NL2023289B1 - Neuromonitoring device and apparatus and method of use during neurosurgery - Google Patents

Neuromonitoring device and apparatus and method of use during neurosurgery Download PDF

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Publication number
NL2023289B1
NL2023289B1 NL2023289A NL2023289A NL2023289B1 NL 2023289 B1 NL2023289 B1 NL 2023289B1 NL 2023289 A NL2023289 A NL 2023289A NL 2023289 A NL2023289 A NL 2023289A NL 2023289 B1 NL2023289 B1 NL 2023289B1
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NL
Netherlands
Prior art keywords
electrically conductive
cannula
neuromonitoring
conductive portion
elongate member
Prior art date
Application number
NL2023289A
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Dutch (nl)
Inventor
John Labuschagne Jason
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John Labuschagne Jason
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Publication date
Application filed by John Labuschagne Jason filed Critical John Labuschagne Jason
Priority to NL2023289A priority Critical patent/NL2023289B1/en
Priority to PCT/IB2020/055440 priority patent/WO2020250140A1/en
Application granted granted Critical
Publication of NL2023289B1 publication Critical patent/NL2023289B1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00071Electrical conductivity
    • A61B2018/00083Electrical conductivity low, i.e. electrically insulating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • A61B2018/0044Spinal cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • A61B2018/00446Brain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00875Resistance or impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means
    • A61B2090/0808Indication means for indicating correct assembly of components, e.g. of the surgical apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36017External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin

Abstract

This invention relates to a neuromonitoring apparatus which may be utilised together with a biopsy device, endoscope or an ablation device. The invention, further, relates 5 to a method of utilising the neuromonitoring apparatus during neuromonitoring and surgery. There is provided for the neuromonitoring apparatus to be comprised of a cannula having an elongate working channel which is insertable into tissue of a patient; and an electrically conductive elongate member which is configured to be passed down the elongate working channel of said cannula, the surface of the electrically conductive 10 elongate member being electrically insulated with an exposed electrically conductive portion located at a distal region of said electrically conductive elongate member and which is shaped and configured to be located in the outlet opening of the cannula, wherein, in use, the exposed electrically conductive portion transmits an electrical conductivity signal of the tissue of the patient. 15 Fig. 1

Description

P34144NLOO/RLA
NEUROMONITORING DEVICE AND APPARATUS AND METHOD OF USE DURING NEUROSURGERY
FIELD OF THE INVENTION This invention relates to a neuromonitoring device and apparatus. More particularly, but not exclusively so, this invention relates to a neuromonitoring device which may be utilised, together with a biopsy device, endoscope or an ablation device during percutaneous intracranial monitoring and surgery. The invention, further, relates to a method of utilising the neuromonitoring device and apparatus during neuromonitoring and surgery.
BACKGROUND TO THE INVENTION Diagnosis and treatment of conditions affecting the brain are notoriously difficult and complex. The brain is a delicate soft tissue structure that controls bodily functions through a complex neural network which is connected to the rest of the body through the spinal cord. Both the brain and the spinal cord are protected by bony structures which present unique challenges during the diagnosis and treatment of conditions affecting the brain. Furthermore, owing to the complex nature of the brain, it is of the utmost importance that the surgeon identifies and performs targeted investigation and/or treatment (e.g. ablation, stimulation, manipulation etc.) on the relevant lesion or tissue, whilst leaving surrounding brain tissue intact and undamaged, or at least minimising damage to surrounding tissue. Typically, patients present with symptoms that require a physician to capture images of the brain. These images may reveal lesions of uncertain causes. In order to recommend the correct treatment, a physician may require a brain biopsy to obtain a specimen that a pathologist can review for an accurate diagnosis. Often, a neurosurgeon will use stereotactic equipment to localize the preferable site for the biopsy, manipulation or surgery. This allows the neurosurgeon to map the brain in a three-dimensional coordinate system and select the appropriate target coordinates for guiding a biopsy needle/suction device and/or neuromonitoring probe. In mapping the brain, the neurosurgeon often employs a process known as stereotaxis. Stereotaxis is a process by which neurosurgeons use MRI or CT imaging studies, targeted algorithms and a computer to locate and target a tumour or other lesion inside the brain. Stereotaxis processes and techniques have no doubt proved themselves to be of immense assistance to neurosurgeons. However, there remains a need for a device and method by which brain tissue and lesions may be investigated directly and in real- time prior to ablation of a targeted lesion or for manipulation or surgery. Monitoring of neural elements can reduce the likelihood of neural damage during surgery near or in delicate neural structures. Signals from intro-operative neuromonitoring probes are recorded and evaluated for signs of irritation or damage to neural structures, via commercially available neuromonitoring devices. A disadvantage of these neuromonitoring devices is that neuromonitoring can only be done during open surgery which presents the known risks and complications to patients.
OBJECT OF THE INVENTION It is accordingly an object of the present invention to provide a neuromonitoring device and apparatus with which a neurosurgeon may intraoperatively and directly investigate brain tissue and lesions.
SUMMARY OF THE INVENTION According to a first aspect of the present invention, there is provided a neuromonitoring device for a cannula, the cannula comprising: — an elongate working channel which extends from an inlet opening to an outlet opening, the elongate working channel being insertable into tissue of a patient, the neuromonitoring device comprising:
— an electrically conductive elongate member which is configured to be inserted through the inlet opening of the cannula and to be passed down the elongate working channel of said cannula, the surface of the electrically conductive elongate member being electrically insulated with an exposed electrically conductive portion located at a distal region of said electrically conductive elongate member and which is shaped and configured to be located in the outlet opening of the cannula, wherein, in use, the exposed electrically conductive portion transmits an electrical conductivity signal of the tissue of the patient.
There is provided for the outlet opening of the cannula to take the form of a side window at a distal region of the elongate working channel and for the elongate working channel to terminate at a distal region, further, there is provided for the exposed electrically conductive portion of the electrically conductive elongate member to be shaped and configured to be located in the side window of the cannula.
There is provided for the cannula to take the form of any one of an endoscope and a neuro-navigation device.
The exposed electrically conductive portion may have electrical impedance spectroscopy capability. It is envisaged that the electrically conductive portion may have interdigitated electrodes for electrical impedance sensing. The exposed electrically conductive portion may be covered in a microelectrode array which is configured for multi-point electrical impedance sensing.
The neuromonitoring device may include a guide for receiving a complementary formation located on the cannula. The invention further provides for the neuromonitoring device to include a guideline which is complementary to a guideline of the cannula such that the exposed electrically conductive portion is operatively located in the outlet opening.
There is further provided for the neuromonitoring device to further comprise an adjustable sheath arrangement which is configured to reversibly cover a portion of the exposed electrically conductive portion.
The adjustable sheath arrangement may be separate from the neuromonitoring device and may be shaped and configured to be insertable through the inlet opening and passed down the elongate working channel of the cannula so as to, at least partially, encapsulate the neuromonitoring device.
There is provided for the exposed electrically conductive portion to fit in the outlet opening by means of an integral attachment feature. The integral attachment feature may be any one of an annular snap-fit, a cantilever snap-fit and a torsional snap-fit. According to a second aspect of the present invention, there is provided a neuromonitoring apparatus comprising: — a cannula comprising: o an elongate working channel which extends from an inlet opening to an outlet opening, the elongate working channel being insertable into tissue of a patient; and — an electrically conductive elongate member which is configured to be inserted through the inlet opening of the cannula and to be passed down the elongate working channel of said cannula, the surface of the electrically conductive elongate member being electrically insulated with an exposed electrically conductive portion located at a distal region of said electrically conductive elongate member and which is shaped and configured to be located in the outlet opening of the cannula, wherein, in use, the exposed electrically conductive portion transmits an electrical conductivity signal of the tissue of the patient.
There is provided for the outlet opening of the cannula to take the form of a side window at a distal region of the elongate working channel and for the elongate working channel to terminate at a distal region, further, there is provided for the exposed electrically conductive portion of the electrically conductive elongate member to be shaped and configured to be located in the side window of the cannula. The exposed electrically conductive portion may have electrical impedance spectroscopy capability. It is envisaged that the electrically conductive portion may have interdigitated electrodes for electrical impedance sensing. The exposed electrically conductive portion may be covered in a microelectrode array which is configured for multi-point electrical impedance sensing.
The electrically conductive elongate member may include a guide for receiving a 5 complementary formation located on the cannula. The invention further provides for the electrically conductive elongate member to include a guideline which is complementary to a guideline of the cannula such that the exposed electrically conductive portion is located in the outlet opening.
There is provided for the neuromonitoring apparatus to further comprise an adjustable sheath arrangement which is configured to reversibly cover a portion of the exposed electrically conductive portion.
The adjustable sheath arrangement may be shaped and configured to be insertable through the inlet opening of the cannula and passed down the elongate working channel of said cannula so as to, at least partially, encapsulate the electrically conductive elongate member.
It is envisaged that the electrically conductive elongate member may include a formation which is complementary to a formation disposed on the cannula for receiving the electrically conductive elongate member.
There is further provided for the exposed electrically conductive portion to fit in the outlet opening by means of an integral attachment feature. The integral attachment feature may be any one of an annular snap-fit, a cantilever snap-fit and a torsional snap-fit.
There is provided for the cannula to take the form of any one of an endoscope and a neuro-navigation device.
According to a third aspect of the present invention, there is provided a method of intra- operative neuromonitoring using the neuromonitoring device and/or apparatus in accordance with the first and second embodiments, the method including the steps of:
— inserting, at least partially, the cannula of the neuromonitoring apparatus into tissue of the patient; — positioning the outlet opening of the cannula proximate the targeted tissue of the patient; — inserting the electrically conductive elongate member into the inlet opening of the cannula; — passing the electrically conductive elongate member down the elongate working channel of the cannula; — aligning the exposed electrically conductive portion with the outlet opening of the cannula; and — transmitting, via the exposed electrically conductive portion and the electrically conductive elongate member, an electrical conductivity signal of the targeted tissue of the patient.
The step of aligning the exposed electrically conductive portion with the outlet opening of the cannula may include the step of aligning a guideline provided on the electrically conductive elongate member with a complimentary guideline of the cannula such that the exposed electrically conductive portion is located in the outlet opening.
There is provided for the cannula to take the form of any one of an endoscope and a neuro-navigation device.
The invention yet further provides for the method of intra-operative neuromonitoring to be followed by the step of performing a biopsy including the steps of withdrawing the electrically conductive elongate member from the cannula and inserting a biopsy needle, suction device etc. and performing a biopsy.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS Two embodiments of the invention are described below, by way of non-limiting examples only and with reference to the accompanying drawings in which:
figure 1 is a perspective view of the neuromonitoring apparatus according to a first embodiment of the invention with the electrically conductive elongate member outside of the cannula; figure 2 is a perspective view of the neuromonitoring apparatus according to the first embodiment of the invention with the electrically conductive elongate member inside the cannula; figure 3 is a side view of the neuromonitoring apparatus according to the first embodiment of the invention with the electrically conductive elongate member inside the cannula; and figure 4 is a perspective view of a neuromonitoring apparatus according to a second embodiment of the invention with the electrically conductive elongate member outside of the cannula.
DETAILED DESCRIPTION OF THE INVENTION With reference to the accompanying drawings, in which like numerals refer to like features, a first embodiment of the neuromonitoring apparatus is generally indicated by reference numeral 10 in figures 1 to 3 and a second embodiment of the neuromonitoring apparatus is generally indicated by reference number 100 in figure 4.
As shown in figure 1, the neuromonitoring apparatus 10 includes a cannula 12 and a neuromonitoring device in the form of an electrically conductive elongate member 14.
The cannula 12 includes an elongate working channel 16 which extends from an inlet opening 18 of the cannula 12 and terminates at a distal region 20 of the cannula 12.
The cannula 12 has a side window 22 proximate the distal region 20 which operatively exposes an inside portion of the elongate working channel 16 to tissue (not shown) of the patient (not shown) which is adjacent to the side window 22. In a preferred embodiment of the invention, the elongate working channel 16 is made of an electrically conductive material (e.g. 304 stainless steel).
The electrically conductive elongate member 14 is configured to be inserted through the inlet opening 18 of the cannula 12 and to be passed down the elongate working channel 16 of the cannula 12. The electrically conductive elongate member 14 has an exposed electrically conductive portion 24 located at a distal region of the electrically conductive elongate member 14. The exposed electrically conductive portion 24 is shaped and configured to be located in the side window 22 of the cannula 12. The remaining surface of the electrically conductive elongate member 14 is electrically insulated so as to not transmit an electrical current or signal between the elongate working channel 16 and the electrically conductive elongate member. The electrically conductive elongate member 14 is preferably manufactured from biocompatible Pebax® tubing and stainless steel.
The electrically conductive elongate member 14 further includes a cable 26 for transmitting an electrical signal which is received by the electrically conductive elongate member 14 to an EMG processor (not shown). As will be explained below, the processor may be utilised to calculate the electrical impedance to enable a surgeon to discriminate between different tissue types and to record and evaluate signs of irritation/damage to the relevant neural structure in the known manner.
Inuse, as shown in figures 2 and 3, the elongate working channel 16 is, at least partially, inserted into tissue (not shown) of a patient (not shown). Hereafter, the electrically conductive elongate member 14 is inserted through the inlet opening 18 of the cannula 12 and passed down the elongate working channel 16 of said cannula 12. The electrically conductive elongate member 14 is passed down the elongate working channel 16 of the cannula 12 until the exposed electrically conductive portion 24 fits within the side window 22 of the cannula 12. In this respect, guide lines 28 and 30 are respectively provided on the electrically conductive elongate member 14 and cannula 12 respectively to ensure proper alignment of the exposed electrically conductive portion 24 with the side window 22.
With the exposed electrically conductive portion 24 located in the side window 22 of the cannula 12, the electrical conductivity of tissue of the patient which is adjacent to the side window 22 may be transmitted to the EMG processing unit (not shown). Therefore, the electrical properties of the tissue which is adjacent to the side window 22 can be investigated by measuring the electrical impedance between the elongate working channel 16 and the exposed electrically conductive portion 24 as mentioned above.
In an alternative embodiment, the exposed electrically conductive portion 24 itself may have electrical impedance spectroscopy capability. The exposed electrically conductive portion 24 may have interdigitated electrodes (not shown) for electrical impedance sensing. In this embodiment, the electrical impedance between the interdigitated electrodes is measured, as opposed to the elongate working channel 16 and the exposed electrically conductive portion 24.
In a still further embodiment, the exposed electrically conductive portion 24 may be covered in a microelectrode array which is configured for multi-point electrical impedance sensing.
It is known that the electrical impedance is considered as a prominent indicator to discriminate between tissue types and to investigate the biological behaviours or changes of biological matters due to its high sensitivity. For example, the differences of electrical impedances between normal and cancerous tissues have been reported on.
Therefore, by measuring the electrical impedance of tissue (not shown), the neuromonitoring apparatus 10 provides a surgeon with a real-time analysis of the tissue type and its characteristics which is adjacent to the side window 22 and exposed electrically conductive portion 24. The location of the side window 22 furthermore allows adistinct and enlarged geometry to which the stimulation current can be delivered. The neuromonitoring apparatus 10 is utilised to pass an electrical stimulus via the electrically conductive elongate member 14 to tissue (not shown) of the patient (not shown) which is adjacent to the side window 22. By passing an electrical stimulus to the exposed electrically conductive portion 24 of the electrically conductive elongate member 14, a stimulus can be applied to tissue (not shown) of the patient (not shown) to determine, by using standard intro-operative neuro-monitoring methods, including, but not limited to, EMG, motor evoked potentials, direct nerve stimulation, cortical and subcortical stimulation, if the tissue adjacent to the side window 22 and exposed electrically conductive portion 24 is eloquent tissue or not, and if it can or should be manipulated, biopsied or if it should be preserved.
The elongate working channel 16 may also have interdigitated electrodes or a microelectrode array configured along its length and on its surface.
This will enable the surgeon to monitor tissue which is adjacent to the length of the elongate working channel 16. In this embodiment, a further cable for transmitting an electrical signal which is received by the elongate working channel 16, via the interdigitated electrodes or microelectrode array which is arranged along the length of the elongate working channel 16, to a processor (not shown). As mentioned above, the guidelines 28 and 30 indicate to the surgeon when the exposed electrically conductive portion 24 is located in the side window 22 of the cannula 12 to avoid actuation of the electrically conductive portion 24 when not exposed in the side window 22. Such incorrect use may lead to electrical signals flowing in the elongate working channel 16 thereby providing incorrect information to the surgeon and/or damage tissue of the patient.
The exposed electrically conductive portion is also configured to fit in the side window by means of an integral attachment feature (not shown) to ensure that the two components are properly fitted in alignment for the operation described above.
The integral attachment feature may be any one of an annular snap-fit, a cantilever snap-fit and a torsional snap-fit.
Further to this feature, the electrically conductive elongate member may include a formation (not shown) which is complementary to a guide of the cannula for receiving a complementary formation of the cannula to ensure that the components are properly fitted.
This minimises human error and promotes safety to the patient.
In alternative embodiment not shown, the neuromonitoring apparatus 10 includes an adjustable sheath arrangement (not shown) which is configured to reversibly cover a portion of the exposed electrically conductive portion 22 if required.
The adjustable sheath arrangement (not shown) may take many forms.
For example, the adjustable sheath arrangement (not shown) may take the form of a second cannula (not shown) which has a second, adjustable, side window (not shown). The second cannula {not shown) may be shaped and configured to encapsulate, at least partially, the electrically conductive elongate member 14, whilst said electrically conductive elongate member 14 is located in the working cannula 16 of the ablation device 12. Here, the second side window {not shown) would leave a portion of the exposed electrically conductive portion 22 exposed to tissue (not shown) which is adjacent to the side window 22 of the working cannula 16. The shape of the second side window (not shown) may be any form, including a circle, a rectangular, etc. The extent to which the second side window (not shown) exposes the exposed electrically conductive portion 24 may be adjustable. There is provided for the second side window (not shown) to be smaller in size than the side window 22 of the cannula 12. For example, the second side window (not shown) may be shorter in length or thinner than the side window 22 of the cannula 12.
With reference to figure 4, the neuromonitoring apparatus 100 according to a second embodiment of the invention includes a cannula 120 and a neuromonitoring device in the form of an electrically conductive elongate member 140.
The cannula 120 includes an elongate working channel 160 which extends from an inlet opening 180 of the cannula 120 to an outlet opening of the cannula 120. In this embodiment, the cannula 120 takes the form of an endoscope.
The outlet opening 200 includes a window 220 which operatively exposes an inside portion of the elongate working channel 160 to tissue (not shown) of the patient (not shown) which is adjacent to the window 220.
The electrically conductive elongate member 140 is configured to be inserted through the inlet opening 180 of the cannula 120 and to be passed down the elongate working channel 160 of the cannula 120. The electrically conductive elongate member 140 has an exposed electrically conductive portion 240 located at a distal region of said electrically conductive elongate member 140. The exposed electrically conductive portion 240 is shaped and configured to be located in the window 220 of the cannula
120. The remaining surface of the electrically conductive elongate member 140 is electrically insulated so as to not transmit an electrical current or signal between the elongate working channel 160 and the electrically conductive elongate member 140.
The electrically conductive elongate member 140 is preferably manufactured from biocompatible Pebax® tubing and stainless steel.
The electrically conductive elongate member 140 further includes a cable 260 for transmitting an electrical signal which is received by the electrically conductive elongate member 140 to an EMG processor (not shown).
There is provided for the exposed electrically conductive portion 240 to include the same features and functionality as it does according to the first aspect of the invention. Further, there is provided for the second embodiment of the invention to include guidelines and guide formations similar to the first embodiment of the invention.
It will be appreciated by those skilled in the art that the invention may be utilised during any percutaneous surgery procedure or intraoperatively (e.g. into an open wound site). For example, the invention could be utilised during spinal surgery, prostate surgery, gastro-intestinal surgery, a key-hole surgery procedure. The invention may prove to be particularly useful for surgeries where the target organ or tissue cannot be mapped accurately. Here, the transmitted electrical impedance signal, by itself, could be used to determine the accurate positioning and of the side window of the ablation device.
A significant advantage of the current invention provides for neuro-navigated neuromonitoring as opposed to the known neuromonitoring during open surgery. In this respect, the cannula of the invention will be suitable for use as an endoscope and a neuro-navigation device. This is particularly useful in that the surgeon is now able to properly assess the tissue before any biopsy, surgery or the like is performed. A further significant advantage includes that the surgeon can neuro-monitor tissue before a biopsy is performed leading to a more targeted and sound approach.
It will be appreciated by those skilled in the art that the invention is not limited to the precise details as described herein and that many variations are possible without departing from the scope of the invention. As such, the present invention extends to all functionally equivalent structures, methods and uses that are within its scope.
The description is presented by way of example only in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention.
In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention.
The words which have been used herein are words of description and illustration, rather than words of limitation.

Claims (29)

CONCLUSIESCONCLUSIONS 1. Een neuromonitoring-apparaat voor een canule, waarbij de canule omvat: - een langwerpig werkkanaal dat zich uitstrekt van een inlaatopening naar een uitlaatopening, waarbij het langwerpige werkkanaal kan worden ingebracht in weefsel van een patiënt, waarbij de neuromonitoring-inrichting omvat: - een elektrisch geleidend langwerpig orgaan dat is geconfigureerd om te worden ingebracht door de inlaatopening van de canule en om door het langwerpige werkkanaal van de canule te worden geleid, waarbij het oppervlak van het elektrisch geleidende langwerpige element elektrisch geïsoleerd is met een blootliggend elektrisch geleidend deel gelokaliseerd op een distaal gebied van het elektrisch geleidende langwerpige orgaan en dat is gevormd en geconfigureerd om te worden geplaatst in de uitlaatopening van de canule, waarbij, tijdens gebruik, het blootgestelde elektrisch geleidende deel een elektrisch geleidbaarheidsignaal van het weefsel van de patiënt uitzendt.A neuromonitoring device for a cannula, the cannula comprising: an elongated working channel extending from an inlet opening to an outlet opening, the elongated working channel being insertable into tissue of a patient, the neuromonitoring device comprising: an electrically conductive elongate member configured to be introduced through the inlet opening of the cannula and to be passed through the elongated working channel of the cannula, the surface of the electrically conductive elongate member being electrically insulated with an exposed electrically conductive portion located on a distal region of the electrically conductive elongate member and which is formed and configured to be placed in the outlet opening of the cannula, wherein, in use, the exposed electrically conductive portion transmits an electrical conductivity signal from the patient's tissue. 2. Neuromonitoring-inrichting volgens conclusie 1, waarbij de uitlaatopening van de canule een zijvenster is op een distaal gebied van het langwerpige werkkanaal, het langwerpige werkkanaal eindigt op een distaal gebied; en waarbij het blootgelegde elektrisch geleidende gedeelte van het elektrisch geleidende langwerpige orgaan is gevormd en geconfigureerd om te worden geplaatst in het zijvenster van de canule.The neuromonitoring device of claim 1, wherein the outlet opening of the cannula is a side window at a distal region of the elongated working channel, the elongated working channel terminating at a distal region; and wherein the exposed electrically conductive portion of the electrically conductive elongate member is formed and configured to be placed in the side window of the cannula. 3. De neuromonitoring-inrichting volgens conclusie 1 of conclusie 2, waarbij de canule één van een endoscoop en een neuro-navigatie-inrichting is.The neuromonitoring device of claim 1 or claim 2, wherein the cannula is one of an endoscope and a neuro-navigation device. 4. Neuromonitoring-inrichting volgens één van de voorgaande conclusies, waarbij het blootgestelde elektrisch geleidende gedeelte een elektrisch impedantiespectroscopie- vermogen heeft.The neuromonitoring device of any of the preceding claims, wherein the exposed electrically conductive portion has electrical impedance spectroscopy capability. 5. De neuromonitoring-inrichting volgens conclusie 4, waarbij het elektrisch geleidende gedeelte in elkaar grijpende elektroden heeft voor elektrische impedantiedetectie.The neuromonitoring device of claim 4, wherein the electrically conductive portion has intermeshing electrodes for electrical impedance detection. 6. Neuromonitoring-inrichting volgens conclusie 4, waarbij het blootgestelde elektrisch geleidende gedeelte is bedekt met een micro-elektrodenarray die is geconfigureerd voor meerpunts elektrische impedantiedetectie.The neuromonitoring device of claim 4, wherein the exposed electrically conductive portion is covered with a microelectrode array configured for multipoint electrical impedance detection. 7. Neuromonitoring-inrichting volgens één van de voorgaande conclusies, waarbij de neuromonitoring-inrichting een geleiding omvat voor het ontvangen van een complementaire formatie die zich op de canule bevindt.The neuromonitoring device of any preceding claim, wherein the neuromonitoring device includes a guide for receiving a complementary formation located on the cannula. -15--15- 8. De neuromonitoring-inrichting volgens één van de voorgaande conclusies, waarbij de neuromonitoring-inrichting een geleidingslijn omvat die complementair is aan een geleidingslijn van de canule zodanig dat het blootgestelde elektrisch geleidende deel werkzaam is geplaatst in de uitlaatopening.The neuromonitoring device of any one of the preceding claims, wherein the neuromonitoring device comprises a guide line complementary to a guide line of the cannula such that the exposed electrically conductive portion is operably located in the outlet opening. 9. De neuromonitoring-inrichting volgens één van de voorgaande conclusies, waarbij de neuromonitoring-inrichting verder een instelbare mantelopstelling omvat die is geconfigureerd om reversibel een deel van het blootgestelde elektrisch geleidende deel te bedekken.The neuromonitoring device of any preceding claim, wherein the neuromonitoring device further comprises an adjustable sheath arrangement configured to reversibly cover a portion of the exposed electrically conductive portion. 10. Neuromonitoring-inrichting volgens conclusie 9, waarbij de instelbare mantelopstelling gescheiden is van de neuromonitoring-inrichting en is gevormd en geconfigureerd om ingebracht te kunnen worden door de inlaatopening en door het langwerpige werkkanaal van de canule te worden gevoerd om daarbij, ten minste gedeeltelijk, de neuromonitoring- inrichting te omhullen.The neuromonitoring device of claim 9, wherein the adjustable sheath arrangement is separate from the neuromonitoring device and is configured and configured to be inserted through the inlet opening and passed through the elongated working channel of the cannula to thereby, at least in part. envelop the neuromonitoring device. 11. Neuromonitoring-inrichting volgens één van de voorgaande conclusies, waarbij het blootgestelde elektrisch geleidende deel past in de uitlaatopening door middel van een integraal bevestigingselement.The neuromonitoring device of any preceding claim, wherein the exposed electrically conductive portion fits into the outlet opening by means of an integral fastener. 12. Neuromonitoring-inrichting volgens conclusie 11, waarbij het integrale bevestigingselement een ringvormige snap-passing, een cantilever-snap-fit en een torsie- snap-fit is.The neuromonitoring device of claim 11, wherein the integral fastener is an annular snap fit, a cantilever snap fit, and a torsion snap fit. 13. Een neuomonitoringapparaat bestaande uit: - een canule bestaande uit: - een langwerpig werkkanaal dat zich uitstrekt van een inlaatopening naar een uitlaatopening, waarbij het langwerpige werkkanaal kan worden ingebracht in weefsel van een patiënt; en - een elektrisch geleidend langwerpig orgaan dat is geconfigureerd om te worden ingebracht door de inlaatopening van de canule en om door het langwerpige werkkanaal van de canule te worden geleid, waarbij het oppervlak van het elektrisch geleidende langwerpige element elektrisch geïsoleerd is met een blootliggend elektrisch geleidend deel gelokaliseerd op een distaal gebied van het elektrisch geleidende langwerpige orgaan en dat is gevormd en geconfigureerd om te worden geplaatst in de uitlaatopening van de canule, waarbij, tijdens gebruik, het blootgestelde elektrisch geleidende deel een elektrisch geleidbaarheidsignaal van het weefsel van de patiënt uitzendt.13. A neuro-monitoring device comprising: a cannula comprising: an elongated working channel extending from an inlet opening to an outlet opening, wherein the elongated working channel is insertable into tissue of a patient; and - an electrically conductive elongate member configured to be inserted through the inlet opening of the cannula and to be passed through the elongated working channel of the cannula, the surface of the electrically conductive elongate member being electrically insulated with an exposed electrically conductive portion located on a distal region of the electrically conductive elongate member and which is shaped and configured to be placed in the outlet port of the cannula, wherein, in use, the exposed electrically conductive portion transmits an electrical conductivity signal from the patient's tissue. -16 --16 - 14. Neuromonitoringapparaat volgens conclusie 14, waarbij de uitlaatopening van de canule een zijvenster is op een distaal gebied van het langwerpige werkkanaal, het langwerpige werkkanaal eindigt op een distaal gebied; en waarbij het blootgelegde elektrisch geleidende gedeelte van het elektrisch geleidende langwerpige orgaan is gevormd en geconfigureerd om te worden geplaatst in het zijvenster van de canule.The neuromonitoring device of claim 14, wherein the outlet opening of the cannula is a side window on a distal region of the elongated working channel, the elongated working channel terminating at a distal region; and wherein the exposed electrically conductive portion of the electrically conductive elongate member is formed and configured to be placed in the side window of the cannula. 15. Het neuromonitoringapparaat volgens één van de conclusies 13 en 14, waarbij het blootgestelde elektrisch geleidende gedeelte een elektrisch impedantiespectroscopie- vermogen heeft.The neuromonitoring device of any of claims 13 and 14, wherein the exposed electrically conductive portion has an electrical impedance spectroscopy capability. 16. Het neuromonitoringapparaat volgens conclusie 15, waarbij het elektrisch geleidende gedeelte in elkaar grijpende elektroden heeft voor elektrische impedantiedetectie.The neuromonitoring device of claim 15, wherein the electrically conductive portion has intermeshing electrodes for electrical impedance detection. 17. Het neuromonitoringapparaat volgens conclusie 15, waarbij het blootgestelde elektrisch geleidende gedeelte is bedekt met een micro-elektrodenarray die is geconfigureerd voor meerpunts elektrische impedantiedetectie.The neuromonitoring device of claim 15, wherein the exposed electrically conductive portion is covered with a microelectrode array configured for multipoint electrical impedance detection. 18. Neuromonitoringapparaat volgens één van de conclusies 13 - 17, waarbij het elektrisch geleidende langwerpige deel een geleiding omvat voor het ontvangen van een complementaire formatie die zich op de canule bevindt.The neuromonitoring device of any of claims 13 to 17, wherein the electrically conductive elongate portion includes a guide for receiving a complementary formation located on the cannula. 19. Neuromonitoringapparaat volgens één van de conclusies 13 - 18, waarbij het elektrisch geleidende langwerpige orgaan een geleidingslijn omvat die complementair is aan een geleidingslijn van de canule zodanig dat het blootgestelde elektrisch geleidende deel zich in de uitlaatopening bevindt.The neuromonitoring device of any of claims 13 to 18, wherein the electrically conductive elongate member includes a guide line complementary to a guide line of the cannula such that the exposed electrically conductive portion is in the outlet opening. 20. Neuromonitoringapparaat volgens één van de conclusies 13 - 1, waarbij de neuromonitoring-inrichting verder een instelbare mantelopstelling omvat die is geconfigureerd om reversibel een deel van het blootgestelde elektrisch geleidende deel te bedekken.The neuromonitoring device of any of claims 13-1, wherein the neuromonitoring device further comprises an adjustable sheath arrangement configured to reversibly cover a portion of the exposed electrically conductive portion. 21. Neuromonitoringapparaat volgens conclusie 20, waarbij de instelbare mantelopstelling is gevormd en geconfigureerd om door de inlaatopening van de canule inbrengbaar te zijn en door het langwerpige werkkanaal van de canule wordt gevoerd om, ten minste gedeeltelijk, het elektrisch geleidende langwerpig orgaan in te kapselen.The neuromonitoring device of claim 20, wherein the adjustable sheath arrangement is configured and configured to be insertable through the inlet opening of the cannula and is passed through the elongated working channel of the cannula to encapsulate, at least in part, the electrically conductive elongate member. 22. Neuromonitoringapparaat volgens één van de conclusies 13 - 21, waarbij het elektrisch geleidende langwerpige orgaan een formatie omvat die complementair is aan een formatieThe neuromonitoring device of any one of claims 13 to 21, wherein the electrically conductive elongated member comprises a formation complementary to a formation -17 - die is aangebracht op de canule voor het ontvangen van het elektrisch geleidende langwerpige orgaan.-17 - which is mounted on the cannula for receiving the electrically conductive elongate member. 23. Neuromonitoringapparaat volgens één van de conclusies 13 - 22, waarbij het blootgestelde elektrisch geleidende deel van de elektrisch geleidende langwerpige organen past in de uitlaatopening door middel van een integraal bevestigingselement.The neuromonitoring device of any one of claims 13 to 22, wherein the exposed electrically conductive portion of the electrically conductive elongate members fits into the outlet opening by means of an integral fastener. 24. Neuromonitoringapparaat volgens conclusie 23, waarbij het integrale bevestigings- kenmerk er een is van een ringvormige klikpassing, een cantilever snap-fit en een torsie- snap-passing.The neuromonitoring device of claim 23, wherein the integral mounting feature is one of an annular snap fit, a cantilever snap fit, and a torsional snap fit. 25. Het neuromonitoringapparaat volgens één van de conclusies 13 - 24, waarbij de canule een endoscoop of een neuro-navigatie-inrichting is.The neuromonitoring device of any of claims 13 to 24, wherein the cannula is an endoscope or a neuro-navigation device. 26. Een methode voor intra-operatieve neuromonitoring met behulp van de neuromonitoring- inrichting en / of -inrichting in overeenstemming met de eerste en tweede uitvoeringsvormen, waarbij de werkwijze de stappen omvat van: - inbrengen van, althans gedeeltelijk, de canule van het neuromonitoringapparaat in weefsel van de patiënt; - positionering van de uitlaatopening van de canule nabij het beoogde weefsel van de patiënt; - het inbrengen van het elektrisch geleidende langwerpige orgaan in de inlaatopening van de canule; - het leiden van het elektrisch geleidende langwerpige orgaan langs het langwerpige werkkanaal van de canule; - uitlijnen van het blootgestelde elektrisch geleidende deel met de uitlaatopening van de canule; en - het via het blootliggende elektrisch geleidende gedeelte en het elektrisch geleidende langwerpige orgaan verzenden van een elektrisch geleidbaarheidsignaal van het beoogde weefsel van de patiënt.A method of intraoperative neuromonitoring using the neuromonitoring device and / or device according to the first and second embodiments, the method comprising the steps of: inserting, at least in part, the cannula of the neuromonitoring device in tissue of the patient; positioning the cannula outlet opening near the target tissue of the patient; - inserting the electrically conductive elongate member into the inlet opening of the cannula; guiding the electrically conductive elongate member along the elongated working channel of the cannula; aligning the exposed electrically conductive portion with the outlet opening of the cannula; and - transmitting an electrical conductivity signal from the target tissue of the patient through the exposed electrically conductive portion and the electrically conductive elongate member. 27. De werkwijze volgens conclusie 26, waarbij de stap van het uitlijnen van het blootgestelde elektrisch geleidende deel met de uitlaatopening van de canule de stap omvat van het uitlijnen van een geleidingslijn aangebracht op het elektrisch geleidende langwerpige deel met een complementaire richtlijn van de canule zodanig dat de blootgestelde elektrisch geleidend gedeelte bevindt zich in de uitlaatopening.The method of claim 26, wherein the step of aligning the exposed electrically conductive portion with the outlet opening of the cannula comprises the step of aligning a guide line disposed on the electrically conductive elongate portion with a complementary alignment of the cannula such as that the exposed electrically conductive portion is located in the outlet opening. 28. De werkwijze volgens één van de conclusies 26 en 27, waarbij de canule één van een endoscoop en een neuro-navigatie-inrichting is.The method of any of claims 26 and 27, wherein the cannula is one of an endoscope and a neuro-navigation device. -18 --18 - 29. De werkwijze volgens één van de conclusies 26 tot 28, waarbij de werkwijze wordt gevolgd door de stap van het uitvoeren van een biopsie omvattende de stappen van: - terugtrekken van het elektrisch geleidende langwerpige orgaan uit de canule; - inbrengen van een biopsienaald, afzuiginrichting en dergelijke; en - een biopsie uitvoeren.The method of any of claims 26 to 28, wherein the method is followed by the step of performing a biopsy comprising the steps of: - withdrawing the electrically conductive elongate member from the cannula; inserting a biopsy needle, suction device and the like; and - perform a biopsy.
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