Patent Description:
A nerve of a patient may be stimulated by applying electrical energy to the nerve via a stimulation probe. The stimulation probe may include a stimulating electrode tip. A surgeon may touch a location on a patient with the electrode tip to provide a voltage and/or current to a location on the patient and stimulate nerve activity and may result in a muscle response (or muscle activity). A return (or anodal) needle may be attached: via a wire, to the mono-polar stimulation probe; and to the patient away from (i) sensors, and (ii) an area being stimulated. The sensors can include electrodes that are attached to the patient and used to monitor the muscle activity.

Nerve monitoring systems such as the NIM-Response® <NUM> and/or NIM-Neuro® <NUM> nerve monitoring systems, sold by Medtronic, Inc. , may be used to monitor electromyography (EMG) responses. In particular, the monitoring systems may provide stimulation at a selected nerve and a response sensed or detected at muscles remote from the location of the stimulation. Monitoring the EMG responses may be used to determine whether one or more nerves has been damaged during a select procedure. In various systems, the monitoring system may be controlled by a monitor user that is spaced apart from a procedure user and a subject. Therefore, the monitor user may require instructions from the procedure user to operate the monitoring system according to a selected use by the procedure user.

A stimulation monitoring system is provided as defined by claim <NUM>.

A nerve monitoring system may be used to monitor the integrity of a nerve. During a procedure, a procedure user may operate and/or alter an operation of the nerve monitoring system with the switches provided for use by the procedure user. The switches may include hardware that can be manipulated by the procedure user at the procedure user's location. Therefore, instructions or control to the nerve monitoring system may be provided at a location remote from the monitoring system.

The monitoring system may include a processor and display system for displaying results from the nerve monitoring. The monitoring system, however, may not be immediately available for placement in a sterile field or for placement proximal to a subject. The subject may be monitored with the monitoring system for a selected procedure. The procedure user may include a surgeon. The surgeon may be sterile for the selected procedure. Switches may be connected to a monitoring and/or stimulating instrument during a procedure. Switches may also or alternatively be connected adjacent to or to the surgeon and connected with the instrument and the monitoring system. The switches may be sterile and appropriate for placement in the sterile field.

The switches may include a physical connection to the monitoring system with a length of conductive material. The physical connection may include a wire (e.g. copper or aluminum wire), conductive polymer, or other appropriate conductive material. The physical connection may allow for both a signal from the remote to the monitoring system to interact with the monitoring system and/or to transmit a signal to and/or from the instrument.

Further areas of applicability of the present disclosure will become apparent from the detailed description, the claims and the drawings. The detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

With initial reference to <FIG> a monitoring system <NUM>, such as a NIM® nerve integrity monitoring system, sold by Medtronic, Inc. having a place of business in Minneapolis, MN, is illustrated in an environmental setting. The monitoring system may also include portions similar to those described in <CIT>. The monitoring system <NUM> may include a monitor assembly <NUM> that has a display screen or device <NUM> and one or more input devices. The input device may include one or more systems or structures to input commands of information such as a knob 24a, a touch screen 24b, a keyboard 24c, or other appropriate input devices. Input devices may also include other tactile input devices, audio input devices, visual input devices, etc..

The monitor assembly <NUM> may further include a processor <NUM> and a memory <NUM>. It is understood that the processor <NUM> may access the memory <NUM> to execute instructions stored thereon or access other data stored with the memory <NUM>. The memory <NUM> may include a physical memory, such as a spinning hard disk drive, solid state memory, or other appropriate types of memory. Further, the memory <NUM> may not be incorporated into the monitor assembly <NUM>, but may be accessed by processor <NUM>, such as via a communications network. The processor <NUM> may be a general purpose processor that is operable to execute instructions for generating a selected output, as discussed further herein. The processor <NUM> may further include onboard memory. Moreover, the processor <NUM> may include a specific purpose processor such as an application specific integrated circuit (ASIC). Accordingly, the processor <NUM> may execute instructions stored on memory <NUM>, which may be a non-transitory memory, to provide an output for display on the display device <NUM>.

The monitoring system <NUM> may further include a stimulation portion and/or generator. The stimulation portion may be configured to generate a voltage based upon control by the processor <NUM>. The processor <NUM> may execute instructions of a program stored on the memory <NUM> and/or control by a user <NUM>. As discussed herein, the monitoring system <NUM>, therefore, may be operated to generate a stimulation at or with a stimulation instrument based upon control of the user <NUM>.

The information displayed on the display device <NUM> may include information selected by the user <NUM>. The selection made by the user <NUM> may be desired or selected information regarding a subject <NUM>. The subject <NUM> is illustrated as a human subject, but it is understood that the subject may be any appropriate living subject, including non-human subjects. Further, the monitoring system <NUM> may be used with non-living subjects. Non-living subjects may have systems that are selected to be monitored for selected activity, such as electrical activity, and the monitoring system <NUM> may be used. In selected embodiments, however, the user <NUM> may be performing a surgical procedure on the subject <NUM>. The user <NUM>, therefore, may select to monitor nerve response and/or integrity such as by monitoring electromyography (EMG) responses.

One or more stimulation or monitoring assemblies may be incorporated in the monitoring system <NUM> and connected with the monitor assembly <NUM>. For example, in various procedures such as a thyroidectomy or other thyroid surgeries, monitoring of a recurrent laryngeal nerve (RLN), a vagus nerve, or other appropriate nerve <NUM>, in the subject <NUM>. Other or alternative nerves may also be monitored, including other selected cranial nerves and/or spinal nerves. Monitoring of the RLN may include a nerve monitoring esophageal tube <NUM>, which may have one or more conductive electrodes <NUM> that are in contact with selected portions of the subject <NUM>. The electrode <NUM> may be affixed to an exterior of the tube <NUM> and/or incorporated into the structure of the tube <NUM>. The electrode <NUM> can be connected to the monitor assembly <NUM> via a connection <NUM>.

In addition, other instruments may be connected to the monitor assembly <NUM>, such as electrode assemblies, including an electrode that may send or receive periodic stimulation pulses. In various embodiments, one or more stimulation instruments <NUM> may be used. The stimulation instrument <NUM> may be connected to the monitor assembly <NUM> with a connector <NUM>. The connector <NUM> may allow for a physical connection between the stimulation instrument <NUM> and the monitoring assembly <NUM>. The connector <NUM> may include a conductive member (e.g. a metal wire, conductive polymer, etc.). The stimulation instrument <NUM> may include various instruments such as surgical instruments and the like. Examples of various types of stimulation instruments include those disclosed in <CIT> and <CIT>.

According to various embodiments, for example as illustrated in <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> the instrument <NUM> is illustrated as an instrument 50a that may include the switches <NUM> as switches 100a. It is understood that in various embodiments the instrument <NUM> may be provided to include features either separately and/or in combination as discussed further herein. Accordingly, discussion of the instrument 50a is understood to include various features that may be provided in the instrument 50a alone and/or in combination with other features as discussed further herein.

In various embodiments, therefore, the instrument 50a may include the switch or switch assembly 100a. The instrument 50a may include a housing or handle <NUM>. In various embodiments, the housing <NUM> may include two portions which may include a first or left portion <NUM> and a second or right portion 120R. The two housing portions <NUM>, 120R may be formed separately, such as with a selected molding procedure, such as injection molding. The two housing portions <NUM>, 120R may then be fit and connected together to form the housing <NUM> of the instrument 50a. In various embodiments, the two housing portions <NUM>, 120R may be snap fit together, adhered together, mechanically connected, or otherwise assembled together into the housing <NUM>. For example, the two housing portions <NUM>, 120R may be connected with an adhesive and/or sonically welded together.

The housing assembly <NUM> may include a selected geometry, as illustrated in <FIG>. The geometry of the housing <NUM> may be provided to indicate to the user <NUM> by feel or touch an orientation and/or feature of the instrument 50a. The housing <NUM>, therefore, may include a waist or center region <NUM> generally near the switch assembly 100a. The waist region <NUM> may include a minimum outer dimension, such as a circumference. The housing <NUM> may further include a swelled or enlarged portion region <NUM> proximal thereto relative to a distal end <NUM>. The housing <NUM> may further include a proximal region <NUM> that may also be of an enlarged geometry relative to the waist region <NUM>. Generally, the waist region <NUM> may have a selected external perimeter dimension that is smaller than either the enlarged region <NUM> and/or the proximal region <NUM>. In various embodiments, the enlarged region <NUM> may have a maximum external perimeter to that of the proximal region <NUM>.

In various embodiments, the housing <NUM> may house various portions such as a printed circuit board (PCB) <NUM> that is held in a selected location relative to the housing <NUM>, such as the left housing <NUM> with one or more projections or stabilization portion, such as a projection <NUM>. The PCB <NUM> may include or provide connections between various components, such as electrical switches including a first switch <NUM>, a second switch <NUM>, and a third switch <NUM>. The switches <NUM>-<NUM> may be activated with pushbuttons or lever portions such as a first button portion <NUM>, a second button portion <NUM>, and a third button portion <NUM>. Each of the switches <NUM>-<NUM> may be operated with one of the push buttons <NUM>-<NUM>, thus allowing individual signaling with each switch. In various embodiments, more or less than three switches and/or push buttons may be provided.

The switches <NUM>-<NUM> may provide signals to the monitoring system <NUM> through various connectors, such the connector <NUM>. The switches <NUM>-<NUM> may be appropriate switches, such as a KMR633NGLFG switch sold by C&K switches having a place of business in Waltham, Massachusetts. The switches may require a selected force to activate to provide to a user a feedback regarding activation operation, such as about <NUM> Newton (N) to about <NUM> N, including about <NUM> N to about <NUM> N, including about <NUM> N. The switches may provide a signal through a control signal carrier lead or wire <NUM> that may include a plurality of pins or connections connecting to the controller <NUM>. Further, a stimulation signal may be carried on a separate wire <NUM> that is connected directly to a probe or stimulation portion or member <NUM>, also referred to as a probe or stimulation probe.

The switch assembly may provide a feedback to the user <NUM> regarding operation of depression of one or more of the switches <NUM>-<NUM>. For example, the switch may provide an audible or tactile click, vibrate, illuminate, etc. Further, separate light emissions portions (e.g., light emitting diodes (LEDs)), vibration motors, speakers, etc. may provide auditory, tactile/haptic, and/or optical feedback to the user <NUM> regarding depression of one or more of the switches. The feedback may differ, such as a different sound and/or color of light, for each of the switches <NUM>-<NUM>.

The stimulation member <NUM> may be connected to the stimulation lead <NUM> substantially directly with selected connection portion, such as a crimp socket or member <NUM>. The crimp socket <NUM> may connect directly to the lead portion <NUM> such that a stimulation signal is provided directly from the controller <NUM> through the probe <NUM>. In various embodiments the probe <NUM> may include an insulated cover <NUM> so that only a selected portion, such as a distal tip <NUM>, is exposed. By having only the distal tip <NUM> exposed, the stimulation signal or voltage is provided only at the distal tip <NUM> and not along the length of the probe <NUM> due to the covering <NUM>.

The housing <NUM> may be formed of the two portions or members <NUM> and 120R and fit together, as discussed above. Each of the housing portions <NUM>, 120R may have a selected geometry, such as a proximal end or region <NUM> that may extend at a non-perpendicular angle relative to a long axis <NUM> of the housing <NUM>. The probe <NUM> may generally extend along the axis <NUM> and/or provided substantially parallel thereto. The rear wall <NUM> may extend at the angle <NUM> relative to the axis <NUM> for various purposes. The angle <NUM> is generally about <NUM> degrees to about <NUM> degrees, including about <NUM> degrees. Further, a stress relief member or portion <NUM> may hold the wire or connector <NUM> relative to the housing <NUM> to assist in reducing strain and/or protecting the cable <NUM> from the or engagement with the housing <NUM>. Further the housing portion, such as the housing <NUM> may include selected projections, such as projections <NUM> to engage or guide the cable <NUM> through the housing <NUM>.

The housing <NUM>, such as the left portion <NUM>, may include a distal end or region <NUM>. The distal region <NUM> may be a substantially unitary member or portion that is formed as one piece. The distal end <NUM> may include a bore or passage <NUM>. In various embodiments, the probe <NUM> may be press fit into the bore <NUM> by moving the probe <NUM> generally in the direction of arrow <NUM>. The press fitting of the probe <NUM> into the bore <NUM> may allow for a frictional engagement of the probe <NUM> relative to the distal portion <NUM> of the housing <NUM>. The probe <NUM> may include interference portions, such as depressions and/or ridges <NUM> to engage the distal portion <NUM>.

In various embodiments, however, the housing portion <NUM> may be molded around the or about the probe <NUM>. The probe <NUM> may include the interference portions <NUM> (e.g. splines, ridges, projections, etc.). The housing member <NUM> may be molded about or around the probe <NUM> such that the distal portion <NUM> captures or is molded around a proximal or end <NUM> of the probe <NUM>. In various embodiments, for example, the distal portion <NUM> alone or with the housing portion <NUM> may be injection molded (i.e., overmolded) onto the probe <NUM>. Thus, the probe <NUM> may be substantially held relative to the housing member <NUM> during a use. The connector <NUM> may be connected to the probe end <NUM>, for example, after the housing member <NUM> is molded around the probe <NUM>.

The PCB <NUM> may also be fit to the housing member <NUM>. The right housing member 120R may be connected to the first housing <NUM>. As discussed above, the PCB <NUM> may include a selected number of switches, such as the switches <NUM>-<NUM>. Each of these switches <NUM>-<NUM> may be actuated by the respective push button members <NUM>-<NUM>. In various embodiments, the connections of the switches <NUM>-<NUM> may be sealed to the PCB <NUM>, such as with a flowable sealer, including the DOWSIL™ DOW3140 RTV coating, sold by DOW, having a place of business in Michigan.

With continuing reference to <FIG>, and with particular reference to <FIG>, each of the respective pushbuttons <NUM>-<NUM> may be activated or moved to encounter one or more of the respective switches <NUM>-<NUM>. With reference to the push button <NUM>, operation of the buttons and switches will be discussed. It is understood that each of the buttons and switches may be operated in a substantially similar manner, thus discussion of only the pushbutton <NUM> and the switch <NUM> is understood to relate to all of the pushbutton and switches.

The push button <NUM> may include a contact portion or surface <NUM>. The surface <NUM> may be contacted by one or more digits of the user <NUM> to operate the selected switch. The button <NUM> may also include a rocker portion or projection <NUM> that may be received in a depression or groove <NUM> formed as or with a projection <NUM> within the housing, such the housing <NUM>. The projection <NUM> held within the groove <NUM> allows the button member <NUM> to move a selected distance, such as to operate or depress the switch <NUM>. The switch <NUM> may be held by the PCB <NUM> such that the switch <NUM> does not substantially move relative to the housing <NUM>. By pushing on the surface <NUM>, however, the button member <NUM> may move toward the switch <NUM> to activate or send a signal via the switch <NUM>.

In various embodiments, the button member <NUM> may include a mass or projection or surface <NUM> that engages a push or activation surface or portion <NUM> of the switch <NUM>. The button member <NUM>, such as by pushing on the surface <NUM>, generally in the direction of arrow <NUM> may allow the button member <NUM> to activate the respective switch <NUM>. It is understood that each of the switches <NUM>-<NUM> may be operated in a substantially similar manner relative to and/or with the respective button members <NUM>, <NUM>.

Each of the respective switches may perform various features or functions. In various embodiments, the switch <NUM> may be operated by the button member <NUM> to provide a recording or notification at a selected time. As discussed above, the monitoring system <NUM> may be used to provide a signal for stimulation of a selected nerve and/or a location of a response relative to the nerve. The recording button <NUM> may provide a signal to the system <NUM> to record the signal at a selected time.

The other buttons may be used to increase or decrease a simulation. For example, the button member <NUM> may be operated to depress the switch <NUM> to increase a stimulation. The button <NUM> may be operated to operate the switch <NUM> to decrease stimulation. The increase and decrease buttons may be used to stepwise increase or decrease the stimulation a selected amount (e.g. steps of about <NUM> volts to about <NUM> volts per press).

The housing assembly <NUM> may include a bore or passage to allow movement of the button members <NUM> and access to the button members <NUM>-<NUM> by the user <NUM>. For example, a first passage <NUM> may be formed through the housing member <NUM>, a second passage <NUM>, and a third passage <NUM> may allow for the respective buttons <NUM>, <NUM>, <NUM> to be accessed by the user <NUM>. Thus, it is understood that the user <NUM> may operate the system <NUM> by using selected buttons in a selected manner. Further, the user <NUM> may move the probe tip <NUM> relative to the subject <NUM> by movement of the housing <NUM> that is engaged to the probe tip <NUM>.

As discussed above, the instrument <NUM> may be provided in various embodiments including portions or elements that are discussed herein and may be included either alone and/or in combination with other elements. Accordingly, an instrument 50b and <FIG> is illustrated to include various features and portions. The instrument 50b may include a switch assembly portion 100b. The instrument assembly 50b may include various portions, such as those as discussed above and further herein, which may be included with various other embodiments and/or substituted herein or therein. Nevertheless, the instrument 50b will be described and illustrated in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>.

The instrument 50b may include the connector <NUM> similar to the connector <NUM> discussed above. The connector <NUM> may include two portions, such as the signal portion <NUM> and the stimulation portion <NUM>. The two portions <NUM>, <NUM> may be connected similarly as that discussed above, including the signal or control portion <NUM> transmitting signals from the switch assembly 100b and the stimulation connector <NUM> providing a stimulation signal or voltage to poll <NUM>. Further, the probe <NUM> may be substantially similar or identical to the probe <NUM> as discussed above and will be discussed in detail here. It is understood, however, that to the stimulation signal may be transmitted through the stimulation connector <NUM> to the probe <NUM>.

The instrument 50b may include a housing <NUM> that may be similar to the housing <NUM> discussed above. The housing <NUM> may include two portions such as a first or left portion <NUM> and a second or right portion 250R. The two portions <NUM>, 250R may be formed separately and assembled into a single housing assembly that may be grasped by the user <NUM>. The two housing portions <NUM>, 250R may be interconnected and/or fixed together in an appropriate manner, such as that discussed above.

Further the housing portion <NUM> may extend from a proximal end <NUM> to a distal end <NUM>. The housing <NUM> may include a rear or proximal wall <NUM> that may extend along a plane or axis that is at a non-perpendicular angle <NUM> to a long axis <NUM> of the housing <NUM>. The non-perpendicular angle <NUM> may be defined relative to the long axis <NUM>. The angle <NUM> is generally about <NUM> degrees to about <NUM> degrees, including about <NUM> degrees. The probe <NUM> may generally extend aligned with and/or parallel to the long axis <NUM>.

The housing assembly <NUM>, similar to that discussed above, further includes a waist or center region <NUM> generally near the switch assembly 100b and a swell or enlarged portion region <NUM> distal thereto relative to the proximal end <NUM>. A proximal region <NUM> of the housing <NUM> may further include an enlarged geometry relative to the waist region <NUM>. Generally, the waist region <NUM> may have a selected external perimeter dimension that is smaller than either the enlarged region <NUM> and/or the proximal region <NUM>. Further, the enlarged region <NUM> may have a maximum external dimension or perimeter (e.g., circumference) of the housing <NUM>. It is understood that the handle assembly <NUM> may include a similar geometry, as discussed or illustrated above.

The instrument 50b includes the switch assembly 100b, according to various embodiments. The switch assembly 100b may be positioned within the housing <NUM>. The cable or connector <NUM> may be positioned within the housing <NUM>. The cable <NUM> may be positioned or held within projections and strain releases <NUM> to assist in holding the connector <NUM> within the housing <NUM> during use and manipulation of the instrument 50b.

The switch assembly 100b may be positioned such that it may be accessed through an opening <NUM> formed within the housing <NUM>. The switch assembly 100b may include depressible members <NUM>, <NUM>, and <NUM>. All of the depressible members <NUM> - <NUM> may be formed as a single unitary member or button portion <NUM>. It is understood, however, any appropriate number of depressible portions may be provided greater or less than three as well. The button portion <NUM> may be formed of a selected material, such as silicone rubber or equivalent material. The button portion <NUM> may be covered by a button cover <NUM> that has one or more passages <NUM> to allow access to the individual button portions <NUM> - <NUM>.

The switch assembly may provide a feedback to the user <NUM> regarding operation of depression of one or more of the depressible members <NUM> - <NUM>. For example, the switch assembly 100b may provide an audible or tactile click, vibrate, illuminate, etc. Further, separate light emissions portions (e.g., light emitting diodes (LEDs), vibration motors, speakers, etc. may provide auditory, tactile/haptic, and/or optical feedback to the user <NUM> regarding depression of one or more of the depressible members <NUM> - <NUM>. The feedback may differ, such as a different sound and/or color of light, for each of the depressible members <NUM> - <NUM>.

The switch assembly 100b may further include a printed circuit board (PCB) <NUM>. The printed circuit board <NUM> may include a plurality of traces that form a plurality switch pads <NUM>, <NUM>, and <NUM>. Each of the switch pads <NUM> - <NUM> may include traces that form circuits that are completed by conductive portions defined or formed by each of the respective individual button portions <NUM> - <NUM>. For example, as illustrated in <FIG>, each of the individual button portions <NUM> - <NUM> may include a contact pad or plug <NUM>, <NUM>, <NUM>, respectively. Each of the conductive pads <NUM> - <NUM> may be formed of selected material, such as a graphite or carbon plug, metal plug, or the like. The contact pads <NUM> - <NUM> may be positioned to allow for contact with the trace pads <NUM> - <NUM> to complete a circuit, as discussed herein. The switches or circuits may be completed to provide a signal to the controller <NUM>.

Accordingly the switch assembly 100b may be assembled into the housing <NUM> such that the PCB <NUM> is held or positioned relative to various projections, such as switch projections <NUM>, within the housing member, such as the left housing member <NUM>. The user <NUM> may grasp the housing <NUM> and depress or press on one or more of the switch portions <NUM> - <NUM> to move the conductive plug portion <NUM> - <NUM> into contact with respective switch or trace pads <NUM> - <NUM>. The housing projections <NUM> may hold the PCB <NUM> in place during force applied to the respective button portions <NUM> - <NUM>.

Within particular reference to <FIG>, each of the button portions may include a similar features as the button <NUM>, which will be discussed in further detail. The button <NUM> may include an exterior surface <NUM> that may be contacted and pressed with a selected portion of the user, such as a digit. The exterior surface <NUM> may be pressed generally in the direction of arrow <NUM> to move the contact portion <NUM> into contact with the pad <NUM> at a selected time. When contact is made, the switch may be sensed to be activated by the system <NUM>.

The button <NUM> may include a main body portion <NUM> that defines the exterior surface <NUM>. A biasing portion or surface <NUM> may be formed to extend between the body portion <NUM> and a base <NUM>. The base <NUM> may be positioned on the board <NUM>. The biasing surface or portion <NUM> may extend around the body portion <NUM> and bias or hold the body portion <NUM> at a distance away from the PCB <NUM>. Therefore, the user <NUM> may overcome the biasing force and press the main body <NUM> generally in the direction of arrow <NUM>. Once the force of the user <NUM> is removed, the biasing portion <NUM> may bias and/or move the main body <NUM> generally in the direction of arrow <NUM> such that the conductive pad <NUM> moves away from the trace pad <NUM>. The biasing portion <NUM> may include selected dimensions, such as a length or extent dimension <NUM> of about <NUM> millimeters (mm) to about <NUM>, including about <NUM> and a thickness or girth dimension <NUM> of about <NUM> millimeters (mm) to about <NUM>, including about <NUM>. The entire pushbutton member <NUM>, or alternatively, only the biasing portions <NUM> may be formed of a selected material such as Silicone Rubber with about a <NUM> Shore A to about a <NUM> Shore A, including about a <NUM> Shore A. Thus, the selected dimensions may provide a selected tactile and/or audible feedback to the user <NUM> regarding operation of each of the depressible members <NUM> - <NUM>, as discussed above. Thus, the feedback, such as haptic feedback, may be integral with the pushbutton member <NUM>.

The cover <NUM> may be positioned over the button member <NUM>. The cover <NUM> may include a body or cover surface or region <NUM> and a board contacting portion <NUM>. Thus the button cover <NUM> may cover the button portion <NUM> in the assembly of the instrument 50b.

The switch assembly 100b may include the switch portions that operate similar to that as discussed above including the three buttons <NUM>, <NUM>, and <NUM>. The respective buttons may be used to operate the system <NUM> in a manner similar to that as discussed above, such as to increase or decrease (including each button having a single operation, such as only increasing or decreasing) a stimulation voltage and/or record a voltage is at the time. Thus, the switch assembly 100b may operate similar to that switch assembly 100a, as discussed above, but it may include the various portions and/or alternative portions as discussed above.

The instrument 50b that includes the probe <NUM> may be formed such that the probe <NUM> passes through a distal or probe bore <NUM> formed or defined through the distal end <NUM>. The probe <NUM> may be engaged and held within a crimp member <NUM> similar to that as discussed above. The probe <NUM> may be formed separately from the housing <NUM> and passed through the bore or hole <NUM> and fit into the connector <NUM>. In various embodiments, however, the probe <NUM> may be over molded during formation of the housing <NUM>. In various embodiments, in addition and/or alternatively thereto, a sealing member <NUM> may also be provided around the probe <NUM> and relative to the housing <NUM> to assist in sealing and/or holding the probe <NUM> in a selected position relative to the connector <NUM> and the housing <NUM>. Accordingly, the instrument 50b may be formed in the plurality pieces into the assembly for use by the user.

With reference to <FIG>, <FIG>, and <FIG> an instrument assembly 50c is illustrated. The instrument assembly 50c may include a probe 158c that extends between a distal end <NUM> and a proximal end <NUM>. The proximal end may be held and/or encased within a handle or housing <NUM> as illustrated in <FIG>. The housing <NUM> may be substantially cylindrical and sized and shaped to be grasped and manipulated with less than all of a digits of the hand 30a. For example, the handle <NUM> may be similar in diameter to a pencil, such as about <NUM> to about <NUM> centimeters (cm) at a maximum diameter. The distal end <NUM> may have an exposed tip portion <NUM> that may contact various selected portions, such as of the subject <NUM>, for providing stimulation thereto. The probe 158c may be covered and/or coated by an insulation material or <NUM>, similar to that discussed above, between the housing <NUM> and the distal tip <NUM> to insulate or allow stimulation to be provided only through the distal tip <NUM>. The probe 158c may include the exterior coating <NUM>, as illustrated in <FIG>, which may be at least partially encapsulated within the housing <NUM>.

The housing <NUM> may be formed of a substantially insulating material, such as an electrically insulating material. In various embodiments, the housing <NUM> may be formed of one or more members and/or overmolded onto the probe 158c. For example, the probe 158c may include one or more ridges or projections <NUM> that may be held or over molded in an overmold portion <NUM> of the housing <NUM>. In various embodiments, the probe 158c may be held a distance <NUM> within the handle <NUM>. The distance <NUM> may be selected for various appropriate purposes and procedures and may include about <NUM> to about <NUM> centimeters (cm), including about <NUM> to <NUM>, including about <NUM>. Therefore, the probe 158c may be held substantially fixed relative to the housing <NUM>.

Accordingly during use, the user <NUM> may grasp the housing <NUM> to manipulate or move the probe 158c. For example, the user <NUM> may position the distal or stimulating tip <NUM> relative to the patient <NUM> for stimulating the selected portion, as discussed above.

Additionally the probe assembly 50c may include leads or connections similar to those discussed above. For example, a crimp connection <NUM> may connect to the probe 158c within the housing <NUM>. The crimp <NUM> may be connected to a lead or wire <NUM> that extends through at least a portion of the housing <NUM>. The lead <NUM> may be formed of selected cable or wire that extends from a switch assembly 100c. The switch assembly 100c may be similar to the switch assembly 100b, discussed above, save that the switch assembly 100c is a separate unit from the housing <NUM>.

The switch assembly 100c may include a switch housing <NUM> that encapsulates switching portions, as discussed herein, and is connected with the line or lead <NUM> to the housing <NUM> and the connector <NUM>. Extending from the switch assembly 100c may be the conductor or connector <NUM> that includes or connects with the controller connector <NUM> and the stimulator connector <NUM>.

Accordingly, the probe assembly 50c may be connected with the stimulation assembly <NUM>, as discussed above, for monitoring or stimulating the subject <NUM> for selected procedures. The probe assembly 50c may be used for selected applications, for example, when the probe 158c is selected to be a selected length and/or when the housing <NUM> is selected to be substantially minimal. Further, the probe assembly 50c may include a connector <NUM> that allows for connection of the connector cabling <NUM> to a selected material, such as the surgical drape, the dressings of the user <NUM>, or other appropriate positions for connecting the cable <NUM>.

With continued reference to <FIG> and further reference to <FIG>, the switched assembly 100c is illustrated in greater detail. The switch assembly 100c includes the housing <NUM> which may include a first or top housing 550a and a second or bottom housing portion 550b. The housing <NUM> including the two portions 550a, 550b, may be assembled to house a button portion 300c that may be positioned adjacent or on a PCB 310c. The button assembly 300c may be similar to the button assembly <NUM>, as discussed above, and the PCB 310c may be similar to the PCB <NUM>, as discussed above. For example, the button portion 300c may provide selected feedback similar to that discussed above. Therefore, the details thereof will not be repeated in detail, but only provided in brevity for the current discussion.

The button assembly 100c may be similar to the button assembly 100b as discussed above, but be included in the housing <NUM> separate from another housing, such as the housing <NUM>. Therefore, the handle or housing assembly <NUM> may not allow for single handed interaction with the button assembly 100c, as illustrated in <FIG> of the instrument 50b. Nevertheless, the button assembly 100c may include portions that are substantially similar to the button assembly 100b, as discussed above. Therefore the button assembly 100c will be described with brevity with distinctions provided in detail.

Generally, the housing 550b may include a portions or supports, such as the support <NUM> that may support the PCB 310c within the housing <NUM>. The top housing portion 550a may be formed to engage the bottom housing 550b to fix the two housing portions 550a, 550b around the button portion 300c and the PCB 310c.

The top housing portion 550a may include passages or openings such as a first passage <NUM>, a second passage <NUM>, and a third passage <NUM> to allow access to respective button portions. The button portions of the button assembly 300c may include a first button portion <NUM>, a second button portion <NUM>, and a third button portion <NUM>. Each of the button portions <NUM>-<NUM> may extend through the respective openings <NUM>-<NUM> to allow access by the user <NUM>.

The PCB 310c may include pad traces <NUM>, <NUM>, <NUM> similar to the pad traces <NUM>-<NUM> as discussed above. Each of the button portions <NUM>-<NUM> may include conductive plug portions (not illustrated in <FIG>) similar to the conductive plug portions <NUM>-<NUM>, as discussed above. Similarly, as discussed above, the plug portions may contact the trace portions <NUM>-<NUM> to complete a connection to allow for a signal to be transmitted from the switch assembly 100c. Accordingly the switch assembly 100c, as illustrated in <FIG>, may include a portion substantially similar to the switch assembly 100d as illustrated in <FIG>.

The button assembly 300c may interact with the PCB 310c to provide in signals or instructions to the monitor <NUM> as discussed above. The button assembly 300c may include various portions, such as biasing or flex portion <NUM>, <NUM>, <NUM>, for each of the button portions <NUM>-<NUM>. As discussed above the flex portion <NUM>-<NUM> may allow for the button portions <NUM>-<NUM> to be pushed toward the PCB 310c by the user and be biased or moved away from the PCB 310c by the biasing portion <NUM>-<NUM>. Therefore the user <NUM> may press the button portions <NUM>-<NUM> to provide a command or signal to the monitor system <NUM>, as discussed above.

The button assembly 100c, being separate from the handle, such as the handle housing <NUM>, may allow for the button assembly 100c to be positioned for ease of access by the user <NUM> and/or an alternative user for various purposes. Thus, the button assembly 100c may be usable by one or more users to interact with the monitoring system <NUM> as discussed above. Nevertheless, the button assembly 100c may also include various portions and/or alternative features, such as those discussed above, to allow for interaction with the monitoring system <NUM>.

As discussed herein, the probe <NUM> may be provided at various portions. The probe <NUM>, according to various embodiments, may be provided at selected lengths. For example, the probe <NUM> may extend from a respective housing or handle <NUM>, <NUM> a length of about be about <NUM> to about <NUM>, including about <NUM> to about <NUM>. In various embodiments, the probe <NUM> may have a length from the handle to the distal end of about <NUM>, about <NUM>, and about <NUM> to about <NUM>.

The probe <NUM>, as discussed above, may include the selected distal tip. In various embodiments, the distal tips may be substantially flat and/or include a curved end. In various embodiments, the distal tip may be substantially spherical.

According to various embodiments, the switch portion <NUM>, according to various embodiments, need not be physically connected to the conductor <NUM> for communicating with the monitoring assembly <NUM>. As discussed above, the conductor <NUM> allows a signal from the switch portion <NUM> to be carried to the monitoring assembly <NUM> and/or a stimulation signal from the monitoring assembly <NUM> to be delivered through the instrument <NUM> to the patient <NUM>, such as to the nerve <NUM>. The switch portion <NUM>, however, may include a wireless communication system or portion, such as those generally known in the art, to communicate with the monitoring assembly <NUM>. The switch portion <NUM> may be operated, as discussed above, however, an instruction from the surgeon <NUM> may be communicated to the monitoring assembly <NUM> with a wireless or over the air (OTA) transmission. Also, transmissions from the monitoring assembly <NUM> regarding operation of the monitoring assembly <NUM> may be wireless or OTA to the switch portion <NUM>. The conductor <NUM>, or other selected conductor, may be connected to the selected instrument for providing the stimulation to the electrodes. Control, or at least selected control, of the monitoring assembly <NUM> may be with the switch portion <NUM> that is wirelessly communicating with the monitoring assembly <NUM>.

Instructions may be executed by a processor and may include may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, data structures, and/or objects.

The apparatuses and methods described in this application may be partially or fully implemented by a special purpose computer created by configuring a general purpose computer to execute one or more particular functions embodied in computer programs. The computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium. The computer programs may also include or rely on stored data. The computer programs may include a basic input/output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc..

The computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language), etc. As examples only, source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (active server pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.

Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard <NUM>-<NUM>, IEEE standard <NUM>-<NUM>, and/or IEEE standard <NUM>-<NUM>. In various implementations, IEEE <NUM>-<NUM> may be supplemented by draft IEEE standard <NUM>. 11ac, draft IEEE standard <NUM>. 11ad, and/or draft IEEE standard <NUM>.

A processor or module or 'controller' may be replaced with the term 'circuit. ' The term 'module' may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip.

Claim 1:
A stimulation monitoring system positioned in a non-sterile field separate from a sterile field in which a subject is positioned, the stimulation monitoring system, comprising:
a stimulation system (<NUM>);
a conductor (<NUM>) physically configured to be connected to the stimulation system; and
a stimulation instrument (<NUM>) configured to be positioned within the sterile field near the subject and connected to the stimulation system via the conductor, the stimulation instrument having a housing (<NUM>) defining a handle configured to be grasped by a user during use of the stimulation instrument;
a switch assembly (100a) comprising a plurality of push buttons (<NUM>-<NUM>) and a plurality of switches (<NUM>-<NUM>); and characterized in that
the switch assembly is included within the handle of the stimulation instrument;
wherein each push button of the plurality of push buttons is configured to engage one switch of the plurality of switches;
wherein each switch is configured to provide a signal to the stimulation system for operation of the stimulation system;
wherein the stimulation instrument is operable to deliver a generated stimulation from the stimulation system.