US20230301596A1 - Pledget stimulation and recording electrodes assemblies - Google Patents
Pledget stimulation and recording electrodes assemblies Download PDFInfo
- Publication number
- US20230301596A1 US20230301596A1 US18/201,238 US202318201238A US2023301596A1 US 20230301596 A1 US20230301596 A1 US 20230301596A1 US 202318201238 A US202318201238 A US 202318201238A US 2023301596 A1 US2023301596 A1 US 2023301596A1
- Authority
- US
- United States
- Prior art keywords
- electrode
- electrode assembly
- pledget substrate
- pledget
- nerve
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6879—Means for maintaining contact with the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/388—Nerve conduction study, e.g. detecting action potential of peripheral nerves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
- A61B5/4064—Evaluating the brain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/40—Detecting, measuring or recording for evaluating the nervous system
- A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
- A61B5/407—Evaluating the spinal cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6838—Clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6877—Nerve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6879—Means for maintaining contact with the body
- A61B5/6882—Anchoring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
-
- 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
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0553—Paddle shaped electrodes, e.g. for laminotomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0558—Anchoring or fixation means therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
- A61B2505/05—Surgical care
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0475—Special features of memory means, e.g. removable memory cards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B2562/125—Manufacturing methods specially adapted for producing sensors for in-vivo measurements characterised by the manufacture of electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6848—Needles
Definitions
- the present technology is generally related to stimulation and recording electrode assemblies as well as methods of conducting an intraoperative tissue monitoring and/or stimulation procedure.
- Nerve monitoring is used in surgical procedures where nerves are at risk.
- a nerve integrity monitor and a hand held stimulator probe provide intermittent stimulation only when the surgeon probes the nerve. Nerves can be at risk, however, in between stimulations due to surgical incision “blind” trauma caused by manipulation and stretching during tumor removal, and cumulative trauma or damage that may result in neurapraxia.
- Automatic periodic stimulation APS
- CIONM Continuous Intraoperative Nerve Monitoring
- Intraoperative NIM nerve monitoring systems enable surgeons to identify, confirm, and monitor motor nerve function to help reduce the risk of nerve damage during various procedures including ENT and general surgeries.
- NIM® Nerve Monitoring System which includes an electromyographic (EMG) monitor for intraoperative use during various surgeries in which a nerve may be at risk due to unintentional manipulation.
- EMG electromyographic
- NIM nerve monitoring probes having electrodes are placed in the appropriate muscle locations in the patient for the procedure being performed. These electrodes are connected to the NIM Nerve Monitoring System, which continuously monitors EMG activity from muscles innervated by the affected nerve.
- EMG electromyographic
- the NIM® System warns the surgeon and operating room staff, providing both visual alerts on the color touchscreen monitor and audio feedback to help minimize trauma to the nerve.
- NIM® Nerve Monitoring System Surgeons can use monopolar and bipolar stimulating probes and dissection instruments with the NIM® Nerve Monitoring System to assist in early nerve identification and confirmation. These tools may be used to locate, identify, and map the particular nerve and branches, as well as verify nerve function and integrity to help surgeons perform critical procedures while preserving nerve function and improving patient safety.
- the present disclosure provides improvements associated with the related art.
- aspects of this disclosure generally relate to stimulation and/or recording electrode assemblies that can be affixed to bioelectric tissue, such as a nerve, without the use of adhesive.
- aspects of the disclosure are related to stimulation and/or recording electrode assemblies and systems that are particularly useful for Automatic Periodic Stimulation (APS). Such embodiments are compatible with nerve monitoring systems to provide continuous stimulation of a nerve during surgery. Disclosed embodiments are useful for evoked potential monitoring throughout the body including cranial and peripheral and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
- APS Automatic Periodic Stimulation
- Disclosed embodiments are useful for stimulation, biopotential recording, therapeutic stimulation and automatic periodic stimulation (APS) to nerves during evoked potential monitoring procedures including but not limited to: intracranial, extracranial, intratemporal, extratemporal, neck dissections, thoracic surgeries, and upper and lower extremities, degenerative treatments, pedicle screw procedures, fusion cages, rhizotomy, orthopedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures.
- APS automatic periodic stimulation
- an intraoperative electrode assembly having a pledget substrate made at least partially of a material that is hydrophilic as well as one or more electrodes supported by and positioned within the pledget substrate.
- the material is a rayon/polyethylene terephthalate blend.
- the electrode assembly further includes a lead wire assembly interconnected to each electrode.
- the lead wire assembly includes at an insulating jacket positioned around a wire core and the electrode assembly further including an insulating cup interconnecting the electrode and the insulating jacket. The cup may be configured to rotate about the pledget substrate.
- the pledget substrate includes two separable bodies, each including an electrode.
- aspects of the disclosure also include methods of conducting an intraoperative procedure.
- the methods include providing an electrode assembly including, a pledget substrate having a first surface that is hydrophilic, one or more electrodes supported by and positioned within the pledget substrate, and a lead wire assembly interconnected to the electrode(s).
- the method continues by creating an incision to access tissue of a patient and applying the pledget substrate to the tissue.
- the one or more electrodes can be activated.
- Activating the electrode(s) can include recording bioelectric responses of the tissue sensed from the electrode(s).
- activating the electrode(s) can include stimulation of bioelectric tissue applied from the electrode(s).
- the disclosed embodiments provide for continuous intraoperative monitoring in current and new procedures that place nerves at risk without extra dissection or wrapping of the electrode assembly around the entirety of the respective nerve. In this way, the disclosed embodiments are more easily applied to a nerve, thus requiring less skill (either actual or perceived) from the clinician.
- FIG. IA is a perspective top view of one embodiment of an electrode assembly.
- FIG. IB is a perspective bottom view of the electrode assembly of FIG. IA
- FIG. IC is a cross-sectional view of the electrode assembly of FIG. IA-IB .
- FIG. ID is an additional perspective view of the electrode assembly of FIG. IA-IC .
- FIG. 2 A is a perspective top view of another embodiment of an electrode assembly.
- FIG. 2 B is a perspective bottom view of the electrode assembly of FIG. 2 A .
- FIG. 2 C is a cross-sectional view of the electrode assembly of FIGS. 2 A- 2 B .
- FIG. 3 A is a perspective view of an electrode that can be used in the embodiments ofFIGS. 1A-2C.
- FIG. 3 B is an alternate perspective view of the electrode of FIG. 3 A .
- FIG. 4 A is a side view of a lead wire assembly that can be used in the embodiments of FIGS. 1 A- 2 C .
- FIG. 4 B is a perspective view of the lead wire assembly of FIG. 4 A .
- FIG. 5 is a cross-sectional view of a clip and a pin interconnected to the lead wire assembly such as that of FIGS. 4 A- 4 B .
- FIG. 6 is a perspective view of an alternate electrode assembly, which is largely similar to embodiments previously illustrated but wherein the electrode assembly includes two electrodes.
- FIG. 7 A is a top perspective view of an alternate electrode assembly.
- FIG. 7 B is a bottom perspective view of the electrode assembly of FIG. 7 A
- FIG. 7 C is cross-sectional view of the electrode assembly of FIG. 7 A
- FIG. 8 is a perspective view of a base material and hub of the electrode assembly of FIGS. 7 A- 7 C .
- FIG. 9 is a perspective view of an electrode of the electrode assembly of FIGS. 7 A- 7 C .
- FIG. 10 is a perspective view of a cup of the electrode assembly of FIGS. 7 A- 7 C .
- FIG. 11 is a schematic illustration of the electrode assembly of FIG. 1 wrapped around a 0.3 mm diameter nerve.
- FIG. 12 is a schematic view of an alternate electrode assembly.
- FIG. 13 is a schematic view of the electrode assembly of FIG. 12 operatively secured to thyroid cartilage.
- FIG. 14 is a partial, schematic illustration of a pledget substrate including apertures in which sutures and/or staples can be inserted to secure the pledget substrate to a tissue.
- FIG. 15 is a partial, schematic illustration of a pledget substrate including mirco hooks to secure the pledget substrate to tissue.
- FIG. 16 is a partial, schematic illustration of a pledget substrate including mirco needles to secure the pledget substrate to tissue.
- FIGS. 17 - 19 are a block diagrams of various systems of the disclosure suitable for stimulation and recording during thyroidectomy and neck dissection cancer surgeries.
- FIG. 20 is a block diagram of a system of the disclosure suitable for parotid surgery or scull base surgery continuous monitoring stimulation of a facial nerve.
- FIG. 21 is a block diagram of a system of the disclosure suitable for scull base surgery with an electrode assembly for continuous monitoring stimulation of a facial nerve and an electrode assembly for direct nerve monitoring of an 8 th cranial nerve.
- Nerve monitoring is used in surgical procedures where nerves are at risk.
- a system including a nerve integrity monitor and a hand held stimulator probe having an electrode provides intermittent stimulation only when the surgeon probes the nerve. Nerves can be at risk, however, in between stimulations due to surgical incision “blind” trauma caused by manipulation and stretching during tumor removal, and cumulative trauma or damage that may result in neuropraxia.
- Automatic periodic stimulation APS
- CIONM continuous intraoperative nerve monitoring
- the electrode provides continuous, periodic stimulation of nerve used for trending amplitude and latency in real time which includes adjustable alarm limits for significant baseline changes. This early warning helps alert the surgeon to stop surgical trauma as most injury is immediacy reversible but can become permanent if prolonged.
- aspects of the disclosure relate to pledget stimulation and recording electrode assemblies that are particularly useful with APS, for example.
- Such embodiments are compatible with nerve monitoring systems to provide continuous nerve stimulation during a surgical procedure.
- Two compatible nerve monitoring system include NIM Eclipse® (Part number 945NCCPUE4), NIM-Response® 3.0 (Part number 8253001) and NIM-Neuro® 3.0 nerve (part number 8253401) monitoring systems all available from Medtronic, Inc. of Minneapolis, Minnesota.
- the disclosed electrode assemblies are particularly useful for monitoring a facial nerve at a main trunk in head and neck procedures, as well as the facial nerve in lateral skull base procedure (LSB) procedures.
- the electrode assembly can be used for short procedures less than 24 hours or implanted in the patient longer than 24 hours.
- An electrode surface of the electrode assembly maybe coated to deliver a drug during contact or enhanced treatment such as through electro-paresis.
- Other disclosed embodiments are particularly useful for thyroid laryngeal monitoring without an electromyogram (EMG) endotracheal tube.
- EMG electromyogram
- Such an electrosurgical endotracheal tube is disclosed in Mcfarlin et al., U.S. Pat. Application No. 16/108,682, filed Aug. 22, 2018, the entire contents of which are herein incorporated by reference in its entirety.
- the electrode assemblies of the disclosure can be used in evoked potential intraoperative monitoring systems during surgical procedures and are an alternative which simplifies stimulation of tissue over current methods including cuffed APS electrodes or needle electrodes used for stimulation.
- the electrode assemblies of the present disclosure simplify recording of tissue over such current methods.
- the electrode assembly 10 includes one or more electrodes 12 supported by and positioned within a pledget substrate 14 with one or more spacers 16 , 18 .
- the one or more electrodes 12 are evoked potential monitoring electrodes.
- the electrode assembly 10 further includes a lead wire assembly 20 including at least one insulating jacket 22 positioned around a wire core 26 .
- the electrode 12 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode.
- two electrodes can be provided to provide bipolar stimulation or recording and is configured to communicate electrical stimulus to tissues and thus must provide the appropriate surface area for contacting tissue for the current density.
- the material in which the electrode 12 is formed or surface treatment (not shown) provided on the electrode 12 at the base 30 (or interface at which the electrode 12 contacts the nerve or other bioelectric tissue) can be selected to enhance the bioelectric interface to tissue via selection of such preferred base metals, sintering to increase surface area, or plaiting.
- Suitable material examples for the electrode 12 at the interface or base 30 include stainless steel, copper, gold, iridium, palladium, platinum, rubidium, ruthenium, silver, conductive plastics or inks.
- Conductive plastics or inks can be used on the surface of the top 32 or base 30 to enhance conductions delivery to the tissue.
- a conductive ink may have about 40-60% conductive silver particles with polyvinylchloride (PVC) particles with a solvent that evaporates to dry the ink on a surface of the electrode 12 .
- Conductive plastic constructed of conductive particles and polymeric particles are fused together to form a conductive plastic.
- the electrode 12 is also configured to allow for crimping and strain relief of the lead wire assembly 20 .
- the electrode 12 can be configured to include a base 30 , a top 32 , and an axle 34 interconnecting the top 32 and the base 30 . Such features capture the spacers 16 , 18 and pledget substrate 14 .
- the top 32 can include a domed portion 36 interconnected to a flanged portion 38 extending outwardly with respect to the domed portion 36 and the axle 34 .
- the top 32 includes first and second channels 40 , 42 , which are configured to retain portions of the lead wire assembly 20 .
- the first channel 40 is positioned within the domed portion 36 and can be crimped to the exposed wire core 26 proximate the top 32 using a single point crimp.
- the second channel 42 can be used to provide strain relief within the wire core 26 and can optionally be positioned to extend within the flanged portion 38 .
- the top 32 is configured to provide a low profile wire core 26 interface.
- the first channel 40 is configured to retain both the jacket 22 and the wire core 26 and the second channel 42 is configured to retain only the wire core 26 .
- the electrode 12 can be made of an adhesive compatible material or can otherwise provide an adhesive compatible surface so that the wire core 26 can be secured to the top 32 of the electrode 12 with adhesive (not shown).
- the base 30 can optionally contain or have applied thereto a bioactive agent or therapeutic (drug or anesthetic) which delivery can be enhanced by iontophoresis.
- bioactive agents include, but are not limited to, steroids dexamethasone, and methylprednisolone or anesthetic agents such as lidocaine xylocaine epinephrine.
- the electrode 12 can aid in applying such local drug or anesthetics to selected locations which the electrode 12 (coupled with a current return electrode) delivers the externally applied potential difference where the movements of ions across a membrane enhanced using for therapeutic purposes.
- the electrode 12 can optionally be selectively electrically insulated.
- the electrode 12 can be coated in an insulator completely (e.g., using chemical vapor deposition). This coating can then be selectively removed (e.g., using a laser) to expose desired areas.
- the electrode 12 can be masked and then an insulating coating can be applied.
- the pledget substrate 14 includes a round shaped body 50 of material that affixes from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve/tissue under wet conditions.
- the pledget substrate 14 is configured to interface with nerves within the range of about 1 mm to about 4 mm. Further, the pledget substrate 14 is free to rotate with respect to both of the wire core 26 of the lead wire assembly 20 and the electrode 12 .
- the body 50 is made of a porous material to allow for suction of fluids and may be provided with a coating (not visible) including of an aqueous solution of binder, water and a surfactant, which ties down the surface fibers of the body 50 and eliminates fraying of the body 50 while providing additional strength to the body 50 for its application to bioelectric tissue.
- the coating can further include a pigment to provide chromatic differentiation of a stimulation or nerve side of the pledget substrate 14 .
- a first side 52 of the body 50 can include a coating of a first color
- a second side 54 of the body 50 can include a coating of a second color or, alternatively, no color.
- the tissue/stimulating side 54 coating may be hydrophilic while the, opposing, side 52 of the pledget substrate 14 may have a hydrophobic coating to enhance electrical current steering.
- the body 50 be made of a lint-free material that maintains a high degree of absorbency.
- a suitable material for the body 50 is spunbond rayon (about 0.33 mm thick).
- Other suitable materials include rayon/ polyethylene terephthalate (PET) blends and PET/viscose blends, for example. Tests evaluating suitable materials for the pledget substrate 14 , and any alternate pledget substrates disclosed herein, are further discussed below with respect to Tables 5-14.
- the lead wire assembly 20 can optionally further include a sleeve 23 as is visible in FIG. ID .
- the sleeve 23 can be made of a material such as cotton or the like, which allows the clinician to stick the lead wire assembly 20 to a portion of a patient’s anatomy (not shown).
- the sleeve 23 can be optionally slidable along a length a of the jacket 22 so that the sleeve 23 can be selectively positioned at a portion along the jacket 22 , wetted with water or the like, and then pressed onto the anatomy to facilitate adhesion of the sleeve 23 (and thus adhesion of the lead wire assembly) to the anatomy.
- the lead wire assembly 20 additionally includes a connector 25 configured to be connected to a nerve monitoring system such as those disclosed herein, for example, configured to activate the electrode(s) 12 to record bioelectric responses of the tissue sensed from the electrode 12 (see also, FIGS. 17 - 21 ). In alternate embodiments, stimulation ofbioelectric tissue from the electrode(s) 12 .
- an electrode assembly 10 ′ of the present disclosure need not include a pledget substrate 14 ′ including a body 50 ′ having a round shape and can have an alternate shape, such as a square shape. Other shapes, including irregular shapes, are envisioned. As indicated with like reference numerals referring to like features as described herein, all other aspects of the electrode assembly 10 ′ can be configured similarly and operate in ways described above with respect to the embodiment 10 of FIG. IA-IC except as explicitly stated.
- the electrode assembly IO of the disclosed embodiments can have two spacers 16 , 18 including the first spacer 16 and the second spacer 18 located on opposing sides of the pledget substrate 14 .
- the first spacer 16 includes an aperture (not clearly visible) through which the electrode 12 is positioned.
- the first spacer 16 can provide strain relief within the pledget substrate 14 and also provides electrical current directivity and insulation between the electrode axle 34 and pledget substrate 14 .
- the first spacer 16 is made of polyethylene.
- the second spacer 18 also defines an aperture (not clearly visible) through which the electrode axle 34 is positioned.
- the second spacer 18 can also provide strain relief within the pledget substrate 14 and provide for free rotation of the pledget substrate 14 about the electrode 12 as well as surface for adhesion of the body 50 .
- the second spacer 18 additionally provides electrical current directivity, chromatic differentiation of stimulating and nerve sides of the pledget substrate 14 , allows the electrode 12 and wire core 26 to rotate freely and can include a feature 60 , which enhances the ability to manipulate the electrode 12 .
- the feature 60 is a lip that can be grabbed by a standard surgical instrument.
- the second spacer 18 further includes a retaining structure 62 , such as a bowl, that can at least in part be defined by the feature 60 , to retain liquid adhesive (not shown) used to secure the top 32 of the electrode 12 to the wire core 26 after the adhesive dries or is cured.
- the second spacer 18 can be made of nylon.
- FIGS. 3 A- 3 B illustrate an alternate lead wire assembly 20 ′.
- the lead wire assembly 20 ′ is substantially similar to the lead wire assembly 20 discussed herein but instead of only including a single insulating jacket (e.g., jacket 22 ), the lead wire assembly 20 ′ includes an inner jacket 22 a , outer jacket 22 b surrounding the wire core 26 .
- Both of the inner and outer jackets 22 a , 22 b can optionally be provided to insulate the wire core 26 and to eliminate a potential need to splice the lead wire assembly 20 .
- the outer jacket 22 b can be at least partially stripped from the inner jacket 22 a .
- a release agent 28 such as silicone or the like can be applied between the inner and outer jackets 22 a , 22 b to prevent adhesion between the inner and outer jackets 22 a , 22 b .
- a length L of approximately 6 inches of the inner jacket 22 a will be exposed with respect to the outer jacket 22 b .
- the lead wire assemblies 20 , 20 ′ are malleable and pliable having a thread-like flexibility while having a high-tensile strength. In some embodiments, the lead wire assembly 20 , 20 ′ can support at least 0.5 lb. break strength.
- the inner and outer jackets 22 a , 22 b (or single jacket 22 ) provides electrical insulation to the wire core 26 and, in some embodiments, is or are collectively thin to maintain flexibility of the lead wire assembly 20 or jacket 22 , 22 a / 22 b .
- the jacket 22 or outer jacket 22 b is made of a low-reflectivity material such as polyvinyl chloride (PVC) and provides electrical insulation of 1000VC dielectric strength.
- PVC polyvinyl chloride
- the inner jacket can be made of polytetrafluoroethylene (PTFE), for example.
- the wire core 26 is malleable to retain a deformed shape and can optionally be made of 300 series stainless steel 40AWG single strand material.
- the j acket(s) 22 , 22 a , 22 b can be of a specific color, such as yellow to provide contrast with a patient’s anatomy.
- the lead wire assembly 20 , 20 ′ can further support electrical connections to the electrode 12 and/or APS system, for example, via a pin jack 70 or the like that provides the electrical communication a patient interface (not shown).
- the pin jack 70 can be protected for International Electrotechnical Commission 60601 compliance.
- a clip 80 can be secured to the lead wire assembly 20 ′ (or the lead wire assembly 20 in a similar fashion) to secure the lead wire assembly 20 ′ to an ear of the patient or, a sterile drape that covers the patient during surgery, for example, to provide strain relief
- the clip 80 can be configured to include two arms 82 , 84 that include a hinged connection 86 biased in the closed position.
- the hinged connection 86 can include a pin about which the two arms 82 , 84 can rotate.
- the two arms 82 , 84 can be spring biased into the closed position.
- the clip 80 includes a mounting block 88 that secures one arm 82 to the jacket 22 b .
- the mounting block 88 can be configured to allow the clip 80 to slide along a length of the lead wire assembly 20 ′ with light resistance (e.g., 0.3 lbs. or less).
- the mounting block 88 can be connected to the clip 80 as to allow the clip 80 to rotate or spin 360 degrees with respect to the mounting block 88 .
- the electrode assembly can include a plurality of electrodes 12 .
- FIG. 6 illustrates an electrode assembly 10 ′′ including two spaced apart electrodes 12 supported in a generally oval-shaped pledget substrate 14 ′′. Each electrode 12 is connected and supported within the pledget substrate 14 ′′ with one or more spacers 16 and further in ways described above with respect to other embodiments.
- all other aspects of the electrode assembly IO including other properties of the pledget substrate 14 ′′, can be configured similarly and operate in ways described above with respect to the embodiments 10 or 10 ′ of FIG. IA- 5 except as explicitly stated to differ.
- the electrode assembly 110 includes an evoked potential monitoring electrode 112 supported by and positioned within a pledget substrate 114 with a hub 160 having an aperture 162 and first and second flanges 164 a , 164 b extending radially from the aperture 162 .
- the hub 160 is over-molded to the pledget substrate 114 and is made of a rigid material, such as polyethylene, and optionally includes a color pigment, for example.
- the hub 160 is believed to improve the physical retention of the pledget substrate 114 by retaining and encapsulating fibers of the pledget substrate 114 material.
- the hub 160 further is configured to provide for free rotation of the pledget substrate 114 about the hub 160 /electrode 112 and reduces deformation of the pledget substrate 114 due to lateral stresses imparted on the pledget substrate 114 .
- the electrode 112 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode.
- two electrodes can be provided in the electrode assembly 110 .
- Each electrode 112 can include a base 130 configured for contact with tissue and an axle 134 extending therefrom.
- a channel 142 extends within the axle 134 and is configured to receive the wire core 126 of the lead wire assembly 120 .
- the axle 134 and the first portion 192 of cup 190 are configured such that the axle 134 can be positioned within the channel 196 .
- the material in which the electrode 112 is formed or surface treatment (not shown) provided on the base 130 of the electrode 112 (or interface at which the electrode 112 contacts the tissue) can be selected to enhance the bioelectric interface to tissue via selection of such preferred base metals, sintering to increase surface area, or plaiting.
- the axle 134 and optionally a portion of the base 130 includes a selectively-applied coating 139 applied exterior to a channel 142 extending through the axle 134 .
- the coating 139 eliminates shunting and ensures that all of the stimulation current is delivered to the base 130 of the electrode 112 and, therefore, delivered to the contacting tissue. This improves the consistence of the electrode assembly 110 performance in both bloodless “dry” and flooded “wet” surgical fields.
- this configuration provides a smooth, low-friction surface about which the hub 160 can rotate within the pledget substrate 114 .
- the selectively-applied coating 139 ensures electrical conductivity in the crimped and nerve contacting areas while electrically insulating all other surfaces of the electrode 112 .
- suitable materials for the coating 139 include, but are not limited to, floropolymer, diamond-like-coating (DLC), parylene silicone dioxide, aluminum oxide, halar, cured photopolymer, ceramic and polyimide coatings.
- Suitable material examples and other properties for the electrode 112 can be similar to those disclosed with respect to electrode 12 except as expressly stated.
- the electrode assembly 110 further includes a lead wire assembly 120 including at least one insulating jacket 122 positioned around a wire core 126 .
- the at least one insulating jacket 122 includes an inner polyester layer and an outer woven nylon layer positioned over the wire core 126 as is illustrated in FIG. 7 C .
- the electrode assembly 110 is provided with a cup 190 .
- the cup 190 can be made of nylon, optionally including pigment, and includes a first portion 192 and a second portion 194 .
- a channel 196 sized to receive the lead wire assembly 120 extends through both the first and second portions 192 , 194 .
- the first portion 192 defines a generally circular perimeter and includes a plurality ofrecesses or landing zones 198 a - c , which provide grips for interfacing with standard surgical instruments for manipulation both during assembly and use.
- the landing zones 198 a - c are spaced approximately 120 degrees from one another.
- the second portion 194 can optionally include a textured surface 200 .
- the pledget substrate 114 includes a round or other shaped body 150 of material that affixes to patient tissue from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve/tissue under “wet” conditions.
- the pledget substrate 114 is configured to interface with nerves within the range of about 1 to about 4 mm. Further, the pledget substrate 114 is free to rotate with respect to both of the wire core 126 of the lead wire assembly 120 and the electrode 112 .
- the body 150 is made of a porous material to allow for suction of fluids and may be provided with a coating (not visible) including of an aqueous solution of binder, water and a surfactant, which ties down the surface fibers of the body 150 and eliminates fraying of the body 150 while providing additional strength to the body 150 for its application to tissue.
- the coating can further include a pigment to provide chromatic differentiation of a stimulation or nerve side of the pledget substrate 114 .
- a first side 152 of the body 150 can include a coating of a first color
- a second side 154 of the body 150 can include a coating of a second color or, alternatively, no color.
- the tissue/stimulating side 154 coating may be hydrophilic while the, opposing, side 152 of the pledget substrate 114 may have a hydrophobic coating to enhance electrical current steering. It is desirable that the body 150 be made of a lint-free material that maintains a high degree of absorbency. Suitable materials for the body 150 include those disclosed with respect to other embodiments herein. Except as explicitly stated, the lead wire assembly 120 can be identically configured to lead wire assemblies 20 , 20 ′ disclosed above.
- FIG. 11 illustrates the electrode assembly 10 operatively affixed to a nerve N.
- the nerve has a 0.3 mm diameter.
- other electrode assemblies of the present disclosure can be configured to affix to the nerve N in an identical manner and that the tissue (e.g., nerve) to which the electrode assembly is applied is not to be limited to the illustrated nerve N.
- the electrode assembly 210 includes a plurality (e.g., four) potential monitoring electrodes 212 supported by and positioned within a pledget substrate 214 .
- each electrode 212 can be supported in the pledget substrate 214 in any manner as disclosed with respect to aforementioned embodiments.
- Each electrode 212 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode. Suitable configurations, material examples and properties for each electrode 212 can be similar to those disclosed with respect to electrodes 12 and 112 except as expressly stated.
- the electrode assembly 210 further includes a lead wire assembly 220 including a lead wire (not visible) at least partially covered by an insulating jacket 222 , as disclosed with respect to prior embodiments, for each of the electrodes 212 . Except as explicitly stated or illustrated, the lead wire assembly 220 can be configured similar to lead wire assemblies 20 , 20 ′, 120 disclosed above.
- the pledget substrate 214 includes two bodies 250 a , 250 b of material interconnected or in contact with one another at a joining region 213 .
- the joining region 213 has a reduced width or thickness as compared to a maximum width of each of the two bodies 250 a , 250 b . It could be described that the two bodies 250 a , 250 b result in an irregular outer boundary of the pledget substrate 214 as a whole. In this way, the bodies 250 a , 250 b can be cut or otherwise separated at the joining region 213 .
- the two bodies 250 a , 250 b are each round or oblong and have identical proportions.
- the two bodies 250 a , 2850 b can be moved or prepositioned with respect to one another.
- This design is particularity beneficial in obtaining consistent laryngeal EMG data.
- contact between an EMG ET tube surface tube electrodes and the larynx is constantly changing during the course of a procedure thereby forcing the surgeon to manipulate the EMG ET tube every time there is a doubt to rule out a false negative result.
- the electrode assembly 210 affixes to thyroid cartilage T as shown in FIG. 13 , moves with the larynx and identifies laryngeal EMG twitches.
- the joining region 213 includes perforations 215 to assist in optionally separating the two bodies 250 a , 250 b .
- the pledget substrate 214 affixes to patient tissue from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve or tissue under wet conditions.
- the electrodes 212 and pledget substrate 214 can be identically configured and function in ways identical to other disclosed embodiments except as explicitly stated.
- electrodes 212 can be supported within the pledget substrate 214 in any way described herein.
- each pledget substrate was dunked in saline and operatively placed on a vagus nerve. Stimulation was set at 1 mA with an EMG response of -1100 ⁇ V on both electrode assemblies when the surgical field was “dry”.
- 2-3 drops from a syringe of saline were placed directly on the respective pledget substrates, they both experienced a decreased EMG response (approximately 50% on the electrode assembly of FIG. IA and approximately 30% on the electrode assembly of FIG. 7 A ), however, the electrode assembly of FIG. 7 A recovered quickly where the electrode assembly of FIG. IA did not recover until the surgical field was dried.
- any of the pledget substrates of the present disclosure can optionally be secured to a nerve or other tissue in a variety of manners.
- a few example methods, which can be utilized individually or in combination, are illustrated in FIGS. 14 - 16 .
- the pledget substrate 314 can be secured to tissue with stiches or staples (not shown).
- apertures 315 can be provided in the pledget substrate 314 for the surgeon to thread standard suture or staples therethrough to secure the respective electrode assembly to the tissue via sutures and/or staples.
- FIG. 15 illustrates a pledget substrate 414 that includes micro-hooks 415 (generally referenced) for securing the electrode assembly to tissue.
- Each of the hooks 415 are semi-rigid (similar to hook fasteners used in hook and loop fastening systems) so that as the hooks 415 are pressed into tissue, they engage the tissue and for removal, the flexibility of each hook 415 naturally straightens after outward pulling forces are applied so that each hook 415 can be pulled free from the tissue.
- FIG. 16 illustrates a pledget substrate 514 that includes micro needles 515 (generally referenced) to assist in securing the pledget substrate 514 to tissue.
- Micro needles 515 reduce the impedance of the tissue interface and can also be used on the surface of the skin.
- the micro needles if provided in an array configuration (generally represented by reference numeral 515 ), can provide the path for stimulation as well as improve adhesion of the pledget substrate 514 to the tissue.
- the mirco needles 515 can be straight (perpendicular) or angled (not perpendicular) with respect to a plane defined by the pledget substrate 514 , as desired.
- each pledget substrate sample was threaded with a suture near an edge of the pledget substrate sample.
- the pledget substrate sample was fully saturated with 0.9% saline and placed on a stainless steel sheet.
- the pledget substrate sample was pull tested at a 45 degree angle to the planar surface of the stainless steel sheet in the direction of the a central axis of the pledget substrate sample.
- the peel ratings were assigned as indicated in Table 2 below and the results of each test are presented in Tables 5-14.
- each pledget substrate sample was sheared using surgical scissors and ranked qualitatively based on the integrity of the edge (i.e. did the sample exhibit a clean edge?, were there fibers extending beyond the cut line?, etc.) Shearing was performed on a dry pledget substrate sample. To score each material, the Likert Scale Qualitative Quality Ratings were used as detailed in Table 3 above.
- the pledget substrate sample made of a 70% Rayon/ 30% PET blend performed superior overall as compared to other tested samples.
- the sample made of a 50% Rayon /50% PET blend also performed quite well overall as compared to the other samples.
- Abrasion/Roughness (Dry) Good 0.10 0.3 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Poor 0.86 0.9 NIA Conforms better in preferred orientation - anisotropic Wettability Very Poor 1.00 0.0 Wettability Rating: Hydrophobic (saline drop will sit on surface) Lateral stress deformation Acceptable 0.29 0.6 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4): 2.00 1.71
- Abrasion/Roughness (Dry) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Acceptable 0.86 1.7 NIA Conforms better in preferred orientation - anisotropic Wettability Acceptable 1.00 2.0 Wettability Rating: Medium (absorbs saline fairly well with some delay) Lateral stress deformation Good 0.29 0.9 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4); 3.00 2.96
- FIGS. 17 - 19 which include block diagrams of various systems 600 - 800 of the disclosure suitable for stimulation and recording during thyroidectomy and neck dissection cancer surgeries.
- one of the electrode assemblies 604 of the disclosure e.g., electrode assembly 10 , 10 ′, 110
- an evoke potential monitoring system 602 which can be any of the type disclosed herein or known in the art including NIM Eclipse ® (Part number 945NCCPUE4), NIM-Response ® 3.0 (Part number 8253001) and NIM-Neuro ® 3.0 nerve (part number 8253401), referenced above.
- the system 600 includes an EMG tube 606 .
- EMG tube Any known EMG tube is suitable.
- One example including model number 82-29707, TriVantage® EMG Tube 7 mm, available from Medtronic Xomed, Inc., Jacksonville, Florida.
- a neural stimulation probe 608 is also provided. Suitable probes 608 include a Standard Prass Flush-Tippart (model number 8225101) or Incrementing Standard Prass Flush tip (model number 82-25825) both available from Medtronic Xomed, Inc., Jacksonville, Florida.
- the system 700 of FIG. 18 is similar and includes evoke potential monitoring system 602 , one of the electrode assemblies 612 of the disclosure for EMG recording that is operatively connected to evoke monitoring system 602 and also an APS nerve stimulation electrode 610 (e.g., model number 8228052 APS Electrode 2 mm, available from Medtronic Xomed, Inc., Jacksonville, Florida) operatively connected to evoke potential monitoring system 602 .
- This system also includes stimulation probe 608 .
- the system 800 of FIG. 19 includes evoke potential monitoring system 602 operatively connected to an electrode assembly of the disclosure 604 for nerve stimulation, EMG tube 614 for recurrent laryngeal nerve and vagus nerve recording, one electrode assembly of the disclosure 616 for superior laryngeal nerve recording and also stimulation probe 608 .
- FIG. 20 is a block diagram of a system 900 of the disclosure suitable for parotid surgery or scull base surgery continuous monitoring stimulation of a facial nerve.
- the system 900 includes evoke potential monitoring system 602 operatively connected to one electrode assembly of the disclosure 604 provided for stimulation of a facial nerve and a needle EMG recording electrode 618 .
- a needle EMG recording electrode is model number 82-27411 Paired Subdermal Electrodes 4-CH, available from Medtronic Xomed, Inc., Jacksonville, Florida.
- the system 900 includes the stimulation probe 608 .
- FIG. 21 is a block diagram of a system 1000 of the disclosure suitable for scull base surgery with an electrode assembly for continuous monitoring stimulation of a facial nerve and an electrode assembly of the disclosure for direct nerve monitoring of an 8 th cranial nerve.
- the system 1000 includes evoke potential monitoring system 602 operatively connected to one electrode assembly of the disclosure 604 for attachment to and stimulation of a facial nerve.
- the evoke potential monitoring system 602 is connected to a needle EMG recording electrode 618 .
- evoke potential monitoring system 602 is one electrode assembly of the disclosure 620 for attaching to and recording bioelectric responses from an 8 th cranial nerve.
- Stimulation probe 608 is also connected to evoke potential monitoring system.
- Electrode assemblies disclosed herein can be used in a method of evoked potential monitoring used intraoperatively for nerve stimulation or biopotential recording throughout the body including cranial and peripheral and mixed motor nerves, for example. As indicated above, particularly with respect to FIGS. 17 - 21 , it is envisioned that electrode assemblies of the disclosure can be used exclusively to replace or conjunction with standard electrodes, needle electrodes, continuous monitoring electrodes or with EMG tubes as a complementary method to apply evoked potential monitoring.
- Electrode assemblies of the disclosure can be used for evoked potential monitoring throughout the body including cranial and peripheral more or sensory or mixed motor-sensory nerves during surgery, including cerebral cortex, spinal cord, and spinal nerve roots.
- the electrode assemblies of the disclosure can be used for stimulation, biopotential recording, therapeutic stimulation and automatic periodic stimulation (APS) continuous monitoring of nerves during evoked potential monitoring procedures including, but not limited to: intracranial, extracranial, intratemporal, extratemporal, neck dissections, thoracic surgeries, and upper and lower extremities, degenerative treatments, cortical mapping, pedicle screw procedures, fusion cages, rhizotomy, orthopedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures.
- APS automatic periodic stimulation
- Evoked potential monitoring is typically accomplished by stimulating the nerve with a hand-held stimulator probe for locating and assessing neural function.
- Continuous monitoring stimulation of the vagus nerve is accomplished by use of Automatic Periodic Stimulation (APS).
- Recording the EMG responses is typically conducted by recording EMG from innervated muscle with an EMG tube (endorectal tube with integrated recording electrodes) or invasive needle electrodes placed in the muscles of the larynx percutaneously or intraorally.
- the present inventors have discovered current methods have shortcomings.
- the APS electrodes need to place circumferentially around the stimulated nerve which invasive and presents risk for neurological damage without careful dissection surgical skill.
- EMG tubes are specialty electrodes are complex and expensive. Both conventional devices are dependent on operator placement to be effective and time consuming to reposition.
- Electrode assemblies of the disclosure for evoked potential monitoring (stimulation and/or recording) with electrode assemblies of the disclosure simplify device, placement positioning, and replacement if needed for improving the cost effectiveness and product application ease-of-use.
- the electrode assemblies of the disclosure can be replace an APS electrode in known systems ( FIGS. 17 and 19 ).
- the electrode assemblies of the disclosure can be wetted and placed on the nerve as compared to a known APS electrode that requires 360 degree dissection of the nerve the electrode will be applied to.
- the electrode assemblies of the disclosure can be used throughout the body.
- the electrodes assemblies can be used to stimulate the vagus nerve during continuous monitoring during thyroid and neck dissection procedures.
- Electrode assemblies of the disclosure can also be used for stimulation during continuous monitoring of the facial nerves during parotid or skull base procedures ( FIGS. 20 - 21 ).
- the electrode assemblies of the disclosure can also replace use of an EMG tube ( FIG. 18 ).
- the new electrode assemblies of the disclosure can be wetted and placed latterly on the exposed trachea as compared to an EMG tube electrode, which must be placed at intubation and positioned carefully to record proper EMG responses.
- the EMG tube can be displaced during surgery which is difficult to visualize and remedy as it is also maintaining the patient airway during the operation.
- the pledget substrate placement is visually apparent and easily replaced or moved during the thyroid surgery.
- a twisted pair pledget substrate can be positioned with one electrode on each side of the trachea for single channel referential EMG recording or a pair can be placed on each side of the trachea for two channel side specific recording.
- electrode assemblies of the disclosure can be placed directly on the cricothyroid muscle for recording specific superior laryngeal nerve responses as compared to needle electrodes, which are invasive and can damage the delicate musculature.
- the electrode assemblies of the disclosure can record 8th cranial nerve evoked response or provide continuous stimulation of the facial nerve intracranially ( FIG. 21 ).
- Methods of using the electrode assemblies of the disclosure are easier and less evasive to place on delicate intracranial nerves.
- the electrode assemblies of the disclosure can be replace the use of a Cueva C-shaped electrode for cranial stimulation or recording nerve.
- the electrode assemblies of the disclosure can be wetted and placed on the nerve with minimal manipulation as compared to placing the Cueva C-shaped electrode around the nerve requires that the delicate intracranial nerve be dissected to accept the Cueva electrode.
- Electrode assemblies 10 , 10 ′, 10 ′′, 110 , 210 of the present disclosure can optionally be delivered through a cannula inserted within a skin incision to access bioelectric tissue of a patient.
- the tissue can be a nerve, such as a recurrent laryngeal nerve, a superior laryngeal nerve, a vagus nerve, peripheral or a cranial nerve.
- the tissue can be a trachea.
- the tissue can be innervated muscle or cricothyroid muscle.
- the cannula and skin incision are equal to or greater than 2.5 mm.
- the pledget substrate is applied to the tissue. Therefore, no dissection of the nerve or tissue on which the pledget substrate is secured is required.
- Such application can include optionally wetting the pledget substrate with saline and then wrapping the pledget substrate around the tissue.
- micro hooks or micro needles are provided on the pledget substrate, they may be applied to be inserted within the tissue.
- the pledget substrate can be sewn or stapled into the tissue through the apertures. Due to the hydrophilic nature of the pledget substrate, the pledget substrate will naturally absorb moisture present at the target tissue, which will retain the pledget substrate to the nerve.
- the substrate is wrapped around less than an entire circumference (i.e.
- methods can include recording bioelectric responses of the tissue sensed from one or more electrodes of the electrode assembly.
- the bioelectric response can include EMG activity or direct nerve recording.
- the stimulation is therapeutic stimulation applied to the tissue.
- the user can optionally disconnect the first and second bodies of the pledget substrate, either along the perforation or otherwise, as desired, it is to be understood that the system provided in the method includes one evoke potential monitoring system operatively connected to the electrode assembly.
- the connector of the lead wire assembly can be secured to the evoke potential monitoring system of the type disclosed herein either prior to or after the electrode assembly is positioned on the tissue.
- stimulation can be applied to the tissue via the electrode of the electrode assembly of FIG. 7 A , the user may optionally adjust the direction of the lead wire assembly via rotating the cup about the pledget substrate.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Neurology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Medical Informatics (AREA)
- Neurosurgery (AREA)
- Radiology & Medical Imaging (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Physiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Psychology (AREA)
- Electrotherapy Devices (AREA)
- Surgical Instruments (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
Description
- This is a continuation application and claims priority to U.S. Application Serial No. 16/152,624, filed Oct. 5, 2018; which claim the benefit of U.S. Application Serial No. 62/568,841, filed Oct. 6, 2017. The entire disclosure of each of the above applications is incorporated herein by reference.
- The present technology is generally related to stimulation and recording electrode assemblies as well as methods of conducting an intraoperative tissue monitoring and/or stimulation procedure.
- Nerve monitoring is used in surgical procedures where nerves are at risk. With some systems, a nerve integrity monitor and a hand held stimulator probe provide intermittent stimulation only when the surgeon probes the nerve. Nerves can be at risk, however, in between stimulations due to surgical incision “blind” trauma caused by manipulation and stretching during tumor removal, and cumulative trauma or damage that may result in neurapraxia. Automatic periodic stimulation (APS), however, provides Continuous Intraoperative Nerve Monitoring (CIONM). Intraoperative NIM nerve monitoring systems enable surgeons to identify, confirm, and monitor motor nerve function to help reduce the risk of nerve damage during various procedures including ENT and general surgeries.
- One such system is Medtronic, Inc.’s NIM® Nerve Monitoring System, which includes an electromyographic (EMG) monitor for intraoperative use during various surgeries in which a nerve may be at risk due to unintentional manipulation. NIM nerve monitoring probes having electrodes are placed in the appropriate muscle locations in the patient for the procedure being performed. These electrodes are connected to the NIM Nerve Monitoring System, which continuously monitors EMG activity from muscles innervated by the affected nerve. When a particular nerve has been activated or stimulated, the NIM® System warns the surgeon and operating room staff, providing both visual alerts on the color touchscreen monitor and audio feedback to help minimize trauma to the nerve.
- Surgeons can use monopolar and bipolar stimulating probes and dissection instruments with the NIM® Nerve Monitoring System to assist in early nerve identification and confirmation. These tools may be used to locate, identify, and map the particular nerve and branches, as well as verify nerve function and integrity to help surgeons perform critical procedures while preserving nerve function and improving patient safety.
- The present disclosure provides improvements associated with the related art.
- Aspects of this disclosure generally relate to stimulation and/or recording electrode assemblies that can be affixed to bioelectric tissue, such as a nerve, without the use of adhesive.
- Aspects of the disclosure are related to stimulation and/or recording electrode assemblies and systems that are particularly useful for Automatic Periodic Stimulation (APS). Such embodiments are compatible with nerve monitoring systems to provide continuous stimulation of a nerve during surgery. Disclosed embodiments are useful for evoked potential monitoring throughout the body including cranial and peripheral and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. Disclosed embodiments are useful for stimulation, biopotential recording, therapeutic stimulation and automatic periodic stimulation (APS) to nerves during evoked potential monitoring procedures including but not limited to: intracranial, extracranial, intratemporal, extratemporal, neck dissections, thoracic surgeries, and upper and lower extremities, degenerative treatments, pedicle screw procedures, fusion cages, rhizotomy, orthopedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures.
- Aspects of the disclosure include an intraoperative electrode assembly having a pledget substrate made at least partially of a material that is hydrophilic as well as one or more electrodes supported by and positioned within the pledget substrate. In various embodiments, the material is a rayon/polyethylene terephthalate blend. The electrode assembly further includes a lead wire assembly interconnected to each electrode. In various embodiments, the lead wire assembly includes at an insulating jacket positioned around a wire core and the electrode assembly further including an insulating cup interconnecting the electrode and the insulating jacket. The cup may be configured to rotate about the pledget substrate. In some embodiments, the pledget substrate includes two separable bodies, each including an electrode.
- Aspects of the disclosure also include methods of conducting an intraoperative procedure. The methods include providing an electrode assembly including, a pledget substrate having a first surface that is hydrophilic, one or more electrodes supported by and positioned within the pledget substrate, and a lead wire assembly interconnected to the electrode(s). The method continues by creating an incision to access tissue of a patient and applying the pledget substrate to the tissue. Then, the one or more electrodes can be activated. Activating the electrode(s) can include recording bioelectric responses of the tissue sensed from the electrode(s). In alternate embodiments, activating the electrode(s) can include stimulation of bioelectric tissue applied from the electrode(s).
- The disclosed embodiments provide for continuous intraoperative monitoring in current and new procedures that place nerves at risk without extra dissection or wrapping of the electrode assembly around the entirety of the respective nerve. In this way, the disclosed embodiments are more easily applied to a nerve, thus requiring less skill (either actual or perceived) from the clinician.
- The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
-
FIG. IA is a perspective top view of one embodiment of an electrode assembly. -
FIG. IB is a perspective bottom view of the electrode assembly ofFIG. IA -
FIG. IC is a cross-sectional view of the electrode assembly ofFIG. IA-IB . -
FIG. ID is an additional perspective view of the electrode assembly ofFIG. IA-IC . -
FIG. 2A is a perspective top view of another embodiment of an electrode assembly. -
FIG. 2B is a perspective bottom view of the electrode assembly ofFIG. 2A . -
FIG. 2C is a cross-sectional view of the electrode assembly ofFIGS. 2A-2B . -
FIG. 3A is a perspective view of an electrode that can be used in the embodiments ofFIGS. 1A-2C. -
FIG. 3B is an alternate perspective view of the electrode ofFIG. 3A . -
FIG. 4A is a side view of a lead wire assembly that can be used in the embodiments ofFIGS. 1A-2C . -
FIG. 4B is a perspective view of the lead wire assembly ofFIG. 4A . -
FIG. 5 is a cross-sectional view of a clip and a pin interconnected to the lead wire assembly such as that ofFIGS. 4A-4B . -
FIG. 6 is a perspective view of an alternate electrode assembly, which is largely similar to embodiments previously illustrated but wherein the electrode assembly includes two electrodes. -
FIG. 7A is a top perspective view of an alternate electrode assembly. -
FIG. 7B is a bottom perspective view of the electrode assembly ofFIG. 7A -
FIG. 7C is cross-sectional view of the electrode assembly ofFIG. 7A -
FIG. 8 is a perspective view of a base material and hub of the electrode assembly ofFIGS. 7A-7C . -
FIG. 9 is a perspective view of an electrode of the electrode assembly ofFIGS. 7A-7C . -
FIG. 10 is a perspective view of a cup of the electrode assembly ofFIGS. 7A-7C . -
FIG. 11 is a schematic illustration of the electrode assembly ofFIG. 1 wrapped around a 0.3 mm diameter nerve. -
FIG. 12 is a schematic view of an alternate electrode assembly. -
FIG. 13 is a schematic view of the electrode assembly ofFIG. 12 operatively secured to thyroid cartilage. -
FIG. 14 is a partial, schematic illustration of a pledget substrate including apertures in which sutures and/or staples can be inserted to secure the pledget substrate to a tissue. -
FIG. 15 is a partial, schematic illustration of a pledget substrate including mirco hooks to secure the pledget substrate to tissue. -
FIG. 16 is a partial, schematic illustration of a pledget substrate including mirco needles to secure the pledget substrate to tissue. -
FIGS. 17-19 are a block diagrams of various systems of the disclosure suitable for stimulation and recording during thyroidectomy and neck dissection cancer surgeries. -
FIG. 20 is a block diagram of a system of the disclosure suitable for parotid surgery or scull base surgery continuous monitoring stimulation of a facial nerve. -
FIG. 21 is a block diagram of a system of the disclosure suitable for scull base surgery with an electrode assembly for continuous monitoring stimulation of a facial nerve and an electrode assembly for direct nerve monitoring of an 8th cranial nerve. - Nerve monitoring is used in surgical procedures where nerves are at risk. A system including a nerve integrity monitor and a hand held stimulator probe having an electrode provides intermittent stimulation only when the surgeon probes the nerve. Nerves can be at risk, however, in between stimulations due to surgical incision “blind” trauma caused by manipulation and stretching during tumor removal, and cumulative trauma or damage that may result in neuropraxia. Automatic periodic stimulation (APS), however, provides continuous intraoperative nerve monitoring (CIONM). The electrode provides continuous, periodic stimulation of nerve used for trending amplitude and latency in real time which includes adjustable alarm limits for significant baseline changes. This early warning helps alert the surgeon to stop surgical trauma as most injury is immediacy reversible but can become permanent if prolonged.
- Aspects of the disclosure relate to pledget stimulation and recording electrode assemblies that are particularly useful with APS, for example. Such embodiments are compatible with nerve monitoring systems to provide continuous nerve stimulation during a surgical procedure. Two compatible nerve monitoring system include NIM Eclipse® (Part number 945NCCPUE4), NIM-Response® 3.0 (Part number 8253001) and NIM-Neuro® 3.0 nerve (part number 8253401) monitoring systems all available from Medtronic, Inc. of Minneapolis, Minnesota. The disclosed electrode assemblies are particularly useful for monitoring a facial nerve at a main trunk in head and neck procedures, as well as the facial nerve in lateral skull base procedure (LSB) procedures. The electrode assembly can be used for short procedures less than 24 hours or implanted in the patient longer than 24 hours. An electrode surface of the electrode assembly maybe coated to deliver a drug during contact or enhanced treatment such as through electro-paresis. Other disclosed embodiments are particularly useful for thyroid laryngeal monitoring without an electromyogram (EMG) endotracheal tube. Such an electrosurgical endotracheal tube is disclosed in Mcfarlin et al., U.S. Pat. Application No. 16/108,682, filed Aug. 22, 2018, the entire contents of which are herein incorporated by reference in its entirety. The electrode assemblies of the disclosure can be used in evoked potential intraoperative monitoring systems during surgical procedures and are an alternative which simplifies stimulation of tissue over current methods including cuffed APS electrodes or needle electrodes used for stimulation. The electrode assemblies of the present disclosure simplify recording of tissue over such current methods. Examples of such current methods are more thoroughly disclosed in Sinclair, C.F., Tellez, M.J., Tapia, O.R., & Ulkatan, S. (2017). Contralateral RI and R2 components of the laryngeal adductor reflex in humans under general anesthesia. The Laryngoscope, 127 12, E443-E448. The use of the disclosed embodiments, however, is not intended to be limited to any specific procedure and examples of particular systems in which the electrode assemblies can be incorporated and methods of use will be further disclosed below.
- One example embodiment of an
electrode assembly 10 is illustrated inFIG. IA-IC . Theelectrode assembly 10 includes one ormore electrodes 12 supported by and positioned within apledget substrate 14 with one ormore spacers more electrodes 12 are evoked potential monitoring electrodes. Theelectrode assembly 10 further includes alead wire assembly 20 including at least one insulatingjacket 22 positioned around awire core 26. - The
electrode 12 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode. In some embodiments, as further disclosed below with respect toFIG. 6 , for example, two electrodes can be provided to provide bipolar stimulation or recording and is configured to communicate electrical stimulus to tissues and thus must provide the appropriate surface area for contacting tissue for the current density. The material in which theelectrode 12 is formed or surface treatment (not shown) provided on theelectrode 12 at the base 30 (or interface at which theelectrode 12 contacts the nerve or other bioelectric tissue) can be selected to enhance the bioelectric interface to tissue via selection of such preferred base metals, sintering to increase surface area, or plaiting. Suitable material examples for theelectrode 12 at the interface orbase 30 include stainless steel, copper, gold, iridium, palladium, platinum, rubidium, ruthenium, silver, conductive plastics or inks. Conductive plastics or inks can be used on the surface of the top 32 orbase 30 to enhance conductions delivery to the tissue. For example, a conductive ink may have about 40-60% conductive silver particles with polyvinylchloride (PVC) particles with a solvent that evaporates to dry the ink on a surface of theelectrode 12. Conductive plastic constructed of conductive particles and polymeric particles are fused together to form a conductive plastic. - The
electrode 12 is also configured to allow for crimping and strain relief of thelead wire assembly 20. As also shown inFIGS. 2A-2B , theelectrode 12 can be configured to include abase 30, a top 32, and anaxle 34 interconnecting the top 32 and thebase 30. Such features capture thespacers pledget substrate 14. Moreover, the top 32 can include adomed portion 36 interconnected to aflanged portion 38 extending outwardly with respect to thedomed portion 36 and theaxle 34. The top 32 includes first andsecond channels lead wire assembly 20. In one embodiment, thefirst channel 40 is positioned within thedomed portion 36 and can be crimped to the exposedwire core 26 proximate the top 32 using a single point crimp. Thesecond channel 42 can be used to provide strain relief within thewire core 26 and can optionally be positioned to extend within theflanged portion 38. In certain embodiments, the top 32 is configured to provide a lowprofile wire core 26 interface. In the illustrated embodiment, thefirst channel 40 is configured to retain both thejacket 22 and thewire core 26 and thesecond channel 42 is configured to retain only thewire core 26. Theelectrode 12 can be made of an adhesive compatible material or can otherwise provide an adhesive compatible surface so that thewire core 26 can be secured to the top 32 of theelectrode 12 with adhesive (not shown). - The base 30 can optionally contain or have applied thereto a bioactive agent or therapeutic (drug or anesthetic) which delivery can be enhanced by iontophoresis. Examples of bioactive agents include, but are not limited to, steroids dexamethasone, and methylprednisolone or anesthetic agents such as lidocaine xylocaine epinephrine. The
electrode 12 can aid in applying such local drug or anesthetics to selected locations which the electrode 12 (coupled with a current return electrode) delivers the externally applied potential difference where the movements of ions across a membrane enhanced using for therapeutic purposes. - Although not shown, the
electrode 12 can optionally be selectively electrically insulated. In such embodiments, theelectrode 12 can be coated in an insulator completely (e.g., using chemical vapor deposition). This coating can then be selectively removed (e.g., using a laser) to expose desired areas. Alternatively, theelectrode 12 can be masked and then an insulating coating can be applied. - The
pledget substrate 14 includes a round shapedbody 50 of material that affixes from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve/tissue under wet conditions. In various embodiments, thepledget substrate 14 is configured to interface with nerves within the range of about 1 mm to about 4 mm. Further, thepledget substrate 14 is free to rotate with respect to both of thewire core 26 of thelead wire assembly 20 and theelectrode 12. Thebody 50 is made of a porous material to allow for suction of fluids and may be provided with a coating (not visible) including of an aqueous solution of binder, water and a surfactant, which ties down the surface fibers of thebody 50 and eliminates fraying of thebody 50 while providing additional strength to thebody 50 for its application to bioelectric tissue. The coating can further include a pigment to provide chromatic differentiation of a stimulation or nerve side of thepledget substrate 14. In this way, afirst side 52 of thebody 50 can include a coating of a first color and a second side 54 of thebody 50 can include a coating of a second color or, alternatively, no color. In some embodiments, the tissue/stimulating side 54 coating may be hydrophilic while the, opposing,side 52 of thepledget substrate 14 may have a hydrophobic coating to enhance electrical current steering. It is desirable that thebody 50 be made of a lint-free material that maintains a high degree of absorbency. One example of a suitable material for thebody 50 is spunbond rayon (about 0.33 mm thick). Other suitable materials include rayon/ polyethylene terephthalate (PET) blends and PET/viscose blends, for example. Tests evaluating suitable materials for thepledget substrate 14, and any alternate pledget substrates disclosed herein, are further discussed below with respect to Tables 5-14. - The
lead wire assembly 20 can optionally further include asleeve 23 as is visible inFIG. ID . Thesleeve 23 can be made of a material such as cotton or the like, which allows the clinician to stick thelead wire assembly 20 to a portion of a patient’s anatomy (not shown). In such embodiments, thesleeve 23 can be optionally slidable along a length a of thejacket 22 so that thesleeve 23 can be selectively positioned at a portion along thejacket 22, wetted with water or the like, and then pressed onto the anatomy to facilitate adhesion of the sleeve 23 (and thus adhesion of the lead wire assembly) to the anatomy. Thelead wire assembly 20 additionally includes aconnector 25 configured to be connected to a nerve monitoring system such as those disclosed herein, for example, configured to activate the electrode(s) 12 to record bioelectric responses of the tissue sensed from the electrode 12 (see also,FIGS. 17-21 ). In alternate embodiments, stimulation ofbioelectric tissue from the electrode(s) 12. - As generally illustrated in
FIGS. 2A-2B , anelectrode assembly 10′ of the present disclosure need not include apledget substrate 14′ including abody 50′ having a round shape and can have an alternate shape, such as a square shape. Other shapes, including irregular shapes, are envisioned. As indicated with like reference numerals referring to like features as described herein, all other aspects of theelectrode assembly 10′ can be configured similarly and operate in ways described above with respect to theembodiment 10 ofFIG. IA-IC except as explicitly stated. - As shown, the electrode assembly IO of the disclosed embodiments can have two
spacers first spacer 16 and thesecond spacer 18 located on opposing sides of thepledget substrate 14. Thefirst spacer 16 includes an aperture (not clearly visible) through which theelectrode 12 is positioned. Thefirst spacer 16 can provide strain relief within thepledget substrate 14 and also provides electrical current directivity and insulation between theelectrode axle 34 andpledget substrate 14. In one example embodiment, thefirst spacer 16 is made of polyethylene. Thesecond spacer 18 also defines an aperture (not clearly visible) through which theelectrode axle 34 is positioned. Thesecond spacer 18 can also provide strain relief within thepledget substrate 14 and provide for free rotation of thepledget substrate 14 about theelectrode 12 as well as surface for adhesion of thebody 50. Thesecond spacer 18 additionally provides electrical current directivity, chromatic differentiation of stimulating and nerve sides of thepledget substrate 14, allows theelectrode 12 andwire core 26 to rotate freely and can include afeature 60, which enhances the ability to manipulate theelectrode 12. In one example, thefeature 60 is a lip that can be grabbed by a standard surgical instrument. Thesecond spacer 18 further includes a retainingstructure 62, such as a bowl, that can at least in part be defined by thefeature 60, to retain liquid adhesive (not shown) used to secure the top 32 of theelectrode 12 to thewire core 26 after the adhesive dries or is cured. In one example embodiment, thesecond spacer 18 can be made of nylon. - Turning now also to
FIGS. 3A-3B , which illustrate an alternatelead wire assembly 20′. Thelead wire assembly 20′ is substantially similar to thelead wire assembly 20 discussed herein but instead of only including a single insulating jacket (e.g., jacket 22), thelead wire assembly 20′ includes aninner jacket 22 a,outer jacket 22 b surrounding thewire core 26. Both of the inner andouter jackets wire core 26 and to eliminate a potential need to splice thelead wire assembly 20. In this way, theouter jacket 22 b can be at least partially stripped from theinner jacket 22 a. In addition, arelease agent 28 such as silicone or the like can be applied between the inner andouter jackets outer jackets inner jacket 22 a will be exposed with respect to theouter jacket 22 b. - The
lead wire assemblies lead wire assembly outer jackets wire core 26 and, in some embodiments, is or are collectively thin to maintain flexibility of thelead wire assembly 20 orjacket jacket 22 orouter jacket 22 b is made of a low-reflectivity material such as polyvinyl chloride (PVC) and provides electrical insulation of 1000VC dielectric strength. Where provided, the inner jacket can be made of polytetrafluoroethylene (PTFE), for example. Thewire core 26 is malleable to retain a deformed shape and can optionally be made of 300 series stainless steel 40AWG single strand material. The j acket(s) 22, 22 a, 22 b can be of a specific color, such as yellow to provide contrast with a patient’s anatomy. As shown with respect to thelead wire assembly 20 inFIG. 5 , thelead wire assembly electrode 12 and/or APS system, for example, via a pin jack 70 or the like that provides the electrical communication a patient interface (not shown). The pin jack 70 can be protected for International Electrotechnical Commission 60601 compliance. - As generally illustrated in
FIG. 5 , aclip 80 can be secured to thelead wire assembly 20′ (or thelead wire assembly 20 in a similar fashion) to secure thelead wire assembly 20′ to an ear of the patient or, a sterile drape that covers the patient during surgery, for example, to provide strain relief Theclip 80 can be configured to include twoarms 82, 84 that include a hingedconnection 86 biased in the closed position. The hingedconnection 86 can include a pin about which the twoarms 82, 84 can rotate. The twoarms 82, 84 can be spring biased into the closed position. Theclip 80 includes a mounting block 88 that secures onearm 82 to thejacket 22 b. The mounting block 88 can be configured to allow theclip 80 to slide along a length of thelead wire assembly 20′ with light resistance (e.g., 0.3 lbs. or less). In addition, the mounting block 88 can be connected to theclip 80 as to allow theclip 80 to rotate or spin 360 degrees with respect to the mounting block 88. - As previously suggested with respect to the embodiment of
FIG. IA-ID , in an alternate electrode assembly, the electrode assembly can include a plurality ofelectrodes 12.FIG. 6 illustrates anelectrode assembly 10″ including two spaced apartelectrodes 12 supported in a generally oval-shapedpledget substrate 14″. Eachelectrode 12 is connected and supported within thepledget substrate 14″ with one ormore spacers 16 and further in ways described above with respect to other embodiments. As indicated with like reference numerals referring to like features as described herein, all other aspects of the electrode assembly IO”, including other properties of thepledget substrate 14″, can be configured similarly and operate in ways described above with respect to theembodiments FIG. IA-5 except as explicitly stated to differ. - Turning now also to
FIG. 7A-10 , which illustrate analternate electrode assembly 110. Theelectrode assembly 110 includes an evokedpotential monitoring electrode 112 supported by and positioned within apledget substrate 114 with ahub 160 having anaperture 162 and first andsecond flanges 164 a, 164 b extending radially from theaperture 162. Thehub 160 is over-molded to thepledget substrate 114 and is made of a rigid material, such as polyethylene, and optionally includes a color pigment, for example. Thehub 160 is believed to improve the physical retention of thepledget substrate 114 by retaining and encapsulating fibers of thepledget substrate 114 material. Thehub 160 further is configured to provide for free rotation of thepledget substrate 114 about thehub 160/electrode 112 and reduces deformation of thepledget substrate 114 due to lateral stresses imparted on thepledget substrate 114. - As with prior embodiments, the
electrode 112 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode. In some embodiments, as previously discussed with respect toFIG. 6 , two electrodes can be provided in theelectrode assembly 110. Eachelectrode 112 can include a base 130 configured for contact with tissue and anaxle 134 extending therefrom. Achannel 142 extends within theaxle 134 and is configured to receive thewire core 126 of thelead wire assembly 120. As can be seen inFIG. 7C , theaxle 134 and thefirst portion 192 ofcup 190 are configured such that theaxle 134 can be positioned within thechannel 196. The material in which theelectrode 112 is formed or surface treatment (not shown) provided on thebase 130 of the electrode 112 (or interface at which theelectrode 112 contacts the tissue) can be selected to enhance the bioelectric interface to tissue via selection of such preferred base metals, sintering to increase surface area, or plaiting. In the illustrated embodiment, theaxle 134 and optionally a portion of thebase 130 includes a selectively-appliedcoating 139 applied exterior to achannel 142 extending through theaxle 134. Thecoating 139 eliminates shunting and ensures that all of the stimulation current is delivered to thebase 130 of theelectrode 112 and, therefore, delivered to the contacting tissue. This improves the consistence of theelectrode assembly 110 performance in both bloodless “dry” and flooded “wet” surgical fields. In addition, this configuration provides a smooth, low-friction surface about which thehub 160 can rotate within thepledget substrate 114. Moreover, the selectively-appliedcoating 139 ensures electrical conductivity in the crimped and nerve contacting areas while electrically insulating all other surfaces of theelectrode 112. Examples of suitable materials for thecoating 139 include, but are not limited to, floropolymer, diamond-like-coating (DLC), parylene silicone dioxide, aluminum oxide, halar, cured photopolymer, ceramic and polyimide coatings. Suitable material examples and other properties for theelectrode 112 can be similar to those disclosed with respect toelectrode 12 except as expressly stated. - The
electrode assembly 110 further includes alead wire assembly 120 including at least one insulatingjacket 122 positioned around awire core 126. In one example embodiment, the at least one insulatingjacket 122 includes an inner polyester layer and an outer woven nylon layer positioned over thewire core 126 as is illustrated inFIG. 7C . To minimize the volume of adhesive (not shown) required to pot theelectrode 112 andwire core 126, theelectrode assembly 110 is provided with acup 190. Thecup 190 can be made of nylon, optionally including pigment, and includes afirst portion 192 and asecond portion 194. Achannel 196 sized to receive thelead wire assembly 120 extends through both the first andsecond portions first portion 192 defines a generally circular perimeter and includes a plurality ofrecesses or landing zones 198 a-c, which provide grips for interfacing with standard surgical instruments for manipulation both during assembly and use. In one embodiment, the landing zones 198 a-c are spaced approximately 120 degrees from one another. Thesecond portion 194 can optionally include atextured surface 200. - The
pledget substrate 114 includes a round or othershaped body 150 of material that affixes to patient tissue from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve/tissue under “wet” conditions. In various embodiments, thepledget substrate 114 is configured to interface with nerves within the range of about 1 to about 4 mm. Further, thepledget substrate 114 is free to rotate with respect to both of thewire core 126 of thelead wire assembly 120 and theelectrode 112. Thebody 150 is made of a porous material to allow for suction of fluids and may be provided with a coating (not visible) including of an aqueous solution of binder, water and a surfactant, which ties down the surface fibers of thebody 150 and eliminates fraying of thebody 150 while providing additional strength to thebody 150 for its application to tissue. The coating can further include a pigment to provide chromatic differentiation of a stimulation or nerve side of thepledget substrate 114. In this way, afirst side 152 of thebody 150 can include a coating of a first color and asecond side 154 of thebody 150 can include a coating of a second color or, alternatively, no color. In some embodiments, the tissue/stimulatingside 154 coating may be hydrophilic while the, opposing,side 152 of thepledget substrate 114 may have a hydrophobic coating to enhance electrical current steering. It is desirable that thebody 150 be made of a lint-free material that maintains a high degree of absorbency. Suitable materials for thebody 150 include those disclosed with respect to other embodiments herein. Except as explicitly stated, thelead wire assembly 120 can be identically configured to leadwire assemblies - Turning now also to
FIG. 11 , which illustrates theelectrode assembly 10 operatively affixed to a nerve N. In this illustrative example, the nerve has a 0.3 mm diameter. It will be understood that other electrode assemblies of the present disclosure can be configured to affix to the nerve N in an identical manner and that the tissue (e.g., nerve) to which the electrode assembly is applied is not to be limited to the illustrated nerve N. - Turning now also to
FIGS. 12-13 , which illustrate analternate electrode assembly 210. Theelectrode assembly 210 includes a plurality (e.g., four)potential monitoring electrodes 212 supported by and positioned within apledget substrate 214. In example embodiments, eachelectrode 212 can be supported in thepledget substrate 214 in any manner as disclosed with respect to aforementioned embodiments. - Each
electrode 212 can be used as recording and stimulating electrode as well as therapeutic stimulating electrode. Suitable configurations, material examples and properties for eachelectrode 212 can be similar to those disclosed with respect toelectrodes electrode assembly 210 further includes alead wire assembly 220 including a lead wire (not visible) at least partially covered by an insulating jacket 222, as disclosed with respect to prior embodiments, for each of theelectrodes 212. Except as explicitly stated or illustrated, thelead wire assembly 220 can be configured similar to leadwire assemblies - The
pledget substrate 214 includes twobodies region 213. In one embodiment, the joiningregion 213 has a reduced width or thickness as compared to a maximum width of each of the twobodies bodies pledget substrate 214 as a whole. In this way, thebodies region 213. In one example embodiment, the twobodies bodies bodies 250 a, 2850 b can be moved or prepositioned with respect to one another. This design is particularity beneficial in obtaining consistent laryngeal EMG data. In many situations, contact between an EMG ET tube surface tube electrodes and the larynx is constantly changing during the course of a procedure thereby forcing the surgeon to manipulate the EMG ET tube every time there is a doubt to rule out a false negative result. Conversely, with theelectrode assembly 210, theelectrode assembly 210 affixes to thyroid cartilage T as shown inFIG. 13 , moves with the larynx and identifies laryngeal EMG twitches. It will be understood that any of the disclosed electrode assemblies can be secured to tissue in a similar manner as illustrated inFIGS. 11 and 13 , for example. In one embodiment, the joiningregion 213 includesperforations 215 to assist in optionally separating the twobodies pledget substrate 214 affixes to patient tissue from surface tension via Van der Waals forces or bio adhesion such as tissue clotting, drying or scar tissue healing, for example, and is configured to maintain fixation to a nerve or tissue under wet conditions. Theelectrodes 212 andpledget substrate 214 can be identically configured and function in ways identical to other disclosed embodiments except as explicitly stated. For example,electrodes 212 can be supported within thepledget substrate 214 in any way described herein. - In one experiment, the electrode assemblies of
FIGS. IA and 7A were comparatively tested. To test, each pledget substrate was dunked in saline and operatively placed on a vagus nerve. Stimulation was set at 1 mA with an EMG response of -1100 µV on both electrode assemblies when the surgical field was “dry”. When 2-3 drops from a syringe of saline were placed directly on the respective pledget substrates, they both experienced a decreased EMG response (approximately 50% on the electrode assembly ofFIG. IA and approximately 30% on the electrode assembly ofFIG. 7A ), however, the electrode assembly ofFIG. 7A recovered quickly where the electrode assembly ofFIG. IA did not recover until the surgical field was dried. - Any of the pledget substrates of the present disclosure can optionally be secured to a nerve or other tissue in a variety of manners. A few example methods, which can be utilized individually or in combination, are illustrated in
FIGS. 14-16 . As illustrated inFIG. 14 , thepledget substrate 314 can be secured to tissue with stiches or staples (not shown). In this embodiment, apertures 315 (generally referenced) can be provided in thepledget substrate 314 for the surgeon to thread standard suture or staples therethrough to secure the respective electrode assembly to the tissue via sutures and/or staples. - Turning now also to
FIG. 15 , which illustrates a pledget substrate 414 that includes micro-hooks 415 (generally referenced) for securing the electrode assembly to tissue. Each of thehooks 415 are semi-rigid (similar to hook fasteners used in hook and loop fastening systems) so that as thehooks 415 are pressed into tissue, they engage the tissue and for removal, the flexibility of eachhook 415 naturally straightens after outward pulling forces are applied so that eachhook 415 can be pulled free from the tissue. - Turning now also to
FIG. 16 , which illustrates apledget substrate 514 that includes micro needles 515 (generally referenced) to assist in securing thepledget substrate 514 to tissue. Micro needles 515 reduce the impedance of the tissue interface and can also be used on the surface of the skin. The micro needles, if provided in an array configuration (generally represented by reference numeral 515), can provide the path for stimulation as well as improve adhesion of thepledget substrate 514 to the tissue. In such embodiments, the mirco needles 515 can be straight (perpendicular) or angled (not perpendicular) with respect to a plane defined by thepledget substrate 514, as desired. - As indicated previously, various pledget material substrates were tested to evaluate desirable characteristics including tissue adhesion, ability to remove from tissue, abrasion/roughness (both when dry and wet), pliability and conformability, wettability, lateral stress deformation and post shearing integrity. Each sample tested was a circular swatch of material having a diameter of 0.250 inches.
- To test adhesion, a suture was threaded in the center of each pledget substrate sample. The pledget substrate sample was fully saturated with 0.9% saline and placed on a stainless steel sheet. The pledget substrate sample was pull tested in a direction normal to the planar surface of the stainless steel sheet. The adhesion ratings were assigned as indicated in Table 1 below and the results of each test are presented in Tables 5-14.
-
TABLE 1 Adhesion Ratings More than 1200 mg = Very Good 1001 mg to 1200 mg = Good 801 mg to 1000 mg = Acceptable 601 mg to 800 mg = Poor Less than 600 mg = Very Poor - To test each substrate material’s ability to remove or peel from tissue each pledget substrate sample was threaded with a suture near an edge of the pledget substrate sample. The pledget substrate sample was fully saturated with 0.9% saline and placed on a stainless steel sheet. The pledget substrate sample was pull tested at a 45 degree angle to the planar surface of the stainless steel sheet in the direction of the a central axis of the pledget substrate sample. The peel ratings were assigned as indicated in Table 2 below and the results of each test are presented in Tables 5-14.
-
TABLE 2 Peel Ratings Morethan 300 mg = Very Good 251 mg to 300 mg = Good 201 mg to 250 mg = Acceptable 151 mg to 200 mg = Poor Less than 150 mg = Very Poor - To test each substrate materials’ abrasion or roughness both dry and wet, samples of each substrate material were qualitatively evaluated by hand. To score each material, the Likert Scale Qualitative Quality Ratings were used as detailed in Table 3 below.
-
TABLE 3 Likert Scale Qualitative Quality Ratings Very Good Good Acceptable Poor Very Poor - To test each substrate material’s pliability/conformability, a 2 mm steel gauge pin was placed on a stainless steel surface. A pledget substrate sample fully saturated with 0.9% saline was draped over the pin and pressed using gloved fingers to conform the pledget substrate sample to the pin geometry. The force was removed and the pledget substrate samples were evaluated based on how well the pledget substrate remained conformed to the pin and
stainless steel surface 30 seconds after force removal. To score each material, the Likert Scale Qualitative Quality Ratings were used as detailed in Table 3 above. - To test wettability of each pledget substrate material, a drop of water was applied to the surface of a pledget substrate sample. The substrate sample was observed to see if it was: A) Hydrophilic (absorbs saline well); B) Medium (absorbs saline fairly well with some delay); or C) Hydrophobic (saline drop will sit on surface). The wettability ratings were assigned as summarized in Table 4 below.
-
TABLE 4 Wettability Ratings Very Good = Hydrophilic (absorbs saline well) Acceptable = Medium (absorbs saline fairly well with some delay) Very Poor = Hydrophobic (saline drop will sit on surface) - To test lateral stress deformation of each pledget substrate sample, samples were “stretched” laterally and evaluated based on materials willingness to plastically deform along any axis. To score each material, the Likert Scale Qualitative Quality Ratings were used as detailed in Table 3 above.
- To test post shearing integrity of each pledget substrate sample, each pledget substrate sample was sheared using surgical scissors and ranked qualitatively based on the integrity of the edge (i.e. did the sample exhibit a clean edge?, were there fibers extending beyond the cut line?, etc.) Shearing was performed on a dry pledget substrate sample. To score each material, the Likert Scale Qualitative Quality Ratings were used as detailed in Table 3 above.
- As can be seen by the results presented in Tables 5-14 below, the pledget substrate sample made of a 70% Rayon/ 30% PET blend performed superior overall as compared to other tested samples. The sample made of a 50% Rayon /50% PET blend also performed quite well overall as compared to the other samples.
-
TABLE 5 A - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 100% Rayon Resin-bond 31.1 0.28 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Poor 0.86 0.9 750 Peel Acceptable 0.86 1.7 250 Abrasion/Roughnes s (Dry) Very Poor 0.10 0.0 NIA Feels like a clothes dryer sheet Abrasion/Roughnes s (Wet) Poor 0.40 0.4 NIA Pliability/conformability Poor 0.86 0.9 NIA Conforms better in preferred orientation -anisotropic. Thinnest Material tested Wettability Very Good 1.00 4.0 Wettability Rating: Hydrophilic (absorbs saline well) Lateral stress deformation Very Good 0.29 12 Post shearing integrity Very Good 0.27 1.1 NIA Overall Score (0 to 4): 2.13 2.17 -
TABLE 6 B - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 100% Rayon Spunlace 53 0.37 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Acceptable 0.86 1.7 1000 Peel Good 0.86 2.6 300 Clings well to surface Abrasion/Roughness (Drv) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Very Good 0.86 3.4 NIA Conforms well in all orientations -Isotropic Wettability Very Good 1.00 4.0 Wettability Rating: Hydrophilic (absorbs saline well) Lateral stress deformation Very Poor 0.29 0.0 Easily deforms, risk that it may come free of final device. Post shearing integrity Acceptable 0.27 0.5 NIA Overall Score (0 to 4): 2.88 3.08 -
TABLE 7 C - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 65% Rayon/ 35 % PET Spunlace 50 0.35 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Very Good 0.86 3.4 1250 Peel Good 0.86 2.6 300 Abrasion/Roughness (Drv) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Good 0.86 2.6 NIA Conforms better in preferred orientation -anisotropic Wettability Very Good 1.00 4.0 Wettability Rating: Hydrophilic (absorbs saline well) Lateral stress deformation Poor 0.29 0.3 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4): 3.00 3.27 -
TABLE 8 D - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 80%PET /20% Viscose Spunlace 35 0.32 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Good 0.86 2.6 1100 Peel Acceptable 0.86 1.7 250 Very hydrophobic! Can leave a droplet sitting on sample. -relates to strength? Abrasion/Roughness (Dry) Good 0.10 0.3 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Poor 0.86 0.9 NIA Conforms better in preferred orientation - anisotropic Wettability Very Poor 1.00 0.0 Wettability Rating: Hydrophobic (saline drop will sit on surface) Lateral stress deformation Acceptable 0.29 0.6 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4): 2.00 1.71 -
TABLE 9 E - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 50 % Rayon 150% PET Spunlace 50 0.35 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Very Good 0.86 3.4 1250 Peel Very Good 0.86 3.4 325 Good peel strength -Sticks better in preferred orientation - anisotropic Abrasion/Roughness (Dry) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Good 0.86 2.6 NIA Wettability Acceptable 1.00 2.0 Wettability Rating: Medium (absorbs saline fairly well with some delay) Lateral stress deformation Good 0.29 0.9 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4): 3.13 3.15 -
TABLE 10 F - Sample Composition Technology Basis Weight, g/m2 Thickness, mm American Surgical Delicot® Product Reference Number 63-08 Spunlace 63 0.33 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Very Good 0.86 3.4 1250 Peel Very Good 0.86 3.4 400 Dry material exhibits some level ofbeing hydrophobic - relates to strength? Abrasion/Roughness (Dry) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Acceptable 0.86 1.7 NIA Conforms better in preferred orientation - anisotropic Wettability Acceptable 1.00 2.0 Wettability Rating: Medium (absorbs saline fairly well with some delay) Lateral stress deformation Good 0.29 0.9 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4); 3.00 2.96 -
TABLE 11 G - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 100% polypropylene Spunbound 36 approx. 0.33 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Acceptable 0.86 1.7 900 This sample is hard to wet and loses water and therefore adhesion easily Peel Acceptable 0.86 1.7 250 This sample is hard to wet and loses water and therefore adhesion easily Abrasion/Roughness (Dry) Good 0.10 0.3 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Very Poor 0.86 0.0 NIA Wettability Very Poor 1.00 0.0 Wettability Rating: Hydrophobic (saline drop will sit on surface) Lateral stress deformation Very Good 0.29 1.2 Post shearing integrity Good 0.27 0.8 NIA Overall Score (0 to 4): 2.25 1.58 -
TABLE 12 H - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 100% polypropylene Spunbound 40 approx. 0.33 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Poor 0.86 0.9 750 This sample is hard to wet and loses water and therefore adhesion easily Peel Acceptable 0.86 1.7 250 This sample is hard to wet and loses water and therefore adhesion easily Abrasion/Roughness (Dry) Good 0.10 0.3 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Very Poor 0.86 0.0 NIA Wettability Very Poor 1.00 0.0 Wettability Rating: Hydrophobic (saline drop will sit on surface) Lateral stress deformation Very Good 0.29 12 Post shearing integrity Good 0.27 0.8 NIA Overall Score (0 to 4): 2.13 1.39 -
TABLE 13 I - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 100% polypropylene Spunbound 45 approx. 0.33 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Poor 0.86 0.9 750 This sample is hard to wet and loses water and therefore adhesion easily Peel Acceptable 0.86 1.7 250 This sample is hard to wet and loses water and therefore adhesion easily Abrasion/Roughness (Dry) Good 0.10 0.3 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Very Poor 0.86 0.0 NIA Wettability Very Poor 1.00 0.0 Wettability Rating: Hydrophobic (saline drop will sit on surface) Lateral stress deformation Very Good 0.29 12 Post shearing integrity Good 0.27 0.8 NIA Overall Score (0 to 4): 2.13 1.39 -
TABLE 14 J - Sample Composition Technology Basis Weight, g/m2 Thickness, mm 70% Rayon/ 30 % PET Spunlace 40 0.23 Evaluation: Test Rating Weighting Weighted Score Quantitative Value (mg) Comments Adhesion Very Good 0.86 3.4 1250 Peel Very Good 0.86 3.4 350 Abrasion/Roughness (Dry) Very Good 0.10 0.4 NIA Abrasion/Roughness (Wet) Very Good 0.40 1.6 NIA Pliability/conformability Good 0.86 2.6 NIA Wettability Very Good 1.00 4.0 Wettability Rating: Hydrophilic (absorbs saline well) Lateral stress deformation Poor 0.29 0.3 Post shearing integrity Poor 0.27 0.3 NIA Overall Score (0 to 4): 3.13 3.45 - Referring now in addition to
FIGS. 17-19 , which include block diagrams of various systems 600-800 of the disclosure suitable for stimulation and recording during thyroidectomy and neck dissection cancer surgeries. With thesystem 600 ofFIG. 17 , one of theelectrode assemblies 604 of the disclosure (e.g.,electrode assembly potential monitoring system 602, which can be any of the type disclosed herein or known in the art including NIM Eclipse® (Part number 945NCCPUE4), NIM-Response® 3.0 (Part number 8253001) and NIM-Neuro® 3.0 nerve (part number 8253401), referenced above. In addition, thesystem 600 includes an EMG tube 606. Any known EMG tube is suitable. One example including model number 82-29707, TriVantage® EMG Tube 7 mm, available from Medtronic Xomed, Inc., Jacksonville, Florida. Aneural stimulation probe 608 is also provided.Suitable probes 608 include a Standard Prass Flush-Tippart (model number 8225101) or Incrementing Standard Prass Flush tip (model number 82-25825) both available from Medtronic Xomed, Inc., Jacksonville, Florida. - The system 700 of
FIG. 18 is similar and includes evokepotential monitoring system 602, one of the electrode assemblies 612 of the disclosure for EMG recording that is operatively connected to evokemonitoring system 602 and also an APS nerve stimulation electrode 610 (e.g., model number 8228052 APS Electrode 2 mm, available from Medtronic Xomed, Inc., Jacksonville, Florida) operatively connected to evokepotential monitoring system 602. This system also includesstimulation probe 608. - The
system 800 ofFIG. 19 includes evokepotential monitoring system 602 operatively connected to an electrode assembly of thedisclosure 604 for nerve stimulation,EMG tube 614 for recurrent laryngeal nerve and vagus nerve recording, one electrode assembly of the disclosure 616 for superior laryngeal nerve recording and alsostimulation probe 608. -
FIG. 20 is a block diagram of asystem 900 of the disclosure suitable for parotid surgery or scull base surgery continuous monitoring stimulation of a facial nerve. Thesystem 900 includes evokepotential monitoring system 602 operatively connected to one electrode assembly of thedisclosure 604 provided for stimulation of a facial nerve and a needleEMG recording electrode 618. One example of a suitable needle EMG recording electrode is model number 82-27411 Paired Subdermal Electrodes 4-CH, available from Medtronic Xomed, Inc., Jacksonville, Florida. In addition thesystem 900 includes thestimulation probe 608. -
FIG. 21 is a block diagram of asystem 1000 of the disclosure suitable for scull base surgery with an electrode assembly for continuous monitoring stimulation of a facial nerve and an electrode assembly of the disclosure for direct nerve monitoring of an 8th cranial nerve. Thesystem 1000 includes evokepotential monitoring system 602 operatively connected to one electrode assembly of thedisclosure 604 for attachment to and stimulation of a facial nerve. In addition, the evokepotential monitoring system 602 is connected to a needleEMG recording electrode 618. Additionally connected to evokepotential monitoring system 602 is one electrode assembly of the disclosure 620 for attaching to and recording bioelectric responses from an 8th cranial nerve.Stimulation probe 608 is also connected to evoke potential monitoring system. - Electrode assemblies disclosed herein can be used in a method of evoked potential monitoring used intraoperatively for nerve stimulation or biopotential recording throughout the body including cranial and peripheral and mixed motor nerves, for example. As indicated above, particularly with respect to
FIGS. 17-21 , it is envisioned that electrode assemblies of the disclosure can be used exclusively to replace or conjunction with standard electrodes, needle electrodes, continuous monitoring electrodes or with EMG tubes as a complementary method to apply evoked potential monitoring. - Electrode assemblies of the disclosure can be used for evoked potential monitoring throughout the body including cranial and peripheral more or sensory or mixed motor-sensory nerves during surgery, including cerebral cortex, spinal cord, and spinal nerve roots. The electrode assemblies of the disclosure can be used for stimulation, biopotential recording, therapeutic stimulation and automatic periodic stimulation (APS) continuous monitoring of nerves during evoked potential monitoring procedures including, but not limited to: intracranial, extracranial, intratemporal, extratemporal, neck dissections, thoracic surgeries, and upper and lower extremities, degenerative treatments, cortical mapping, pedicle screw procedures, fusion cages, rhizotomy, orthopedic surgery, open and percutaneous lumbar and cervical surgical procedures, and thoracic surgical procedures.
- As indicated above, use of the disclosed electrode assemblies for evoked potential monitoring methods can replace or supplant current methods. For example, during thyroidectomy procedures nerve monitoring is used to preserve and protect the nerves of the larynx (recurrent laryngeal nerve, superior laryngeal nerve, vagus nerve). Evoked potential monitoring (stimulating and recording) is typically accomplished by stimulating the nerve with a hand-held stimulator probe for locating and assessing neural function. Continuous monitoring stimulation of the vagus nerve is accomplished by use of Automatic Periodic Stimulation (APS). Recording the EMG responses is typically conducted by recording EMG from innervated muscle with an EMG tube (endorectal tube with integrated recording electrodes) or invasive needle electrodes placed in the muscles of the larynx percutaneously or intraorally. The present inventors have discovered current methods have shortcomings. The APS electrodes need to place circumferentially around the stimulated nerve which invasive and presents risk for neurological damage without careful dissection surgical skill. EMG tubes are specialty electrodes are complex and expensive. Both conventional devices are dependent on operator placement to be effective and time consuming to reposition.
- Methods of the disclosure for evoked potential monitoring (stimulation and/or recording) with electrode assemblies of the disclosure simplify device, placement positioning, and replacement if needed for improving the cost effectiveness and product application ease-of-use. The electrode assemblies of the disclosure can be replace an APS electrode in known systems (
FIGS. 17 and 19 ). The electrode assemblies of the disclosure can be wetted and placed on the nerve as compared to a known APS electrode that requires 360 degree dissection of the nerve the electrode will be applied to. The electrode assemblies of the disclosure can be used throughout the body. For example, the electrodes assemblies can be used to stimulate the vagus nerve during continuous monitoring during thyroid and neck dissection procedures. Electrode assemblies of the disclosure can also be used for stimulation during continuous monitoring of the facial nerves during parotid or skull base procedures (FIGS. 20-21 ). - It is envisioned that the electrode assemblies of the disclosure can also replace use of an EMG tube (
FIG. 18 ). The new electrode assemblies of the disclosure can be wetted and placed latterly on the exposed trachea as compared to an EMG tube electrode, which must be placed at intubation and positioned carefully to record proper EMG responses. Also, the EMG tube can be displaced during surgery which is difficult to visualize and remedy as it is also maintaining the patient airway during the operation. The pledget substrate placement is visually apparent and easily replaced or moved during the thyroid surgery. A twisted pair pledget substrate can be positioned with one electrode on each side of the trachea for single channel referential EMG recording or a pair can be placed on each side of the trachea for two channel side specific recording. - It is further envisioned that electrode assemblies of the disclosure can be placed directly on the cricothyroid muscle for recording specific superior laryngeal nerve responses as compared to needle electrodes, which are invasive and can damage the delicate musculature.
- For example, the electrode assemblies of the disclosure can record 8th cranial nerve evoked response or provide continuous stimulation of the facial nerve intracranially (
FIG. 21 ). Methods of using the electrode assemblies of the disclosure are easier and less evasive to place on delicate intracranial nerves. The electrode assemblies of the disclosure can be replace the use of a Cueva C-shaped electrode for cranial stimulation or recording nerve. The electrode assemblies of the disclosure can be wetted and placed on the nerve with minimal manipulation as compared to placing the Cueva C-shaped electrode around the nerve requires that the delicate intracranial nerve be dissected to accept the Cueva electrode. - One method of conducting an intraoperative nerve monitoring and/or stimulation procedure using the systems 600-1000 can generally be conducted as follows.
Electrode assemblies FIG. 12 utilized, the user can optionally disconnect the first and second bodies of the pledget substrate, either along the perforation or otherwise, as desired, it is to be understood that the system provided in the method includes one evoke potential monitoring system operatively connected to the electrode assembly. The connector of the lead wire assembly can be secured to the evoke potential monitoring system of the type disclosed herein either prior to or after the electrode assembly is positioned on the tissue. - In alternate embodiments, stimulation can be applied to the tissue via the electrode of the electrode assembly of
FIG. 7A , the user may optionally adjust the direction of the lead wire assembly via rotating the cup about the pledget substrate. - Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure. It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.
Claims (20)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US18/201,238 US20230301596A1 (en) | 2017-10-06 | 2023-05-24 | Pledget stimulation and recording electrodes assemblies |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762568841P | 2017-10-06 | 2017-10-06 | |
US16/152,624 US11672487B2 (en) | 2017-10-06 | 2018-10-05 | Pledget stimulation and recording electrode assemblies |
US18/201,238 US20230301596A1 (en) | 2017-10-06 | 2023-05-24 | Pledget stimulation and recording electrodes assemblies |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/152,624 Continuation US11672487B2 (en) | 2017-10-06 | 2018-10-05 | Pledget stimulation and recording electrode assemblies |
Publications (1)
Publication Number | Publication Date |
---|---|
US20230301596A1 true US20230301596A1 (en) | 2023-09-28 |
Family
ID=63963600
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/152,624 Active 2041-12-06 US11672487B2 (en) | 2017-10-06 | 2018-10-05 | Pledget stimulation and recording electrode assemblies |
US16/152,639 Active 2041-03-17 US11412986B2 (en) | 2017-10-06 | 2018-10-05 | Methods of recording responses of and stimulating bioelectric tissue |
US18/201,238 Pending US20230301596A1 (en) | 2017-10-06 | 2023-05-24 | Pledget stimulation and recording electrodes assemblies |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/152,624 Active 2041-12-06 US11672487B2 (en) | 2017-10-06 | 2018-10-05 | Pledget stimulation and recording electrode assemblies |
US16/152,639 Active 2041-03-17 US11412986B2 (en) | 2017-10-06 | 2018-10-05 | Methods of recording responses of and stimulating bioelectric tissue |
Country Status (8)
Country | Link |
---|---|
US (3) | US11672487B2 (en) |
EP (1) | EP3691525A1 (en) |
JP (1) | JP7266028B2 (en) |
KR (1) | KR20200067846A (en) |
CN (1) | CN111093493A (en) |
AU (1) | AU2018346604A1 (en) |
CA (1) | CA3073215A1 (en) |
WO (1) | WO2019071080A1 (en) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA3073215A1 (en) * | 2017-10-06 | 2019-04-11 | Medtronic Xomed, Inc. | Pledget stimulation and recording electrode assemblies |
US10729342B2 (en) | 2018-02-28 | 2020-08-04 | Medtronic Xomed, Inc. | Nerve monitoring and/or stimulation electrode assemblies |
CN110353635B (en) * | 2019-08-06 | 2020-07-17 | 浙江大学 | Neural detection device of neck operation |
CN110786845B (en) * | 2019-11-06 | 2020-06-02 | 清华大学 | Preparation method of self-adjusting binding force flexible electronic system |
JP7456230B2 (en) | 2020-03-26 | 2024-03-27 | Nok株式会社 | Biological electrode |
USD937420S1 (en) * | 2020-03-27 | 2021-11-30 | Top-Rank Health Care Co., Ltd. | Tens electrode |
USD937419S1 (en) * | 2020-03-27 | 2021-11-30 | Top-Rank Health Care Co., Ltd. | TENS electrode |
CN117771545A (en) * | 2024-02-26 | 2024-03-29 | 苏州新云医疗设备有限公司 | Implantable electric stimulator and electric stimulation system |
Family Cites Families (151)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2660175A (en) * | 1951-08-10 | 1953-11-24 | Clyde E Thrasher | Electrocardiograph electrode |
US2714196A (en) * | 1953-03-16 | 1955-07-26 | George M Melehan | Self-holding tool for testing electric circuits |
US2916719A (en) * | 1956-01-09 | 1959-12-08 | Bell Telephone Labor Inc | Terminal insulator |
US3072877A (en) * | 1961-05-05 | 1963-01-08 | George O Landwehr | Connection device |
US3085577A (en) * | 1961-06-12 | 1963-04-16 | Vector Mfg Company Inc | Body electrode |
US3295515A (en) * | 1963-11-05 | 1967-01-03 | Beckman Instruments Inc | Electrode assembly |
US3420223A (en) * | 1964-12-31 | 1969-01-07 | Nasa | Electrode for biological recording |
US3498291A (en) * | 1966-02-10 | 1970-03-03 | Lockheed Aircraft Corp | Body signal sensing electrode apparatus |
US3574305A (en) * | 1967-09-09 | 1971-04-13 | Hellige & Co Gmbh F | Electrode serving for the detection of electrophysiological potentials or currents |
US3599629A (en) * | 1968-08-28 | 1971-08-17 | Lexington Instr | Oxidized surface biopotential skin electrode |
US3998215A (en) * | 1968-12-18 | 1976-12-21 | Minnesota Mining And Manufacturing Company | Bio-medical electrode conductive gel pads |
US3581736A (en) * | 1968-12-20 | 1971-06-01 | Ilias Zenkich | Electrocardiograph electrode |
US3651547A (en) * | 1970-07-21 | 1972-03-28 | Hidenosuke Ishizaki | Socket member of snap fastener |
US3740703A (en) * | 1971-11-24 | 1973-06-19 | R Sessions | Terminal clamp |
US3946730A (en) * | 1972-01-21 | 1976-03-30 | Ndm Corporation | Biomedical electrode assembly |
US3750094A (en) * | 1972-03-09 | 1973-07-31 | Zenco Engineering Corp | Electrical connector |
US3830229A (en) * | 1972-08-09 | 1974-08-20 | J Johnson | Disposable body electrodes |
US3868165A (en) * | 1972-11-28 | 1975-02-25 | Donald I Gonser | Clamp for a passive electrode |
US3882853A (en) * | 1973-02-15 | 1975-05-13 | Cardiodynamics | Biomedical electrode |
US3890420A (en) * | 1973-06-04 | 1975-06-17 | Theodore C Neward | Method of making a bipolar electrode structure |
US4090752A (en) * | 1974-10-07 | 1978-05-23 | Baxter Travenol Laboratories, Inc. | Diagnostic electrode assembly |
US3993049A (en) * | 1974-12-26 | 1976-11-23 | Kater John A R | Electrodes and materials therefor |
US4274420A (en) * | 1975-11-25 | 1981-06-23 | Lectec Corporation | Monitoring and stimulation electrode |
US4066078A (en) * | 1976-02-05 | 1978-01-03 | Johnson & Johnson | Disposable electrode |
US4040697A (en) | 1976-04-07 | 1977-08-09 | Component Manufacturing Service, Inc. | Electrical connector |
US4126126A (en) * | 1976-07-27 | 1978-11-21 | C. R. Bard, Inc. | Non-metallic pregelled electrode |
AR216293A1 (en) | 1976-12-02 | 1979-12-14 | Leon De Pedro F | SELF-FIXING TOOTH ELECTRODE AND A GRIPPER FOR ITS MANEUVERING |
US4080961A (en) | 1976-12-22 | 1978-03-28 | Eaton Crosby J | Fetus scalp electrode instrument |
US4112941A (en) * | 1977-01-06 | 1978-09-12 | Minnesota Mining And Manufacturing Company | Electrode and magnetic connector assembly |
US4207904A (en) * | 1977-01-28 | 1980-06-17 | Greene Ronald W | Constant power density electrode adapted to be useful in bio-medical applications |
US4178052A (en) | 1977-10-13 | 1979-12-11 | Tronomed, Inc. | Medical terminal clip member for attachment to patient electrodes |
US4254764A (en) | 1979-03-01 | 1981-03-10 | Neward Theodore C | Clip electrode |
JPS5625681Y2 (en) * | 1978-12-20 | 1981-06-18 | ||
CA1111919A (en) | 1979-10-17 | 1981-11-03 | Davor Grunwald | Connector for electrodes |
US4522211A (en) * | 1979-12-06 | 1985-06-11 | C. R. Bard, Inc. | Medical electrode construction |
AU543967B2 (en) * | 1980-01-23 | 1985-05-09 | Minnesota Mining And Manufacturing Company | Conductive adhesive and biomedical electrode |
US4332257A (en) * | 1980-02-11 | 1982-06-01 | Bunker Ramo Corporation | Medical clip and electrode constructions |
JPS5933361Y2 (en) * | 1980-03-14 | 1984-09-18 | 日東電工株式会社 | electrode pad |
US4327737A (en) * | 1980-05-15 | 1982-05-04 | Roman Szpur | Medical electrode assembly |
US4331153A (en) * | 1980-11-13 | 1982-05-25 | Healy James W | Disposable EKG electrode |
US4385793A (en) | 1981-05-11 | 1983-05-31 | Allied Corporation | Medical terminal clip with anti-tangle device |
US4490005A (en) * | 1982-06-21 | 1984-12-25 | Minnesota Mining And Manufacturing Company | Electrical connector |
US4823794A (en) * | 1982-07-12 | 1989-04-25 | Pierce William S | Surgical pledget |
US4466441A (en) * | 1982-08-02 | 1984-08-21 | Medtronic, Inc. | In-line and bifurcated cardiac pacing lead connector |
GB2131297B (en) * | 1982-12-04 | 1986-04-30 | Bevans Lounds Clark | Body engaging electrode |
US4549545A (en) * | 1984-03-05 | 1985-10-29 | Ethicon Inc. | Segmented polyurethane surgical buttressing pledgets |
US4936306A (en) * | 1985-02-15 | 1990-06-26 | Doty James R | Device and method for monitoring evoked potentials and electroencephalograms |
US4617935A (en) * | 1985-03-12 | 1986-10-21 | Ndm Corporation | Medical electrode |
US4827939A (en) * | 1985-07-18 | 1989-05-09 | Baxter International Inc. | Medical electrode with reusable conductor and method of manufacture |
US4649923A (en) * | 1985-10-16 | 1987-03-17 | Murray Electronics Associates Limited | Temperature indicating electrotherapy electrode |
US4938231A (en) * | 1985-10-22 | 1990-07-03 | Telectronics N.V. | Defibrillator electrode |
US4653501A (en) * | 1986-04-17 | 1987-03-31 | Baxter Travenol Laboratories, Inc. | Medical electrode with reusable conductor |
US4777954A (en) | 1986-06-30 | 1988-10-18 | Nepera Inc. | Conductive adhesive medical electrode assemblies |
US4706680A (en) * | 1986-06-30 | 1987-11-17 | Nepera Inc. | Conductive adhesive medical electrode assemblies |
US4757817A (en) * | 1987-03-09 | 1988-07-19 | Lead-Lok, Inc. | Adhesive electrode pad |
EP0293068A1 (en) * | 1987-05-27 | 1988-11-30 | Teijin Limited | An electric therapeutic apparatus |
US4979517A (en) * | 1988-02-01 | 1990-12-25 | Physio-Control Corporation | Disposable stimulation electrode with long shelf life and improved current density profile |
US5078138A (en) * | 1988-09-22 | 1992-01-07 | Minnesota Mining And Manufacturing Company | Biomedical electrode construction having a non-woven material |
US5326272A (en) * | 1990-01-30 | 1994-07-05 | Medtronic, Inc. | Low profile electrode connector |
US5197471A (en) * | 1990-05-24 | 1993-03-30 | Otero Servio T A | Dry medical electrode |
US5464387A (en) * | 1991-07-24 | 1995-11-07 | Alza Corporation | Transdermal delivery device |
US5415164A (en) * | 1991-11-04 | 1995-05-16 | Biofield Corp. | Apparatus and method for screening and diagnosing trauma or disease in body tissues |
JP2818075B2 (en) * | 1992-05-27 | 1998-10-30 | 久光製薬株式会社 | Interface for iontophoresis |
US5421748A (en) | 1992-08-10 | 1995-06-06 | Filtec Filtertechnologie Fuer Die Elektronikindustrie | High-density, high-voltage-proof, multi-contact connector assembly |
US5232383A (en) * | 1992-10-21 | 1993-08-03 | Barnick Robert C | Medical snap connector |
US5431166A (en) * | 1993-01-22 | 1995-07-11 | Ludlow Corporation | Low profile medical electrode |
US5375594A (en) | 1993-03-29 | 1994-12-27 | Cueva; Roberto A. | Removable medical electrode system |
US5406945A (en) * | 1993-05-24 | 1995-04-18 | Ndm Acquisition Corp. | Biomedical electrode having a secured one-piece conductive terminal |
US5402780A (en) * | 1993-09-02 | 1995-04-04 | Faasse, Jr.; Adrian L. | Medical electrode with offset contact stud |
US5566672A (en) * | 1994-01-03 | 1996-10-22 | Labeltape Meditect, Inc. | Biomedical electrode |
JP2716361B2 (en) * | 1994-02-16 | 1998-02-18 | 株式会社アドバンス | Printed electrodes for living body |
US6135953A (en) * | 1996-01-25 | 2000-10-24 | 3M Innovative Properties Company | Multi-functional biomedical electrodes |
US6415170B1 (en) * | 1996-12-09 | 2002-07-02 | 3M Innovative Properties Company | Biomedical electrode and method for its manufacture |
US5928142A (en) * | 1996-12-17 | 1999-07-27 | Ndm, Inc. | Biomedical electrode having a disposable electrode and a reusable leadwire adapter that interfaces with a standard leadwire connector |
US5931861A (en) | 1997-04-25 | 1999-08-03 | Medtronic, Inc. | Medical lead adaptor having rotatable locking clip mechanism |
US5897406A (en) * | 1997-08-15 | 1999-04-27 | Molex Incorporated | Electrical terminal for glass sheets |
EP0962233A1 (en) * | 1998-06-03 | 1999-12-08 | Sport-Elec S.A. | Electrode unit for electrotherapy |
US6240323B1 (en) * | 1998-08-11 | 2001-05-29 | Conmed Corporation | Perforated size adjustable biomedical electrode |
US6223088B1 (en) * | 1998-11-09 | 2001-04-24 | Katecho, Incorporated | Electrode and connector assembly and method for using same |
KR20000074441A (en) * | 1999-05-21 | 2000-12-15 | 문국현 | Fluid Intake Intensifier |
US6308105B1 (en) | 1999-07-15 | 2001-10-23 | Medtronic Inc. | Medical electrical stimulation system using an electrode assembly having opposing semi-circular arms |
JP4601105B2 (en) * | 1999-12-24 | 2010-12-22 | スリーエム イノベイティブ プロパティズ カンパニー | Conductive adhesive and bioelectrode |
US6623664B2 (en) * | 1999-12-24 | 2003-09-23 | 3M Innovative Properties Company | Conductive adhesive and biomedical electrode |
US6321103B1 (en) * | 2000-03-21 | 2001-11-20 | The Ludlow Company Lp | Fetal spiral electrode sleeve and wire interconnect system |
JP3887796B2 (en) * | 2000-04-13 | 2007-02-28 | 日本光電工業株式会社 | Biological electrode |
US6496727B1 (en) * | 2000-05-31 | 2002-12-17 | Becton, Dickinson And Company | Medicament-loaded transdermal reservoir and method for its formation |
US20040176831A1 (en) * | 2000-07-13 | 2004-09-09 | Gliner Bradford Evan | Apparatuses and systems for applying electrical stimulation to a patient |
US20050021118A1 (en) * | 2000-07-13 | 2005-01-27 | Chris Genau | Apparatuses and systems for applying electrical stimulation to a patient |
US20020035381A1 (en) * | 2000-09-18 | 2002-03-21 | Cameron Health, Inc. | Subcutaneous electrode with improved contact shape for transthoracic conduction |
WO2004019902A1 (en) * | 2002-08-30 | 2004-03-11 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive gel composition for iontophoresis preparation and process for producing the same |
US20040111139A1 (en) * | 2002-12-10 | 2004-06-10 | Mccreery Douglas B. | Apparatus and methods for differential stimulation of nerve fibers |
US7627384B2 (en) | 2004-11-15 | 2009-12-01 | Bio Control Medical (B.C.M.) Ltd. | Techniques for nerve stimulation |
US7477939B2 (en) * | 2003-06-30 | 2009-01-13 | Johnson & Johnson Consumer Companies, Inc. | Methods of treating a wound with galvanic generated electricity |
US7797058B2 (en) | 2004-08-04 | 2010-09-14 | Ndi Medical, Llc | Devices, systems, and methods employing a molded nerve cuff electrode |
US8275454B2 (en) * | 2003-12-26 | 2012-09-25 | Hisamitsu Pharmaceutical Co., Inc. | Iontophoresis device activated in use |
KR20050072965A (en) * | 2004-01-08 | 2005-07-13 | 림스테크널러지주식회사 | Active dry sensor module for measurement of bioelectricity |
US20060258973A1 (en) * | 2005-04-27 | 2006-11-16 | Kevin Volt | Micro-current Iontophoretic Percutaneous Absorptive Patch |
US7620439B2 (en) * | 2005-08-04 | 2009-11-17 | 3M Innovative Properties Company | Conductive adhesives and biomedical articles including same |
US20070185432A1 (en) * | 2005-09-19 | 2007-08-09 | Transport Pharmaceuticals, Inc. | Electrokinetic system and method for delivering methotrexate |
JP4805693B2 (en) * | 2006-03-01 | 2011-11-02 | Tti・エルビュー株式会社 | Iontophoresis device and manufacturing method thereof |
US7761131B2 (en) * | 2006-05-30 | 2010-07-20 | Tyco Healthcare Group Lp | Medical electrode containing a hydrophilic polymer |
US7346380B2 (en) * | 2006-06-16 | 2008-03-18 | Axelgaard Manufacturing Co., Ltd. | Medical electrode |
US8868211B2 (en) | 2006-08-15 | 2014-10-21 | Case Western Reserve University | Nerve cuff for implantable electrode |
US7445522B2 (en) * | 2006-12-05 | 2008-11-04 | Tyco Healthcare Group Lp | Electrode connector |
US8238995B2 (en) * | 2006-12-08 | 2012-08-07 | General Electric Company | Self-adhering electrodes and methods of making the same |
US8197844B2 (en) * | 2007-06-08 | 2012-06-12 | Activatek, Inc. | Active electrode for transdermal medicament administration |
US8406843B2 (en) * | 2008-04-04 | 2013-03-26 | Mark Tiegs | ECG monitoring electrode |
CA2722982A1 (en) | 2008-05-02 | 2009-11-05 | Medtronic, Inc. | Self expanding electrode cuff |
US9014778B2 (en) * | 2008-06-24 | 2015-04-21 | Biosense Webster, Inc. | Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems |
US9737225B2 (en) * | 2008-06-24 | 2017-08-22 | Biosense Webster, Inc. | Patch and sensor assembly for use in medical device localization and mapping systems |
US20100082088A1 (en) * | 2008-08-27 | 2010-04-01 | Ali Fassih | Treatment of sweating and hyperhydrosis |
US7819710B2 (en) * | 2008-09-23 | 2010-10-26 | Tyco Electronics Corporation | Termination cap for terminating an electrical lead directly to a stud of an electrode and an electrode lead assembly containing such termination cap |
US8251736B2 (en) * | 2008-09-23 | 2012-08-28 | Tyco Electronics Corporation | Connector assembly for connecting an electrical lead to an electrode |
US8515520B2 (en) | 2008-12-08 | 2013-08-20 | Medtronic Xomed, Inc. | Nerve electrode |
US9084551B2 (en) | 2008-12-08 | 2015-07-21 | Medtronic Xomed, Inc. | Method and system for monitoring a nerve |
US20100168831A1 (en) | 2008-12-30 | 2010-07-01 | Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College | Implantable clip-on micro-cuff electrode for functional stimulation and bio-potential recording |
US9061134B2 (en) * | 2009-09-23 | 2015-06-23 | Ripple Llc | Systems and methods for flexible electrodes |
JP5463136B2 (en) * | 2009-12-22 | 2014-04-09 | 帝國製薬株式会社 | Electrode device used for iontophoresis therapy |
JP5841951B2 (en) * | 2010-02-01 | 2016-01-13 | プロテウス デジタル ヘルス, インコーポレイテッド | Data collection system |
KR101034998B1 (en) * | 2010-02-18 | 2011-05-17 | 대한메디칼시스템(주) | Connecting structure for snap electrode and electric wire |
KR101203768B1 (en) | 2011-02-23 | 2012-11-21 | 신현우 | Low-frequency stimulation electrode conductive hydrogel patch containing ingredients for alleviating pain and inflammation |
US8868217B2 (en) * | 2011-06-27 | 2014-10-21 | Bioness Neuromodulation Ltd. | Electrode for muscle stimulation |
US8812100B2 (en) * | 2012-05-10 | 2014-08-19 | Ethicon Endo-Surgery, Inc. | Device and method for self-positioning of a stimulation device to activate brown adipose tissue depot in a supraclavicular fossa region |
US9114250B2 (en) | 2012-10-02 | 2015-08-25 | Cardiac Pacemakers, Inc. | Pinch to open cuff electrode |
WO2014055393A1 (en) | 2012-10-02 | 2014-04-10 | Cardiac Pacemakers, Inc. | Pinch to open cuff electrode |
US9108039B2 (en) * | 2012-11-15 | 2015-08-18 | Zoll Medical Corporation | Electrode construction for crevice corrosion protection |
US20140142410A1 (en) * | 2012-11-19 | 2014-05-22 | Strohl Medical | Nerve Stimulation Electrodes |
EP2948090B1 (en) * | 2013-01-23 | 2018-09-12 | Medtronic Xomed, Inc. | Navigated surgical instrument comprising a flexible circuit sheet |
US9226680B1 (en) * | 2013-02-12 | 2016-01-05 | David Kendricks | Patient electrode connectors for electrocardiograph monitoring system |
CA2919379C (en) * | 2013-08-01 | 2021-03-30 | Tendyne Holdings, Inc. | Epicardial anchor devices and methods |
US9901262B2 (en) * | 2013-12-18 | 2018-02-27 | Promedica Health System, Inc. | Mobile transducer holder assembly |
US11219413B2 (en) * | 2014-08-26 | 2022-01-11 | Dexcom, Inc. | Systems and methods for securing a continuous analyte sensor to a host |
KR102403492B1 (en) | 2014-10-30 | 2022-06-02 | 주식회사 인바디 | Electrode for measuring living body signal |
WO2016080082A1 (en) * | 2014-11-17 | 2016-05-26 | 積水化成品工業株式会社 | Pad for electrodes |
JP6370204B2 (en) * | 2014-12-09 | 2018-08-08 | 日本光電工業株式会社 | Defibrillation pad |
JP2018501061A (en) * | 2014-12-22 | 2018-01-18 | スリーエム イノベイティブ プロパティズ カンパニー | Biomedical electrode with discontinuous primer layer |
WO2016109851A1 (en) * | 2015-01-04 | 2016-07-07 | Thync, Inc. | Methods and apparatuses for transdermal stimulation of the outer ear |
CA2994436A1 (en) * | 2015-08-26 | 2017-03-02 | Element Science, Inc. | Wearable devices |
US10596367B2 (en) | 2016-01-13 | 2020-03-24 | Setpoint Medical Corporation | Systems and methods for establishing a nerve block |
US20170216584A1 (en) * | 2016-01-29 | 2017-08-03 | Insung Information Co., Ltd. | Sheet mask for iontophoresis and mask assembly using the same |
EP3219357A1 (en) * | 2016-03-17 | 2017-09-20 | BIOTRONIK SE & Co. KG | System, method and tool for implanting peripheral nerve electrode cuff |
US10413183B2 (en) * | 2016-04-08 | 2019-09-17 | Medtronic Minimed, Inc. | Insertion device |
US10653331B2 (en) | 2016-05-24 | 2020-05-19 | Konan Medical Usa, Inc. | Electrode sensor |
US9955882B2 (en) | 2016-08-31 | 2018-05-01 | Medtronic Xomed, Inc. | System to monitor neural integrity |
US10994130B2 (en) | 2016-09-06 | 2021-05-04 | Biocircuit Technologies, Inc. | Devices and methods for repairing damage to a nerve |
US20180085573A1 (en) * | 2016-09-27 | 2018-03-29 | National Guard Health Affairs | Skull implanted electrode assembly for brain stimulation |
CA3073215A1 (en) * | 2017-10-06 | 2019-04-11 | Medtronic Xomed, Inc. | Pledget stimulation and recording electrode assemblies |
US10729342B2 (en) * | 2018-02-28 | 2020-08-04 | Medtronic Xomed, Inc. | Nerve monitoring and/or stimulation electrode assemblies |
JPWO2019230730A1 (en) * | 2018-05-30 | 2021-08-12 | リンテック株式会社 | Cloth material with electrode wiring |
US20210228441A1 (en) * | 2020-01-27 | 2021-07-29 | Zoll Medical Corporation | Dual Sensor Implementations for Providing Resuscitative Chest Compression Feedback |
US11367974B1 (en) * | 2021-06-14 | 2022-06-21 | Daniel R. Judd | ECG electrode connector |
-
2018
- 2018-10-05 CA CA3073215A patent/CA3073215A1/en active Pending
- 2018-10-05 AU AU2018346604A patent/AU2018346604A1/en not_active Abandoned
- 2018-10-05 KR KR1020207011720A patent/KR20200067846A/en unknown
- 2018-10-05 JP JP2020516544A patent/JP7266028B2/en active Active
- 2018-10-05 EP EP18792807.2A patent/EP3691525A1/en active Pending
- 2018-10-05 US US16/152,624 patent/US11672487B2/en active Active
- 2018-10-05 CN CN201880058050.1A patent/CN111093493A/en active Pending
- 2018-10-05 WO PCT/US2018/054530 patent/WO2019071080A1/en unknown
- 2018-10-05 US US16/152,639 patent/US11412986B2/en active Active
-
2023
- 2023-05-24 US US18/201,238 patent/US20230301596A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
JP2020536600A (en) | 2020-12-17 |
US20190104956A1 (en) | 2019-04-11 |
KR20200067846A (en) | 2020-06-12 |
JP7266028B2 (en) | 2023-04-27 |
US11672487B2 (en) | 2023-06-13 |
CA3073215A1 (en) | 2019-04-11 |
EP3691525A1 (en) | 2020-08-12 |
WO2019071080A1 (en) | 2019-04-11 |
US11412986B2 (en) | 2022-08-16 |
AU2018346604A1 (en) | 2020-03-19 |
US20190104995A1 (en) | 2019-04-11 |
CN111093493A (en) | 2020-05-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20230301596A1 (en) | Pledget stimulation and recording electrodes assemblies | |
JP6902464B2 (en) | Selective nerve fiber blocking methods and systems | |
US11426109B2 (en) | Nerve monitoring and/or stimulation electrode assemblies | |
McAdams | Biomedical electrodes for biopotential monitoring and electrostimulation | |
CN206576856U (en) | A kind of adjustable neurostimulation probe in direction | |
JP6131390B2 (en) | Multi-electrode lead having a substrate for MECHO / baroreceptor stimulation | |
Hannan et al. | Frequency-dependent characterisation of impedance changes during epileptiform activity in a rat model of epilepsy | |
Beck et al. | Intraoperative facial nerve monitoring Technical aspects | |
US20070213796A1 (en) | Ring electrode | |
Stechison | Neurophysiologic monitoring during cranial base surgery | |
WO2020086254A1 (en) | Stimulation probe assemblies and methods of use |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: MEDTRONIC XOMED, INC., COLORADO Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CANTWELL, MATTHEW L.;HACKER, DAVID C.;PRISCO, JOHN R.;AND OTHERS;SIGNING DATES FROM 20171102 TO 20171114;REEL/FRAME:063774/0274 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
AS | Assignment |
Owner name: MEDTRONIC XOMED, INC., FLORIDA Free format text: CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE'S ADDRESS PREVIOUSLY RECORDED AT REEL: 063774 FRAME: 0274. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT;ASSIGNORS:CANTWELL, MATTHEW L.;HACKER, DAVID C.;PRISCO, JOHN R.;AND OTHERS;SIGNING DATES FROM 20171102 TO 20171114;REEL/FRAME:064008/0915 |