WO2014049737A1 - Insertion instrument - Google Patents

Insertion instrument Download PDF

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Publication number
WO2014049737A1
WO2014049737A1 PCT/JP2012/074761 JP2012074761W WO2014049737A1 WO 2014049737 A1 WO2014049737 A1 WO 2014049737A1 JP 2012074761 W JP2012074761 W JP 2012074761W WO 2014049737 A1 WO2014049737 A1 WO 2014049737A1
Authority
WO
WIPO (PCT)
Prior art keywords
insertion rod
stimulation
pusher
electrode
wire
Prior art date
Application number
PCT/JP2012/074761
Other languages
French (fr)
Japanese (ja)
Inventor
美仁 福井
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2012/074761 priority Critical patent/WO2014049737A1/en
Publication of WO2014049737A1 publication Critical patent/WO2014049737A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters

Definitions

  • the present invention relates to an insertion tool for inserting an insertion rod into a living body.
  • Spinal cord electrical stimulation therapy which is one of electrical stimulation therapies, is a stimulation therapy that electrically stimulates nerves in the spinal cord in order to relieve pain transmitted to the brain through the spinal cord.
  • test stimulus In spinal cord electrical stimulation therapy, a test stimulus (hereinafter referred to as “test stimulus”) is usually performed to confirm the effectiveness of pain relief by electrical stimulation.
  • test stimulus only an electrode lead having a stimulation electrode for electrically stimulating the spinal cord at its distal end is inserted into the epidural space outside the spinal dura covering the spinal cord. Then, the degree of pain relief is examined by connecting the electrode lead to an extracorporeal stimulation device and conducting electrical stimulation of spinal nerves under various stimulation patterns with the stimulation electrode.
  • an electrical stimulation device is implanted (hereinafter referred to as “main implantation”).
  • the electrode lead is advanced to a predetermined position in the epidural space by puncturing from the back, and a test stimulation device is connected to the electrode lead to perform electrical stimulation of the spinal cord, thereby determining the optimum position of the electrode lead.
  • the stimulation device for testing is removed from the electrode lead while the electrode lead is left in the epidural space, a small incision is made on the back portion of the electrode lead, and then the stimulation device for permanent implantation in the patient's waist A small incision is made in the lumbar region.
  • a subcutaneous tunnel is formed from the small incision in the waist toward the small incision in the back where the electrode lead is inserted. .
  • This subcutaneous tunnel is formed by pushing a long insertion rod having a reduced diameter.
  • a subcutaneous pocket is formed from a small incision in the waist and the stimulator is placed.
  • the lead wire extended from the stimulation device is wound on the subcutaneous tunnel and connected to the electrode lead including the stimulation electrode placed in the epidural space at the small incision in the back.
  • the stimulation device placed in the living body applies electrical stimulation to the electrode lead, and the stimulation of the spinal cord with the stimulation electrode makes it possible to alleviate the patient's pain.
  • a technique for implanting an electrical stimulation device in a living body a technique is known in which a subcutaneous tunnel is formed in a living body using an insertion tool comprising a long and thin insertion rod and a hollow sheath mounted so as to cover the insertion rod.
  • an insertion tool comprising a long and thin insertion rod and a hollow sheath mounted so as to cover the insertion rod.
  • the insertion rod has moderate strength, the tip of the insertion rod is closer to the body surface than the subcutaneous tissue when passing the insertion rod under the skin, especially when passing through the curved part of the body. May get caught in the dermis layer of the skin. For this reason, it is difficult to advance the insertion rod subcutaneously with a small force.
  • the tip of the insertion rod is caught under the skin, it is possible to push the insertion rod without being caught under the skin by pushing the tip of the insertion rod under the skin from the body surface.
  • the diameter of the insertion rod is only a few millimeters.
  • the skin from the waist to the back is thick, and fat and the like are easily attached to the skin. For this reason, the doctor cannot grasp
  • the present invention has been made in view of such a situation, and an object thereof is to allow an insertion rod to be easily inserted into a living body.
  • the insertion tool includes an insertion rod having one end inserted into the living body, a pressing tool that presses one end of the insertion rod inserted into the living body from the body surface, and one end connected to the pressing tool.
  • a pusher wire having a length substantially equal to the length of the pusher wire, a pusher wire fixing part for fixing the other end of the insertion rod and the other end of the pusher wire, and a grasping part for inserting the insertion rod into the living body.
  • the doctor can press down one end of the insertion rod inserted into the living body from the body surface with the pressing tool while the pressing tool wire having a length substantially equal to that of the insertion rod is stretched. For this reason, one end of the insertion rod can be easily grasped from the body surface, and the insertion rod can be easily inserted into the living body by pressing the pusher.
  • FIG. 1 is a perspective view showing an entire electrical stimulation apparatus according to an embodiment of the present invention.
  • FIG. 1A is a perspective view illustrating a configuration example of an electrode lead, an auxiliary lead, and a stimulation device.
  • FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead is connected to the electrode lead. It is a functional block diagram centering on the stimulation circuit which concerns on one embodiment of this invention. It is an external appearance perspective view which shows the structural example of the insertion tool which concerns on one embodiment of this invention.
  • FIG. 4 is an explanatory view showing an example of a cross-sectional view of the insertion tool shown in FIG. 3 along the line AA ′.
  • FIG. 5A is an explanatory diagram illustrating a state in which the insertion rod is inserted into the living body.
  • FIG. 5B is an explanatory view showing an example using an insertion rod receiving portion. It is explanatory drawing which shows the implantation procedure 1 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. It is explanatory drawing which shows the implantation procedure 2 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. It is explanatory drawing which shows the implantation procedure 3 in the living body of the electric stimulator which concerns on one embodiment of this invention.
  • FIG. 22A is an explanatory diagram showing a state of an operation of attaching the distal end portion of the extension to the insertion rod.
  • FIG. 22B is a configuration diagram of a bending prevention rod. It is explanatory drawing which shows the implantation procedure 18 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention.
  • FIG. 1 is a perspective view showing a schematic configuration example of each part constituting the electrical stimulation apparatus 1 according to the first embodiment of the present invention.
  • FIG. 1A is a perspective view illustrating a configuration example of the electrode lead 2, the auxiliary lead 3, and the stimulation device 4.
  • FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead 3 is connected to the electrode lead 2.
  • the electrical stimulation device 1 stimulates nerves and / or muscles in a living body with electrical stimulation signals (hereinafter referred to as “electrical stimulation signals”).
  • electrical stimulation signals In spinal cord electrical stimulation therapy, the nerves of the spinal cord are stimulated. Is.
  • the electrical stimulation device 1 is implanted in a living body, and an electrode lead 2 that is used to guide and stimulate an electrical stimulation signal to nerves and / or muscles, and an electrode lead 2.
  • Auxiliary lead 3 used in connection with the electrode lead 2 and a stimulation device 4 for supplying an electrical stimulation signal to the electrode lead 2.
  • the auxiliary lead 3 is used by being connected to the electrode lead 2 at the time of the test stimulus when the electrode lead 2 is implanted into the living body, and is removed from the electrode lead 2 after the test stimulus is completed.
  • the electrode lead 2 is configured as a substantially cylindrical long body, and at one end thereof, four stimulation electrodes 5 for stimulating spinal nerves are provided. The other end is provided with a connector 7 to which a terminal electrode 8 of the auxiliary lead 3 described later or a terminal electrode 15 of the stimulating device 4 is connected.
  • the end portion of the electrode lead 2 on the side close to the stimulation device 4 in a state in which the stimulation device 4 is connected to the electrode lead 2 is referred to as a proximal end, and is located at a far position.
  • the end on the side where it is arranged is called the distal end. That is, the end on the side where the stimulation electrode 5 is provided is the distal end, and the end on the side where the connector 7 is provided is the proximal end.
  • the stimulation electrode 5 is made of a material having conductivity and biocompatibility, such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy), and is hollow. It is formed in a substantially cylindrical shape.
  • the number of stimulation electrodes 5 is four, but this number is merely an example, and the number of stimulation electrodes 5 can be arbitrarily set.
  • the electrode lead 2 is provided with a body 6 as a lead portion, and four stimulation electrodes 5 are formed at the tip of the body 6.
  • the body 6 is fixed so that the four stimulation electrodes 5 are exposed to the living body when the electrode lead 2 is placed in the living body.
  • the body 6 is made of a flexible and biocompatible material, for example, a long body formed of a resin material such as silicone or polyurethane in a substantially cylindrical shape. It is preferable that it is 3 mm.
  • a substantially cylindrical hole (shown in the figure) that opens at the proximal end serving as a connection portion with the connector 7 and communicates through the hollow portion of the stimulation electrode 5 to the vicinity of the distal end. Is omitted in the axial direction.
  • This hole is a hole into which a stylet for pushing the electrode lead 2 and keeping the shape of the electrode lead 2 is inserted while the stimulation electrode 5 is inserted into the living body. Represented as “Lumette for Lett”
  • the connector 7 is formed of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, in a hollow and substantially cylindrical shape, and has a contact electrode (not shown) therein.
  • the contact electrode and the stimulation electrode 5 are electrically connected by a conducting wire (not shown), and this conducting wire is completely embedded in the body 6.
  • the terminal electrode 8 of the auxiliary lead 3 or the terminal electrode 15 of the stimulation device 4 is inserted into the hollow portion of the connector 7.
  • a groove 7 a as a connection mechanism with the auxiliary lead 3 is provided at the proximal end of the connector 7.
  • the outer shape of the connector 7 is preferably 3 to 9 mm.
  • the auxiliary lead 3 is configured as a substantially cylindrical long body, and four terminal electrodes 8 corresponding to the stimulation electrodes 5 of the electrode lead 2 are provided at one end thereof. At the other end, four terminal electrodes 9 corresponding to the stimulation electrodes 5 of the electrode lead 2 are provided.
  • the terminal electrode 8 and the terminal electrode 9 are made of a conductive and biocompatible material such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, 90% platinum / 10% iridium alloy). And is held by a body 10 made of an elongated body formed in a substantially cylindrical shape.
  • the terminal electrode 8 and the terminal electrode 9 are electrically connected by a conductive wire (not shown) completely embedded in the body 10.
  • the material of the body 10 is a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane.
  • the terminal electrode 8 is inserted into the connector 7 of the electrode lead 2, and the terminal electrode 9 is connected to an extracorporeal stimulation device (not shown) that generates an electrical stimulation signal for test stimulation.
  • an extracorporeal stimulation device (not shown) that generates an electrical stimulation signal for test stimulation.
  • the end portion of the auxiliary lead 3 on the side close to the extracorporeal stimulation device in a state in which the extracorporeal stimulation device is connected to the terminal electrode 9 is referred to as a proximal end, and the far end is located.
  • the end on the side where it is arranged is called the distal end. That is, the end of the electrode lead 2 on the side where the terminal electrode 8 accommodated in the connector 7 is provided is the distal end, and the end on the side where the terminal electrode 9 to which the extracorporeal stimulation device is connected is proximal. End.
  • an engaging member 11 is provided near the center of the body 10 in the axial direction as a connection mechanism with the connector 7 of the electrode lead 2.
  • the engaging member 11 is formed on the circumference of the body 10 so as to protrude from the body 10, and a claw portion (not shown) that engages with the groove portion 7 a of the connector 7 of the electrode lead 2 at the tip thereof. Is formed.
  • the material of the engaging member 11 is not limited to silicone or polyurethane, and any material may be used as long as it is flexible and biocompatible.
  • the auxiliary lead 3 is provided with a stylet lumen (not shown) penetrating from the proximal end to the distal end.
  • the stylet lumen communicates from the proximal end of the auxiliary lead 3 to the vicinity of the distal end of the electrode lead 2.
  • the stimulating device 4 includes a housing 13 and an extension 14 that relays the stimulating device 4 and the electrode lead 2. Inside the housing 13, a stimulation circuit 12 that generates an electrical stimulation signal and applies the generated electrical stimulation signal to the stimulation electrode 5 is provided.
  • the housing 13 is made of a relatively hard and biocompatible metal or resin, such as titanium or epoxy, and has a substantially rectangular parallelepiped shape.
  • the extension 14 is formed in a substantially cylindrical shape, and its axial center portion is hollow. At the end (distal end) of the extension 14 accommodated in the connector 7 of the electrode lead 2, the terminal electrode 15 corresponding to the stimulation electrode 5, and when held in the connector 7, the electrode lead 2 is fixed with a fixing screw. A fixing ring 17 to be fixed is provided.
  • the terminal electrode 15 is held by a body 16 made of an elongated body formed in a substantially cylindrical shape, and is connected to the stimulation circuit 12 inside the housing 13 by a lead wire (not shown) embedded in the body 16. Yes. That is, the proximal end of the extension 14 is embedded in the housing 13 of the stimulating device 4 and is formed integrally with the housing 13.
  • the body 16 is made of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, and its outer diameter is preferably 1 to 3 mm.
  • the terminal electrode 15, the fixing ring 17, and the conductor are conductive and biocompatible materials such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, 90% platinum / 10% iridium alloy), etc. Is used.
  • the stimulation circuit 12 is a circuit in which a small component such as a custom IC is mounted on a circuit board.
  • the stimulation circuit 12 generates an electrical stimulation signal and performs control to apply the generated electrical stimulation signal to the stimulation electrode 5.
  • the stimulation circuit 12 and each electrode of the terminal electrode 15 associated with the stimulation electrode 5 are connected to the body of the extension 14. 16 are electrically connected by conductive wires (not shown) embedded therein.
  • the electrical configuration of the stimulation circuit 12 will be described later with reference to FIG.
  • FIG. 2 is a functional block diagram showing the electrical configuration of the stimulation circuit 12 and the terminal electrode 15 of the extension 14 connected to the stimulation circuit 12 according to an embodiment of the present invention.
  • the stimulation circuit 12 includes a coil unit 21, a charging unit 22, a rechargeable battery 23, a communication unit 24, a control unit 25, a stimulation parameter setting unit 26, an oscillation unit 27, an electrode configuration setting unit 28, a switch Part 29.
  • the coil unit 21 is a resonance circuit composed of, for example, a coil and a capacitor.
  • the coil unit 21 receives an electromagnetic wave for charging transmitted from an external controller (not shown). Then, an alternating current generated from the coil unit 21 with this reception is output to the charging unit 22.
  • the coil unit 21 receives an electromagnetic wave on which predetermined information is transmitted, which is transmitted from an external controller (not shown), and the received electromagnetic wave is output from the coil unit 21 to the communication unit 24.
  • the charging unit 22 has a built-in rectifier circuit, converts the alternating current output from the coil unit 21 into a direct current, and acquires power. Then, the rechargeable battery 23 is charged with the acquired power.
  • the rechargeable battery 23 is a rechargeable battery such as a lithium ion battery. Although not shown in FIG. 2, the rechargeable battery 23 supplies the accumulated power to each block constituting the stimulation circuit 12.
  • the communication unit 24 demodulates the electromagnetic wave received by the coil unit 21 and extracts information carried on the electromagnetic wave. Then, the extracted information is output to the stimulation parameter setting unit 26 and the electrode configuration setting unit 28 via the control unit 25.
  • the information output to the stimulation parameter setting unit 26 is information regarding the stimulation intensity of the electrical stimulation signal (hereinafter referred to as “stimulation parameter”)
  • the information output to the electrode configuration setting unit 28 is information regarding the electrode configuration ( Hereinafter, this is referred to as “electrode configuration information”.
  • the stimulation intensity of the electrical stimulation signal is determined by the pulse voltage, pulse current, pulse width, or frequency of the electrical stimulation signal, and values such as the pulse voltage are set as stimulation parameters.
  • the electrode configuration information includes information for changing the polarity of the electrical stimulation signal and information for causing the switch unit 29 to select the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal. Signal.
  • the stimulation parameter setting unit 26 generates a stimulation intensity change signal for changing the stimulation intensity of the electrical stimulation signal generated by the oscillation unit 27 based on the stimulation parameter input from the communication unit 24.
  • the oscillation unit 27 generates an electrical stimulation signal based on the stimulation intensity change signal input from the stimulation parameter setting unit 26, and outputs the electrical stimulation signal to the switch unit 29.
  • the electrode configuration setting unit 28 selects an electrode configuration corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal generated by the oscillation unit 27 based on the electrode configuration information input from the communication unit 24. A selection signal is generated.
  • the stimulation intensity change signal output from the stimulation parameter setting unit 26 is output to the oscillation unit 27, and the electrode configuration selection signal output from the electrode configuration setting unit 28 is output to the switch unit 29.
  • the switch unit 29 determines the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal input from the oscillation unit 27 based on the electrode configuration selection signal input from the electrode configuration setting unit 28.
  • a microcomputer or the like is used as the control unit 25, and the control unit 25 controls each block of the stimulation circuit 12.
  • FIG. 3 is an external perspective view showing a configuration example of the insertion tool 50.
  • FIG. 4 is an explanatory diagram showing an example of a cross-sectional view of the insertion tool 50 shown in FIG. 3 along the line AA ′.
  • the insertion tool 50 includes a pressing tool wire fixing part 51, a gripping part 52, a pressing tool wire fastening part 53, a pressing tool wire 54, an insertion rod 55, a pressing tool 56, and an insertion rod receiving part 57.
  • the pusher wire fixing portion 51 is formed in a substantially cylindrical shape with a relatively hard resin having biocompatibility such as epoxy, and fixes one end of the insertion rod 55 and one end of the pusher wire 54.
  • the pusher wire fixing portion 51 includes a bobbin 51 a and an elastic portion 51 b. One end of the elastic portion 51 b is connected to the bobbin 51 a and the other end is connected to the casing of the pusher wire fixing portion 51.
  • the pusher wire fixing portion 51 is formed with a pusher wire penetration portion 51c through which the pusher wire 54 passes, an insertion rod fixing portion 51d for fixing one end of the insertion rod 55, and a bobbin guide 51e.
  • the pusher wire 54 is fixed to the core part of the bobbin 51 a provided in the pusher wire fixing part 51.
  • the pusher wire 54 may be a flexible resin material having biocompatibility such as nylon or polypropylene and having a predetermined tensile strength.
  • One end of the pusher wire 54 is connected to the pusher 56 and is formed to have a length substantially equal to that of the insertion rod 55.
  • An internal thread is formed in the insertion rod fixing portion 51d. Then, one end of an insertion rod 55 formed with a male screw is screwed into and fixed to the insertion rod fixing portion 51d.
  • the bobbin 51a is pulled in a direction opposite to the pulling direction of the pusher wire 54 by the elastic portion 51b.
  • a tension spring is used for the elastic portion 51b.
  • the elastic portion 51b has a function of moving the bobbin 51a by a predetermined distance in the direction in which the pusher wire 54 is pulled when the pusher wire 54 is pulled with a force larger than the elastic force of the elastic portion 51b.
  • the bobbin 51a moves within a range (about 2 to 3 cm) where the bobbin guide 51e is formed.
  • the material of the bobbin 51a the same material as the pusher wire fixing portion 51 can be used.
  • the material of the tension spring biocompatible stainless steel or the like can be used.
  • the grasping part 52 is a part held by the doctor when the insertion rod 55 is inserted into the living body, and is formed in a substantially cylindrical shape using a relatively hard resin having biocompatibility such as epoxy as a material. Yes.
  • a through hole 52a through which the insertion rod 55 passes and a female screw 52b in a direction perpendicular to the through hole 52a are formed at the center of the grip portion 52.
  • the diameter of the through hole 52 a is slightly larger than the diameter of the insertion rod 55. For this reason, even if the insertion rod 55 is inserted in the through hole 52 a, the grip portion 52 can be moved with respect to the insertion rod 55.
  • the insertion rod 55 that penetrates the through hole 52a formed in the grip portion 52 is configured as a long body using, for example, a relatively hard and biocompatible stainless steel as a material, and the diameter thereof is, for example, about 2 mm.
  • the distal end portion inserted into the living body has a conical shape, and the other end is formed with a male screw for fixing to the insertion rod fixing portion 51d.
  • the insertion rod 55 is fixed at two points by the insertion rod fixing portion 51 d and the grip portion 52. For this reason, the doctor can easily control the position of the distal end portion of the insertion rod 55 inserted into the living body by having the pusher wire fixing portion 51 and the grip portion 52.
  • the pressing wire fastening portion 53 formed in the grip portion 52 fixes the insertion rod 55 penetrating the through hole 52a to the grip portion 52 at a predetermined position.
  • a male screw formed on the pusher wire fastening portion 53 is screwed into and fixed to the female screw 52b of the grip portion 52. Since the male screw of the pusher wire fastening portion 53 strongly presses the insertion rod 55 within the through hole 52a, the grip portion 52 cannot be easily moved with respect to the insertion rod 55. For this reason, the doctor can insert the insertion rod 55 into the living body by holding the grip portion 52 and applying force to the insertion rod 55. The doctor can move the grip 52 on the insertion rod 55 to a position where it is easy to apply a force to the insertion rod 55 by loosening the male screw of the pusher wire fastening portion 53.
  • a through hole 53 a through which the pusher wire 54 is inserted is formed in a portion where the pusher wire fastening portion 53 is exposed from the grip portion 52.
  • the pusher wire 54 inserted into the through-hole 53a is stretched with a predetermined tensile force between the pusher wire fixing portion 51 and the pusher wire fixing portion 51. For this reason, the pressing tool wire 54 inserted into the through hole 53a is in a state where a certain tension is applied to the bobbin 51a.
  • the same material as the insertion rod 55 can be used as the material of the pressing wire fastening portion.
  • the pusher 56 to which the pusher wire 54 is connected is formed of, for example, epoxy resin, and is used to push down one end (hereinafter also referred to as “tip portion”) of the insertion rod 55 from the body surface.
  • the length of the pusher wire 54 is substantially equal to the length from the portion fixed to the pusher wire fixing portion 51 to the tip portion of the insertion rod 55 inserted into the living body. For this reason, even if the doctor cannot visually recognize the distal end portion of the insertion rod 55 inserted into the living body from the body surface, if the doctor pulls the pressing tool wire 54 along the body surface, the position of the pressing tool 56 is determined.
  • the tip part of can be adjusted to a certain position.
  • FIG. 5 is an explanatory diagram showing how to use the pusher 56 and the insertion rod receiving portion 57.
  • FIG. 5A is an explanatory diagram showing a state where the insertion rod 55 is inserted into the living body.
  • FIG. 5B is an explanatory diagram showing an example using the insertion rod receiving portion 57.
  • the pusher 56 is formed with an insertion rod receiving portion 57 to which one end of the insertion rod 55 is pressed.
  • the insertion rod receiving portion 57 is formed in a protruding shape with respect to the pusher 56, and a recess 57a (see FIG. 3) is formed near the center thereof.
  • As the material of the insertion rod receiving portion 57 the same material as the pusher 56 can be used.
  • the insertion rod receiving portion 57 has the following uses.
  • one end of the insertion rod 55 is inserted subcutaneously about 3 to 6 mm from the body surface, and a subcutaneous tunnel is formed in the living body. Since this procedure is generally performed with the patient rolling his / her back, when the insertion rod 55 is pushed subcutaneously, the tip of the insertion rod 55 is caught by the dermis layer of the skin 59 on the body surface side of the subcutaneous tissue. There is. At this time, since the diameter of the insertion rod 55 is very thin, the insertion rod 55 may bend and not advance further when a force for pushing the subcutaneous is applied.
  • the doctor performs an operation of pushing the pusher 56 subcutaneously from the body surface.
  • the insertion rod 55 is very thin, it is difficult to know where the tip portion is from the body surface.
  • the pusher wire 54 is stretched as described above, the pusher 56 The position can be adjusted to the position of the tip portion of the insertion rod 55. For this reason, the distal end portion of the insertion rod 55 is easily inserted subcutaneously without being caught by the dermis layer of the skin 59.
  • the incised portion is inserted because the skin 59 is cut.
  • the resistance to push the rod 55 suddenly decreases.
  • the tip of the insertion rod 55 may jump out of the body surface, bend in an unintended direction, or jump up, which may injure the doctor's hand or the patient's tissue.
  • the pusher fixed to the pusher 56 as described above by pulling the pusher 56 with a force larger than a predetermined threshold in the vicinity where the tip of the insertion rod 55 is exposed to the body surface.
  • the bobbin 51 a is pulled through the wire 54.
  • the pulling force stretches the elastic portion 51b (see FIG. 4), moves the bobbin 51a along the bobbin guide 51e, and positions the pusher 56 ahead of the distal end portion of the insertion rod 55.
  • the pusher 56 is turned over, and the insertion rod receiving portion 57 is pushed subcutaneously from the place where the skin 59 is incised.
  • the tip of the insertion rod 55 comes out of the skin, the tip of the insertion rod 55 is inserted.
  • the doctor determines a target spinal stimulation site in advance based on the distribution of pain of the patient.
  • the electrode lead 2 is inserted from the target stimulation site from the lower position of three or more vertebral bodies of the spine.
  • local anesthesia is performed with a syringe 32 on the skin and subcutaneous tissue where the electrode lead 2 is to be inserted.
  • the doctor inserts the epidural needle 33 having a hollow center with a split type or a slit into the position where the electrode lead 2 is to be inserted under the fluoroscopy. The tip is inserted into the epidural space 31.
  • the tip of the electrode lead 2 through which the stylet 34 is inserted is passed through the hollow portion of the epidural needle 33, and the electrode lead 2 is inserted into the living body 30.
  • the electrode lead 2 is inserted into the epidural space 31 by pushing the stylet 34 in the axial direction from the proximal end.
  • the doctor further pushes the proximal end of the stylet 34 in the axial direction, thereby causing the position of the electrode lead 2 in the epidural space 31 to face upward, and targeting the stimulation electrode 5 of the electrode lead 2. Locate near the stimulation site.
  • the extracorporeal stimulation device 35 connects, for example, a housing 35a having a stimulation circuit (not shown) therein, a clip portion 35b that is held with the terminal electrode 9 of the auxiliary lead 3 interposed therebetween, and a clip portion 35b and the housing 35a. It consists of a lead part 35c.
  • the clip portion 35b has a contact electrode (not shown) on the inner side thereof, and this contact electrode is connected to a stimulation circuit inside the housing 35a by a lead wire (not shown) embedded in the lead portion 35c.
  • the clip portion 35 b connects the terminal electrode 9 and the contact electrode by sandwiching the terminal electrode 9 of the auxiliary lead 3, whereby the stimulation electrode 5 is connected to the stimulation circuit of the extracorporeal stimulation device 35.
  • the stimulation circuit in the housing 35a selects the stimulation electrode 5 that emits an electrical stimulation signal based on an instruction input by an indicator 35d such as a stylus pen on the operation surface of the housing 35a, the voltage of the electrical stimulation signal, Adjust frequency, pulse width, etc.
  • the electrical stimulation signal thus adjusted is output to the stimulation electrode 5, thereby stimulating a portion of the nerve close to the position of the stimulation electrode 5.
  • This test stimulation is performed in a state where the terminal electrode 9 of the auxiliary lead 3 is sandwiched by the clip portion 35b of the extracorporeal stimulation device 35. Then, the doctor determines the optimum position of the stimulation electrode 5, the voltage, frequency, pulse width, etc. of the electrical stimulation signal while listening to the response to the nerve stimulation from the patient.
  • the doctor inserts the insertion rod 55 of the insertion tool 50 into the small incision portion provided in the waist using the insertion tool 50 for forming the subcutaneous tunnel, and makes a small incision on the back.
  • a subcutaneous tunnel is formed by pushing it to the part. The formation of a subcutaneous tunnel is generally performed with the patient rolling his back to stretch the curvature of the back.
  • the diameter of the insertion rod 55 inserted under the skin is, for example, about 2 mm.
  • the distal end portion of the insertion rod 55 inserted into the living body 30 has a conical shape, and the other end of the insertion rod 55 is connected to a pusher wire fixing portion 51 formed in a substantially cylindrical shape.
  • a grip portion 52 formed in a substantially cylindrical shape is provided at a predetermined position in the axial direction of the insertion rod 55, and the grip portion 52 can be moved and fixed to an arbitrary position in the axial direction of the insertion rod 55. It is attached to the insertion rod 55 in a possible form.
  • the pusher 56 is a mechanism for pressing the distal end portion of the insertion rod 55 from the body surface, and is formed as a plate-like substantially rectangular parallelepiped.
  • a pusher wire 54 having a length substantially the same as the length of the insertion rod 55 is connected to the end of the pusher 56.
  • the other end of the pusher wire 54 is fixed to a pusher wire fixing part 51, and a part in the middle is passed through a through hole of a pusher wire fastening part 53 provided in the grip part 52.
  • the distal end portion of the insertion rod 55 may be caught on the dermis layer on the body surface side than the subcutaneous tissue, but the diameter of the insertion rod 55 is very large. Since it is thin, the insertion rod 55 may bend and not move forward when a force for pushing the skin is applied. At this time, in a state where the pusher wire 54 is stretched (the bobbin 51a is not moving), the distal end portion of the insertion rod 55 is subcutaneously pushed forward by pushing the insertion rod 55 under the skin while pressing the body surface with the pusher 56. Therefore, the tip of the insertion rod 55 can be easily advanced subcutaneously.
  • the stimulator sizer 58 is a subcutaneous pocket type taking mechanism for forming a subcutaneous pocket in which the housing 13 of the stimulator 4 is implanted.
  • the stimulator sizer 58 is made of, for example, a relatively hard resin having biocompatibility such as an epoxy resin as a material.
  • the stimulator sizer 58 is configured to have almost the same shape as the housing 13 of the stimulator 4 and is inserted into a small incision portion.
  • the distal end portion has a conical shape or a tapered shape.
  • a bending prevention rod 60 in which a connection portion with the insertion rod 55 and a rod for preventing the extension 14 from being bent are integrally formed is used as the connection mechanism.
  • the bending prevention rod 60 includes a connection portion 61, a rod 62, and an electrode protection cover 63 as shown in FIG. 22B.
  • the connecting portion 61 is a mechanism for connecting the end portion of the insertion rod 55 and the tip portion of the extension 14.
  • the connection portion 61 is made of, for example, relatively hard stainless steel having biocompatibility as a material, and has a substantially cylindrical shape having a diameter slightly larger than the diameter of the insertion rod 55, and is formed at both end portions in the axial direction.
  • a recess for storing the insertion rod 55 and a recess for storing the tip end portion of the extension 14 are formed. With the end of the insertion rod 55 and the tip of the extension 14 accommodated in these recesses, a screw (not shown) is screwed in a direction perpendicular to the formation direction of the recesses, so that the insertion rod 55 and the extension 14 are connected.
  • the connection is made through the connection unit 61.
  • the rod 62 is a rod for preventing the extension 14 from being bent in a subcutaneous pocket or a subcutaneous tunnel.
  • a relatively hard stainless steel having biocompatibility is used as a material.
  • the diameter of the rod 62 is, for example, substantially the same as the diameter of the stylet 34.
  • the end portion of the rod 62 is connected to the recessed portion of the recess for storing the tip end portion of the extension 14 of the connection portion 61.
  • the length of the rod 62 is substantially the same as the entire length of the extension 14. When a groove-shaped receiving part that accommodates the end of the rod 62 is provided on the housing 13 side of the stimulator 4, the length of the rod 62 corresponds to the entire length of the extension 14 and the depth of the receiving part. The length is added to the length.
  • the electrode protection cover 63 is connected to the end of the connection portion 61 on the side to which the extension 14 is connected.
  • the electrode protection cover 63 protects the terminal electrode 15 provided at the distal end portion of the extension 14 in a state where the extension 14 is connected to the connection portion 61.
  • the electrode protection cover 63 is flexible as a material and has biocompatibility. A certain silicone or polyurethane is used, and it has a cylindrical shape with a hollow center.
  • FIG. 26 is a diagram illustrating a state in which the housing 13 of the stimulation device 4 is accommodated in the subcutaneous pocket.
  • the distal end portion of the insertion rod 55 when the insertion rod 55 is inserted into the living body, the distal end portion of the insertion rod 55 is pressed from the body surface with the pusher wire 54 stretched. Thereby, the doctor can guess the front-end
  • the pusher wire 54 is fixed to the bobbin 51a, and the length of the pusher wire 54 is substantially equal to the length of the insertion rod 55. For this reason, the doctor can easily grasp the position of the distal end portion of the insertion rod 55 by stretching the pusher wire 54.
  • the doctor holds the body surface ahead of the distal end portion of the insertion rod 55 with the pusher 56 by further pulling the pusher 56 before the distal end portion of the insertion rod 55 reaches the back incision. Can do.
  • the doctor turns over the pusher 56 and presses the insertion rod receiving portion 57 at the location of the back incision.
  • the distal end portion of the insertion rod 55 comes into contact with the recess 57a provided in the insertion rod receiving portion 57, and the distal end portion of the insertion rod 55 can be prevented from jumping out of the body surface or jumping up at the back incision portion. . For this reason, there is no case where the back-incised portion is unintentionally widened.
  • the pusher wire 54 and the insertion rod 55 are respectively passed through the through holes formed in the grip portion 52. For this reason, even in a living body having a curved surface, the direction of the insertion rod 55 is less likely to be mistaken, and the insertion rod 55 can be inserted by pushing the pusher 56 at an appropriate position.
  • the bobbin 51a can be rotated, and the pusher wire 54 is housed in the pusher wire fixing portion 51 while being wound around the bobbin 51a.
  • the bobbin 51a rotates and pushes. It is good also as a structure which the tool wire 54 unwinds.
  • the bobbin 51a may be a reel mechanism, and the pusher wire 54 may be easily wound up by rotating the handle.
  • colors may be separately applied every 10 cm, or a shallow groove may be cut on the circumference. Thereby, the pusher wire 54 unwound from the bobbin 51a can be easily known.
  • the insertion wire fixing portion 51d may be provided with a garter spring, and the insertion rod 55 may be fixed by forming an unevenness at one end of the insertion rod 55 so that the garter spring is in close contact with the recess.
  • a magnet having a strong magnetic force may be provided in the insertion wire fixing portion 51d, and one end of the metal insertion rod 55 may be fixed by the magnetic force.
  • the grip portion 52 is movable with respect to the insertion rod 55, it may be immovable if there is a sufficient length from the tip portion of the insertion rod 55 to the grip portion 52. Even in this case, it is possible to apply a sufficient force to the tip portion of the insertion rod 55.
  • the bobbin 51a is attached to the pusher wire fixing portion 51
  • the bobbin 51a may be attached to the pusher 56.
  • a spring spring and a stopper may be attached to the bobbin 51a, and the pusher wire 54 may be wound around the bobbin 51a when the pusher 56 is not used. Thereby, the pusher wire 54 can be easily accommodated.
  • the shape of the grip portion 52 is not limited to a cylindrical shape.
  • it may be a rectangular parallelepiped shape, and may be any shape as long as a doctor can easily apply force.
  • the surface of the grip portion 52 may be subjected to anti-slip processing by providing unevenness or the like.
  • a light emitter may be provided at the distal end of the insertion rod 55 so that the distal end of the insertion rod 55 inserted into the living body emits light to inform the doctor of the distal end of the insertion rod 55.
  • the tip of the insertion rod 55 may be formed of a magnetic element, and a magnetic sensor for detecting a magnetic field generated from the magnetic element may be incorporated in the pusher 56. If the sensor value is displayed on the pusher 56 according to the strength of the magnetic field detected by the magnetic sensor, the doctor can easily know that the tip of the insertion rod 55 is near the pusher 56.
  • SYMBOLS 1 Electrical stimulation apparatus, 2 ... Electrode lead, 3 ... Auxiliary lead, 4 ... Stimulation apparatus, 5 ... Stimulation electrode, 12 ... Stimulation circuit, 50 ... Insertion tool, 51 ... Pusher wire fixing part, 52 ... Gripping part, 53 ... Pushing wire fastening part, 54 ... Pushing wire, 55 ... Pushing rod, 56 ... Pushing tool, 57 ... Pushing rod receiving part

Abstract

An insertion instrument (50) comprises: an insertion rod (55), one end whereof is inserted into a living body; a press instrument (56) which depresses the leading end part of the insertion rod (55) from the surface of the body; and a press instrument wire (54), one end whereof is connected to the press instrument (56), and which is approximately equal in length to the insertion rod (55). The insertion instrument (50) further comprises: a press instrument wire anchoring unit (51) which anchors the other end of the insertion rod (55) and the other end of the press instrument wire (54); and a hold part (52) whereby the insertion rod (55) is inserted into the living body.

Description

挿通具Insertion tool
　本発明は、挿通ロッドを生体内に挿通させる挿通具に関する。 The present invention relates to an insertion tool for inserting an insertion rod into a living body.
　従来、痛み治療において、薬物療法、神経ブロック療法、外科的療法に効果を示さない場合や、副作用などによりその治療が継続できない場合に、神経を電気刺激することにより痛みを緩和する電気刺激療法が効果を挙げている。電気刺激療法の１つである脊髄電気刺激療法は、脊髄を介して脳へ伝播する痛みを緩和するために、脊髄の神経を電気刺激する刺激療法である。 Conventionally, in the treatment of pain, when there is no effect on drug therapy, nerve block therapy, or surgical therapy, or when the treatment cannot be continued due to side effects, etc., there is an electrical stimulation therapy that alleviates pain by electrically stimulating the nerve. Has an effect. Spinal cord electrical stimulation therapy, which is one of electrical stimulation therapies, is a stimulation therapy that electrically stimulates nerves in the spinal cord in order to relieve pain transmitted to the brain through the spinal cord.
　脊髄電気刺激療法では、通常、電気刺激による疼痛緩和の有効性を確かめるために、まず試験的な刺激（以下、「試験刺激」という）が行われる。試験刺激では、脊髄を電気刺激する刺激電極をその先端部に有する電極リードのみが、脊髄を覆う脊髄硬膜の外側にある硬膜外腔に挿入される。そして、電極リードを体外刺激装置に接続し、刺激電極で脊髄の神経の電気刺激を様々な刺激パターンの下で行って、疼痛緩和の程度を調べることが行われる。この試験刺激で所定の効果が認められた場合には、電気刺激装置の植え込み（以下、「本植え込み」という）が実施される。 In spinal cord electrical stimulation therapy, a test stimulus (hereinafter referred to as “test stimulus”) is usually performed to confirm the effectiveness of pain relief by electrical stimulation. In the test stimulation, only an electrode lead having a stimulation electrode for electrically stimulating the spinal cord at its distal end is inserted into the epidural space outside the spinal dura covering the spinal cord. Then, the degree of pain relief is examined by connecting the electrode lead to an extracorporeal stimulation device and conducting electrical stimulation of spinal nerves under various stimulation patterns with the stimulation electrode. When a predetermined effect is recognized by this test stimulus, an electrical stimulation device is implanted (hereinafter referred to as “main implantation”).
　ここで、生体内に電気刺激装置を植え込む手順を簡単に説明する。
　始めに、背中から穿刺により電極リードを硬膜外腔の所定位置に進め、試験用の刺激装置を電極リードに接続して脊髄の電気刺激を行い、電極リードの最適な位置が決定される。次に、硬膜外腔内に電極リードを留置したまま試験用の刺激装置を電極リードから取り外し、電極リードの背中の刺入部位を小切開した後、患者の腰部に本植え込み用の刺激装置を留置するために、腰部が小切開される。さらに、生体内で刺激装置を電極リードに接続するために、腰部の小切開された箇所から、電極リードが刺入されている背中の小切開された箇所に向けて、皮下トンネルが形成される。この皮下トンネルは、直径を小さくした長尺の挿通ロッドを押し込むことで形成される。 Here, a procedure for implanting the electrical stimulation device in the living body will be briefly described.
First, the electrode lead is advanced to a predetermined position in the epidural space by puncturing from the back, and a test stimulation device is connected to the electrode lead to perform electrical stimulation of the spinal cord, thereby determining the optimum position of the electrode lead. Next, the stimulation device for testing is removed from the electrode lead while the electrode lead is left in the epidural space, a small incision is made on the back portion of the electrode lead, and then the stimulation device for permanent implantation in the patient's waist A small incision is made in the lumbar region. Furthermore, in order to connect the stimulation device to the electrode lead in vivo, a subcutaneous tunnel is formed from the small incision in the waist toward the small incision in the back where the electrode lead is inserted. . This subcutaneous tunnel is formed by pushing a long insertion rod having a reduced diameter.
　その後、腰部の小切開から皮下ポケットが形成されて刺激装置が留置される。この際に、皮下トンネルには、刺激装置から延ばされたリード線が這わされて、背中の小切開された箇所で硬膜外腔に留置された刺激電極を含む電極リードに接続される。これにより、生体内に留置された刺激装置が電極リードに電気刺激を加え、刺激電極で脊髄の神経を電気刺激することで患者の疼痛を緩和することが可能となる。 After that, a subcutaneous pocket is formed from a small incision in the waist and the stimulator is placed. At this time, the lead wire extended from the stimulation device is wound on the subcutaneous tunnel and connected to the electrode lead including the stimulation electrode placed in the epidural space at the small incision in the back. As a result, the stimulation device placed in the living body applies electrical stimulation to the electrode lead, and the stimulation of the spinal cord with the stimulation electrode makes it possible to alleviate the patient's pain.
　生体内に電気刺激装置を植え込むための技術として、細長い挿通ロッドとこの挿通ロッドを覆うように装着された中空のシースから成る挿通具を用いて生体内に皮下トンネルを形成する技術が知られている（例えば、特許文献１を参照。）。 As a technique for implanting an electrical stimulation device in a living body, a technique is known in which a subcutaneous tunnel is formed in a living body using an insertion tool comprising a long and thin insertion rod and a hollow sheath mounted so as to cover the insertion rod. (For example, refer to Patent Document 1).
米国特許第７２１８９７０号明細書US Pat. No. 7,218,970
　ところで、生体内に電気刺激装置が植え込まれる患者の負担をできるだけ軽くし、低侵襲とするためには、挿通ロッドによって形成される皮下トンネルの大きさも小さくすることが望ましい。しかし、挿通ロッドは適度な強度を有しているものの、皮下に挿通ロッドを通す際、特に体が湾曲している部分に通す際には、挿通ロッドの先端が皮下組織よりも体表側にある皮膚の真皮層に引っかかる場合がある。このため、小さな力で挿通ロッドを皮下に進めることは難しい。 Incidentally, it is desirable to reduce the size of the subcutaneous tunnel formed by the insertion rod in order to reduce the burden on the patient who is implanted with the electrical stimulation device in the living body as much as possible and to minimize the invasiveness. However, although the insertion rod has moderate strength, the tip of the insertion rod is closer to the body surface than the subcutaneous tissue when passing the insertion rod under the skin, especially when passing through the curved part of the body. May get caught in the dermis layer of the skin. For this reason, it is difficult to advance the insertion rod subcutaneously with a small force.
　挿通ロッドの先端が皮下で引っかかっても、挿通ロッドの皮下にある先端部分を体表から押すことによって、挿通ロッドを皮下で引っかけずに押し進めることは可能である。しかし、挿通ロッドの直径は数ｍｍ程度しかない。また、腰部から背中にかけての皮膚は厚く、皮下に脂肪等も付きやすい。このため、医師は、挿通ロッドの先端部分が生体内のどの位置にあるかを体表から容易に把握することができなかった。 Even if the tip of the insertion rod is caught under the skin, it is possible to push the insertion rod without being caught under the skin by pushing the tip of the insertion rod under the skin from the body surface. However, the diameter of the insertion rod is only a few millimeters. In addition, the skin from the waist to the back is thick, and fat and the like are easily attached to the skin. For this reason, the doctor cannot grasp | ascertain easily from the body surface where the front-end | tip part of an insertion rod exists in a biological body.
　本発明はこのような状況に鑑みて成されたものであり、生体内に挿通ロッドを容易に挿通できるようにすることを目的とする。 The present invention has been made in view of such a situation, and an object thereof is to allow an insertion rod to be easily inserted into a living body.
　本発明に係る挿通具は、一端が生体内に挿通される挿通ロッドと、生体内に挿通された挿通ロッドの一端を体表面から押下する押し具と、押し具に一端が接続され、挿通ロッドとほぼ等しい長さの押し具ワイヤと、挿通ロッドの他端及び押し具ワイヤの他端を固定する押し具ワイヤ固定部と、挿通ロッドを生体内に挿通させる把持部と、を備える。 The insertion tool according to the present invention includes an insertion rod having one end inserted into the living body, a pressing tool that presses one end of the insertion rod inserted into the living body from the body surface, and one end connected to the pressing tool. A pusher wire having a length substantially equal to the length of the pusher wire, a pusher wire fixing part for fixing the other end of the insertion rod and the other end of the pusher wire, and a grasping part for inserting the insertion rod into the living body.
　本発明によれば、医師は、挿通ロッドとほぼ等しい長さの押し具ワイヤが張られた状態で、生体内に挿通された挿通ロッドの一端を体表面から押し具で押下することができる。このため、体表面から挿通ロッドの一端を容易に把握することができ、押し具を押すことで、生体内に挿通ロッドを容易に挿通できるようになる。 According to the present invention, the doctor can press down one end of the insertion rod inserted into the living body from the body surface with the pressing tool while the pressing tool wire having a length substantially equal to that of the insertion rod is stretched. For this reason, one end of the insertion rod can be easily grasped from the body surface, and the insertion rod can be easily inserted into the living body by pressing the pusher.
本発明の一実施の形態例に係る電気刺激装置の全体を示す斜視図である。図１Ａは、電極リードと、補助リードと、刺激装置の構成例を示す斜視図である。図１Ｂは、電極リードに補助リードが接続された状態の構成例を示す斜視図である。1 is a perspective view showing an entire electrical stimulation apparatus according to an embodiment of the present invention. FIG. 1A is a perspective view illustrating a configuration example of an electrode lead, an auxiliary lead, and a stimulation device. FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead is connected to the electrode lead. 本発明の一実施の形態例に係る刺激回路を中心とする機能ブロック図である。It is a functional block diagram centering on the stimulation circuit which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る挿通具の構成例を示す外観斜視図である。It is an external appearance perspective view which shows the structural example of the insertion tool which concerns on one embodiment of this invention. 図３に示した挿通具を、Ａ－Ａ′線において断面視した例を示す説明図である。FIG. 4 is an explanatory view showing an example of a cross-sectional view of the insertion tool shown in FIG. 3 along the line AA ′. 本発明の一実施の形態例に係る押し具と、挿通ロッド受け部の使用方法を示す説明図である。図５Ａは、生体内に挿通ロッドを挿通する様子を示す説明図である。図５Ｂは、挿通ロッド受け部を用いた例を示す説明図である。It is explanatory drawing which shows the usage method of the pressing tool which concerns on one embodiment of this invention, and an insertion rod receiving part. FIG. 5A is an explanatory diagram illustrating a state in which the insertion rod is inserted into the living body. FIG. 5B is an explanatory view showing an example using an insertion rod receiving portion. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１を示す説明図である。It is explanatory drawing which shows the implantation procedure 1 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２を示す説明図である。It is explanatory drawing which shows the implantation procedure 2 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順３を示す説明図である。It is explanatory drawing which shows the implantation procedure 3 in the living body of the electric stimulator which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順４を示す説明図である。It is explanatory drawing which shows the implantation procedure 4 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順５を示す説明図である。It is explanatory drawing which shows the implantation procedure 5 in the living body of the electric stimulator which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順６を示す説明図である。It is explanatory drawing which shows the implantation procedure 6 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順７を示す説明図である。It is explanatory drawing which shows the implantation procedure 7 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順８を示す説明図である。It is explanatory drawing which shows the implantation procedure 8 in the biological body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順９を示す説明図である。It is explanatory drawing which shows the implantation procedure 9 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１０を示す説明図である。It is explanatory drawing which shows the implantation procedure 10 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１１を示す説明図である。It is explanatory drawing which shows the implantation procedure 11 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１２を示す説明図である。It is explanatory drawing which shows the implantation procedure 12 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１３を示す説明図である。It is explanatory drawing which shows the implantation procedure 13 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１４を示す説明図である。It is explanatory drawing which shows the implantation procedure 14 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１５を示す説明図である。It is explanatory drawing which shows the implantation procedure 15 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１６を示す説明図である。It is explanatory drawing which shows the implantation procedure 16 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１７及び手順１８を示す説明図である。図２２Ａは、挿通ロッドにエクステンションの先端部分を取り付ける作業の様子を示す説明図である。図２２Ｂは、折れ曲がり防止ロッドの構成図である。It is explanatory drawing which shows the implantation procedure 17 and the procedure 18 in the biological body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. FIG. 22A is an explanatory diagram showing a state of an operation of attaching the distal end portion of the extension to the insertion rod. FIG. 22B is a configuration diagram of a bending prevention rod. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１８を示す説明図である。It is explanatory drawing which shows the implantation procedure 18 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順１９を示す説明図である。It is explanatory drawing which shows the implantation procedure 19 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２０を示す説明図である。It is explanatory drawing which shows the implantation procedure 20 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２１を示す説明図である。It is explanatory drawing which shows the implantation procedure 21 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２２を示す説明図である。It is explanatory drawing which shows the implantation procedure 22 in the living body of the electrical stimulation apparatus which concerns on the example of 1 embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２３を示す説明図である。It is explanatory drawing which shows the implantation procedure 23 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２４を示す説明図である。It is explanatory drawing which shows the implantation procedure 24 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention. 本発明の一実施の形態例に係る電気刺激装置の生体内への植え込み手順２５を示す説明図である。It is explanatory drawing which shows the implantation procedure 25 in the living body of the electrical stimulation apparatus which concerns on one embodiment of this invention.
　以下、本発明を実施するための形態例について説明する。以下に述べる実施の形態例は、本発明の好適な具体例である。そのため、技術的に好ましい種々の限定が付されている。しかしながら、本発明の範囲は、下記の説明において特に本発明を限定する旨の記載がない限り、これらの形態に限られるものではない。例えば、以下の説明で挙げる各パラメータの数値的条件は好適例に過ぎず、説明に用いた各図における寸法、形状及び配置関係も概略的なものである。説明は、以下の順序で行う。
１．一実施の形態（挿通具の構成例）
　１－１．電気刺激装置の構成
　１－２．刺激回路の回路構成
　１－３．挿通具の構成
　１－４．電気刺激装置の植え込み方法
２．一実施の形態の変形例 Embodiments for carrying out the present invention will be described below. The embodiments described below are preferable specific examples of the present invention. Therefore, various technically preferable limitations are attached. However, the scope of the present invention is not limited to these embodiments unless otherwise specified in the following description. For example, the numerical conditions of each parameter given in the following description are only preferred examples, and the dimensions, shapes, and arrangement relationships in the drawings used for the description are also schematic. The description will be made in the following order.
1. One embodiment (configuration example of insertion tool)
1-1. Configuration of electrical stimulation device 1-2. Circuit configuration of stimulation circuit 1-3. Configuration of insertion tool 1-4. 1. Implanting method of electrical stimulation device Modification of one embodiment
＜１．一実施の形態（挿通具の構成例）＞
［１－１．電気刺激装置の構成］
　本発明の一実施の形態の例（以下、「本例」という。）を、添付図面を参照して説明する。
　まず、一実施形態に係る電気刺激装置１の機械的な構成について説明する。
　図１は、本発明の第１の実施形態に係る電気刺激装置１を構成する各部の概略構成例を示す斜視図である。図１Ａは、電極リード２と、補助リード３と、刺激装置４の構成例を示す斜視図である。図１Ｂは、電極リード２に補助リード３が接続された状態の構成例を示す斜視図である。 <1. One Embodiment (Configuration Example of Insertion Tool)>
[1-1. Configuration of electrical stimulation device]
An example of an embodiment of the present invention (hereinafter referred to as “this example”) will be described with reference to the accompanying drawings.
First, the mechanical configuration of the electrical stimulation device 1 according to an embodiment will be described.
FIG. 1 is a perspective view showing a schematic configuration example of each part constituting the electrical stimulation apparatus 1 according to the first embodiment of the present invention. FIG. 1A is a perspective view illustrating a configuration example of the electrode lead 2, the auxiliary lead 3, and the stimulation device 4. FIG. 1B is a perspective view illustrating a configuration example in a state where the auxiliary lead 3 is connected to the electrode lead 2.
　電気刺激装置１は、電気的な刺激信号（以下、「電気的刺激信号」という）により、生体内の神経及び／又は筋肉を刺激するものであり、脊髄電気刺激療法では脊髄の神経を刺激するものである。図１Ａに示すように、この電気刺激装置１は、生体内に植え込まれ、神経及び／又は筋肉に電気的刺激信号を導いてこれを刺激するために用いられる電極リード２と、電極リード２に接続して使用される補助リード３と、電極リード２に電気的刺激信号を供給する刺激装置４とを備える。 The electrical stimulation device 1 stimulates nerves and / or muscles in a living body with electrical stimulation signals (hereinafter referred to as “electrical stimulation signals”). In spinal cord electrical stimulation therapy, the nerves of the spinal cord are stimulated. Is. As shown in FIG. 1A, the electrical stimulation device 1 is implanted in a living body, and an electrode lead 2 that is used to guide and stimulate an electrical stimulation signal to nerves and / or muscles, and an electrode lead 2. Auxiliary lead 3 used in connection with the electrode lead 2 and a stimulation device 4 for supplying an electrical stimulation signal to the electrode lead 2.
　補助リード３は、電極リード２の生体内への植え込み時の試験刺激の時に、電極リード２に接続されて使用されるものであり、試験刺激の終了後は電極リード２から取り外される。 The auxiliary lead 3 is used by being connected to the electrode lead 2 at the time of the test stimulus when the electrode lead 2 is implanted into the living body, and is removed from the electrode lead 2 after the test stimulus is completed.
　始めに、電極リード２について説明する。電極リード２は、略円筒形状の長尺体として構成され、その一端には、脊髄の神経を刺激するための４つの刺激電極５が設けられている。他端には、後述する補助リード３のターミナル電極８、又は刺激装置４のターミナル電極１５が接続される、コネクタ７が設けられている。 First, the electrode lead 2 will be described. The electrode lead 2 is configured as a substantially cylindrical long body, and at one end thereof, four stimulation electrodes 5 for stimulating spinal nerves are provided. The other end is provided with a connector 7 to which a terminal electrode 8 of the auxiliary lead 3 described later or a terminal electrode 15 of the stimulating device 4 is connected.
　なお、以降の説明では、電極リード２に刺激装置４が接続された状態で刺激装置４に対して近い位置に配置される側の電極リード２の端部を近位端と称し、遠い位置に配置される側の端部を遠位端と称する。すなわち、刺激電極５が設けられた側の端部は遠位端となり、コネクタ７が設けられた側の端部は近位端となる。 In the following description, the end portion of the electrode lead 2 on the side close to the stimulation device 4 in a state in which the stimulation device 4 is connected to the electrode lead 2 is referred to as a proximal end, and is located at a far position. The end on the side where it is arranged is called the distal end. That is, the end on the side where the stimulation electrode 5 is provided is the distal end, and the end on the side where the connector 7 is provided is the proximal end.
　刺激電極５は、導電性があって生体適合性がある素材、例えばステンレス鋼、ＭＰ３５Ｎ合金、プラチナ、またはプラチナ合金（例えば、プラチナ９０％／イリジウム１０％合金）等の素材でできており、中空の略円筒状に形成されている。なお、本例では、刺激電極５の数を４つとしたが、この数はあくまでも一例であって、刺激電極５の数は任意に設定できる。 The stimulation electrode 5 is made of a material having conductivity and biocompatibility, such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy), and is hollow. It is formed in a substantially cylindrical shape. In this example, the number of stimulation electrodes 5 is four, but this number is merely an example, and the number of stimulation electrodes 5 can be arbitrarily set.
　電極リード２には、リード部としてのボディ６が設けられ、ボディ６の先端に４つの各刺激電極５が形成されている。ボディ６は、電極リード２を生体内に配置した際に４つの各刺激電極５が生体に対して剥き出しになるように固定している。ボディ６は、柔軟性があって、かつ生体適合性がある素材、例えばシリコーンやポリウレタン等の樹脂素材が略円筒形状に形成された長尺体から作られており、その外径は、１～３ｍｍであることが好ましい。 The electrode lead 2 is provided with a body 6 as a lead portion, and four stimulation electrodes 5 are formed at the tip of the body 6. The body 6 is fixed so that the four stimulation electrodes 5 are exposed to the living body when the electrode lead 2 is placed in the living body. The body 6 is made of a flexible and biocompatible material, for example, a long body formed of a resin material such as silicone or polyurethane in a substantially cylindrical shape. It is preferable that it is 3 mm.
　長尺体として構成されたボディ６には、コネクタ７との接続部分となる近位端で開口して、刺激電極５の中空部分を経て遠位端付近まで連通する略円筒形状の孔（図示略）が軸方向に開けられている。この孔（内腔）は、生体内への刺激電極５の挿入時に電極リード２を押し進めるとともに、電極リード２の形状を保つためのスタイレットが挿入される孔であり、以降の説明では「スタイレット用ルーメン」として表される。 In the body 6 configured as an elongated body, a substantially cylindrical hole (shown in the figure) that opens at the proximal end serving as a connection portion with the connector 7 and communicates through the hollow portion of the stimulation electrode 5 to the vicinity of the distal end. Is omitted in the axial direction. This hole (lumen) is a hole into which a stylet for pushing the electrode lead 2 and keeping the shape of the electrode lead 2 is inserted while the stimulation electrode 5 is inserted into the living body. Represented as “Lumette for Lett”
　コネクタ７は、柔軟性があって、かつ生体適合性がある素材、例えばシリコーンやポリウレタン等の樹脂素材が中空の略円筒状に形成され、その内部に不図示のコンタクト電極を有する。コンタクト電極と刺激電極５とは、不図示の導線により電気的に接続されており、この導線は、ボディ６の内部に完全に埋め込まれている。コネクタ７の中空部分には、前述したように、補助リード３のターミナル電極８、又は刺激装置４のターミナル電極１５が挿入される。コネクタ７の近位端には、補助リード３との接続機構としての溝部７ａが設けられている。コネクタ７の外形は、３～９ｍｍであることが好ましい。 The connector 7 is formed of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, in a hollow and substantially cylindrical shape, and has a contact electrode (not shown) therein. The contact electrode and the stimulation electrode 5 are electrically connected by a conducting wire (not shown), and this conducting wire is completely embedded in the body 6. As described above, the terminal electrode 8 of the auxiliary lead 3 or the terminal electrode 15 of the stimulation device 4 is inserted into the hollow portion of the connector 7. A groove 7 a as a connection mechanism with the auxiliary lead 3 is provided at the proximal end of the connector 7. The outer shape of the connector 7 is preferably 3 to 9 mm.
　補助リード３は、略円筒形状の長尺体として構成され、その一端には、電極リード２の各刺激電極５と対応する４つのターミナル電極８が設けられている。また他端にも、電極リード２の各刺激電極５と対応する４つのターミナル電極９が設けられている。ターミナル電極８及びターミナル電極９は、導電性があって生体適合性がある素材、例えばステンレス鋼、ＭＰ３５Ｎ合金、プラチナ、またはプラチナ合金（例えば、プラチナ９０％／イリジウム１０％合金）等の素材が中空の略円筒状に形成され、略円筒形状に形成された長尺体よりなるボディ１０によって保持されている。ターミナル電極８とターミナル電極９は、ボディ１０の内部に完全に埋め込まれた不図示の導線により電気的に接続されている。ボディ１０の素材には、柔軟性があって、かつ生体適合性がある素材、例えばシリコーンやポリウレタン等の樹脂素材が用いられる。 The auxiliary lead 3 is configured as a substantially cylindrical long body, and four terminal electrodes 8 corresponding to the stimulation electrodes 5 of the electrode lead 2 are provided at one end thereof. At the other end, four terminal electrodes 9 corresponding to the stimulation electrodes 5 of the electrode lead 2 are provided. The terminal electrode 8 and the terminal electrode 9 are made of a conductive and biocompatible material such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, 90% platinum / 10% iridium alloy). And is held by a body 10 made of an elongated body formed in a substantially cylindrical shape. The terminal electrode 8 and the terminal electrode 9 are electrically connected by a conductive wire (not shown) completely embedded in the body 10. The material of the body 10 is a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane.
　ターミナル電極８は、電極リード２のコネクタ７に挿入され、ターミナル電極９には、試験刺激用の電気的刺激信号を生成する体外刺激装置（図示略）が接続される。なお、以降の説明では、ターミナル電極９に体外刺激装置が接続された状態で体外刺激装置に対して近い位置に配置される側の補助リード３の端部を近位端と称し、遠い位置に配置される側の端部を遠位端と称する。すなわち、電極リード２のコネクタ７に収容されるターミナル電極８が設けられた側の端部は遠位端となり、体外刺激装置が接続されるターミナル電極９が設けられた側の端部は近位端となる。 The terminal electrode 8 is inserted into the connector 7 of the electrode lead 2, and the terminal electrode 9 is connected to an extracorporeal stimulation device (not shown) that generates an electrical stimulation signal for test stimulation. In the following description, the end portion of the auxiliary lead 3 on the side close to the extracorporeal stimulation device in a state in which the extracorporeal stimulation device is connected to the terminal electrode 9 is referred to as a proximal end, and the far end is located. The end on the side where it is arranged is called the distal end. That is, the end of the electrode lead 2 on the side where the terminal electrode 8 accommodated in the connector 7 is provided is the distal end, and the end on the side where the terminal electrode 9 to which the extracorporeal stimulation device is connected is proximal. End.
　また、ボディ１０の軸方向における中心付近には、電極リード２のコネクタ７との接続機構としての係合部材１１が設けられている。係合部材１１は、ボディ１０の円周上にボディ１０から突出するように形成されており、その先端には、電極リード２のコネクタ７の溝部７ａに係合する爪部（図示略）が形成されている。なお、係合部材１１の素材は、シリコーンやポリウレタンに限定されるものではなく、柔軟性があって、かつ生体適合性がある素材であればどのような素材であってもよい。さらに、補助リード３には、その近位端から遠位端までを貫通するスタイレット用ルーメン（図示略）が設けられている。 Also, an engaging member 11 is provided near the center of the body 10 in the axial direction as a connection mechanism with the connector 7 of the electrode lead 2. The engaging member 11 is formed on the circumference of the body 10 so as to protrude from the body 10, and a claw portion (not shown) that engages with the groove portion 7 a of the connector 7 of the electrode lead 2 at the tip thereof. Is formed. The material of the engaging member 11 is not limited to silicone or polyurethane, and any material may be used as long as it is flexible and biocompatible. Further, the auxiliary lead 3 is provided with a stylet lumen (not shown) penetrating from the proximal end to the distal end.
　すなわち、図１Ｂに示すように、補助リード３が電極リード２と接続された状態では、スタイレット用ルーメンが、補助リード３の近位端から電極リード２の遠位端付近まで連通することになる。 That is, when the auxiliary lead 3 is connected to the electrode lead 2 as shown in FIG. 1B, the stylet lumen communicates from the proximal end of the auxiliary lead 3 to the vicinity of the distal end of the electrode lead 2. Become.
　次に、刺激装置４の構成について再び図１Ａに戻って説明する。刺激装置４は、筐体１３と、刺激装置４と電極リード２とを中継するエクステンション１４とを有する。筐体１３の内部には、電気的刺激信号を生成して、生成した電気的刺激信号を刺激電極５に印加する刺激回路１２が設けられている。 Next, the configuration of the stimulation device 4 will be described again with reference to FIG. 1A. The stimulating device 4 includes a housing 13 and an extension 14 that relays the stimulating device 4 and the electrode lead 2. Inside the housing 13, a stimulation circuit 12 that generates an electrical stimulation signal and applies the generated electrical stimulation signal to the stimulation electrode 5 is provided.
　筐体１３は、比較的硬く、生体適合性がある金属や樹脂、例えばチタンやエポキシ等の素材でできており、略直方体形状に形成されている。 The housing 13 is made of a relatively hard and biocompatible metal or resin, such as titanium or epoxy, and has a substantially rectangular parallelepiped shape.
　エクステンション１４は、略円筒状に形成され、その軸心部分は中空とされている。エクステンション１４の、電極リード２のコネクタ７に収容される端部（遠位端）には、刺激電極５と対応するターミナル電極１５と、コネクタ７に収容されたときに固定ねじで電極リード２に固定される固定用リング１７が設けられている。 The extension 14 is formed in a substantially cylindrical shape, and its axial center portion is hollow. At the end (distal end) of the extension 14 accommodated in the connector 7 of the electrode lead 2, the terminal electrode 15 corresponding to the stimulation electrode 5, and when held in the connector 7, the electrode lead 2 is fixed with a fixing screw. A fixing ring 17 to be fixed is provided.
　ターミナル電極１５は、略円筒形状に形成された長尺体よりなるボディ１６によって保持されており、ボディ１６内部に埋め込まれた不図示の導線により筐体１３の内部で刺激回路１２と接続されている。すなわち、エクステンション１４の近位端は刺激装置４の筐体１３内に埋め込まれており、筐体１３と一体に形成されている。ボディ１６は、柔軟性があって、かつ生体適合性がある素材、例えばシリコーンやポリウレタン等の樹脂素材で作られており、その外径は、１～３ｍｍであることが好ましい。ターミナル電極１５、固定用リング１７及び導線には、導電性があって生体適合性がある素材、例えばステンレス鋼、ＭＰ３５Ｎ合金、プラチナ、またはプラチナ合金（例えば、プラチナ９０％／イリジウム１０％合金）等が用いられる。 The terminal electrode 15 is held by a body 16 made of an elongated body formed in a substantially cylindrical shape, and is connected to the stimulation circuit 12 inside the housing 13 by a lead wire (not shown) embedded in the body 16. Yes. That is, the proximal end of the extension 14 is embedded in the housing 13 of the stimulating device 4 and is formed integrally with the housing 13. The body 16 is made of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, and its outer diameter is preferably 1 to 3 mm. The terminal electrode 15, the fixing ring 17, and the conductor are conductive and biocompatible materials such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, 90% platinum / 10% iridium alloy), etc. Is used.
　刺激回路１２は、回路基板上にカスタムＩＣなどの小型な部品を実装した回路であり、電気的刺激信号を生成し、この生成した電気的刺激信号を刺激電極５に印加する制御を行う。刺激回路１２が生成した電気的刺激信号を各刺激電極５に独立して供給するために、刺激回路１２と、刺激電極５と対応づけられたターミナル電極１５の各電極とを、エクステンション１４のボディ１６に埋め込まれている各導線（図示略）で電気的に接続している。なお、刺激回路１２の電気的な構成については、図２を参照して後述する。 The stimulation circuit 12 is a circuit in which a small component such as a custom IC is mounted on a circuit board. The stimulation circuit 12 generates an electrical stimulation signal and performs control to apply the generated electrical stimulation signal to the stimulation electrode 5. In order to independently supply the electrical stimulation signal generated by the stimulation circuit 12 to each stimulation electrode 5, the stimulation circuit 12 and each electrode of the terminal electrode 15 associated with the stimulation electrode 5 are connected to the body of the extension 14. 16 are electrically connected by conductive wires (not shown) embedded therein. The electrical configuration of the stimulation circuit 12 will be described later with reference to FIG.
［１－２．刺激回路の回路構成］
　次に、刺激装置４に収納された刺激回路１２の電気的な構成について、図２を参照して説明する。
　図２は、本発明の一実施の形態例に係る刺激回路１２、及び刺激回路１２に接続されるエクステンション１４のターミナル電極１５の電気的構成を示す機能ブロック図である。 [1-2. Circuit configuration of stimulation circuit]
Next, the electrical configuration of the stimulation circuit 12 housed in the stimulation apparatus 4 will be described with reference to FIG.
FIG. 2 is a functional block diagram showing the electrical configuration of the stimulation circuit 12 and the terminal electrode 15 of the extension 14 connected to the stimulation circuit 12 according to an embodiment of the present invention.
　刺激回路１２は、コイル部２１と、充電部２２と、充電池２３と、通信部２４と、制御部２５と、刺激パラメータ設定部２６と、発振部２７と、電極構成設定部２８と、スイッチ部２９とを備える。 The stimulation circuit 12 includes a coil unit 21, a charging unit 22, a rechargeable battery 23, a communication unit 24, a control unit 25, a stimulation parameter setting unit 26, an oscillation unit 27, an electrode configuration setting unit 28, a switch Part 29.
　コイル部２１は、例えばコイルとコンデンサで構成される共振回路である。コイル部２１は、充電池２３の充電を行う場合、図示しない体外のコントローラから送信される充電用の電磁波を受信する。そして、この受信に伴ってコイル部２１から発生する交流電流が充電部２２に出力される。また、コイル部２１は図示しない体外のコントローラから送信される、所定の情報が乗せられた電磁波を受信し、受信した電磁波が当該コイル部２１から通信部２４に出力される。 The coil unit 21 is a resonance circuit composed of, for example, a coil and a capacitor. When the rechargeable battery 23 is charged, the coil unit 21 receives an electromagnetic wave for charging transmitted from an external controller (not shown). Then, an alternating current generated from the coil unit 21 with this reception is output to the charging unit 22. The coil unit 21 receives an electromagnetic wave on which predetermined information is transmitted, which is transmitted from an external controller (not shown), and the received electromagnetic wave is output from the coil unit 21 to the communication unit 24.
　充電部２２は、整流回路を内蔵し、コイル部２１から出力された交流電流を直流電流に変換して電力を取得する。そして、取得した電力で充電池２３の充電を行う。充電池２３は、例えばリチウムイオン電池等の充電可能な電池である。図２に図示はしていないが、この充電池２３は、蓄積している電力を、刺激回路１２を構成する各ブロックに供給している。 The charging unit 22 has a built-in rectifier circuit, converts the alternating current output from the coil unit 21 into a direct current, and acquires power. Then, the rechargeable battery 23 is charged with the acquired power. The rechargeable battery 23 is a rechargeable battery such as a lithium ion battery. Although not shown in FIG. 2, the rechargeable battery 23 supplies the accumulated power to each block constituting the stimulation circuit 12.
　通信部２４は、コイル部２１が受信した電磁波を復調し、電磁波に乗せられている情報を取り出す。そして、取り出した情報を、制御部２５を介して刺激パラメータ設定部２６及び電極構成設定部２８に出力する。刺激パラメータ設定部２６に出力される情報は、電気的刺激信号の刺激強度に関する情報（以下、「刺激パラメータ」という）であり、電極構成設定部２８に出力される情報は、電極構成に関する情報（以下、「電極構成情報」という）である。 The communication unit 24 demodulates the electromagnetic wave received by the coil unit 21 and extracts information carried on the electromagnetic wave. Then, the extracted information is output to the stimulation parameter setting unit 26 and the electrode configuration setting unit 28 via the control unit 25. The information output to the stimulation parameter setting unit 26 is information regarding the stimulation intensity of the electrical stimulation signal (hereinafter referred to as “stimulation parameter”), and the information output to the electrode configuration setting unit 28 is information regarding the electrode configuration ( Hereinafter, this is referred to as “electrode configuration information”.
　電気的刺激信号の刺激強度は、当該電気的刺激信号のパルス電圧、パルス電流、パルス幅あるいは周波数により決定されるものであり、これらパルス電圧等の値が、刺激パラメータとして設定される。また、電極構成情報は、電気的刺激信号の極性を変更するための情報と、電気的刺激信号を出力する刺激電極５に対応したターミナル電極１５をスイッチ部２９に選択させるための情報とを含む信号である。 The stimulation intensity of the electrical stimulation signal is determined by the pulse voltage, pulse current, pulse width, or frequency of the electrical stimulation signal, and values such as the pulse voltage are set as stimulation parameters. The electrode configuration information includes information for changing the polarity of the electrical stimulation signal and information for causing the switch unit 29 to select the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal. Signal.
　刺激パラメータ設定部２６は、通信部２４から入力される刺激パラメータに基づいて、発振部２７で発生する電気的刺激信号の刺激強度を変更するための刺激強度変更信号を生成する。発振部２７は、刺激パラメータ設定部２６から入力される刺激強度変更信号に基づいて、電気的刺激信号を生成し、電気的刺激信号をスイッチ部２９に出力する。 The stimulation parameter setting unit 26 generates a stimulation intensity change signal for changing the stimulation intensity of the electrical stimulation signal generated by the oscillation unit 27 based on the stimulation parameter input from the communication unit 24. The oscillation unit 27 generates an electrical stimulation signal based on the stimulation intensity change signal input from the stimulation parameter setting unit 26, and outputs the electrical stimulation signal to the switch unit 29.
　電極構成設定部２８は、通信部２４から入力される電極構成情報に基づいて、発振部２７で発生する電気的刺激信号を出力する刺激電極５に対応したターミナル電極１５を選択するための電極構成選択信号を生成する。なお、刺激パラメータ設定部２６から出力される刺激強度変更信号は発振部２７に出力され、電極構成設定部２８から出力される電極構成選択信号はスイッチ部２９に出力される。 The electrode configuration setting unit 28 selects an electrode configuration corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal generated by the oscillation unit 27 based on the electrode configuration information input from the communication unit 24. A selection signal is generated. The stimulation intensity change signal output from the stimulation parameter setting unit 26 is output to the oscillation unit 27, and the electrode configuration selection signal output from the electrode configuration setting unit 28 is output to the switch unit 29.
　スイッチ部２９は、電極構成設定部２８から入力される電極構成選択信号に基づいて、発振部２７から入力される電気的刺激信号を出力する刺激電極５に対応したターミナル電極１５を決定する。なお、制御部２５には、例えばマイクロコンピュータ等が用いられ、制御部２５は、刺激回路１２の各ブロックを制御する。 The switch unit 29 determines the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal input from the oscillation unit 27 based on the electrode configuration selection signal input from the electrode configuration setting unit 28. For example, a microcomputer or the like is used as the control unit 25, and the control unit 25 controls each block of the stimulation circuit 12.
［１－３．挿通具の構成］
　図３は、挿通具５０の構成例を示す外観斜視図である。
　図４は、図３に示した挿通具５０を、Ａ－Ａ′線において断面視した例を示す説明図である。 [1-3. Configuration of insertion tool]
FIG. 3 is an external perspective view showing a configuration example of the insertion tool 50.
FIG. 4 is an explanatory diagram showing an example of a cross-sectional view of the insertion tool 50 shown in FIG. 3 along the line AA ′.
　挿通具５０は、押し具ワイヤ固定部５１、把持部５２、押し具ワイヤ留め部５３、押し具ワイヤ５４、挿通ロッド５５、押し具５６、及び挿通ロッド受け部５７を備える。 The insertion tool 50 includes a pressing tool wire fixing part 51, a gripping part 52, a pressing tool wire fastening part 53, a pressing tool wire 54, an insertion rod 55, a pressing tool 56, and an insertion rod receiving part 57.
　押し具ワイヤ固定部５１は、例えばエポキシ等の生体適合性のある比較的硬い樹脂で略円柱状に形成されており、挿通ロッド５５の一端、及び押し具ワイヤ５４の一端を固定する。押し具ワイヤ固定部５１は、ボビン５１ａと弾性部５１ｂを備えており、弾性部５１ｂの一端は、ボビン５１ａに接続され、その他端が押し具ワイヤ固定部５１の筐体に接続される。また、押し具ワイヤ固定部５１には、押し具ワイヤ５４が貫通する押し具ワイヤ貫通部５１ｃと、挿通ロッド５５の一端を固定する挿通ロッド固定部５１ｄと、ボビンガイド５１ｅが形成される。 The pusher wire fixing portion 51 is formed in a substantially cylindrical shape with a relatively hard resin having biocompatibility such as epoxy, and fixes one end of the insertion rod 55 and one end of the pusher wire 54. The pusher wire fixing portion 51 includes a bobbin 51 a and an elastic portion 51 b. One end of the elastic portion 51 b is connected to the bobbin 51 a and the other end is connected to the casing of the pusher wire fixing portion 51. The pusher wire fixing portion 51 is formed with a pusher wire penetration portion 51c through which the pusher wire 54 passes, an insertion rod fixing portion 51d for fixing one end of the insertion rod 55, and a bobbin guide 51e.
　押し具ワイヤ固定部５１が備えるボビン５１ａの芯部には、押し具ワイヤ５４の一端が固定されている。押し具ワイヤ５４は、例えばナイロンやポリプロピレン等の生体適合性がある柔軟な樹脂素材を用い、所定の引っ張り強度を有するものであればよい。押し具ワイヤ５４は、押し具５６に一端が接続され、挿通ロッド５５とほぼ等しい長さに形成されている。
　挿通ロッド固定部５１ｄには、雌ねじが形成される。そして、挿通ロッド固定部５１ｄには、雄ねじが形成された挿通ロッド５５の一端がねじ込まれて固定される。 One end of the pusher wire 54 is fixed to the core part of the bobbin 51 a provided in the pusher wire fixing part 51. The pusher wire 54 may be a flexible resin material having biocompatibility such as nylon or polypropylene and having a predetermined tensile strength. One end of the pusher wire 54 is connected to the pusher 56 and is formed to have a length substantially equal to that of the insertion rod 55.
An internal thread is formed in the insertion rod fixing portion 51d. Then, one end of an insertion rod 55 formed with a male screw is screwed into and fixed to the insertion rod fixing portion 51d.
　ボビン５１ａは、弾性部５１ｂによって、押し具ワイヤ５４の引っ張り方向とは逆の方向に引っ張られている。弾性部５１ｂには、例えば、引っ張りバネが用いられている。そして、弾性部５１ｂは、この弾性部５１ｂの弾性力より大きい力で押し具ワイヤ５４が引っ張られた場合に、押し具ワイヤ５４が引っ張られた方向に所定の距離だけボビン５１ａを移動させる機能を持つ。本例では、ボビンガイド５１ｅが形成される範囲（約２～３ｃｍ）でボビン５１ａが移動することとなる。ボビン５１ａの素材には、押し具ワイヤ固定部５１と同様のものを用いることができる。引っ張りバネの素材には、生体適合性のあるステンレス鋼等を用いることができる。 The bobbin 51a is pulled in a direction opposite to the pulling direction of the pusher wire 54 by the elastic portion 51b. For example, a tension spring is used for the elastic portion 51b. The elastic portion 51b has a function of moving the bobbin 51a by a predetermined distance in the direction in which the pusher wire 54 is pulled when the pusher wire 54 is pulled with a force larger than the elastic force of the elastic portion 51b. Have. In this example, the bobbin 51a moves within a range (about 2 to 3 cm) where the bobbin guide 51e is formed. As the material of the bobbin 51a, the same material as the pusher wire fixing portion 51 can be used. For the material of the tension spring, biocompatible stainless steel or the like can be used.
　把持部５２は、医師が挿通ロッド５５を生体内に挿通させる際に手に持つ部分で、素材として例えば、エポキシ等の生体適合性のある比較的硬い樹脂を用い、略円柱状に形成されている。把持部５２の中心には、挿通ロッド５５が貫通する貫通孔５２ａと、貫通孔５２ａに垂直な方向の雌ねじ５２ｂが形成される。貫通孔５２ａの直径は、挿通ロッド５５の直径に比べてわずかに大きくしてある。このため、貫通孔５２ａに挿通ロッド５５が挿入されていても、挿通ロッド５５に対して把持部５２を移動させることができる。 The grasping part 52 is a part held by the doctor when the insertion rod 55 is inserted into the living body, and is formed in a substantially cylindrical shape using a relatively hard resin having biocompatibility such as epoxy as a material. Yes. A through hole 52a through which the insertion rod 55 passes and a female screw 52b in a direction perpendicular to the through hole 52a are formed at the center of the grip portion 52. The diameter of the through hole 52 a is slightly larger than the diameter of the insertion rod 55. For this reason, even if the insertion rod 55 is inserted in the through hole 52 a, the grip portion 52 can be moved with respect to the insertion rod 55.
　把持部５２に形成された貫通孔５２ａを貫通する挿通ロッド５５は、素材として例えば、比較的硬く、生体適合性のあるステンレス鋼等を用いた長尺体として構成され、その直径は例えば２ｍｍ程度で、生体に挿入される先端部分は円錐形状とされ、他端は挿通ロッド固定部５１ｄに固定するために雄ねじが形成されている。挿通ロッド５５は、挿通ロッド固定部５１ｄと把持部５２によって２点で固定される。このため、医師は、押し具ワイヤ固定部５１と把持部５２を持つことにより、生体内に挿通される挿通ロッド５５の先端部分の位置制御を行いやすくなる。 The insertion rod 55 that penetrates the through hole 52a formed in the grip portion 52 is configured as a long body using, for example, a relatively hard and biocompatible stainless steel as a material, and the diameter thereof is, for example, about 2 mm. Thus, the distal end portion inserted into the living body has a conical shape, and the other end is formed with a male screw for fixing to the insertion rod fixing portion 51d. The insertion rod 55 is fixed at two points by the insertion rod fixing portion 51 d and the grip portion 52. For this reason, the doctor can easily control the position of the distal end portion of the insertion rod 55 inserted into the living body by having the pusher wire fixing portion 51 and the grip portion 52.
　把持部５２に形成された押し具ワイヤ留め部５３は、貫通孔５２ａを貫通する挿通ロッド５５を所定の位置で把持部５２に固定する。このとき、把持部５２の雌ねじ５２ｂには、押し具ワイヤ留め部５３に形成された雄ねじがねじ込まれて固定されている。そして、押し具ワイヤ留め部５３の雄ねじは、貫通孔５２ａ内で挿通ロッド５５を強く圧迫するため、挿通ロッド５５に対して把持部５２を容易に移動させることができない。このため、医師は、把持部５２を把持して、挿通ロッド５５に力を加えることにより、挿通ロッド５５を生体内に挿通させることができる。また、医師は、押し具ワイヤ留め部５３の雄ねじを緩めることで、挿通ロッド５５に力を加え易い位置に把持部５２を挿通ロッド５５上で移動させることができる。 The pressing wire fastening portion 53 formed in the grip portion 52 fixes the insertion rod 55 penetrating the through hole 52a to the grip portion 52 at a predetermined position. At this time, a male screw formed on the pusher wire fastening portion 53 is screwed into and fixed to the female screw 52b of the grip portion 52. Since the male screw of the pusher wire fastening portion 53 strongly presses the insertion rod 55 within the through hole 52a, the grip portion 52 cannot be easily moved with respect to the insertion rod 55. For this reason, the doctor can insert the insertion rod 55 into the living body by holding the grip portion 52 and applying force to the insertion rod 55. The doctor can move the grip 52 on the insertion rod 55 to a position where it is easy to apply a force to the insertion rod 55 by loosening the male screw of the pusher wire fastening portion 53.
　把持部５２から押し具ワイヤ留め部５３が露出する部分には、押し具ワイヤ５４が挿通される貫通孔５３ａが形成される。この貫通孔５３ａに挿入された押し具ワイヤ５４は、押し具ワイヤ固定部５１との間で所定の引っ張り力で張られる。このため、貫通孔５３ａに挿通された押し具ワイヤ５４は、ボビン５１ａとの間で一定のテンションがかかった状態となる。押し具ワイヤ留め部の素材には、例えば、挿通ロッド５５と同様のものを用いることができる。 A through hole 53 a through which the pusher wire 54 is inserted is formed in a portion where the pusher wire fastening portion 53 is exposed from the grip portion 52. The pusher wire 54 inserted into the through-hole 53a is stretched with a predetermined tensile force between the pusher wire fixing portion 51 and the pusher wire fixing portion 51. For this reason, the pressing tool wire 54 inserted into the through hole 53a is in a state where a certain tension is applied to the bobbin 51a. For example, the same material as the insertion rod 55 can be used as the material of the pressing wire fastening portion.
　押し具ワイヤ５４が接続される押し具５６は、例えばエポキシ樹脂によって形成され、挿通ロッド５５の一端（以下、「先端部分」とも呼ぶ）を体表面から押下するために用いられるため、所定の硬度を有する。押し具ワイヤ５４の長さは、押し具ワイヤ固定部５１に固定された部分から挿通ロッド５５の生体内に挿通される先端部分までの長さにほぼ等しい。このため、医師は、生体内に挿通された挿通ロッド５５の先端部分を体表面から視認できなくても、体表面に沿って押し具ワイヤ５４を引っ張れば、押し具５６の位置を挿通ロッド５５の先端部分がある位置に合わせることができる。 The pusher 56 to which the pusher wire 54 is connected is formed of, for example, epoxy resin, and is used to push down one end (hereinafter also referred to as “tip portion”) of the insertion rod 55 from the body surface. Have The length of the pusher wire 54 is substantially equal to the length from the portion fixed to the pusher wire fixing portion 51 to the tip portion of the insertion rod 55 inserted into the living body. For this reason, even if the doctor cannot visually recognize the distal end portion of the insertion rod 55 inserted into the living body from the body surface, if the doctor pulls the pressing tool wire 54 along the body surface, the position of the pressing tool 56 is determined. The tip part of can be adjusted to a certain position.
　ここで、押し具５６と、挿通ロッド受け部５７の使用法について説明する。
　図５は、押し具５６と、挿通ロッド受け部５７の使用方法を示す説明図である。図５Ａは、生体内に挿通ロッド５５を挿通する様子を示す説明図である。図５Ｂは、挿通ロッド受け部５７を用いた例を示す説明図である。 Here, how to use the pusher 56 and the insertion rod receiving portion 57 will be described.
FIG. 5 is an explanatory diagram showing how to use the pusher 56 and the insertion rod receiving portion 57. FIG. 5A is an explanatory diagram showing a state where the insertion rod 55 is inserted into the living body. FIG. 5B is an explanatory diagram showing an example using the insertion rod receiving portion 57.
　押し具５６には、挿通ロッド５５の一端が押し当てられる挿通ロッド受け部５７が形成されている。挿通ロッド受け部５７は、押し具５６に対して突起状に形成され、その中心付近には、凹部５７ａ（図３を参照）が形成されている。挿通ロッド受け部５７の素材として、押し具５６と同様のものを用いることができる。この挿通ロッド受け部５７は、以下の用途を持っている。 The pusher 56 is formed with an insertion rod receiving portion 57 to which one end of the insertion rod 55 is pressed. The insertion rod receiving portion 57 is formed in a protruding shape with respect to the pusher 56, and a recess 57a (see FIG. 3) is formed near the center thereof. As the material of the insertion rod receiving portion 57, the same material as the pusher 56 can be used. The insertion rod receiving portion 57 has the following uses.
　図５Ａに示すように、体表面から約３～６ｍｍ程度の皮下に挿通ロッド５５の一端が挿通され、生体内に皮下トンネルが形成される。この手技は、一般的に患者が背中を丸めた状態で行われるため、挿通ロッド５５を皮下に押し進めていくと、その先端部分が皮下組織よりも体表側にある皮膚５９の真皮層に引っかかることがある。このとき、挿通ロッド５５の直径が非常に細いため、皮下を押し進める力が加わったときに挿通ロッド５５がたわんで先に進まなくなってしまうことがある。ここで、挿通ロッド５５の先端部分が皮膚５９の真皮層に引っかからないようにするため、医師は押し具５６を体表面から皮下に向けて押し込む操作を行う。また、挿通ロッド５５が非常に細いために、体表からその先端部がどこにあるのかを知ることは難しいが、上述したように押し具ワイヤ５４が張られた状態であれば、押し具５６の位置は挿通ロッド５５の先端部分の位置に合わせることができる。このため、挿通ロッド５５の先端部分は皮膚５９の真皮層で引っかかることなく、容易に皮下に挿通されていく。 As shown in FIG. 5A, one end of the insertion rod 55 is inserted subcutaneously about 3 to 6 mm from the body surface, and a subcutaneous tunnel is formed in the living body. Since this procedure is generally performed with the patient rolling his / her back, when the insertion rod 55 is pushed subcutaneously, the tip of the insertion rod 55 is caught by the dermis layer of the skin 59 on the body surface side of the subcutaneous tissue. There is. At this time, since the diameter of the insertion rod 55 is very thin, the insertion rod 55 may bend and not advance further when a force for pushing the subcutaneous is applied. Here, in order to prevent the distal end portion of the insertion rod 55 from being caught by the dermis layer of the skin 59, the doctor performs an operation of pushing the pusher 56 subcutaneously from the body surface. Further, since the insertion rod 55 is very thin, it is difficult to know where the tip portion is from the body surface. However, if the pusher wire 54 is stretched as described above, the pusher 56 The position can be adjusted to the position of the tip portion of the insertion rod 55. For this reason, the distal end portion of the insertion rod 55 is easily inserted subcutaneously without being caught by the dermis layer of the skin 59.
　図５Ｂに示すように、切開の近くまで挿通ロッド５５の先端部分が達し、挿通ロッド５５の先端を皮下から体表へ出す際に、切開された箇所は皮膚５９が切られているために挿通ロッド５５を押し進める抵抗が急に小さくなる。このとき、挿通ロッド５５の先端が体表から飛び出し過ぎたり、意図しない方向に曲がったり、跳ね上がったりすることによって、医師の手や患者の組織を傷つけかねない。 As shown in FIG. 5B, when the distal end portion of the insertion rod 55 reaches the vicinity of the incision, and the distal end of the insertion rod 55 is removed from the subcutaneous surface to the body surface, the incised portion is inserted because the skin 59 is cut. The resistance to push the rod 55 suddenly decreases. At this time, the tip of the insertion rod 55 may jump out of the body surface, bend in an unintended direction, or jump up, which may injure the doctor's hand or the patient's tissue.
　このような事態を防ぐため、挿通ロッド５５の先端を体表に出す付近では、押し具５６を所定の閾値より大きい力で引っ張ることで、前述のように、押し具５６に固定された押し具ワイヤ５４を介してボビン５１ａが引っ張られる。その引っ張りの力が弾性部５１ｂ（図４を参照）を伸ばしてボビン５１ａをボビンガイド５１ｅに沿って移動させ、押し具５６を挿通ロッド５５の先端部分より先に位置させる。そして、押し具５６をひっくり返して、挿通ロッド受け部５７を皮膚５９が切開された箇所から皮下に押し込み、挿通ロッド５５の先端が皮下から外に出たときに、挿通ロッド５５の先端が挿通ロッド受け部５７の凹部５７ａに接触するようにする。このような操作によって、体表から出た挿通ロッド５５の先端が不用意に医師の手や患者の組織を傷つけないようにしている。 In order to prevent such a situation, the pusher fixed to the pusher 56 as described above by pulling the pusher 56 with a force larger than a predetermined threshold in the vicinity where the tip of the insertion rod 55 is exposed to the body surface. The bobbin 51 a is pulled through the wire 54. The pulling force stretches the elastic portion 51b (see FIG. 4), moves the bobbin 51a along the bobbin guide 51e, and positions the pusher 56 ahead of the distal end portion of the insertion rod 55. Then, the pusher 56 is turned over, and the insertion rod receiving portion 57 is pushed subcutaneously from the place where the skin 59 is incised. When the tip of the insertion rod 55 comes out of the skin, the tip of the insertion rod 55 is inserted. It is made to contact the recessed part 57a of the rod receiving part 57. FIG. By such an operation, the tip of the insertion rod 55 protruding from the body surface is prevented from inadvertently damaging the doctor's hand or the patient's tissue.
［１－４．電気刺激装置の植え込み方法］
　次に、この電気刺激装置１を用いて、例えば、硬膜外腔から脊髄の神経の電気刺激を行う場合における電極リード２、刺激装置４の植え込み方法の一例について、図６～図３０を参照して説明する。図６～図３０は、人体を背中側から見た説明図である。 [1-4. Implanting method of electrical stimulation device]
Next, with reference to FIGS. 6 to 30, an example of a method for implanting the electrode lead 2 and the stimulation device 4 when performing electrical stimulation of spinal nerves from the epidural space using the electrical stimulation device 1 will be described. To explain. 6 to 30 are explanatory views of the human body as seen from the back side.
（手順１）
　まず、医師は、患者の痛みの分布状況に基づき、予め目標とする脊髄の刺激部位を決定する。そして、この目標とする刺激部位から、一般的に、脊椎の３椎体以上の低位から電極リード２の挿入が行われる。図６に示すように、電極リード２の挿入予定箇所の皮膚と皮下組織に注射器３２で局部麻酔を行う。
（手順２）
　続いて、医師は、図７に示すように、電極リード２の挿入予定箇所に、分割式あるいはスリット付きの中心が中空とされた硬膜外針３３を、Ｘ線透視下で患者の背中側から穿刺して、その先端を硬膜外腔３１まで挿入する。 (Procedure 1)
First, the doctor determines a target spinal stimulation site in advance based on the distribution of pain of the patient. In general, the electrode lead 2 is inserted from the target stimulation site from the lower position of three or more vertebral bodies of the spine. As shown in FIG. 6, local anesthesia is performed with a syringe 32 on the skin and subcutaneous tissue where the electrode lead 2 is to be inserted.
(Procedure 2)
Subsequently, as shown in FIG. 7, the doctor inserts the epidural needle 33 having a hollow center with a split type or a slit into the position where the electrode lead 2 is to be inserted under the fluoroscopy. The tip is inserted into the epidural space 31.
（手順３）
　次に、医師は、図８に示すように、電極リード２に装着された補助リード３のスタイレット用ルーメンに、スタイレット３４を挿入し、その先端部分を電極リード２の遠位端近辺まで到達させる。これにより、電極リード２及び補助リード３の形状が略直線状に変形する。 (Procedure 3)
Next, as shown in FIG. 8, the doctor inserts the stylet 34 into the stylet lumen of the auxiliary lead 3 attached to the electrode lead 2, and the tip portion thereof reaches the vicinity of the distal end of the electrode lead 2. To reach. Thereby, the shape of the electrode lead 2 and the auxiliary lead 3 is deformed into a substantially linear shape.
　そして、スタイレット３４が挿通された電極リード２の先端を硬膜外針３３の中空部分に通し、電極リード２を生体３０内に挿入する。電極リード２を硬膜外針３３に挿入後は、スタイレット３４を基端から軸方向に押すことにより、電極リード２を硬膜外腔３１内に挿入する。続いて、医師は、スタイレット３４の基端を軸方向にさらに押すことにより、硬膜外腔３１内での電極リード２の位置を上向けさせ、電極リード２の刺激電極５を目標とする刺激部位の近くに位置させる。 Then, the tip of the electrode lead 2 through which the stylet 34 is inserted is passed through the hollow portion of the epidural needle 33, and the electrode lead 2 is inserted into the living body 30. After the electrode lead 2 is inserted into the epidural needle 33, the electrode lead 2 is inserted into the epidural space 31 by pushing the stylet 34 in the axial direction from the proximal end. Subsequently, the doctor further pushes the proximal end of the stylet 34 in the axial direction, thereby causing the position of the electrode lead 2 in the epidural space 31 to face upward, and targeting the stimulation electrode 5 of the electrode lead 2. Locate near the stimulation site.
（手順４）
　次に、医師は、図９に示すように、電極リード２及び補助リード３内に挿通されたスタイレット３４を少し引き抜くことで、電極リード２の刺激電極５が設けられた部分を中空にする。
（手順５）
　その状態で、図１０に示すように、補助リード３から露出しているターミナル電極９の部分に、試験刺激用の体外刺激装置３５を接続させ、試験刺激を行う。 (Procedure 4)
Next, as shown in FIG. 9, the doctor slightly pulls out the stylet 34 inserted into the electrode lead 2 and the auxiliary lead 3 to hollow out the portion of the electrode lead 2 where the stimulation electrode 5 is provided. .
(Procedure 5)
In this state, as shown in FIG. 10, the external stimulation device 35 for test stimulation is connected to the portion of the terminal electrode 9 exposed from the auxiliary lead 3 to perform the test stimulation.
　体外刺激装置３５は、例えば、不図示の刺激回路を内部に有する筐体３５ａと、補助リード３のターミナル電極９を挟んで保持するクリップ部３５ｂと、クリップ部３５ｂと筐体３５ａとを接続するリード部３５ｃとよりなる。クリップ部３５ｂは、その内側に不図示のコンタクト電極を有しており、このコンタクト電極はリード部３５ｃ内に埋め込まれた不図示の導線により筐体３５ａ内部の刺激回路と接続されている。クリップ部３５ｂは、補助リード３のターミナル電極９を挟むことでターミナル電極９とコンタクト電極とを接続するものであり、これにより、刺激電極５が体外刺激装置３５の刺激回路に接続される。筐体３５ａ内の刺激回路は、筐体３５ａの操作面に対するスタイラスペン等の指示体３５ｄによる指示入力に基づいて、電気的刺激信号を発する刺激電極５の選択や、電気的刺激信号の電圧や周波数、パルス幅等を調整する。このように調整が行われた電気的刺激信号が刺激電極５に出力されることにより、当該刺激電極５の位置に近い部分の神経が刺激される。 The extracorporeal stimulation device 35 connects, for example, a housing 35a having a stimulation circuit (not shown) therein, a clip portion 35b that is held with the terminal electrode 9 of the auxiliary lead 3 interposed therebetween, and a clip portion 35b and the housing 35a. It consists of a lead part 35c. The clip portion 35b has a contact electrode (not shown) on the inner side thereof, and this contact electrode is connected to a stimulation circuit inside the housing 35a by a lead wire (not shown) embedded in the lead portion 35c. The clip portion 35 b connects the terminal electrode 9 and the contact electrode by sandwiching the terminal electrode 9 of the auxiliary lead 3, whereby the stimulation electrode 5 is connected to the stimulation circuit of the extracorporeal stimulation device 35. The stimulation circuit in the housing 35a selects the stimulation electrode 5 that emits an electrical stimulation signal based on an instruction input by an indicator 35d such as a stylus pen on the operation surface of the housing 35a, the voltage of the electrical stimulation signal, Adjust frequency, pulse width, etc. The electrical stimulation signal thus adjusted is output to the stimulation electrode 5, thereby stimulating a portion of the nerve close to the position of the stimulation electrode 5.
　この試験刺激は、体外刺激装置３５のクリップ部３５ｂで補助リード３のターミナル電極９を挟んだ状態で行われる。そして、医師は、患者から神経刺激に対する反応を聞きながら、最適な刺激電極５の位置や、電気的刺激信号の電圧、周波数、パルス幅等を決定する。 This test stimulation is performed in a state where the terminal electrode 9 of the auxiliary lead 3 is sandwiched by the clip portion 35b of the extracorporeal stimulation device 35. Then, the doctor determines the optimum position of the stimulation electrode 5, the voltage, frequency, pulse width, etc. of the electrical stimulation signal while listening to the response to the nerve stimulation from the patient.
（手順６）
　次に、医師は、補助リード３のターミナル電極９から体外刺激装置３５のクリップ部３５ｂを取り外した後、図１１に示すように、硬膜外針３３の穿刺孔を中心に小切開を加える。
（手順７）
　その後、図１２に示すように、決定した最適な位置から刺激電極５が移動しないように電極リード２及び補助リード３を保持しながら、スタイレット３４を補助リード３及び電極リード２から抜き去り、続いて補助リード３を電極リード２から取り外す。
（手順８）
　そして、図１３に示すように、決定した最適な位置から刺激電極５が移動しないように電極リード２を保持しながら、硬膜外針３３全体を生体３０から抜き、そのスリット部分を引き裂いて、硬膜外針３３を電極リード２の表面から取り去る。 (Procedure 6)
Next, after removing the clip portion 35b of the extracorporeal stimulation device 35 from the terminal electrode 9 of the auxiliary lead 3, the doctor makes a small incision around the puncture hole of the epidural needle 33 as shown in FIG.
(Procedure 7)
Thereafter, as shown in FIG. 12, the stylet 34 is removed from the auxiliary lead 3 and the electrode lead 2 while holding the electrode lead 2 and the auxiliary lead 3 so that the stimulation electrode 5 does not move from the determined optimum position. Subsequently, the auxiliary lead 3 is removed from the electrode lead 2.
(Procedure 8)
Then, as shown in FIG. 13, while holding the electrode lead 2 so that the stimulation electrode 5 does not move from the determined optimal position, the entire epidural needle 33 is removed from the living body 30, and the slit portion is torn, The epidural needle 33 is removed from the surface of the electrode lead 2.
（手順９）
　続いて、医師は、図１４に示すように、刺激装置４の植え込み予定位置である腰部の所定の位置と、刺激装置４から背中の小切開部分までに設ける皮下トンネルの形成予定位置の皮下組織に、注射器３２を用いて局部麻酔を打つ。
（手順１０）
　そして、図１５に示すように、腰部の刺激装置４の植え込み予定位置に小切開を加える。 (Procedure 9)
Subsequently, as shown in FIG. 14, the doctor places the subcutaneous tissue at the predetermined position of the waist where the stimulation device 4 is to be implanted and the position where the subcutaneous tunnel is to be formed from the stimulation device 4 to the small incision portion of the back. Next, local anesthesia is performed using the syringe 32.
(Procedure 10)
Then, as shown in FIG. 15, a small incision is made at a planned implantation position of the lumbar stimulation device 4.
（手順１１）
　次に、医師は、図１６に示すように、皮下トンネルを形成するための挿通具５０を用いて、腰部に設けた小切開部分に挿通具５０の挿通ロッド５５を挿入し、背中の小切開部分まで押し進めることで皮下トンネルを形成する。皮下トンネルの形成は、一般的に、背中の湾曲を伸ばすために、患者が背中を丸めた状態で行われる。 (Procedure 11)
Next, as shown in FIG. 16, the doctor inserts the insertion rod 55 of the insertion tool 50 into the small incision portion provided in the waist using the insertion tool 50 for forming the subcutaneous tunnel, and makes a small incision on the back. A subcutaneous tunnel is formed by pushing it to the part. The formation of a subcutaneous tunnel is generally performed with the patient rolling his back to stretch the curvature of the back.
　皮下に挿入される挿通ロッド５５の直径は、例えば２ｍｍ程度とされる。生体３０内に挿入される挿通ロッド５５の先端部分は円錐形状とされ、挿通ロッド５５の他端は、略円筒形状に形成された押し具ワイヤ固定部５１が接続されている。挿通ロッド５５の軸方向における所定の位置には、略円筒状に形成された把持部５２が設けられており、この把持部５２は、挿通ロッド５５の軸方向の任意の位置に移動及び固定が可能な形態で、挿通ロッド５５に取り付けられている。 The diameter of the insertion rod 55 inserted under the skin is, for example, about 2 mm. The distal end portion of the insertion rod 55 inserted into the living body 30 has a conical shape, and the other end of the insertion rod 55 is connected to a pusher wire fixing portion 51 formed in a substantially cylindrical shape. A grip portion 52 formed in a substantially cylindrical shape is provided at a predetermined position in the axial direction of the insertion rod 55, and the grip portion 52 can be moved and fixed to an arbitrary position in the axial direction of the insertion rod 55. It is attached to the insertion rod 55 in a possible form.
　押し具５６とは、挿通ロッド５５の先端部分を体表から押さえるための機構であり、板状の略直方体として形成される。押し具５６の端部には、挿通ロッド５５の長さと略同一の長さを有する押し具ワイヤ５４が接続されている。押し具ワイヤ５４の他端は押し具ワイヤ固定部５１に固定されており、その途中の部分は、把持部５２に設けられた押し具ワイヤ留め部５３の貫通孔を通されている。 The pusher 56 is a mechanism for pressing the distal end portion of the insertion rod 55 from the body surface, and is formed as a plate-like substantially rectangular parallelepiped. A pusher wire 54 having a length substantially the same as the length of the insertion rod 55 is connected to the end of the pusher 56. The other end of the pusher wire 54 is fixed to a pusher wire fixing part 51, and a part in the middle is passed through a through hole of a pusher wire fastening part 53 provided in the grip part 52.
　ところで、患者が背中を丸めた状態で挿通ロッド５５を皮下に押し進めていくと、その先端部分が皮下組織よりも体表側にある真皮層に引っかかることがあるが、挿通ロッド５５の直径が非常に細いため、皮下を押し進める力が加わったときに挿通ロッド５５がたわんで先に進まなくなってしまうことがある。このとき、押し具ワイヤ５４を張った状態（ボビン５１ａは移動していない）で、押し具５６で体表を押しつけながら挿通ロッド５５を皮下内で押し進めることにより、挿通ロッド５５の先端部分が皮下でひっかからなくなるため、挿通ロッド５５の先端部分を皮下で進め易くなる。
（手順１２）
　図１７に示すように、挿通ロッド５５の先端部分が背中の小切開部分に近づいたところで、医師は押し具５６をひっくり返してその表裏を反対とし、ボビン５１ａがボビンガイド５１ｅに沿って移動するまで押し具５６を引っ張った状態で挿通ロッド受け部５７を小切開部分に押しつける。そして、挿通ロッド５５の先端部分が挿通ロッド受け部５７の凹部５７ａに収まるように、挿通ロッド５５を押し進める。このような操作を行うことにより、背中の小切開部分で、挿通ロッド５５の先端部分が挿通ロッド受け部５７の凹部５７ａに収容される。そして、押し具５６を挿通ロッド５５の先端部分から外し、背中の小切開部分から挿通ロッド５５の先端が１０ｃｍ程出るまでに、ゆっくりと挿通ロッド５５を押し進める。 By the way, when the patient pushes the insertion rod 55 under the condition that the back is rolled up, the distal end portion of the insertion rod 55 may be caught on the dermis layer on the body surface side than the subcutaneous tissue, but the diameter of the insertion rod 55 is very large. Since it is thin, the insertion rod 55 may bend and not move forward when a force for pushing the skin is applied. At this time, in a state where the pusher wire 54 is stretched (the bobbin 51a is not moving), the distal end portion of the insertion rod 55 is subcutaneously pushed forward by pushing the insertion rod 55 under the skin while pressing the body surface with the pusher 56. Therefore, the tip of the insertion rod 55 can be easily advanced subcutaneously.
(Procedure 12)
As shown in FIG. 17, when the distal end portion of the insertion rod 55 approaches the small incision portion on the back, the doctor turns the pusher 56 upside down and the bobbin 51a moves along the bobbin guide 51e. With the pusher 56 pulled until the insertion rod receiving portion 57 is pressed against the small incision portion. Then, the insertion rod 55 is pushed forward so that the distal end portion of the insertion rod 55 is accommodated in the recess 57 a of the insertion rod receiving portion 57. By performing such an operation, the distal end portion of the insertion rod 55 is accommodated in the recess 57a of the insertion rod receiving portion 57 at the small incision portion on the back. Then, the pusher 56 is removed from the distal end portion of the insertion rod 55, and the insertion rod 55 is slowly pushed forward until the distal end of the insertion rod 55 comes out about 10 cm from the small incision portion on the back.
（手順１３）
　次に、医師は、図１８に示すように、挿通ロッド５５から押し具ワイヤ固定部５１と把持部５２を取り外し、挿通ロッド５５に刺激装置サイザー５８を取り付けた後に、再び挿通ロッド５５に把持部５２（図中では押し具ワイヤ留め部５３を取り外した状態を示している）を取り付ける。刺激装置サイザー５８とは、刺激装置４の筐体１３が植え込まれる皮下ポケットを形成するための、皮下ポケット型取り機構である。刺激装置サイザー５８は、素材として例えばエポキシ樹脂などの生体適合性がある比較的硬い樹脂が用いられ、刺激装置４の筐体１３とほぼ同一の形状として構成してあり、小切開部分に挿入される先端部分は、皮下に挿入し易くするために、円錐形状又はテーパー形状としている。 (Procedure 13)
Next, as shown in FIG. 18, the doctor removes the pusher wire fixing portion 51 and the grip portion 52 from the insertion rod 55, attaches the stimulator sizer 58 to the insertion rod 55, and then again attaches the grip portion to the insertion rod 55. 52 (in the figure, a state in which the pressing wire fastening portion 53 is removed) is attached. The stimulator sizer 58 is a subcutaneous pocket type taking mechanism for forming a subcutaneous pocket in which the housing 13 of the stimulator 4 is implanted. The stimulator sizer 58 is made of, for example, a relatively hard resin having biocompatibility such as an epoxy resin as a material. The stimulator sizer 58 is configured to have almost the same shape as the housing 13 of the stimulator 4 and is inserted into a small incision portion. In order to facilitate insertion under the skin, the distal end portion has a conical shape or a tapered shape.
（手順１４）
　図１９に示すように、刺激装置サイザー５８が取り付けられた挿通ロッド５５を皮下で背中の小切開方向に押し進めることにより、刺激装置サイザー５８が生体３０の皮下に押し込まれる。
（手順１５）
　そして、図２０に示すように、挿通ロッド５５を挿入方向と反対の方向に引き抜き、刺激装置サイザー５８を皮下から取り出すことで、刺激装置サイザー５８が挿入されていた位置に皮下ポケットが形成される。
（手順１６）
　刺激装置４用の皮下ポケットを形成した後は、医師は、図２１に示すように、挿通ロッド５５から刺激装置サイザー５８及び把持部５２を取り外す。 (Procedure 14)
As shown in FIG. 19, the stimulating device sizer 58 is pushed under the skin of the living body 30 by pushing the insertion rod 55 attached with the stimulating device sizer 58 subcutaneously in the small incision direction of the back.
(Procedure 15)
Then, as shown in FIG. 20, by pulling out the insertion rod 55 in the direction opposite to the insertion direction and taking out the stimulator sizer 58 under the skin, a subcutaneous pocket is formed at the position where the stimulator sizer 58 has been inserted. .
(Procedure 16)
After forming the subcutaneous pocket for the stimulator 4, the doctor removes the stimulator sizer 58 and the grip 52 from the insertion rod 55 as shown in FIG. 21.
（手順１７）
　次に、医師は、刺激装置４のエクステンション１４及び筐体１３を、腰部の皮下ポケット形成箇所から背中の小切開部分へ向かって牽引する。牽引を行うために、まず、図２２Ａに示すように皮下トンネル内を挿通されている挿通ロッド５５の末端部分に、刺激装置４のエクステンション１４の先端部分を取り付ける作業を行う。エクステンション１４には挿通ロッド５５との接続機構がないため、接続機構を取り付ける必要がある。 (Procedure 17)
Next, the doctor pulls the extension 14 and the housing 13 of the stimulator 4 from the place where the subcutaneous pocket is formed in the waist toward the small incision portion on the back. In order to perform the traction, first, as shown in FIG. 22A, an operation of attaching the distal end portion of the extension 14 of the stimulating device 4 to the end portion of the insertion rod 55 inserted through the subcutaneous tunnel is performed. Since the extension 14 has no connection mechanism with the insertion rod 55, it is necessary to attach a connection mechanism.
　本実施の形態では、接続機構として、挿通ロッド５５との接続部と、エクステンション１４の折れ曲がりを防止するためのロッドとが一体に形成された、折れ曲がり防止ロッド６０を用いる。折れ曲がり防止ロッド６０は、図２２Ｂに示すように、接続部６１と、ロッド６２と、電極保護カバー６３とを有する。 In this embodiment, a bending prevention rod 60 in which a connection portion with the insertion rod 55 and a rod for preventing the extension 14 from being bent are integrally formed is used as the connection mechanism. The bending prevention rod 60 includes a connection portion 61, a rod 62, and an electrode protection cover 63 as shown in FIG. 22B.
　接続部６１は、挿通ロッド５５の末端部分とエクステンション１４の先端部分とを接続する機構である。接続部６１は、例えば、素材として生体適合性がある比較的硬いステンレス鋼が用いられ、挿通ロッド５５の直径よりもわずかに大きな直径を有する略円筒状の形状とされ、軸方向における両端部分に、挿通ロッド５５収納用の凹部と、エクステンション１４の先端部分収納用の凹部が形成されている。これらの凹部に挿通ロッド５５の端部とエクステンション１４の先端部分が収容された状態で、凹部の形成方向と垂直な方向に不図示のねじがねじ込まれることで、挿通ロッド５５とエクステンション１４とが接続部６１を介して接続される。 The connecting portion 61 is a mechanism for connecting the end portion of the insertion rod 55 and the tip portion of the extension 14. The connection portion 61 is made of, for example, relatively hard stainless steel having biocompatibility as a material, and has a substantially cylindrical shape having a diameter slightly larger than the diameter of the insertion rod 55, and is formed at both end portions in the axial direction. A recess for storing the insertion rod 55 and a recess for storing the tip end portion of the extension 14 are formed. With the end of the insertion rod 55 and the tip of the extension 14 accommodated in these recesses, a screw (not shown) is screwed in a direction perpendicular to the formation direction of the recesses, so that the insertion rod 55 and the extension 14 are connected. The connection is made through the connection unit 61.
　ロッド６２は、エクステンション１４が皮下ポケットや皮下トンネル内で折れ曲がってしまうことを防止するためのロッドで、素材として例えば生体適合性がある比較的硬いステンレス鋼が用いられる。挿通ロッド５５に接続させたエクステンション１４を牽引した後、最終的に刺激装置４の筐体１３を腰部の皮下ポケットに植え込む際には、体外から筐体１３を皮下ポケット内に押し込む作業が必要となる。エクステンション１４は、前述したように柔軟性のある素材で形成されているため、このように押し込む力が加わることで、エクステンション１４が、皮下ポケットや皮下トンネル内で折れ曲がってしまう可能性がある。エクステンション１４の全長に渡ってロッド６２を通せば、エクステンション１４に強度が出るため、皮下ポケットや皮下トンネル内で折れ曲がってしまうことがなくなる。 The rod 62 is a rod for preventing the extension 14 from being bent in a subcutaneous pocket or a subcutaneous tunnel. For example, a relatively hard stainless steel having biocompatibility is used as a material. After pulling the extension 14 connected to the insertion rod 55, when the housing 13 of the stimulator 4 is finally implanted into the subcutaneous pocket of the waist, it is necessary to push the housing 13 into the subcutaneous pocket from outside the body. Become. Since the extension 14 is formed of a flexible material as described above, there is a possibility that the extension 14 is bent in the subcutaneous pocket or the subcutaneous tunnel by applying the pushing force. If the rod 62 is passed through the entire length of the extension 14, the extension 14 becomes strong, so that it will not be bent in the subcutaneous pocket or the subcutaneous tunnel.
　ロッド６２の直径は、例えば、スタイレット３４の直径とほぼ同一とされる。ロッド６２の端部は、接続部６１のエクステンション１４の先端部分収納用の凹部のくぼみの部分に接続されている。ロッド６２の長さは、エクステンション１４の全長と略同一とされる。刺激装置４の筐体１３側に、ロッド６２の端部を収容する溝形状の受け部を設ける場合には、ロッド６２の長さを、エクステンション１４の全長と、受け部の深さに相当する長さとを足した長さとする。 The diameter of the rod 62 is, for example, substantially the same as the diameter of the stylet 34. The end portion of the rod 62 is connected to the recessed portion of the recess for storing the tip end portion of the extension 14 of the connection portion 61. The length of the rod 62 is substantially the same as the entire length of the extension 14. When a groove-shaped receiving part that accommodates the end of the rod 62 is provided on the housing 13 side of the stimulator 4, the length of the rod 62 corresponds to the entire length of the extension 14 and the depth of the receiving part. The length is added to the length.
　接続部６１のエクステンション１４が接続される側の端部には、電極保護カバー６３が接続されている。電極保護カバー６３は、エクステンション１４が接続部６１に接続された状態で、エクステンション１４の先端部分に設けられたターミナル電極１５を保護するものであり、例えば素材として柔軟性があって生体適合性があるシリコーンやポリウレタンが用いられ、中心が空洞とされた円筒状の形状とされる。 The electrode protection cover 63 is connected to the end of the connection portion 61 on the side to which the extension 14 is connected. The electrode protection cover 63 protects the terminal electrode 15 provided at the distal end portion of the extension 14 in a state where the extension 14 is connected to the connection portion 61. For example, the electrode protection cover 63 is flexible as a material and has biocompatibility. A certain silicone or polyurethane is used, and it has a cylindrical shape with a hollow center.
（手順１８）
　医師は、図２２Ｂに示すように、折れ曲がり防止ロッド６０のロッド６２を、エクステンション１４の軸心部分の内腔に挿入し、ロッド６２の先端部分を刺激装置４の筐体１３まで到達させる。これにより、図２３に示すように、エクステンション１４に挿通ロッド５５との接続機構が取り付けられ、エクステンション１４内にロッド６２が挿通される。このとき、接続部６１に接続されたエクステンション１４のターミナル電極１５は、電極保護カバー６３によって覆われるため、皮下トンネル内をエクステンション１４が牽引される際に、ターミナル電極１５に体液が付着することを防ぐことができる。 (Procedure 18)
As shown in FIG. 22B, the doctor inserts the rod 62 of the bending prevention rod 60 into the lumen of the axial center portion of the extension 14, and causes the tip portion of the rod 62 to reach the housing 13 of the stimulation device 4. Accordingly, as shown in FIG. 23, a connection mechanism with the insertion rod 55 is attached to the extension 14, and the rod 62 is inserted into the extension 14. At this time, since the terminal electrode 15 of the extension 14 connected to the connection portion 61 is covered with the electrode protection cover 63, when the extension 14 is pulled through the subcutaneous tunnel, body fluid adheres to the terminal electrode 15. Can be prevented.
（手順１９）
　続いて、医師は、図２４に示すように、生体３０の背中の小切開部分から露出した挿通ロッド５５の先端部分に把持部５２を取り付け、把持部５２を握った状態で挿通ロッド５５を引き抜く方向に引っ張る。
（手順２０）
　そして、エクステンション１４の先端部分が背中の小切開部分から出るまで、挿通ロッド５５の牽引を続ける。これにより、図２５に示すように、皮下トンネル内をエクステンション１４が挿通する。
（手順２１）
　そして、エクステンション１４とともに牽引された刺激装置４の筐体１３が、腰部の小切開部分に到達した時点で、医師は、エクステンション１４を牽引しながら筐体１３を皮下ポケット内に押し込む。図２６は、刺激装置４の筐体１３が皮下ポケット内に収容された状態を示す図である。 (Procedure 19)
Next, as shown in FIG. 24, the doctor attaches the grip portion 52 to the distal end portion of the insertion rod 55 exposed from the small incision portion of the back of the living body 30, and pulls out the insertion rod 55 while holding the grip portion 52. Pull in the direction.
(Procedure 20)
Then, the insertion rod 55 is continuously pulled until the distal end portion of the extension 14 comes out from the small incision portion on the back. As a result, as shown in FIG. 25, the extension 14 is inserted through the subcutaneous tunnel.
(Procedure 21)
Then, when the casing 13 of the stimulator 4 pulled together with the extension 14 reaches the small incision portion of the waist, the doctor pushes the casing 13 into the subcutaneous pocket while pulling the extension 14. FIG. 26 is a diagram illustrating a state in which the housing 13 of the stimulation device 4 is accommodated in the subcutaneous pocket.
（手順２２）
　刺激装置４の筐体１３が皮下ポケット内に収容された後は、医師は、エクステンション１４に接続されている折れ曲がり防止ロッド６０から挿通ロッド５５を取り外し、さらに、図２７に示すように、エクステンション１４に取り付けられていた折れ曲がり防止ロッド６０の接続を解除し、ロッド６２を引き抜く。 (Procedure 22)
After the housing 13 of the stimulating device 4 is accommodated in the subcutaneous pocket, the doctor removes the insertion rod 55 from the anti-bending rod 60 connected to the extension 14, and further, as shown in FIG. The connection of the anti-bending rod 60 attached to the rod is released, and the rod 62 is pulled out.
（手順２３）
　次に、医師は、図２８に示すように、背中の小切開部分から指や鉗子（図示略）を皮下に入れて鈍的切開を行い、皮下ポケットを形成する。
（手順２４）
　そして、図２９に示すように、エクステンション１４の先端部分を電極リード２のコネクタ７に挿入、六角レンチ等を用いて固定ねじで固定した後、コネクタ７及びエクステンション１４を、形成した皮下ポケットに収納する。
（手順２５）
　最後に、医師は、図３０に示すように、背中の皮下ポケットの小切開部分と、腰部の皮下ポケットの小切開部分とをそれぞれ縫合する。 (Procedure 23)
Next, as shown in FIG. 28, the doctor inserts a finger or forceps (not shown) subcutaneously from a small incision portion on the back to make a blunt incision to form a subcutaneous pocket.
(Procedure 24)
Then, as shown in FIG. 29, after the distal end portion of the extension 14 is inserted into the connector 7 of the electrode lead 2 and fixed with a fixing screw using a hexagon wrench or the like, the connector 7 and the extension 14 are stored in the formed subcutaneous pocket. To do.
(Procedure 25)
Finally, as shown in FIG. 30, the doctor sutures the small incision portion of the subcutaneous pocket on the back and the small incision portion of the subcutaneous pocket on the waist.
　以上説明した一実施の形態例に係る挿通具５０によれば、生体内に挿通ロッド５５を挿通する際に、押し具ワイヤ５４を張った状態で体表面から挿通ロッド５５の先端部分を押さえる。これにより、医師は、挿通ロッド５５の先端部分を押し具ワイヤ５４の位置から推測し、挿通ロッド５５を容易に皮下に通すことができる。また、挿通ロッド５５の先端部分を押さえることで、挿通ロッド５５の先端部分が生体内で引っかかることを防ぐことができる。 According to the insertion tool 50 according to the embodiment described above, when the insertion rod 55 is inserted into the living body, the distal end portion of the insertion rod 55 is pressed from the body surface with the pusher wire 54 stretched. Thereby, the doctor can guess the front-end | tip part of the insertion rod 55 from the position of the pusher wire 54, and can pass the insertion rod 55 subcutaneously easily. Further, by pressing the distal end portion of the insertion rod 55, the distal end portion of the insertion rod 55 can be prevented from being caught in the living body.
　また、押し具ワイヤ５４は、ボビン５１ａに固定されており、押し具ワイヤ５４の長さが挿通ロッド５５の長さにほぼ等しくなる。このため、医師は、押し具ワイヤ５４を張ることで、挿通ロッド５５の先端部分の位置を把握しやすくなる。 Further, the pusher wire 54 is fixed to the bobbin 51a, and the length of the pusher wire 54 is substantially equal to the length of the insertion rod 55. For this reason, the doctor can easily grasp the position of the distal end portion of the insertion rod 55 by stretching the pusher wire 54.
　また、医師は、挿通ロッド５５の先端部分が背中切開の箇所まで到達する前に、さらに押し具５６を引っ張ることにより、挿通ロッド５５の先端部分よりも先の体表面を押し具５６で押さえることができる。このとき、医師は、押し具５６をひっくり返して背中切開の箇所に挿通ロッド受け部５７を押し当てる。これにより、挿通ロッド受け部５７に設けた凹部５７ａに挿通ロッド５５の先端部分が接触し、背中切開の部分で挿通ロッド５５の先端部分が体表から飛び出し過ぎたり、跳ね上がったりすることを防止できる。このため、背中切開した箇所を意図せず広げるようなことがない。 Further, the doctor holds the body surface ahead of the distal end portion of the insertion rod 55 with the pusher 56 by further pulling the pusher 56 before the distal end portion of the insertion rod 55 reaches the back incision. Can do. At this time, the doctor turns over the pusher 56 and presses the insertion rod receiving portion 57 at the location of the back incision. As a result, the distal end portion of the insertion rod 55 comes into contact with the recess 57a provided in the insertion rod receiving portion 57, and the distal end portion of the insertion rod 55 can be prevented from jumping out of the body surface or jumping up at the back incision portion. . For this reason, there is no case where the back-incised portion is unintentionally widened.
　また、押し具ワイヤ５４と挿通ロッド５５は、それぞれ把持部５２に形成された貫通孔に通される。このため、曲面を有する生体内であっても、挿通ロッド５５の方向を見誤ることが少なくなり、適切な位置で押し具５６を押し込んで挿通ロッド５５を挿通することができる。 Further, the pusher wire 54 and the insertion rod 55 are respectively passed through the through holes formed in the grip portion 52. For this reason, even in a living body having a curved surface, the direction of the insertion rod 55 is less likely to be mistaken, and the insertion rod 55 can be inserted by pushing the pusher 56 at an appropriate position.
＜２．一実施の形態の変形例＞
　なお、ボビン５１ａを回転可能とし、押し具ワイヤ５４がボビン５１ａに巻回された状態で押し具ワイヤ固定部５１に収納され、押し具ワイヤ５４が引っ張られることで、ボビン５１ａが回転し、押し具ワイヤ５４がほどけていく構成としてもよい。また、ボビン５１ａをリール機構とし、ハンドルを回転させることにより、押し具ワイヤ５４を容易に巻き上げるようにしてもよい。この際に、押し具ワイヤ５４の表面には、例えば、１０ｃｍ毎に色を塗り分けたり、周上に浅い溝を切ったりしてもよい。これにより、ボビン５１ａからほどけた押し具ワイヤ５４を容易に知ることができる。 <2. Modification of Embodiment>
The bobbin 51a can be rotated, and the pusher wire 54 is housed in the pusher wire fixing portion 51 while being wound around the bobbin 51a. When the pusher wire 54 is pulled, the bobbin 51a rotates and pushes. It is good also as a structure which the tool wire 54 unwinds. Alternatively, the bobbin 51a may be a reel mechanism, and the pusher wire 54 may be easily wound up by rotating the handle. At this time, on the surface of the pusher wire 54, for example, colors may be separately applied every 10 cm, or a shallow groove may be cut on the circumference. Thereby, the pusher wire 54 unwound from the bobbin 51a can be easily known.
　また、挿通ワイヤ固定部５１ｄには、ガータースプリングを設け、挿通ロッド５５の一端に凹凸を形成することにより、この凹部にガータースプリングが密着するようにして、挿通ロッド５５を固定してもよい。また、挿通ワイヤ固定部５１ｄに磁力が強い磁石を設け、金属製とした挿通ロッド５５の一端を磁力で固定してもよい。 Alternatively, the insertion wire fixing portion 51d may be provided with a garter spring, and the insertion rod 55 may be fixed by forming an unevenness at one end of the insertion rod 55 so that the garter spring is in close contact with the recess. Alternatively, a magnet having a strong magnetic force may be provided in the insertion wire fixing portion 51d, and one end of the metal insertion rod 55 may be fixed by the magnetic force.
　また、把持部５２は、挿通ロッド５５に対して可動としたが、挿通ロッド５５の先端部分から把持部５２まで十分な長さがあれば、不動としてもよい。この場合であっても、挿通ロッド５５の先端部分に十分な力を加えることが可能である。 Further, although the grip portion 52 is movable with respect to the insertion rod 55, it may be immovable if there is a sufficient length from the tip portion of the insertion rod 55 to the grip portion 52. Even in this case, it is possible to apply a sufficient force to the tip portion of the insertion rod 55.
　また、ボビン５１ａを押し具ワイヤ固定部５１に取付けた構成としたが、押し具５６にボビン５１ａを取付けた構成としてもよい。また、ボビン５１ａにゼンマイばねとストッパを取付けておき、押し具５６を使用しないときにはボビン５１ａに押し具ワイヤ５４を巻き上げるようにしてもよい。これにより、押し具ワイヤ５４を容易に収納することができる。 Further, although the bobbin 51a is attached to the pusher wire fixing portion 51, the bobbin 51a may be attached to the pusher 56. Further, a spring spring and a stopper may be attached to the bobbin 51a, and the pusher wire 54 may be wound around the bobbin 51a when the pusher 56 is not used. Thereby, the pusher wire 54 can be easily accommodated.
　また、把持部５２の形状は、円筒形に限らない。例えば、直方体形状としてもよく、医師が力を加えやすい形状であればどのような形状であってもよい。また、把持部５２の表面には凹凸を設ける等によって滑り止め加工を施していてもよい。 Further, the shape of the grip portion 52 is not limited to a cylindrical shape. For example, it may be a rectangular parallelepiped shape, and may be any shape as long as a doctor can easily apply force. Further, the surface of the grip portion 52 may be subjected to anti-slip processing by providing unevenness or the like.
　また、挿通ロッド５５の先端に発光体を設けて、生体内に挿通された挿通ロッド５５の先端が発光することによって、医師に挿通ロッド５５の先端を知らせるようにしてもよい。この場合、医師が視認する光の強さによって、挿通ロッド５５の先端が体表面からどれだけ深い位置にあるかを確認することも可能となる。 Alternatively, a light emitter may be provided at the distal end of the insertion rod 55 so that the distal end of the insertion rod 55 inserted into the living body emits light to inform the doctor of the distal end of the insertion rod 55. In this case, it is also possible to confirm how deep the tip of the insertion rod 55 is from the body surface by the intensity of light visually recognized by the doctor.
　また、挿通ロッド５５の先端を磁性素子で形成し、この磁性素子から生じる磁界を検出する磁気センサを押し具５６に内蔵してもよい。この磁気センサが検出した磁界の強さに応じてセンサ値を押し具５６に表示させれば、医師は押し具５６の真下付近に挿通ロッド５５の先端があることを容易に知ることができる。 Further, the tip of the insertion rod 55 may be formed of a magnetic element, and a magnetic sensor for detecting a magnetic field generated from the magnetic element may be incorporated in the pusher 56. If the sensor value is displayed on the pusher 56 according to the strength of the magnetic field detected by the magnetic sensor, the doctor can easily know that the tip of the insertion rod 55 is near the pusher 56.
　１…電気刺激装置、２…電極リード、３…補助リード、４…刺激装置、５…刺激電極、１２…刺激回路、５０…挿通具、５１…押し具ワイヤ固定部、５２…把持部、５３…押し具ワイヤ留め部、５４…押し具ワイヤ、５５…挿通ロッド、５６…押し具、５７…挿通ロッド受け部 DESCRIPTION OF SYMBOLS 1 ... Electrical stimulation apparatus, 2 ... Electrode lead, 3 ... Auxiliary lead, 4 ... Stimulation apparatus, 5 ... Stimulation electrode, 12 ... Stimulation circuit, 50 ... Insertion tool, 51 ... Pusher wire fixing part, 52 ... Gripping part, 53 ... Pushing wire fastening part, 54 ... Pushing wire, 55 ... Pushing rod, 56 ... Pushing tool, 57 ... Pushing rod receiving part

Claims (6)

  1. 　一端が生体内に挿通される挿通ロッドと、
    　生体内に挿通された前記挿通ロッドの一端を体表面から押下する押し具と、
    　前記押し具に一端が接続され、前記挿通ロッドとほぼ等しい長さの押し具ワイヤと、
    　前記挿通ロッドの他端及び前記押し具ワイヤの他端を固定する押し具ワイヤ固定部と、
    　前記挿通ロッドを前記生体内に挿通させる把持部と、を備える
    　挿通具。     An insertion rod whose one end is inserted into the living body,
    A pusher for pressing one end of the insertion rod inserted into the living body from the body surface;
    One end is connected to the pusher, and a pusher wire having a length substantially equal to the insertion rod;
    A pressing wire fixing part for fixing the other end of the insertion rod and the other end of the pressing wire;
    A gripping part that allows the insertion rod to be inserted into the living body.
  2. 　前記押し具ワイヤの他端が、前記押し具ワイヤ固定部内で前記挿通ロッドの軸方向に所定の距離だけ移動できる
    　請求項１に記載の挿通具。     The insertion tool according to claim 1, wherein the other end of the pressing tool wire can move by a predetermined distance in the axial direction of the insertion rod within the pressing tool wire fixing portion.
  3. 　前記押し具ワイヤの他端と前記押し具ワイヤ固定部とを接続する弾性部を備える
    　請求項２に記載の挿通具。     The insertion tool according to claim 2, further comprising an elastic part that connects the other end of the pusher wire and the pusher wire fixing part.
  4. 　前記押し具は、前記挿通ロッドの一端が押し当てられる挿通ロッド受け部を備える
    　請求項１～３のいずれかに記載の挿通具。     The insertion tool according to any one of claims 1 to 3, wherein the pressing tool includes an insertion rod receiving portion against which one end of the insertion rod is pressed.
  5. 　前記把持部に形成された貫通孔に挿入される前記挿通ロッドを所定の位置で前記把持部に固定する押し具ワイヤ留め部を備える
    　請求項１～３のいずれかに記載の挿通具。     The insertion tool according to any one of claims 1 to 3, further comprising a pusher wire fastening part that fixes the insertion rod inserted into a through-hole formed in the grip part to the grip part at a predetermined position.
  6. 　前記押し具ワイヤ留め部に形成された貫通孔に挿入された前記押し具ワイヤが、前記ワイヤ固定部との間で所定の引っ張り力で張られる
    　請求項５に記載の挿通具。     The penetration tool according to claim 5, wherein the pusher wire inserted into a through hole formed in the pusher wire fastening portion is stretched with a predetermined tensile force between the wire fixing portion and the wire.
PCT/JP2012/074761 2012-09-26 2012-09-26 Insertion instrument WO2014049737A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3118938U (en) * 2005-11-30 2006-02-09 元継 深谷 Subcutaneous puncture tool for surgical thread
JP2006175070A (en) * 2004-12-22 2006-07-06 Terumo Corp Medical appliance set
JP2011515159A (en) * 2008-03-18 2011-05-19 レイク リージョン マニュファクチュアリング インコーポレイテッド Subcutaneous tunnel device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006175070A (en) * 2004-12-22 2006-07-06 Terumo Corp Medical appliance set
JP3118938U (en) * 2005-11-30 2006-02-09 元継 深谷 Subcutaneous puncture tool for surgical thread
JP2011515159A (en) * 2008-03-18 2011-05-19 レイク リージョン マニュファクチュアリング インコーポレイテッド Subcutaneous tunnel device

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