminal portion provided at one end of the lead portion; a storage portion provided at the other end of the lead portion; Provided between the first terminal portion and the storage portion, electrically connected to the first terminal portion by the conductive wire, and a living body by an electrical stimulation signal supplied from the first terminal portion An electrode lead having a stimulation electrode for electrical stimulation;
A stimulation device having a stimulation circuit for supplying the electrical stimulation signal to the stimulation electrode,
An electrical stimulation device in which a surplus portion of the lead portion is stored in the storage portion. The electrode lead is connected to an electrode control unit provided for each stimulation electrode, an electrode identification information storage unit that stores electrode identification information assigned in correspondence with the arrangement of the stimulation electrodes, and the electrode control unit. And a lead identification information storage unit for storing lead identification information for identifying the electrode leads,
The stimulation circuit designates the electrode lead and the stimulation electrode in the electrode lead using the lead identification information and the electrode identification information, and sends the electrical stimulation signal to the stimulation electrode in the designated electrode lead. The electrical stimulation device according to claim 1 to be supplied. The electrode lead has a second terminal portion provided in the storage portion,
A state in which the second terminal portion of one of the electrode leads and the first terminal portion of the other electrode lead are connected in series, and at least two of the electrode leads are connected to the stimulation device The electrical stimulation device according to claim 1, wherein a surplus portion of the lead portion of the other electrode lead is housed by the housing portion. The electrical stimulation device according to claim 3, wherein the storage unit separately stores a surplus portion of the lead portion of one electrode lead and a surplus portion of the lead portion of another electrode lead. The storage portion has a columnar first shaft portion provided with first and second collar portions at both ends, and a columnar second shaft portion provided with a third collar portion at one end. The lead portion of the one electrode lead between the first and second collar portions provided on the first shaft portion in a state where the first shaft portion and the second shaft portion are combined. 5. The electrical stimulation device according to claim 4, wherein the lead portion of the other electrode lead is wound between the second and third collar portions provided on the second shaft portion. The first shaft portion of the one electrode lead housing portion is integrally connected to the first terminal portion of the lead portion of the other electrode lead, and the one electrode lead has. The electrical stimulation device according to claim 5, wherein the second terminal portion is provided. The electrical stimulation device according to claim 6, wherein the third collar portion is deformed so as to cover the lead portion wound around the first shaft portion and the second shaft portion.