EP3349639A1 - Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs - Google Patents

Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs

Info

Publication number
EP3349639A1
EP3349639A1 EP16847542.4A EP16847542A EP3349639A1 EP 3349639 A1 EP3349639 A1 EP 3349639A1 EP 16847542 A EP16847542 A EP 16847542A EP 3349639 A1 EP3349639 A1 EP 3349639A1
Authority
EP
European Patent Office
Prior art keywords
probe
shaft
pedicle
tip
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP16847542.4A
Other languages
German (de)
English (en)
Other versions
EP3349639A4 (fr
Inventor
Avery M. JACKSON III
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority claimed from PCT/US2016/052484 external-priority patent/WO2017049288A1/fr
Publication of EP3349639A1 publication Critical patent/EP3349639A1/fr
Publication of EP3349639A4 publication Critical patent/EP3349639A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00043—Operational features of endoscopes provided with output arrangements
    • A61B1/00045—Display arrangement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/05—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances characterised by the image sensor, e.g. camera, being in the distal end portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3135—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for examination of the epidural or the spinal space
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1615—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0023—Surgical instruments, devices or methods, e.g. tourniquets disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • 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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/407—Evaluating the spinal cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation

Definitions

  • This invention relates generally to surgical instruments. More specifically, the invention relates to a pedicle probe for use in forming holes in a vertebral pedicle in preparation for pedicle screw insertion.
  • the probe incorporates at least one endoscope to enable the surgeon to see the area being treated.
  • a light is integrated with the probe to illuminate the area being treated, and in a preferred embodiment irrigation means is associated with the probe to flush debris away from the area being treated to prevent the view from being obstructed.
  • the probe is provided with mechanomyography (MMG) or electromyography (EMG) capability to alert the surgeon if the pedicle is about to be breached.
  • MMG mechanomyography
  • EMG electromyography
  • a replaceable tip is provided on the distal end of the probe, and in a still further preferred embodiment the entire probe is disposable.
  • the probe of the invention may have any one or any combination of these features.
  • Bone-to-metal connection may be accomplished by insertion of screws into the pedicle to stabilize a spinal segment.
  • the pedicle is a dense, stem-like structure projecting from the posterior of a vertebra, and there are two pedicles per vertebra that connect to other structures. Since the pedicle is the strongest point of attachment of the spine, significant forces can be applied to the spine without failure of the bone-to-metal connection.
  • a long, thin, metal probe is inserted through the pedicle and into the vertebral body, forming a hole for reception of the screw.
  • Conventional pedicle probes may be straight or curved, and comprise an elongate solid metal shaft with an enlarged hand grip on the proximal end.
  • the probe may have a shaped distal end adapted for forming a hole through the pedicle, or a separate awl or reamer may first be used to form a hole through the pedicle, and the probe then inserted into the cancellous bone of the pedicle and into the vertebral body to develop a path for the screw.
  • the gear shift probe has a round head on its proximal end
  • the Fox probe has a flat discshaped head on its proximal end.
  • advancement of the probe should be smooth and consistent.
  • a sudden plunge suggests breaking out of the pedicle laterally, and an increase in resistance indicates abutment against the pedicle or vertebral body cortex.
  • Applicant's earlier US patent, number 6,855,105 discloses an endoscopic pedicle probe having a camera at its distal end connected with an endoscopic monitor via a fiber optic bundle extending through the probe to provide the surgeon with a view of the area being treated, thus overcoming many of the shortcomings of conventional pedicle probes.
  • US patent 8,255,044 discloses a system that uses the principles of electromyography to alert the surgeon when a breach is about to occur and potentially cause damage to nerves.
  • the system in that patent takes advantage of the insulating characteristics of the walls of the pedicle and the conductivity of adjacent nerve roots and uses electromyographic monitoring to perform dynamic pedicle integrity assessments to detect a breach or potential breach of the pedicle and alert the surgeon.
  • the system in the '044 patent involves establishing electrical communication between a stimulation source and the interior of a pedicle hole during the hole formation, hole preparation, and/or screw introduction steps of pedicle screw fixation.
  • the system automatically detects and communicates to the user whether the integrity of the pedicle has been compromised, i.e. breached or about to be breached.
  • the probe in this patent is made of electrically conductive material and is connected with a source of electrical energy to apply an electric field to the probe.
  • a plunger 41 is manually applied to a device 65 to establish electrical connection with the source of electrical energy.
  • a flexible insulating sheath is placed around the probe body.
  • MMG mechanomyography
  • EMG electromyography
  • MMG has a faster response than EMG, indicating a higher sensitivity for detection of nerves at a lower threshold.
  • Muscle response to electrical stimulus varies with the distance of the nerve from the source of the stimulus and MMG can tell the surgeon exactly how far away he or she is from the nerve. Working with different levels of current, the surgeon is able to establish a relationship between the current and distance, allowing the surgeon to determine precisely how far a nerve is from the stimulus probe.
  • MMG detects the presence of a nerve on average 1.2 seconds earlier than EMG, using approximately half the amount of stimulating current. Since electrical resistance is highly variable, depending on the conducting tissue, EMG monitoring systems may utilize currents as high as 200 niA. The MMG system typically has a maximum current output of 6 niA, nearly 35 times less than comparable EMG systems.
  • MMG is a more sensitive indicator for locating nerves, and the surgeon can, without looking, know within a millimeter or two where he or she is in relation to the nerve. By utilizing a system that requires less electrical current, the surgeon is able to further decrease the risk of injury to patients.
  • Sentio, LLC of Wixom MI has developed a mechanomyography (MMG) surgical access tool for locating and mapping motor nerve roots and their peripheral extensions during lateral access spinal fusion surgery.
  • MMG mechanomyography
  • the Sentio MMG system adheres accelerometer sensors to the surface of the skin directly over muscles innervated by the nerves the surgeon wishes to identify.
  • a stimulator probe is manipulated by the surgeon about the surgical site to stimulate for the presence of motor nerves. When a nerve is identified, the surgeon is provided with a "stop” alert. At any time the surgeon is stimulating and receiving a "go” alert, the surgeon can infer that a "go” alert when using stimulation current at:
  • 1mA means the Sentio probe is at least 1mm from the nerve
  • 5mA means the Sentio probe is at least 5mm from the nerve
  • 15mA means the Sentio probe is at least 15mm from the nerve.
  • Sentio MMG® measures the same physiological phenomena associated with muscle contraction as EMG, but does so via mechanical means as opposed to electrical. MMG does not involve needles, therefore reducing the risk of needle sticks to the surgeon and operating room (OR) staff and further reducing the chance of infection to the patient and OR personnel; does not require any skin prep; and readings require only a single sensor patch to be adhered to the skin, whereas EMG requires three electrode areas to be prepared.
  • the Sentio system In use of the Sentio system, an incision is made in the side of the patient and the surgeon inserts a dilator through the incision and to the level of the spine. A small electrical signal is sent through the dilator to stimulate nerves and guide the surgeon in placement of the dilator directly over the disc space and in front of the lumbar nerve structures. This system does not involve the use of a pedicle probe or placement of pedicle screws.
  • the present invention is an intuitive and ergonomic pedicle probe incorporating state of the art scope technology and robust functionality. It uses mechanomyography or electromyography to monitor neuromuscular responses during a procedure for pedicle screw placement and provides real-time visual confirmation of screw trajectory and pedicle soundness. Use of the probe of the invention results in decreased radiation exposure compared to other pedicle screw placement technologies, and provides enhanced quality of care with the ability to document pedicle integrity.
  • the probe of the invention has integrated visualization, illumination, irrigation, aspiration, and neuromonitoring. This allows the surgeon to detect a potential breach before it occurs, and the extent and location of any breach that does occur during pedicle cannulation.
  • the probe is compatible with common arthroscopy operating room equipment. In a preferred embodiment it is a disposable single-use pedicle probe.
  • the probe of the invention enables real-time visualization of the surgical site during surgery and increases accuracy of pedicle screw placement. It decreases radiation exposure due to use of a C-arm, is easy to use, and minimizes litigation risk. [00029] For the patient, the probe of the invention significantly lowers the chance of injury to the spinal cord and nerves, minimizes radiation exposure, enables less time under anesthesia, and provides a better surgical outcome.
  • the probe comprises an elongate shaft of conductive material shielded by a sleeve or sheath of non-conductive material telescopically engaged on the shaft.
  • a conductive tip is attached to the distal end of the shaft so that neuromuscular response can be induced at the target site by supplying electrical energy to the shaft and tip.
  • a connector such as an alligator clip can be attached to the probe so that the Sentio system can supply electrical energy to the probe.
  • the invention provides the surgeon with a warning when a nerve is approached or a breach is about to occur so that the surgeon can adjust the position of the probe and avoid a breach and/or contact with a nerve.
  • the tip is securely removably attached to the distal end of the shaft of the probe and can be replaced when worn or damaged or when a tip having different characteristics is desired.
  • a light and endoscope can be incorporated together in a single unit, thus requiring only a single bore extending longitudinally through the probe to accommodate these two features.
  • the endoscope and light provide the surgeon with a visual indication of the position of the probe relative to the pedicle and surrounding structure during a surgical procedure, enabling the surgeon to directly confirm the location of the probe and ensuring accurate placement of the hole for receiving a pedicle screw.
  • Irrigation means associated with the probe flushes the area being treated with a fluid, such as, e.g. saline, to remove body fluids and debris that might otherwise obscure the view.
  • a fluid such as, e.g. saline
  • One suitable endoscope incorporating a light is the Medigus LEDprobe, an integrated camera and illumination device available from Medigus, Ltd. of Omer, Israel.
  • the Medigus LEDprobe is a 1.8/2.0mm diameter rigid endoscope which includes a 1.2mm camera in the distal tip of the device. It is equipped with high quality 100 140° field of view (FOV) optics and a large LED located in the handle of the device.
  • the device has a stainless steel shaft and illumination is led through the shaft towards the distal tip of the device where the camera is located via fiber-for-illumination.
  • the LED is powered by the video processor and, therefore, no additional peripherals are required other than a monitor.
  • the camera used with this system has a diameter of only 1.2 mm and a length of only 5 mm. It has high quality 100 degree FOV optics and a shielded camera cable with a metal connector as well as a video processor.
  • the endoscopic pedicle probe of the invention puts the surgeon "in the pedicle” with the use of endoscopy and avoids breaches by using EMG or MMG.
  • the positioning of the probe can be directly and accurately visually observed during surgery, whereby the surgeon can avoid placing the screw too medial, lateral, cranial, caudal, or deep.
  • the surgeon will know if the wall of the pedicle is about to be breached, and the position of the probe can be adjusted to avoid a breach.
  • the surgeon can also avoid parallax that may cause errors when using fluoroscopic guidance.
  • the probe of the invention will not represent an additional instrument needed for pedicle screw placement. Accordingly, there will be no additional costs or equipment needed to perform the standard spinal fusion.
  • the probe of the invention can be utilized in the cervical spine for lateral mass screw placement, pedicle screw placement, or trans-articular screw placement. It can be used in the thoracic, lumbar, and sacral spine for pedicle screw placement and trans-laminar screw placement, and can be used in standard open spine fusion or in minimally invasive percutaneous spine fusion.
  • FIG. 1 is an isometric view of a typical prior art device.
  • FIG. 2 depicts a system incorporating a probe with MMG or EMG capability according to the invention.
  • FIG. 3 is an enlarged fragmentary view of the pedicle probe of the invention, looking at an angle from slightly above and positioned to form a hole in a pedicle.
  • FIG. 4 is an enlarged fragmentary view of the proximal end of the probe of the invention, looking at a slight angle from above.
  • FIG. 5A is an enlarged fragmentary isometric view showing one side of the distal end of the probe of the invention.
  • FIG. 5B is a further enlarged fragmentary isometric view of the area within the square in FIG. 5A.
  • FIGS. 6A and 6B are views similar to FIGS. 5A and 5B, but showing the opposite side of the distal end of the probe.
  • FIG. 7 is a further enlargement of the distal end of the probe as shown in FIG.
  • FIG. 8 is a further enlargement of the distal end of the probe as shown in FIG.
  • FIG. 9 is an enlarged side view in elevation of the head of the probe and through which all connections are made.
  • FIG. 10 is an enlarged side view in elevation of the head of the probe, taken at 90° to FIG. 11.
  • FIG. 11 is a longitudinal sectional view taken along line 11-11 in FIG. 10.
  • FIG. 12 is a side view in elevation of the tip of the invention, shown removed from the probe shaft.
  • FIG. 13 is a longitudinal sectional view of the tip of FIG. 12.
  • FIG. 14 is an enlarged end view looking toward the proximal end of the probe shaft.
  • FIG. 15 is an enlarged end view looking toward the distal end of the probe shaft.
  • FIG. 16 is a side view in elevation of the sheath that is applied to the probe shaft in assembling the probe of the invention.
  • FIG. 17 is a longitudinal sectional view of the sheath of FIG. 16.
  • FIG. 18 is a side view in elevation of the probe shaft of the invention, shown with the sheath removed.
  • FIG. 19 is a longitudinal sectional view of the shaft of FIG., 18.
  • FIG. 20 is an enlarged fragmentary view looking at a slight angle toward the distal end of the probe shaft.
  • FIG. 21 is an enlarged fragmentary view similar to FIG. 20, but looking toward the opposite side of the shaft.
  • FIG. 22 shows a j amshidi needle being used for form a hole in a pedicle for receipt of a k-wire.
  • FIG. 23 shows a k-wire inserted and the j amshidi removed.
  • FIG. 24 shows the probe of the invention being placed, after which the k-wire is removed.
  • FIG. 25 shows the probe of the invention being manipulated to form a hole in the pedicle for receipt of a pedicle screw.
  • FIG. 26 shows the k-wire replaced and the probe being removed.
  • FIG. 1 An awl as commonly used in the prior art to form a hole in a pedicle is indicated generally at 10 in FIG. 1.
  • the awl has an enlarged head 11 at the proximal end for engagement with the hand of the surgeon, and an elongate shaft 12 terminating in a tip end 13 for forming the hole.
  • EMG electromyography
  • MMG mechanomyography
  • An MMG system generally is regarded as having a faster response and a higher sensitivity for detection of nerves at a lower threshold than does EMG.
  • a suitable MMG system usable with the probe of the invention can be the Sentio MMG system available from Sentio LLC of Wixom, Michigan.
  • a system as it might be constituted according to the invention when using either a mechanomyographic (MMG) monitoring system or an electromyographic monitoring (EMG) monitoring system is represented schematically at 20 in FIG. 2.
  • the system would include a control unit 21 connected via a data cable 22 with a patient module 23.
  • An EMG or MMG harness 24 and return electrode 25 are connected with the patient module, and a pedicle probe 26 according to the preferred form of the invention is also connected to the patient module via an electrical lead 27.
  • the invention capitalizes on the insulating characteristics of bone, specifically that of the medial wall of the pedicle, and the conductivity of the adjacent nerve roots.
  • a stimulation signal applied to the target site will cause the various muscle groups coupled to the nerve roots to react.
  • electromyographic or mechanomyographic monitoring in the present invention to assess whether the muscle groups in the leg are innervating in response to the application of a stimulation signal does not require visual observation of twitching of the nerves.
  • the harness 24 relies on needles to detect subtle changes in electrical signals in muscle.
  • a mechanomyographic system such as the Sentio MMG® system employs proprietary accelerometer technology in the harness 24.
  • These non-invasive accelerometer-based sensors measure MMG (mechanomyography) activity, or the mechanical "twitch" associated with muscle contraction.
  • control unit 21 includes a touch screen display 28 and a base 29, which collectively contain the essential processing capabilities for controlling the system 20.
  • the data cable 22 establishes digital and/or analog electrical connections and communications between the control unit 21 and patient module 23.
  • the main functions of the control unit 21 include receiving user commands via the touch screen display 28, activating stimulation, processing signal data according to defined algorithms as known in US patent 8,255,044, for example, displaying received parameters and processed data, and monitoring system status and reporting fault conditions.
  • the touch screen display 28 is preferably equipped with a graphical user interface (GUI) capable of communicating information to the user and receiving instructions from the user.
  • GUI graphical user interface
  • the display 28 and/or base 29 may contain patient module interface circuitry that commands the stimulation sources, receives digitized signals and other information from the patient module 23, processes the EMG or MMG responses to extract characteristic information for each muscle group, and displays the processed data to the operator via the display 28.
  • the probe 20 comprises a head 30 adapted to be held in the hand of the surgeon for manipulation of the probe, an elongate body 31 secured at its proximal end to the head, and a tip 32 secured to the distal end of the body for forming a hole in a pedicle P.
  • the body 31 is made up of a central shaft 33 enclosed in a sleeve or sheath 34.
  • the shaft and tip are made of an electrically conductive material (e.g. a suitable metal), and the sheath is made of an electrically non-conductive material (e.g. plastic).
  • the sheath is slid over the shaft from the distal end of the shaft and the proximal end of the sheath is threaded at 34' or otherwise configured for attachment to the head.
  • An inturned lip or shoulder 35 at the distal end of the sleeve engages against the distal end of the shaft to hold the shaft rearwardly against the head.
  • the tip 32 is attached to the distal end of the shaft by engagement of a shaped end
  • a center bore 40 extends through the length of the shaft 33 for receiving a k-wire 41 (see FIGS. 23 and 24) during minimally invasive surgery (MIS).
  • This bore also serves for supply of an irrigating fluid to the surgical site when the k-wire is removed, and for aspirating the irrigating fluid and debris from the site.
  • a second bore 42 extends through the shaft at one side of the center bore for receiving an endoscopic camera 43 and third and fourth bores 44 and 45 are on opposite sides of the center bore for receiving fiber optic light bundles 46 to illuminate the surgical site (see FIGS. 5B, 6B, 8 and 14).
  • the tip 32 has corresponding bores aligned with the bores in the shaft. See, for example, the irrigation/aspiration bore 47 in FIG. 8 and bore 48 in FIG. 13 for receiving the camera.
  • the distal end of the tip is recessed or cut away at 49 to provide clearance for the camera and lights, and a transparent shield 50 is positioned on the tip at the proximal end of the cut away area in overlying relationship to the camera and light source.
  • the head 30 has a plurality of lateral ports in its side, including a port 51 for connection with a source 51' of irrigating fluid, a port 52 for connection to a suction source 52' for aspiration of fluid and tissue away from the surgical site, and a port 53 for insertion of the endoscope 43 into the bore extending through the shaft.
  • a longitudinal bore 54 extends through the center of the head for receiving a k-wire (see FIG. 11). Cut-outs 55 are provided in the area immediately above the lateral ports to expose the proximal end of the shaft 33 so that a variety of EMG/MMG clips can be attached to the shaft.
  • the sleeve 31 is connected to the head by a threaded connection 56 in the bottom of the head (see FIG. 11). Irrigation ports 61 in the tip 32 (see FIG. 6B) double as cutting flutes.
  • a jamshidi 60 is used to form a pilot hole in a pedicle P (see FIG. 22), and a k-wire 41 is then inserted and the jamshidi removed (see FIG. 23).
  • the probe of the invention is then put in place and the k-wire removed, as shown in FIG. 24.
  • the surgeon then initiates irrigation and aspiration and applies axial pressure to the probe 26 while rotating it, visually observing until a safe and sufficient cannulation is present, as depicted in FIG. 25.
  • the k-wire is then replaced and the probe removed as depicted in FIG. 26, after which the hole is tapped and a screw placed.
  • the endoscopic pedicle probe of the invention provides the surgeon with an illuminated, direct visual indication of the exact location of the probe and alerts the surgeon if a breach has occurred or is about to occur. It provides for flushing body fluids and debris away from the area being treated, whereby the hole can be formed with accuracy and precision.
  • the pedicle probe disclosed herein may be reusable, or the entire probe, inclusive or not inclusive of the endoscope, may be made disposable following a single use.
  • Materials suitable for this purpose such as hard plastics or carbon fiber, for example, may be used in the construction of the probe.
  • the probe shaft and tip are made of an electrically conductive material such as metal, and the sheath is made of a non-conductive material such as plastic.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Optics & Photonics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Neurology (AREA)
  • Surgical Instruments (AREA)

Abstract

Cette invention concerne une sonde pédiculaire endoscopique possédant un corps allongé avec une extrémité proximale et une extrémité distale. Une pointe disposée sur l'extrémité distale est poussée dans le pédicule pour former le trou, et une tête élargie sur l'extrémité proximale permet à un chirurgien de manipuler la sonde. Le corps possède un arbre interne avec un manchon cylindrique emmanché de façon télescopique au-dessus de celui-ci. Un endoscope s'étend à travers un alésage longitudinal dans l'arbre, avec une caméra au niveau de l'extrémité de pointe reliée à un moniteur pour permettre à un chirurgien d'observer visuellement la zone traitée. Une lumière s'étend à travers un autre alésage pour éclairer la zone, et un alésage supplémentaire achemine un fluide d'irrigation vers la zone et à partir de celle-ci. Le manchon est constitué d'un matériau électriquement non conducteur et l'arbre et la pointe sont faits d'un matériau électriquement conducteur pour permettre la stimulation des nerfs au niveau de la zone de traitement.
EP16847542.4A 2015-09-17 2016-09-19 Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs Withdrawn EP3349639A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562219798P 2015-09-17 2015-09-17
PCT/US2016/052484 WO2017049288A1 (fr) 2015-09-17 2016-09-19 Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs

Publications (2)

Publication Number Publication Date
EP3349639A1 true EP3349639A1 (fr) 2018-07-25
EP3349639A4 EP3349639A4 (fr) 2019-05-01

Family

ID=62388373

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16847542.4A Withdrawn EP3349639A4 (fr) 2015-09-17 2016-09-19 Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs

Country Status (2)

Country Link
EP (1) EP3349639A4 (fr)
CN (1) CN108135441A (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020033862A1 (fr) * 2018-08-09 2020-02-13 Optical Spine Sonde endoscopique éclairée translucide
CN112888477A (zh) * 2018-10-22 2021-06-01 美敦力施美德公司 刺激探针组件和使用方法
CN110123316A (zh) * 2019-04-11 2019-08-16 中国科学院苏州生物医学工程技术研究所 一种无创喉肌电监测装置
CN113303802A (zh) * 2020-05-22 2021-08-27 河南省洛阳正骨医院（河南省骨科医院） 一种用于脊柱外科手术用脊椎探针

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5569291A (en) * 1995-02-01 1996-10-29 Ethicon Endo-Surgery, Inc. Surgical penetration and dissection instrument
GB9609750D0 (en) * 1996-05-10 1996-07-17 Wild Andrew M Surgical instrument assembly for use in endoscopic surgery
US7819877B2 (en) * 2001-06-27 2010-10-26 BePuy Products, Inc. Method and apparatus for endoscopic minimally invasive orthopaedic plating procedures
US20150080755A1 (en) * 2012-05-16 2015-03-19 Avery M. Jackson, III Illuminated Endoscopic Pedicle Probe With Electromyographic Monitoring

Also Published As

Publication number Publication date
EP3349639A4 (fr) 2019-05-01
CN108135441A (zh) 2018-06-08

Similar Documents

Publication Publication Date Title
US20180185036A1 (en) Illuminated endoscopic pedicle probe with dynamic real time monitoring for proximity to nerves
US11712218B2 (en) System and methods for nerve monitoring
US7981144B2 (en) Implant equipped for nerve location and method of use
US8977352B2 (en) Systems and methods for performing surgical procedures and assessments
RU2313299C2 (ru) Устройство контроля за прохождением в анатомические элементы
US20180177385A1 (en) Illuminated Endoscopic Pedicle Probe With Electromyographic Monitoring
US20150342521A1 (en) Surgical apparatus and system
WO2009105106A2 (fr) Implant équipé pour une localisation nerveuse et son procédé d'utilisation
JP6842735B1 (ja) 医療手技における使用のためのハンドヘルドデバイス
WO2011014598A1 (fr) Système de stimulation neurophysiologique et procédés d'utilisation avec des instruments sans fil
EP3349639A1 (fr) Sonde pédiculaire endoscopique éclairée à surveillance dynamique en temps réel de la proximité par rapport aux nerfs
US20170238788A1 (en) Illuminated Endoscopic Pedicle Probe With Dynamic Real Time Monitoring For Proximity To Nerves
CA3129771C (fr) Adaptateur de dispositif de stimulation
JP2024506167A (ja) 医療手技において使用するためのハンドヘルドデバイス

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20180315

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

AX Request for extension of the european patent

Extension state: BA ME

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20190329

RIC1 Information provided on ipc code assigned before grant

Ipc: A61B 1/06 20060101ALI20190325BHEP

Ipc: A61B 1/00 20060101AFI20190325BHEP

Ipc: A61B 90/00 20160101ALI20190325BHEP

Ipc: A61B 1/05 20060101ALI20190325BHEP

Ipc: A61B 5/00 20060101ALI20190325BHEP

Ipc: A61B 5/0488 20060101ALI20190325BHEP

Ipc: A61B 1/015 20060101ALI20190325BHEP

Ipc: A61B 90/30 20160101ALI20190325BHEP

Ipc: A61B 1/313 20060101ALI20190325BHEP

Ipc: A61B 17/00 20060101ALI20190325BHEP

Ipc: A61B 17/16 20060101ALI20190325BHEP

Ipc: A61B 1/018 20060101ALI20190325BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Effective date: 20191210