Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1613—Component parts
  • A61B17/1626—Control means; Display units
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8875—Screwdrivers, spanners or wrenches
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
  • A61B5/4029—Detecting, measuring or recording for evaluating the nervous system for evaluating the peripheral nervous systems
  • A61B5/4041—Evaluating nerves condition
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
  • A61B5/4519—Muscles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
  • A61B5/4523—Tendons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4887—Locating particular structures in or on the body
  • A61B5/4893—Nerves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical 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
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1402—Probes for open surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00022—Sensing or detecting at the treatment site
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00137—Details of operation mode
  • A61B2017/00154—Details of operation mode pulsed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
  • A61B2017/00424—Surgical instruments, devices or methods with special provisions for gripping ergonomic, e.g. fitting in fist
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery

Definitions

• the invention relates generally to tissue identification and integrity testing, and more particularly to systems and methods for safeguarding against nerve and muscle injury during surgical procedures, location and stimulation of nerves and muscles, identification and assessment of nerve and muscle integrity following traumatic injuries, and verification of range of motion and attributes of muscle contraction during reconstructive surgery.
• Background of the Invention Even with today' s sophisticated medical devices, surgical procedures are not risk- free. Each patient's anatomy differs, requiring the surgeon to be ever vigilant to these differences so that the intended result is accomplished.
• the positioning of nerves and other tissues within a human or animal's body is one example of how internal anatomy differs from patient to patient. While these differences may be slight, if the surgeon fails to properly identify one or several nerves, the nerves may be bruised, stretched, or even severed during an operation.
• the negative effects of nerve damage can range from lack of feeling on that part of the body to loss of muscle control.
• the invention provides devices, systems, and methods for intra-operative stimulation.
• the intra- operative stimulation enables accurate evaluation of the neuromuscular system to guide repair or reconstructive surgery.
• One aspect of the invention provides devices, systems, and methods comprising a tissue stimulation system having a housing having a proximal end and a distal end, an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, and the operative element extends from the proximal end of the housing.
• the housing proximal end comprises an operative element adjustment portion to allow movement of the operative element, with the electrical stimulation being in the form of a stimulation signal having an amplitude and a duration for providing a first indication.
• a stimulation control device is electrically coupled to the operative element, the stimulation control device comprising a power source and stimulation signal generating circuitry.
• the tissue stimulation system may conform to the IPXl water ingress standard.
• the stimulation control device is positioned within the housing.
• the housing comprises a gripping base portion and the operative element adjustment portion.
• the operative element adjustment portion comprises a flexible nose cone .
• the first indication comprises a visual indication located on the housing, and the housing may be tubular.
• the visual indication may also include a reflective element.
• the visual indication may comprise an illuminating circumferential ring indicator, the illuminating circumferential ring indicator being visible around the circumference of the tubular housing.
• a tissue stimulation system comprising a housing, such as a tubular shaped housing, having a proximal end and a distal end, an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the operative element extending from the proximal end of the housing, and wherein the electrical stimulation is in the form of a signal having an amplitude and a duration for providing a first indication to the user of close proximity of the operative element to the targeted tissue region, and a stimulation control device electrically coupled to the operative element, the stimulation control device comprising stimulation signal generating circuitry.
• the housing may include a first control device for turning the stimulation signal to the operative element on and off and for providing adjustment of the stimulation signal amplitude, the first control device being electrically coupled to the stimulation control device.
• the housing may also include a second control device for providing adjustment of the stimulation signal duration, the second control device being electrically coupled to the stimulation control device.
• tissue stimulation system may be sterilized using ethylene oxide, for example, and prepackaged for single use.
• the stimulation signal of the tissue stimulation system includes an amplitude that may range between about zero milliamps and about 20 milliamps, allowing for accurate selective stimulation of both muscles and nerves, and also identification of nerves and muscles, muscle attachments, or to contract muscles to assess the quality of surgical interventions.
• the tissue stimulation signal duration may include a range between about zero microseconds and about 200 microseconds, for example.
• the first indication provided by the tissue stimulation system may include, for example, audio and visual indications.
• the tissue stimulation system may further include a second indication means to provide confirmation of power on to the device and delivery of a stimulation signal to the electrically conductive surface.
• the first and second indication means may be combined into a single indication means.
• the operative element of the tissue stimulation system may comprise a probe, for example, where the electrically conductive surface of the probe comprises between about 1 millimeter and about 10 millimeters of the proximal end of the probe, and the probe comprises a diameter between about 0.5 millimeters and about 1.5 millimeters.
• the tissue stimulation system may also further include a return electrode electrically coupled to the stimulation control device.
• tissue stimulation system such as a medical device comprising a housing having a proximal end and a distal end, the housing sized and configured to be held by a user in either the left or right hand, a probe having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the probe extending from the proximal end of the housing.
• the housing proximal end comprises a probe adjustment portion to allow movement of the probe.
• the electrical stimulation is in the form of a signal having an amplitude and a duration for providing a physical motor response, a stimulation control device electrically coupled to the probe and sized and configured to be positioned within the housing, the stimulation control device comprising stimulation signal generating circuitry.
• the housing may include a first control device for turning the stimulation signal to the probe on and off and for providing adjustment of the stimulation signal amplitude, the first control device being electrically coupled to the stimulation control device.
• the housing may also include a second control device for providing adjustment of the stimulation signal duration, the second control device being electrically coupled to the stimulation control device.
• a stimulation control device electrically coupled to at least one surgical tool, which can comprise, e.g., a cutting, grasping, drilling, screwing, and/or viewing tool.
• the application of stimulation voltage or current to the device allows the clinician to observe muscle contraction or changes in the nervous system response when the surgical tool is in close proximity to viable nerve or muscle tissue.
• the surgical tool thus becomes a neural/muscular stimulating electrode.
• different surgical tools individually deployed in association with different medical procedures, can make use of a singe, stimulation control device, to which a selected surgical tool can be temporarily coupled for use.
• the stimulation control device may be embedded within the surgical tool to provide a medical device capable of providing stimulation, as described above.
• a hand held stimulation probe or monitor includes the stimulation control device and at least one stimulation electrode within a unified housing to provide an ergonomic stimulation device.
• the hand held stimulation probe can be a sterile, single use instrument intended for use during surgical procedures to identify nerves and muscles, muscle attachments, or to contract muscles to assess the quality of surgical interventions or the need for surgical interventions, or to evaluate the function of nerves already identified through visual or audible means, or by other nervous system monitoring instruments .
• Yet another aspect of the invention provides devices, systems, and methods, including a method of testing a tissue region of a patient that includes providing a tissue stimulation system having an operative element extending from a proximal end of a housing, the housing proximal end comprising an operative element adjustment portion to allow movement of the operative element, moving a first control device to an activation position causing a stimulation signal to be generated by the stimulation system and transmitted to the operative element, engaging the patient with the operative element at a targeted tissue region, and observing the targeted tissue region for a first indication.
• the method may further include engaging the patient with a second electrode which is electrically coupled to the stimulation system, the second electrode allowing the stimulation signal to flow from the operative element, through the patient's body to the second electrode, and back to the stimulation system.
• a hand held tissue stimulation apparatus including a tubular shaped housing comprising a gripping base portion and an operative element adjustment portion, the gripping base portion comprising a first housing element and a second housing element, a stimulation control device positioned within the gripping base portion, a battery positioned within the gripping base portion and coupled to the stimulation control device to provide power to the stimulation control device, a visual indication coupled to a proximal end of the gripping base portion, the visual indication comprising an illuminating circumferential ring indicator, the illuminating circumferential ring indicator being visible around the circumference of the tubular housing, and an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region, the operative element being coupled to the stimulation control device and extending from the proximal end of the operative element adjustment portion.
• the operative element adjustment portion comprises a flexible nose cone sized and configured to allow movement of the operative element, and the visual indication further includes a reflector element.
• a return electrode electrically may be coupled to the stimulation control device.
• a kit of devices provides tissue stimulation to a targeted tissue region.
• the kit may include a hand held stimulation probe including a housing sized and configured to be held with either a left or right hand, the stimulation probe being sterilized and disposable, and including an operative element extending from a proximal end of the housing, the housing proximal end comprising an operative element adjustment portion to allow movement of the operative element, a lead including a return electrode coupled to the stimulation probe, and instructions for use describing the unpacking and tissue contact procedure for the stimulation probe.
• Additional aspects of the invention provide a stimulation control device electrically coupled to a tissue cutting instrument, or a stimulation control device electrically coupled to a drilling instrument, or a stimulation control device electrically coupled to a pilot auger for hard surface rotary probing prior to pilot hole drilling, or a stimulation control device electrically coupled to a fixation device, which is commonly used in spinal stabilization procedures and internal bone fixation procedures.
• Fig. 1 is a diagrammatic view of a system usable in association with a family of different monitoring and treatment devices for use in different medical procedures.
• Fig. 2 is a perspective view showing an exemplary embodiment of the system shown in Fig. 1, the stimulation control device being removably coupled to a stimulation probe, and showing the stimulation signal path through the system.
• Fig. 3A is a side view with a portion broken away and in section showing the stimulation probe having the stimulation control device embedded within the stimulation probe.
• Fig. 3B is a side view with a portion broken away and in section showing the stimulation probe having the stimulation control device embedded within the stimulation probe, and showing an optional needle-like return electrode.
• Fig. 3C is a side view with a portion broken away and in section showing an additional embodiment of the stimulation probe having a housing that includes a gripping base and a flexible nose cone, and an illuminating ring indicator.
• Fig. 4A is a side view of the stimulation probe of Fig. 3c, showing the users hand in a position on the stimulation probe to move the flexible nose cone.
• Fig. 4B is a side view of the stimulation probe of Fig. 4A, showing the users hand flexing the flexible nose cone.
• Fig. 5 is a side view with a portion broken away and in section showing elements of the flexible nose cone, the ring indicator, and the gripping base.
• Fig. 6 is a graphical view of a desirable biphasic stimulus pulse output of the stimulation device.
• Fig. 7 is a view showing how the geometry of the stimulation control device shown in Fig. 2 aids in its positioning during a surgical procedure.
• Fig. 8 is a block diagram of a circuit that the stimulation control device shown throughout the Figs, can incorporate.
• Figs. 9A and 9B are perspective views showing the stimulation control device in use with a cutting device .
• Figs. 1OA and 1OB are perspective views showing the stimulation control device in use with a drilling or screwing device.
• Figs. HA and HB are perspective views showing the stimulation control device in use with a pilot auger device.
• Figs. 12A and 12B are perspective views showing the stimulation control device in use with a fixation device.
• Fig. 13 is a plane view of a kit used in conjunction with the stimulation probe shown in Fig. 3C, and including the stimulation probe and instructions for use.
• Fig. 14 is a perspective view of the stimulation probe shown in Fig. 3C.
• Fig. 15 is an exploded view of the stimulation probe shown in Fig. 14.
• This Specification discloses various systems and methods for safeguarding against nerve, muscle, and tendon injury during surgical procedures or confirming the identity and/or location of nerves, muscles, and tendons and evaluating their function or the function of muscles enervated by those nerves.
• the systems and methods are particularly well suited for assisting surgeons in identification of nerves and muscles in order to assure nerve and muscle integrity during medical procedures using medical devices such as stimulation monitors, cutting, drilling, and screwing devices, pilot augers, and fixation devices. For this reason, the systems and methods will be described in the context of these medical devices.
• the systems and methods desirably allow the application of a stimulation signal at sufficiently high levels for the purposes of locating, stimulating, and evaluating nerve or muscle, or both nerve and muscle integrity in numerous medical procedures, including, but not limited to, evaluating proximity to a targeted tissue region, evaluating proximity to a nerve or to identify nerve tissue, evaluating if a nerve is intact (i.e., following a traumatic injury) to determine if a repair may be needed, evaluating muscle contraction to determine whether or not the muscle is innervated and/or whether the muscle is intact and/or whether the muscle is severed, and evaluating muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.
• Fig. 1 shows an illustrative system 20 for locating and identifying tissue and safeguarding against tissue and/or bone injury during surgical procedures.
• the system 20 is configured for locating, monitoring, and stimulating tissue and other structures throughout the body.
• the system 20 includes a stimulation control device 22 operating individually or in conjunction with one or more of a family of stimulating medical devices including, for example, a stimulation monitor or probe 100, a cutting device 200, a drilling or screwing device 300, a pilot auger 400, and a fixation device 500.
• the stimulation control device 22 functions in the system 20 to generate an electrical stimulation signal 29.
• the stimulation signal 29 flows from the stimulation control device 22 through a lead 24 to a medical device (e.g., stimulation probe 100).
• the stimulation signal 29 then flows through a predefined insulated path 124 within the stimulation probe 100 and to an operative element, such as an electrically conductive surface, i.e., a coupled electrode 110.
• the electrode 110 is to be positioned on or near a region of a patient to be stimulated.
• a return electrode (or indifferent electrode) 38 provides an electrical path from the body back to the control device 22.
• the stimulation control device 22 may operate in a monopolar or bipolar configuration, as will be described in greater detail later.
• the stimulation signal 29 is adapted to provide an indication or status of the device.
• the indication may include a physical motor response (e.g., twitching) , and/or one or more visual or audio signals from the stimulation control device 22, which indicate to the surgeon the status of the device, and/or close proximity of the electrode 110 to a nerve, or a muscle, or a nerve and a muscle.
• the stimulation control device may also indicate to the surgeon that the stimulation control device is operating properly and delivering a stimulus current. II. Medical Devices
• the configuration of the stimulating medical devices that form a part of the system can vary in form and function. Various representative embodiments of illustrative medical devices will be described.
• Figs. 3A to 3C show various embodiments of a hand held stimulation monitor or probe 50 for identification and testing of nerves and/or muscles during surgical procedures.
• the stimulation probe 50 may accommodate within a generally tubularly housing 112 the electrical circuitry of a stimulation control device 22.
• the stimulation probe 50 is desirably an ergonomic, sterile, single use instrument intended for use during surgical procedures to identify nerves and muscles, muscle attachments, or to contract muscles to assess the quality of surgical interventions or the need for surgical interventions, or to evaluate the function of nerves already identified through visual means.
• the stimulation probe 50 may be sterilized using ethylene oxide, for example.
• the stimulation probe 50 is preferably sized small enough to be held and used by one hand during surgical procedures, and is ergonomically designed for use in either the left or right hand.
• the stimulation probe 50 may have a width of about 20 millimeters to about 30 millimeters, and desirably about 25 millimeters.
• the length of the stimulation probe 50 (not including the operative element 110) may be about 18 centimeters to about 22 centimeters, and desirably about 20 centimeters.
• the operative element 110 may also include an angle or bend to facilitate access to deep as well as superficial structures without the need for a large incision. " The operative element 110 will be described in greater detail later.
• a visual or audio indicator 126 incorporated with the housing 112 provides reliable feedback to the surgeon as to the request and delivery of stimulus current.
• the stimulation probe 50 includes a housing 112 that comprises a gripping base portion 60 and an operative element adjustment portion 62.
• the operative element 110 extends from the proximal end of the adjustment portion 62.
• the adjustment portion as will be described as a nose cone 62, may be flexible. This flexibility allows the surgeon to use either a finger or a thumb positioned on the nose cone 62 to make fine adjustments to the position of stimulating tip 111 of the operative element 110 at the targeted tissue region (see Figs. 4A and 4B) .
• the surgeon is able to grasp the gripping base 60 with the fingers and palm of the hand, and position the thumb on the nose cone 62, and with pressure applied with the thumb, cause the stimulating tip 111 to move while maintaining a steady position of the gripping base portion 62.
• This flexible nose cone 62 feature allows precise control of the position of the stimulating tip 111 with only the movement of the surgeon's thumb (or finger, depending on how the stimulating probe is held) .
• the flexible nose cone 62 may comprise a single element or it may comprise at least an inner portion 64 and an outer portion 66, as shown in Fig. 5.
• the inner portion 64 of the nose cone 62 may be made of a thermoplastic material having some flexibility.
• One example may be LUSTRAN ® ABS 348, or similar material.
• the outer portion 66 may comprise a softer over molded portion and may be made of a thermoplastic elastomer material having some flexibility.
• One example may be VERSAFLEXTM OM 3060-1 from GLS Corp.
• the nose cone 62 is desirably generally tapered.
• the nose cone 62 may be rounded, as shown in Figs.
• the nose cone 62 may be more conical in shape, as shown in Fig. 3C.
• the nose cone 62 may also include one or more features, such as ribs or dimples 72, as shown in Fig. 14, to improve the gripping, control, and stability of the stimulation probe 50 within the surgeon's hand.
• the gripping base portion 60 of the housing 112 may also include an overmolded portion 68.
• the overmolded portion 68 may comprise the full length of the gripping base portion 60, or only a portion of the gripping base 60.
• the soft overmolded portion 68 may include one or more features, such as dimples or ribs 70, as shown, to improve the gripping, control, and stability of the stimulation probe 50 within the surgeon's hand.
• the overmolded portion 68 may comprise the same or similar material as the thermoplastic elastomer material used for the outer portion 66 of the flexible nose cone 62.
• the stimulation probe 50 includes a housing 112 that carries an insulated lead 124.
• the insulated lead 124 connects the operative element 110 positioned at the housing's proximal end 114 to the circuitry 22 within the housing 112 (see Fig. 3A) . It is to be appreciated that the insulated lead is not necessary and the operative element 110 may be coupled to the circuitry 22 (see Fig. 3C) .
• the lead 124 within the housing 112 is insulated from the housing 112 using common insulating means (e.g., wire insulation, washers, gaskets, spacers, bushings, and the like) .
• the conductive tip 111 of the operative element 110 is positioned in electrical conductive contact with at least one muscle, or at least one nerve, or at least one muscle and nerve.
• the stimulation probe 50 is monopolar and is equipped with a single operative element (i.e., electrode) 110 at the housing proximal end 114.
• a return electrode 130, 131 may be coupled to the stimulation probe 50 and may be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the various return electrodes 130, 131 are coupled to the housing distal end 118.
• the stimulation device 50 itself may be bipolar by including a return electrode in the operative element 110, which precludes the use of a return electrode coupled to the stimulation probe 50.
• the stimulation probe 50 may accommodate within the housing 112 the electrical circuitry of a stimulation control device 22.
• the stimulation probe 50 may have one or more user operable controls. Two are shown - 155 and 160.
• Power switch 155 serves a dual purpose of turning the stimulation probe 50 ON and OFF (or standby) , and also can be stepped to control the stimulation signal amplitude selection within a predefined range (e.g., 0.5, 2.0, and 20 mA) .
• the switch may be a four position switch. Before the first use of the stimulation probe 50, the power switch 155 is in the OFF position and keeps the stimulation probe off.
• the OFF position now corresponds to a standby condition, where no stimulation would be delivered.
• the stimulation probe 50 once the stimulation probe 50 has been turned on, it cannot be turned off, it can only be returned to the standby condition and will remain operational for a predetermined time, e.g., at least about seven hours. This feature is intended to allow the stimulation probe 50 to only be a single use device, so it can not be turned OFF and then used again at a later date.
• the pulse control device 160 allows for adjustment of the stimulation signal pulse width from a predefined range (e.g., about zero to about 200 microseconds) .
• the pulse control 160 may be a potentiometer to allow a slide control to increase or decrease the stimulation signal pulse width within the predefined range.
• the stimulation pulse may have a non- adjustable frequency in the range of about 10Hz to about 20Hz, and desirably about 16Hz.
• the stimulation pulse desirably has a biphasic waveform with controlled current during the cathodic (leading) phase, and net DC current less than 10 microamps, switch adjustable from about 0.5 milliamps to about 20 milliamps, and pulse durations adjustable from about zero microseconds up to about 200 microseconds.
• a typical, biphasic stimulus pulse is shown in Fig. 6.
• the operative element 110 exits the housing 112 at the proximal end 114 to deliver stimulus current to the excitable tissue.
• the operative element 110 comprises a length and a diameter of a conductive material, and is desirably fully insulated with the exception of the most proximal end, e.g. about 1.0 millimeters to about 10 millimeters, and desirably about 4 millimeters to about 6 millimeters, which is non- insulated and serves as the stimulating tip or surface (or also referred to as active electrode) 111 to allow the surgeon to deliver the stimulus current only to the intended tissue.
• the small area of the stimulating surface 111 (the active electrode) of the operative element 110 ensures a high current density that will stimulate nearby excitable tissue.
• the insulation material 113 may comprise a medical grade heat shrink.
• the conductive material of the operative element 110 comprises a diameter having a range between about 0.5 millimeters to about 1.5 millimeters, and may be desirably about 1.0 millimeters.
• the length of the operative element 110 may be about 50 millimeters to about 60 millimeters, although it is to be appreciated that the length may vary depending on the particular application.
• the operative element 110 may include one or more bends to facilitate accurate placement of the stimulating surface 111.
• the conductive material of operative element 110 is made of a stainless steel 304 solid wire, although other known conductive materials may be used.
• a return electrode 130 or 131 provides an electrical path from the body back to the control device 22 within the housing 112.
• the return electrode 130 may be placed on the surface of intact skin (e.g., surface electrodes as used for ECG monitoring during surgical procedures) or it might be needle-like 131 (see Figs. 3B and 3C) , and be placed in the surgical field or penetrate through intact skin.
• the housing's distal end 118 can incorporate a connector or jack 120 which provides options for return current pathways, such as through a surface electrode 130 or a needle electrode 131, having an associated plug 122.
• a return electrode and associated lead may be an integral part of the stimulation probe 50, i.e., no plug or connector, as shown in Fig. 3C.
• the device 50 may desirably incorporate a visual or audio indicator 126 for the surgeon.
• This visual or audio indicator 126 allows the surgeon to confirm that the stimulator 50 is delivering stimulus current to the tissue it is contacting.
• the indicator 126 (which can take the form, e.g., of a light emitting diode (LED)) allows the surgeon to confirm that the stimulating tip 111 is in place, the instrument is turned ON, and that stimulus current is flowing.
• LED light emitting diode
• the indicator 126 may be configured to illuminate continuously in one color when the stimulation probe 50 is turned on but not in contact with tissue. After contact with tissue is made, the indicator 126 may flash
• the indicator 126 may illuminate in a different color, and may illuminate continuously or may flash.
• the indicator 126 comprises a ring indicator 128 that provides a visual indication around at least a portion, and desirably all of the circumference of the stimulation probe 50 generally near the flexible nose cone 62.
• the visual ring indicator 128 may be an element of the gripping portion 60, or it may be an element of the flexible nose cone 62, or the ring indicator may positioned between the gripping portion 60 and the flexible nose cone 62.
• the ring indicator 128 may also include a reflective element 129 to improve and focus the illumination effect of the light emitting source, e.g., one or more LEDs.
• the ring indicator 128 and the reflective element may be a single component, or more than one component (as can be seen in Figs. 5 and 15) .
• Audio feedback also makes possible the feature of assisting the surgeon with monitoring nerve integrity during surgery.
• the insulated lead 124 connects to the operative element 110 that, in use, is positioned within the surgical field on a nerve distal to the surgical site. Stimulation of the nerve causes muscle contraction distally.
• the stimulation control device 22 incorporated within the housing 112 may be programmed to provide an audio tone followed by a stimulation pulse at prescribed intervals. The audio tone reminds the surgeon to observe the distal muscle contraction to confirm upon stimulation that the nerve is functioning and intact.
• Fig. 15 shows an exploded view of a representative stimulation probe 50.
• the stimulation control device 22 is positioned within the housing 112.
• a battery 34 is electrically coupled to the control device 22.
• a first housing element 90 and a second housing element 92 partially encapsulate the control device 22.
• the ring indicator 128 and the reflective element 129 are coupled to the proximal end of the housing 112.
• the operative element 110 extends through the nose cone 62 and couples to the control device 22.
• the stimulation probe 50 will be constructed in a manner to conform to at least the IPXl standard for water ingress.
• the stimulation control device 22 may be housed in a separate case, with its own input/output (I/O) controls 26.
• the stimulation control device 22 is sized small enough to be easily removably fastened to a surgeon' s arm or wrist during the surgical procedure, or otherwise positioned in close proximity to the surgical location (as shown in Fig. I) 1 to provide sufficient audio and/or visual feedback to the surgeon.
• the separate stimulation control device 22 can be temporarily coupled by a lead to a family of various medical devices for use.
• the present invention includes a method of identifying/locating tissue, e.g., a nerve or muscle, in a patient that comprises the steps of providing a handheld stimulation probe 50, 100 as set forth above, engaging a patient with the first operative element 110 and the second electrode 130, moving the power switch 155 to an activation position causing a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first operative element 110, through the patient's body to the second electrode 130, and back to the stimulation control device 22.
• the method may also include the step of observing the indicator 126 to confirm the stimulation probe 50, 100 is generating a stimulation signal.
• the method may also include the step of observing a tissue region to observe tissue movement or a lack thereof .
• the stimulation control device 22 includes a circuit 32 that generates electrical stimulation waveforms.
• a battery 34 desirably provides the power.
• the control device 22 also desirably includes an on-board, programmable microprocessor 36, which carries embedded code. The code expresses pre-programmed rules or algorithms for generating the desired electrical stimulation waveforms using the stimulus output circuit 46 and for operating the visible or audible indicator 126 based on the controls actuated by the surgeon.
• the size and configuration of the stimulation control device 22 makes for an inexpensive device, which is without manual internal circuit adjustments. It is likely that the stimulation control device 22 of this type will be fabricated using automated circuit board assembly equipment and methods .
• a stimulation control device 22 as just described may be electrically coupled through a lead, or embedded within various devices commonly used in surgical procedures (as previously described for the stimulation probe 50) .
• a device 200 is shown that incorporates all the features disclosed in the description of the stimulation probe 50, 100, except the device 200 comprises the additional feature of providing an "energized" surgical device or tool.
• Fig. 9A shows the tool to be a cutting device 200 (e.g., scalpel) removably- coupled to a stimulation control device 22. In the embodiment shown, the cutting device
• the 200 includes a body 212 that carries an insulated lead 224.
• the insulated lead 224 connects to an operative element, such as electrode 210, positioned at the body proximal end 214 and a plug-in receptacle 219 at the body distal end 118.
• the lead 224 within the body 212 is insulated from the body 212 using common insulating means (e.g., wire insulation, washers, gaskets, spacers, bushings, and the like) .
• the electrode 210 performs the cutting feature (e.g., knife or razor).
• the electrode 210 performs the cutting feature in electrical conductive contact with at least one muscle, or at least one nerve, or at least one muscle and nerve.
• the cutting device 200 desirably includes a plug- in receptacle 216 for the electrode 210, allowing for use of a variety of cutting electrode shapes and types (e.g., knife, razor, pointed, blunt, curved), depending on the specific surgical procedure being performed.
• the lead 224 electrically connects the electrode 210 to the stimulation control device 22 through plug-in receptacle 219 and lead 24.
• the cutting device 200 is mono-polar and is equipped with a single electrode 210 at the body proximal end 214.
• the stimulation control device 22 includes a return electrode 38 which functions as a return path for the stimulation signal.
• Electrode 38 may be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the return electrode 38 may be attached to the stimulation device 22 by way of a connector or plug- in receptacle 39.
• the cutting device 200 may be bipolar, which precludes the use of the return electrode 38.
• the cutting device 200 accommodates within the body 212 the electrical circuitry of the stimulation control device 22.
• the cutting device 200 may have at least two operational slide controls, 255 and 260.
• Power switch 255 serves a dual purpose of turning the stimulation signal to the cutting device 200 on and off, and also is stepped to control the stimulation signal amplitude selection from a predefined range (e.g., 0.5, 2.0, and 20 mA) .
• the pulse control switch 260 allows for adjustment of the stimulation signal pulse width from a predefined range (e.g., zero through 200 microseconds).
• a second plug-in receptacle 220 may be positioned for receipt of a second lead 222.
• Lead 222 connects to electrode 230 which functions as a return path for the stimulation signal when the cutting device 200 is operated in a mono-polar mode .
• the device 200 may incorporate a visual or audio indicator for the surgeon, as previously described.
• the present invention includes a method of identifying/locating tissue, e.g., a nerve or muscle, in a patient that comprises the steps of providing cutting device 200 as set forth above, engaging a patient with the first electrode 210 and the second electrode 230, moving the power switch 255 to an activation position causing a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first electrode 210, through the patient's body to the second electrode 230, and back to the stimulation control device 22.
• the method may also include the step of observing the indicator 126 to confirm the cutting device 200 is generating a stimulation signal.
• the method may also include the step of observing a tissue region to observe tissue movement or a lack thereof. 2. Drilling Device In Figs.
• a device 300 is shown that incorporates all the features disclosed in the description of the stimulation probe 50, 100, except the device 300 comprises the additional feature of providing an "energized" surgical device or tool, which comprises a drilling device 300.
• drilling device 300 is removably coupled to a stimulation control device 22.
• the drilling device In the embodiment shown, the drilling device
• 300 includes a body 312 that carries an insulated lead
• the insulated lead 324 connects to an operative element, such as electrode 310, positioned at the body proximal end 314 and a plug-in receptacle 319 at the body distal end 318.
• the lead 324 within the body 312 is insulated from the body 312 using common insulating means (e.g., wire insulation, washers, gaskets, spacers, bushings, and the like) .
• the electrode 310 performs the drilling feature.
• the electrode 310 may also perform a screwing feature as well.
• the electrode 310 performs the drilling feature in electrical conductive contact with a hard structure (e.g., bone).
• the drilling device 300 desirably includes a plug-in receptacle or chuck 316 for the electrode 310, allowing for use of a variety of drilling and screwing electrode shapes and sizes (e.g., 1/4 and 3/8 inch drill bits, Phillips and flat slot screw drivers) , depending on the specific surgical procedure being performed.
• the lead 324 electrically connects the electrode 310 to the stimulation control device 22 through plug-in receptacle 319 and lead 324.
• the drilling device 300 is mono-polar and is equipped with a single electrode 310 at the body proximal end 314. In the mono-polar mode, the stimulation control device 22 includes a return electrode 38 which functions as a return path for the stimulation signal.
• Electrode 38 may be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the return electrode 38 may be attached to the stimulation device 22 by way of a connector or plug- in receptacle 39.
• the drilling device 300 may be bipolar, which precludes the use of the return electrode 38.
• the drilling device 300 is shown to accommodate within the body 312 the electrical circuitry of the stimulation control device 22.
• the drilling device 300 may have at least two operational slide controls, 355 and 360.
• Power switch 355 serves a dual purpose of turning the stimulation signal to the drilling device 300 on and off, and also is also stepped to control the stimulation signal amplitude selection from a predefined range (e.g., 0.5, 2.0, and 20 mA) .
• the pulse control switch 360 allows for adjustment of the stimulation signal pulse width from a predefined range (e.g., zero through 200 microseconds).
• a second plug-in receptacle 320 may be positioned for receipt of a second lead 322.
• Lead 322 connects to electrode 330 which functions as a return path for the stimulation signal when the drilling device 300 is operated in a mono-polar mode.
• the device 300 may incorporate a visual or audio indicator for the surgeon, as previously- described.
• the present invention includes a method of identifying/locating tissue, e.g., a nerve or muscle, in a patient that comprises the steps of providing a drilling device 300 as set forth above, engaging a patient with the first electrode 310 and the second electrode 330, moving the power switch 355 to an activation position causing a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first electrode 310, through the patient's body to the second electrode 330, and back to the stimulation control device 22.
• the method may also include the step of observing the indicator 126 to confirm the drilling device 400 is generating a stimulation signal.
• the method may also include the step of observing a tissue region to observe tissue movement or a lack thereof. 3. Pilot Auger
• An additional aspect of the invention provides systems and methods for controlling operation of a family of stimulating devices comprising a stimulation control device electrically coupled to a pilot auger for hard surface rotary probing.
• Fig. HA shows a pilot auger device 400 removably- coupled to a stimulation control device 22.
• the pilot auger device 400 includes a body 412 that carries an insulated lead 424.
• the insulated lead 424 connects to an operative element, such as an electrode 410, positioned at the body proximal end 414 and a plug-in receptacle 419 at the body distal end 418.
• the lead 424 within the body 412 is insulated from the body 412 using common insulating means (e.g., wire insulation, washers, gaskets, spacers, bushings, and the like) .
• the electrode 410 performs the pilot augering feature.
• the electrode 410 performs the pilot augering feature in electrical conductive contact with a hard structure (e.g., bone).
• the pilot auger device 400 desirably includes a plug- in receptacle or chuck 416 for the electrode 410, allowing for use of a variety of pilot augering electrode shapes and sizes (e.g., 1/32, 1/16, and 1/8 inch), depending on the specific surgical procedure being performed.
• the lead 24 electrically connects the electrode 410 to the stimulation control device 22 through plug-in receptacle 419 and lead 24.
• the pilot auger device 400 is mono-polar and is equipped with a single electrode 410 at the body proximal end 414.
• the stimulation control device 22 includes a return electrode 38 which functions as a return path for the stimulation signal.
• Electrode 38 may be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the return electrode 38 may be attached to the stimulation device 22 by way of a connector or plug- in receptacle 39.
• the pilot auger device 400 may be bipolar, which precludes the use of the return electrode 38.
• the pilot auger device 400 may accommodate within the body 412 the electrical circuitry of the stimulation control device 22.
• a second plug-in receptacle 420 may be positioned for receipt of a second lead 422.
• Lead 422 connects to electrode 430 which functions as a return path for the stimulation signal when the pilot auger device 400 is operated in a mono-polar mode.
• the pilot auger device 400 includes a power switch 455. When moved to an activation position, a stimulation signal is generated by the stimulation control device 22. Additionally, the device 400 may incorporate a visual or audio indicator for the surgeon, as previously described.
• the present invention includes a method of identifying/locating tissue, e.g., a nerve or muscle, in a patient that comprises the steps of providing a pilot auger device 400 as set forth above, engaging a patient with the first electrode 410 and the second electrode 430, moving the power switch 455 to an activation position causing a stimulation signal to be generated by the stimulation control device 22 and transmitted to the first electrode 410, through the patient's body to the second electrode 430, and back to the stimulation control device 22.
• the method may also include the step of observing the indicator 126 to confirm the pilot auger device 400 is generating a stimulation signal.
• the method may also include the step of observing a tissue region to observe tissue movement or a lack thereof.
• An additional aspect of the invention provides systems and methods for controlling operation of a family of stimulating devices comprising a stimulation control device electrically coupled to a fixation device or a wrench or screwdriver for placing the fixation device.
• a fixation device e.g., orthopedic hardware, pedicle screws
• fusion spinal stabilization procedures
• internal bone fixation procedures e.g., internal bone fixation procedures
• FIG. 12A shows a fixation device 500 removably coupled to a stimulation control device 22.
• the fixation device 500 includes a rectangularly shaped body 512 that also serves as an operative element, such as electrode 510.
• the fixation device 500 may take on an unlimited number of shapes as necessary for the particular procedure taking place.
• Pedicle screws 535 may be used to secure the fixation device to the bony structure.
• the electrode 510 performs the fixation feature in electrical conductive contact with a hard structure (e.g., bone) .
• the fixation device 500 or wrench or screwdriver for placing the fixation device desirably includes a plug-in receptacle 519.
• the fixation device 500 may take on an unlimited variety of shapes and sizes depending on the specific surgical procedure being performed.
• the lead 24 electrically connects the electrode 510 to the stimulation control device 22 through plug-in receptacle 519.
• the fixation device 500 is mono-polar and is equipped with the single electrode 510.
• the stimulation control device 22 includes a return electrode 38 which functions as a return path for the stimulation signal.
• Electrode 38 may ⁇ be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the return electrode 38 may be attached to the stimulation device 22 by way of a connector or plug- in receptacle 39.
• the fixation device 500 may be bipolar, which precludes the use of the return electrode 38.
• the fixation device 500 may be bipolar, which precludes the use of the return electrode 38.
• the fixation device may be a pedicle screw 535.
• the pedicle screw 535 is removably coupled to a stimulation control device 22.
• the pedicle screw 535 includes a head 570 and a shaft 572, which both serve as an operative element, such as electrode 574.
• the electrode 574 performs the fixation feature in electrical conductive contact with a hard structure (e.g., bone), as the pedicle screw 535 is being positioned within a bony structure.
• the lead 24 electrically connects the electrode 574 to the stimulation control device 22, through a break-away connection or other similar electrical connective means.
• the fixation device 535 may take on an unlimited variety of shapes and sizes depending on the specific surgical procedure being performed.
• the stimulation control device 22 includes a return electrode 38 which functions as a return path for the stimulation signal.
• Electrode 38 may be any of a variety of electrode types (e.g., paddle, needle, wire, or surface), depending on the surgical procedure being performed.
• the fixation device 500 may be bipolar, which precludes the use of the return electrode 38.
• the present invention includes a method of identifying/locating tissue, e.g., a nerve or muscle, in a patient that comprises the steps of providing a fixation device 500 as set forth above, engaging a patient with the first electrode 510 and the second electrode 38, turning power on to the stimulation control device 22 through the I/O controls 26, causing a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first electrode 510, through the patient's body to the second electrode 38, and back to the stimulation control device 22.
• the method may also include the step of observing the indicator 126 to confirm the fixation device 500 is generating a stimulation signal.
• the method may also include the step of observing a tissue region to observe tissue movement or a lack thereof.
• the stimulation control device 22 can incorporate various technical features to enhance its universality.
• the stimulation control device 22 can be sized small enough to be held and used by one hand during surgical procedures, or to be installed within a stimulation probe or surgical device.
• the angle of the stimulating tip facilitates access to deep as well as superficial structures without the need for a large incision.
• Visual and/or audible indication incorporated in the housing provides reliable feedback or status to the surgeon as to the request and delivery of stimulus current.
• the stimulation control device 22 may also be sized small enough to be easily removably fastened to a surgeon' s arm or wrist during the surgical procedure, or positioned in close proximity to the surgical location (as shown in Fig. I) 1 to provide sufficient audio and/or visual feedback to the surgeon.
• a representative battery 34 may include a size "N" alkaline battery. In one embodiment, two size “N” alkaline batteries in series are included to provide a 3 volt power source. This configuration is sized and configured to provide an operating life of at least seven hours of operation - either continuous or intermittent stimulation.
• the stimulation control device 22 desirably uses a standard, commercially available micro-power, flash programmable microcontroller 36.
• the microcontroller 36 reads the controls operated by the surgeon, controls the timing of the stimulus pulses, and controls the feedback to the user about the status of the instrument (e.g., an LED with 1, 2, or more colors that can be on, off, or flashing) .
• the microcontroller operates at a low voltage and low power.
• the microcontroller send low voltage pulses to the stimulus output stage 46 that converts these low voltage signals into the higher voltage, controlled voltage, or controlled current, stimulus pulses that are applied to the electrode circuit.
• This stimulus output stage 46 usually involves the use of a series capacitor to prevent the presence of DC current flow in the electrode circuit in normal operation or in the event of an electronic component failure.
• the stimulation probe 50, 100 make possible the application of a stimulation signal at sufficiently high levels for the purposes of locating, stimulating, and evaluating nerve or muscle, or both nerve and muscle integrity in numerous medical procedures, including, but not limited to, evaluating proximity to a targeted tissue region, evaluating proximity to a nerve or to identify nerve tissue, evaluating if a nerve is intact (i.e., following a traumatic injury) to determine if a repair may be needed, evaluating muscle contraction to determine whether or not the muscle is innervated and/or whether the muscle is intact and/or whether the muscle is severed, and evaluating muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure .
• kit 82 can take various forms.
• kit 82 comprises a sterile, wrapped assembly.
• a representative kit 82 includes an interior tray 84 made, e.g., from die cut cardboard, plastic sheet, or thermo- formed plastic material, which hold the contents.
• Kit 82 also desirably includes instructions for use 80 for using the contents of the kit to carry out a desired therapeutic and/or diagnostic objectives.
• the instructions 80 guide the user through the steps of unpacking the stimulation probe 50, positioning the electrodes, and disposing of the single use disposable stimulator 50.
• Representative instructions may include, but are not limited to: • Remove the stimulation probe 50 from sterile package 88.
• the return electrode is desirably positioned in an area remote from the area to be stimulated. 2.
• the return electrode is desirably not positioned across the body from the side being stimulated.
• the return electrode is desirably not in muscle tissue .
• the stimulation probe 50 desirably is turned ON before the operative element 110 makes contact with tissue.
• the indicator 126 will be illuminated yellow (for example) continuously if the stimulation probe 50 is ON, but not in contact with tissue.
• the indicator 126 will flash yellow indicating that stimulation is being delivered. • A flashing red (for example) indicator 126 means that stimulation has been requested, but no stimulation is being delivered because of inadequate connection of the operative element 110 or the return electrode 131 to the patient tissue. Check the return electrode contact and position, and check the operative element 110 contact and position.

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