WO2024263796A2 - Systems and methods for implanting electrodes in the brain - Google Patents

Systems and methods for implanting electrodes in the brain Download PDF

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Publication number
WO2024263796A2
WO2024263796A2 PCT/US2024/034843 US2024034843W WO2024263796A2 WO 2024263796 A2 WO2024263796 A2 WO 2024263796A2 US 2024034843 W US2024034843 W US 2024034843W WO 2024263796 A2 WO2024263796 A2 WO 2024263796A2
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WO
WIPO (PCT)
Prior art keywords
lead
stylet body
brain
distal portion
stylet
Prior art date
Application number
PCT/US2024/034843
Other languages
French (fr)
Other versions
WO2024263796A3 (en
Inventor
Jared Floyd
Tanner Chas DIXON
Roshanne Malekmadani
Shashank NAGESH
Original Assignee
Iota Biosciences, Inc.
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 Iota Biosciences, Inc. filed Critical Iota Biosciences, Inc.
Publication of WO2024263796A2 publication Critical patent/WO2024263796A2/en
Publication of WO2024263796A3 publication Critical patent/WO2024263796A3/en

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Classifications

    • 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
    • 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
    • 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease

Definitions

  • Deep brain stimulation is a neurostimulation therapy that can be used to treat neurodegenerative disorders such as epilepsy and Parkinson’s disease (PD).
  • DBS Deep brain stimulation
  • an artificial electrical current is provided to specific parts of the brain to stimulate neurons, which in turn eases the symptoms experienced in different brain conditions.
  • high-frequency stimulation is provided to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or internal globus pallidus (GPi)) to correct imbalances in excitation-inhibition in the basal ganglia circuit.
  • STN subthalamic nucleus
  • GPi internal globus pallidus
  • DBS can ease motor symptoms experienced in PD and decrease the need for pharmacological treatment.
  • Deep brain stimulation systems commonly include one or more leads (e.g., comprising electrodes) implanted in the brain and a pulse generator (e.g., stimulator battery) implanted in the upper chest of the patient.
  • a pulse generator e.g., stimulator battery
  • One or more small incisions are made in the scalp of a patient, followed by one or more small openings in the skull that allow for lead implantation in the brain.
  • a stereotactic frame can be used.
  • a cannula can be used when inserting leads into the brain to maintain an open channel through which the lead can be introduced to the target.
  • the stereotactic frame guides and can engage with a stylet to implant an otherwise-flexible lead comprising the electrodes into the brain.
  • the lead may be a stimulation lead, a sensing lead, or a combination lead (e.g., a sensing and stimulating lead).
  • the proper depth of the lead when implanted into the brain can be satisfied using a depth stop positioned on the stylet body.
  • the ny-2750764.1 Attorney Docket No.: 78895-20033.40 depth stop indicates the proper depth once it engages, for example, with the stereotactic frame and/or the cannula.
  • a small incision is made in the upper chest to create a soft tissue pocket for the pulse generator.
  • the leads are connected to the pulse generator, for example, using extension wires tunneled underneath the skin between the leads extending from the skull and the pulse generator in the upper chest.
  • extension leads can shift, causing pain and discomfort for the patient. Additionally, the extension leads may loosen, detach from the pulse generator, or break, each of which requires subsequent surgical procedures to fix, reattach, or replace the leads. Additional surgical procedures can increase the risk of intraoperative and/or postoperative surgical complications, such as infection, bleeding, swelling, and in more severe cases, coma, sepsis, and stroke. Moreover, implanting the leads and the pulse generator requires preparation of at least two surgical sites (e.g., the upper chest and one or more sites on the skull), and each of the procedures are typically executed individually in separate visits, which is a source of inefficiency in the surgical suite that is also accompanied by increased risk of surgical complications (i.e., due to the number of procedures).
  • the lead may be designed such that it extends from the appropriate implantation site of the electrodes in the brain to an implantation site on the surface of the skull suitable for a pulse generator (e.g., a cranially mounted implantable pulse generator, or IPG) with minimal excess lead length between the sites.
  • the lead may comprise a lumen along the length of the lead configured to removably house a stylet body used to aid in implanting the lead comprising the electrodes into the brain.
  • a distal portion of the stylet body may be housed within the lead, and a proximal portion of the stylet body may be removably attached to a depth stop.
  • the depth stop can contact a stereotactic frame mounted on the skull and/or cannula inserted in the brain to indicate the proper depth of the electrodes on the lead in the brain.
  • a system for implanting electrodes in a brain comprising: a lead comprising a lumen and one or more electrodes disposed on the lead; and a ny-2750764.1 Attorney Docket No.: 78895-20033.40 stylet body comprising a distal portion and a proximal portion, wherein the distal portion is configured to be removably housed in the lumen such that a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and the proximal portion of the stylet body is configured to be removably attached to a depth stop.
  • a position of the depth stop attached along a length of the proximal portion of the stylet body corresponds to a predetermined depth in the brain to which the lead is to be inserted.
  • the predetermined depth in the brain disposes between 40% and 80% of a length of the lead external to a skull.
  • the system comprises the depth stop.
  • the depth stop is configured to contact a proximal surface of a holder of a stereotactic frame to stop the insertion of the lead into the brain at the predetermined depth.
  • the depth stop is configured to contact a proximal end of a cannula inserted into the brain to stop the insertion of the lead into the brain at the predetermined depth.
  • the proximal portion of the stylet body comprises a first diameter and the distal portion of the stylet body comprises a second diameter different from the first diameter.
  • the first diameter is less than or equal to a diameter of the depth stop such that the depth stop can be removably secured to the proximal portion of the stylet body.
  • the second diameter is less than or equal to a diameter of the lumen such that the distal portion of the stylet body can be removably inserted into the lumen.
  • the stylet body comprises a length between 10 cm and 50 cm.
  • the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body.
  • a cross-section of the proximal portion of the stylet body and/or a cross-section of the distal portion of the stylet body is a square, circle, ellipse, rectangle, triangle, or curvilinear triangle.
  • the cross-section of the proximal portion comprises a first geometric shape and the cross-section of the distal portion comprises a second geometric shape different from the first geometric shape.
  • the stylet body comprises one or more biocompatible materials.
  • the proximal portion of the stylet body comprises a first biocompatible material and the distal portion of the stylet body comprises a second biocompatible material different from the first biocompatible material.
  • the one or more biocompatible materials comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.
  • the stylet body is sterilizable, such that the stylet body is reusable.
  • a deep brain stimulation system is provided, comprising: the system of any one of aforementioned embodiments; and a pulse generator configured to be implanted in or on a skull and coupled to the lead.
  • a method for implanting electrodes into a brain comprising: attaching a depth stop to a proximal portion of a stylet body; inserting a distal portion of the stylet body removably housed in a lumen of a lead into the brain, wherein a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and wherein a portion of the lead comprises one or more electrodes; and removing the distal portion of the stylet body from the lumen of the lead inserted into the brain, thereby leaving behind at least the portion of the lead comprising the one or more electrodes in the brain.
  • attaching the depth stop to the proximal portion of the stylet body comprises attaching the depth stop at a position along a length of the proximal portion that corresponds to a predetermined depth in the brain to which the lead is inserted.
  • the method comprises, prior to inserting the distal portion of the stylet body into the brain, mounting a stereotactic frame on a skull such that a holder of the stereotactic frame is aligned with an implantation site in the skull.
  • ny-2750764.1 Attorney Docket No.: 78895-20033.40
  • the distal portion of the stylet body is inserted through the holder of the stereotactic frame and into the brain until the depth stop contacts a proximal surface of the holder.
  • removing the distal portion of the stylet body from the lumen of the lead comprises removing the stylet body from the holder of the stereotactic frame.
  • the method comprises removing the stereotactic frame from being mounted on the skull following removal of the stylet body from the lumen of the lead and the holder of the stereotactic frame.
  • the method comprises, prior to inserting the distal portion of the stylet body into the brain, inserting a cannula to the predetermined depth in the brain.
  • the distal portion of the stylet body is inserted through the cannula and into the brain until the depth stop contacts a proximal end of the cannula inserted in the brain.
  • the method comprises removing the cannula from the brain following removal of the stylet body from the lumen of the lead.
  • the method comprises, prior to removing the stylet body from the lumen of the lead, securing the lead to an external surface of a skull.
  • the lead is secured to the external surface of the skull at a location proximate to a burr hole in the skull from which the lead exits.
  • the method comprises, prior to inserting the distal portion of the stylet body into the brain, inserting the distal portion into the lumen of the lead.
  • the method comprises positioning the depth stop on the proximal portion of the stylet body such that between 40% and 80% of a length of the lead is disposed external to a skull when the distal portion of the stylet body is inserted to a predetermined depth in the brain.
  • the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body.
  • the method comprises generating a resection in a skull configured to receive an implantable pulse generator (IPG) and implanting the IPG in the resection.
  • IPG implantable pulse generator
  • the method comprises, after inserting the lead to the brain, connecting the implantable pulse generator with one or more electrical contacts disposed on a proximal portion of the lead.
  • FIG.1A illustrates a perspective view of a lead and stylet system, in accordance with some embodiments.
  • FIG.1B illustrates another perspective view of the lead and stylet system, in accordance with some embodiments.
  • FIG.1C illustrates a close-up partial view of the lead, in accordance with some embodiments.
  • FIG.1D illustrates a cross-sectional partial view of the lead, in accordance with some embodiments.
  • FIG.2A illustrates a perspective view of a depth stop, in accordance with some embodiments.
  • FIG.2B illustrates another perspective view of the depth stop, in accordance with some embodiments.
  • FIG.3 illustrates a perspective view of an assembly comprising the lead, stylet, and depth stop, in accordance with some embodiments.
  • FIG.4A illustrates a perspective view of the lead and stylet system with a stereotactic frame, in accordance with some embodiments.
  • FIG.4B illustrates a detailed view of the lead and stylet system with the stereotactic frame, in accordance with some embodiments.
  • DETAILED DESCRIPTION A lead and stylet system and method for implanting the lead using the stylet is described herein.
  • the stylet body and lead may be used during a deep brain stimulation (DBS) ny-2750764.1 Attorney Docket No.: 78895-20033.40 implantation procedure to implant a lead of a suitable length for a cranially mounted pulse generator (e.g., an implantable pulse generator, or IPG) into the brain.
  • a cranially mounted pulse generator e.g., an implantable pulse generator, or IPG
  • the length of the lead may be shorter than that used in DBS systems comprising an IPG implanted in the chest.
  • the stylet of the lead and stylet system described herein may facilitate proper implantation of the shorter lead into the brain by disposing the distal portion of the stylet body in a lumen of the lead. Moreover, a proximal portion of the stylet body can attach to a depth stop that engages with a stereotactic frame and/or cannula inserted in the brain to indicate a proper insertion depth of the electrodes in the brain.
  • the DBS system discussed herein may include a cranially mounted IPG rather than an IPG implanted in the chest of the patient, thus negating the need for long leads and/or extension wires that are tunneled between the skull and chest.
  • the cranially mounted IPG can also reduce the number of surgical sites necessary to implant the DBS system, which also can also reduce the amount of time expended during the DBS implantation procedure. Attempting use of these long leads with a cranially mounted IPG, for example, by bundling the excess lead length at the implantation site within a pocket in the scalp, can cause scalp erosion, thus necessitating a system with a shorter lead length.
  • the shorter lead length can also result in more efficient power transfer during deep brain stimulation than longer leads used in DBS systems with chest mounted IPGs. However, the shorter lead length may leave a minimal length of lead external to the skull that does not extend to the stereotactic frame for proper alignment and placement.
  • FIGS.1A-1B illustrate a system 100 for implanting electrodes in the brain, the system 100 comprising a lead 102 and a stylet body 104.
  • Lead 102 may comprise a lumen 108 and one or more electrodes 106 disposed on the lead.
  • the lead 102 may be a stimulation lead, a sensing lead, or a combination lead (e.g., a lead that can both sense and stimulate).
  • Stylet body 104 may comprise a distal portion 110 and a proximal portion 112, the distal portion 110 configured to be removably housed in lumen 108.
  • a length of lead 102 may extend from an end of distal portion 110 of stylet body 104 to a midpoint within distal portion 110 of stylet body 104.
  • the proximal portion 112 may be configured to be removably attached to a depth stop (e.g., ny-2750764.1 Attorney Docket No.: 78895-20033.40 depth stop 200 illustrated at least in FIGS. 2A-2B).
  • a depth stop e.g., ny-2750764.1 Attorney Docket No.: 78895-20033.40 depth stop 200 illustrated at least in FIGS. 2A-2B.
  • stylet body 104 may comprise a proximal portion 112 comprising a first diameter and a distal portion 110 comprising a second diameter.
  • the first diameter and second diameter may be substantially the same, or the first diameter and second diameter may be different (as shown).
  • the cross-sectional shape of the proximal portion 112 and the distal portion 110 of stylet body 104 may be different.
  • the cross-sectional shape of one or more portions of stylet body 104 may be a square, circle, ellipse, rectangle, triangle, curvilinear triangle, or another polygonal shape.
  • the first diameter of proximal portion 112 of stylet body 104 may be less than or equal to 3 mm, 2.75 mm, 2.5 mm, 2.25 mm, 2 mm, 1.75 mm, or 1.5 mm. In some embodiments, the first diameter of proximal portion 112 of stylet body 104 may be greater than or equal to 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. The first diameter of the proximal portion 112 may be less than or equal to the diameter of the depth stop (e.g., the diameter of a receiving portion 202 of depth stop 200, shown at least in FIGS. 2A-2B).
  • the diameter of the depth stop e.g., the diameter of a receiving portion 202 of depth stop 200, shown at least in FIGS. 2A-2B.
  • the second diameter of distal portion 110 of stylet body 104 may be less than or equal to 1.5 mm, 1.25 mm, 1.0 mm, 0.75 mm, or 0.5 mm. In some embodiments, the second diameter of distal portion 110 of stylet body 104 may be greater than or equal to 0.1 mm, 0.25 mm, 0.5 mm, or 0.75 mm. The second diameter of the distal portion 110 of stylet body 104 may be less than or equal to the diameter of the lead lumen 108, such that the distal portion 110 may be removably inserted into the lumen 108.
  • the length of stylet body 104 may be less than or equal to 5 cm, 10 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, or 60 cm. In some embodiments, the length of stylet body 104 may be greater than or equal to 5 cm, 10 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, or 60 cm. In some embodiments, stylet body 104 may be selected such that the length of distal portion 110 is greater than or equal to the length of a selected lead 102 for a given patient.
  • distal portion 110 may comprise approximately half of the length of stylet body 104, and proximal portion 112 may comprise the other approximate half of ny-2750764.1 Attorney Docket No.: 78895-20033.40 the length of stylet body 104.
  • distal portion 110 may comprise about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more of the length of stylet body 104, whereas proximal portion 112 may comprise the remaining about 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% of the length of stylet body 104.
  • stylet body 104 may be manufactured from one or more biocompatible materials.
  • stylet body 104 may comprise one or more biocompatible materials including but not limited to polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium (e.g., nickel titanium), a mixture of polymers, a mixture of medical-grade metals, or a mixture of polymers and medical-grade metals.
  • distal portion 110 may comprise a first mixture of materials (e.g., one or more materials) and proximal portion 112 may comprise a second mixture of materials (e.g., one or more materials) different from the first mixture of materials.
  • distal portion 110 may comprise one or more medical-grade metals (e.g., stainless steel, titanium, etc.) and proximal portion 112 may comprise one or more polymers (e.g., PC, PEEK, PPSU, PET, etc.).
  • proximal portion 112 may comprise one or more polymers (e.g., PC, PEEK, PPSU, PET, etc.).
  • distal portion 110 may comprise a mixture of medical-grade metals and polymers, such as one or more medical-grade metals coated with one or more polymers.
  • the material(s) of stylet body 104 may be selected such that stylet body 104 is sterilizable and can be reused for multiple lead stimulation implantation procedures.
  • stylet body 104 may be sterilizable using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and/or other sterilization methods (e.g., chlorine dioxide gas, vaporized peracetic acid, nitrogen dioxide, etc.).
  • Lead 102 may be configured to provide artificial electrical current to a region of the brain via one or more electrodes 106 disposed on the lead.
  • lead 102 may comprise an array of electrodes 106 disposed at least at the distal end of lead 102.
  • a plurality of electrodes may be disposed along at least a portion of the length of the lead.
  • the electrodes 106 may comprise segmented electrodes configured to direct current to a specific location and/or in a specific direction. Segmented electrodes may introduce benefits over, for example, solid ring electrodes which are axisymmetric in geometry and therapy. 9 ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0062] As shown at least in FIGS.1A-1D, lead 102 may additionally comprise one or more electrical contacts 109. Electrical contacts 109 may be configured to electrically couple with an implantable pulse generator (IPG) to be implanted in the skull.
  • IPG implantable pulse generator
  • the IPG may comprise a receiving portion configured to receive and connect to electrical contacts 109.
  • the IPG when implanted, can generate stimulation pulses that can be provided to electrical contacts 109, and the stimulation pulses can travel within lead 102 (e.g., via one or more extension wires electrically connecting electrical contacts 109 and electrodes 106) to electrodes 106. Electrodes 106 can then stimulate the region of the brain in which electrodes 106 are implanted with the stimulation pulses.
  • lead 102 may comprise a lumen 108 configured to removably house distal portion 110 of stylet body 104.
  • Lumen 108 may be a through-hole extending through at least a portion of the length of lead 102.
  • lumen 108 may extend from a proximal end of lead 102 toward a distal end of lead 102.
  • the proximal end may be configured to initially receive stylet body 104.
  • Lumen 108 may not extend through the distal end of lead 102, such that when distal portion 110 of stylet body 104 is inserted into lead 102, it can be inserted until reaching a midpoint within lead 102 at which lumen 108 ends.
  • lumen 108 may comprise about 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% of the length of lead 102.
  • the cross-sectional shape of lumen 108 may be substantially the same as that of the distal portion 110 of stylet body 104.
  • the diameter of lumen 108 may be less than or equal to 1.5 mm, 1.25 mm, 1.0 mm, 0.75 mm, or 0.5 mm. In some embodiments, the diameter of lumen 108 may be greater than or equal to 0.25 mm, 0.5 mm, 0.75 mm, or 1 mm.
  • the length of lead 102 may extend from an electrode implantation site in the brain to an IPG implantation site in the skull with minimal excess lead length. Thus, the length may be shorter than a lead of a deep brain stimulation (DBS) system comprising a pulse generator implanted in the chest.
  • DBS deep brain stimulation
  • the length of lead 102 may be less than or equal to 50 cm, 40 cm, 30 cm, 20 cm, 15 cm, 10 cm, 5 cm, or 1 cm. In some embodiments, the length of lead 102 may be greater than or equal to 0.5 cm, 1 cm, 5 cm, 10 cm, 15 cm, or 20 cm.
  • the lead 102 may be selected such that the length of the lead corresponds with one or more measurements of a patient. Thus, different length leads 102 may be used for different patients.
  • the length of lead ny-2750764.1 Attorney Docket No.: 78895-20033.40 102 may be less than that of stylet body 104 such that lead 102 does not engage with a proximal end of stylet body 104.
  • lead 102 may span from an end of distal portion 112 of stylet body 104 to a midpoint within distal portion 112 of stylet body 104.
  • FIG.3 illustrates an assembly 300 in which stylet body 104 is removably inserted within lumen 108 of lead 102.
  • Lead 102 may comprise one or more biocompatible materials to allow the lead to be safely implanted into the brain of a patient.
  • the technical features and materials of lead 102 are not intended to be limited to the disclosure provided herein and rather may encompass any one or more features of leads known to one of ordinary skill in the art.
  • stylet body 104 may be configured to be removably attached to a depth stop.
  • stylet body 104 may attach directly to a depth stop (e.g., rather than a lead).
  • the stylet body 104 may attach indirectly to a depth stop (e.g., the lead may attach to the depth stop).
  • FIGS. 2A-2B illustrate an exemplary depth stop 200 configured to be removably attached to stylet body 104.
  • depth stop 200 may comprise a receiving portion 202 (e.g., a through-hole) configured to receive at least the proximal portion 112 of stylet body 104.
  • Depth stop 200 may comprise an opening such that a user can removably insert stylet body 104 into the receiving portion 202 of depth stop 200.
  • depth stop 200 may comprise a semi-annular-shaped body, and the opening within the annular shape may be sized such that stylet body 104 can be removably inserted through the opening.
  • depth stop 200 may comprise a fastener 204 that can engage with stylet body 104 when inserted within receiving portion 202 of depth stop 200 to maintain a position of depth stop 200 on stylet body 104.
  • the user may rotate, turn, push, and/or pull a knob 206 coupled to fastener 204 to translate fastener 204 into/out of receiving portion 202.
  • fastener 204 may comprise threads that allow for fine adjustment of fastener 204 by rotating knob 206.
  • fastener 204 may be translatable between two or more positions (e.g., a locked position and an unlocked position), and the user may engage with knob ny-2750764.1 Attorney Docket No.: 78895-20033.40 206 (e.g., by rotating, pushing, pulling, and/or turning knob 206) to translate fastener 204 between the two or more positions.
  • depth stop 200 may be configured to clamp to a stylet wire rather than stylet body 104.
  • the lead and stylet system 100 as described herein may be provided as components of a deep brain stimulation system.
  • the deep brain stimulation system may comprise at least lead 102 and stylet body 104 as discussed herein, as well as a pulse generator configured to be implanted in a skull and coupled to lead 102.
  • depth stop 200 may be included in the deep brain stimulation system.
  • the lead and stylet system described herein is not limited to deep brain stimulation (DBS) systems with cranially mounted pulse generators and may be used and/or adapted for use in other systems, including but not limited to other DBS systems in which the IPG may be implanted elsewhere on the human body (other than the skull).
  • DBS deep brain stimulation
  • the lead and stylet system 100 may be used to implant electrodes (e.g., electrodes 106) into the brain.
  • electrodes 106 may be implanted to perform deep brain stimulation.
  • a method for implanting electrodes 106 into a brain may comprise attaching a depth stop 200 to a proximal portion 112 of a stylet body 104.
  • depth stop 200 may be attached to stylet body 104 at a position along a length of proximal portion 112 that can correspond to a predetermined depth in the brain to which lead 102 is inserted.
  • the method may comprise inserting distal portion 110 of stylet body 104 into lumen 108 of lead 102.
  • lead 102 and stylet body 104 may be provided to a user assembled, such as is illustrated with assembly 300 in FIG.3.
  • the length of lead 102 may span from an end of distal portion 110 of stylet body 104 to a midpoint within distal portion 110 of stylet body 104.
  • the method may include generating a resection (e.g., a burr hole) in the surface of the skull at a predetermined location corresponding to an intended electrode implantation site in the brain.
  • a resection e.g., a burr hole
  • the method may comprise mounting a stereotactic frame on a skull.
  • FIGS. 4A-4B illustrate an exemplary stereotactic frame 400 that can be mounted on the skull.
  • Mounting stereotactic frame 200 may include adjusting the position of the frame in one or more axes (e.g., X, Y, and Z labeled on stereotactic frame 400 illustrated in FIG. 4). In some embodiments, stereotactic frame 400 may already be mounted on the skull, such that the method may not include mounting the frame to the skull.
  • Stereotactic frame 400 may comprise a holder 402 configured to receive stylet body 104 and maintain a position of stylet body 104 (inserted in lead 102) while inserting lead 102 to the brain.
  • holder 402 may comprise a receiving portion 404 (e.g., a through-hole) configured to receive stylet body 104.
  • Stereotactic frame 400 (e.g., one or more moveable components of stereotactic frame 400) may be positioned such that holder 402 can be aligned with an implantation site in the skull.
  • holder 402 may be positioned superior to the implantation site on the skull at a distance from the implantation site.
  • the position of holder 402 may be modified in one or more planes relative to stereotactic frame 400.
  • the position of holder 402 may be adjustable in one or more directions represented by arrow 406, arrow 408, and/or arrow 410 in FIG.4.
  • the method may include inserting a cannula to a predetermined depth in the brain.
  • the cannula may be inserted through a burr hole generated in the surface of the skull and into the brain.
  • the cannula may be used to generate an opening within the brain to facilitate lead implantation.
  • One or more of the example stereotactic frame systems discussed herein may be used in conjunction with a cannula.
  • the method may include inserting distal portion 110 of stylet body 104 removably housed in lumen 108 of lead 102 into the brain.
  • distal portion 110 removably housed in lead 102 may be inserted through holder 402 and into the brain (e.g., via a burr hole in the skull) until depth stop 200 contacts holder 402.
  • depth stop 200 may contact a proximal surface of holder 402 when the lead 102 and stylet body 104 assembly is inserted through receiving portion 404 of holder 402 and to a predetermined depth in the brain.
  • the position at which depth stop 200 on stylet body 104 contacts holder 402 may signify an appropriate implantation depth of electrodes 106 disposed on lead 102.
  • ny-2750764.1 Attorney Docket No.: 78895-20033.40
  • distal portion 110 of stylet body 104 (removably housed in lumen 108 of lead 102) may be inserted through the cannula and into the brain.
  • the distal portion 110 of stylet body 104 may be inserted into the brain until depth stop 200 attached to proximal portion 112 of stylet body 104 contacts the cannula inserted in the brain.
  • depth stop 200 may contact a proximal end of the cannula.
  • the position at which depth stop 200 on stylet body 104 contacts the proximal end of the cannula may signify an appropriate implantation depth of electrodes 106 disposed on lead 102.
  • the position of depth stop 200 on proximal portion 112 of stylet body 104 may be selected such that when the distal portion 110 of stylet body 104 removably housed in lead 102 is inserted into the brain until the depth stop contacts holder 402 (or in some embodiments a cannula), approximately 40% and 80% of lead 102 can be disposed external to the skull. In some embodiments, about 20%, 30%, 40%, 50%, 60%, 70%, or 80% of lead 102 may be disposed external to the skull upon proper implantation of the lead in the brain.
  • the method may include removing distal portion 110 from lumen 108 of lead 102, thereby leaving behind at least the portion of lead 102 comprising the one or more electrodes 106 implanted in the brain.
  • a user may remove distal portion 110 of stylet body 104 from lumen 108 of lead 102, and subsequently may remove stylet body 104 from holder 402 of stereotactic frame 400.
  • the method may comprise securing lead 102 to an external surface of the skull.
  • securing lead 102 to the skull may occur following removal of stylet body 104 from lead 102.
  • Lead 102 may be secured to the external surface of the skull at a location proximate to a burr hole in the skull from which lead 102 (and optionally stylet body 104) exits.
  • a lead fixation device may be used to secure a portion of lead 102 to the skull at a location adjacent to the burr hole. The lead fixation device may be used to secure the lead 102 to the skull prior to removing stylet body 104 from lumen 108 and/or prior to removal of stereotactic frame 400, as described herein.
  • the method may include removing stereotactic frame 400 from being mounted on the skull following removal of stylet body 104 from lumen 108 of lead 102 and holder 402 of ny-2750764.1 Attorney Docket No.: 78895-20033.40 stereotactic frame 400.
  • stereotactic frame 400 and/or depth stop 200 may be removed prior to removal of stylet body 104 from lumen 108 of lead 102.
  • the method may comprise removing the cannula from the brain following removal of stylet body 104 from lumen 108 of lead 102.
  • the cannula may comprise a peel-away cannula, which is partially split in two pieces axially such that the cannula can be separated and removed while the lead 102 is held in place with stereotactic frame 400.
  • the stereotactic frame 400 and stylet body 104 can be removed.
  • the method may include connecting lead 102 with an implantable pulse generator (IPG).
  • IPG implantable pulse generator
  • lead 102 may comprise one or more electrical contacts 109 on a proximal portion of the lead, and the one or more electrical contacts 109 may be connected with an IPG configured to be mounted in or on the skull.
  • the method may include generating a resection in the skull that may be configured to receive a cranially mounted IPG.
  • the resection may be generated prior to implanting lead 102 in the skull.
  • the method may include implanting the IPG into the resection in the skull.
  • the use of lead 102 and/or stylet body 104 may not be limited to deep brain stimulation (DBS) systems comprising cranially mounted IPGs.
  • DBS deep brain stimulation
  • lead 102 and/or stylet body 104 may be used in DBS implantation procedures in which the IPG is mounted elsewhere in the human body (e.g., in the chest).
  • the method may include connecting lead 102 with one or more extension leads electrically connected with an IPG.
  • the method may also include preparing an additional implantation site, such as in the chest, and implanting the IPG in the chest.

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Abstract

Provided herein are lead and stylet systems and methods of using the sty let to implant the lead into the brain. The leads may be used for deep brain stimulation (DBS) and may be connected to a cranially mounted implantable pulse generator (IPG) of a DBS sy stem. The lead may comprise a lumen configured to removably house the stylet to assist in implanting electrodes disposed on the lead in the brain. The lead and stylet systems described herein may allow for minimal excess lead length between the implantation site of the lead in the brain and the IPG (e.g., implanted in the skull).

Description

Attorney Docket No.: 78895-20033.40 SYSTEMS AND METHODS FOR IMPLANTING ELECTRODES IN THE BRAIN CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No.63/509,236, filed June 20, 2023, the contents of which are incorporated herein in its entirety. FIELD [0002] This disclosure relates generally to leads and stylets, and more specifically to leads and stylets for implanting electrodes in the brain during deep brain stimulation (DBS) implantation procedures. BACKGROUND [0003] Deep brain stimulation (DBS) is a neurostimulation therapy that can be used to treat neurodegenerative disorders such as epilepsy and Parkinson’s disease (PD). In DBS, an artificial electrical current is provided to specific parts of the brain to stimulate neurons, which in turn eases the symptoms experienced in different brain conditions. For example, in patients with PD, high-frequency stimulation is provided to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or internal globus pallidus (GPi)) to correct imbalances in excitation-inhibition in the basal ganglia circuit. DBS can ease motor symptoms experienced in PD and decrease the need for pharmacological treatment. [0004] Deep brain stimulation systems commonly include one or more leads (e.g., comprising electrodes) implanted in the brain and a pulse generator (e.g., stimulator battery) implanted in the upper chest of the patient. One or more small incisions are made in the scalp of a patient, followed by one or more small openings in the skull that allow for lead implantation in the brain. To accurately align on the skull and implant electrodes in targeted brain areas, a stereotactic frame can be used. In some instances, a cannula can be used when inserting leads into the brain to maintain an open channel through which the lead can be introduced to the target. The stereotactic frame guides and can engage with a stylet to implant an otherwise-flexible lead comprising the electrodes into the brain. The lead may be a stimulation lead, a sensing lead, or a combination lead (e.g., a sensing and stimulating lead). The proper depth of the lead when implanted into the brain can be satisfied using a depth stop positioned on the stylet body. The ny-2750764.1 Attorney Docket No.: 78895-20033.40 depth stop indicates the proper depth once it engages, for example, with the stereotactic frame and/or the cannula. [0005] In addition to implanting the lead in the brain, a small incision is made in the upper chest to create a soft tissue pocket for the pulse generator. The leads are connected to the pulse generator, for example, using extension wires tunneled underneath the skin between the leads extending from the skull and the pulse generator in the upper chest. However, these extension leads can shift, causing pain and discomfort for the patient. Additionally, the extension leads may loosen, detach from the pulse generator, or break, each of which requires subsequent surgical procedures to fix, reattach, or replace the leads. Additional surgical procedures can increase the risk of intraoperative and/or postoperative surgical complications, such as infection, bleeding, swelling, and in more severe cases, coma, sepsis, and stroke. Moreover, implanting the leads and the pulse generator requires preparation of at least two surgical sites (e.g., the upper chest and one or more sites on the skull), and each of the procedures are typically executed individually in separate visits, which is a source of inefficiency in the surgical suite that is also accompanied by increased risk of surgical complications (i.e., due to the number of procedures). SUMMARY [0006] Described herein are lead and stylet systems and methods of using the stylet to implant the lead into the brain during, for example, a deep brain stimulation (DBS) implantation procedure. The lead may be designed such that it extends from the appropriate implantation site of the electrodes in the brain to an implantation site on the surface of the skull suitable for a pulse generator (e.g., a cranially mounted implantable pulse generator, or IPG) with minimal excess lead length between the sites. The lead may comprise a lumen along the length of the lead configured to removably house a stylet body used to aid in implanting the lead comprising the electrodes into the brain. A distal portion of the stylet body may be housed within the lead, and a proximal portion of the stylet body may be removably attached to a depth stop. Thus, when implanting the lead using the stylet with the depth stop attached to the stylet, the depth stop can contact a stereotactic frame mounted on the skull and/or cannula inserted in the brain to indicate the proper depth of the electrodes on the lead in the brain. [0007] In some embodiments, a system for implanting electrodes in a brain is provided, comprising: a lead comprising a lumen and one or more electrodes disposed on the lead; and a ny-2750764.1 Attorney Docket No.: 78895-20033.40 stylet body comprising a distal portion and a proximal portion, wherein the distal portion is configured to be removably housed in the lumen such that a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and the proximal portion of the stylet body is configured to be removably attached to a depth stop. [0008] In some embodiments, a position of the depth stop attached along a length of the proximal portion of the stylet body corresponds to a predetermined depth in the brain to which the lead is to be inserted. [0009] In some embodiments, the predetermined depth in the brain disposes between 40% and 80% of a length of the lead external to a skull. [0010] In some embodiments, the system comprises the depth stop. [0011] In some embodiments, the depth stop is configured to contact a proximal surface of a holder of a stereotactic frame to stop the insertion of the lead into the brain at the predetermined depth. [0012] In some embodiments, the depth stop is configured to contact a proximal end of a cannula inserted into the brain to stop the insertion of the lead into the brain at the predetermined depth. [0013] In some embodiments, the proximal portion of the stylet body comprises a first diameter and the distal portion of the stylet body comprises a second diameter different from the first diameter. [0014] In some embodiments, the first diameter is less than or equal to a diameter of the depth stop such that the depth stop can be removably secured to the proximal portion of the stylet body. [0015] In some embodiments, the second diameter is less than or equal to a diameter of the lumen such that the distal portion of the stylet body can be removably inserted into the lumen. [0016] In some embodiments, the stylet body comprises a length between 10 cm and 50 cm. [0017] In some embodiments, the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body. [0018] In some embodiments, a cross-section of the proximal portion of the stylet body and/or a cross-section of the distal portion of the stylet body is a square, circle, ellipse, rectangle, triangle, or curvilinear triangle. ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0019] In some embodiments, the cross-section of the proximal portion comprises a first geometric shape and the cross-section of the distal portion comprises a second geometric shape different from the first geometric shape. [0020] In some embodiments, the stylet body comprises one or more biocompatible materials. [0021] In some embodiments, the proximal portion of the stylet body comprises a first biocompatible material and the distal portion of the stylet body comprises a second biocompatible material different from the first biocompatible material. [0022] In some embodiments, the one or more biocompatible materials comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals. [0023] In some embodiments, the stylet body is sterilizable, such that the stylet body is reusable. [0024] In some embodiments, a deep brain stimulation system is provided, comprising: the system of any one of aforementioned embodiments; and a pulse generator configured to be implanted in or on a skull and coupled to the lead. [0025] In some embodiments, a method for implanting electrodes into a brain, the method comprising: attaching a depth stop to a proximal portion of a stylet body; inserting a distal portion of the stylet body removably housed in a lumen of a lead into the brain, wherein a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and wherein a portion of the lead comprises one or more electrodes; and removing the distal portion of the stylet body from the lumen of the lead inserted into the brain, thereby leaving behind at least the portion of the lead comprising the one or more electrodes in the brain. [0026] In some embodiments, attaching the depth stop to the proximal portion of the stylet body comprises attaching the depth stop at a position along a length of the proximal portion that corresponds to a predetermined depth in the brain to which the lead is inserted. [0027] In some embodiments, the method comprises, prior to inserting the distal portion of the stylet body into the brain, mounting a stereotactic frame on a skull such that a holder of the stereotactic frame is aligned with an implantation site in the skull. ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0028] In some embodiments, the distal portion of the stylet body is inserted through the holder of the stereotactic frame and into the brain until the depth stop contacts a proximal surface of the holder. [0029] In some embodiments, removing the distal portion of the stylet body from the lumen of the lead comprises removing the stylet body from the holder of the stereotactic frame. [0030] In some embodiments, the method comprises removing the stereotactic frame from being mounted on the skull following removal of the stylet body from the lumen of the lead and the holder of the stereotactic frame. [0031] In some embodiments, the method comprises, prior to inserting the distal portion of the stylet body into the brain, inserting a cannula to the predetermined depth in the brain. [0032] In some embodiments, the distal portion of the stylet body is inserted through the cannula and into the brain until the depth stop contacts a proximal end of the cannula inserted in the brain. [0033] In some embodiments, the method comprises removing the cannula from the brain following removal of the stylet body from the lumen of the lead. [0034] In some embodiments, the method comprises, prior to removing the stylet body from the lumen of the lead, securing the lead to an external surface of a skull. [0035] In some embodiments, the lead is secured to the external surface of the skull at a location proximate to a burr hole in the skull from which the lead exits. [0036] In some embodiments, the method comprises, prior to inserting the distal portion of the stylet body into the brain, inserting the distal portion into the lumen of the lead. [0037] In some embodiments, the method comprises positioning the depth stop on the proximal portion of the stylet body such that between 40% and 80% of a length of the lead is disposed external to a skull when the distal portion of the stylet body is inserted to a predetermined depth in the brain. [0038] In some embodiments, the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body. [0039] In some embodiments, the method comprises generating a resection in a skull configured to receive an implantable pulse generator (IPG) and implanting the IPG in the resection. ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0040] In some embodiments, the method comprises, after inserting the lead to the brain, connecting the implantable pulse generator with one or more electrical contacts disposed on a proximal portion of the lead. BRIEF DESCRIPTION OF THE FIGURES [0041] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings. [0042] FIG.1A illustrates a perspective view of a lead and stylet system, in accordance with some embodiments. [0043] FIG.1B illustrates another perspective view of the lead and stylet system, in accordance with some embodiments. [0044] FIG.1C illustrates a close-up partial view of the lead, in accordance with some embodiments. [0045] FIG.1D illustrates a cross-sectional partial view of the lead, in accordance with some embodiments. [0046] FIG.2A illustrates a perspective view of a depth stop, in accordance with some embodiments. [0047] FIG.2B illustrates another perspective view of the depth stop, in accordance with some embodiments. [0048] FIG.3 illustrates a perspective view of an assembly comprising the lead, stylet, and depth stop, in accordance with some embodiments. [0049] FIG.4A illustrates a perspective view of the lead and stylet system with a stereotactic frame, in accordance with some embodiments. [0050] FIG.4B illustrates a detailed view of the lead and stylet system with the stereotactic frame, in accordance with some embodiments. DETAILED DESCRIPTION [0051] A lead and stylet system and method for implanting the lead using the stylet is described herein. The stylet body and lead may be used during a deep brain stimulation (DBS) ny-2750764.1 Attorney Docket No.: 78895-20033.40 implantation procedure to implant a lead of a suitable length for a cranially mounted pulse generator (e.g., an implantable pulse generator, or IPG) into the brain. As discussed herein, the length of the lead may be shorter than that used in DBS systems comprising an IPG implanted in the chest. The stylet of the lead and stylet system described herein may facilitate proper implantation of the shorter lead into the brain by disposing the distal portion of the stylet body in a lumen of the lead. Moreover, a proximal portion of the stylet body can attach to a depth stop that engages with a stereotactic frame and/or cannula inserted in the brain to indicate a proper insertion depth of the electrodes in the brain. [0052] The DBS system discussed herein may include a cranially mounted IPG rather than an IPG implanted in the chest of the patient, thus negating the need for long leads and/or extension wires that are tunneled between the skull and chest. The cranially mounted IPG can also reduce the number of surgical sites necessary to implant the DBS system, which also can also reduce the amount of time expended during the DBS implantation procedure. Attempting use of these long leads with a cranially mounted IPG, for example, by bundling the excess lead length at the implantation site within a pocket in the scalp, can cause scalp erosion, thus necessitating a system with a shorter lead length. The shorter lead length can also result in more efficient power transfer during deep brain stimulation than longer leads used in DBS systems with chest mounted IPGs. However, the shorter lead length may leave a minimal length of lead external to the skull that does not extend to the stereotactic frame for proper alignment and placement. Thus, the stylet provided herein can be fed into the lumen of the lead at a distal portion of the stylet body and attach with a depth stop that contacts the stereotactic frame to properly align and place the lead. [0053] FIGS.1A-1B illustrate a system 100 for implanting electrodes in the brain, the system 100 comprising a lead 102 and a stylet body 104. Lead 102 may comprise a lumen 108 and one or more electrodes 106 disposed on the lead. The lead 102 may be a stimulation lead, a sensing lead, or a combination lead (e.g., a lead that can both sense and stimulate). Stylet body 104 may comprise a distal portion 110 and a proximal portion 112, the distal portion 110 configured to be removably housed in lumen 108. For example, a length of lead 102 may extend from an end of distal portion 110 of stylet body 104 to a midpoint within distal portion 110 of stylet body 104. The proximal portion 112 may be configured to be removably attached to a depth stop (e.g., ny-2750764.1 Attorney Docket No.: 78895-20033.40 depth stop 200 illustrated at least in FIGS. 2A-2B). Each of the stylet body 104 and lead 102 are described in greater detail below. Stylet Body [0054] As shown at least in FIGS. 1A-1B, stylet body 104 may comprise a proximal portion 112 comprising a first diameter and a distal portion 110 comprising a second diameter. The first diameter and second diameter may be substantially the same, or the first diameter and second diameter may be different (as shown). In some embodiments, rather than different diameter measurements, the cross-sectional shape of the proximal portion 112 and the distal portion 110 of stylet body 104 may be different. For example, the cross-sectional shape of one or more portions of stylet body 104 may be a square, circle, ellipse, rectangle, triangle, curvilinear triangle, or another polygonal shape. [0055] In some embodiments, the first diameter of proximal portion 112 of stylet body 104 may be less than or equal to 3 mm, 2.75 mm, 2.5 mm, 2.25 mm, 2 mm, 1.75 mm, or 1.5 mm. In some embodiments, the first diameter of proximal portion 112 of stylet body 104 may be greater than or equal to 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. The first diameter of the proximal portion 112 may be less than or equal to the diameter of the depth stop (e.g., the diameter of a receiving portion 202 of depth stop 200, shown at least in FIGS. 2A-2B). [0056] In some embodiments, the second diameter of distal portion 110 of stylet body 104 may be less than or equal to 1.5 mm, 1.25 mm, 1.0 mm, 0.75 mm, or 0.5 mm. In some embodiments, the second diameter of distal portion 110 of stylet body 104 may be greater than or equal to 0.1 mm, 0.25 mm, 0.5 mm, or 0.75 mm. The second diameter of the distal portion 110 of stylet body 104 may be less than or equal to the diameter of the lead lumen 108, such that the distal portion 110 may be removably inserted into the lumen 108. [0057] In some embodiments, the length of stylet body 104 may be less than or equal to 5 cm, 10 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, or 60 cm. In some embodiments, the length of stylet body 104 may be greater than or equal to 5 cm, 10 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, or 60 cm. In some embodiments, stylet body 104 may be selected such that the length of distal portion 110 is greater than or equal to the length of a selected lead 102 for a given patient. [0058] In some embodiments, distal portion 110 may comprise approximately half of the length of stylet body 104, and proximal portion 112 may comprise the other approximate half of ny-2750764.1 Attorney Docket No.: 78895-20033.40 the length of stylet body 104. For example, distal portion 110 may comprise about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more of the length of stylet body 104, whereas proximal portion 112 may comprise the remaining about 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% of the length of stylet body 104. [0059] In some embodiments, stylet body 104 may be manufactured from one or more biocompatible materials. For example, stylet body 104 may comprise one or more biocompatible materials including but not limited to polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium (e.g., nickel titanium), a mixture of polymers, a mixture of medical-grade metals, or a mixture of polymers and medical-grade metals. In some embodiments, distal portion 110 may comprise a first mixture of materials (e.g., one or more materials) and proximal portion 112 may comprise a second mixture of materials (e.g., one or more materials) different from the first mixture of materials. For example, distal portion 110 may comprise one or more medical-grade metals (e.g., stainless steel, titanium, etc.) and proximal portion 112 may comprise one or more polymers (e.g., PC, PEEK, PPSU, PET, etc.). In another example, distal portion 110 may comprise a mixture of medical-grade metals and polymers, such as one or more medical-grade metals coated with one or more polymers. [0060] In some embodiments, the material(s) of stylet body 104 may be selected such that stylet body 104 is sterilizable and can be reused for multiple lead stimulation implantation procedures. For example, stylet body 104 may be sterilizable using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and/or other sterilization methods (e.g., chlorine dioxide gas, vaporized peracetic acid, nitrogen dioxide, etc.). Lead [0061] Lead 102 may be configured to provide artificial electrical current to a region of the brain via one or more electrodes 106 disposed on the lead. For example, lead 102 may comprise an array of electrodes 106 disposed at least at the distal end of lead 102. In some embodiments, a plurality of electrodes may be disposed along at least a portion of the length of the lead. The electrodes 106 may comprise segmented electrodes configured to direct current to a specific location and/or in a specific direction. Segmented electrodes may introduce benefits over, for example, solid ring electrodes which are axisymmetric in geometry and therapy. 9 ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0062] As shown at least in FIGS.1A-1D, lead 102 may additionally comprise one or more electrical contacts 109. Electrical contacts 109 may be configured to electrically couple with an implantable pulse generator (IPG) to be implanted in the skull. For example, the IPG may comprise a receiving portion configured to receive and connect to electrical contacts 109. Therefore, when implanted, the IPG can generate stimulation pulses that can be provided to electrical contacts 109, and the stimulation pulses can travel within lead 102 (e.g., via one or more extension wires electrically connecting electrical contacts 109 and electrodes 106) to electrodes 106. Electrodes 106 can then stimulate the region of the brain in which electrodes 106 are implanted with the stimulation pulses. [0063] As mentioned above and shown at least in FIG.1D, lead 102 may comprise a lumen 108 configured to removably house distal portion 110 of stylet body 104. Lumen 108 may be a through-hole extending through at least a portion of the length of lead 102. For example, lumen 108 may extend from a proximal end of lead 102 toward a distal end of lead 102. The proximal end may be configured to initially receive stylet body 104. Lumen 108 may not extend through the distal end of lead 102, such that when distal portion 110 of stylet body 104 is inserted into lead 102, it can be inserted until reaching a midpoint within lead 102 at which lumen 108 ends. In some embodiments, lumen 108 may comprise about 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% of the length of lead 102. [0064] The cross-sectional shape of lumen 108 may be substantially the same as that of the distal portion 110 of stylet body 104. For example, in the instance the cross-section of lumen 108 is circular in shape, the diameter of lumen 108 may be less than or equal to 1.5 mm, 1.25 mm, 1.0 mm, 0.75 mm, or 0.5 mm. In some embodiments, the diameter of lumen 108 may be greater than or equal to 0.25 mm, 0.5 mm, 0.75 mm, or 1 mm. [0065] The length of lead 102 may extend from an electrode implantation site in the brain to an IPG implantation site in the skull with minimal excess lead length. Thus, the length may be shorter than a lead of a deep brain stimulation (DBS) system comprising a pulse generator implanted in the chest. For example, the length of lead 102 may be less than or equal to 50 cm, 40 cm, 30 cm, 20 cm, 15 cm, 10 cm, 5 cm, or 1 cm. In some embodiments, the length of lead 102 may be greater than or equal to 0.5 cm, 1 cm, 5 cm, 10 cm, 15 cm, or 20 cm. The lead 102 may be selected such that the length of the lead corresponds with one or more measurements of a patient. Thus, different length leads 102 may be used for different patients. The length of lead ny-2750764.1 Attorney Docket No.: 78895-20033.40 102 may be less than that of stylet body 104 such that lead 102 does not engage with a proximal end of stylet body 104. For example, as discussed herein, lead 102 may span from an end of distal portion 112 of stylet body 104 to a midpoint within distal portion 112 of stylet body 104. FIG.3 illustrates an assembly 300 in which stylet body 104 is removably inserted within lumen 108 of lead 102. [0066] Lead 102 may comprise one or more biocompatible materials to allow the lead to be safely implanted into the brain of a patient. The technical features and materials of lead 102 are not intended to be limited to the disclosure provided herein and rather may encompass any one or more features of leads known to one of ordinary skill in the art. Lead, Stylet, and Depth Stop Assembly [0067] As discussed herein, stylet body 104 may be configured to be removably attached to a depth stop. For example, stylet body 104 may attach directly to a depth stop (e.g., rather than a lead). In some embodiments, the stylet body 104 may attach indirectly to a depth stop (e.g., the lead may attach to the depth stop). FIGS. 2A-2B illustrate an exemplary depth stop 200 configured to be removably attached to stylet body 104. As shown, depth stop 200 may comprise a receiving portion 202 (e.g., a through-hole) configured to receive at least the proximal portion 112 of stylet body 104. For example, FIG. 3 illustrates an assembly 300 in which depth stop 200 is attached to proximal portion 112 of stylet body 104. [0068] Depth stop 200 may comprise an opening such that a user can removably insert stylet body 104 into the receiving portion 202 of depth stop 200. For example, depth stop 200 may comprise a semi-annular-shaped body, and the opening within the annular shape may be sized such that stylet body 104 can be removably inserted through the opening. [0069] As shown in FIG.2B, depth stop 200 may comprise a fastener 204 that can engage with stylet body 104 when inserted within receiving portion 202 of depth stop 200 to maintain a position of depth stop 200 on stylet body 104. The user may rotate, turn, push, and/or pull a knob 206 coupled to fastener 204 to translate fastener 204 into/out of receiving portion 202. For example, fastener 204 may comprise threads that allow for fine adjustment of fastener 204 by rotating knob 206. In some embodiments, fastener 204 may be translatable between two or more positions (e.g., a locked position and an unlocked position), and the user may engage with knob ny-2750764.1 Attorney Docket No.: 78895-20033.40 206 (e.g., by rotating, pushing, pulling, and/or turning knob 206) to translate fastener 204 between the two or more positions. [0070] In some embodiments, depth stop 200 may be configured to clamp to a stylet wire rather than stylet body 104. [0071] In some embodiments, the lead and stylet system 100 as described herein may be provided as components of a deep brain stimulation system. For example, the deep brain stimulation system may comprise at least lead 102 and stylet body 104 as discussed herein, as well as a pulse generator configured to be implanted in a skull and coupled to lead 102. In some embodiments, depth stop 200 may be included in the deep brain stimulation system. Nonetheless, it is to be understood by one of ordinary skill in the art that the lead and stylet system described herein is not limited to deep brain stimulation (DBS) systems with cranially mounted pulse generators and may be used and/or adapted for use in other systems, including but not limited to other DBS systems in which the IPG may be implanted elsewhere on the human body (other than the skull). Method of Using the Lead and Stylet System [0072] As discussed herein, the lead and stylet system 100 may be used to implant electrodes (e.g., electrodes 106) into the brain. For example, electrodes 106 may be implanted to perform deep brain stimulation. A method for implanting electrodes 106 into a brain may comprise attaching a depth stop 200 to a proximal portion 112 of a stylet body 104. For example, depth stop 200 may be attached to stylet body 104 at a position along a length of proximal portion 112 that can correspond to a predetermined depth in the brain to which lead 102 is inserted. [0073] In some embodiments, the method may comprise inserting distal portion 110 of stylet body 104 into lumen 108 of lead 102. In some embodiments, lead 102 and stylet body 104 may be provided to a user assembled, such as is illustrated with assembly 300 in FIG.3. The length of lead 102 may span from an end of distal portion 110 of stylet body 104 to a midpoint within distal portion 110 of stylet body 104. [0074] In some embodiments, the method may include generating a resection (e.g., a burr hole) in the surface of the skull at a predetermined location corresponding to an intended electrode implantation site in the brain. ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0075] In some embodiments, the method may comprise mounting a stereotactic frame on a skull. For example, FIGS. 4A-4B illustrate an exemplary stereotactic frame 400 that can be mounted on the skull. Mounting stereotactic frame 200 may include adjusting the position of the frame in one or more axes (e.g., X, Y, and Z labeled on stereotactic frame 400 illustrated in FIG. 4). In some embodiments, stereotactic frame 400 may already be mounted on the skull, such that the method may not include mounting the frame to the skull. [0076] Stereotactic frame 400 may comprise a holder 402 configured to receive stylet body 104 and maintain a position of stylet body 104 (inserted in lead 102) while inserting lead 102 to the brain. For example, as shown in FIG. 4B, holder 402 may comprise a receiving portion 404 (e.g., a through-hole) configured to receive stylet body 104. [0077] Stereotactic frame 400 (e.g., one or more moveable components of stereotactic frame 400) may be positioned such that holder 402 can be aligned with an implantation site in the skull. For example, holder 402 may be positioned superior to the implantation site on the skull at a distance from the implantation site. The position of holder 402 may be modified in one or more planes relative to stereotactic frame 400. As shown in FIG.4, the position of holder 402 may be adjustable in one or more directions represented by arrow 406, arrow 408, and/or arrow 410 in FIG.4. [0078] In some embodiments, the method may include inserting a cannula to a predetermined depth in the brain. For example, the cannula may be inserted through a burr hole generated in the surface of the skull and into the brain. The cannula may be used to generate an opening within the brain to facilitate lead implantation. One or more of the example stereotactic frame systems discussed herein may be used in conjunction with a cannula. [0079] The method may include inserting distal portion 110 of stylet body 104 removably housed in lumen 108 of lead 102 into the brain. For example, distal portion 110 removably housed in lead 102 may be inserted through holder 402 and into the brain (e.g., via a burr hole in the skull) until depth stop 200 contacts holder 402. For example, as shown at least in FIG.4B, depth stop 200 may contact a proximal surface of holder 402 when the lead 102 and stylet body 104 assembly is inserted through receiving portion 404 of holder 402 and to a predetermined depth in the brain. The position at which depth stop 200 on stylet body 104 contacts holder 402 may signify an appropriate implantation depth of electrodes 106 disposed on lead 102. ny-2750764.1 Attorney Docket No.: 78895-20033.40 [0080] In the instance a cannula as discussed herein has been previously inserted into the brain, distal portion 110 of stylet body 104 (removably housed in lumen 108 of lead 102) may be inserted through the cannula and into the brain. The distal portion 110 of stylet body 104 may be inserted into the brain until depth stop 200 attached to proximal portion 112 of stylet body 104 contacts the cannula inserted in the brain. For example, depth stop 200 may contact a proximal end of the cannula. The position at which depth stop 200 on stylet body 104 contacts the proximal end of the cannula may signify an appropriate implantation depth of electrodes 106 disposed on lead 102. [0081] The position of depth stop 200 on proximal portion 112 of stylet body 104 may be selected such that when the distal portion 110 of stylet body 104 removably housed in lead 102 is inserted into the brain until the depth stop contacts holder 402 (or in some embodiments a cannula), approximately 40% and 80% of lead 102 can be disposed external to the skull. In some embodiments, about 20%, 30%, 40%, 50%, 60%, 70%, or 80% of lead 102 may be disposed external to the skull upon proper implantation of the lead in the brain. [0082] Once the stylet body 104 and lead 102 is inserted to a predetermined depth in the brain, the method may include removing distal portion 110 from lumen 108 of lead 102, thereby leaving behind at least the portion of lead 102 comprising the one or more electrodes 106 implanted in the brain. For example, a user may remove distal portion 110 of stylet body 104 from lumen 108 of lead 102, and subsequently may remove stylet body 104 from holder 402 of stereotactic frame 400. [0083] In some embodiments, prior to removing the distal portion 110 of stylet body 104 from lumen 108 of lead 102, the method may comprise securing lead 102 to an external surface of the skull. In some embodiments, securing lead 102 to the skull may occur following removal of stylet body 104 from lead 102. Lead 102 may be secured to the external surface of the skull at a location proximate to a burr hole in the skull from which lead 102 (and optionally stylet body 104) exits. For example, a lead fixation device may be used to secure a portion of lead 102 to the skull at a location adjacent to the burr hole. The lead fixation device may be used to secure the lead 102 to the skull prior to removing stylet body 104 from lumen 108 and/or prior to removal of stereotactic frame 400, as described herein. [0084] The method may include removing stereotactic frame 400 from being mounted on the skull following removal of stylet body 104 from lumen 108 of lead 102 and holder 402 of ny-2750764.1 Attorney Docket No.: 78895-20033.40 stereotactic frame 400. In some embodiments, stereotactic frame 400 and/or depth stop 200 may be removed prior to removal of stylet body 104 from lumen 108 of lead 102. [0085] In the instance a cannula has been inserted into the brain, the method may comprise removing the cannula from the brain following removal of stylet body 104 from lumen 108 of lead 102. For example, the cannula may comprise a peel-away cannula, which is partially split in two pieces axially such that the cannula can be separated and removed while the lead 102 is held in place with stereotactic frame 400. Once the lead 102 is fixated to the skull, the stereotactic frame 400 and stylet body 104 can be removed. [0086] In some embodiments, the method may include connecting lead 102 with an implantable pulse generator (IPG). As discussed herein, lead 102 may comprise one or more electrical contacts 109 on a proximal portion of the lead, and the one or more electrical contacts 109 may be connected with an IPG configured to be mounted in or on the skull. In some embodiments, the method may include generating a resection in the skull that may be configured to receive a cranially mounted IPG. The resection may be generated prior to implanting lead 102 in the skull. The method may include implanting the IPG into the resection in the skull. [0087] As discussed herein, the use of lead 102 and/or stylet body 104 may not be limited to deep brain stimulation (DBS) systems comprising cranially mounted IPGs. For example, lead 102 and/or stylet body 104 may be used in DBS implantation procedures in which the IPG is mounted elsewhere in the human body (e.g., in the chest). Thus, in these instances, the method may include connecting lead 102 with one or more extension leads electrically connected with an IPG. The method may also include preparing an additional implantation site, such as in the chest, and implanting the IPG in the chest. [0088] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art. [0089] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and/or” as used herein refers to and encompasses any and all possible ny-2750764.1 Attorney Docket No.: 78895-20033.40 combinations of one or more of the associated listed items. It is further to be understood that the terms “includes, “including,” “comprises,” and/or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and/or units but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and/or groups thereof. [0090] The numerical ranges disclosed inherently support any range or value within the disclosed numerical ranges, including the endpoints, even though a precise range limitation is not stated verbatim in the specification because this disclosure can be practiced throughout the disclosed numerical ranges. [0091] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated. [0092] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims. ny-2750764.1

Claims

Attorney Docket No.: 78895-20033.40 CLAIMS What is claimed is: 1. A system for implanting electrodes in a brain, comprising: a lead comprising a lumen and one or more electrodes disposed on the lead; and a stylet body comprising a distal portion and a proximal portion, wherein the distal portion is configured to be removably housed in the lumen such that a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and the proximal portion of the stylet body is configured to be removably attached to a depth stop. 2. The system of claim 1, wherein a position of the depth stop attached along a length of the proximal portion of the stylet body corresponds to a predetermined depth in the brain to which the lead is to be inserted. 3. The system of claim 1 or 2, wherein the predetermined depth in the brain disposes between 40% and 80% of a length of the lead external to a skull. 4. The system of any one of claims 1-3, comprising the depth stop. 5. The system of claim 4, wherein the depth stop is configured to contact a proximal surface of a holder of a stereotactic frame to stop the insertion of the lead into the brain at the predetermined depth. 6. The system of claim 4 or claim 5, wherein the depth stop is configured to contact a proximal end of a cannula inserted into the brain to stop the insertion of the lead into the brain at the predetermined depth. 7. The system of any one of claims 1-6, wherein the proximal portion of the stylet body comprises a first diameter and the distal portion of the stylet body comprises a second diameter different from the first diameter. ny-2750764.1 Attorney Docket No.: 78895-20033.40 8. The system of claim 7, wherein the first diameter is less than or equal to a diameter of the depth stop such that the depth stop can be removably secured to the proximal portion of the stylet body. 9. The system of claim 7 or 8, wherein the second diameter is less than or equal to a diameter of the lumen such that the distal portion of the stylet body can be removably inserted into the lumen. 10. The system of any one of claims 1-9, wherein the stylet body comprises a length between 10 cm and 50 cm. 11. The system of claim 10, wherein the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body. 12. The system of any one of claims 1-11, wherein a cross-section of the proximal portion of the stylet body and/or a cross-section of the distal portion of the stylet body is a square, circle, ellipse, rectangle, triangle, or curvilinear triangle. 13. The system of claim 12, wherein the cross-section of the proximal portion comprises a first geometric shape and the cross-section of the distal portion comprises a second geometric shape different from the first geometric shape. 14. The system of any one of claims 1-13, wherein the stylet body comprises one or more biocompatible materials. 15. The system of claim 14, wherein the proximal portion of the stylet body comprises a first biocompatible material and the distal portion of the stylet body comprises a second biocompatible material different from the first biocompatible material. 16. The system of claim 14 or 15, wherein the one or more biocompatible materials comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), ny-2750764.1 Attorney Docket No.: 78895-20033.40 polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals. 17. The system of any one of claims 12-16, wherein the stylet body is sterilizable, such that the stylet body is reusable. 18. A deep brain stimulation system, comprising: the system of any one of claims 1-17; and a pulse generator configured to be implanted in or on a skull and coupled to the lead. 19. A method for implanting electrodes into a brain, the method comprising: attaching a depth stop to a proximal portion of a stylet body; inserting a distal portion of the stylet body removably housed in a lumen of a lead into the brain, wherein a length of the lead spans from an end of the distal portion of the stylet body to a midpoint within the distal portion of the stylet body, and wherein a portion of the lead comprises one or more electrodes; and removing the distal portion of the stylet body from the lumen of the lead inserted into the brain, thereby leaving behind at least the portion of the lead comprising the one or more electrodes in the brain. 20. The method of claim 19, wherein attaching the depth stop to the proximal portion of the stylet body comprises attaching the depth stop at a position along a length of the proximal portion that corresponds to a predetermined depth in the brain to which the lead is inserted. 21. The method of claim 19 or 20, comprising, prior to inserting the distal portion of the stylet body into the brain, mounting a stereotactic frame on a skull such that a holder of the stereotactic frame is aligned with an implantation site in the skull. 22. The method of claim 21, wherein the distal portion of the stylet body is inserted through the holder of the stereotactic frame and into the brain until the depth stop contacts a proximal surface of the holder. ny-2750764.1 Attorney Docket No.: 78895-20033.40 23. The method of claim 21 or 22, wherein removing the distal portion of the stylet body from the lumen of the lead comprises removing the stylet body from the holder of the stereotactic frame. 24. The method of any one of claims 20-23, comprising removing the stereotactic frame from being mounted on the skull following removal of the stylet body from the lumen of the lead and the holder of the stereotactic frame. 25. The method of any one of claims 19-24, comprising, prior to inserting the distal portion of the stylet body into the brain, inserting a cannula to the predetermined depth in the brain. 26. The method of claim 25, wherein the distal portion of the stylet body is inserted through the cannula and into the brain until the depth stop contacts a proximal end of the cannula inserted in the brain. 27. The method of claim 25 or 26, comprising removing the cannula from the brain following removal of the stylet body from the lumen of the lead. 28. The method of any one of claims 19-27, comprising, prior to removing the stylet body from the lumen of the lead, securing the lead to an external surface of a skull. 29. The method of claim 28, wherein the lead is secured to the external surface of the skull at a location proximate to a burr hole in the skull from which the lead exits. 30. The method of any one of claims 19-29, comprising, prior to inserting the distal portion of the stylet body into the brain, inserting the distal portion into the lumen of the lead. 31. The method of any one of claims 19-30, comprising positioning the depth stop on the proximal portion of the stylet body such that between 40% and 80% of a length of the lead is disposed external to a skull when the distal portion of the stylet body is inserted to a predetermined depth in the brain. 32. The method of claim 31, wherein the length of the lead is less than the length of the stylet body, such that the lead does not engage with a proximal end of the stylet body. ny-2750764.1 Attorney Docket No.: 78895-20033.40 33. The method of any one of claims 18-32, comprising generating a resection in a skull configured to receive an implantable pulse generator (IPG) and implanting the IPG in the resection. 34. The method of claim 33, comprising, after inserting the lead to the brain, connecting the implantable pulse generator with one or more electrical contacts disposed on a proximal portion of the lead. ny-2750764.1
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US12357835B2 (en) 2020-01-03 2025-07-15 Iota Biosciences, Inc. Ultrasound-based protocol for operating an implantable device

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DE19938549A1 (en) * 1999-08-18 2001-02-22 Uwe Thomas Microprobe system used in neurophysiology and neurosurgery comprises a self-bearing device, a microfiber electrode and a macro-therapy electrode
US7809446B2 (en) * 2005-01-05 2010-10-05 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US8968331B1 (en) * 2010-04-24 2015-03-03 Jerzy Roman Sochor Implantable lead and surgical accessories
US20160121103A1 (en) * 2014-11-03 2016-05-05 Boston Scientific Neuromodulation Corporation Electrical stimulation system with anchoring stylet and methods of making and using

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US12357835B2 (en) 2020-01-03 2025-07-15 Iota Biosciences, Inc. Ultrasound-based protocol for operating an implantable device

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