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WO2024207049A1 - Outil de diagnostic et introducteur d'électrode - Google Patents

Outil de diagnostic et introducteur d'électrode Download PDF

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Publication number
WO2024207049A1
WO2024207049A1 PCT/AU2023/050319 AU2023050319W WO2024207049A1 WO 2024207049 A1 WO2024207049 A1 WO 2024207049A1 AU 2023050319 W AU2023050319 W AU 2023050319W WO 2024207049 A1 WO2024207049 A1 WO 2024207049A1
Authority
WO
WIPO (PCT)
Prior art keywords
channel
introducer tool
surgical introducer
electrode
electrode array
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.)
Pending
Application number
PCT/AU2023/050319
Other languages
English (en)
Inventor
Rohan J HOARE
John Michael Heasman
Owen Burns
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.)
Epi Minder Pty Ltd
Original Assignee
Epi Minder 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 Epi Minder Pty Ltd filed Critical Epi Minder Pty Ltd
Priority to AU2023442506A priority Critical patent/AU2023442506C1/en
Publication of WO2024207049A1 publication Critical patent/WO2024207049A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A61B5/293—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/386—Accessories or supplementary instruments therefor
    • 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
    • A61N1/0526—Head electrodes
    • 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
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/3456—Details of tips blunt
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/271—Arrangements of electrodes with cords, cables or leads, e.g. single leads or patient cord assemblies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • 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
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation

Definitions

  • the present disclosure relates to surgical tools and, more particularly, to an electrode diagnostic tool and electrode introducer.
  • surgeons need to position medical devices subdermally.
  • surgically introduced electrodes are placed subdermally against a patient’s scalp.
  • Placing the electrode against a patient’s scalp typically includes forming an entry and exit incision and passing a catheter between the incisions. The electrode is passed through the catheter.
  • the surgeon will either attempt to get the electrode lead through the catheter by pushing a plastic tube, containing the electrode, from the entry incision or pulling the electrode through with a suction device.
  • Other devices, other than electrodes are also surgically disposed subdermally, in similar ways.
  • the electrode lead may have insufficient structural integrity to push against the friction between the patient’s skin and the skull, especially in leads designed to be unobtrusive and/or maximize patient comfort during long-term use. Additionally, the electrodes must be accurately placed along the surface of the patient’s skull for proper diagnostic purposes.
  • the surgical introducer tool includes a shell configured to receive and to selectively hold and release a housing or chassis of an implantable electrode array.
  • the implantable electrode array may be configured to collect electroencephalography (EEG) data when implanted on a patient’s head.
  • the surgical introducer tool may further include a channel having a proximal end and a distal end and configured to receive a linear electrode lead of the electrode array. Additionally, the surgical introducer tool may include an introducer tip disposed on the distal end of the channel.
  • the surgical introducer tool further includes an alignment feature disposed on the channel.
  • the alignment feature may include a protuberance.
  • the surgical introducer tool may further include a coupling disposed between the shell and the channel to separate the shell from the channel.
  • the coupling may be integrally formed with the shell and the channel. Additionally, the coupling may include a scoring or perforation to facilitate separating the shell from the channel.
  • the surgical introducer tool may include a plurality of electrical contacts disposed on at least one of the shell and the channel and configured to electrically couple to corresponding electrodes of the implantable electrode array. Each of the plurality of electrical contacts may be in electrical communication with a multiplexer.
  • the surgical introducer tool may include a processor configured to control the multiplexer and the processor may be configured to selectively connect two contacts of the plurality of contacts through the multiplexer. In some examples, the processor is disposed in the shell.
  • a surgical introducer tool including a shell configured to receive at least a first portion of a medical device.
  • the surgical introducer tool may also include a channel including a proximal end and a distal end, the proximal end removably coupled to the shell, the channel configured to receive at least a second portion of the medical device.
  • the surgical introducer tool can further include an introducer tip disposed on the distal end of the channel.
  • the shell and the channel are detachably coupled via a perforated or scored coupling.
  • the introducer tip may include a bullet shaped tip.
  • the surgical introducer tool may further include an alignment feature disposed on the channel disposed at a first distance from the proximal end of the channel.
  • the shell also includes a clip disposed on the shell to releasably secure the medical device to the shell.
  • the channel may be U-shaped. In some examples, the channel defines a channel depth and a channel width larger than a diameter of the second portion of the medical device.
  • the surgical introducer tool includes one or more electrical contacts disposed on the channel. Additionally, at least one of the one or more electrical contact may be configured to engage an electrode of the medical device. Also, each of the one or more electrical contacts may be in electrical communication with a multiplexer.
  • a system including an electrode array including an electrode chassis, an electrode lead, and a plurality of electrodes disposed along a length of the electrode lead.
  • the system may further include a surgical introducer tool including: a shell configured to receive at least the electrode chassis and a channel removably coupled to the shell.
  • the channel may be configured to receive the electrode lead and the plurality of electrodes.
  • the electrode chassis may includes a processor, a memory, an analog-to-digital converter, an amplifier, and a reference electrode.
  • the shell is configured to removably secure the electrode housing to the surgical introducer tool.
  • the surgical introducer tool may include an alignment feature.
  • the alignment feature may include a protuberance disposed on the channel.
  • system may further include one or more electrical contacts disposed on the channel configured to engage at least one electrode of the electrode array.
  • the surgical introducer tool may include: a shell configured to receive at least an electrode chassis and a channel removably coupled to the shell.
  • the channel may be configured to receive an electrode lead having a plurality of electrodes disposed along a length of the electrode lead
  • the surgical introducer tool may further include a processor electrically coupled to a plurality of contacts and each of the plurality of contacts may be configured to couple to a respective one of the plurality of electrodes disposed along the length of the electrode lead.
  • the plurality of contacts is disposed on the distal end of the channel.
  • the surgical introducer tool includes a multiplexer disposed between the controller and each of the plurality of contacts.
  • the alignment device may include a shell configured to receive at least a first portion of a surgically implantable electrode array. Additionally, the alignment device may include a channel including a proximal end and a distal end, the channel configured to receive a second portion of the surgically implantable electrode array. Further, the alignment device may include an alignment feature disposed on the channel.
  • the second portion of the surgically implantable electrode array may include an electrode lead including a plurality of electrodes.
  • the alignment feature may be centrally disposed relative to the plurality of electrodes.
  • the alignment feature may include a protuberance.
  • a method of implanting a surgically implantable electrode array includes providing a surgical introducer tool having (i) a shell configured to receive at least a first portion of the surgically implantable electrode array and (ii) a channel configured to receive a second portion of the surgically implantable electrode array
  • the method may further include fitting the first portion of the electrode array into the shell of the surgical introducer tool.
  • the method may include fitting the linear lead portion of the electrode array into the channel of the surgical introducer tool and placing a distal, tip of the surgical introducer tool into an incision on the patient, and sliding the electrode array placement structure into a space in which the electrode array is to be placed.
  • the method may also include positioning the second portion of the surgically implantable electrode array subdermally in the patient. Subsequently, the method may include separating the shell of the surgical introducer tool from the channel of the surgical introducer tool. The method may also include removing from the shell of the surgical introducer tool the first portion of the surgically implantable electrode array. Additionally, the method may include implanting the first portion of the surgically implantable electrode array under the skin after removing it from the shell of the surgical introducer tool. Then, the method includes removing from the channel of the surgical introducer tool the linear lead portion of the surgically implantable electrode array, and removing the channel of the surgical introducer tool from the space, leaving the second portion of the surgically implantable electrode array in the space.
  • the method further includes testing the electrode array by selectively coupling a processor to at least a first contact of a plurality of contacts disposed along the channel of the surgical introducer tool, and each of the contacts may be configured to be in contact with a respective electrode of the electrode array.
  • Testing the electrode array may further include generating, using the processor, a signal to determine whether the respective electrode is operating properly. Additionally, testing the electrode array may further comprise configuring a multiplexer to electrically couple the processor to at least a second contact of the plurality of contacts, the multiplexer disposed between the processor and the plurality of contacts.
  • implanting the first portion of the electrode includes disposing the first portion of the electrode proximate an ear of the patient.
  • fitting the first portion of the surgically implantable electrode array into the shell of the electrode placement structure includes removably securing the first portion of the electrode array to the electrode placement structure.
  • a surgical introducer tool including a tube defining a proximal end and a distal end.
  • the tube includes an introducer tip disposed on the distal end and an opening passing through the introducer tip.
  • the opening has an open configuration and a closed configuration, the open configuration to receive a linear electrode lead of an electrode array.
  • the tube also includes a fulcrum disposed adjacent the introducer tip to actuate the opening between the open configuration and the closed configuration.
  • the introducer tip includes a pre-pinched tube.
  • the introducer tip is bullet shaped.
  • the opening in the closed configuration generates a clamping force.
  • the clamping force may be at least 1 Newton.
  • the fulcrum may actuate the opening from the closed configuration to the open configuration in response to an inwardly directed radial force.
  • the inwardly directed radial force may be perpendicular to the opening transitioning from the closed configuration to the open configuration. The opening transitions from the open position to the closed position in the absence of the inwardly directed radial force.
  • a surgical introducer tool including a core and a flexible outer tube.
  • the core defines an outer diameter and includes a first end and a second end defining a first length extending between the first end and the second end.
  • the outer diameter of the core being approximately equal to an outer diameter of a linear electrode lead of an implantable electrode array.
  • the flexible outer tube has a first opening at a proximal end and a second opening at a distal end, the proximal end and the distal end defining a second length.
  • the first end of the core adjacent to the proximal end of the flexible outer tube and the second length being equal to or less than the first length.
  • the core is configured to pull the linear electrode lead through the flexible outer tube when first end of the core moves away from proximal end of the flexible outer tube.
  • the core is solid. Additionally, the outer flexible tube has a first rigidity and the core has a second rigidity. In some examples, the second rigidity is more rigid than the first rigidity.
  • the outer diameter of the core and the inner diameter of the flexible outer tube form a clearance fit.
  • the surgical introducer tool may utilize saline to form a seal between the core and the flexible outer tube.
  • the outer diameter of the core and the inner diameter of the flexible outer tube form an interference fit.
  • FIG. 1 is a diagram view of a surgically implantable electrode array.
  • FIG. 2 is a perspective view of a first example surgical introducer tool made in accordance with the present disclosure.
  • FIG. 3 is a perspective view of second example surgical introducer tool made in accordance with the present disclosure.
  • FIG. 4 is a perspective view of a surgically implantable electrode array disposed in one of the first or second surgical introducer tools of FIGS. 1 and 2.
  • FIG. 5 is a diagram of a diagnostic device made in accordance with the present disclosure.
  • FIG. 6A is a first diagram of an example diagnostic device system made in accordance with the present disclosure.
  • FIG. 6B is a second diagram of an example diagnostic device system.
  • FIG. 6C is a third diagram of yet another example diagnostic system.
  • Fig. 7 is a flowchart illustrating an example method of operating a surgical introducer tool.
  • FIG. 8A is a perspective view of an alternative surgical introducer tool in a closed configuration.
  • FIG. 8B is a perspective view of the alternative surgical introducer tool of FIG. 8 in an open configuration.
  • FIG. 9 is a perspective view of an alternative introducer tip, in a closed and open configuration, configured for use in connection with the alternative surgical introducer tool of FIG. 8.
  • FIG. 10A is a front view of another surgical introducer tool as applied to a patient’s skull.
  • FIG. 10B is a front view of the surgical introducer tool of FIG. 10A including the introduction of a linear electrode lead portion of an electrode array.
  • FIG. 10C is a front view of the surgical introducer tool of FIGS. 10A and 10B pulling the linear electrode lead portion through the surgical introducer tool.
  • a medical device could include a linear, surgically implantable electrode array configured to measure electroencephalography (EEG) signals. Additionally, the medical device could include devices utilized in spinal cord stimulators and/or deep brain stimulators. However, the surgical introducer tool could be configured to assist in inserting any other implantable medical device.
  • the surgical introducer tool includes a shell configured to receive a first part of a medical device and a channel configured to receive a cable, cord, or wire of the medical device. The channel being sufficiently rigid to insert the cable, cord, and/or wire into the patient.
  • the present disclosure provides a diagnostic device for testing a surgically implantable electrode array prior to placement of the electrode array in a patient.
  • the electrode array may be disposed against the skull or proximate to the surface of the skull (e.g., the sub-galeal layer) of the patient.
  • the diagnostic device includes electrical contacts configured to contact respective electrodes and to test each electrode for functionality.
  • the diagnostic device can be configured to test the electrical functionality of any medical device configured for insertion into a patient.
  • the diagnostic device is integral with the surgical introducer tool while in other examples, the diagnostic device couples to the surgical introducer tool.
  • Fig. 1 illustrates a diagram of an implantable, surgically implantable electrode array 100.
  • the surgically implantable electrode array 100 includes electrode circuitry 102, an electrode lead 104, and a plurality of electrodes 106.
  • the example surgically implantable electrode array 100 can be any typical surgically implantable electrode array, but could comprise more typical or custom surgically implantable electrodes or other medical devices similar to the surgically implantable electrode array 100. Additionally, in some examples, the surgically implantable electrode array 100 could include more than one electrode lead 104. In most examples, the electrode lead 104 is flexible hangs from the electrode circuitry 102.
  • a first portion of the electrode array 100 includes the electrode circuitry 102.
  • the electrode circuitry 102 includes, among other things, an integrated circuit 112, a housing 114 (or chassis), and an RF coil 116.
  • the integrated circuit 112 can include various features including analog-to-digital converters, amplifiers, communication circuitry, processors, memory, power sources, etc.
  • the RF coil 116 is a transmit/receive coil and can support power and data transfer, but in other examples, the RF coil 116 can be limited to either power or data transfer.
  • the electrode circuitry 102 includes a magnet 118 configured to align the RF coil 116 with an external device for power/data transfer.
  • a second portion of the electrode array 100 includes the electrode lead 104.
  • the electrode lead 104 is flexible and includes a proximal end 122a adjacent the electrode housing 114 and a distal end 122b opposite the proximal end 122a.
  • the electrode lead 104 includes the plurality of electrodes 106 and disposed proximate the distal end 122b.
  • the plurality of electrodes 106 includes a first electrode 132a, a second electrode 132b, a third electrode 132c, and a fourth electrode 132d.
  • the plurality of electrodes 106 can include more or fewer electrodes than shown in Fig. 1 .
  • the electrode lead 104 may additionally include an alignment feature 136.
  • the alignment feature 136 may be a colored strip to identify a central position between the plurality of electrodes 106.
  • the alignment feature 136 may consist of an annular bump or other mechanical feature that allows a surgeon to identify the central position by touch (e.g., through the scalp), such as after the electrode lead 104 is disposed subdermally.
  • the alignment feature 136 may include one or more light emitting diodes (LEDs) sufficiently bright to shine through a patient’s skin. A surgeon could use the illumination to identify the central position between the plurality of electrodes 106.
  • LEDs light emitting diodes
  • Fig. 2 illustrates a first example surgical introducer tool 200 (also described herein as an electrode introducer).
  • the surgical introducer tool 200 of Fig. 2 includes a shell 202, a channel 204, and an introducer tip 206.
  • the surgical introducer tool 200 is made of a plastic material but could be made of any biocompatible metal, natural material, or other synthetic polymer suitable in surgical procedures.
  • the shell 202 is configured to receive a first part of a medical device, such as the chassis of an electrode array (e.g., housing 114 of electrode array 100).
  • the shell 202 includes a backplate 212, a first wall 214a, and a second wall 214b opposite the first wall 214a.
  • each of the first wall 214a and the second wall 214b include a top wall 218. Additionally, the first wall 214a, second wall 214b, and the top wall 218 (as shown in cross section A-A) can work together to limit movement of the first part of the medical device relative to the shell 202. In some examples, the first wall 214a, second wall 214b, and the top wall 218 are configured to releasably secure the housing 114 of the electrode array 100.
  • the surgical introducer tool 200 further includes the channel 204 having a proximal end 222a and a distal end 222b.
  • the channel 204 and the shell 202 are manufactured as a one-piece integral construction, but the channel 204 could be manufactured separate from the shell 202 and coupled together with a mechanical linkage or adhesive.
  • the channel 204 is detachably coupled to the shell 202 at a coupling 224 disposed on the proximal end 222a of the channel 204.
  • the coupling 224 is scored or perforated to separate the channel 204 apart from the shell 202.
  • the channel 204 may be U-shaped.
  • the U-shape of the channel may include a rounded bottom (as shown in example cross section B-B) or a flat bottom (as shown in example cross section C-C).
  • the channel 204 is configured to contain a portion of a medical device (e.g., the electrode lead 104).
  • the channel 204 is configured with a width 242 and a height 244 sufficient to contain the medical device. But, in some examples, the channel 204 may bend to receive an electrode lead (e.g., electrode lead 104) larger than the width 242. In various examples, a portion of the medical device may extend beyond the height 244 of the channel.
  • the channel 204 includes a plurality of break points 226.
  • the break points 226 are disposed on the distal end 222b and configured to selectively adjust the length of the channel 204.
  • the channel 204 includes a first break point 228a, second break point 228b, and a third break point 228c, but in other examples, the channel 204 can include more or fewer break points 226.
  • the surgical introducer tool 200 includes the introducer tip 206.
  • the introducer tip 206 is shaped to facilitate insertion of the surgical introducer 200 into a patient.
  • the introducer tip 206 can be bullet shaped (e.g., slightly rounded tip or ogive surface).
  • the introducer tip 206 is uniformly rounded while in other examples the introducer tip 206 is rounded in one direction and generally flat in another direction similar to a rounded or pointed shovel.
  • the introducer tip 206 can facilitate insertion of the surgical introducer tool 200 from an entry incision to an exit incision.
  • each break point of the plurality of break points 226 can break and form a similar shaped introducer tip 206.
  • the introducer tip 206 is configured to have mechanical properties different from the rest of the channel 204.
  • the introducer tip 206 may be more rigid than the channel 204 to better push through tissue and resist buckling.
  • the channel 204 may include an alignment feature 232 similar to the alignment feature 124 (and sometimes referred to as an alignment device).
  • the alignment feature 232 could comprise a color strip to assist a medical practitioner disposing the alignment feature 136 adjacent the alignment feature 232.
  • the alignment feature 232 could include a physical protuberance to assist in physically identifying the alignment feature 232 when the channel 204 is disposed subdermally.
  • the alignment feature 232 could be disposed a predetermined distance from the shell 202 and/or a predetermined distance from the introducer tip 206.
  • a stylet 252 may be used in conjunction with the channel 204.
  • the stylet 252 is configured to add additional rigidity to the channel 204 or assist a medical practitioner in bending the channel to maintain a curve or other shape.
  • the stylet 252 may be made of a metallic wire (e.g., titanium, aluminum, steel, etc.).
  • the stylet 252 passes from the proximal end 222a of the channel 204 to the distal end 222b of the channel 204. While in other examples, the stylet 252 may only pass through a portion of the channel 204.
  • the channel 204 may include one stylet 252 disposed in a base 254 or sidewall 256 of the channel 204. But, as shown in cross sectional view B-B, the channel may include more than one stylet 252. Additionally, the two stylets 252 shown in the cross-sectional view B-B are disposed on a surface of the channel 204. Accordingly, the channel 204 may include one or more stylets disposed anywhere in or on the channel.
  • Fig. 3 illustrates a second example surgical introducer tool 300 (also described herein as an electrode introducer).
  • the surgical introducer tool 300 of Fig. 3 includes a shell 302, a channel 304, and an introducer tip 306.
  • the surgical introducer tool 300 is made of a plastic material but could be made of any biocompatible metal, natural material, or other synthetic polymer suitable in surgical procedures.
  • the shell 302 is configured to receive a first part of a medical device, such as the chassis of an electrode (e.g., housing 114 of electrode array 100).
  • the shell 302 includes a plate 312, a first wall 314a, and a second wall 314b opposite the first wall 314a.
  • each of the first wall 314a and the second wall 314b include a top wall 318.
  • the first wall 314a, second wall 314b, and the top wall 318 (as shown in cross section C-C) can work together to limit movement of the first part of the medical device relative to the shell 302.
  • the top wall 318 can clip the first part of the medical device to the shell 302.
  • the surgical introducer tool 300 further includes the channel 304 having a proximal end 322a and a distal end 322b.
  • the channel 304 and the shell 302 are manufactured as a one-piece, integral construction, but the channel 304 could be manufactured separate from the shell 302 and coupled together with a mechanical linkage or adhesive.
  • the channel 304 is removably coupled to the shell 302 at a coupling 324 disposed on the proximal end 322a of the channel 304.
  • the coupling 324 is scored or perforated to snap the channel 304 apart from the shell 302. Similar to the channel 204, the channel 304 may be U-shaped.
  • the coupling 324 may comprise a perforation 342 or a scoring line 344.
  • the perforation 342 or the scoring line 344 reduces the force needed to separate the channel 304 from the shell 302.
  • the shell 302, the channel 304, and the perforation 342 or scoring line 344 are all manufactured together.
  • the shell 302 and the channel 304 are, subsequently, the coupling is processed to include the perforation 342 or the scoring line 304.
  • the channel 304 includes a plurality of break points 326.
  • the break points 326 are disposed on the distal end 322b and configured to selectively adjust the length of the channel 304.
  • the channel 304 includes a first break point 328a, second break point 328b, and a third break point 328c, but in other examples, the channel 304 can include more or fewer break points 326.
  • the surgical introducer 300 includes the introducer tip 306 similar to the introducer tip 206 of Fig. 2.
  • the introducer tip 306 is shaped to facilitate insertion of the surgical introducer 300 into a patient.
  • the introducer tip 306 can be bullet shaped (e.g., slightly rounded tip or ogive surface).
  • the introducer tip 306 can facilitate insertion of the surgical introducer tool 300 from an entry incision to an exit incision.
  • each of the break points 326 can break and form a similar shaped introducer tip 306.
  • the surgical introducer 300 can further include an alignment feature 332 similar or identical to the alignment feature 232 described in connection with the surgical introducer tool 200 of Fig. 2.
  • Fig. 4 illustrates a surgically implantable electrode array introducer system 400 including a surgically implantable electrode array 402 and a surgical introducer tool 404.
  • the surgical introducer tool 404 can be either the surgical introducer tool 200 of Fig. 2 or the surgical introducer tool 300 of Fig. 3.
  • the surgical introducer tool 404 includes a shell 410a and a channel 410b similar to the surgical introducer tools 200, 300 of Figs. 2 and 3.
  • the shell 410a includes a back wall 412, a first wall 414a, and a second wall 414b.
  • the surgically implantable electrode array 402 is similar to the surgically implantable electrode array 100 of Fig. 1 and includes a housing 422 (or chassis) containing at least some of the electrode circuitry, a reference electrode 423, an electrode lead 424, an RF coil 426, and a centering magnet 428. As shown in Fig. 4, the chassis 422 is disposed in the shell 410a and the electrode lead 424 is disposed in the channel 410b.
  • the reference electrode 423 in Fig. 4 is depicted as a metal surface exposed through the housing 422, in embodiments, the reference electrode 423 may be an electrode separate from (e.g., separately placeable from), but wired to, the housing 422. In still further embodiments, the entire housing 422 may be made of a biocompatible metallic material and may serve as the reference electrode 423.
  • the surgically implantable electrode array 100 may or may not have an internal power source.
  • the surgically implantable electrode array 100 receives power through the RF coil 426, which also serves as a data conduit between an external device (not shown) and the surgically implantable electrode array 100, and which external device also provides power to the surgically implantable electrode array 100 through the RF coil 426.
  • the surgically implantable electrode array 100 may include an on-board power source (e.g., a battery) that may or may not be rechargeable.
  • the battery may be recharged through selective coupling of an external power source that couples to the surgically implantable electrode array 100 using the RF coil 426 (e.g., via inductive coupling).
  • an external power source that couples to the surgically implantable electrode array 100 using the RF coil 426 (e.g., via inductive coupling).
  • the centering magnet 428 may be included in embodiments that utilize the RF coil 426, it should be understood that there are embodiments that use a different type of RF coil 426 or may not use an RF coil 426 at all and, as a result may not require a centering magnet.
  • the RF coil 426 is also not required for data transfer.
  • an antenna coupled to or internal to the housing 422 may communicate data using RF protocols such as the Bluetooth communication protocol.
  • the shell 202, 302 and/or the channel 204, 304 of the surgical introducer tool 200, 300 may include an RF antenna (e.g., configured to be used for communication conforming to the Bluetooth communication protocol), independent from, but coupled to any antenna internal to the housing 422 of the surgically implantable electrode array 402.
  • the antenna disposed in the shell 202, 302 and/or channel 204, 304 of the surgical introducer tool 200, 300 may act to boost the communication signals to and from the surgically implantable electrode array 402 during the implantation and/or registration processes, when the wearable may be further from the electrode array 402 and/or the surgical introducer tool 200, 300 may be interfering with the ability of the internal antenna of the electrode array 402.
  • a diagnostic system 500 is also contemplated and described with reference to Figs. 5 and 6A-6C.
  • Fig. 5 is a schematic diagram illustrating the diagnostic system 500
  • Figs. 6A to 6C are block diagrams illustrating various embodiments of the diagnostic system 500.
  • the diagnostic system 500 is incorporated into the surgical introducer tools 200, 300.
  • the diagnostic system 500 may facilitate testing and/or confirmation of the functionality of a device paired with the surgical introducer tool 200, 300, such as the surgically implantable electrode array 100.
  • the diagnostic system 500 is operable to test the functionality of a surgically implantable electrode array 501 similar to the surgically implantable electrode array 100 of Fig. 1 .
  • the surgically implantable electrode 501 includes electrode circuitry 502 and an electrode lead 504.
  • the electrode lead 504 includes a plurality of electrodes 506, including a first electrode 532a, a second electrode 532b, a third electrode 532c, a fourth electrode 532d, and a reference electrode 532e.
  • the diagnostic system 500 includes a multiplexer 542.
  • the multiplexer 542 is in electrical communication with a plurality of contacts 544a-544e disposed in the channel 304 of the surgical introducer tool and configured to align, respectively, with the electrodes 532a-532e on the electrode lead 504.
  • the contacts 544a-544e are coupled to the multiplexer 542 via a plurality of wired connections 546.
  • the plurality of wired connections 546 are integrated into the shell 302 and the channel 304 of the surgical introducer tool 300, with a first contact 544a, a second contact 544b, a third contact 544c, a fourth contact 544d, and a reference contact 544e.
  • the multiplexer 542 may also be in electrical communication with the electrode circuitry 502 via a connection 547 extending between a connector 549 in the shell 302 and a connector 551 in the electrode circuitry 502.
  • the multiplexer 542 may be configured, via suitable electronics such as a processor 545 controlling the multiplexer 542, to electrically couple various ones of the contacts 544a- 544e and, thereby, to electrically couple various ones of the electrodes 532a-532e.
  • the processor 545 may evaluate connectivity and/or resistance between various pairs of the electrodes 532a- 532e to confirm that there are no shorts between electrodes.
  • the processor 545 may evaluate connectivity between the electrode circuitry 502 and the electrodes 532a-532e to confirm that each of the electrodes 532a-532e is properly coupled to the electrode circuitry 502 (e.g., that there are no opens (i.e., broken connections) between the electrodes 532a-532e and the electrode circuitry 502).
  • the processor 545 may configure the multiplexer 542 such that the processor 545 is coupled on a first output pin to a first one of the contacts 544a-544e, while simultaneously coupling (in succession or concurrently) each of the others of the contacts 544a-544e to an input pin on the processor 545 to look for shorts between the electrodes 532a-532e. (That is, if the signal output from the processor 545 to a first one of the contacts 544a-544e is detected on any one of the others of the contacts 544a- 544e, it can be determined that a short exists.)
  • the processor 642 of the electrode circuitry 501 may be configured (e.g., by the processor 545 of the surgical introducer tools 300) to output a signal to one or more of the electrodes 532a- 532e and, at the same time, the processor 545 may cause the multiplexer 542 to couple the corresponding contact 544a- 544e to an input of the processor 545. If the signal output from the processor 642 is detected by the processor 545, then it can be determined that there is no open between the processor 642 and the electrode 532a-532e being tested. Alternatively, if the signal output from the processor 642 is not detected by the processor 545, then it can be determined that there is an open between the processor 642 and the electrode 532a-532e being tested.
  • a resistive network 553 is also included in the diagnostic system 500 (e.g., in the shell 302) to aid in various diagnostic activities.
  • a ‘simulated’ in-situ environment may be created using a network of resistive pathways between each contact 544a- 544d and the reference electrode contact 544e.
  • the processor 642 in the implant can then generate currents to the various combinations (using the multiplexer 542, through various connectors, for example) of the electrodes 532a-532d (and resistive network 533 in the shell 302) to check for open circuits.
  • the electrode circuitry 502 may include various electrical components, including the processor 642, a memory 644, an analog-to-digital converter 646, an amplifier 648, communication circuitry 652, a battery 654, and a reference electrode 532e.
  • the electrode circuitry 502 may include more or fewer electrical components.
  • each of the electrical components of the electrode circuitry 502 may function in accordance with their typical usage.
  • the processor 642 may be configured to receive, process, and transmit data and the memory 644 may be configured to read, write, and recall data.
  • the analog-to-digital converter 646 may convert analog electrical signals to digital data and the amplifier 648 may be needed to increase the power of a signal.
  • the communication circuitry 652 could include circuitry for various wired and wireless communication (e.g., Bluetooth, near-field communication (NFC), WiFi, radio, etc.).
  • the electrode circuitry 502 may be powered by energy stored in the battery 654.
  • the diagnostic system 500 may be configured to test only for shorts between the electrodes 532a-532e (e.g., may omit connections to the electrode circuitry 502), or may be configured test only for opens between the electrode circuitry 502 and the electrodes 532a- 532e.
  • the multiplexer 542 may be incorporated into the electrode circuitry 502 instead of being incorporated into the surgical introducer tool 300.
  • the surgical introducer tool 300 may include electrical connectivity, via a connector 549 of the of the surgical introducer tool 300 and a corresponding connector 551 of the electrode circuitry 502, for example, between the wired connections 546 to the electrodes 532a-532e and the processor 642 of the electrode circuitry 502, which, in such embodiments, is configured to couple the processor 642 to the electrodes 532a- 532e through the multiplexer 542 such that the processor 642 can evaluate the attached electrodes 532a-532e before (and potentially during and/or after) placement of the electrode array 501 on the patient.
  • the surgical introducer tool 200, 300 may include only the wired connections 546 to the contacts 544a-544e (and thereby to the electrodes 532a-532e), and may provide a connector 549 that facilitates connection, via a corresponding connector 603, of an external testing device 601 that includes the multiplexer 542 and the processor 545 for testing the electrode array 100, and may include connectivity between the connector 549 and the electrode circuitry 502 via a corresponding connector 551 .
  • each surgical introducer tool 200, 300 may include or be associated with an RFID or other unique identifier.
  • the unique identifier may facilitate or otherwise be used to establish a secure connection between the surgical introducer tool 200, 300 and the electrode array 501 (i.e., between the processor 545 of the surgical introducer tool 200, 300 and the processor 642 of the electrode array 501 ).
  • the surgical introducer tool 200, 300 having established a secure connection between itself and the electrode array 501 , may act as an intermediary between, and cooperate with, the electrode array 501 and the external testing device 601 or other device to register the electrode array 501 with a remote server that will be receiving the data generated by and downloaded from the electrode array 501 .
  • any of the embodiments of the diagnostic system 500 described above may further include a user interface 612 for indicating the status of the diagnosis performed.
  • the user interface 612 may configured with one or more light emitting diodes (LEDs) indicating, for example, that the device is intact and/or operating normally, that the device is not intact and/or not operating normally, and/or to indicate specific issues identified (e.g., opens or shorts).
  • LEDs light emitting diodes
  • an LED e.g., a green LED
  • more complex user interfaces 612 may be incorporated that provide specific feedback about each electrode and/or about which electrodes are shorted or disconnected (open).
  • Fig. 7 illustrates an example method 700 of using a surgical introducer tool (e.g., surgical introducer tool 200, 300 of Figs. 2 and 3) to align and implant a surgically implantable electrode array (e.g., surgically implantable electrode 100, 402 of Figs. 1 and 4) into a patient.
  • the method 700 may include sterilizing various medical tools and equipment, including a surgical introducer tool. But in some examples, the surgical introducer tool and/or other medical tools may already be sterilized and provided in sterile packaging.
  • the method 700 includes fitting a first portion of an electrode array into a shell of the surgical introducer tool.
  • the housing 114 of the electrode 100 of Fig. 1 may be inserted into the shell 202, 302 of Figs. 2 and 3.
  • the first portion rests in the shell while, in other examples, the first portion is removably secured to the shell (e.g., the shell holds the first portion with friction, with a clip, etc.).
  • the method 700 includes fitting a linear lead portion into a channel of the surgical introducer tool.
  • the electrode lead 104 may be disposed in the channel 204, 304 of the surgical introducer tool 200, 300 of Figs. 2 and 3.
  • fitting the lead portion 104 of the electrode array 100, 402 into the channel 204, 304 of the surgical introducer tool 200, 300 includes aligning a centering or an alignment feature 136 disposed on the electrode array 100, 402 with an alignment feature 232, 332 disposed on the channel 204, 304.
  • a tip of the surgical introducer tool 200, 300 is inserted into a first incision on a patient.
  • the tip 206, 306 is inserted into an entry incision proximate an ear of a patient to insert an electrode against a skull of the patient.
  • the first incision can be placed elsewhere on a patient’s body to insert a medical device proximate another body part, subdermally.
  • the tip 206, 306 of the surgical introducer tool 200, 300 is passed through a subdermal passageway to an exit incision.
  • the tip 206, 306 passes into the body via the entry incision, through a subdermal passageway, and partially out via an exit incision, leaving most of the channel 204, 304 disposed in the subdermal passageway.
  • the channel 204, 304 is generally U- shaped.
  • the open side of the channel 204, 304 can be placed against the skull, away from the skull, or perpendicular to the skull.
  • the orientation of the channel 204, 304 can be selected based on ease of disposing the electrode lead subdermally, reducing friction, or any other factor relevant to the electrode insertion.
  • the method includes positioning the electrode array 402 on the patient. In some examples, this requires utilizing an alignment feature 232, 332 disposed on the channel 204 of the surgical introducer tool 200 to ensure the electrode array 402 is properly placed. In some examples, electrodes need to be disposed symmetrically about the patient’s head.
  • the shell 202 of the surgical introducer tool 200, 300 is separated from the channel 204 of the surgical introducer tool 200, 300 and the first portion of the electrode array 402 is separated from the surgical introducer tool 200, 300.
  • the shell 202 can be separated from the channel 204 at the coupling 224 as shown in Fig. 2.
  • the shell 202 includes a scoring line or form of perforation to assist in the separation of the shell 202 from the channel 204 of the surgical introducer tool 200, 300.
  • the first portion of the electrode array 402 can bend and twist relative to the channel of the surgical introducer tool 200, 300.
  • the first portion of the electrode array 402 is implanted under the skin of the patient (e.g., subdermally) by removing the electrode array 402 from the channel 204 and removing the channel 204 from the incision.
  • the channel 204 is removed from the incision by sliding the channel 204 out of the incision and away from the electrode array 402.
  • the linear lead of the electrode array 402 is positioned on the patient and the surgical introducer tool 200, 300 is no longer in the incision.
  • FIGS. 8A and 8B illustrate an alternative surgical introducer tool 800.
  • the surgical introducer tool 800 includes a tube 802, an introducer tip 804, and a fulcrum 806.
  • the surgical introducer tool 800 can be made of metal, synthetic polymers, or natural materials, if the material is compatible for surgical use. Additionally, the surgical introducer tool 800 is flexible and capable of conforming to the surface of human bone (e.g., skull, spine, rib, etc.).
  • the tube 802 has a proximal end 812 and a distal end 814.
  • the distal end 814 being opposite the proximal end 812.
  • the tube 802 has an introducer tip 804 disposed on the distal end 814 of the tube 802.
  • the introducer tip 804 is a pinched tube, but in other examples, the introducer tip could be a different structure (e.g., a bullet shaped tip as shown in FIG. 9).
  • the surgical introducer tip also includes an opening 816 passing through the introducer tip 804.
  • the opening 816 has a closed configuration 818a (shown in FIG. 8A) and an open configuration 818b (shown in FIG. 8B).
  • the open configuration 818b is sized to receive a linear electrode lead of an electrode array (e.g., the surgically implantable electrode array 100 of FIG. 1).
  • the fulcrum 806 is configured to actuate the opening 816 between the open configuration 818b and the closed configuration 818a.
  • the fulcrum 806 is an integral portion of the introducer tip 804 and is not a separate component.
  • the fulcrum 806 may be a separate structure coupled with the introducer tip 804 to open and close the introducer tip 804.
  • FIG. 8B illustrates the surgical introducer tip 804 in an open configuration.
  • the introducer tip 804 is opened because an inwardly directed radial force 822 is applied to the fulcrum 806.
  • the inwardly directed radial force 822 is generally perpendicular to the opening 816 transitioning from the closed configuration 818a to the open configuration 818b.
  • the opening 816 transitions from the open position 818b to the closed position 818a in the absence of the inwardly directed radial force 822.
  • FIG. 9 illustrates an alternative surgical introducer tip 902 including an opening 904 transitioning between a closed configuration 906a to an open configuration 906b.
  • the alternative surgical introducer tip 902 is bullet shaped.
  • the surgical introducer tip 902 further includes a fulcrum 912 disposed adjacent to the surgical introducer tip 902. Exerting a force 914 at the fulcrum 912 causes the surgical introducer tip 902 to transition from the closed configuration 904a to the open configuration 904b.
  • the opening transitions from the open position 818b to the closed position 818a in the absence of the inwardly directed radial force 822.
  • the surgical introducer tips 804, 902 are configured to provide a clamping force in the closed configuration 818a, 906a.
  • the opening 816, 904 in the closed configuration 818a, 906a generates a clamping force.
  • the clamping force is at least 1 Newton but could be more or less than 1 Newton.
  • FIGS. 10A, 10B, 10C illustrate another surgical introducer tool 1000.
  • the surgical introducer tool 1000 is similar to the surgical introducer tools 200, 300, 800 of FIGS. 2, 3, 8A, and 8B.
  • the surgical introducer tool 1000 is configured to position a linear lead portion subdermally.
  • the surgical introducer tool 1000 includes a core 1002 and a flexible outer tube 1002.
  • the outer flexible tube 1004 has a first rigidity and the core 1002 has a second rigidity.
  • the second rigidity of the core 1002 is more rigid than the first rigidity of the flexible outer tube 1004.
  • the surgical introducer tool 1000 is disposed along an example patient’s skull 1008, but in other examples, the surgical introducer tool 1000 could be disposed against any other body part.
  • the core 1002 defines an outer diameter 1012 and including a first end 1014 and a second end 1016. The first end 1014 and the second end 1016 are separated by a first length 1018.
  • the outer diameter 1012 is approximately equal (e.g., within 5 percent (%)) to an outer diameter of a linear electrode lead of an implantable electrode array (e.g., the linear electrode lead 104 of FIG. 1 ).
  • the core 1002 is solid, but in some examples, the core 1002 is mostly hollow but at least capped (e.g., enclosed) at the first end 1014.
  • the surgical introducer tool also includes the flexible outer tube 1004.
  • the flexible outer tube has a first opening 1022 at a proximal end 1024 and a second opening 1026 at a distal end 1028.
  • the proximal end 1024 and the distal end 1028 define a second length 1030.
  • the flexible outer tube 1004 has a inner diameter 1032 that is uniform from the proximal end 1024 and the distal end 1028.
  • the first end 1014 of the core 1002 is disposed adjacent the proximal end 1024 of the flexible outer tube 1004.
  • the second length 1030 of the flexible outer tube is less than the first length 1018 of the core 1002.
  • the second end 1016 extends beyond the second opening 1026 of the flexible outer tube 1004.
  • the first length 1018 is equal to the second length 1030.
  • the core 1002 is configured to be removably disposed within the flexible outer tube 1004.
  • the outer diameter 1012 of the core 1002 is less than the inner diameter 1032 of the flexible outer tube 1004.
  • the outer diameter 1012 of the core 1004 and the inner diameter 1032 of the flexible outer tube 1004 form an interference fit.
  • the core 1004 and the flexible outer tube 1004 may form a clearance fit.
  • the flexible outer tube 1004 may be further filled with saline to form a seal around the core 1002.
  • the core 1002 is partially withdrawn from the flexible outer tube 1004 and a linear electrode lead 104 is inserted into the first opening 1022.
  • a gap 1042 is formed between the first end 1014 of the core and the linear electrode lead 104.
  • the core 1002 pulls the linear electrode lead 104 through the flexible outer tube 1004 when first end 1014 of the core 1002 moves away from proximal end 1022 of the flexible outer tube 1004. The movement of the core 1002 pulls the linear electrode lead 104 via suction.
  • the flexible outer tube 1004 can be pulled from the subdermal channel underneath the patient’s skin.
  • a surgical introducer tool comprising: a shell configured to receive and to selectively hold and release a housing or chassis of an implantable electrode array that is configured to collect electroencephalography (EEG) data when implanted on a patient’s head; a channel including a proximal end and a distal end and configured to receive a linear electrode lead of the electrode array; and an introducer tip disposed on the distal end of the channel.
  • EEG electroencephalography
  • each of the plurality of electrical contacts is in electrical communication with a multiplexer.
  • a surgical introducer tool comprising: a shell configured to receive at least a first portion of a medical device; a channel including a proximal end and a distal end, the proximal end removably coupled to the shell, the channel configured to receive at least a second portion of the medical device; and an introducer tip disposed on the distal end of the channel.
  • a system comprising: an electrode array including an electrode chassis, an electrode lead, and a plurality of electrodes disposed along a length of the electrode lead; a surgical introducer tool, comprising: a shell configured to receive at least the electrode chassis; and a channel removably coupled to the shell, the channel configured to receive the electrode lead and the plurality of electrodes.
  • the electrode chassis includes a processor, a memory, an analog-to-digital converter, an amplifier, and a reference electrode.
  • a system comprising: a surgical introducer tool, comprising: a shell configured to receive at least an electrode chassis; and a channel removably coupled to the shell, the channel configured to receive an electrode lead having a plurality of electrodes disposed along a length of the electrode lead; and a processor electrically coupled to a plurality of contacts, each of the plurality of contacts configured to couple to a respective one of the plurality of electrodes disposed along the length of the electrode lead, the plurality of contacts disposed on the distal end of the channel.
  • a surgical introducer tool comprising: a shell configured to receive at least an electrode chassis; and a channel removably coupled to the shell, the channel configured to receive an electrode lead having a plurality of electrodes disposed along a length of the electrode lead; and a processor electrically coupled to a plurality of contacts, each of the plurality of contacts configured to couple to a respective one of the plurality of electrodes disposed along the length of the electrode lead, the plurality of contacts disposed on the distal end of the
  • An alignment device for a surgically implantable electrode array comprising: a shell configured to receive at least a first portion of a surgically implantable electrode array; a channel including a proximal end and a distal end, the channel configured to receive a second portion of the surgically implantable electrode array; and an alignment feature disposed on the channel.
  • a method of implanting a surgically implantable electrode array comprising: providing a surgical introducer tool having (i) a shell configured to receive at least a first portion of the surgically implantable electrode array and (ii) a channel configured to receive a second portion of the surgically implantable electrode array; fitting the first portion of the electrode array into the shell of the surgical introducer tool; fitting the linear lead portion of the electrode array into the channel of the surgical introducer tool; placing a distal, tip of the surgical introducer tool into an incision on the patient, and sliding the electrode array placement structure into a space in which the electrode array is to be placed; positioning the second portion of the surgically implantable electrode array subdermally in the patient; separating the shell of the surgical introducer tool from the channel of the surgical introducer tool; removing from the shell of the surgical introducer tool the first portion of the surgically implantable electrode array; implanting the first portion of the surgically implantable electrode array under the skin after removing it from the shell of the surgical introducer tool; removing from the
  • testing the electrode array further comprises configuring a multiplexer to electrically couple the processor to at least a second contact of the plurality of contacts, the multiplexer disposed between the processor and the plurality of contacts.
  • implanting the first portion of the electrode includes disposing the first portion of the electrode proximate an ear of the patient.
  • a surgical introducer tool comprising: a tube defining a proximal end and a distal end, the tube further comprising: an introducer tip disposed on the distal end; an opening passing through the introducer tip, the opening having an open configuration and a closed configuration, the open configuration to receive a linear electrode lead of an electrode array; a fulcrum disposed adjacent the introducer tip to actuate the opening between the open configuration and the closed configuration.
  • a surgical introducer tool comprising: a core defining an outer diameter and including a first end and a second end defining a first length extending between the first end and the second end, the outer diameter being approximately equal to an outer diameter of a linear electrode lead of an implantable electrode array; and a flexible outer tube having a first opening at a proximal end and a second opening at a distal end, the proximal end and the distal end defining a second length, the first end of the core adjacent the proximal end of the flexible outer tube and the second length being equal to or less than the first length, wherein the core is configured to pull the linear electrode lead through the flexible outer tube when first end of the core moves away from proximal end of the flexible outer tube.

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Abstract

L'invention concerne un outil d'introduction chirurgicale comprenant une coque configurée pour recevoir, maintenir et libérer de manière sélective un boîtier ou un châssis d'un réseau d'électrodes implantables. Le réseau d'électrodes implantables est configuré pour recueillir des données d'électroencéphalographie lorsqu'il est implanté sur la tête d'un patient. L'outil d'introduction chirurgical comprend également un canal comprenant des extrémités proximale et distale et configuré pour recevoir un fil d'électrode linéaire du réseau d'électrodes. L'outil d'introduction chirurgical peut en outre comprendre une pointe d'introduction disposée sur l'extrémité distale du canal.
PCT/AU2023/050319 2023-04-07 2023-04-19 Outil de diagnostic et introducteur d'électrode Pending WO2024207049A1 (fr)

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AU2023442506A AU2023442506C1 (en) 2023-04-07 2023-04-19 Electrode diagnostic tool and introducer

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US202363458063P 2023-04-07 2023-04-07
US63/458,063 2023-04-07

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120277544A1 (en) * 2011-04-28 2012-11-01 Medtronic, Inc. Biodegradable insertion guide for the insertion of a medical device
US20120290057A1 (en) * 2009-01-16 2012-11-15 Carl Lance Boling Apparatus and method for delivering a neurostimulator into the pterygopalatine fossa
US20170340891A1 (en) * 2015-10-15 2017-11-30 Spr Therapeutics, Llc Apparatus and method for positioning, implanting and using a stimulation lead
US20190134381A1 (en) * 2012-08-29 2019-05-09 The Bionics Institute Of Australia Electrical apparatus and methods and apparatus for positioning and implanting components thereof
US20190282803A1 (en) * 2015-09-14 2019-09-19 University Of Iowa Research Foundation Controlled position electrode array
US10568574B2 (en) * 2016-09-01 2020-02-25 The Bionics Institute Of Australia Electrode device for monitoring and/or stimulating activity in a subject
US20210145423A1 (en) * 2019-11-14 2021-05-20 Stimwave Technologies Incorporated Implantation Systems and Related Methods of Implanting Tissue Stimulators

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120290057A1 (en) * 2009-01-16 2012-11-15 Carl Lance Boling Apparatus and method for delivering a neurostimulator into the pterygopalatine fossa
US20120277544A1 (en) * 2011-04-28 2012-11-01 Medtronic, Inc. Biodegradable insertion guide for the insertion of a medical device
US20190134381A1 (en) * 2012-08-29 2019-05-09 The Bionics Institute Of Australia Electrical apparatus and methods and apparatus for positioning and implanting components thereof
US20190282803A1 (en) * 2015-09-14 2019-09-19 University Of Iowa Research Foundation Controlled position electrode array
US20170340891A1 (en) * 2015-10-15 2017-11-30 Spr Therapeutics, Llc Apparatus and method for positioning, implanting and using a stimulation lead
US10568574B2 (en) * 2016-09-01 2020-02-25 The Bionics Institute Of Australia Electrode device for monitoring and/or stimulating activity in a subject
US20210145423A1 (en) * 2019-11-14 2021-05-20 Stimwave Technologies Incorporated Implantation Systems and Related Methods of Implanting Tissue Stimulators

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