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WO2014041608A1 - Fil d'électrode et dispositif de stimulation électrique - Google Patents

Fil d'électrode et dispositif de stimulation électrique Download PDF

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Publication number
WO2014041608A1
WO2014041608A1 PCT/JP2012/073225 JP2012073225W WO2014041608A1 WO 2014041608 A1 WO2014041608 A1 WO 2014041608A1 JP 2012073225 W JP2012073225 W JP 2012073225W WO 2014041608 A1 WO2014041608 A1 WO 2014041608A1
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WO
WIPO (PCT)
Prior art keywords
electrode
lead
stimulation
connector
electrode lead
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2012/073225
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English (en)
Japanese (ja)
Inventor
美仁 福井
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to PCT/JP2012/073225 priority Critical patent/WO2014041608A1/fr
Publication of WO2014041608A1 publication Critical patent/WO2014041608A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0558—Anchoring or fixation means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections

Definitions

  • the present invention relates to an electrode lead and an acupuncture electrical stimulation device used for electrical stimulation therapy for electrically stimulating a living body, and more particularly to an electrode lead and an electrical stimulation device that can be implanted in a living body with minimal invasiveness.
  • Spinal cord electrical stimulation therapy which is one type of electrical stimulation therapy, is a stimulation therapy that electrically stimulates the spinal cord in order to relieve pain transmitted to the brain through the spinal cord.
  • 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 which covers the spinal cord by puncture from the back. Then, the degree of pain relief is examined under various stimulation patterns by connecting the electrode lead to an external electrical stimulation device.
  • FIG. 30 is a schematic diagram schematically showing a procedure for implanting the electrical stimulation device during main implantation.
  • the stimulation electrode 101 of the electrode lead 100 is inserted into the epidural space 31 of the living body 30, and the extension 300, which is a relay lead connecting the electrode lead 100 and the stimulation device 200, passes through the subcutaneous tunnel B ⁇ b> 10. It is a figure which shows the state inserted.
  • Each stimulation electrode 101 is provided at one end of the electrode lead 100, and four terminal electrodes 102 corresponding to the stimulation electrode 101 are provided at the other end. Each electrode of the stimulation electrode 101 and each electrode of the terminal electrode 102 are electrically connected by a lead wire (not shown).
  • the extension 300 is provided with a connector 301 that houses the terminal electrode 102 of the electrode lead 100 at one end, and a terminal electrode 302 at the other end.
  • the terminal electrode 302 is accommodated in the connector 202 of the stimulation apparatus 200.
  • Inside the connector 301 there are provided four contact electrodes (not shown) that are electrically connected to each terminal electrode 102 when the terminal electrode 102 of the electrode lead 100 is accommodated.
  • the contact electrode and the terminal electrode 302 are electrically connected by a conducting wire (not shown).
  • the stimulation apparatus 200 includes a housing 201 and a connector 202 that houses the terminal electrode 302 of the extension 300.
  • an incision is made in the insertion portion of the electrode lead 100 into the living body 30, and an incision B11 is provided.
  • an incision is made in a site to be implanted of the stimulating device 200, for example, the waist, and a subcutaneous pocket B12 is provided by creating a space equivalent to the stimulating device 200 through the incision B13 by blunt dissection.
  • a tunneling tool is inserted from the cut opening B13 toward the cut opening B11.
  • a tunneler composed of an elongated rod and a hollow sheath mounted so as to cover the rod is generally used.
  • Patent Document 1 As a technique for implanting an electrical stimulation device in a living body, a technique disclosed in Patent Document 1 for forming a subcutaneous tunnel in a living body is known.
  • the terminal electrode 102 of the electrode lead 100 is accommodated in the connector 301 of the extension 300 on the cut opening B11 side. Further, the terminal electrode 302 of the extension 300 on the subcutaneous pocket B12 side is accommodated in the connector 202 of the stimulation apparatus 200. Then, in a state where the electrode lead 100 inserted into the epidural space 31 and the stimulation device 200 are connected via the extension 300, the stimulation device 200 is implanted in the subcutaneous pocket B12 provided in the waist.
  • the connector 301 for connecting the electrode lead 100 and the extension 300 can be passed through the subcutaneous tunnel B10. It becomes the end of the side that is not. That is, the end on the side where the terminal electrode 302 is provided passes through the subcutaneous tunnel B10. This is because in order to pass the connector 301 through the subcutaneous tunnel B10, it is necessary to provide a subcutaneous tunnel having a large lumen, and the invasion becomes very large. Further, although the terminal electrode 302 is connected to the stimulating device 200, since the terminal electrode 302 needs to pass through the subcutaneous tunnel B10, a connector for the stimulating device 200 cannot be provided in this portion.
  • the connector between the extension 300 and the stimulation device 200 is provided on the stimulation device 200 side.
  • the provision of the connector 202 in the stimulation device 200 increases the size of the stimulation device 200 accordingly.
  • the size of the subcutaneous pocket B12 for accommodating the stimulating device 200 in the body must be increased, and it is also necessary to widen the incision B13 when forming the subcutaneous pocket B12. That is, in the conventional configuration, there is a limit to miniaturization of the stimulation apparatus 200, so it is difficult to implant the stimulation apparatus 200 into the living body 30 with minimal invasiveness.
  • the present invention has been made in view of such a point, and an object thereof is to allow implantation of an electrical stimulation device into a body with minimal invasiveness.
  • the electrode lead according to the present invention has a first end portion, a second end portion, and a lead portion, and the configuration and function of each portion are as follows.
  • the first end portion is provided with a stimulation electrode that is implanted in the living body and electrically stimulates nerves or muscles.
  • the second end accommodates the first electrode associated with the stimulation electrode provided at the distal end portion of the relay lead connected to the stimulation device that generates the electrical stimulation signal to be applied to the stimulation electrode.
  • a connector is provided. This connector is a connector having a second electrode associated with the first electrode therein.
  • a lead part has a conducting wire which electrically connects a stimulation electrode and the 2nd electrode in a connector inside.
  • the electrical stimulation device is configured to include a stimulation device and an electrode lead, and the configuration and function of each part are as follows.
  • the stimulation apparatus includes a stimulation circuit and a relay lead.
  • the stimulation circuit generates an electrical stimulation signal that is implanted in the living body to electrically stimulate nerves or muscles.
  • the relay lead is connected to a stimulation circuit and has an electrode at the tip portion to which an electrical stimulation signal is applied.
  • the electrode lead has two end portions and a lead portion. One end portion is provided with a connector that internally has an electrode associated with the electrode of the relay lead and that accommodates the distal end portion of the relay lead.
  • a stimulation electrode to which an electrical stimulation signal is applied is provided at the other end.
  • the electrode lead has a conducting wire for electrically connecting the stimulation electrode and the electrode in the connector.
  • the stimulation device can be implanted into the living body with minimal invasiveness.
  • 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.
  • 2A is a cross-sectional view showing a configuration example of an electrode lead and an auxiliary lead according to an embodiment of the present invention, FIG. 2A shows a state where the electrode lead and the auxiliary lead are not connected, and FIG. 2B shows an electrode lead and the auxiliary lead. The state where the lead is connected is shown.
  • FIG. 20A is an explanatory diagram showing a state of an operation of attaching the tip portion of the extension to the insertion rod.
  • FIG. 20B 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 the 1st Example 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.
  • FIG. 2 is a cross-sectional view showing an internal configuration example of the electrode lead 2 and the auxiliary lead 3.
  • FIG. 2A shows a cross-sectional view of the electrode lead 2 with the auxiliary lead 3 removed
  • FIG. 2B shows a cross-sectional view of the electrode lead 2 with the auxiliary lead 3 connected.
  • 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 elongated body, and four stimulation electrodes 5 for stimulating nerves of the spinal cord are provided at one end (first end) thereof.
  • the other end (second 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 stimulation 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.
  • a body 6 as a lead portion is provided between the four stimulation electrodes 5 of the electrode lead 2, a body 6 as a lead portion is provided.
  • 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 the stylet for pushing the electrode lead 2 and keeping the shape of the electrode lead 2 is inserted while the stimulation electrode is inserted into the living body. It is expressed as “Lumen for use”. The structure of the stylet lumen will be described later with reference to FIG.
  • the connector 7 is formed of a flexible and biocompatible material, for example, a resin material such as silicone or polyurethane, in a hollow and substantially cylindrical shape, and has a contact electrode (not shown) therein.
  • the contact electrode and the stimulation electrode 5 are electrically connected by a conducting wire (not shown), and the conducting wire is completely embedded in the body 6.
  • 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 (fourth end) thereof. Also, four terminal electrodes 9 corresponding to the respective stimulation electrodes 5 of the electrode lead 2 are provided at the other end (third end portion).
  • 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 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 (fourth end) on the side where the terminal electrode 8 accommodated in the connector 7 of the electrode lead 2 is provided becomes the distal end, and the terminal electrode 9 to which the extracorporeal stimulation device is connected is provided.
  • the side end (third end) is the 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 portion thereof. Is formed.
  • 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 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 stimulation device 4 includes a housing 13 and an extension 14 as a relay lead that relays the stimulation 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.
  • the extension 14 is made of a flexible and biocompatible material, for example, a long body formed of a resin material such as silicone or polyurethane in a substantially cylindrical shape. It is preferable that it is 3 mm.
  • the terminal electrode 15 corresponding to the stimulation electrode 5 and the fixing screw 7f described later when accommodated in the connector 7 are used.
  • a fixing ring 17 that is fixed to the lead 2 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 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 device 4 according to the present embodiment does not have the connector 202 like the conventional stimulation device 200 described with reference to FIG. Therefore, the stimulation device 4 according to the present embodiment can be made smaller than the conventional stimulation device.
  • the stimulation circuit 12 is a circuit in which a small component such as a custom IC is mounted on a circuit board.
  • the stimulation circuit 12 generates an electrical stimulation signal and performs control to apply the generated electrical stimulation signal to the stimulation electrode 5.
  • 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 cross-sectional view of the electrode lead 2 and the auxiliary lead 3
  • FIG. 2A shows a state where the auxiliary lead 3 is detached from the electrode lead 2
  • FIG. 2B shows a state where the auxiliary lead 3 is connected to the electrode lead 2. Show.
  • an opening 7b for accommodating the auxiliary lead 3 (or extension 14) is formed inside the connector 7 of the electrode lead 2.
  • the opening 7 b is formed in a substantially cylindrical shape, and is opened at the proximal end of the connector 7 to the vicinity of the distal end of the connector 7. In the vicinity of the distal end of the connector 7, the opening 7 b is connected to a stylet lumen 6 a provided in the axial center portion of the body 6.
  • the diameter of the stylet lumen 6a needs to be approximately equal to or slightly larger than the diameter of the stylet. Further, in order to prevent the stimulation electrode 5 from blocking the stylet lumen 6a, the inner diameter of the stimulation electrode 5 needs to be larger than the diameter of the stylet lumen 6a.
  • the contact electrode 7c and the conductive wire 7d are made of a conductive and biocompatible material such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy).
  • the contact electrode 7c is composed of a garter spring or the like, for example.
  • the contact electrode 7c made of a garter spring or the like is disposed so as to slightly protrude from the inner periphery of the opening 7b.
  • the force of the direction tightened with a garter spring acts with respect to the auxiliary
  • a groove 7 a as a connection mechanism with the auxiliary lead 3 is provided over the entire circumference of the connector 7.
  • the groove 7a is formed at a position that enters the distal end side by a predetermined length from the proximal end of the opening 7b.
  • the diameter of the outer periphery of the portion from the proximal end of the opening 7b to the groove 7a is smaller than the diameter of the outer periphery of the portion closer to the distal end than the groove 7a.
  • the electrode lead 2 and the auxiliary lead 3 are structurally connected.
  • the engaging member 11 of the auxiliary lead 3 can be easily attached to and detached from the electrode lead 2 with a small force.
  • a fixing screw hole 7e (first fixing mechanism) is formed in a direction orthogonal to the axial direction of the opening 7b.
  • the fixing screw 7f is screwed into the fixing screw hole 7e, and the fixing screw 7f is fixed to the fixing ring 17 of the extension 14, whereby the extension 14 inserted into the opening 7b and the electrode lead 2 are firmly fixed. Is done.
  • the fixing screw 7f is made of a relatively hard and biocompatible material such as stainless steel. Fixing with the fixing screw 7f is performed at the time of the main implantation of the electrical stimulation device 1 in which the extension 14 and the electrode lead 2 need to be fixed semipermanently.
  • a terminal electrode 8 and a terminal electrode 9 are provided at the proximal end and the distal end of the auxiliary lead 3, respectively.
  • Each of the terminal electrode 8 and the terminal electrode 9 is formed in the circumferential direction, and is provided at a predetermined interval in the axial direction.
  • the arrangement position in the axial direction of each electrode of the terminal electrode 8 is made to correspond to the arrangement position in the axial direction of the contact electrode 7c of the connector 7 which is the accommodation destination.
  • the electrodes of the terminal electrode 8 and the terminal electrode 9 are connected to each other by a conducting wire 3a.
  • the conductive wire 3a is made of a conductive and biocompatible material, such as stainless steel, MP35N alloy, platinum, or platinum alloy (for example, platinum 90% / iridium 10% alloy).
  • the auxiliary lead 3 has a claw portion 11 a formed at the tip end portion of the engaging member 11 protruding from the body 10, and this engages with the groove portion 7 a of the connector 7 of the electrode lead 2. (Second fixing mechanism).
  • the material of the engaging member 11 is not limited to silicone, and any material may be used as long as it is flexible and biocompatible.
  • a stylet lumen 5b penetrating from the proximal end to the distal end of the body 10 is formed in the axial center portion.
  • the stylet lumen 5b of the auxiliary lead 3 and the stylet lumen 6a of the electrode lead 2 communicate with each other with the auxiliary lead 3 connected to the electrode lead 2.
  • the stylet can be inserted from the proximal end of the auxiliary lead 3 to the vicinity of the distal end of the electrode lead 2.
  • FIG. 3 is a functional block diagram showing the electrical configuration of the stimulation circuit 12 according to the first embodiment of the present invention and the terminal electrode 15 of the extension 14 connected to the stimulation circuit 12.
  • the stimulation circuit 12 includes a coil unit 21, a charging unit 22, a rechargeable battery 23, a communication unit 24, a control unit 25, a stimulation parameter setting unit 26, an oscillation unit 27, an electrode configuration setting unit 28, a switch Part 29.
  • the coil unit 21 is a resonance circuit composed of, for example, a coil and a capacitor.
  • 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. 3, 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 oscillating unit 27 generates an electrical stimulation signal based on the stimulation intensity change signal input from the stimulation parameter setting unit 26, and outputs the generated electrical stimulation signal to the switch unit 29.
  • the electrode configuration setting unit 28 is an electrode for selecting the terminal electrode 15 corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal generated by the oscillation unit 27 based on the electrode configuration information input from the communication unit 24. A configuration selection signal is generated.
  • the stimulation intensity change signal output from the stimulation parameter setting unit 26 is output to the oscillation unit 27, and the electrode configuration selection signal output from the electrode configuration setting unit 28 is output to the switch unit 29.
  • the switch unit 29 determines the terminal electrode 15 ⁇ ⁇ corresponding to the stimulation electrode 5 that outputs the electrical stimulation signal input from the oscillation unit 27 based on the electrode configuration selection signal input from the electrode configuration setting unit 28.
  • 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.
  • FIGS. 4 to 28 an example of a method for implanting the electrode lead 2 and the stimulating device 4 when, for example, electrical stimulation of spinal nerves from the epidural space is performed using the electrical stimulating device 1.
  • 4 to 28 are explanatory views of the human body as seen from the back side.
  • 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 is used to connect 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 creating a subcutaneous tunnel, and makes a small incision on the back. Create a subcutaneous tunnel by pushing to the part.
  • the insertion tool 50 for example, a pressing tool wire fixing part 51, a gripping part 52, a pressing tool wire fastening part 53, a pressing tool wire 54, an insertion rod 55, a pressing tool 56, and an insertion rod receiving part 57. Use what has.
  • the insertion rod 55 inserted under the skin is made of, for example, a comparatively hard and biocompatible stainless steel as a long body, and has a diameter of about 2 mm, for example.
  • the distal end portion of the insertion rod 55 inserted into the living body 30 has a conical shape, and the other end of the insertion rod 55 is 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.
  • a material for the pusher wire fixing portion 51 and the grip portion 52 for example, a relatively hard resin having biocompatibility such as epoxy is used.
  • the pusher 56 is a mechanism for pressing the distal end portion of the insertion rod 55 from the body surface, and is formed as a plate-like substantially rectangular parallelepiped.
  • a pusher wire 54 having a length substantially the same as the length of the insertion rod 55 is connected to the end of the pusher 56.
  • the other end of the pusher wire 54 is fixed to the pusher wire fixing part 51, and the middle part of the pusher wire 54 is passed through the hollow part of the pusher wire fastening part 53 provided in the grip part 52.
  • a material of the pusher 56 for example, a relatively hard resin having biocompatibility such as epoxy is used, and for the pusher wire 54, a flexible material having biocompatibility such as polypropylene is used.
  • the insertion rod 55 Since the diameter of the insertion rod 55 is very thin, the insertion rod 55 bends when a force that pushes subcutaneously is applied, and sometimes the distal end portion of the insertion rod 55 is caught on the dermis layer on the body surface side than the subcutaneous tissue and does not advance further. Sometimes. By pushing the insertion rod 55 under the skin while pressing the position of the distal end portion of the insertion rod 55 from the body surface with the pusher 56, the distal end portion of the insertion rod 55 is not scratched by the dermis layer. It becomes easy to proceed under the skin.
  • the insertion rod receiving portion 57 provided on the pusher 56 is formed in a protruding shape with respect to the pusher 56, and a recess is formed near the center thereof.
  • the material of the insertion rod receiving portion 57 can be the same as that of the pusher 56.
  • the distal end portion of the insertion rod 55 is accommodated in the recess of the insertion rod receiving portion 57 inside the small incision on the back.
  • the distal end of the insertion rod 55 may inadvertently damage the doctor's hand or the patient's tissue. Can be prevented.
  • the doctor Next, as shown in FIG. 16, the doctor once removes the pusher wire fixing portion 51 and the grip portion 52 from the insertion rod 55, attaches the stimulator sizer 58 to the insertion rod 55, and then grips the insertion rod 55 again.
  • the part 52 (in the figure, the state which has removed the pressing tool wire fastening part 53) is attached.
  • the stimulator sizer 58 is a subcutaneous pocket type taking mechanism for generating a subcutaneous pocket in which the housing 13 of the stimulator 4 is embedded.
  • 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.
  • 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 portion that accommodates the end of the wire 62 is provided on the housing 13 side of the stimulation device 4, the length of the rod 62 corresponds to the entire length of the extension 14 and the depth of the receiving portion. 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. 24 is a diagram illustrating a state in which the housing 13 of the stimulation device 4 is accommodated in the subcutaneous pocket.
  • the doctor makes a blunt incision by inserting a finger or forceps (not shown) subcutaneously from a small incision portion on the back to generate a subcutaneous pocket.
  • 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 7f (see FIG. 2) using a hexagon wrench or the like, and then the connector 7 and the extension 14 are connected. Store in the generated subcutaneous pocket.
  • the doctor sutures the small incision portion of the back and the small incision portion of the waist.
  • the connector 7 that connects the electrode lead 2 and the extension 14 is provided at the end of the electrode lead 2. In other words, it is not necessary to provide a connector at the end connected to the electrode lead 2 among the ends constituting the extension 14. Therefore, of the end portions constituting the extension 14, the end portion connected to the electrode lead 2 can be passed through the subcutaneous tunnel.
  • the electrical stimulation device 1 can be implanted into the living body 30 with less invasiveness than in the past.
  • the electrical stimulation device 1 since it can be implanted with minimal invasiveness, the risk of infection can be kept small. Furthermore, it is not necessary to perform general anesthesia, and the amount of local anesthesia used can be reduced. Furthermore, since the surgical procedure by the doctor can be minimized, the time for the procedure (surgery) can be shortened.
  • the connector 7 is provided at the end of the electrode lead 2, but the auxiliary lead 3 that can be attached to the connector 7 is provided, so that the electrode can be used for test stimulation. There is no need to replace the lead 2. That is, the electrode lead 2 inserted into the epidural space 31 can be used as it is also during the test stimulation.
  • the stylet lumen 5b is provided over the entire length of the auxiliary lead 3, the electrode lead 2 and the auxiliary lead 3 are connected.
  • the stylet lumen communicates from the end portion of the auxiliary lead 3 to the vicinity of the tip of the electrode lead 2.
  • the stylet 34 can be passed through the electrode lead 2 to which the auxiliary lead 3 is connected.
  • the electrode lead 2 and the auxiliary lead 3 are structurally connected to each other by the meshing mechanism, and therefore the force in the direction of pulling the auxiliary lead 3 out of the electrode lead 2.
  • the auxiliary lead 3 can be removed from the electrode lead 2 simply by adding.
  • the auxiliary lead 3 can be easily moved without moving the position of the stimulation electrode 5 of the electrode lead 2 inserted into the epidural space 31. Can be removed.
  • the connector 7 of the electrode lead 2 and the auxiliary lead 3 are fixed by a meshing method, but the present invention is not limited to this, and is fixed with a screw or the like. It may be.
  • the rechargeable battery 23 is used as a power source.
  • a capacitor may be used to operate while always receiving power from an external controller.
  • the housing 13 can be further reduced in size by the volume occupied by the battery 23.
  • FIG. 29 is a schematic diagram illustrating a schematic configuration example of each unit included in the electrical stimulation device 1A according to the present embodiment.
  • the electrical stimulation device 1 ⁇ / b> A includes an electrode lead 2 ⁇ / b> A, a stimulation device 4 configured integrally with the extension 14, and a connector 7 ⁇ / b> A that connects the electrode lead 2 ⁇ / b> A and the extension 14.
  • the connector 7A is configured to be detachable from the electrode lead 2A.
  • the connector 7A has an electrode lead side connector 7Aa (first connector) and an extension side connector 7Ab (second connector).
  • the electrode lead-side connector 7Aa and the extension-side connector 7Ab are connected via a shaft portion 7Ac so that the electrode insertion ports are arranged in directions opposite to each other by 180 °.
  • the electrode lead-side connector 7Aa accommodates the end of the electrode lead 2A on the side where the terminal electrode 40 is provided, and the extension-side connector 7Ab accommodates the tip of the extension (portion where the terminal electrode 15 is provided). Is done.
  • the electrode lead side connector 7Aa is formed with a fixing screw hole (not shown) that leads to the fixing ring 42 when the terminal electrode 40 of the electrode lead 2 is accommodated, and the extension side connector 7Ab has a terminal electrode 15 of the extension 14.
  • a fixing screw hole (not shown) that leads to the fixing ring 17 when the container is accommodated is formed, and each is fixed firmly by screwing a fixing screw.
  • the connector 7A By configuring the connector 7A in this way, it is possible to use the electrode lead 2A of a type that does not have a connector, which is conventionally used. Even when the conventional electrode lead 2 ⁇ / b> A having no connector is used, it is not necessary to provide a connector on the extension 14 side, so that the other end of the extension 14 is embedded in the housing 13 of the stimulator 4. Can be taken. Thereby, since the housing
  • stimulation circuit 13 ... housing, 14 ... extension, 15 ... Terminal electrode, 16 ... Body, 17 ... Fixing ring, 21 ... Coil part, 22 ... Charging part, 23 ... Rechargeable battery, 24 ... Communication part, 25 ... Control part, 26 ... Stimulation parameter Setting unit, 27 ... oscillation unit, 28 ... electrode configuration setting unit, 29 ... switch unit, 30 ... biometric, 31 ... epidural space

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  • Health & Medical Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
PCT/JP2012/073225 2012-09-11 2012-09-11 Fil d'électrode et dispositif de stimulation électrique Ceased WO2014041608A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/073225 WO2014041608A1 (fr) 2012-09-11 2012-09-11 Fil d'électrode et dispositif de stimulation électrique

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PCT/JP2012/073225 WO2014041608A1 (fr) 2012-09-11 2012-09-11 Fil d'électrode et dispositif de stimulation électrique

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019504675A (ja) * 2016-01-19 2019-02-21 アクソニクス モジュレーション テクノロジーズ インコーポレイテッド マルチチャネルクリップデバイスおよび使用の方法
CN113769265A (zh) * 2021-07-08 2021-12-10 杭州神络医疗科技有限公司 刺激装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060247748A1 (en) * 2005-04-29 2006-11-02 Medtronic, Inc. Lead electrode for use in an MRI-safe implantable medical device
JP2007520254A (ja) * 2003-06-19 2007-07-26 メドトロニック・インコーポレーテッド 医療リードアダプタ
US20100042109A1 (en) * 2008-08-12 2010-02-18 Boston Scientific Neuromodulation Corporation Stylet for guiding leads of implantable electric stimulation systems and methods of making and using
JP2011120845A (ja) * 2009-12-14 2011-06-23 Terumo Corp 電気刺激装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007520254A (ja) * 2003-06-19 2007-07-26 メドトロニック・インコーポレーテッド 医療リードアダプタ
US20060247748A1 (en) * 2005-04-29 2006-11-02 Medtronic, Inc. Lead electrode for use in an MRI-safe implantable medical device
US20100042109A1 (en) * 2008-08-12 2010-02-18 Boston Scientific Neuromodulation Corporation Stylet for guiding leads of implantable electric stimulation systems and methods of making and using
JP2011120845A (ja) * 2009-12-14 2011-06-23 Terumo Corp 電気刺激装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019504675A (ja) * 2016-01-19 2019-02-21 アクソニクス モジュレーション テクノロジーズ インコーポレイテッド マルチチャネルクリップデバイスおよび使用の方法
CN113769265A (zh) * 2021-07-08 2021-12-10 杭州神络医疗科技有限公司 刺激装置

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