WO2022266500A2 - Intubation tool, system and methods - Google Patents

Intubation tool, system and methods Download PDF

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Publication number
WO2022266500A2
WO2022266500A2 PCT/US2022/034087 US2022034087W WO2022266500A2 WO 2022266500 A2 WO2022266500 A2 WO 2022266500A2 US 2022034087 W US2022034087 W US 2022034087W WO 2022266500 A2 WO2022266500 A2 WO 2022266500A2
Authority
WO
WIPO (PCT)
Prior art keywords
stylet
endotracheal tube
placement
assisting
articulating
Prior art date
Application number
PCT/US2022/034087
Other languages
French (fr)
Other versions
WO2022266500A3 (en
Inventor
Benn Douglas HORRISBERGER
David MELANDER
Original Assignee
Tjb Medical, Inc.
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 Tjb Medical, Inc. filed Critical Tjb Medical, Inc.
Priority to EP22825935.4A priority Critical patent/EP4355398A2/en
Publication of WO2022266500A2 publication Critical patent/WO2022266500A2/en
Publication of WO2022266500A3 publication Critical patent/WO2022266500A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/267Instruments 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 the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0418Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation

Definitions

  • the present application is directed to a tool for aiding in endotracheal intubation, in particular a tool for assisting in placement of an endotracheal tube into a trachea.
  • the present disclosure is directed to An intubation tool having a steerable camera for assisting in placement of an endotracheal tube.
  • the intubation tool comprises a stylet having a proximal end and a distal end, the stylet configured for receiving an endotracheal tube.
  • the stylet has an articulating distal end, the articulating distal end being configured to articulate between more than one shape.
  • the tool also includes a handle secured to the proximal end of the stylet.
  • An intubation tool having a steerable camera for assisting in placement of an endotracheal tube having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location of the stylet.
  • articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end.
  • articulation of the distal tip of the stylet can be accomplished with a single finger manipulating a steering control mounted on the stylet. In an embodiment, articulation of the distal tip of the stylet can be accomplished with two fingers manipulating a steering control mounted on the stylet, the steering control sliding along the stylet.
  • articulation of the distal end of the stylet can be accomplished with three fingers from a single hand that articulates the distal end.
  • the articulating distal tip can be articulated with a force of less than 9 Newton.
  • the force necessary move the distal tip should be relatively small so that just the simple force applied by a few figures (such as one, two, or three fingers) is adequate to manipulate the distal tip of the stylet.
  • just one, two or three fingers can be used to easily articulate the tip from a neutral position to a positive or negative position without ever releasing grip on the handle.
  • the operator is able to get multiple types of feedback: They can get the feedback of resistance to articulation (and thus sensing where they are within a patient’s anatomy), but also get feedback from the tip while advancing it into the patient. In this manner the operator has unparalleled awareness to the patient’s anatomy and the position of the tip as it moves through the anatomy.
  • the articulating distal tip can be articulated with a force of from 4 to 9 Newton.
  • the articulating distal tip is deformable upon contact with an obstruction.
  • the articulating distal tip transmits force back to steering control upon contact with an obstruction.
  • translation movement of the steering control results in bending articulation of the articulating distal tip.
  • the translation movement of the steering control by a distance D results in bending articulation of the distal tip by a distance of at least 150 percent of D.
  • D refers to the distance the steering control is moved along the axis of the stylet, either toward or away from the distal tip.
  • the distance D could be 1 centimeter, in which case 150 percent deflection of the distal tip would be 1.5 centimeters.
  • the articulation of the distal tip can be less than 100 percent or more than 150 percent.
  • the amount of translational movement can result in either increased or decreased bending (deflection) of the tip at different points along the path of travel of the steering control.
  • translational movement of the steering control in a first direction results in bending articulation of the articulating distal tip in a first direction
  • translational movement of the steering control in an opposite direction results in bending articulation of the articulating distal tip in a direction opposite the first direction
  • the stylet includes tubing containing at least one lumen.
  • the stylet includes bilumen tubing.
  • the medial portion of the stylet upon removal of the handle from the medial portion of the stylet, has a diameter no greater than 120 percent of the remainder of the stylet.
  • the widest portion of the stylet after removal of the handle is less than the diameter of the interior of the lumen of an endotracheal tube to be installed on the stylet.
  • the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 1 cm.
  • the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 2 cm.
  • the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 3 cm.
  • the handle and stylet provide a clear sight line of angle a of 90 degrees along a dorsal elevation LD of 1 cm.
  • the handle and stylet provide a clear sight line of angle a of 180 degrees along a dorsal elevation LD of 3 cm.
  • the handle and stylet provide a clear sight line of angle a of 270 degrees along a dorsal elevation LD of 3 cm.
  • the stylet has a length at least 1.5 times the length of an endotracheal tube to be installed on the stylet.
  • the stylet has a length at least 2.0 times the length of an endotracheal tube to be installed on the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode. In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube.
  • the stylet articulates in a plane.
  • the plane in which the stylet articulates can be selected by rotation of the handle, resulting in rotation of the stylet.
  • the stylet includes an internal mechanism for articulating the distal end.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • a method for placement of an endotracheal tube the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal
  • the stylet articulates in a plane.
  • the stylet includes an internal mechanism for articulating the distal tip.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal tip, and wherein pulling on the cable from the medial location results in articulating the distal tip of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • An intubation tool having a steerable camera for assisting in placement of an endotracheal tube having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.
  • the cable radial location optimized to facilitate articulation and minimize pull force.
  • the handle is removable from the stylet.
  • the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube.
  • the stylet articulates in a plane.
  • the stylet includes an internal mechanism for articulating the distal end.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • a method for placement of an endotracheal tube the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a medial location and a distal end, the stylet configured for receiving an endotracheal tube, and having an articulating distal end, the articulating distal end being configured to articulate between more than one shape, and ii) a handle secured to the medial location of the stylet, b) inserting the distal end of the stylet of the endotracheal intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial location of the stylet, d) inserting an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet,
  • the endotracheal intubation tool for assisting in placement of an endotracheal tube is removable from the medial location of the stylet.
  • the endotracheal intubation stylet includes an internal mechanism for articulating the distal end.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • FIG. l is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 2 is a drawing showing the position of a patient’s head and neck in advance of insertion of an endotracheal tube, showing the approximate oral axis, pharyngeal axis and laryngeal axis.
  • FIG. 3 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth.
  • FIG. 4 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient.
  • FIG. 5 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient and with the handle removed.
  • FIG. 6 is a drawing showing a patient with a endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient and with the handle removed and the endotracheal tube positioned over the tool stylet and into the patient.
  • FIG. 7 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with a removable handle clipped in place.
  • FIG. 8 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with the handle removed.
  • FIG. 9 is a front view of the distal side of a handle of an endotracheal intubation tool with the stylet of the tool installed.
  • FIG. 10 is a front view of the distal side of a handle of an endotracheal intubation tool with the stylet of the tool installed and handle catch open.
  • FIG. 11 is a front view of the distal side of a handle of An intubation tool having a steerable camera with the stylet of the tool removed and handle catch open.
  • FIG. 12 is a diagram showing the field of view from An intubation tool having a steerable camera made in accordance with the present disclosure.
  • FIG. 13 is a diagram showing the field of view from an endotracheal intubation tool made in accordance with the present disclosure.
  • FIG. 14 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in a neutral position.
  • FIG. 15 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in a downwardly flexed position.
  • FIG. 16 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in an upwardly flexed position.
  • FIG. 17 is a closeup view of the steering base of An intubation tool having a steerable camera stylet.
  • FIG. 18 is view of the distal end of An intubation tool having a steerable camera stylet, with the tip of the stylet articulated
  • FIG. 19 is close up view of the medial portion of a stylet, showing the steering control in a substantially neutral location.
  • FIG. 20 is close up view of the medial portion of a stylet, showing the steering control in a substantially distal location.
  • FIG. 21 is close up view of the medial portion of a stylet, showing the steering control in a substantially proximal location.
  • FIG. 22 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 23 is a perspective view of a steering base made in accordance with an example embodiment.
  • FIG. 24 is a side elevational view of a steering base made in accordance with an example embodiment.
  • FIG. 25 a distal end view of a steering base made in accordance with an example embodiment.
  • FIG. 26 is a cross sectional view of a steering base made in accordance with an example embodiment.
  • FIG. 27 is a perspective view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 28 is a distal end view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 29 is a side view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 30 is a perspective view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 31 is a proximal end view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 32 is a side view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 33 is a perspective view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 34 is an end view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 35 is a side view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section.
  • FIG. 36 is a perspective view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 37 is a side view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 38 is an end view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 39 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 40 is closeup of the endotracheal intubation tool of FIG. 39, enlarging the portion from dotted circle 39 A.
  • FIG. 41 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 42 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation.
  • FIG. 43 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in a downward (or ventral) articulation.
  • FIG. 44 is drawing showing the articulating tip of an endotracheal intubation tool in a neutral position.
  • FIG. 45 is a perspective view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 46 is a side view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section.
  • FIG. 47 is an end view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 48 is a perspective view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
  • FIG. 49 is a side view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
  • FIG. 50 is an end view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
  • FIG. 51 is a perspective view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components.
  • FIG. 52 is a side cross-sectional view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components.
  • FIG. 53 is an end view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components.
  • FIG. 54 is a perspective view of a base member from the proximal end of an articulating tip, showing the base member independent of other components.
  • FIG. 55 is a side view of a base member from the proximal end of an articulating tip, showing the base member independent of other components.
  • FIG. 56 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position.
  • FIG. 57 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 58 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 59 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 60 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 61 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 62 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 63 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position, making contact with an obstruction.
  • FIG. 64 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position, making contact with an obstruction.
  • FIG. 65 is a side view of a handle of an endotracheal intubation tool with the stylet of the tool removed.
  • FIG. 66 is a perspective view of a clasp of a handle of an endotracheal intubation tool.
  • FIG. 67 is a perspective view of a clasp of a base of an endotracheal intubation tool.
  • FIG. 68 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
  • FIG. 69 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
  • FIG. 70 is a side cross-sectional of a vertebrate from an articulating end of an articulating tip, showing the vertebrate independent of other components.
  • FIG. 71 is a graph showing required to articulate a vertebrate relative to flat portion of the vertebrate.
  • FIG. 72 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera.
  • FIG. 73 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera and also showing a monitor showing images of a patient’s airway displayed on a monitor.
  • FIG. 74 is a drawing showing a perspective view of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment having a camera.
  • FIG. 75 is a side view of a handle of an endotracheal intubation tool with the stylet of the tool removed.
  • FIG. 76 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a cross section of the interior of the components of the camera on the end of the articulating tip.
  • FIG. 77 is a side view of camera components of the articulating tip of an endotracheal intubation tool of FIG. 76.
  • FIG. 78 is a side cross sectional view of components of an endotracheal intubation tool, in particular the handle and a portion of the stylet closet to the handle.
  • FIG. 79 is an end cross-sectional view of a vertebrate of the stylet of an endotracheal intubation tool with a camera.
  • FIG. 80 is a side cross sectional view of a portion of an endotracheal intubation tool.
  • FIG. 81 is a perspective view of a base member from the proximal end of an articulating tip for an intubation tool having a camera, showing the base member independent of other components.
  • FIG. 82 is a side cross sectional view of a portion of an endotracheal intubation tool.
  • FIG. 83 is a perspective view of a portion of a steering control of an intubation tool having a steerable camera in accordance with an embodiment.
  • FIG. 84 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing the angle of view of a camera on the tip of the intubation tool.
  • FIG. 85 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 86 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
  • FIG. 87 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation.
  • FIG. 88 is a drawing showing a closeup of a portion of the endotracheal intubation tool of FIG. 87.
  • FIG. 89 is a drawing show a closeup of a vertebra 8950 made in accordance with an implementation an embodiment.
  • FIG. 90 is a drawing show a closeup of a vertebra 9050 made in accordance with an implementation an embodiment.
  • FIG. 91 is a drawing show a closeup of a vertebra 9150 made in accordance with an implementation an embodiment.
  • FIG. 92 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in accordance with an embodiment.
  • FIG. 93 is a drawing show a closeup of a vertebra 9350 made in accordance with an implementation an embodiment.
  • FIG. 94 is a side view of a handle 9406 of an endotracheal intubation tool.
  • FIG. 95 is a side view of a handle 9406 of an endotracheal intubation tool.
  • FIG. 96 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 97 is an end view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed. While embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings and will be described in detail. It should be understood, however, that the scope herein is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope herein. Detailed Description
  • the present disclosure is directed to a device for aiding in endotracheal intubation, in particular a tool for assisting in placement of an endotracheal tube into a trachea.
  • the device also referred to herein as a “tool” includes a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet.
  • the intubation tool comprises a stylet having a proximal end and a distal end, the stylet configured for receiving an endotracheal tube.
  • the stylet has an articulating distal end, the articulating distal end being configured to articulate between more than one shape.
  • the tool also includes a handle secured to the proximal end of the stylet.
  • articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end; and optionally articulation of the distal tip of the stylet can be accomplished with a single finger or two fingers manipulating a steering control mounted on the stylet.
  • the device provides a means for a clinician to apply a low axial force to the articulation collar in order to fully articulate the distal end.
  • the means by which this is possible comes from having a low friction mechanism that allows the cable to slidably pass around the proximal transition of the steering base.
  • This mechanism/design can include a pully-type mechanism or a design which optimizes radius and surface finish to provide a low friction surface and pathway. This radius and surface finish chosen will be highly dependent on the materials and construction of the cable itself.
  • the distal tip typically is in intimate contact with the next most proximal, rigid component, and that component to the next and so on.
  • This contact can be accomplished by pre-tensioning the articulation cable, which places the device in tension from the proximal steering transition to the distal tip of the device.
  • pre-tensioning the articulation cable which places the device in tension from the proximal steering transition to the distal tip of the device.
  • the device allows for two-way articulation in a plane. This two-way can be quite important because it allows more precise placement of the stylet of the device while navigating the tip of the stylet through a patient’s anatomy. Specifically, for example, a clinician must typically cause the tip of the stylus to first pass under the epiglottis, and then flex steeply upward to move past it, next straighten to advance deeper, then flex downward steeply to get over the subglottis, past the vocal chords, into the trachea. A single directional bend is not sufficient to manage entrance in a difficult airway without disturbing a patient’s tissue, often causing discomfort and even potential injury.
  • FIG. l is a drawing showing a side plan view of intubation tool 100 for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • the intubation tool 100 includes a stylet 102 having distal end 110 and proximal end 112 that is flexible and has an articulating tip 114 that allows for precise placement during intubation of a patient, thereby allowing placement with minimal disturbance or damage to the patient.
  • the intubation tool 100 further includes a removable handle 104, shown in an example configuration (with other configurations possible). The removable handle 104 can be gripped during an intubation procedure during which the stylus is placed down the trachea of a patient.
  • the stylet 102 includes a steering control 108 that can slide forward and backward so as to change the shape of articulating tip 114.
  • Stylet 102 further includes a proximal portion 118 and a distal portion 120, both of which are typically flexible but not articulating. Proximal portion 118 of stylet 102 remains outside of a patient during the intubation procedure, while at least some of distal portion 120 is inserted into the patient.
  • FIG. 2 is a drawing showing the position of the head and neck of a patient 220 in advance of insertion of an endotracheal tube, showing the approximate oral axis, pharyngeal axis and laryngeal axis.
  • the patient’s head is shown elevated and tilted by support 222 so as to open up access to the patient’s airway.
  • the oral axis crosses the pharyngeal axis and laryngeal axis, but is not perfectly in-line, and can change as the head of the patient tilts.
  • This geometry can vary by patient and results in challenges during intubation because the pathway for inserting the intubation tube is often partially obscured and/or can be somewhat curved or non-linear.
  • FIG. 3 is a drawing showing a patient An intubation tool having a steerable camera 100 during initial insertion of the distal end of stylet 102 inserted through the mouth of the patient.
  • FIG. 4 shows the stylet 102 extended further into the patient; while FIG. 5 shows the stylet 102 within a patient and the handle removed so that the stylet 102 remains, with proximal portion 118 extending out of the patient’s mouth and ready for placement of the intubation tube (not shown).
  • FIG. 6 is a drawing showing a patient with an endotracheal tube 610 emplaced.
  • FIG. 7 is a drawing showing a side plan view of the endotracheal intubation tool 100 for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with a removable handle 104 clipped in place.
  • FIG. 8 is a drawing showing a side plan view of endotracheal intubation tool 100 the handle removed.
  • the intubation tool 100 includes a stylet 102 having distal end 110 and proximal end 112 that is flexible and has an articulating tip 114 that allows for precise placement during intubation of a patient, thereby allowing placement with minimal disturbance or damage to the patient.
  • the stylet 102 further includes a steering base 730 onto which a steering control 108 is mounted.
  • the steering control 108 is joined to a cable (not shown) that travels down distal portion 120 of the stylet, through articulation collar 734 and to steering cable tip 732, where the ends of the steering cable are secured.
  • Stylet 102 further includes a tube end cap 736 on the proximal end of the stylet 102. It is this tube end cap 736 over which the distal end of an intubation tube passes when the intubation tube is passed over the stylet during intubation.
  • the stylet 102 includes a steering control 108 that can slide forward and backward so as to change the shape of articulating tip 114.
  • Stylet 102 further includes a proximal portion 118 and a distal portion 120, both of which are typically flexible but not articulating. Proximal portion 118 of stylet 102 remains outside of a patient during the intubation procedure, while at least some of distal portion 120 is inserted into the patient.
  • FIG. 9 is a front view of the distal side of a handle 104 of An intubation tool having a steerable camera with the stylet 102 of the tool installed; while FIG. 10 is a front view of the distal side of the handle 104 of the intubation tool with the clasp 106 open, and FIG. 11 is a front view of the distal side of the handle 104 of the intubation tool with the tool removed and handle catch open.
  • FIG. 9 shows a dowel 946 (typically made of metal, such as stainless steel) that the clasp 106 pivots around.
  • the clasp 106 shows a locking member 1046 for snapping into the lower portion of the handle 104.
  • the clasp 106 further includes a recess 1047, while the bottom of the handle 104 includes a recess 1148. Recess 1047 and 1148 combine to surround and hold the stylet 102 when the handle 104 is retained on the stylet 102.
  • FIG. 12 is a diagram showing the field of view from intubation tool made in accordance with the present disclosure.
  • FIG. 13 is a diagram showing the field of view from intubation tool made in accordance with the present disclosure. Both figures show how the intubation tool is designed to allow for improved visibility into a patient during medical procedures. Generally, a relatively unobstructed view is possible relative to alternative devices.
  • the handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
  • the handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet. In an embodiment, the handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • FIG. 14 is view of the distal end of An intubation tool having a steerable camera stylet, showing the articulating tip 114 of the stylet 102 in a neutral position;
  • FIG. 15 is view of the distal end of the stylet, showing articulating tip 114 in an downwardly flexed position;
  • FIG. 16 is view of the distal end of stylet 102, showing the tip of the stylet in an upwardly flexed position. In this neutral position the distal end allows for insertion into a patient without trauma to the patient’s tissue.
  • FIG. 17 is a closeup view of the steering base of An intubation tool having a steerable camera stylet 102.
  • the steering base 1750 includes steering control 108 that readily moves to a distal (left) location or proximal (right) location with the force of one or more fingers.
  • the steering base 1750 includes a path 1768 on which the steering control 108 travels. This path 1768 is generally exposed even when the stylet 102 is mounted on a handle (not shown), allowing the operator to move the steering control 108 so as to articulate the tip of the stylet 102. Further, a proximal section 1760 of the steering base 1750 is shown, this proximal section 1760 including (in this embodiment) regions 1762 and 1764 that are wider areas of the steering base 1750 deigned to secure the stylet 102 in a handle and prevent rotation and sliding of the stylet.
  • FIG. 18 is view of the distal end of An intubation tool having a steerable camera stylet, with the tip of the stylet articulated.
  • FIG. 19 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially neutral location;
  • FIG. 20 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially distal location;
  • FIG. 21 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially proximal location.
  • FIG. 22 is a drawing showing an exploded view of components of An intubation tool having a steerable camera for assisting in placement of an endotracheal tube made in accordance with an example embodiment; further showing two ends of steering cable 2262 and also optional bowden cable 2264 through which the steering cable 2262 passes.
  • the steering cable 2262 terminates in the steering cable tip 732, while also being connected to steering control 108.
  • FIG. 23 is a perspective view of a steering base 730 made in accordance with an example embodiment
  • FIG. 24 is a side elevational view of the steering base 730
  • FIG. 25 a distal end view of a steering base 730
  • FIG. 26 is a cross sectional view of the steering base 730.
  • Channels 2370 and 2372 are shown in steering base 730, and these channels provide pathway 2670 for the steering cable 2262.
  • Sleeve 2238 on the proximal end the stylet is further shown.
  • FIG. 27 is a perspective view of the proximal end cap 736 of An intubation tool having a steerable camera stylet in accordance with an embodiment
  • FIG. 28 is a distal end view of the proximal end cap 736
  • FIG. 29 is a side view of the proximal end cap. Exposed portion 2758 is shown, along with recessed portion 2760 for insertion into the proximal end of the stylet, along with lip 2762 to limit insertion depth of the proximal end cap.
  • FIG. 30 is a perspective view of steering cable tip 732 of An intubation tool having a steerable camera stylet in accordance with an embodiment
  • FIG. 31 is a proximal end view of steering cable tip
  • FIG. 32 is a side view. Exposed portion 3066 is shown, along with recessed portion 3068 as are cable retaining holes 3170 and 3172 are shown.
  • FIG. 33 is a perspective view of steering control 108 showing an internal opening 3380 that fits onto steering base 730.
  • the steering control 108 further includes a protrusion 3382 that fits into a recess in the steering base 730, thereby preventing rotation of the steering control 108.
  • an opening 3384 is formed in the protrusion 3382, and this opening secures the cable connecting to the articulating tip of the stylet;
  • FIG. 34 is an end view of the steering control 108;
  • FIG. 35 is a side view of the steering control 108.
  • FIG. 36 is a perspective view of an articulation collar 3680 of a stylet in accordance with an embodiment; and
  • FIG. 37 is a side view of the articulation collar 734;
  • FIG. 38 is an end view of the articulation collar3680, having pathways 3686 and 3688.
  • FIG. 39 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • the intubation tool 3900 includes a stylet 3902 and a handle 3904 having an articulating tip 3914 and a steering control 4008.
  • the steering control 4008 slides forward and backward (distally and proximally) along the stylet 3902, and this movement of the steering control 4008 moves the tip of the stylet upward and downward (dorsally and ventrally).
  • FIG. 40 is closeup of the endotracheal intubation tool of FIG. 39, enlarging the portion from dotted circle 39A.
  • FIG. 40 shows the distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904, along with base 4007 of handle 3904.
  • the stylet is secured between the clasp 4006 and the base 4007 during placement of the stylet into a patient. After placement of the stylet into the patient the clasp is opened or removed, freeing the stylet from the handle 3904 so that an intubation tube may be inserted over the stylet.
  • rounded surface 4028 of the handle 3904 is typically placed within the palm of the medical professional performing the intubation procedure, and the medical professional fingers wrap around the top of the handle 3904 to grasp the steering control 4008.
  • the medical professional fingers wrap around the top of the handle 3904 to grasp the steering control 4008.
  • 2 or 3 fingers make contact with the steering control 4008 so as to pinch the steering control 4008 between the fingers.
  • Minimal force is thereafter needed to move the steering control forward and backward to articulate the tip of the stylet (not shown).
  • FIG. 41 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • the components include handle 3904, articulating tip 3914, steering control 4008 positioned on a steering base 4130.
  • two lengths of cable 4160 and 4162 which extend through the proximal end of the stylet through proximal sleeve 4138.
  • Tip 4164 is at the most proximal end of the stylet.
  • FIG. 42 is a drawing showing a side perspective view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation.
  • the articulating tip 3914 is shown in a position where the tip is articulated in a dorsal (or upward) orientation.
  • the upward orientation occurs as the steering control 4008 (see, e.g., FIGS. 40 and 41) is drawn in a proximal direction.
  • FIG. 43 is a drawing showing a side perspective view of the endotracheal intubation tool of FIG. 42, with the articulating tip 3914 in a ventral (or downward) orientation.
  • the downward orientation occurs as the steering control 4008 is moved in distal direction.
  • FIG. 44 is drawing showing the articulating tip 3914 of an endotracheal intubation tool in a neutral position.
  • the articulating tip 3914 is in a neutral (or straight) position when no forced is being applied to the tip, such as from the steering control 4008.
  • FIG. 45 is a perspective view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment, the steering control 4008.
  • Steering control 4008 has internal opening 4080 that fits onto steering base.
  • the steering control 4008 further includes a protrusion 4082 that fits into a recess in the steering base, thereby preventing rotation of the steering control 108.
  • Steering control 4008 also includes an opening 4084 for securing the cable connected to the articulating tip of the stylet.
  • the steering control 4008 has to recessed portions 4591 and 4592 for gripping by fingers (although other configurations are possible). Lip 4581 of the steering control 4008 is also shown.
  • FIG. 46 is a side view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section.
  • FIG. 47 is an end view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment.
  • FIG. 48 is a perspective view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate 4850 independent of other components.
  • the vertebrate 4850 has a first distal angled face 4854 and a second distal angled face 4856 separated, in this embodiment, by a distal flat portion 4852, along with two optional transition regions 4857 and 4859.
  • the vertebrate also includes internal pathways 4853 and 4855 through which the cables are passed to secure multiple vertebrate together and to apply tension to articulate the vertebrate relative to one another.
  • FIG. 49 is a side view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate independent of other components.
  • the first angled face 4854 and second angled face 4856 are shown, along with flat portion 4852.
  • These distal angled faces 4854, 4856 and distal flat portion 4852 are on the distal end of the vertebrate (that portion closest to the patient).
  • FIG. 49 further shows the proximal end of the vertebrate, including a first proximal angled face 4960 and a second proximal angled face 4962, and a proximal flat portion 4964.
  • FIG. 50 is a distal end view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate 4850 independent of other components.
  • the vertebrate 4850 has a first distal angled face 4854 and a second distal angled face 4856 separated, in this embodiment, by a distal flat portion 4852, along with two optional transition regions 4857 and 4859.
  • the vertebrate also includes internal pathways 4853 and 4855 through which the cables are passed to secure multiple vertebrate together and to apply tension to articulate the vertebrate relative to one another.
  • FIG. 51 is a perspective view of the tip member 5132 from an end of an articulating tip, showing the tip member 5060 independent of other components.
  • the tip member 5132 has a first proximal angled face 5060 and second proximal angled face 5062, plus a proximal flat portion 5064.
  • Passageways 5053 and 5055 allow for placement of ends of the control cable (not shown) which are typically secured by adhesive or other means in the end of the passageways.
  • FIG. 52 is a side cross-sectional view of the tip member 5060 from an articulating end of an articulating tip, showing the tip member independent of other components
  • FIG. 53 is an end view of the tip member 5060.
  • FIG. 54 is a perspective view of a base member 5460 from the proximal end of an articulating tip, showing the base member independent of other components; and FIG. 55 is a side view of the base member 5460.
  • the base member 5460 includes passageways 5462 and 5464, and also include a stem 5465 that can fit within a hole in the shaft of the stylus to secure it into place.
  • the distal end of the base member 5460 includes distal angled face 5554 and second distal angled face 5556, separated by a distal flat portion 5552
  • FIG. 56 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a base member 5460, multiple vertebrate 5610, 5612, 5614, 5616, and 5620, along with a tip member 5132.
  • a gap 5622 is shown between the vertebrate 5616 and 5620.
  • FIGS. 57 to 62 show the articulating tip in increasing levels of articulation. As the vertebrate start to articulate the gaps 5622 close into contact regions 5723. On the opposite side an opening 5722 becomes larger. The proximal vertebrate articulate first, followed sequentially down the articulating tip to the most distal vertebrate and the tip member 5132.
  • FIGS. 63 and 64 show the articulating around a stylized obstruction 6363, such as a portion of a patient’s anatomy.
  • FIG. 65 is a side view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed, showing a base 4007 and clasp 4006.
  • FIG. 66 is a perspective view of a clasp 4006 of a handle, showing a protrusion 6655 for fitting into a recess 6753 of a base of a handle shown in FIG. 67 to snap the clasp and base together.
  • a recess 6722 in the clasp combines with a recess 6720 in the base to form a passageway through the handle for the stylet.
  • a hinge for the clasp and base is formed from an elevated portion 6751 of the base that fits into a slot 6649 in the clasp, and a pin can be inserted through holes 6645 and 6647 through the elevated portion 6751 of the base. Also shown is a recess 6724 that allows for the stylet to be bent downward and out of the way of the user while gripping the handle 3904
  • FIG. 68 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
  • FIG. 69 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
  • FIG. 70 is a side cross-sectional of a vertebrate from an articulating end of an articulating tip, showing passageways 7050 and 7052.
  • the vertebrate has a total width of W v
  • the distal flat portion 4852 has a width of Wf.
  • FIG. 71 is a graph showing required to articulate a vertebrate relative to flat portion of the vertebrate.
  • FIG. 72 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera.
  • FIG. 72 shows the distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904.
  • the stylet is secured between the clasp 4006 and the base 4007 during placement of the stylet into a patient. After placement of the stylet into the patient the clasp is opened or removed, freeing the stylet from the handle 3904 so that an intubation tube may be inserted over the stylet.
  • the distal end 4020 of the stylet includes a camera at its tip in certain embodiments (shown in subsequent figures, described below). The camera can be used to precisely navigate through the anatomy of a patient, providing additional information on location of the stylet for the medical professional performing the intubation.
  • FIG. 73 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera and also showing a cable 7350 connected to a monitor showing images of a patient’s airway displayed on a monitor 7360.
  • FIG. 74 is a drawing showing a perspective view of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment having a camera, showing distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904.
  • the intubation tool includes a camera and also showing a cable 7350 connected to a monitor showing images of a patient’s airway displayed on a monitor 7360.
  • FIG. 75 is a side view of a handle of an endotracheal intubation tool.
  • the handle includes, in this embodiment, a first set of wires 7552 and a second set of wires 7554.
  • the first set of wires 7552 can be connected to the camera sensor at the tip of the stylet (not shown) and the second set of wires 7554 can be connected to one or more lights at the tip of the stylet.
  • a single set of wires can be used, and that more than two sets of wires can be used.
  • the wires typically it is necessary that the wires provide both a data feed from the camera or cameras on the stylet, while also providing power for lights at the end of the stylet to illuminate the field of view for the camera.
  • FIG. 76 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a cross section of the interior of the components of the camera on the end of the articulating tip.
  • the articulating tip 3914 includes a camera at the distal tip, including one or more lights 7632 and a sensor 7634.
  • FIG. 77 is a side view of camera components of the articulating tip of an endotracheal intubation tool of FIG. 76.
  • the tip includes light 7746 and light 7748.
  • a camera 7750 is also shown.
  • Conductor 7740 and conductor 7742 provide an electrical connection to the light 7746 and light 7748.
  • Conductor 7744 provides an electrical connection to the camera sensor (allowing signals from the camera to be transmitted back through the stylet and handle and then on to a monitor).
  • FIG. 78 is a side cross sectional view of components of an endotracheal intubation tool, in particular the handle and a portion of the stylet closet to the handle, including the steering base 730 and a set of conductive pads 7870 that provide an interface between the stylet and monitor (with conductors running from the camera at the distal end of the stylet to the conductive pads 7870, which make contact with conductive pads on the handle that then transmit signals on their way to the monitor).
  • Optional control circuits and software is typically used, such as to control the resolution, brightness, illumination (from the camera), etc.
  • FIG. 79 is an end cross-sectional view of a vertebrate of the stylet of an endotracheal intubation tool with a camera, the vertebrate including internal passages and that receive a cable to assist with articulation of the tip. Down the center of the vertebrate is an opening 7980 that receives a plurality of conductors 7982.
  • FIG. 80 is a side cross sectional view of a portion of an endotracheal intubation tool; and
  • FIG. 81 is a perspective view of a base member from the proximal end of an articulating tip for an intubation tool having a camera, showing the base member independent of other components.
  • the figures show how the cables can be transitioned from the articulating portion of the stylet to the shaft. In FIG. 80 the cables 8080 and 8082 transition from the perimeter of the shaft to the center of the shaft in the depicted construction.
  • FIG. 81 a base member 8160 from the proximal end of an articulating tip is depicted, showing the base member 8160 independent of other components.
  • the base member 8160 includes passageways 8153 (of which one of two is shown), and also include a stem 8165 that can fit within a hole in the shaft of the stylus to secure it into place.
  • Channel 8130 and channel 8132 provide a pathway for cables (such as power and illumination cables) through the base member 8160.
  • FIG. 82 is a side cross sectional view of a portion of an endotracheal intubation tool also showing passageways 8153.
  • Channel 8130 and channel 8132 provide a pathway for cables (such as power and illumination cables) through the base member 8160.
  • FIG. 83 is a perspective view of a portion of the interior of the steering control of an intubation tool having a steerable camera in accordance with an embodiment, showing passageways 8153 as well as an outer surface that the slidable portion of the control can engage, plus lower slot 8360 for which the steering cable can move.
  • FIG. 84 is a side elevational view of components of an articulating tip 3914 of an endotracheal intubation tool in a neutral position, showing the angle of view of a camera on the tip of the intubation tool.
  • FIG. 84 shows components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a base member 5460, multiple vertebrate 5610, 5612, 5614, 5616, and 5620, along with a tip member 5132.
  • a gap 5622 is shown between the vertebrate 5616 and 5620.
  • FIGS. 57 to 62 show the articulating tip in increasing levels of articulation. As the vertebrate start to articulate the gaps 5622 close into contact regions 5723.
  • FIGS. 85 and 86 show the articulating around a stylized obstruction 6363, such as a portion of a patient’s anatomy.
  • Fig. 86 shows how the camera can have a wide field of view that continues forward even after articulation.
  • the tip of the stylet (where the camera is positioned) is offset from the primary axis of the non articulating portion by a distance of Lo, yet has an orientation of the field of view of the camera that is substantially parallel to the field of view prior to articulation, and is generally overlapping the field of view prior to articulation.
  • the total length of the articulating portion is shown as LA.
  • This feature of the intubation tool is particularly useful because it allows a practitioner to navigate through the anatomy of a patient while still having the camera point substantially forward, rather than upward.
  • the tip of the stylet (and camera) is aligned (in some situations) with the patient’s vocal cords.
  • offset Lo can be more than 10 percent of the length of the articulating section LA; optionally offset Lo can be more than 10 percent of the length of the articulating section LA; optionally offset Lo can be more than 20 percent of the length of the articulating section LA; optionally offset Lo can be more than 30 percent of the length of the articulating section LA; optionally offset Lo can be 10 to 50 percent of the length of the articulating section LA; optionally offset Lo can be 5 to 60 percent of the length of the articulating section LA; optionally offset Lo can be more than 25 percent of the length of the articulating section LA.
  • the camera will typically have a field of view from 30 to 120 degrees, although various degrees are possible.
  • FIG. 87 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation, showing a camera 8410 positioned at the proximal end of the articulating portion. Camera 8410 allows a practitioner to see the tip of the stylet as it is directed through a patient’s airway.
  • FIG. 88 is a drawing showing a closeup of a portion of the endotracheal intubation tool of FIG. 87.
  • FIG. 89 is a drawing show a closeup of a vertebra 8950 made in accordance with an implementation an embodiment.
  • the vertebra includes an outer surface 8951 that is generally conical (does not taper along the length from left to right).
  • FIG. 90 is a drawing show a closeup of a vertebra 9050 made in accordance with an implementation an embodiment.
  • the vertebra includes an outer surface 9051 that tapers, such that the diameter of the vertebra is smaller at one or both of the ends (left and right) where it comes in contact with other vertebra.
  • the taper is “flat” so as to be somewhat a truncated cone. Also, both ends are shown tapered.
  • FIG. 91 is a drawing show a closeup of a vertebra 9150 made in accordance with an implementation an embodiment.
  • the vertebra includes an outer surface 9151 that tapers, such that the diameter of the vertebra is smaller at one or both of the ends (left and right) where it comes in contact with other vertebra.
  • the taper is “curved” so as to have a continuous, smooth taper. Also, both ends are shown tapered.
  • FIG. 92 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in accordance with an embodiment, showing tapered vertebrate 5610 to 5616.
  • the tapered vertebrae have improved overlap w/o protruding edges on the inside curve so that there is less resistance to placement in a patient, and less exposed edges to “catch” and slow down entry because the edges are recessed toward the center of the intubation tool.
  • FIG. 93 is a drawing show a closeup of a vertebra 9350 made in accordance with an implementation an embodiment, showing tapered design.
  • the vertebra 9350 includes first tapered portion 9380 extending from line A to line B; and second tapered portion 9382 extending from line C to line D.
  • the amount of taper is shown from line E to line F; and from line G to line H
  • the extend and amount of taper can vary, but is generally such that the vertebra 9350 has less potential to “catch” as it enters and retracts from a patient’s airway.
  • the amount of taper E-F and G-H is typically the same, but can be different.
  • the extents 9380 and 9382 are each less than 50 percent of the length of the vertebra 9350; optionally less than 45 percent of the length of the vertebra; optionally less than 40 percent of the length of the vertebra; optionally less than 35 percent of the length of the vertebra; optionally less than 30 percent of the length of the vertebra; optionally less than 25 percent of the length of the vertebra; optionally less than 20 percent of the length of the vertebra.
  • the amount of taper is from 10 to 40 percent of the length of the vertebra.
  • the amount of taper E-F and G-H can be, for example, less than 1 percent of the maximum diameter of the vertebra 9350; or less than 1 percent of the maximum diameter of the vertebra 9350; or less than 2 percent of the maximum diameter of the vertebra 9350; or less than 3 percent of the maximum diameter of the vertebra 9350; or less than 4 percent of the maximum diameter of the vertebra 9350; or less than 5 percent of the maximum diameter of the vertebra 9350; or less than 7.5 percent of the maximum diameter of the vertebra 9350; or less than 10 percent of the maximum diameter of the vertebra 9350; or less than 12.5 percent of the maximum diameter of the vertebra 9350; or less than 15 percent of the maximum diameter of the vertebra 9350; or less than 20 percent of the maximum diameter of the vertebra 9350.
  • FIG. 94 is a side view of a handle 9406 of an endotracheal intubation tool with the stylet having a steering control 9463 that can be moved back and forth by a wheel 9461.
  • FIG. 95 is a side view of a handle 9406 of an endotracheal intubation tool with the stylet having a lever 9565 that engages a steering control 9463 and wheel 9461.
  • the steering control 9463 is within the handle 9406 (as opposed to outside) and is manipulated by a wheel, lever, slider or other means, typically from the top of the handle 9406.
  • FIG. 96 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
  • FIG. 97 is an end view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed.
  • the intubation tool 3900 includes a stylet 3902 and a handle 3904 having an articulating tip 3914 and a steering control 4008.
  • the steering control 4008 slides forward and backward (distally and proximally) along the stylet 3902, and this movement of the steering control 4008 moves the tip of the stylet upward and downward (dorsally and ventrally).
  • the handle includes retaining portions 9790 and 9792 that can be used to secure the two ends of the stylet 3902, such as for packaging, carrying by a medical professional in a case or pocket, or even during use (such as having the proximal portion tucked into a recess 9792 to keep out of view during placement of the tip 3914.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet.
  • articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end.
  • articulation of the distal tip of the stylet can be accomplished with a single finger manipulating a steering control mounted on the stylet.
  • articulation of the distal tip of the stylet can be accomplished with a two fingers manipulating a steering control mounted on the stylet, the steering control sliding along the stylet.
  • articulation of the distal end of the stylet can be accomplished with three fingers from a single hand that articulates the distal end.
  • the articulating distal tip can be articulated with a force of less than 9 Newton. In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
  • the articulating distal tip is deformable upon contact with an obstruction.
  • the articulating distal tip transmits force back to steering control upon contact with an obstruction.
  • the stylet includes tubing containing at least one lumen.
  • the stylet includes bilumen tubing.
  • the medial portion of the stylet has a diameter no greater than 120 percent of the remainder of the stylet.
  • the widest portion of the stylet after removal of the handle is less than the diameter of the interior of the lumen of an endotracheal tube to be installed on the stylet.
  • handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 1 cm.
  • handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 2 cm.
  • handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 3 cm.
  • the handle and stylet provide a clear sight line of angle a of 90 degrees along a dorsal elevation LD of 1 cm.
  • the handle and stylet provide a clear sight line of angle a of 180 degrees along a dorsal elevation LD of 3 cm.
  • the handle and stylet provide a clear sight line of angle a of 270 degrees along a dorsal elevation LD of 3 cm.
  • the stylet has a length at least 1.5 times the length of an endotracheal tube to be installed on the stylet.
  • the stylet has a length at least 2.0 times the length of an endotracheal tube to be installed on the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
  • the stylet articulates in a plane.
  • the plane in which the stylet articulates can be selected by rotation the handle.
  • the stylet includes an internal mechanism for articulating the distal end.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the steering element includes a tube surrounding a portion of the medial location of the stylet.
  • a method for placement of an endotracheal tube the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal
  • the stylet articulates in a plane.
  • the stylet includes an internal mechanism for articulating the distal tip.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal tip, and wherein pulling on the cable from the medial location results in articulating the distal tip of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the endotracheal intubation tool is included having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.
  • the cable radial location optimized to facilitate articulation and minimize pull force.
  • the handle is removable from the stylet.
  • the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
  • the stylet articulates in a plane.
  • the stylet includes an internal mechanism for articulating the distal end.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • a method for placement of an endotracheal tube the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a medial location and a distal end, the stylet configured for receiving an endotracheal tube, and having an articulating distal end, the articulating distal end being configured to articulate between more than one shape, and ii) a handle secured to the medial location of the stylet, b) inserting the distal end of the stylet of the endotracheal intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial location of the stylet, d) inserting an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet,
  • the endotracheal intubation tool for assisting in placement of an endotracheal tube is removable from the medial location of the stylet.
  • the endotracheal intubation stylet includes an internal mechanism for articulating the distal end.
  • the stylet further includes a flexible intermediate portion.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the actuator includes a tube surrounding a portion of the medial location of the stylet.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the stylet has a substantially uniform outer diameter.
  • the minimum non-tip diameter of stylet is within 70 percent of the maximum non-tip diameter of the stylet.
  • the minimum non-tip diameter of stylet is within 80 percent of the maximum non-tip diameter of the stylet.
  • the minimum non-tip diameter of stylet is within 90 percent of the maximum non-tip diameter of the stylet.
  • the stylet includes a keyed surface for securing a handle.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet wherein the stylet includes a flexible cable to articulate the distal tip.
  • the distal end of the stylet is in a neutral position when no articulating force is applied.
  • the force to articulate the distal end is less than 2 pounds.
  • the force to articulate the distal end is less than 4 pounds.
  • the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees. In an embodiment, the force to articulate the distal end from 80 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 10 degrees.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and the articulating distal tip includes a plurality of free vertebrate: and b) a removable handle secured to a medial location on of the stylet.
  • the vertebrate have a substantially flat peak
  • the vertebrate have a substantially flat valley
  • the vertebrate interface angle is from 10 to 20 degrees.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • the articulating distal tip can be articulated with a force of 4 to 9 Newton.
  • the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
  • the distal end of the stylet is in a neutral position when no articulating force is applied.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the articulating tip is not rigid.
  • the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the articulating distal tip can be articulated with a force of 4 to 9 Newton.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the articulating tip transmits tactile feedback.
  • the force to articulate the distal end is less than 2 pounds.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
  • the distal end of the stylet is in a neutral position when no articulating force is applied.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the intubation tool is included having a stylet having a proximal end, a distal end, and a medial location
  • the stylet i) configured for receiving an endotracheal tube, ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and iii) a slidable actuator articulating the distal tip, the slidable actuator being engageable around at least 180 degree of the central axis of the stylet.
  • the slidable actuator is engageable around at least 270 of the central axis of the stylet. .
  • a intubation tool for assisting in placement of an endotracheal tube having a) a stylet having a proximal end, a distal end, and a medial location, the stylet including a bi-lumen extrusion, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet.
  • the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
  • handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
  • the articulating distal tip can be articulated with a force of 4 to 9 Newton.
  • the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
  • handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
  • the distal end of the stylet is in a neutral position when no articulating force is applied.
  • a method for placement of an endotracheal tube the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal
  • the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
  • the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
  • the articulating distal tip can be articulated with a force of 4 to 9 Newton.
  • the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
  • a intubation tool for assisting in placement of an endotracheal tube
  • the endotracheal intubation tool is included having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.

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Abstract

An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet.

Description

INTUBATION TOOL, SYSTEM AND METHODS
Field
The present application is directed to a tool for aiding in endotracheal intubation, in particular a tool for assisting in placement of an endotracheal tube into a trachea.
Background
Approximately 8% of the population has partial to zero visual laryngeal exposure resulting in difficult intubation. In many instances, this partial view caused by anatomical variances inhibits placement of an endotracheal tube into the trachea. This inhibition is often due to the inability to manipulate the end of the rigid stylet and (superimposed endotracheal tube) while performing intubation. The spatial limitations imposed allow only modest movements of the stylet/endotracheal tube. Anatomical variances further inhibit the visualization of the trachea mandating precise control of the stylet/ endotracheal tube for successful intubation of the trachea. Therefore, a need exists for a means to aid in placement of an endotracheal tube into a trachea.
Summary of the Invention
The present disclosure is directed to An intubation tool having a steerable camera for assisting in placement of an endotracheal tube. The intubation tool comprises a stylet having a proximal end and a distal end, the stylet configured for receiving an endotracheal tube. The stylet has an articulating distal end, the articulating distal end being configured to articulate between more than one shape. The tool also includes a handle secured to the proximal end of the stylet.
In an embodiment, An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location of the stylet.
In an embodiment, articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end.
In an embodiment, articulation of the distal tip of the stylet can be accomplished with a single finger manipulating a steering control mounted on the stylet. In an embodiment, articulation of the distal tip of the stylet can be accomplished with two fingers manipulating a steering control mounted on the stylet, the steering control sliding along the stylet.
In an embodiment, articulation of the distal end of the stylet can be accomplished with three fingers from a single hand that articulates the distal end.
In an embodiment, the articulating distal tip can be articulated with a force of less than 9 Newton. Generally, the force necessary move the distal tip should be relatively small so that just the simple force applied by a few figures (such as one, two, or three fingers) is adequate to manipulate the distal tip of the stylet. Note that just one, two or three fingers can be used to easily articulate the tip from a neutral position to a positive or negative position without ever releasing grip on the handle. Thus, there is a continuous range of movement from positive to neutral to distal positions (and intermediate positions), all within the fingers in contact with the tool the whole time and make the movement of the tip. This allows for very precise manipulation of the tip, but also allows for sensitive feedback to the operator’s fingers. In this way the operator is able to get multiple types of feedback: They can get the feedback of resistance to articulation (and thus sensing where they are within a patient’s anatomy), but also get feedback from the tip while advancing it into the patient. In this manner the operator has unparalleled awareness to the patient’s anatomy and the position of the tip as it moves through the anatomy.
In an embodiment, the articulating distal tip can be articulated with a force of from 4 to 9 Newton.
In an embodiment, the articulating distal tip is deformable upon contact with an obstruction.
In an embodiment, the articulating distal tip transmits force back to steering control upon contact with an obstruction.
In an embodiment, translation movement of the steering control results in bending articulation of the articulating distal tip.
In an embodiment, the translation movement of the steering control by a distance D results in bending articulation of the distal tip by a distance of at least 150 percent of D.
As used herein, D refers to the distance the steering control is moved along the axis of the stylet, either toward or away from the distal tip. For example, the distance D could be 1 centimeter, in which case 150 percent deflection of the distal tip would be 1.5 centimeters. In alternative embodiments the articulation of the distal tip can be less than 100 percent or more than 150 percent. Also, it will be appreciated that in some embodiments there is a non-linear relationship between translational movement of the steering control and bending articulation of the distal tip. Thus, the amount of translational movement can result in either increased or decreased bending (deflection) of the tip at different points along the path of travel of the steering control.
In an embodiment, translational movement of the steering control in a first direction results in bending articulation of the articulating distal tip in a first direction, and translational movement of the steering control in an opposite direction results in bending articulation of the articulating distal tip in a direction opposite the first direction.
In an embodiment, the stylet includes tubing containing at least one lumen.
In an embodiment, the stylet includes bilumen tubing.
In an embodiment, upon removal of the handle from the medial portion of the stylet, the medial portion of the stylet has a diameter no greater than 120 percent of the remainder of the stylet.
In an embodiment, the widest portion of the stylet after removal of the handle is less than the diameter of the interior of the lumen of an endotracheal tube to be installed on the stylet.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 1 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 2 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 3 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 90 degrees along a dorsal elevation LD of 1 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 180 degrees along a dorsal elevation LD of 3 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 270 degrees along a dorsal elevation LD of 3 cm.
In an embodiment, the stylet has a length at least 1.5 times the length of an endotracheal tube to be installed on the stylet.
In an embodiment, the stylet has a length at least 2.0 times the length of an endotracheal tube to be installed on the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode. In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube.
In an embodiment, the stylet articulates in a plane.
In an embodiment, the plane in which the stylet articulates can be selected by rotation of the handle, resulting in rotation of the stylet.
In an embodiment, the stylet includes an internal mechanism for articulating the distal end.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, a method for placement of an endotracheal tube, the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet and into the trachea of the person, and e) removing the stylet from the patient’s trachea while keeping the endotracheal tube in place.
In an embodiment, the stylet articulates in a plane. In an embodiment, the stylet includes an internal mechanism for articulating the distal tip.
In an embodiment, the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal tip, and wherein pulling on the cable from the medial location results in articulating the distal tip of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the endotracheal intubation tool is included having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.
In an embodiment, the cable radial location optimized to facilitate articulation and minimize pull force.
In an embodiment, the handle is removable from the stylet.
In an embodiment, the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube.
In an embodiment, the stylet articulates in a plane. In an embodiment, the stylet includes an internal mechanism for articulating the distal end.
In an embodiment, where the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, a method for placement of an endotracheal tube, the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a medial location and a distal end, the stylet configured for receiving an endotracheal tube, and having an articulating distal end, the articulating distal end being configured to articulate between more than one shape, and ii) a handle secured to the medial location of the stylet, b) inserting the distal end of the stylet of the endotracheal intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial location of the stylet, d) inserting an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet, and e) removing the stylet from the patient’s trachea while keeping the endotracheal tube in place, wherein the actuation can be performed with a single hand.
In an embodiment, the endotracheal intubation tool for assisting in placement of an endotracheal tube is removable from the medial location of the stylet.
In an embodiment, wherein actuation occurs push/pull action on the tip by allowing 3 finger, 360 degree contact of circular trigger.
In an embodiment, the endotracheal intubation stylet includes an internal mechanism for articulating the distal end.
In an embodiment, the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet. This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.
Brief Description of the Figures
Aspects may be more completely understood in connection with the following drawings, in which:
FIG. l is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
FIG. 2 is a drawing showing the position of a patient’s head and neck in advance of insertion of an endotracheal tube, showing the approximate oral axis, pharyngeal axis and laryngeal axis.
FIG. 3 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth.
FIG. 4 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient.
FIG. 5 is a drawing showing a patient with an endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient and with the handle removed.
FIG. 6 is a drawing showing a patient with a endotracheal intubation tool for assisting in placement of an endotracheal tube during initial insertion of the distal end of the endotracheal intubation tool through the patient’s mouth, the tool substantially inserted into the patient and with the handle removed and the endotracheal tube positioned over the tool stylet and into the patient. FIG. 7 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with a removable handle clipped in place.
FIG. 8 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with the handle removed.
FIG. 9 is a front view of the distal side of a handle of an endotracheal intubation tool with the stylet of the tool installed.
FIG. 10 is a front view of the distal side of a handle of an endotracheal intubation tool with the stylet of the tool installed and handle catch open.
FIG. 11 is a front view of the distal side of a handle of An intubation tool having a steerable camera with the stylet of the tool removed and handle catch open.
FIG. 12 is a diagram showing the field of view from An intubation tool having a steerable camera made in accordance with the present disclosure.
FIG. 13 is a diagram showing the field of view from an endotracheal intubation tool made in accordance with the present disclosure.
FIG. 14 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in a neutral position.
FIG. 15 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in a downwardly flexed position.
FIG. 16 is view of the distal end of An intubation tool having a steerable camera stylet, showing the tip of the stylet in an upwardly flexed position.
FIG. 17 is a closeup view of the steering base of An intubation tool having a steerable camera stylet.
FIG. 18 is view of the distal end of An intubation tool having a steerable camera stylet, with the tip of the stylet articulated
FIG. 19 is close up view of the medial portion of a stylet, showing the steering control in a substantially neutral location.
FIG. 20 is close up view of the medial portion of a stylet, showing the steering control in a substantially distal location.
FIG. 21 is close up view of the medial portion of a stylet, showing the steering control in a substantially proximal location. FIG. 22 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
FIG. 23 is a perspective view of a steering base made in accordance with an example embodiment.
FIG. 24 is a side elevational view of a steering base made in accordance with an example embodiment.
FIG. 25 a distal end view of a steering base made in accordance with an example embodiment.
FIG. 26 is a cross sectional view of a steering base made in accordance with an example embodiment.
FIG. 27 is a perspective view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 28 is a distal end view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 29 is a side view of the proximal end cap of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 30 is a perspective view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 31 is a proximal end view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 32 is a side view of steering cable tip of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 33 is a perspective view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 34 is an end view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 35 is a side view of steering control of An intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section.
FIG. 36 is a perspective view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 37 is a side view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment. FIG. 38 is an end view of an articulation collar of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 39 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
FIG. 40 is closeup of the endotracheal intubation tool of FIG. 39, enlarging the portion from dotted circle 39 A.
FIG. 41 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
FIG. 42 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation.
FIG. 43 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in a downward (or ventral) articulation.
FIG. 44 is drawing showing the articulating tip of an endotracheal intubation tool in a neutral position.
FIG. 45 is a perspective view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 46 is a side view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section.
FIG. 47 is an end view of steering control of an intubation tool having a steerable camera stylet in accordance with an embodiment. FIG. 48 is a perspective view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
FIG. 49 is a side view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
FIG. 50 is an end view of a vertebrate from the articulating end of an articulating tip, showing the vertebrate independent of other components.
FIG. 51 is a perspective view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components.
FIG. 52 is a side cross-sectional view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components. FIG. 53 is an end view of the tip member from an articulating end of an articulating tip, showing the tip member independent of other components.
FIG. 54 is a perspective view of a base member from the proximal end of an articulating tip, showing the base member independent of other components. FIG. 55 is a side view of a base member from the proximal end of an articulating tip, showing the base member independent of other components.
FIG. 56 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position.
FIG. 57 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 58 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 59 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position. FIG. 60 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 61 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 62 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 63 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position, making contact with an obstruction.
FIG. 64 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position, making contact with an obstruction.
FIG. 65 is a side view of a handle of an endotracheal intubation tool with the stylet of the tool removed.
FIG. 66 is a perspective view of a clasp of a handle of an endotracheal intubation tool. FIG. 67 is a perspective view of a clasp of a base of an endotracheal intubation tool.
FIG. 68 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
FIG. 69 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool. FIG. 70 is a side cross-sectional of a vertebrate from an articulating end of an articulating tip, showing the vertebrate independent of other components.
FIG. 71 is a graph showing required to articulate a vertebrate relative to flat portion of the vertebrate. FIG. 72 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera.
FIG. 73 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera and also showing a monitor showing images of a patient’s airway displayed on a monitor.
FIG. 74 is a drawing showing a perspective view of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment having a camera. FIG. 75 is a side view of a handle of an endotracheal intubation tool with the stylet of the tool removed.
FIG. 76 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a cross section of the interior of the components of the camera on the end of the articulating tip. FIG. 77 is a side view of camera components of the articulating tip of an endotracheal intubation tool of FIG. 76.
FIG. 78 is a side cross sectional view of components of an endotracheal intubation tool, in particular the handle and a portion of the stylet closet to the handle.
FIG. 79 is an end cross-sectional view of a vertebrate of the stylet of an endotracheal intubation tool with a camera.
FIG. 80 is a side cross sectional view of a portion of an endotracheal intubation tool.
FIG. 81 is a perspective view of a base member from the proximal end of an articulating tip for an intubation tool having a camera, showing the base member independent of other components. FIG. 82 is a side cross sectional view of a portion of an endotracheal intubation tool.
FIG. 83 is a perspective view of a portion of a steering control of an intubation tool having a steerable camera in accordance with an embodiment. FIG. 84 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing the angle of view of a camera on the tip of the intubation tool.
FIG. 85 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 86 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a partially articulated position.
FIG. 87 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation.
FIG. 88 is a drawing showing a closeup of a portion of the endotracheal intubation tool of FIG. 87.
FIG. 89 is a drawing show a closeup of a vertebra 8950 made in accordance with an implementation an embodiment. FIG. 90 is a drawing show a closeup of a vertebra 9050 made in accordance with an implementation an embodiment.
FIG. 91 is a drawing show a closeup of a vertebra 9150 made in accordance with an implementation an embodiment.
FIG. 92 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in accordance with an embodiment.
FIG. 93 is a drawing show a closeup of a vertebra 9350 made in accordance with an implementation an embodiment.
FIG. 94 is a side view of a handle 9406 of an endotracheal intubation tool.
FIG. 95 is a side view of a handle 9406 of an endotracheal intubation tool. FIG. 96 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment.
FIG. 97 is an end view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed. While embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings and will be described in detail. It should be understood, however, that the scope herein is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope herein. Detailed Description
The present disclosure is directed to a device for aiding in endotracheal intubation, in particular a tool for assisting in placement of an endotracheal tube into a trachea.
The device (also referred to herein as a “tool”) includes a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet. In an embodiment the intubation tool comprises a stylet having a proximal end and a distal end, the stylet configured for receiving an endotracheal tube. The stylet has an articulating distal end, the articulating distal end being configured to articulate between more than one shape. The tool also includes a handle secured to the proximal end of the stylet. Optionally articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end; and optionally articulation of the distal tip of the stylet can be accomplished with a single finger or two fingers manipulating a steering control mounted on the stylet.
The device provides a means for a clinician to apply a low axial force to the articulation collar in order to fully articulate the distal end. The means by which this is possible comes from having a low friction mechanism that allows the cable to slidably pass around the proximal transition of the steering base. This mechanism/design can include a pully-type mechanism or a design which optimizes radius and surface finish to provide a low friction surface and pathway. This radius and surface finish chosen will be highly dependent on the materials and construction of the cable itself. In order to provide tactile feedback to the clinician, who is manipulating the medial section of the device, the distal tip typically is in intimate contact with the next most proximal, rigid component, and that component to the next and so on. This contact can be accomplished by pre-tensioning the articulation cable, which places the device in tension from the proximal steering transition to the distal tip of the device. For the benefits of all of these design features to be realized, they must all fit within a narrow profile, such as a 6 mm diameter envelope so as to facilitate the sliding of a standard intubation tube along its length.
The device allows for two-way articulation in a plane. This two-way can be quite important because it allows more precise placement of the stylet of the device while navigating the tip of the stylet through a patient’s anatomy. Specifically, for example, a clinician must typically cause the tip of the stylus to first pass under the epiglottis, and then flex steeply upward to move past it, next straighten to advance deeper, then flex downward steeply to get over the subglottis, past the vocal chords, into the trachea. A single directional bend is not sufficient to manage entrance in a difficult airway without disturbing a patient’s tissue, often causing discomfort and even potential injury.
Now in reference to the drawings, FIG. l is a drawing showing a side plan view of intubation tool 100 for assisting in placement of an endotracheal tube made in accordance with an example embodiment. The intubation tool 100 includes a stylet 102 having distal end 110 and proximal end 112 that is flexible and has an articulating tip 114 that allows for precise placement during intubation of a patient, thereby allowing placement with minimal disturbance or damage to the patient. The intubation tool 100 further includes a removable handle 104, shown in an example configuration (with other configurations possible). The removable handle 104 can be gripped during an intubation procedure during which the stylus is placed down the trachea of a patient. After the stylus is positioned within the patient the removable handle 104 is removed and an intubation tube slipped over the stylet 102 and into the patient’s trachea (the stylet 102 serving as a guide for the intubation tube), after which the stylet 102 is removed while the intubation tube remains extended partially into the trachea of the intubated patient. Removal of the handle 104 is accomplished in the depicted embodiment by opening clasp 106, as shown later herein. The stylet 102 includes a steering control 108 that can slide forward and backward so as to change the shape of articulating tip 114. Stylet 102 further includes a proximal portion 118 and a distal portion 120, both of which are typically flexible but not articulating. Proximal portion 118 of stylet 102 remains outside of a patient during the intubation procedure, while at least some of distal portion 120 is inserted into the patient.
FIG. 2 is a drawing showing the position of the head and neck of a patient 220 in advance of insertion of an endotracheal tube, showing the approximate oral axis, pharyngeal axis and laryngeal axis. The patient’s head is shown elevated and tilted by support 222 so as to open up access to the patient’s airway. As shown in FIG. 2 the oral axis crosses the pharyngeal axis and laryngeal axis, but is not perfectly in-line, and can change as the head of the patient tilts. This geometry can vary by patient and results in challenges during intubation because the pathway for inserting the intubation tube is often partially obscured and/or can be somewhat curved or non-linear.
FIG. 3 is a drawing showing a patient An intubation tool having a steerable camera 100 during initial insertion of the distal end of stylet 102 inserted through the mouth of the patient. FIG. 4 shows the stylet 102 extended further into the patient; while FIG. 5 shows the stylet 102 within a patient and the handle removed so that the stylet 102 remains, with proximal portion 118 extending out of the patient’s mouth and ready for placement of the intubation tube (not shown). FIG. 6 is a drawing showing a patient with an endotracheal tube 610 emplaced.
FIG. 7 is a drawing showing a side plan view of the endotracheal intubation tool 100 for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the stylet of the tool with a removable handle 104 clipped in place.
FIG. 8 is a drawing showing a side plan view of endotracheal intubation tool 100 the handle removed. The intubation tool 100 includes a stylet 102 having distal end 110 and proximal end 112 that is flexible and has an articulating tip 114 that allows for precise placement during intubation of a patient, thereby allowing placement with minimal disturbance or damage to the patient. The stylet 102 further includes a steering base 730 onto which a steering control 108 is mounted. The steering control 108 is joined to a cable (not shown) that travels down distal portion 120 of the stylet, through articulation collar 734 and to steering cable tip 732, where the ends of the steering cable are secured. By moving the steering control 108 forward and backward (using as little as one, two, or three fingers (for example)) the articulating tip is articulated (or bent) by forces delivered by the cable connecting the steering control 108 to steering cable tip 732. Stylet 102 further includes a tube end cap 736 on the proximal end of the stylet 102. It is this tube end cap 736 over which the distal end of an intubation tube passes when the intubation tube is passed over the stylet during intubation.
Removal of the handle 104 is accomplished in the depicted embodiment by opening clasp 106, as shown later herein. The stylet 102 includes a steering control 108 that can slide forward and backward so as to change the shape of articulating tip 114. Stylet 102 further includes a proximal portion 118 and a distal portion 120, both of which are typically flexible but not articulating. Proximal portion 118 of stylet 102 remains outside of a patient during the intubation procedure, while at least some of distal portion 120 is inserted into the patient.
FIG. 9 is a front view of the distal side of a handle 104 of An intubation tool having a steerable camera with the stylet 102 of the tool installed; while FIG. 10 is a front view of the distal side of the handle 104 of the intubation tool with the clasp 106 open, and FIG. 11 is a front view of the distal side of the handle 104 of the intubation tool with the tool removed and handle catch open. FIG. 9 shows a dowel 946 (typically made of metal, such as stainless steel) that the clasp 106 pivots around. In addition, the clasp 106 shows a locking member 1046 for snapping into the lower portion of the handle 104. The clasp 106 further includes a recess 1047, while the bottom of the handle 104 includes a recess 1148. Recess 1047 and 1148 combine to surround and hold the stylet 102 when the handle 104 is retained on the stylet 102.
FIG. 12 is a diagram showing the field of view from intubation tool made in accordance with the present disclosure. FIG. 13 is a diagram showing the field of view from intubation tool made in accordance with the present disclosure. Both figures show how the intubation tool is designed to allow for improved visibility into a patient during medical procedures. Generally, a relatively unobstructed view is possible relative to alternative devices. In an embodiment, the handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination. In an embodiment, the handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet. In an embodiment, the handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet. In an embodiment, the handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
FIG. 14 is view of the distal end of An intubation tool having a steerable camera stylet, showing the articulating tip 114 of the stylet 102 in a neutral position; FIG. 15 is view of the distal end of the stylet, showing articulating tip 114 in an downwardly flexed position; FIG. 16 is view of the distal end of stylet 102, showing the tip of the stylet in an upwardly flexed position. In this neutral position the distal end allows for insertion into a patient without trauma to the patient’s tissue.
FIG. 17 is a closeup view of the steering base of An intubation tool having a steerable camera stylet 102. The steering base 1750 includes steering control 108 that readily moves to a distal (left) location or proximal (right) location with the force of one or more fingers.
The steering base 1750 includes a path 1768 on which the steering control 108 travels. This path 1768 is generally exposed even when the stylet 102 is mounted on a handle (not shown), allowing the operator to move the steering control 108 so as to articulate the tip of the stylet 102. Further, a proximal section 1760 of the steering base 1750 is shown, this proximal section 1760 including (in this embodiment) regions 1762 and 1764 that are wider areas of the steering base 1750 deigned to secure the stylet 102 in a handle and prevent rotation and sliding of the stylet.
FIG. 18 is view of the distal end of An intubation tool having a steerable camera stylet, with the tip of the stylet articulated. FIG. 19 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially neutral location; FIG. 20 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially distal location; FIG. 21 is close up view of the medial portion of a stylet 102, showing the steering control 108 in a substantially proximal location.
FIG. 22 is a drawing showing an exploded view of components of An intubation tool having a steerable camera for assisting in placement of an endotracheal tube made in accordance with an example embodiment; further showing two ends of steering cable 2262 and also optional bowden cable 2264 through which the steering cable 2262 passes. The steering cable 2262 terminates in the steering cable tip 732, while also being connected to steering control 108.
FIG. 23 is a perspective view of a steering base 730 made in accordance with an example embodiment; FIG. 24 is a side elevational view of the steering base 730; FIG. 25 a distal end view of a steering base 730; and FIG. 26 is a cross sectional view of the steering base 730. Channels 2370 and 2372 are shown in steering base 730, and these channels provide pathway 2670 for the steering cable 2262. Sleeve 2238 on the proximal end the stylet is further shown.
FIG. 27 is a perspective view of the proximal end cap 736 of An intubation tool having a steerable camera stylet in accordance with an embodiment; FIG. 28 is a distal end view of the proximal end cap 736; and FIG. 29 is a side view of the proximal end cap. Exposed portion 2758 is shown, along with recessed portion 2760 for insertion into the proximal end of the stylet, along with lip 2762 to limit insertion depth of the proximal end cap.
FIG. 30 is a perspective view of steering cable tip 732 of An intubation tool having a steerable camera stylet in accordance with an embodiment; FIG. 31 is a proximal end view of steering cable tip; and FIG. 32 is a side view. Exposed portion 3066 is shown, along with recessed portion 3068 as are cable retaining holes 3170 and 3172 are shown.
FIG. 33 is a perspective view of steering control 108 showing an internal opening 3380 that fits onto steering base 730. The steering control 108 further includes a protrusion 3382 that fits into a recess in the steering base 730, thereby preventing rotation of the steering control 108. In addition, an opening 3384 is formed in the protrusion 3382, and this opening secures the cable connecting to the articulating tip of the stylet; FIG. 34 is an end view of the steering control 108; and FIG. 35 is a side view of the steering control 108. FIG. 36 is a perspective view of an articulation collar 3680 of a stylet in accordance with an embodiment; and FIG. 37 is a side view of the articulation collar 734; FIG. 38 is an end view of the articulation collar3680, having pathways 3686 and 3688.
FIG. 39 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment. The intubation tool 3900 includes a stylet 3902 and a handle 3904 having an articulating tip 3914 and a steering control 4008. The steering control 4008 slides forward and backward (distally and proximally) along the stylet 3902, and this movement of the steering control 4008 moves the tip of the stylet upward and downward (dorsally and ventrally).
FIG. 40 is closeup of the endotracheal intubation tool of FIG. 39, enlarging the portion from dotted circle 39A. FIG. 40 shows the distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904, along with base 4007 of handle 3904. The stylet is secured between the clasp 4006 and the base 4007 during placement of the stylet into a patient. After placement of the stylet into the patient the clasp is opened or removed, freeing the stylet from the handle 3904 so that an intubation tube may be inserted over the stylet. During use rounded surface 4028 of the handle 3904 is typically placed within the palm of the medical professional performing the intubation procedure, and the medical professional fingers wrap around the top of the handle 3904 to grasp the steering control 4008. Typically 2 or 3 fingers make contact with the steering control 4008 so as to pinch the steering control 4008 between the fingers. Minimal force is thereafter needed to move the steering control forward and backward to articulate the tip of the stylet (not shown). Thus, merely drawing the fingers forward and backward as they contact the stylet, typically in a pinching arrangement with two or more fingers arranged around the steering control 4008, results in articulation of the tip of the stylet.
FIG. 41 is a drawing showing an exploded view of components of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment. The components include handle 3904, articulating tip 3914, steering control 4008 positioned on a steering base 4130. In the depicted embodiment, two lengths of cable 4160 and 4162 which extend through the proximal end of the stylet through proximal sleeve 4138. Tip 4164 is at the most proximal end of the stylet.
FIG. 42 is a drawing showing a side perspective view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation. In the embodiment shown the articulating tip 3914 is shown in a position where the tip is articulated in a dorsal (or upward) orientation. In the depicted embodiment the upward orientation occurs as the steering control 4008 (see, e.g., FIGS. 40 and 41) is drawn in a proximal direction. FIG. 43 is a drawing showing a side perspective view of the endotracheal intubation tool of FIG. 42, with the articulating tip 3914 in a ventral (or downward) orientation. In the depicted embodiment the downward orientation occurs as the steering control 4008 is moved in distal direction.
FIG. 44 is drawing showing the articulating tip 3914 of an endotracheal intubation tool in a neutral position. In general, the articulating tip 3914 is in a neutral (or straight) position when no forced is being applied to the tip, such as from the steering control 4008.
FIG. 45 is a perspective view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment, the steering control 4008.
Steering control 4008 has internal opening 4080 that fits onto steering base. The steering control 4008 further includes a protrusion 4082 that fits into a recess in the steering base, thereby preventing rotation of the steering control 108. Steering control 4008 also includes an opening 4084 for securing the cable connected to the articulating tip of the stylet. The steering control 4008 has to recessed portions 4591 and 4592 for gripping by fingers (although other configurations are possible). Lip 4581 of the steering control 4008 is also shown. FIG. 46 is a side view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment, with a partial cross section. FIG. 47 is an end view of steering control 4008 of An intubation tool having a steerable camera stylet in accordance with an embodiment.
FIG. 48 is a perspective view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate 4850 independent of other components. The vertebrate 4850 has a first distal angled face 4854 and a second distal angled face 4856 separated, in this embodiment, by a distal flat portion 4852, along with two optional transition regions 4857 and 4859. The vertebrate also includes internal pathways 4853 and 4855 through which the cables are passed to secure multiple vertebrate together and to apply tension to articulate the vertebrate relative to one another.
FIG. 49 is a side view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate independent of other components. The first angled face 4854 and second angled face 4856 are shown, along with flat portion 4852. These distal angled faces 4854, 4856 and distal flat portion 4852 are on the distal end of the vertebrate (that portion closest to the patient). FIG. 49 further shows the proximal end of the vertebrate, including a first proximal angled face 4960 and a second proximal angled face 4962, and a proximal flat portion 4964.
FIG. 50 is a distal end view of a vertebrate 4850 from the articulating end of an articulating tip, showing the vertebrate 4850 independent of other components. The vertebrate 4850 has a first distal angled face 4854 and a second distal angled face 4856 separated, in this embodiment, by a distal flat portion 4852, along with two optional transition regions 4857 and 4859. The vertebrate also includes internal pathways 4853 and 4855 through which the cables are passed to secure multiple vertebrate together and to apply tension to articulate the vertebrate relative to one another.
FIG. 51 is a perspective view of the tip member 5132 from an end of an articulating tip, showing the tip member 5060 independent of other components. The tip member 5132 has a first proximal angled face 5060 and second proximal angled face 5062, plus a proximal flat portion 5064. Passageways 5053 and 5055 allow for placement of ends of the control cable (not shown) which are typically secured by adhesive or other means in the end of the passageways. FIG. 52 is a side cross-sectional view of the tip member 5060 from an articulating end of an articulating tip, showing the tip member independent of other components, and FIG. 53 is an end view of the tip member 5060.
FIG. 54 is a perspective view of a base member 5460 from the proximal end of an articulating tip, showing the base member independent of other components; and FIG. 55 is a side view of the base member 5460. The base member 5460 includes passageways 5462 and 5464, and also include a stem 5465 that can fit within a hole in the shaft of the stylus to secure it into place. The distal end of the base member 5460 includes distal angled face 5554 and second distal angled face 5556, separated by a distal flat portion 5552
FIG. 56 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a base member 5460, multiple vertebrate 5610, 5612, 5614, 5616, and 5620, along with a tip member 5132. A gap 5622 is shown between the vertebrate 5616 and 5620. FIGS. 57 to 62 show the articulating tip in increasing levels of articulation. As the vertebrate start to articulate the gaps 5622 close into contact regions 5723. On the opposite side an opening 5722 becomes larger. The proximal vertebrate articulate first, followed sequentially down the articulating tip to the most distal vertebrate and the tip member 5132. FIGS. 63 and 64 show the articulating around a stylized obstruction 6363, such as a portion of a patient’s anatomy.
FIG. 65 is a side view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed, showing a base 4007 and clasp 4006. FIG. 66 is a perspective view of a clasp 4006 of a handle, showing a protrusion 6655 for fitting into a recess 6753 of a base of a handle shown in FIG. 67 to snap the clasp and base together. A recess 6722 in the clasp combines with a recess 6720 in the base to form a passageway through the handle for the stylet. A hinge for the clasp and base is formed from an elevated portion 6751 of the base that fits into a slot 6649 in the clasp, and a pin can be inserted through holes 6645 and 6647 through the elevated portion 6751 of the base. Also shown is a recess 6724 that allows for the stylet to be bent downward and out of the way of the user while gripping the handle 3904
FIG. 68 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
FIG. 69 is a graph showing force relative to articulation position of an articulating tip of an endotracheal intubation tool.
FIG. 70 is a side cross-sectional of a vertebrate from an articulating end of an articulating tip, showing passageways 7050 and 7052. The vertebrate has a total width of Wv, and the distal flat portion 4852 has a width of Wf.
FIG. 71 is a graph showing required to articulate a vertebrate relative to flat portion of the vertebrate.
FIG. 72 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera. FIG. 72 shows the distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904. The stylet is secured between the clasp 4006 and the base 4007 during placement of the stylet into a patient. After placement of the stylet into the patient the clasp is opened or removed, freeing the stylet from the handle 3904 so that an intubation tube may be inserted over the stylet. The distal end 4020 of the stylet includes a camera at its tip in certain embodiments (shown in subsequent figures, described below). The camera can be used to precisely navigate through the anatomy of a patient, providing additional information on location of the stylet for the medical professional performing the intubation.
FIG. 73 is a drawing showing a side plan view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, the intubation tool including a camera and also showing a cable 7350 connected to a monitor showing images of a patient’s airway displayed on a monitor 7360.
FIG. 74 is a drawing showing a perspective view of an endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment having a camera, showing distal end 4020 of the stylet and the proximal end 4018 of the stylet, as well as clasp 4006 on handle 3904. The intubation tool includes a camera and also showing a cable 7350 connected to a monitor showing images of a patient’s airway displayed on a monitor 7360.
FIG. 75 is a side view of a handle of an endotracheal intubation tool. The handle includes, in this embodiment, a first set of wires 7552 and a second set of wires 7554. In the depicted embodiment the first set of wires 7552 can be connected to the camera sensor at the tip of the stylet (not shown) and the second set of wires 7554 can be connected to one or more lights at the tip of the stylet. However, it will be appreciated that a single set of wires can be used, and that more than two sets of wires can be used. Typically it is necessary that the wires provide both a data feed from the camera or cameras on the stylet, while also providing power for lights at the end of the stylet to illuminate the field of view for the camera.
FIG. 76 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a cross section of the interior of the components of the camera on the end of the articulating tip. The articulating tip 3914 includes a camera at the distal tip, including one or more lights 7632 and a sensor 7634. FIG. 77 is a side view of camera components of the articulating tip of an endotracheal intubation tool of FIG. 76. The tip includes light 7746 and light 7748. A camera 7750 is also shown. Conductor 7740 and conductor 7742 provide an electrical connection to the light 7746 and light 7748. Conductor 7744 provides an electrical connection to the camera sensor (allowing signals from the camera to be transmitted back through the stylet and handle and then on to a monitor).
FIG. 78 is a side cross sectional view of components of an endotracheal intubation tool, in particular the handle and a portion of the stylet closet to the handle, including the steering base 730 and a set of conductive pads 7870 that provide an interface between the stylet and monitor (with conductors running from the camera at the distal end of the stylet to the conductive pads 7870, which make contact with conductive pads on the handle that then transmit signals on their way to the monitor). Optional control circuits and software is typically used, such as to control the resolution, brightness, illumination (from the camera), etc.
FIG. 79 is an end cross-sectional view of a vertebrate of the stylet of an endotracheal intubation tool with a camera, the vertebrate including internal passages and that receive a cable to assist with articulation of the tip. Down the center of the vertebrate is an opening 7980 that receives a plurality of conductors 7982. FIG. 80 is a side cross sectional view of a portion of an endotracheal intubation tool; and FIG. 81 is a perspective view of a base member from the proximal end of an articulating tip for an intubation tool having a camera, showing the base member independent of other components. The figures show how the cables can be transitioned from the articulating portion of the stylet to the shaft. In FIG. 80 the cables 8080 and 8082 transition from the perimeter of the shaft to the center of the shaft in the depicted construction.
In FIG. 81 a base member 8160 from the proximal end of an articulating tip is depicted, showing the base member 8160 independent of other components. The base member 8160 includes passageways 8153 (of which one of two is shown), and also include a stem 8165 that can fit within a hole in the shaft of the stylus to secure it into place. Channel 8130 and channel 8132 provide a pathway for cables (such as power and illumination cables) through the base member 8160.
FIG. 82 is a side cross sectional view of a portion of an endotracheal intubation tool also showing passageways 8153. Channel 8130 and channel 8132 provide a pathway for cables (such as power and illumination cables) through the base member 8160.
FIG. 83 is a perspective view of a portion of the interior of the steering control of an intubation tool having a steerable camera in accordance with an embodiment, showing passageways 8153 as well as an outer surface that the slidable portion of the control can engage, plus lower slot 8360 for which the steering cable can move.
FIG. 84 is a side elevational view of components of an articulating tip 3914 of an endotracheal intubation tool in a neutral position, showing the angle of view of a camera on the tip of the intubation tool. FIG. 84 shows components of an articulating tip of an endotracheal intubation tool in a neutral position, showing a base member 5460, multiple vertebrate 5610, 5612, 5614, 5616, and 5620, along with a tip member 5132. A gap 5622 is shown between the vertebrate 5616 and 5620. FIGS. 57 to 62 show the articulating tip in increasing levels of articulation. As the vertebrate start to articulate the gaps 5622 close into contact regions 5723. On the opposite side an opening 5722 becomes larger. The proximal vertebrate articulate first, followed sequentially down the articulating tip to the most distal vertebrate and the tip member 5132. FIGS. 85 and 86 show the articulating around a stylized obstruction 6363, such as a portion of a patient’s anatomy. Fig. 86 shows how the camera can have a wide field of view that continues forward even after articulation. In this drawing, the tip of the stylet (where the camera is positioned) is offset from the primary axis of the non articulating portion by a distance of Lo, yet has an orientation of the field of view of the camera that is substantially parallel to the field of view prior to articulation, and is generally overlapping the field of view prior to articulation. The total length of the articulating portion is shown as LA. This feature of the intubation tool is particularly useful because it allows a practitioner to navigate through the anatomy of a patient while still having the camera point substantially forward, rather than upward. In the figures shown, where the stylet tip has moved beyond obstruction 6363, the tip of the stylet (and camera) is aligned (in some situations) with the patient’s vocal cords.
Although the amount of offset can vary, in some embodiments offset Lo can be more than 10 percent of the length of the articulating section LA; optionally offset Lo can be more than 10 percent of the length of the articulating section LA; optionally offset Lo can be more than 20 percent of the length of the articulating section LA; optionally offset Lo can be more than 30 percent of the length of the articulating section LA; optionally offset Lo can be 10 to 50 percent of the length of the articulating section LA; optionally offset Lo can be 5 to 60 percent of the length of the articulating section LA; optionally offset Lo can be more than 25 percent of the length of the articulating section LA.
The camera will typically have a field of view from 30 to 120 degrees, although various degrees are possible.
FIG. 87 is a drawing showing a side perspective view of endotracheal intubation tool for assisting in placement of an endotracheal tube made in accordance with an example embodiment, showing the articulating tip in an upward (or dorsal) articulation, showing a camera 8410 positioned at the proximal end of the articulating portion. Camera 8410 allows a practitioner to see the tip of the stylet as it is directed through a patient’s airway. FIG. 88 is a drawing showing a closeup of a portion of the endotracheal intubation tool of FIG. 87.
FIG. 89 is a drawing show a closeup of a vertebra 8950 made in accordance with an implementation an embodiment. The vertebra includes an outer surface 8951 that is generally conical (does not taper along the length from left to right).
FIG. 90 is a drawing show a closeup of a vertebra 9050 made in accordance with an implementation an embodiment. The vertebra includes an outer surface 9051 that tapers, such that the diameter of the vertebra is smaller at one or both of the ends (left and right) where it comes in contact with other vertebra. In this embodiment the taper is “flat” so as to be somewhat a truncated cone. Also, both ends are shown tapered.
FIG. 91 is a drawing show a closeup of a vertebra 9150 made in accordance with an implementation an embodiment. The vertebra includes an outer surface 9151 that tapers, such that the diameter of the vertebra is smaller at one or both of the ends (left and right) where it comes in contact with other vertebra. In this embodiment the taper is “curved” so as to have a continuous, smooth taper. Also, both ends are shown tapered.
FIG. 92 is a side elevational view of components of an articulating tip of an endotracheal intubation tool in accordance with an embodiment, showing tapered vertebrate 5610 to 5616. The tapered vertebrae have improved overlap w/o protruding edges on the inside curve so that there is less resistance to placement in a patient, and less exposed edges to “catch” and slow down entry because the edges are recessed toward the center of the intubation tool.
FIG. 93 is a drawing show a closeup of a vertebra 9350 made in accordance with an implementation an embodiment, showing tapered design. The vertebra 9350 includes first tapered portion 9380 extending from line A to line B; and second tapered portion 9382 extending from line C to line D. The amount of taper is shown from line E to line F; and from line G to line H The extend and amount of taper can vary, but is generally such that the vertebra 9350 has less potential to “catch” as it enters and retracts from a patient’s airway. In general extents 9380 and 9382 are the same, but can also be different. Similarly, the amount of taper E-F and G-H is typically the same, but can be different. In an example embodiment the extents 9380 and 9382 are each less than 50 percent of the length of the vertebra 9350; optionally less than 45 percent of the length of the vertebra; optionally less than 40 percent of the length of the vertebra; optionally less than 35 percent of the length of the vertebra; optionally less than 30 percent of the length of the vertebra; optionally less than 25 percent of the length of the vertebra; optionally less than 20 percent of the length of the vertebra. In some implementations the amount of taper is from 10 to 40 percent of the length of the vertebra. The amount of taper E-F and G-H can be, for example, less than 1 percent of the maximum diameter of the vertebra 9350; or less than 1 percent of the maximum diameter of the vertebra 9350; or less than 2 percent of the maximum diameter of the vertebra 9350; or less than 3 percent of the maximum diameter of the vertebra 9350; or less than 4 percent of the maximum diameter of the vertebra 9350; or less than 5 percent of the maximum diameter of the vertebra 9350; or less than 7.5 percent of the maximum diameter of the vertebra 9350; or less than 10 percent of the maximum diameter of the vertebra 9350; or less than 12.5 percent of the maximum diameter of the vertebra 9350; or less than 15 percent of the maximum diameter of the vertebra 9350; or less than 20 percent of the maximum diameter of the vertebra 9350.
FIG. 94 is a side view of a handle 9406 of an endotracheal intubation tool with the stylet having a steering control 9463 that can be moved back and forth by a wheel 9461. FIG. 95 is a side view of a handle 9406 of an endotracheal intubation tool with the stylet having a lever 9565 that engages a steering control 9463 and wheel 9461. As such, in this embodiment the steering control 9463 is within the handle 9406 (as opposed to outside) and is manipulated by a wheel, lever, slider or other means, typically from the top of the handle 9406.
FIG. 96 is a drawing showing a side plan view of endotracheal intubation tool 3900 for assisting in placement of an endotracheal tube made in accordance with an example embodiment. FIG. 97 is an end view of a handle 3904 of an endotracheal intubation tool with the stylet of the tool removed. The intubation tool 3900 includes a stylet 3902 and a handle 3904 having an articulating tip 3914 and a steering control 4008. The steering control 4008 slides forward and backward (distally and proximally) along the stylet 3902, and this movement of the steering control 4008 moves the tip of the stylet upward and downward (dorsally and ventrally). The handle includes retaining portions 9790 and 9792 that can be used to secure the two ends of the stylet 3902, such as for packaging, carrying by a medical professional in a case or pocket, or even during use (such as having the proximal portion tucked into a recess 9792 to keep out of view during placement of the tip 3914.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet.
In an embodiment, wherein articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end.
In an embodiment, wherein articulation of the distal tip of the stylet can be accomplished with a single finger manipulating a steering control mounted on the stylet.
In an embodiment, wherein articulation of the distal tip of the stylet can be accomplished with a two fingers manipulating a steering control mounted on the stylet, the steering control sliding along the stylet.
In an embodiment, wherein articulation of the distal end of the stylet can be accomplished with three fingers from a single hand that articulates the distal end.
In an embodiment, the articulating distal tip can be articulated with a force of less than 9 Newton. In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
In an embodiment, the articulating distal tip is deformable upon contact with an obstruction.
In an embodiment, the articulating distal tip transmits force back to steering control upon contact with an obstruction.
In an embodiment, wherein translation movement of a steering control results in bending articulation of the articulating distal tip.
In an embodiment, wherein translation movement of a steering control by a distance D results in bending articulation of the distal tip by a distance of at least 150 percent of D.
In an embodiment, wherein translation movement of the steering control in a first direction results in bending articulation of the articulating distal tip in a first direction, and translational movement of the steering control in an opposite direction results in bending articulation of the articulating distal tip in a direction opposite the first direction.
In an embodiment, the stylet includes tubing containing at least one lumen.
In an embodiment, the stylet includes bilumen tubing.
In an embodiment, wherein upon removal of the handle from the medial portion of the stylet, the medial portion of the stylet has a diameter no greater than 120 percent of the remainder of the stylet.
In an embodiment, the widest portion of the stylet after removal of the handle is less than the diameter of the interior of the lumen of an endotracheal tube to be installed on the stylet.
In an embodiment, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 1 cm.
In an embodiment, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 2 cm.
In an embodiment, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 3 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 90 degrees along a dorsal elevation LD of 1 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 180 degrees along a dorsal elevation LD of 3 cm.
In an embodiment, the handle and stylet provide a clear sight line of angle a of 270 degrees along a dorsal elevation LD of 3 cm. In an embodiment, the stylet has a length at least 1.5 times the length of an endotracheal tube to be installed on the stylet.
In an embodiment, the stylet has a length at least 2.0 times the length of an endotracheal tube to be installed on the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
In an embodiment, the stylet articulates in a plane.
In an embodiment, the plane in which the stylet articulates can be selected by rotation the handle.
In an embodiment, the stylet includes an internal mechanism for articulating the distal end.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, further can include a steering element.
In an embodiment, the steering element includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, a method for placement of an endotracheal tube, the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet and into the trachea of the person, and e) removing the stylet from the patient’s trachea while keeping the endotracheal tube in place.
In an embodiment, the stylet articulates in a plane.
In an embodiment, the stylet includes an internal mechanism for articulating the distal tip.
In an embodiment, the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal tip, and wherein pulling on the cable from the medial location results in articulating the distal tip of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the endotracheal intubation tool is included having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.
In an embodiment, the cable radial location optimized to facilitate articulation and minimize pull force.
In an embodiment, the handle is removable from the stylet.
In an embodiment, the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
In an embodiment, the stylet articulates in a plane.
In an embodiment, the stylet includes an internal mechanism for articulating the distal end.
In an embodiment, where the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, a method for placement of an endotracheal tube, the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a medial location and a distal end, the stylet configured for receiving an endotracheal tube, and having an articulating distal end, the articulating distal end being configured to articulate between more than one shape, and ii) a handle secured to the medial location of the stylet, b) inserting the distal end of the stylet of the endotracheal intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial location of the stylet, d) inserting an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet, and e) removing the stylet from the patient’s trachea while keeping the endotracheal tube in place, wherein the actuation can be performed with a single hand.
In an embodiment, the endotracheal intubation tool for assisting in placement of an endotracheal tube is removable from the medial location of the stylet.
In an embodiment, wherein actuation occurs push/pull action on the tip by allowing three finger, 360 degree contact of circular trigger. In an embodiment, the endotracheal intubation stylet includes an internal mechanism for articulating the distal end.
In an embodiment, the stylet further includes a flexible intermediate portion.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, further can include an actuator.
In an embodiment, the actuator includes a tube surrounding a portion of the medial location of the stylet.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the stylet has a substantially uniform outer diameter.
In an embodiment, the minimum non-tip diameter of stylet is within 70 percent of the maximum non-tip diameter of the stylet.
In an embodiment, the minimum non-tip diameter of stylet is within 80 percent of the maximum non-tip diameter of the stylet.
In an embodiment, the minimum non-tip diameter of stylet is within 90 percent of the maximum non-tip diameter of the stylet.
In an embodiment, the stylet includes a keyed surface for securing a handle.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet wherein the stylet includes a flexible cable to articulate the distal tip.
In an embodiment, the distal end of the stylet is in a neutral position when no articulating force is applied.
In an embodiment, the force to articulate the distal end is less than 2 pounds.
In an embodiment, the force to articulate the distal end is less than 4 pounds.
In an embodiment, the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees. In an embodiment, the force to articulate the distal end from 80 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 10 degrees.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and the articulating distal tip includes a plurality of free vertebrate: and b) a removable handle secured to a medial location on of the stylet.
In an embodiment, the vertebrate have a substantially flat peak
In an embodiment, the vertebrate have a substantially flat valley
In an embodiment, the vertebrate interface angle is from 10 to 20 degrees.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
In an embodiment, the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
In an embodiment, the distal end of the stylet is in a neutral position when no articulating force is applied.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the articulating tip is not rigid.
In an embodiment, the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet, wherein the articulating tip transmits tactile feedback. In an embodiment, the force to articulate the distal end is less than 2 pounds.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
In an embodiment, the distal end of the stylet is in a neutral position when no articulating force is applied.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and iii) a slidable actuator articulating the distal tip, the slidable actuator being engageable around at least 180 degree of the central axis of the stylet.
In an embodiment, the slidable actuator is engageable around at least 270 of the central axis of the stylet. .
In an embodiment, the slidable actuator is engageable around at 360 of the central axis of the stylet. In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the intubation tool is included having a) a stylet having a proximal end, a distal end, and a medial location, the stylet including a bi-lumen extrusion, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and b) a removable handle secured to a medial location on of the stylet.
In an embodiment, the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
In an embodiment, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
In an embodiment, the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
In an embodiment, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
In an embodiment, the distal end of the stylet is in a neutral position when no articulating force is applied.
In an embodiment, a method for placement of an endotracheal tube, the method is included, the method a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool is included, the method i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers, and ii) a handle secured to a medial position on the stylet, b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx, c) removing the handle from the medial portion of the stylet, d) placing an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet and into the trachea of the person, and e) removing the stylet from the patient’s trachea while keeping the endotracheal tube in place.
In an embodiment, the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
In an embodiment, the stylet includes an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
In an embodiment, the articulating distal tip can be articulated with a force of 4 to 9 Newton.
In an embodiment, the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
In an embodiment, a intubation tool for assisting in placement of an endotracheal tube, the endotracheal intubation tool is included having a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape, and b) a handle secured to the medial location of the stylet, wherein actuation is provided by a cable.
It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.
The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. As such, aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope herein.

Claims

We Claim:
1. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; b) a removable handle secured to a medial location on of the stylet; and c) a camera.
2. The intubation tool having a steerable camera for assisting in placement of an endotracheal tube of claim 1, wherein the camera is positioned at the stylet tip.
3. The intubation tool having a steerable camera for assisting in placement of an endotracheal tube of claim 1, wherein the camera includes a CMOS sensor.
4. The intubation tool having a steerable camera for assisting in placement of an endotracheal tube of claim 1, wherein the stylet includes conductive tabs.
5. The intubation tool having a steerable camera for assisting in placement of an endotracheal tube of claim 1, wherein the camera is positioned to view the tip.
6. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein articulation of the distal tip of the stylet can be accomplished with a single hand that holds the removable handle and articulates the distal end.
7. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein articulation of the distal tip of the stylet can be accomplished with a single finger manipulating a steering control mounted on the stylet.
8. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein articulation of the distal tip of the stylet can be accomplished with a two fingers manipulating a steering control mounted on the stylet, the steering control sliding along the stylet.
9. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein articulation of the distal end of the stylet can be accomplished with three fingers from a single hand that articulates the distal end.
10. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the articulating distal tip can be articulated with a force of less than 9 Newton.
11. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the articulating distal tip can be articulated with a force of 4 to 9 Newton.
12. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the articulating distal tip is deformable upon contact with an obstruction.
13. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the articulating distal tip transmits force back to steering control upon contact with an obstruction.
14. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein translation movement of a steering control results in bending articulation of the articulating distal tip.
15. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein translation movement of a steering control by a distance D results in bending articulation of the distal tip by a distance of at least 150 percent of D.
16. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein translation movement of the steering control in a first direction results in bending articulation of the articulating distal tip in a first direction; and translational movement of the steering control in an opposite direction results in bending articulation of the articulating distal tip in a direction opposite the first direction.
17. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet comprises tubing containing at least one lumen.
18. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet comprises bilumen tubing.
19. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein upon removal of the handle from the medial portion of the stylet, the medial portion of the stylet has a diameter no greater than 120 percent of the remainder of the stylet.
20. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the widest portion of the stylet after removal of the handle is less than the diameter of the interior of the lumen of an endotracheal tube to be installed on the stylet.
21. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 1 cm.
22. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 2 cm.
23. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a clear sight line of angle a of 20 degrees along a dorsal elevation LD of 3 cm.
24. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the handle and stylet provide a clear sight line of angle a of 90 degrees along a dorsal elevation LD of 1 cm.
25. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the handle and stylet provide a clear sight line of angle a of 180 degrees along a dorsal elevation LD of 3 cm.
26. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the handle and stylet provide a clear sight line of angle a of 270 degrees along a dorsal elevation LD of 3 cm.
27. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet has a length at least 1.5 times the length of an endotracheal tube to be installed on the stylet.
28. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet has a length at least 2.0 times the length of an endotracheal tube to be installed on the stylet.
29. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
26. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
30. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
31. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
32. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
33. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
34. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet articulates in a plane.
35. The intubation tool for assisting in placement of an endotracheal tube of claim 34, wherein the plane in which the stylet articulates can be selected by rotation the handle.
36. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet includes an internal mechanism for articulating the distal end.
37. The intubation tool for assisting in placement of an endotracheal tube of claim 1, wherein the stylet comprises an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
38. The intubation tool for assisting in placement of an endotracheal tube of claim 1, further comprising a steering element.
39. The intubation tool for assisting in placement of an endotracheal tube of claim 35, wherein the steering element comprises a tube surrounding a portion of the medial location of the stylet.
40. A method for placement of an endotracheal tube, the method comprising: a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers; and ii) a handle secured to a medial position on the stylet; b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx; c) removing the handle from the medial portion of the stylet; d) placing an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet and into the trachea of the person; and e) removing the stylet from the patient’ s trachea while keeping the endotracheal tube in place, wherein the stylet includes a camera.
38. The method for placement of an endotracheal tube of claim 37, wherein the stylet articulates in a plane.
39. The method for placement of an endotracheal tube of claim 37, wherein the stylet includes an internal mechanism for articulating the distal tip.
40. The method for placement of an endotracheal tube of claim 37, wherein the stylet further comprises a flexible intermediate portion.
41. The method for placement of an endotracheal tube of claim 37, wherein the stylet comprises an internal cable connected to the distal tip, and wherein pulling on the cable from the medial location results in articulating the distal tip of the stylet.
42. The method for placement of an endotracheal tube of claim 37, further comprising an actuator.
43. The method for placement of an endotracheal tube of claim 37, wherein the actuator comprises a tube surrounding a portion of the medial location of the stylet.
44. The method for placement of an endotracheal tube of claim 37, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
45. The method for placement of an endotracheal tube of claim 37, wherein handle and stylet provide a substantially clear sight line of at least 180 degrees along the dorsal line of the handle and stylet combination.
46. The method for placement of an endotracheal tube of claim 37, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
47. The method for placement of an endotracheal tube of claim 37, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 2 cm of the central axis of the stylet.
48. The method for placement of an endotracheal tube of claim 37, wherein handle and stylet provide a substantially clear sight line of at least 270 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
49. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the endotracheal intubation tool comprising: a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape; and b) a handle secured to the medial location of the stylet; wherein actuation is provided by a cable.
50. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the cable radial location optimized to facilitate articulation and minimize pull force.
51. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the handle is removable from the stylet.
52. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the handle is removable from the medial location of the stylet to allow placement of an endotracheal tube in place.
53. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the stylet articulates in a plane.
54. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the stylet includes an internal mechanism for articulating the distal end.
55. The intubation tool for assisting in placement of an endotracheal tube of claim 49, where the stylet further comprises a flexible intermediate portion.
56. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the stylet comprises an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
57. The intubation tool for assisting in placement of an endotracheal tube of claim 49, further comprising an actuator.
58. The intubation tool for assisting in placement of an endotracheal tube of claim 49, wherein the actuator comprises a tube surrounding a portion of the medial location of the stylet.
59. A method for placement of an endotracheal tube, the method comprising: a) providing An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: i) a stylet having a medial location and a distal end, the stylet configured for receiving an endotracheal tube, and having an articulating distal end, the articulating distal end being configured to articulate between more than one shape; and ii) a handle secured to the medial location of the stylet; b) inserting the distal end of the stylet of the endotracheal intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx; c) removing the handle from the medial location of the stylet; d) inserting an endotracheal tube over the medial location of the stylet and down toward the distal end of the stylet; and e) removing the stylet from the patient’ s trachea while keeping the endotracheal tube in place; wherein the actuation can be performed with a single hand.
60. The method for placement of an endotracheal tube of claim 59, wherein the endotracheal intubation tool for assisting in placement of an endotracheal tube is removable from the medial location of the stylet.
61. The method for placement of an endotracheal tube of claim 59, wherein actuation occurs push/pull action on the tip by allowing three finger, 360 degree contact of circular trigger.
62. The method for placement of an endotracheal tube of claim 59, wherein the endotracheal intubation stylet includes an internal mechanism for articulating the distal end.
63. The method for placement of an endotracheal tube of claim 59, wherein the stylet further comprises a flexible intermediate portion.
64. The method for placement of an endotracheal tube of claim 59, wherein the stylet comprises an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
65. The method for placement of an endotracheal tube of claim 59, further comprising an actuator.
66. The method for placement of an endotracheal tube of claim 59, wherein the actuator comprises a tube surrounding a portion of the medial location of the stylet.
67. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet; wherein the stylet has a substantially uniform outer diameter.
68. The intubation tool of claim 67, wherein the minimum non-tip diameter of stylet is within 70 percent of the maximum non-tip diameter of the stylet.
69. The intubation tool of claim 67, wherein the minimum non-tip diameter of stylet is within 80 percent of the maximum non-tip diameter of the stylet.
70. The intubation tool of claim 67, wherein the minimum non-tip diameter of stylet is within 90 percent of the maximum non-tip diameter of the stylet.
71. The intubation tool of claim 67, wherein the stylet comprises a keyed surface for securing a handle.
72. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet wherein the stylet comprises a flexible cable to articulate the distal tip.
73. The intubation tool for assisting in placement of an endotracheal tube of claim 72, wherein the distal end of the stylet is in a neutral position when no articulating force is applied.
74. The intubation tool for assisting in placement of an endotracheal tube of claim 72, wherein the force to articulate the distal end is less than 2 pounds.
75. The intubation tool for assisting in placement of an endotracheal tube of claim 72, wherein the force to articulate the distal end is less than 4 pounds.
76. The intubation tool for assisting in placement of an endotracheal tube of claim 72, wherein the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
77. The intubation tool for assisting in placement of an endotracheal tube of claim 72, wherein the force to articulate the distal end from 80 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 10 degrees.
78. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape, and the articulating distal tip comprises a plurality of free vertebrate: and b) a removable handle secured to a medial location on of the stylet.
79. The intubation tool of claim 78, wherein the vertebrate have a substantially flat peak.
80. The intubation tool of claim 78, wherein the vertebrate have a substantially flat valley.
81. The intubation tool of claim 78, wherein the vertebrate interface angle is from 10 to
20 degrees.
82. The intubation tool of claim 78, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
83. The intubation tool of claim 78, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
84. The intubation tool of claim 78, wherein the articulating distal tip can be articulated with a force of 4 to 9 Newton.
85. The intubation tool of claim 78, wherein the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
86. The intubation tool of claim 78, wherein the distal end of the stylet is in a neutral position when no articulating force is applied.
87. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet; wherein the articulating tip is non-rigid.
88. The intubation tool for assisting in placement of an endotracheal tube of claim 87, wherein the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
89. The intubation tool for assisting in placement of an endotracheal tube of claim 87, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
90. The intubation tool for assisting in placement of an endotracheal tube of claim 87, wherein articulating force is applied in-line along the axis of the stylet.
91. The intubation tool for assisting in placement of an endotracheal tube of claim 87, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
92. The intubation tool for assisting in placement of an endotracheal tube of claim 87, wherein the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
93. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet; wherein the articulating tip transmits the majority of tactile feedback to the vicinity of the removable handle.
94. The intubation tool for assisting in placement of an endotracheal tube of claim 93, wherein the force to articulate the distal end is less than 2 pounds.
95. The intubation tool for assisting in placement of an endotracheal tube of claim 94, wherein the stylet comprises an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
96. The intubation tool for assisting in placement of an endotracheal tube of claim 93, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
97. The intubation tool for assisting in placement of an endotracheal tube of claim 93, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
98. The intubation tool for assisting in placement of an endotracheal tube of claim 93, wherein the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
99. The intubation tool for assisting in placement of an endotracheal tube of claim 93, wherein the distal end of the stylet is in a neutral position when no articulating force is applied.
100. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a stylet having a proximal end, a distal end, and a medial location, the stylet: i) configured for receiving an endotracheal tube; ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and iii) a slidable actuator articulating the distal tip, the slidable actuator being engageable around at least 180 degree of the central axis of the stylet.
101. The intubation tool of claim 100, wherein the slidable actuator is engageable around at least 270 of the central axis of the stylet.
102. The intubation tool of claim 100, wherein the slidable actuator is engageable around at 360 of the central axis of the stylet.
103. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: a) a stylet having a proximal end, a distal end, and a medial location, the stylet including a bi-lumen extrusion, the stylet: i) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape; and b) a removable handle secured to a medial location on of the stylet.
104. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
105. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein handle and stylet provide a substantially clear sight-line along the length of the stylet when the stylet is in a non-articulated mode.
106. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein the articulating distal tip can be articulated with a force of 4 to 9 Newton.
107. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
108. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein handle and stylet provide a substantially clear sight line of at least 90 degrees along a dorsal line of the handle and stylet combination, within 1 cm of the central axis of the stylet.
109. The intubation tool for assisting in placement of an endotracheal tube of claim 103, wherein the distal end of the stylet is in a neutral position when no articulating force is applied.
110. A method for placement of an endotracheal tube, the method comprising: a) providing an intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the intubation tool comprising: i) a stylet having a proximal end, distal end, and intermediate medial portion, the stylet configured for receiving an endotracheal tube, and having an articulating distal tip, the articulating distal tip being configured to articulate between more than one shape using one to three fingers; and ii) a handle secured to a medial position on the stylet; b) inserting the distal end of the stylet of the intubation tool into the trachea of a person, including articulating the distal end of the stylet during insertion to aid in passage through the larynx.
111. The method for placement of an endotracheal tube of claim 110, wherein the force to articulate the distal end from 60 to 90 degrees is within 150 percent of the force to articulate the distal end from 0 to 30 degrees.
112. The method for placement of an endotracheal tube of claim 110, wherein the stylet comprises an internal cable connected to the distal end, and wherein pulling on the cable from the medial location results in articulating the distal end of the stylet.
113. The method for placement of an endotracheal tube of claim 110, wherein the articulating distal tip can be articulated with a force of 4 to 9 Newton.
114. The method for placement of an endotracheal tube of claim 110, wherein the handle of the tool includes a grip extension oriented at 90 degrees to the plane of movement of the distal end of the stylus.
115. An intubation tool having a steerable camera for assisting in placement of an endotracheal tube, the endotracheal intubation tool comprising: a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip end being configured to articulate between more than one shape; and b) a handle secured to the medial location of the stylet; wherein the articulating tip comprises vertebrate with a flat portion having a width of Wf and the overall vertebrate having a width of Wv, and Wf is less than 50 percent of Wv.
116. An intubation tool for assisting in placement of an endotracheal tube, the endotracheal intubation tool comprising: a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip formed of vertebrae end being configured to articulate between more than one shape; wherein at least some of the vertebrae have a tapered cross section.
117. An intubation tool for assisting in placement of an endotracheal tube, the endotracheal intubation tool comprising: a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip formed of vertebrae end being configured to articulate between more than one shape; further comprising a handle having a mechanism for engaging a controller positioned within the handle, the controller able to control the shape of the articulating distal tip
118. An intubation tool for assisting in placement of an endotracheal tube, the endotracheal intubation tool comprising: a) a stylet having a medial location and a distal end, the stylet: i.) configured for receiving an endotracheal tube, and ii) having an articulating distal tip, the articulating tip formed of vertebrae end being configured to articulate between more than one shape; further comprising a handle having retainers for securing one or both ends of the stylet in a bent configuration.
PCT/US2022/034087 2021-06-18 2022-06-17 Intubation tool, system and methods WO2022266500A2 (en)

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Cited By (1)

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US11871904B2 (en) 2019-11-08 2024-01-16 Covidien Ag Steerable endoscope system with augmented view

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US20080236575A1 (en) * 2007-03-29 2008-10-02 Robert Michael Chuda Intubation device with video, stylet steering, prep and storage system
US8652033B2 (en) * 2010-09-23 2014-02-18 Karl Storz Endovision, Inc. Video stylet with directable tip
US10149957B2 (en) * 2013-10-03 2018-12-11 University Of Utah Research Foundation Tracheal intubation system including a laryngoscope
CN112839562A (en) * 2018-11-06 2021-05-25 格伦·P·加德纳 Guide tube needle
US20200254204A1 (en) * 2019-01-15 2020-08-13 Thomas Brian Moffat Flexible articulating intubation tool

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Publication number Priority date Publication date Assignee Title
US11871904B2 (en) 2019-11-08 2024-01-16 Covidien Ag Steerable endoscope system with augmented view

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