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WO2018005936A1 - Dispositif de fixation d'une électrode intracrânienne - Google Patents

Dispositif de fixation d'une électrode intracrânienne Download PDF

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Publication number
WO2018005936A1
WO2018005936A1 PCT/US2017/040225 US2017040225W WO2018005936A1 WO 2018005936 A1 WO2018005936 A1 WO 2018005936A1 US 2017040225 W US2017040225 W US 2017040225W WO 2018005936 A1 WO2018005936 A1 WO 2018005936A1
Authority
WO
WIPO (PCT)
Prior art keywords
clamp
electrode
anchor
securing
intracranial electrode
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2017/040225
Other languages
English (en)
Inventor
Heather Nicole PINCKARD-DOVER
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.)
BioVentures LLC
Original Assignee
BioVentures LLC
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 BioVentures LLC filed Critical BioVentures LLC
Publication of WO2018005936A1 publication Critical patent/WO2018005936A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0539—Anchoring of brain electrode systems, e.g. within burr hole
    • 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
    • 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 disclosure is directed to devices and methods for securing intracranial electrodes in a location proximal to the brain.
  • this disclosure is directed to a bayonetted clamp with a silicone endplate that secures an intracranial electrode.
  • Deep brain stimulation is a neurosurgical procedure involving the implantation of a neurostimulator, which sends electrical impulses, through implanted electrodes, to specific parts of the brain for the treatment of movement and affective disorders.
  • DBS in select brain regions may provide therapeutic benefits for movement and affective disorders such as Parkinson's disease, essential
  • OCD OCD
  • the deep brain stimulation system may include an implanted pulse generator (IPG), an intracranial electrode, and an extension.
  • IPG is a battery- powered neurostimulator encased in a titanium housing, which sends electrical pulses to the brain to interfere with neural activity at the target site.
  • the intracranial electrode is a coiled wire insulated in polyurethane with four platinum iridium electrodes and is placed in one or two different nuclei of the brain.
  • the intracranial electrode is connected to the IPG by the extension, an insulated wire that runs below the skin, from the head, down the side of the neck, behind the ear to the IPG, which is placed subcutaneously below the clavicle or, in some cases, the abdomen.
  • All three components are surgically implanted inside the body.
  • a hole is drilled in the skull and the intracranial electrode is inserted stereotactically.
  • One approach uses a conventional stereotactic frame system that is secured to the patient. In this approach, preoperative images of the patient are used to determine the proper trajectory to the target, as measured and aligned relative to the frame. Using
  • the electrode is aligned and advanced through a burr hole in the skull to the predetermined target.
  • the stereotactic accessories must then be carefully removed while holding the device in place. This step can be clumsy and inexact. If the electrode moves, it must be repositioned. Even after the stereotactic accessories have been removed, the electrode or other device must be secured. This procedure may also cause electrode movement.
  • the current device for marking the depth of the electrode is a small wheel with a screw that screws down to secure on the electrode. Removal of this wheel is difficult and can easily cause displacement of electrode.
  • One of the most common securing devices for the electrode is a plastic round structure that secures onto skull using 2 4mm screws, the electrode is then passed though the round structure. A small plastic insert is placed around the electrode and snaps into the securing device. A small limb then closes around the electrode to secure it in place. The electrode is then placed in groove of initial round structure and a small plastic cap pops on to secure the electrode.
  • the device may sit approximately 4mm above the skull and is often a site of skin erosion.
  • FIG. 1 is an illustration of the clamp device implanted in the brain and securing an intracranial electrode.
  • FIG. 2 is a top view of the clamp device.
  • the device 100 of the present invention generally comprises a clamp 108, a connector element 110, one or more elevated plates 114, an anchor 104, and an anchor element 112.
  • the clamp 108, connector element 110, one or more elevated plates 114, and anchor element 112 are a unitary body.
  • the device 100 may have a proximal end and a distal end, with the clamp 108 at the proximal end and the anchor element 112 or one or more elevated plates 114 at the distal end.
  • the connector element 110 may be located at a point between the clamp 108 and the anchor element 112.
  • the connector element 110 is bayoneted.
  • the clamp 108 may open and close around an intracranial electrode 102.
  • the clamp 108 may be silicone coated in one aspect.
  • the device 100 may elevate to the surface of the skull with the connector element 110.
  • the connector element 110 may be connected to the clamp 108 at one end and connected to one or more elevated plates 114 or the anchor element 112 at an opposite end.
  • the elevated plates 114 may be on the surface of the skull 106 and connected to the anchor element 112.
  • the anchor element 112 may include an opening for at least one anchor 104.
  • a cap 116 may be attached to the elevated plates 114 to secure the electrode 102 in place once implanted in the brain.
  • the device 100 may be implanted into a subject at a location that is proximate to or touching the brain or skull.
  • a method of implanting the device 100 into a subject is provided.
  • the device may be used to mark the length for inserting the electrode.
  • the device 100 may comprise at least one clamp for holding an electrode, such as a deep brain stimulator electrode.
  • the device 100 may comprise a single clamp 108 that is sufficient for holding the electrode.
  • the device 100 may comprise a clamp 108 that may open and close around an electrode, such as an intracranial electrode 102, as illustrated in FIG. 1.
  • the clamp 108 may surround and hold the intracranial electrode 102 in place once the proper location and depth is determined.
  • the clamp 108 may be coated with silicone or another non-conductive material to provide friction to further decrease movement of the electrode.
  • the clamp 108 may be opened and closed by squeezing or actuating the elevated plates 114, or by using a handle connected to the elevated plates 114.
  • the one or more clamps 108 may have a cylindrical or circular shape as illustrated in FIG. 2.
  • Other possible shapes of the clamp may be, in a non-limiting example, oval, rectangular, hexagonal, or any three- dimensional shape.
  • the clamp has a size that allows one or more intracranial electrodes to fit between the endplates of the clamp and be secured in place when the clamp is in the closed position.
  • the clamp 108 may have an inner diameter ranging from about 0.5 mm to about 3 mm. In one aspect, the clamp 108 may have an inner diameter of about 1 .5 mm when it is closed.
  • the clamp 108 may be used as a stopper to prevent the intracranial electrode 102 from being implanted too deep.
  • the device 100 may include a connector element 110.
  • the connector element 110 may have a proximal end and a distal end.
  • the connector element 110 may connect between the clamp 108 at its proximal end and the anchor element 112 or one or more elevated plates 114 at its distal end.
  • the connector element 110 may traverse though the burr hole as it may have one end adjacent to the brain and another end at or near the skull surface.
  • the distal end may be on the surface of the skull 106.
  • the connector element 110 may have a bend that heads superior to place the elevated plates 114 above the skull.
  • the connector element 110 may include a lateral component, a vertical
  • the device 100 may include one or more elevated plates 114.
  • the elevated plates 114 may be on the surface of the skull 106.
  • the elevated plates may be in continuity with the anchor element 112.
  • the device 100 may include parallel elevated plates 114 that may allow for an electrode 102 to run between them, providing support and direction for the electrode 102.
  • the elevated plates 114 may measure about 3 mm by 3mm. In various aspects, the dimensions of the elevated plates 114 may range from about 1 mm to about 10 mm.
  • the electrode may run between the two elevated plates 114.
  • the parallel elevated plates 114 may be about 1 mm to about 3 mm apart from one another when the clamp is closed. In one aspect, parallel elevated plates 114 may be about 1 .5 mm apart.
  • the elevated plates 114 may provide for a mechanism for opening and closing the clamp 108.
  • a handle may be attached to the elevated plates 114 to aid in the opening and closing of the clamp 108.
  • the elevated plates 114 may have a minimal profile to minimize contact with the skin overlying the skull 106.
  • a cap 116 may be placed over at least a part of the elevated plates 114 to further immobilize the electrode outside the skull.
  • the device may include an anchor element 112.
  • the anchor element 112 may be in continuity with the elevated plates 114 and the connector element 110.
  • the anchor element 112 allows for the device 100 to be anchored to the skull 106 of the patient.
  • the anchor element 112 may include an opening for receiving at least one anchor 104.
  • One of ordinary skill in the art would appreciate that the opening would have a size sufficient to accept an anchor 104 for securing the device to the skull 106.
  • the inside diameter of a round anchor element 112 may be such that a 4mm screw fits snuggly securing the device 100 to the skull 106.
  • the anchor element 112 may be attached to the connector element 110 and one or more elevated plates 114. In another aspect, the anchor element 112 may be integral to the elevated plates 114. The anchor element 112 may be round providing a hinge mechanism between the elevated plates 114 and the clamp 108 allowing opening and closing. The anchor element 112 may be round or any shape sufficient to receive an anchor 104. In an aspect, a cap 116 may be placed over at least a part of the anchor element 112 to further immobilize the electrode outside the skull.
  • the device may include at least one anchor 104.
  • the anchor may be a bone screw.
  • the screw may be a 4 mm screw.
  • a method for percutaneous placement of the device 100 may include placing a clamp from a device for securing the electrode at a location on the electrode that marks the desired length of the electrode, introducing the electrode into the brain, wherein the clamp prevents passing the electrode too deep, verifying the electrode is in the correct position, removing the clamp from the electrode, securing the clamp to the electrode adjacent to the brain, and securing the device to the skull with at least one anchor in an anchor element of the device.
  • the device may be secured to the electrode using the clamp and secured to the skull using an anchor though an anchor element.
  • the clamp may grasp the electrode by being opened and closed by squeezing the elevated plates in one aspect.
  • the burr hole may be filled with a sealant, such as duraseal or gelform, to prevent CSF leakage.
  • the method may include pushing the elevated plates together to open the clamp and sliding it around the electrode at the desired length of the electrode to prevent the electrode from passing further through a stereotactic placement device.
  • the electrode may then be passed through the stereotactic placement device. Once the electrode is verified to be in desired position, the electrode is held by the surgeon just adjacent to the brain. The device is removed from the electrode. The stereotactic placement device may then be moved out of the way.
  • the elevated plates may again be pushed together to open the clamp.
  • the clamp may then be allowed to slip around the electrode near its insertion point at the brain.
  • the anchor element may be made to be flush with the skull surface. The anchor should then be placed through the anchor element.
  • the distal electrode can then be draped through the elevated plates and the cap placed over them further securing the electrode in the desired direction

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychology (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne également des dispositifs et des procédés pour fixer une électrode intracrânienne dans un emplacement proximal au cerveau. Le dispositif peut avoir une pince à baïonnette avec une plaque d'extrémité en silicone qui fixe l'électrode intracrânienne.
PCT/US2017/040225 2016-07-01 2017-06-30 Dispositif de fixation d'une électrode intracrânienne Ceased WO2018005936A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662357697P 2016-07-01 2016-07-01
US62/357,697 2016-07-01

Publications (1)

Publication Number Publication Date
WO2018005936A1 true WO2018005936A1 (fr) 2018-01-04

Family

ID=60785243

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/040225 Ceased WO2018005936A1 (fr) 2016-07-01 2017-06-30 Dispositif de fixation d'une électrode intracrânienne

Country Status (1)

Country Link
WO (1) WO2018005936A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11633589B2 (en) 2021-03-05 2023-04-25 QV Bioelectronics Ltd. Biphasic injectable electrode
US11717680B2 (en) 2021-03-05 2023-08-08 QV Bioelectronics Ltd. Cranial prosthetic

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5364367A (en) * 1993-04-30 1994-11-15 Minnesota Mining And Manufacturing Company Cannula anchor
US5843150A (en) * 1997-10-08 1998-12-01 Medtronic, Inc. System and method for providing electrical and/or fluid treatment within a patient's brain
US6134477A (en) * 1999-04-30 2000-10-17 Medtronic, Inc. Adjustable medical lead fixation system
US6356792B1 (en) * 2000-01-20 2002-03-12 Electro Core Technologies, Llc Skull mounted electrode lead securing assembly
US20020111659A1 (en) * 2001-02-09 2002-08-15 Davis Scott J. Implantable therapy delivery element adjustable anchor
US20050182420A1 (en) * 2004-02-13 2005-08-18 Schulte Gregory T. Low profile apparatus for securing a therapy delivery device within a burr hole
US8038685B2 (en) * 2007-03-27 2011-10-18 Cranial Medical Systems, Inc. Anchoring apparatus and methods for use

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5364367A (en) * 1993-04-30 1994-11-15 Minnesota Mining And Manufacturing Company Cannula anchor
US5843150A (en) * 1997-10-08 1998-12-01 Medtronic, Inc. System and method for providing electrical and/or fluid treatment within a patient's brain
US6134477A (en) * 1999-04-30 2000-10-17 Medtronic, Inc. Adjustable medical lead fixation system
US6356792B1 (en) * 2000-01-20 2002-03-12 Electro Core Technologies, Llc Skull mounted electrode lead securing assembly
US20020111659A1 (en) * 2001-02-09 2002-08-15 Davis Scott J. Implantable therapy delivery element adjustable anchor
US20050182420A1 (en) * 2004-02-13 2005-08-18 Schulte Gregory T. Low profile apparatus for securing a therapy delivery device within a burr hole
US8038685B2 (en) * 2007-03-27 2011-10-18 Cranial Medical Systems, Inc. Anchoring apparatus and methods for use

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11633589B2 (en) 2021-03-05 2023-04-25 QV Bioelectronics Ltd. Biphasic injectable electrode
US11717680B2 (en) 2021-03-05 2023-08-08 QV Bioelectronics Ltd. Cranial prosthetic

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