WO2004012809A1 - A method and system for inserting an electrode - Google Patents

A method and system for inserting an electrode Download PDF

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Publication number
WO2004012809A1
WO2004012809A1 PCT/AU2003/000989 AU0300989W WO2004012809A1 WO 2004012809 A1 WO2004012809 A1 WO 2004012809A1 AU 0300989 W AU0300989 W AU 0300989W WO 2004012809 A1 WO2004012809 A1 WO 2004012809A1
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WO
WIPO (PCT)
Prior art keywords
probe
electrode
introducer
kit
site
Prior art date
Application number
PCT/AU2003/000989
Other languages
French (fr)
Other versions
WO2004012809A8 (en
Inventor
Zoran Milijasevic
Original Assignee
Neopraxis Pty Ltd
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 Neopraxis Pty Ltd filed Critical Neopraxis Pty Ltd
Priority to AU2003249766A priority Critical patent/AU2003249766A1/en
Publication of WO2004012809A1 publication Critical patent/WO2004012809A1/en
Publication of WO2004012809A8 publication Critical patent/WO2004012809A8/en

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Classifications

    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints

Definitions

  • This invention relates to the percutaneous insertion of an electrode into a patient's body. More particularly, the invention relates to a method of, and system for, percutaneously inserting an electrode into a patient's body. The invention also relates to a kit for use in percutaneously serting an electrode into a patient's body.
  • SCI spinal cord injury
  • FES functional electrical stimulators
  • Electrode leads are placed subcutaneously in the patient's body by an appropriate tunnelling technique.
  • the electrode leads terminate in electrodes at the site to be stimulated. It is of importance that these electrodes be accurately placed in the patient's body at the relevant site so that correct neural stimulation can occur. Also, it is desirable to place these electrodes with minimum amount of invasiveness so as to ⁇ nimise the discomfort to the patient.
  • a method of inserting an electrode into a patient's body to a site where neural stimulation is to occur comprising the steps of: percutaneously inserting a probe towards the site, the probe being of an electrically conductive material; stimulating a point at which the probe te ⁇ nates by feeding an electrical signal through the probe to a distal tip of the probe and, once an appropriate location for stimulation has been located, retaining the probe in the desired position; and inserting an electrode assembly having an electrode at its distal end percutaneously so that the electrode lies in register with the distal tip of the probe at the appropriate location at the site to be stimulated.
  • the step of inserting the electrode assembly may include the further steps of: placing an introducer over the probe and mserting the introducer percutaneously so that a distal end of the introducer is in register with the distal tip of the probe, the introducer including a dilating means; removing the probe and the dilating means; inserting the electrode assembly through the introducer so that the electrode is positioned at said appropriate location; and removing the introducer,
  • the method may include monitoring the position of the introducer relative to the probe as the introducer is placed over the probe. This may be effected either by depth markings on the probe and or the introducer.
  • the method may include using a stimulation telemetry system such that tissue-to-probe impedance is monitored during placement of the introducer relative to the probe.
  • the method may include inserting the probe by manipulating a gripping means mounted on the probe.
  • the method may include, once the electrode has been located at the appropriate location, anchoring the electrode at the appropriate location at the site to be . stimulated.
  • a system for inserting an electrode into a patient's body to a site where neural stimulation is to occur including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly terminating, at its distal end in an electrode, the electrode assembly being insertable towards the site via the introducer so that the electrode is located, in use, after determination of an appropriate location at the site to be stimulated, at said appropriate location.
  • the probe may be of a conductive material.
  • the probe has a needle-like configuration having a tapering, or pointed, distal tip and a proximal end and a solid probe body between the distal tip and the proximal end.
  • At least the probe body may be covered with an insulating material.
  • the insulating material may be a coating.
  • the insulating material may teraiinate short of the distal tip and short of the proximal end so that a connector can be electrically connected to the proximal end for energising the distal tip of the probe.
  • the introducer may comprise a sleeve in which the dilating means, or dilator, is received.
  • the dilator may be in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe.
  • the tube may have a tapered distal end for facilitating its percutaneous insertion.
  • the sleeve may include a removal facilitating means.
  • the removal facilitating means may include a rupturable portion at a proximal end of the sleeve.
  • the rupturable portion may include a pair of gripping members or wings projecting radially outwardly from the distal end of the sleeve.
  • the wings may be interconnected by zones of weakness which, when a radially outwardly extending force is applied to the wings, causes the zones of weakness to rupture.
  • the electrode assembly may include an electrode lead of a flexible material.
  • the electrode lead may have an electrically conductive core surrounded by an insulating material.
  • the electrically conductive core may connect to the electrode arranged at the distal end of the electrode lead.
  • the electrode may be an annular electrode of a biocompatible material, for example, a platinum material.
  • An anchoring means may be carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body.
  • the anchoring means may be in the form of a helix or auger.
  • the helix may be a fixed helix projecting beyond an end of the electrode.
  • the anchoring means may be displaceable relative to the electrode.
  • the helix may be rotatably mounted and retractable with respect to the electrode.
  • the anchoring means may be a series of tines arranged on the body of the electrode lead which engage the surrounding tissue to secure the lead in place.
  • the system may include a gripping means for enabling the probe to be gripped and inserted percutaneously.
  • the gripping means may be adjustably and removably mounted on the probe.
  • the gripping means may be in the form of a pin vice which can be displaced along the length of the probe and locked in position on the probe to provide grip and purchase for manipulating the probe.
  • the pin vice can also function as a position marker to provide an indication of position and depth of the probe during the insertion process.
  • the probe and the introducer may include depth markings so that the introducer can be positioned with respect to the probe.
  • the system may include a stimulation telemetry system such that tissue-to- probe impedance is monitored during placement of the introducer. The introducer is in correct register with the probe as soon as the tissue-to-probe impedance reaches a predetermined value, for example, if the impedance doubles from its starting value.
  • the system may include an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly.
  • the inserting means may be in the form of a stylet which is received in a passage of the electrode lead of the electrode assembly to engage a proximal end of the electrode.
  • Rotation of the stylet may either rotate the entire electrode lead or the helix relative to the electrode lead, depending on the arrangement of the helix, ie, whether it is a fixed helix or a rotatable helix.
  • a kit for use in inserting an electrode into a patient's body to a site where neural stimulation is to occur including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly terminating, at its distal end in an electrode, the electrode being locatable, after determination of an appropriate location in the site to be stimulated, at said appropriate location.
  • the probe may have a needle-like configuration having a tapering distal tip and a proximal end and a solid probe body between the distal tip and the proximal end. At least the probe body may be covered with an insulating material.
  • the introducer may comprise a sleeve in which the dilating means, or dilator, is received.
  • the dilator may be in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe.
  • the tube may have a tapered distal end for facilitating its percutaneous insertion.
  • the sleeve may include a removal facilitating means.
  • the removal facilitating means may include a rupturable portion at a proximal end of the sleeve.
  • the rupturable portion may extend the length of the sleeve.
  • the electrode assembly may include an electrode lead of- a flexible material.
  • the electrode lead may have an electrically conductive core surrounded by an insulating material.
  • the electrode may be an annular electrode of a biocompatible material.
  • An anchoring means may be carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body.
  • the anchoring means may be displaceable relative to the electrode.
  • the kit may include a gripping means for enabling the probe to be gripped and inserted percutaneously.
  • the probe and the introducer may include depth markings so that the introducer can be positioned with respect to the probe.
  • the kit may further include an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly.
  • the inserting means may be in the form of a stylet which is received in a passage of the electrode assembly to engage a proximal end of the electrode.
  • the invention extends also to a probe for use in the system as described above, the probe including: an elongate, solid, resiliently flexible element of an electrically conductive material; and a coating of an insulating material covering the element but terminating short of a proximal end and a distal end of the element so that said ends of the element are uninsulated.
  • the covering may be a coating of an insulating material such as a PTFE material.
  • the coating is of a coloured material so that it is readily distinguishable from the uninsulated ends of the element.
  • Figures 1-8 show various steps of a method, in accordance with a first aspect of the invention, of inserting an electrode into a patient's body;
  • Figure 9 shows a side view of a probe, for use with the method;
  • Figure 10 shows a side view of an inserting means associated with an electrode assembly carrying the electrode to be inserted
  • Figure 11 shows, on a smaller scale in comparison with Figure 10, a side view of an electrode assembly in combination with the inserting means.
  • reference number 10 generally designates an electrode assembly to be inserted, percutaneously into a patient's body (see Figure 11).
  • the method includes making a small incision 12 of about 1 cm in length in skin 14 of a patient's body 20 using a scalpel 16, Once the incision 12 has been made, a probe IS ( Figure 2) is inserted through the incision 12.
  • the probe 18 has a tapered or pointed distal tip or end 22 ( Figure 9) to facilitate its insertion into the skin 14 through the incision 12.
  • a system also in accordance with the invention, for inserting the electrode assembly 10 into the patient's body 20 makes use of a gripping means in the form of a pin vice 24 ( Figure 2).
  • the pin vice 24 is removably and slidably mountable on the probe 18 and is lockable in position on the probe 18 to provide purchase/grip and to facilitate manipulation of the probe 18.
  • the probe 18 comprises an elongate, resilientiy flexible element 26, A major part of the length of the element 26 is covered with a coating 28 of an electrically insulating material.
  • the coating 28 is of a different colour from the element 26 to render it readily distinguishable.
  • the coating 28 terminates short of the distal end 22 of the element 26, as illustrated at 30, to provide an uninsulated tip 22. Similarly, the coating 28 terrninates short of a proximal end 32 of the element 26, as illustrated at 34, to provide an uninsulated proximal end 32 of the probe 18, for connection to a stimulation/telemetry system.
  • the probe 18 is inserted, via its distal end 22, into the skin 14.
  • an introducer 36 is mounted over the probe 18.
  • the introducer 36 comprises a dilating means ox dilator 38.
  • the dilator 38 has a central passage through it so that the dilator 38 is slidably mountable relative to the probe 18 with the probe 18 passing through the passage of the dilator 38.
  • the introducer 36 further includes a sleeve 40 slidably mounted over the dilator 38.
  • the sleeve 40 has an open bore in which the dilator 38 is received.
  • the dilator 38 has a tapered distal end 42 and, once the probe 18 is in position in the patient's body, the distal end 42 of the dilator 38 is positioned in alignment with the distal end 22 of the probe 18. This is done by monitoring the tissue-probe impedance as the introducer 36 slides over the probe 18. As the tissue-probe impedance increases by a preset percentage, for example a 100% increase, the stimulation telemetry hardware emits an audible sound to the user, indicative of correct alignment of the dilator 38 relative to the probe 18.
  • the sleeve 40 is displaced relative to the dilator 38 so that the distal end of the sleeve 40 is in register or alignment with the tip
  • the probe 18 is removed from the passage of the dilator 38 and the dilator 38 is removed from the bore of the sleeve 40, 5 As illustrated in Figure 6 of the drawings, the electrode assembly 10 is introduced into a proximal end of the bore of the sleeve 40.
  • the electrode assembly 10 comprises an electrode lead 46 with an annular electrode 48 arranged at a distal end of the lead 46.
  • the electrode 48 is of a biocompatible material such as a platinum material.
  • the electrode 48 encloses an 0 anchor in the form of a helix 50.
  • the helix 50 can either be a fixed anchor in which case it projects from the distal end of the electrode 48 or it can be a retractable anchor which is retractable into the body of the electrode 48.
  • a passage or lumen 52 is defined through the electrode lead 46.
  • the helix 50 can be electrically active or insulated (passive). 5
  • an inserting means in the form of a stiffening stylet 54 is inserted into the lumen 52 of the electrode lead 46.
  • the stylet 54 has a shaft 60 with a knob 56 mounted at a proximal end of the shaft 60 for manipulating the electrode assembly 10 when the stylet 54 is received in 0 the passage 52 of the electrode lead 46 of the electrode assembly 10.
  • a screwdriver- type tip 58 is arranged at a distal end of the shaft 60 of the stylet 54,
  • the tip 58 of the stylet 54 cooperates with a receiving formation 62 of the electrode 48.
  • the tip 58 of the stylet 54 engages the receiving formation 62 of the 25 electrode 48 and, by rotating the knob 56 of the stylet 54, the distal end of the electrode assembly 10 is rotated to drive the helix 50 into tissue at the site in the patient's body
  • an engaging formation (not shown) is arranged distally of the knob 56 on the shaft 60 of the stylet 30 54.
  • This engaging formation engages a complementary fo ⁇ nation (also not shown) at a proximal end of the electrode lead 46 so that the entire lead 46 rotates when the tip 58 is received in the receiving formation 62 of the electrode 48.
  • the helix 50 is a retractable anchor
  • the helix 50 is extended from the distal end of the electrode 48 by rotating an internal element of the electrode 35 lead 46. Conversely, to retract the helix 50, the internal element is rotated in an opposite direction.
  • the sleeve 40 has, at its proximal end, a pai of diametrically opposed, radially outwardly extending wings 64. These wings 64 are connected together by a pair of opposed rupturable zones in the form of lines of weakness 66. As shown in Figure 7 of the drawings, by pulling on the wings 64 in radially opposite directions, the zones 66 rupture enabling the sleeve 40 to be withdrawn, Finally, as shown in Figure 8 of the drawings, the anchoring of the electrode assembly 10 is tested to ensure that the electrode 48 is anchored in position relative to surrounding tissue and adjacent to a nerve to be innervated.
  • a further incision (not shown) is made in the patient's body and the electrode lead 46 is arranged subcutaneously in the patient's body 20.
  • An electrode lead (not shown), extending from a functional electrical stimulator (FES) (also not shown), which had been tunnelled to the approximate location of the site of the patient's body 20 is connected to a proximal end 68 of the lead 46 of the electrode assembly 10 and is inserted into the further incision.
  • FES functional electrical stimulator
  • an electrode 48 can be percutaneously inserted into a patient's body without the need for a large incision at the site to be stimulated. This reduces the likelihood of infection and the degree of discomfort and scarring experienced by the recipient. Also, the electrodes 48 to be arranged at any one site can be rapidly and efficiently placed.
  • the present invention enables electrodes 48 to be positioned at a number of sites, such as proximal the sacral nerves in the lower region of the spine to treat disorders associated with pelvic floor disorders, as well as proximal the nerves associated with the muscles in human limbs to provide movement to a person suffering from paralysis or the like.

Abstract

A system for inserting an electrode into a patient's body to a site where neural stimulation is to occur includes a percutaneously insertable probe (18) of an electrically conductive material. An introducer (36) is mountable over the probe to be percutaneously insertable, in use, into the patient's body. The introducer includes a dilator (38). An electrode assembly (10) is inserted through the introducer, in use, and terminates at its distal end in an electrode (48). The electrode is locatable, after determination of an appropriate location at the site to be stimulated, at that appropriate location.

Description

"A method and system for inserting an electrode" Field of the Invention
This invention relates to the percutaneous insertion of an electrode into a patient's body. More particularly, the invention relates to a method of, and system for, percutaneously inserting an electrode into a patient's body. The invention also relates to a kit for use in percutaneously serting an electrode into a patient's body.
Background to the Invention
Persons suffering from spinal cord injury (SCI) may have diminished sensation and control over parts of their body. Various systems have been proposed to provide stimulators to stimulate these parts of the patient's body to enable the patient to have a measure of control over those parts of the body.
The applicant has proposed various multipurpose functional electrical stimulators (FES) which can be used in the stimulation of numerous sites in the patient's body. These stimulators are described more fully in the applicant's International Patent Application Nos. PCT/AU03/00043, PCT/AU03/00044, PCT/AU03/00139 and PCT/AU03/00277. The teachings of me aforegoing applications are incorporated herein by reference.
Conventionally, a stimulator(s) is/are implanted in the patient's body in a region proximal the desired stimulation site. Electrode leads are placed subcutaneously in the patient's body by an appropriate tunnelling technique. The electrode leads terminate in electrodes at the site to be stimulated. It is of importance that these electrodes be accurately placed in the patient's body at the relevant site so that correct neural stimulation can occur. Also, it is desirable to place these electrodes with minimum amount of invasiveness so as to πύnimise the discomfort to the patient.
Summary of the Invention
According to a first aspect of the invention, there is provided a method of inserting an electrode into a patient's body to a site where neural stimulation is to occur, the method comprising the steps of: percutaneously inserting a probe towards the site, the probe being of an electrically conductive material; stimulating a point at which the probe teπ nates by feeding an electrical signal through the probe to a distal tip of the probe and, once an appropriate location for stimulation has been located, retaining the probe in the desired position; and inserting an electrode assembly having an electrode at its distal end percutaneously so that the electrode lies in register with the distal tip of the probe at the appropriate location at the site to be stimulated.
The step of inserting the electrode assembly may include the further steps of: placing an introducer over the probe and mserting the introducer percutaneously so that a distal end of the introducer is in register with the distal tip of the probe, the introducer including a dilating means; removing the probe and the dilating means; inserting the electrode assembly through the introducer so that the electrode is positioned at said appropriate location; and removing the introducer,
Further, the method may include monitoring the position of the introducer relative to the probe as the introducer is placed over the probe. This may be effected either by depth markings on the probe and or the introducer. In addition, or instead, the method may include using a stimulation telemetry system such that tissue-to-probe impedance is monitored during placement of the introducer relative to the probe.
The method may include inserting the probe by manipulating a gripping means mounted on the probe.
Still further, the method may include, once the electrode has been located at the appropriate location, anchoring the electrode at the appropriate location at the site to be . stimulated.
According to a second aspect of the invention, there is provided a system for inserting an electrode into a patient's body to a site where neural stimulation is to occur, the system including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly terminating, at its distal end in an electrode, the electrode assembly being insertable towards the site via the introducer so that the electrode is located, in use, after determination of an appropriate location at the site to be stimulated, at said appropriate location.
As indicated above, the probe may be of a conductive material. Preferably, the probe has a needle-like configuration having a tapering, or pointed, distal tip and a proximal end and a solid probe body between the distal tip and the proximal end. At least the probe body may be covered with an insulating material. The insulating material may be a coating. The insulating material may teraiinate short of the distal tip and short of the proximal end so that a connector can be electrically connected to the proximal end for energising the distal tip of the probe.
The introducer may comprise a sleeve in which the dilating means, or dilator, is received. The dilator may be in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe. The tube may have a tapered distal end for facilitating its percutaneous insertion.
The sleeve may include a removal facilitating means. The removal facilitating means may include a rupturable portion at a proximal end of the sleeve. The rupturable portion may include a pair of gripping members or wings projecting radially outwardly from the distal end of the sleeve. The wings may be interconnected by zones of weakness which, when a radially outwardly extending force is applied to the wings, causes the zones of weakness to rupture.
The electrode assembly may include an electrode lead of a flexible material. The electrode lead may have an electrically conductive core surrounded by an insulating material. The electrically conductive core may connect to the electrode arranged at the distal end of the electrode lead. The electrode may be an annular electrode of a biocompatible material, for example, a platinum material.
An anchoring means may be carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body. The anchoring means may be in the form of a helix or auger. The helix may be a fixed helix projecting beyond an end of the electrode. Instead, the anchoring means may be displaceable relative to the electrode. Thus, the helix may be rotatably mounted and retractable with respect to the electrode. Alternatively, the anchoring means may be a series of tines arranged on the body of the electrode lead which engage the surrounding tissue to secure the lead in place.
The system may include a gripping means for enabling the probe to be gripped and inserted percutaneously. The gripping means may be adjustably and removably mounted on the probe. The gripping means may be in the form of a pin vice which can be displaced along the length of the probe and locked in position on the probe to provide grip and purchase for manipulating the probe. The pin vice can also function as a position marker to provide an indication of position and depth of the probe during the insertion process.
To achieve correct registry, the probe and the introducer may include depth markings so that the introducer can be positioned with respect to the probe. In addition, or instead, the system may include a stimulation telemetry system such that tissue-to- probe impedance is monitored during placement of the introducer. The introducer is in correct register with the probe as soon as the tissue-to-probe impedance reaches a predetermined value, for example, if the impedance doubles from its starting value.
The system may include an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly. The inserting means may be in the form of a stylet which is received in a passage of the electrode lead of the electrode assembly to engage a proximal end of the electrode. Rotation of the stylet may either rotate the entire electrode lead or the helix relative to the electrode lead, depending on the arrangement of the helix, ie, whether it is a fixed helix or a rotatable helix. According to a third aspect of the invention, there is provided a kit for use in inserting an electrode into a patient's body to a site where neural stimulation is to occur, the kit including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly terminating, at its distal end in an electrode, the electrode being locatable, after determination of an appropriate location in the site to be stimulated, at said appropriate location.
The probe may have a needle-like configuration having a tapering distal tip and a proximal end and a solid probe body between the distal tip and the proximal end. At least the probe body may be covered with an insulating material.
The introducer may comprise a sleeve in which the dilating means, or dilator, is received. The dilator may be in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe. The tube may have a tapered distal end for facilitating its percutaneous insertion.
The sleeve may include a removal facilitating means. The removal facilitating means may include a rupturable portion at a proximal end of the sleeve. The rupturable portion may extend the length of the sleeve.
The electrode assembly may include an electrode lead of- a flexible material. The electrode lead may have an electrically conductive core surrounded by an insulating material. The electrode may be an annular electrode of a biocompatible material.
An anchoring means may be carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body. The anchoring means may be displaceable relative to the electrode. The kit may include a gripping means for enabling the probe to be gripped and inserted percutaneously.
The probe and the introducer may include depth markings so that the introducer can be positioned with respect to the probe. The kit may further include an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly. The inserting means may be in the form of a stylet which is received in a passage of the electrode assembly to engage a proximal end of the electrode.
The invention extends also to a probe for use in the system as described above, the probe including: an elongate, solid, resiliently flexible element of an electrically conductive material; and a coating of an insulating material covering the element but terminating short of a proximal end and a distal end of the element so that said ends of the element are uninsulated.
The covering may be a coating of an insulating material such as a PTFE material. Preferably, the coating is of a coloured material so that it is readily distinguishable from the uninsulated ends of the element.
Brief Description of the Drawings
The invention is now described by way of example with reference to the accompanying diagrammatic drawings in which:-
Figures 1-8 show various steps of a method, in accordance with a first aspect of the invention, of inserting an electrode into a patient's body; Figure 9 shows a side view of a probe, for use with the method;
Figure 10 shows a side view of an inserting means associated with an electrode assembly carrying the electrode to be inserted; and
Figure 11 shows, on a smaller scale in comparison with Figure 10, a side view of an electrode assembly in combination with the inserting means.
Detailed Description of the Drawings
In the drawings, reference number 10 generally designates an electrode assembly to be inserted, percutaneously into a patient's body (see Figure 11). As an initial step, the method includes making a small incision 12 of about 1 cm in length in skin 14 of a patient's body 20 using a scalpel 16, Once the incision 12 has been made, a probe IS (Figure 2) is inserted through the incision 12. The probe 18 has a tapered or pointed distal tip or end 22 (Figure 9) to facilitate its insertion into the skin 14 through the incision 12. To facilitate manipulation of the probe 18, a system, also in accordance with the invention, for inserting the electrode assembly 10 into the patient's body 20 makes use of a gripping means in the form of a pin vice 24 (Figure 2). The pin vice 24 is removably and slidably mountable on the probe 18 and is lockable in position on the probe 18 to provide purchase/grip and to facilitate manipulation of the probe 18.
The probe 18 comprises an elongate, resilientiy flexible element 26, A major part of the length of the element 26 is covered with a coating 28 of an electrically insulating material. Preferably, the coating 28 is of a different colour from the element 26 to render it readily distinguishable.
The coating 28 terminates short of the distal end 22 of the element 26, as illustrated at 30, to provide an uninsulated tip 22. Similarly, the coating 28 terrninates short of a proximal end 32 of the element 26, as illustrated at 34, to provide an uninsulated proximal end 32 of the probe 18, for connection to a stimulation/telemetry system.
In use, once the incision 12 has been made, the probe 18 is inserted, via its distal end 22, into the skin 14. When the tip 22 is more or less in the desired position in a patient's body 20, as determined by monitoring the patient's response to electrical stimulation applied at the uninsulated proximal end of the probe, an introducer 36 is mounted over the probe 18. The introducer 36 comprises a dilating means ox dilator 38. The dilator 38 has a central passage through it so that the dilator 38 is slidably mountable relative to the probe 18 with the probe 18 passing through the passage of the dilator 38.
The introducer 36 further includes a sleeve 40 slidably mounted over the dilator 38. The sleeve 40 has an open bore in which the dilator 38 is received.
The dilator 38 has a tapered distal end 42 and, once the probe 18 is in position in the patient's body, the distal end 42 of the dilator 38 is positioned in alignment with the distal end 22 of the probe 18. This is done by monitoring the tissue-probe impedance as the introducer 36 slides over the probe 18. As the tissue-probe impedance increases by a preset percentage, for example a 100% increase, the stimulation telemetry hardware emits an audible sound to the user, indicative of correct alignment of the dilator 38 relative to the probe 18. Once it has been determined that the distal end 22 of the probe 18 and the tip 42 of the dilator 38 are correctly positioned, the sleeve 40 is displaced relative to the dilator 38 so that the distal end of the sleeve 40 is in register or alignment with the tip
42 of the dilator 38 and the distal end 22 of the probe 18.
The probe 18 is removed from the passage of the dilator 38 and the dilator 38 is removed from the bore of the sleeve 40, 5 As illustrated in Figure 6 of the drawings, the electrode assembly 10 is introduced into a proximal end of the bore of the sleeve 40.
The electrode assembly 10 comprises an electrode lead 46 with an annular electrode 48 arranged at a distal end of the lead 46. The electrode 48 is of a biocompatible material such as a platinum material. The electrode 48 encloses an 0 anchor in the form of a helix 50. The helix 50 can either be a fixed anchor in which case it projects from the distal end of the electrode 48 or it can be a retractable anchor which is retractable into the body of the electrode 48. A passage or lumen 52 is defined through the electrode lead 46. Furthermore, the helix 50 can be electrically active or insulated (passive). 5 To facilitate the insertion of the electrode assembly 10 so that its electrode 48 lies at the correct position at the site of the patient's body, an inserting means in the form of a stiffening stylet 54 is inserted into the lumen 52 of the electrode lead 46.
The stylet 54 has a shaft 60 with a knob 56 mounted at a proximal end of the shaft 60 for manipulating the electrode assembly 10 when the stylet 54 is received in 0 the passage 52 of the electrode lead 46 of the electrode assembly 10. A screwdriver- type tip 58 is arranged at a distal end of the shaft 60 of the stylet 54,
The tip 58 of the stylet 54 cooperates with a receiving formation 62 of the electrode 48. In the case where the helix 50 is fixed and projects distally beyond the electrode 48, the tip 58 of the stylet 54 engages the receiving formation 62 of the 25 electrode 48 and, by rotating the knob 56 of the stylet 54, the distal end of the electrode assembly 10 is rotated to drive the helix 50 into tissue at the site in the patient's body
20.
Further, in the case where the helix 50 is a fixed, projecting anchor, an engaging formation (not shown) is arranged distally of the knob 56 on the shaft 60 of the stylet 30 54. This engaging formation engages a complementary foπnation (also not shown) at a proximal end of the electrode lead 46 so that the entire lead 46 rotates when the tip 58 is received in the receiving formation 62 of the electrode 48.
In the case where the helix 50 is a retractable anchor, the helix 50 is extended from the distal end of the electrode 48 by rotating an internal element of the electrode 35 lead 46. Conversely, to retract the helix 50, the internal element is rotated in an opposite direction. Once the electrode 48 of the electrode assembly 10 has been positioned and anchored in position by means of the helix 50, the Stylet 54 is withdrawn from the electrode assembly 10.
To remove the sleeve 40 of the introducer, the sleeve 40 has, at its proximal end, a pai of diametrically opposed, radially outwardly extending wings 64. These wings 64 are connected together by a pair of opposed rupturable zones in the form of lines of weakness 66. As shown in Figure 7 of the drawings, by pulling on the wings 64 in radially opposite directions, the zones 66 rupture enabling the sleeve 40 to be withdrawn, Finally, as shown in Figure 8 of the drawings, the anchoring of the electrode assembly 10 is tested to ensure that the electrode 48 is anchored in position relative to surrounding tissue and adjacent to a nerve to be innervated.
As a final step, a further incision (not shown) is made in the patient's body and the electrode lead 46 is arranged subcutaneously in the patient's body 20. An electrode lead (not shown), extending from a functional electrical stimulator (FES) (also not shown), which had been tunnelled to the approximate location of the site of the patient's body 20 is connected to a proximal end 68 of the lead 46 of the electrode assembly 10 and is inserted into the further incision. Once the connection to the proximal end 68 of the electrode assembly 10 has been made, the further incision which had been made to arrange the electrode assembly 10 subcutaneously is sutured closed.
It is an advantage of the invention that an electrode 48 can be percutaneously inserted into a patient's body without the need for a large incision at the site to be stimulated. This reduces the likelihood of infection and the degree of discomfort and scarring experienced by the recipient. Also, the electrodes 48 to be arranged at any one site can be rapidly and efficiently placed.
Typically, the present invention enables electrodes 48 to be positioned at a number of sites, such as proximal the sacral nerves in the lower region of the spine to treat disorders associated with pelvic floor disorders, as well as proximal the nerves associated with the muscles in human limbs to provide movement to a person suffering from paralysis or the like.
It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAMS: A method of inserting an electrode into a patient's body to a site where neural stimulation is to occur, the method comprising the steps of; percutaneously inserting a probe towards the site, the probe being of an electrically conductive material; stimulating a point at which the probe terrninates by feeding an. electrical signal through the probe to a distal tip of the probe and, once an appropriate location for stimulation has been located, retaining the probe in the desired position; and inserting an electrode assembly having an electrode at its distal end percutaneously so that the electrode lies in register with the distal tip of the probe at the appropriate location at the site to be stimulated.
2. The method of claim 1 in which the step of inserting the electrode assembly includes the further steps of: placing an introducer over the probe and inserting the introducer percutaneously so that a distal end of the introducer is in register with the distal tip of the probe, the introducer including a dilating means; removing the probe and the dilating means; inserting the electrode assembly through the introducer so that the electrode is positioned at said appropriate location; and removing the introducer.
3. The method of claim 2 which includes monitoring the position of the introducer relative to the probe as the introducer is placed over the probe.
4. The method of claim 2 or claim 3 which includes using a stimulation telemetry system such that tissue-to-probe impedance is monitored during placement of the introducer relative to the probe.
5. The method of any one of the preceding claims which includes inserting the probe by manipulating a gripping means mounted on the probe.
6. The method of any one of the preceding claims which includes anchoring the electrode at the appropriate location at the site to be stimulated.
7. A system for mserting an electrode into a patient's body to a site where neural stimulation is to occur, the system including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly terminating, at its distal end in an electrode, the electrode assembly being insertable towards the site via the introducer so that the electrode is located, in use, after determination of an appropriate location at the site to be stimulated, at said appropriate location.
8. The system of claim 7 in which the probe has a needle configuration having a tapering distal tip and a proximal end and a solid probe body between the distal tip and the proximal end.
9. The system of claim 8 in which at least the probe body is covered with an insulating material.
10. The system of any one of claims 7 to 9 in which the introducer comprises a sleeve in which the dilating means is received.
11. The system of claim 10 in which the dilating means is in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe.
12. The system of claim 11 in which the tube has a tapered distal end for facilitating its percutaneous insertion.
13. The system of any one of claims 10 to 12 in which the sleeve includes a removal facilitating means.
14. The system of claim 13 in which the removal facilitating means includes a rupturable portion at a proximal end of the sleeve.
15. The system of any one of claims 7 to 14 in which the electrode assembly includes an electrode lead of a flexible material.
16. The system of claim 15 in which the electrode lead has an electrically conductive core surrounded by an insulating material.
17. The system of any one of claims 7 to 16 in which the electrode is an annular electrode of a biocompatible material,
18. The system of any one of claims 7 to 17 in which an anchoring means is carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body.
1 . The system of claim 18 in which the anchoring means is displaceable relative to the electrode.
20. The system of any one of claims 7 to 19 which includes a gripping means for enabling the probe to be gripped and inserted percutaneously.
21. The system of any one of claims 7 to 20 in which the probe and the introducer include depth markings so that the introducer can be positioned with respect to the probe.
22. The system of any one of claims 7 to 21 which includes a stimulation telemetry system such that tissue-to-probe impedance is monitored during placement of the introducer.
23. The system of any one of claims 7 to 22 which includes an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly.
24. The system of claim 23 in which the inserting means is in the form of a stylet which is received in a passage of the electrode assembly to engage a proximal end of the electrode.
25. A kit for use in inserting an electrode into a patient's body to a site where neural stimulation is to occur, the kit including: a percutaneously insertable probe of an electrically conductive material; an introducer mountable over the probe to be percutaneously inserted, in use, into the patient's body, the introducer including a dilating means; and an electrode assembly teπninating, at its distal end in an electrode, the electrode being beatable, after determination of an appropriate location in the site to be stimulated, at said appropriate location.
26. The kit of claim 25 in which the probe has a needle configuration having a tapering distal tip and a proximal end and a solid probe body between the distal tip and the proximal end.
27. The kit of claim 26 in which at least the probe body is covered with an insulating material.
28. The kit of any one of claims 25 to 27 in which the introducer comprises a sleeve in which the dilating means is received.
29. The kit of claim 28 in which the dilating means is in the form of a tube having a passage through which the probe can pass when the introducer is placed over the probe,
30. The kit of claim 29 in which the tube has a tapered distal end for facilitating its percutaneous insertion.
31. The kit of any one of claims 28 to 30 in which the sleeve includes a removal facilitating means.
32. The kit of claim 31 in which the removal facilitating means includes a rupturable portion at a proximal end of the sleeve.
33. The kit of any one of claims 25 to 32 in which the electrode assembly includes an electrode lead of a flexible material.
34. The kit of claim 33 in which the electrode lead has an electrically conductive core surrounded by an insulating material.
35. The kit of any one of claims 25 to 34 in which the electrode is an annular electrode of a biocompatible material.
36. The kit of any one of claims 25 to 35 in which an anchoring means is carried by the electrode for anchoring the electrode at the appropriate location at the site of the patient's body.
7. The kit of claim 36 in which the anchoring means is displaceable relative to the electrode.
38. The kit of any one of claims 25 to 37 which includes a gripping means for enabling the probe to be gripped and inserted percutaneously.
39. The kit of any one of claims 25 to 38 in which the probe and the introducer include depth markings so that the introducer can be positioned with respect to the probe.
40. The kit of any one of claims 25 to 39 which includes an inserting means associated with the electrode assembly for facilitating insertion and placement of the electrode of the electrode assembly.
41. The kit of claim 40 in which the mserting means is in the form of a stylet which is received in a passage of the electrode assembly to engage a proximal end of the electrode.
42. A probe for use in the system as claimed in any one of claims 7 to 24, the probe including: an elongate, solid, resiliently flexible element of an electrically conductive material; and a coating of an insulating material covering the element but teπninating short of a proximal end and a distal end of the element so that said ends of the element are uninsulated.
43. The probe of claim 42 in which the covering is a coating of an insulating material
44. The probe of claim 43 in which the coating is of a coloured material so that it is readily distinguishable from the uninsulated ends of the element.
PCT/AU2003/000989 2002-08-06 2003-08-06 A method and system for inserting an electrode WO2004012809A1 (en)

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