A guide device with a bendable tip for endotracheal intubation

Abstract

A guide device for endotracheal intubation, comprising: (a) an elongate body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm; (b) a controllable bendable tip at the distal end of the body, bendable over a range of at least 120 degrees; and (c) at least one human-finger manipulatable control which: (i) located along said elongated body, at a distance of at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and (ii) when manipulated, bend said tip, wherein bending said tip to 90 degrees is achieved by applying a force of no more than 3 Newton by the at least one human finger, wherein all of the device fits within a lumen of an endotracheal tube.

Description

[0001] A GUIDE DEVICE WITH A BENDABLE TIP FOR ENDOTRACHEAL INTUBATION

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority Israel Patent Application No. 310171 filed on 15 January 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND

[0005] The present invention, in some embodiments thereof, relates to a guide device and, more particularly, but not exclusively, to a guide device for endotracheal intubation.

[0006] International Patent application No. W02020210327 discloses “Provided is a single or double lumen endotracheal tube (ET) and methods of use thereof. The ET is capable of multidirectional distal deflection and provides stylet and endoscope securement during operation. Also provided is a stylet, optionally for use with the ET and methods of use thereof.” (abstract)

[0007] U.S. Patent Application No. 9888832 discloses “A stylet assembly for performing a nasal endotracheal intubation of a patient is disclosed. The stylet assembly includes an elongated tube as a stylet for the intubation defining a longitudinal axis, a proximal end, and a distal end for entering the trachea of the patient. The elongated tube includes (i) a rigid section adjacent the proximal end, (ii) an articulation section adjacent the distal end and adapted to curve into the patient's trachea upon actuation, and (iii) a flexible section between the rigid section and the articulation section, the flexible section being adapted to curve to an internal shape of at least one of the patient's nose, nasal cavity, pharynx, and larynx during nasal intubation. The stylet assembly can further include an actuator housing, a control wire for actuating the articulating section, and a hand grip for maneuvering the stylet assembly.” (abstract)

[0008] International Patent application No. EP1977678 discloses “The invention relates to an intubation assisting device, comprising a flexible fiber package (32) and a control unit (31) with the fiber package connected thereto, whereby an endotracheal tube is intended to be positioned over the fiber package. The fiber package (32) features a light conductive element (17) for communicating light to a distal end (22) of the fiber package, a fiberoptic element (8) for supplying the control unit with an image of the object immediately ahead of the fiber package's distal end, and a pulling means (19) for flexing the fiber package in one specific direction. The control unit

[0009] (31) includes elements (1-7) for presenting the user with an image supplied by the fiberoptic element (8), and actuating elements (20) for operating the pulling means (19). The fiber package

[0010] (32) features two parallel light conductive elements (17), the element couple constituted thereby having one side thereof provided with said pulling means (19) and its opposite side with said fiberoptic element (8). The control unit features a camera element (4) provided with a screen element (2) for displaying an image” (abstract)

[0011] U.S. Patent Application No. 20190350440 discloses “An endoscope system, comprises an endoscope device that includes a handle, a shaft projecting from the handle, a flexible tip coupled to a distal portion of the shaft, and a pair of pull wires extending from the handle portion through the shaft portion and coupled to the flexible tip. The handle portion includes a control wheel assembly coupled to the pair of pull wires. The handle includes a control lever coupled to the control wheel assembly. Manipulation of the control lever causes rotation of the control wheel assembly, which then causes deflection of the flexible tip via the pull wires. The control wheel assembly comprises at least two control wheels. Each of the at least two control wheels are capable of independent rotation to provide accurate tensioning of the pair of pull wires during assembly of the endoscope system.” (abstract).

[0012] U.S. Patent Application No. 8677990 discloses “An inexpensive, endo-tracheal intubation device is disclosed. Methods of making and using the inexpensive, endo-tracheal intubation device are also disclosed.” (abstract).

[0013] U.S. Patent Application No. 9199051 discloses “A device for use with an endotracheal tube. The device includes a shaft having a wall with a flexible region proximate a tip of the shaft. The shaft both distally and proximally of the flexible region is of a higher durometer than the durometer of the flexible region.” (abstract)

[0014] U.S. Patent Application No. 10149957 discloses “A tracheal intubation system including a laryngoscope is disclosed. An endotracheal tube exchange system is also disclosed. In some examples, the system includes a laryngoscope, a stylet, and an endotracheal tube. In some examples the stylet is an articulating stylet. An endotracheal tube with one or more depth-assessment bands is also disclosed. An articulating stylet with one or more depth-assessment bands and an orientation mark is also disclosed. A method of positioning an endotracheal tube in a patient is also disclosed. A method of positioning a stylet for placement of an endotracheal tube is also disclosed. A method of performing an endotracheal tube exchange procedure is also disclosed.” (abstract)

[0015] U.S. Patent Application No. 671897 discloses “An intubation system for intubating a patient includes an esophageal obturator 10, an intubation slide 30, a directing guide wire assembly 48 and an airway tube 60. In a method for obtaining an unobstructed airway into the patient's lungs, the esophageal obturator 10 is used to occlude the patient's esophagus F. The intubation slide 30 is inserted into the patient's mouth C and provides a guide for a directing guide wire 50 of the assembly 48 to locate a distal end 59 of the wire in the patient's trachea E. A distal end of the airway tube 60, which surrounds, or may be slipped over, the emplaced assembly 48, is also thereby located in the patient's trachea E. The obturator 10, the slide 30 and the assembly 48 are removed, thereby leaving the airway tube 60 in place to provide ventilation for the patient.” (abstract)

[0016] U.S. Patent Application No. 10974005 discloses “Present invention is a tip adjustable stylet to be inserted into a tubular structure and to be pushed out its distal aperture to form curvatures. The device comprises a bendable member, a retracting string, an intersegment and a control handle. The bendable member has a control ring at its proximal end and a tip at its distal end. An operator can push the bendable member distally from the proximal end along the lumen of the tubular structure. Predetermined extensibility and length of the retracing string limit distance of the bendable member being pushed and hold the distal portion of the bendable member backward when the bendable member is been pushed forward outside of the tubular structure's distal aperture, thereby to bend the distal portion of the bendable member into the curves therefore to move its tip to a target location, such as patient's vocal cords opening.” (abstract)

[0017] U.S. Patent Application No. 10478578 discloses “A bougie for insertion in a patient, the bougie including: (i) a main shaft having proximal and distal ends and a bore extending axially therein; (ii) a movable tip having proximal and distal ends, the proximal end of the movable tip being connected to the distal end of the main shaft; (iii) a control member having proximal and distal ends, the control member being mounted for sliding movement in the bore of the main shaft; and (iv) the distal end of the control member being coupled to the distal end of the movable tip, the arrangement being such that an operator can slide the control member relative to the main shaft so as to cause displacement of the tip relative to the axial direction of the main shaft.” (abstract).

[0018] Scientific publication “First clinical experience of tracheal intubation with the SensaScope®, a novel steerable semirigid video stylet." by P. Biro, U. Battig, J. Henderson, B. Seifert, disclosing that “The SensaScope® is a hybrid steerable semirigid S-shaped video stylet.... The SensaScope® is a reliable and effective device for tracheal intubation under vision of the normal airway. It has great potential to facilitate management of difficult airway situations in anaesthetized and paralysed patients.” (abstract).

[0019] Scientific publication “Retrograde tracheal intubation." by S. S. Dhara, disclosing that “Successful management of difficult tracheal intubation by retrograde intubation has been reported for almost 50 years and can be used whether or not it is anticipated. There are numerous reports of variations to the basic technique to enhance reproducibility of this guided blind procedure. A review and analysis of the equipment and techniques provides a better understanding of this effective technique”, (abstract) A product called “steerable Tracheal Intubation Guide (S.T.I.G)” of Lateral Medical LTD is apparently being sold on: www (dot)lateralmedical(dot)com / anaesthetics-critical-care / airway- management / flexible-tip-bougie / .

[0020] SUMMARY

[0021] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0022] Example 1. A guide device for endotracheal intubation, comprising:

[0023] (a) an elongate body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0024] (b) a controllable bendable tip at the distal end of the body, bendable over a range of at least 120 degrees; and

[0025] (c) at least one human-finger manipulatable control which:

[0026] (i) located along said elongated body, at a distance of at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0027] (ii) when manipulated, bend said tip, wherein all of the device fits within a lumen of an endotracheal tube.

[0028] Example 2. The guide device according to example 1, wherein said control does not extend out of said maximum diameter.

[0029] Example 3. The guide device according to examples 1 or 2, wherein the elongated body is at least 45 cm long.

[0030] Example 4. The guide device according to any of examples 1-3, wherein the elongated body is at least 70 cm long and the control is distanced 15-30 cm from the proximal end of the elongated body.

[0031] Example 5. The guide device according to any of examples 1, wherein the at least one control is located at a proximal portion of the elongated body, wherein a length of the proximal portion is a third of a length of the elongated body.

[0032] Example 6. The guide device according to any of examples 1-5, wherein said control, when manipulated, bends said tip, wherein bending said tip to 90 degrees is achieved by applying a force of no more than 2-3 Newton (200-300 gram force) by the at least one human finger Example 7. The guide device according to any of examples 1-6, wherein the controllable bendable tip is bendable over a range of at least 120, wherein at lest 90 dagrees of the said range are at one side of a longitudinal axis of the elongated body.

[0033] Example 8. The guide device according to any of examples 1-7, wherein the tip comprises a flexure and a head, wherein the flexure is connected to the head at one end thereof and to the distal end of the elongated body at the other end thereof.

[0034] Example 9. The guide device according to example 8, wherein the flexure comprises a spring.

[0035] Example 10. The guide device according to any of examples 1-9, comprises at least one filament coupling the control with the tip by extending along the spring and connecting to the head of the tip, and whereby manipulating the control the at least one filament applied tension on the tip which together with the axial contrast of the spring causes the tip to bend.

[0036] Example 11. The guide device according to example 10, wherein the at least one filament is connected to the head at two points of connection.

[0037] Example 12. The guide device according to example 11, wherein the two points of connection are at an annular distance of 180 degrees, which defines two radial directions for bending the tip, wherein the two radial directions at 180 degrees apart.

[0038] Example 13. The guide device according to example 11, wherein the two points of connection are at an annular distance different from 180 degrees defining bending of the tip in two radial directions with an annular distance different from 180 degrees.

[0039] Example 14. The guide device according to any one of examples 10-13, wherein the at least one filament is rigid enough, such that when pushing the control the at least one filament applied compression on the tip which together with the axial contrast of the spring causes the tip to bend.

[0040] Example 15. The guide device according to any one of examples 10-14, wherein the at least one filament is connected to the head at a single point of connection, and wherein the at least one filament can apply tension or compression on the tip which defines bending toward two radial directions for bending the tip.

[0041] Example 16. The guide device according to example 1, wherein the at least one control is a linear slide button, which can be moved back and forth allowing to bend the tip toward two radial directions.

[0042] Example 17. The guide device according to example 16, wherein the linear slide button comprises pumps on a surface thereon, wherein said slide button does not extend out of said maximum diameter Example 18. The guide device according to example 1, wherein the at least one control is a rotational button.

[0043] Example 19. The guide device according to example 18, wherein the rotational button can be moved clockwise and counterclockwise allowing to bend the tip in two radial directions.

[0044] Example 20. The guide device according to any of examples 16 or 18, wherein the at least one control is a pair of controls, wherein each bent the tip toward two radial directions.

[0045] Example 21. The guide device according to example 20, wherein the four radial directions are along two movement plains.

[0046] Example 22. The guide device according to example 21, wherein the two movements plain are orthogonal.

[0047] Example 23. The guide device according to example 21, wherein the two movements plain are not orthogonal.

[0048] Example 24. The guide device according to example 1, wherein the at least one control is a spherical slide button, defining more than four bending directions.

[0049] Example 25. The guide device according to example 1, wherein the at least one control is a joystick, defining more than four bending directions.

[0050] Example 26. The guide device according to example 1, wherein the control is at least one loop configured to be pulled.

[0051] Example 27. The guide device according to examples 1 or 26, wherein the at least one loop is a pair of loops, each defining a bending direction.

[0052] Example 28. The guide device according to example 15-27, comprises at least one filament that couples between the at least one loop and the tip, wherein the at least one filament is sufficiently rigid such that the at least one loop can be pushed or pulled.

[0053] Example 29. The guide device according to any of examples 27-28, wherein the elongated body has a maximum diameter smaller than 8 mm.

[0054] Example 30. The guide device according to example 1, wherein the control is configured to move continuously defining a continuously bending motion of the tip.

[0055] Example 31. The guide device according to example 1, wherein the control is configured to move in steps defining a stepped motion of the tip.

[0056] Example 32. The guide device according to example 1, wherein the control can be locked to set a fixed bent position of the tip.

[0057] Example 33. The guide device according to example 1, comprises an imaging system, wherein the imaging system comprises a video camera at or near the tip. Example 34. The guide device according to example 1, wherein the imaging system comprises a control for operating the video camera, wherein the control for operating the camera is located adjacent to the at least one human-finger manipulable control.

[0058] Example 35. The guide device according to example 34, wherein the control for operating the video camera is located at the proximal end of the elongated body.

[0059] Example 36. The guide device of example 1, wherein the elongated body comprises a wall defining an inner lumen, and wherein the at least one filament extends within the inner lumen.

[0060] Example 37. The guide device of example 36, wherein the at least one filament is incorporated within the wall of the elongated shaft, wherein the inner lumen can comprise a battery and a wiring of the imaging system.

[0061] Example 38. The guide device according to example 1, wherein the tip is in line with the longitudinal axis of the elongated body in a retracted position.

[0062] Example 39. The guide device according to example 1, wherein the tip can be pre-set to a bent position relative to the longitudinal axis of the elongated body, in a retracted position.

[0063] Example 40. A guide device for endotracheal intubation, comprising:

[0064] (a) an elongated body at least 50 cm long, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0065] (b) a controllable bendable tip at the distal end of the body, that can be bent along more than one movement plane, relative to the longitudinal axis of the elongated body ;

[0066] (c) at least one human-finger manipulable control which:

[0067] (i) located along said elongated body, distance at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0068] (ii) when manipulated, bend said tip, wherein all of the device fits within a lumen of an endotracheal tube.

[0069] Example 41. A guide device for endotracheal intubation, comprising:

[0070] (a) an elongated body at least 50 cm long, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0071] (b) a controllable bendable tip at the distal end of the body, comprising an imaging device;

[0072] (c) at least one human-finger manipulable control which:

[0073] (i) located along said elongated body, distance at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0074] (ii) when manipulated, bend said tip, wherein all of the device fits within a lumen of an endotracheal tube. Example 42. A guide device for endotracheal intubation, comprising:

[0075] (a) an elongated body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0076] (b) a controllable first bending joint at a tip at the distal end of the body;

[0077] (c) at least one additional bending joint located proximally from said first bending joint, at a distance of at least 0.8 mm;

[0078] (c) at least one human-finger manipulatable control which:

[0079] (i) located along said elongated body, distance at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0080] (ii) when manipulated, bend said tip, by the at least one human finger.

[0081] Example 43. The guide device of example 42, wherein said elongated body has a maximum diameter smaller than 8 mm, and wherein all of the device fits within a lumen of an endotracheal tube.

[0082] Example 44. The guide device of any of examples 42-43, wherein the control is a rotational button, and wherein the device comprises a first rotational button for manipulating said first bending joint and a second rotational button for manipulating said second bending joint.

[0083] Example 45. A guide device for endotracheal intubation, comprising:

[0084] (a) an elongate body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0085] (b) a controllable bendable tip at the distal end of the body, bendable over a range of at least 120 degrees; and

[0086] (c) at least one human-finger manipulatable control which:

[0087] (i) located along said elongated body, at a distance of at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0088] (ii) when manipulated, bend said tip, wherein all of the device fits within said maximum diameter.

[0089] Example 46. A method for inserting a guide device with a movable tip into a patient's trachea through the vocal cords of the patient, comprising: inserting the guide device into the patient's mouth; viewing the vocal cords of the patient using a guide device with an imaging device at and / or near the movable tip; manipulating a control of the guide device while gripping the guide device in an insertion position; bending the movable tip of the guide device to overcome obstructions toward the trachea; advancing the guide device toward the trachea; and loading an endotracheal tube onto the guide device from a proximal end thereof and over the control; and inserting the endotracheal tube into the trachea over the guide device.

[0090] Example 47. The method according to example 46, comprises depressing and moving the patient's tongue before inserting the guide device, using a tongue depressor.

[0091] Example 48. The method according to any of examples example 46-47, comprises selecting if to insert the guide device pre-loaded with an endotracheal tube or bare of endotracheal.

[0092] Example 49. The method according to any of examples 46-48, wherein the loading comprises loading the endotracheal tube on the guide device before inserting thereof into the patient's mouth.

[0093] Example 50. The method according to any of examples 46-49, wherein the loading comprises loading the endotracheal tube over the proximal end of the guide device, passing the endotracheal tube over the control, into the patient's mouth to the movable tip at the distal end.

[0094] Example 51. The method according to any of examples 46-50, wherein the loading comprises loading the endotracheal tube such that the control is not covered or partially covered by the endotracheal tube.

[0095] Example 52. The method according to any of examples example 46-51, comprises setting a curvature to the body of the guide device.

[0096] Example 53. The method according to any of examples 46-52, comprises setting a pre-set angle to the tip.

[0097] Example 54. The method according to any of examples 46-53, wherein the inserting comprises inserting the guide device into the patient’s mouth perpendicular relative to a lying patient.

[0098] Example 55. The method according to example 54, wherein the inserting comprises positioning the physician’s elbows adjacent to the body thereof, wherein the elbows are at an angle of 90 degrees.

[0099] Example 56. The method according to examples 54 or 55, wherein the method comprises standing in an upright posture.

[0100] Example 57. The method according to example 54, wherein the viewing comprises viewing the vocal cords on a screen or a monitor positioned according to the operator's convenience. Example 58. The method according to example 46, wherein the manipulating comprises manipulating the control one-handed, using a single finger, while the hand remains in an insertion position.

[0101] Example 59. The method according to example 46 or 58, wherein the manipulating comprises applying a force of no more than 2-3 Newton (200-300gram force) for bending the movable tip to an angle of 0-120 degrees.

[0102] Example 60. The method according to example 46, wherein the bending comprises bending the movable tip along more than one movement plane.

[0103] Example 61. The method according to example 46, wherein the loading comprises loading the endotracheal tube on the guide device before inserting thereof into the patient's mouth.

[0104] Example 62. The method according to example 54, comprises documenting placement of the endotracheal tube within the trachea, by recording a video or by taking at least one screenshot.

[0105] Example 63. A method for inserting a guide device with a movable tip into a patient's trachea through the vocal cords of the patient, comprising: inserting the guide device into the patient's mouth, perpendicularly relative to the patient; viewing the vocal cords of the patient using a guide device with an imaging device at or near the movable tip; manipulating a control of the guide device while gripping the guide device in an insertion position; bending the movable tip of the guide device to overcome obstructions toward the trachea; advancing the guide device toward the trachea; and inserting the endotracheal tube into the trachea over the guide device.

[0106] Example 64. A method for inserting a guide device with a movable tip into a patient's trachea through the vocal cords of the patient, comprising: inserting the guide device into the patient's mouth; viewing the vocal cords of the patient using a guide device with an imaging device at and / or near the movable tip; manipulating a control of the guide device while gripping the guide device in an insertion position; bending the movable tip of the guide device along more than one movement plane to overcome obstructions toward the trachea; advancing the guide device toward the trachea; and loading an endotracheal tube onto the guide device from a proximal end thereof and over the control; and inserting the endotracheal tube into the trachea over the guide device.

[0107] Example 65. A guide device for endotracheal intubation, comprising:

[0108] (a) an elongate body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0109] (b) a controllable bendable tip at the distal end of the body, bendable over a range of at least 120 degrees; and

[0110] (c) at least one human-finger manipulatable control which:

[0111] (i) located along said elongated body, at a distance of at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0112] (ii) when manipulated, bend said tip, wherein bending said tip to 90 degrees is achieved by applying a force of no more than 3 Newton by the at least one human finger, wherein all of the device fits within a lumen of an endotracheal tube.

[0113] Example 66. The guide device according to example 65, wherein the elongated body comprises a fixed angle proximal to the bendable tip.

[0114] Example 67. The guide device according to example 66, wherein the fixed angle comprises an angle of 120 degrees.

[0115] Example 68. The guide device according to any of examples 65-67, wherein the bendable tip comprises a bending joint.

[0116] Example 69. The guide device according to example 68, wherein the bendable tip comprises an additional bending joint proximal to the bending joint.

[0117] Example 70. The guide device according to any of examples 65-69, wherein the at least one control comprises a pair of controls.

[0118] Example 71. The guide device according to example 70, wherein a first control of the pair of controls bends the bending joint and a second control of the pair of controls bends the additional bending joint.

[0119] Example 72. The guide device according to example 70, wherein each control of the pair of controls bent the tip toward two radial directions, wherein the pair of controls define four radial directions.

[0120] Example 73. The guide device according to example 72, wherein the four radial directions are along two movement planes.

[0121] Example 74. The guide device according to example 73, wherein the two movement planes are orthogonal. Example 75. The guide device according to example 73, wherein the two movements planes are not orthogonal.

[0122] Example 76. The guide device according to any of examples 65-75, wherein the control can be locked in an unretracted position.

[0123] Example 77. The guide device according to example 76, comprising a release button for unlocking the control.

[0124] Example 78. The guide device according to any of examples 65-77, wherein the control is configured to be locked once the bendable tip is released.

[0125] Example 79. The guide device according to any of examples 65-78, wherein the at least one control comprises a rotational button.

[0126] Example 80. The guide device according to any of examples 65-79, wherein the at least one control comprises a linear slide button.

[0127] Example 81. The guide device according to any of examples 65-80, wherein said control does not extend out of said maximum diameter.

[0128] Example 82. The guide device according to any of examples 65-81, wherein the elongated body is at least 70 cm long and the control is distanced 15-30 cm from the proximal end of the elongated body.

[0129] Example 83. The guide device according to any of examples 65-82, wherein the at least one control is located at a proximal portion of the elongated body, wherein a length of the proximal portion is a third of a length of the elongated body.

[0130] Example 84. The guide device according to any of examples 65-83, wherein at least 90 degrees of the range of at least 120 degrees are at one side of a longitudinal axis of the elongated body.

[0131] Example 85. The guide device according to any of examples 65-84, wherein the tip comprises a flexure and a head, wherein the flexure is connected to the head at one end thereof and to the distal end of the elongated body at the other end thereof.

[0132] Example 86. The guide device according to example 85, wherein the flexure comprises a spring.

[0133] Example 87. The guide device according to any of examples 85-86, comprises at least one filament coupling the control with the tip, and whereby manipulating the control the at least one filament applied tension on the tip which together with the axial contrast of the flexure causes the tip to bend.

[0134] Example 88. The guide device according to any of examples 65-87, wherein the control is configured to move continuously defining a continuously bending motion of the tip. Example 89. The guide device according to any of examples 65-88, wherein the control is configured to move in steps defining a stepped motion of the tip.

[0135] Example 90. The guide device according to any of examples 65-89, comprises an imaging system, wherein the imaging system comprises a video camera at or near the tip.

[0136] Example 91. The guide device according to example 90, wherein the imaging system comprises a control for operating the video camera.

[0137] Example 92. The guide device according to any of examples 87-91, wherein the elongated body comprises a wall defining an inner lumen, and wherein the at least one filament extends within the inner lumen.

[0138] Example 93. The guide device according to any of examples 87-92, wherein the at least one filament is incorporated within the wall of the elongated body, wherein the inner lumen can comprise a battery and a wiring of an imaging system.

[0139] Example 94. The guide device according to any of examples 65-93, wherein the tip is in line with the longitudinal axis of the elongated body in a retracted position.

[0140] Example 95. A guide device for endotracheal intubation, comprising:

[0141] (a) an elongated body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0142] (b) a controllable first bending joint at a tip at the distal end of the body;

[0143] (c) at least one additional bending joint located proximally from said first bending joint, at a distance of at least 0.8 mm;

[0144] (d) at least one human-finger manipulatable control which:

[0145] (i) located along said elongated body, distance at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and

[0146] (ii) when manipulated, bend said tip, by the at least one human finger.

[0147] Example 96. A guide device for endotracheal intubation, comprising:

[0148] (a) an elongated body at least 50 cm long, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;

[0149] (b) a controllable bendable tip at the distal end of the body,;

[0150] (c) at least one human-finger manipulable control which:

[0151] (i) located along said elongated body, distance at least 5 mm from said proximal end,

[0152] (ii) when manipulated, bend said tip,

[0153] (iii) can be locked in an unretracted position, thereby fixing the bendable tip in a bent position. Example 97. A method for inserting a guide device with a movable tip into a patient's trachea through the vocal cords of the patient, comprising: inserting the guide device into the patient's mouth; viewing the vocal cords of the patient using a guide device with an imaging device at and / or near the movable tip; manipulating a control of the guide device while gripping the guide device in an insertion position; bending the movable tip of the guide device to overcome obstructions toward the trachea; advancing the guide device toward the trachea; and passing an endotracheal tube the over the control; and inserting the endotracheal tube into the trachea over the guide device.

[0154] Example 98. The method according to example 97, wherein the inserting the guide device comprises inserting the guide device into the patient’s mouth perpendicular relative to a lying patient.

[0155] Example 99. The method according to any of claism 33-34, wherein the inserting the guide device comprises positioning the physician’s elbows adjacent to the body thereof, wherein the elbows are at an angle of 90 degrees.

[0156] Example 100. The method according to any of examples 97-99, wherein the method comprises standing in an upright posture.

[0157] Example 101. The method according to any of examples 97-100, wherein the viewing comprises viewing the vocal cords on a screen or a monitor positioned according to the operator's convenience.

[0158] Example 102. The method according to any of examples 97-101, wherein the manipulating comprises applying a force of no more than 2-3 Newton (200-300gram force) for bending the movable tip to an angle of 0-120 degrees.

[0159] Example 103. The method according to any of examples 97-102, wherein the manipulating comprises bending more than one bending joint of the movable tip.

[0160] Example 104. The method according to example 103, wherein the bending more than one bending joint comprises bending a proximal bending joint for advancing the movable tip toward the vocal cords of the patient.

[0161] Example 105. The method according to example 103 or example 104, wherein the bending more than one bending joint comprises bending a distal bending joint for passing through the glottis of the patient. Example 106. The method according to any of examples 103-105, wherein the bending more than one bending joint comprises manipulating the movable tip into an “s” shape by bending two bending joints.

[0162] Example 107. The method according to any of examples 97-106, wherein the bending comprises bending the movable tip along more than one movement plane.

[0163] Example 108. The method according to any of examples 97-107, comprising allowing the movable tip to be fixed in a bent position by locking the control in an unretracted position.

[0164] Example 109. The method according to example 108, comprising unlocking the control.

[0165] Example 110. The method according to any of examples 97-109, comprising documenting placement of the endotracheal tube within the trachea, by recording a video or by taking at least one screenshot.

[0166] Example 111. The method according to any of examples 97-110, comprising depressing and moving the patient's tongue before inserting the guide device, using a tongue depressor.

[0167] Example 112. The method according to any of examples 97-110, comprising selecting if to insert the guide device pre-loaded with an endotracheal tube or bare of endotracheal.

[0168] Example 113. The method according to example 112, comprising loading the endotracheal tube over the proximal end of the guide device, passing the endotracheal tube over the control, into the patient's mouth toward the movable tip at the distal end.

[0169] Example 114. The method according to example 113, wherein the loading comprises loading the endotracheal tube such that the control is not covered or partially covered by the endotracheal tube.

[0170] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0171] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0172] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0173] In the drawings:

[0174] FIG. 1A is a schematic block diagram of a guide device for endotracheal intubation in accordance with some exemplary embodiments of the invention;

[0175] FIG. IB is a schematic block diagram of a guide device with an imaging system, for endotracheal intubation, in accordance with some exemplary embodiments of the invention;

[0176] FIG. 1C is a schematic block diagram of a guide device for endotracheal intubation, loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention;

[0177] FIG. ID is a schematic block diagram of a guide device for endotracheal intubation, having relatively bulky control, loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention;

[0178] FIG. IE is a schematic block diagram of a guide device with a control mechanism, for endotracheal intubation, in accordance with some exemplary embodiments of the invention;

[0179] FIG. IF is a schematic block diagram of a guide device with a curved elongated shaft, for endotracheal intubation, in accordance with some exemplary embodiments of the invention;

[0180] FIG. 2 is a simplified flow chart of an endotracheal intubation procedure using a guide device, in accordance with some exemplary embodiments of the invention;

[0181] FIG. 3 illustrates a guide device as used by a physician (Pl) performing endotracheal intubation on a patient (P2), in accordance with some exemplary embodiments of the invention;

[0182] FIG. 4A is a side view of a guide device, having a bendable tip, in accordance with some exemplary embodiments of the invention;

[0183] FIG. 4B is a cross-sectional schematic view of endotracheal intubation performed on a patient, where the guide device’s tip is positioned in front of the patient’s vocal cords, in accordance with some exemplary embodiments of the invention;

[0184] FIG. 4C is a cross-sectional schematic view of endotracheal intubation performed on a patient, using a guide device, where a laryngoscope or mouth opener and / or tongue depressor is positioned within the patient’s mouth, in accordance with some exemplary embodiments of the invention;

[0185] FIG. 4D-G are cross-sectional schematic views of an endotracheal intubation performed on a patient, using a guide device, showing the visual field of a camera located at the guide device’s tip, during the guide device insertion, in accordance with some exemplary embodiments of the invention; FIG. 5A a schematic cross-sectional side view of a guide device, in a natural position, in accordance with some exemplary embodiments of the invention;

[0186] FIG. 5B is a schematic cross-sectional side view of a guide device, in a first working position, in accordance with some exemplary embodiments of the invention.

[0187] FIG. 5C, showing a schematic cross-sectional side view of a guide device, in a second working position in accordance with some exemplary embodiments of the invention;

[0188] FIG. 6A is a perspective view of an embodiment of a slide button, in accordance with some exemplary embodiments of the invention;

[0189] FIG. 6B is a slide button incorporated within the elongated shaft of the guide device, in accordance with some exemplary embodiments of the invention;

[0190] FIG. 7A is a schematic side view of a spring of a guide device’s movable tip, in accordance with some exemplary embodiments of the invention;

[0191] FIG. 7B is a front view of a spring connected to an elongated shaft and a movable tip’s head, in accordance with some exemplary embodiments of the invention;

[0192] FIG. 8A is a schematic cross-sectional side view of an embodiment of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention;

[0193] FIG. 8B is a partial cross-sectional upper view of an embodiment of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention;

[0194] FIG. 8C is a schematic cross-sectional side view of an embodiment of a slide button, in accordance with some exemplary embodiments of the invention;

[0195] FIG. 8D is a schematic cross-sectional side view of an embodiment of a moveable tip, in accordance with some exemplary embodiments of the invention;

[0196] FIG. 8E is a schematic cross-sectional side view of an embodiment of a guide device with an imaging system and a moveable tip in a bent position, in accordance with some exemplary embodiments of the invention;

[0197] FIG. 8F is an example of an imaging device, in accordance with some exemplary embodiments of the invention;

[0198] FIG. 8G is a schematic cross-sectional side view of an inner section of a control, in accordance with some exemplary embodiments of the invention;

[0199] FIG. 8H is a schematic cross-sectional side view of a tube connector for connecting a movable tip to a guide device, in accordance with some exemplary embodiments of the invention;

[0200] FIG. 81 is a perspective view of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention; FIG. 8J is a schematic cross-sectional view of a guide device, having at least one filament within the walls of an elongated shaft, in accordance with some exemplary embodiments of the invention;

[0201] FIG. 9A is a schematic cross-sectional side view of a guide device, having a movable tip that can be bent in more than one plane, in a natural position, in accordance with some exemplary embodiments of the invention

[0202] FIG. 9B is a schematic cross-sectional side view of a guide device, having a movable tip that can be bent in more than one plane in a first working position, in accordance with some exemplary embodiments of the invention;

[0203] FIG. 9C is a schematic cross-sectional side view of the control mechanism of a guide device, having a movable tip that can be bent in more than one plane, in accordance with some exemplary embodiments of the invention;

[0204] FIG. 9D is a fractional back view of a guide device having two controls, in accordance with some exemplary embodiments of the invention;

[0205] FIG. 9E is a fractional cross-section side view of a guide device having two controls, in accordance with some exemplary embodiments of the invention;

[0206] FIG. 9F is a fractional front view of a guide device having two controls, in accordance with some exemplary embodiments of the invention;

[0207] FIGs. 10A-C show a flow chart of a method for performing an intubation procedure using a guide device bare of an endotracheal tube, in accordance with some exemplary embodiments of the invention;

[0208] FIGs. 11A-B show a flow chart of a method for performing an intubation procedure using a guide device pre-loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention;

[0209] FIG. 12A is a schematic cross-sectional side view of a guide device with a control in the form of at least one loop, in a natural position, in accordance with some exemplary embodiments of the invention;

[0210] FIG. 12B is a schematic cross-sectional side view of a guide device with a control in the form of at least one loop, in a first working position, in accordance with some exemplary embodiments of the invention;

[0211] FIG. 12C is a schematic cross-sectional side view of the control mechanism of a guide device with a control in the form of at least one loop, in a second working position in accordance with some exemplary embodiments of the invention; FIG. 13 A is a partial schematic cross-sectional side view of a guide device a gear, in accordance with some exemplary embodiments of the invention;

[0212] FIG. 13B is a partial schematic cross-sectional upper view of a guide device, in accordance with some exemplary embodiments of the invention;

[0213] FIG. 14 is apartial schematic cross-sectional side view of a guide device with a variant of a slide button, in accordance with some exemplary embodiments of the inventio;

[0214] FIG. 15A is a partial schematic cross-sectional side view of a guide device with a variant of a movable tip, in a natural position, in accordance with some exemplary embodiments of the invention;

[0215] FIG. 15B is a partial schematic cross-sectional front view of a guide device with a variant of a movable tip, in a working position, in accordance with some exemplary embodiments of the invention;

[0216] FIG. 16A is a partial schematic cross-sectional side view of a guide device with a variant of a movable tip, in a natural position, in accordance with some exemplary embodiments of the invention;

[0217] FIG. 16B is a partial schematic cross-sectional front view of a guide device with a variant of a movable tip, in a bent position, in accordance with some exemplary embodiments of the invention;

[0218] FIGs. 17A-B are an embodiment of a movable tip in a natural position (Fig. 17A) and in a bent position (Fig. 17B), in accordance with some exemplary embodiments of the invention;

[0219] FIG. 18 is an embodiment of a movable tip in a natural position, in accordance with some exemplary embodiments of the invention;

[0220] FIG. 19 is a control for motorized operation, in accordance with some exemplary embodiments of the invention;

[0221] FIG. 20 is a side view of a guide device, having more than one bending joint, in accordance with some exemplary embodiments of the invention;

[0222] FIGs. 21A-B are cross-sectional side views of a guide device, having more than one bending joint, within a patient’s airway, in accordance with some exemplary embodiments of the invention;

[0223] FIGs. 22A-B are perspective views of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention;

[0224] FIGs. 22C is a perspective view of a guide device having a pair of rotational buttons, in accordance with some exemplary embodiments of the invention; FIG. 23A is a side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention;

[0225] FIGs. 23B-F depict a cross-sectional side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention; and FIG. 23B is an exploded side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention.

[0226] FIGs. 24A-C are schematic fractional cross-sectional side views of a guide device having at least one lockable control, in accordance with some exemplary embodiments of the invention;

[0227] FIG. 24D is a schematic cross-sectional side view of a movable tip having two bending joints, in accordance with some exemplary embodiments of the invention;

[0228] FIGs. 25A-B are schematic cross-sectional side views of a distal portion of a guide device having a bent natural position, in accordance with some exemplary embodiments of the invention;

[0229] FIG. 25C is a schematic side view of a guide device having a bent natural position, in accordance with some exemplary embodiments of the invention;

[0230] FIGs. 26A-B are schematic cross-sectional side views of a distal portion of a guide device having a straight natural position, in accordance with some exemplary embodiments of the invention;

[0231] FIG. 27A is a top view of a guide device having a tip with two bending joints controlled by slide buttons, in a retracted position, in accordance with some exemplary embodiments of the invention;

[0232] FIG. 27B is a side view of a guide device, having a tip with two bending joints controlled by slide buttons, in a bent position, in accordance with some exemplary embodiments of the invention;

[0233] FIG. 27C is a cross-sectional side view of a movable tip having a tip with two bending joints, in a retracted position, in accordance with some exemplary embodiments of the invention;

[0234] FIG. 27D is a cross-sectional side view of a portion of a slide button, in accordance with some exemplary embodiments of the invention;

[0235] FIG. 27E is a cross-sectional view of a portion of a slide button, in accordance with some exemplary embodiments of the invention; and

[0236] FIG. 27F is a fractional side view of a guide device, having a tip with two bending joints controlled by slide buttons, in a bent position, in accordance with some exemplary embodiments of the invention. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0237] The present invention, in some embodiments thereof, relates to a method and apparatus for performing intubation and, more particularly, but not exclusively, to a method and apparatus for performing intubation using a bendable tip.

[0238] An aspect of some embodiments of the invention relates to a vertical approach for inserting an endotracheal tube into a patient's mouth, by inserting a tube introducer (e.g., a guide device) into the patient’s mouth perpendicularly relative to the patient (for example, lying on his back). In some embodiments, inserting the tube introducer while viewing the patient’s vocal cords by videoimaging (for example video laryngoscope and / or a camera incorporated in the tube introducer) reduces the need for the operator to directly view the vocal cords, which typically requires form the operator to stand in a bent posture and / or to incline the tube introducer while inserting thereof into the patient’s mouth. In some embodiments, the vertical approach allows the operator to have an upright posture, which potentially improves the ergonomics of the operator. Alternatively or additionally, the operator can place an external screen according to a specific preferable posture, having the potential advantage of increasing the comfort of the operator while performing intubation. It is noted that increasing the comfort of the physician may potentially result in improving the speed at which the process is performed.

[0239] In the lack of an imaging system, the operator directly views the vocal cord along the inclined tube introducer which might result in the end of the introducer (e.g., proximal end) poking the operator’s eye, and / or in using a not-long enough tube introducer. In some embodiments, the perpendicular position of the tube introducer potentially prevents the end of the tube introducer from touching the operator's eye(s) and / or face, which might occur when tilting the tube introducer. Avoiding contact of the tube introducer end with the operator's eye(s) and / or face has the potential advantage of reducing the operator’s discomfort, distractions, and / or visual disturbances during performing intubation. It is noted that improving the operator’s comfort and / or reducing disturbances in concentration and / or vision may potentially shorten the time for the operator to reach tracheal placement, and / or potentially reduce the risk for misplacement of the endotracheal tube. Shortening the time of intubation and / or avoiding misplacement of the endotracheal tube is significant since until reaching tracheal placement and connecting the endotracheal tube to ventilation, the patient is usually not breathing.

[0240] An aspect of some embodiments of the invention relates to a tube introducer (e.g., guide device) with an adjustable tip (e.g., a movable tip) that can be bent to more than 90 degrees (between the bent position and the retracted position of the tip, where the retracted position is in line with the longitudinal axis of the introducer). In some particular embodiments, the adjustable tip can be bent to 0-120 degrees. In some embodiments, the tube introducer is used to insert an endotracheal tube into a patient with a “difficult airway”. A “difficult airway” describes anatomical challenges in viewing the vocal cords, glottis and / or laryngeal anatomy, which can result from unusual anatomical features and / or shape of the patient's airway. “Difficult airway” also describes challenges of passing an endotracheal tube into the trachea, which can result from the presence of obstructions such as tumors, swelling, or foreign objects in the airway.

[0241] In some embodiments, the adjustable tip can be maneuvered to pass obstructions and / or to adapt to the shape of the airway. In some embodiments, severe cases of difficult airways require bending the adjustable tip to relatively high angles, of up to about 120 degrees and more, in order to pass into the trachea.

[0242] In some embodiments, when the vertical approach is applied, an increased bent angle is required to pass through the vocal cords and to overcome additional challenges of a difficult airway (relative to the required angle if the tube introducer is inclined). In some embodiments, the increased bent angle compensates for the angular deviation from the axial direction of the airway. In some embodiments, an angle of about 30-90 degrees is required for inserting the adjustable tip through the gap between the vocal cords. For example, 20-70 degrees, or 60-80 degrees, or 85-100 degrees, or 80 -90 degrees, or lower or higher or intermediate degrees of angels. In some embodiments, severe cases of “difficult airway” may require relatively increased tip bending (up to about 120 degrees) to reach and / or pass the tube introducer through the vocal cords.

[0243] In some embodiments, the adjustable tip is operated by a control, which is distal from the end of the tube introducer. The location of the control allows an operator to insert the introducer vertically into the mouth of a patient while reaching the control and / or operating the control. In some embodiments, the control is located such that the distance thereof from the tip allows the insertion of the tube introducer into a patient's trachea while the control remains exterior. In some embodiments, the radial width of the control is limited such that an endotracheal tube can be sleeved thereover, and the distance of the control from the end of the tube introducer (e.g., proximal end) is sufficient for loading the endotracheal tube after placing the tube introducer within the trachea.

[0244] In addition, the control is positioned on the tube introducer in a location that allows a steady posture of the operator. In some embodiments, the operator holds the tube introducer such that the operator's elbows are relatively close to the body thereof and / or at an angle of approximately 90 degrees, while the control is reachable. This position allows the physician to apply sufficient force on the tube introducer for inserting thereof into the trachea. If needed, the operator can manipulate the adjustable tip by using the control to navigate the tube introducer into the trachea. The location of the control allows to use thereof one-handed with the hand holding the tube introducer, optionally with a single finger, such as the thumb or index finger, while remaining in an insertion position. This has the potential advantage of reducing the need for an assistant to operate the control. In some embodiments, the force required for operating the control is relatively small, having the potential advantage of facilitating the operation one-handed and / or with a single finger. In some embodiments, the guide device comprises a flexure, such as a spring, providing flexibility that allows to bend the adjustable tip to 90 degrees and more, for example to 0-120 degrees, while potentially applying minimal and / or reduced force. For example, in some embodiments, the adjustable tip can be bent to angles of 0-90 degrees by applying a force of no more than 2-3 Newton (200 - 300 grams force) on the control. In addition, in some embodiments, the flexure (for example a spring) has a symmetrical structure relative to its longitudinal axis, potentially requiring equal and or substantially equal force to bend the adjustable tip in more than one radial bending direction (relative to the longitudinal axis of the adjustable tip).

[0245] In some embodiments, the introducer is designed to apply a little force to actuate the control, potentially reducing the finger’s fatigue and / or strain during operation.

[0246] In some embodiments, the flexure lacks a backbone (for example, a spring) which may result in reduced resistance to bending. In some embodiments, the absence of a backbone potentially allows the bending of the movable tip using a relatively small force. In some embodiments, the flexure comprises a backbone with a structure designed to potentially reduce resistance to movement (e.g., bending). For example, the backbone may be a thin element and / or positioned along the center of the flexure, potentially providing sufficient support while allowing for bending the movable tip using a relatively small force.

[0247] In some embodiments, the movable tip is covered with a sufficiently thin cover (such as a silicon cover) and / or a cover that comprises a flexible and / or soft material, for potentially reducing the resistance of the tip to bending.

[0248] An aspect of some embodiments of the invention relates to a tube introducer for tracheal intubation comprising an adjustable tip and an imaging system, that can fit within an endotracheal tube. The imaging system is located at and / or near the adjustable tip and allows the operator to view the progress of the tube introducer within the oral cavity, as it passes through the vocal cords and when situated within the trachea. In some embodiments, the adjustable tip can be maneuvered to improve the view within the trachea. Additionally, the adjustable tip can be maneuvered to overcome challenges to reach tracheal placement. These features are not facilitated by the video laryngoscope where the camera is located on the laryngoscope blade and therefore static. In some embodiments, the combination of an adjustable tip and an imaging system at and / or near the tip potentially allows viewing the vocal cords and passing the tip in through the glottis, even in severe cases of “difficult airway”. In addition, this combination, optionally together with applying the vertical approach, potentially shortens and simplifies the intubation process, having the potential advantage of reducing the need for an experienced operator.

[0249] An aspect of some embodiments of the invention relates to a tube introducer with an adjustable distal tip that can independently bend in more than one movement plane. Moving the adjustable distal tip in more than one movement plane allows radial adjustment of the position thereof without rotating the introducer. This may have a considerable significance when the tube introducer is curved and rotating thereof may result in misalignment between the curvature thereof and the shape of the airway. Additionally, rotating the introducer prior to tracheal placement alters the position of the control relative to the palm and / or finger(s) of the operator which may result in interfering with accessing the control and / or compromising the operator's convenience while using the control.

[0250] In some embodiments, increasing the radial range of motion of the adjustable distal tip along more than one movement plane potentially enhances the ability thereof to pass obstructions along the airway. This ability can be considerably significant in the case of an anterior larynx, and oral cavity abscess or tumor.

[0251] In some embodiments, the bending of the adjustable distal tip in more than one movement plane is performed using an introducer with at least one control, which can be fit within an endotracheal tube.

[0252] In some embodiments, the adjustable distal tip can be bent to an angle of about 0-120 degrees relative to the longitudinal axis of the introducer, along each plane. In some embodiments, the adjustable distal tip can be bent in two orthogonal movement planes. Moving the introducer tip in two vertical planes can potentially facilitate passing the introducer into the trachea, for example in the event of an oral cavity space-occupying lesion, obstructing visualization of the vocal cords and trachea.

[0253] In some embodiments, the tube introducer comprises a separate control for each movement plane, optionally, two sliders. The two sliders can be substantially identical and / or have different functions. For example, one slider can define a continuous movement along a first plane while a second slider defines a stepped movement along a second plane. In another example, the first slider, when released, returns to a natural position whereas the second slider, when released, locks a bent position. In some embodiments, the control allows continuous radial movement so that the adjustable distal tip can be rotated and bent toward any radial direction. In some embodiments, the control can be in the form of a joystick and / or a ball scroll button, for example allowing the rotation of the adjustable distal tip by rotating thereof and / or bending the adjustable distal tip by pressing thereof. A single control potentially simplifies the use of the introducer, which may result in simplifying the intubation performance.

[0254] In some embodiments, the camera at the introducer tip video records the progress of the introducer tip within the trachea, providing evidence for tracheal placement of the introducer’s tip, and of the endotracheal tube. Alternatively, or additionally, to video recording, a screenshot of the introducer and thereafter of the endotracheal tube is obtained following positioning thereof within the trachea.

[0255] An aspect of some embodiments of the invention relates to a tube introducer having more than one movement point, for potentially improving the adjustment of the introducer to the shape of a patient’s airway. In some embodiments, at least one of the more than one movement point is a pivot point. In some embodiments the more than one movement point is a pair of pivot points, where the first is located at the adjustable distal tip of the tube introducer and a second pivot point is distant from the first point in the proximal direction. The pair of pivot points has the potential advantage of further facilitating the advancement of the tube introducer into the trachea and / or reducing the risk of injuring the tissues. In some embodiments, the second pivot point can be used to bring the adjustable distal tip in proximity to the vocal cords, for example, by potentially preventing the tube introducer from becoming lodged in the internal surface of the airway, while the first pivot point can be bent to insert the adjustable distal tip through the vocal cords.

[0256] Referring now to the drawings, Fig. 1A showing a schematic block diagram of a guide device 100 for endotracheal intubation, in accordance with some exemplary embodiments of the invention.

[0257] Guide device 100, comprises an elongated shaft (e.g., body) 102 having a distal end 104 and a proximal end 106. In some embodiments, guide device 100 comprises a control 108 located along the body of elongated shaft 102.

[0258] In some embodiments, elongated body 102 has sufficient length for an endotracheal tube to be loaded thereon from proximal end 106. For example, in some embodiments, elongated shaft 102 is about 70 mm long, for example, about 50-65 cm, 55-70 cm, 50-90 cm, or 70 mm, or lower or higher or intermediate ranges or lengths.

[0259] Control 108 is positioned at a distance 110 from proximal end 106 of guide device 100.

[0260] In some embodiments, distance 110 is sufficiently long to accommodate a physician’s fingers and / or palm actuating control 108. In some embodiments, distance 110 is sufficiently long to accommodate the physician’s fingers and / or palm, holding elongated shaft 102, at and / or near control 108.

[0261] In some embodiments, control 108 is sufficiently distal from distal end 104 and / or movable tip 112 such that an endotracheal tube can be loaded on the guide device (e.g., where the distal end of the endotracheal tube is aligned with distal end 104 of elongated shaft 102 and / or moveable tip 112) without covering control 108.

[0262] In some embodiments, a movable tip 112 is positioned at distal end of 104 of elongated body 102. In some embodiments, moveable tip 112 is manipulated by control 108, optionally, for navigating guide device 100 toward the trachea, optionally, by a physician, alternatively or additionally, by a robotic arm.

[0263] In some embodiments, movable tip 112 is bendable. In some embodiments movable tip 112 can be bent according to the shape of a patient’s airway, having the potential advantage of facilitating the progress of guide device 100 within the pathway toward the trachea.

[0264] Alternatively or additionally to bending motion, other tip movements are encompassed. For example, moveable tip 102 can be steered, twisted, and / or curved. These motions, as the bending motion, have the potential advantage of reducing and / or potentially preventing soft tissue damage, the creation of false routes and / or bleeding.

[0265] Referring to Fig. IB, showing a schematic block diagram of a guide device 100 with an imaging system, for endotracheal intubation, in accordance with some exemplary embodiments of the invention.

[0266] In some embodiments, guide device 100 comprises an imaging system 150 that comprises a camera and a light source. In some embodiments, the camera is incorporated into movable tip 112. Alternatively or additionally the camera can be located adjacent to movable tip 112, for example, at distal end 104. In some embodiments, imaging system 150 is transmitting wireless, for example by WIFI and / or Bluetooth. Alternatively or additionally, the imaging system is wired to an exterior screen and / or monitor. In some embodiments, the imaging system comprises a battery. In addition, in some embodiments, the imaging device is wired to connect thereof to an external power source.

[0267] Referring to Fig. 1C, showing a schematic block diagram of a guide device for endotracheal intubation, loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention. Referring also to Fig. ID, showing a schematic block diagram of a guide device for endotracheal intubation, having relatively bulky control, loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention.

[0268] In some embodiments, guide device 100 is shaped and / or sized to fit within a lumen of an endotracheal tube. In some embodiments, the effective width of guide device 100, including the diameter of elongated shaft 102 and the width of control 108 is limited to fit within a lumen of an endotracheal tube. In some embodiments, the width of control 108 which is typically the bulkiest part of guide device 100 (radially passing the cross-section of elongated shaft 102) is limited to allow the passage of the endotracheal tube thereover (as shown in Fig. ID).

[0269] Referring to Fig. IE, showing a schematic block diagram of a guide device 100 with a control mechanism, for endotracheal intubation, in accordance with some exemplary embodiments of the invention.

[0270] In some embodiments, elongated shaft 102 comprises a wall 114 defining an inner lumen 116. In some embodiments, inner lumen 116 comprises a control mechanism 109, optionally, extending along thereof, coupling between control 108 and movable tip 112.

[0271] In some embodiments, inner lumen 116 is sufficiently wide to further accommodate the wiring of imaging system 150 (shown in Fig. IB), as described later in this document.

[0272] Referring to Fig. IF, showing a schematic block diagram of a guide device 100 with a curved elongated shaft, for endotracheal intubation, in accordance with some exemplary embodiments of the invention.

[0273] In some embodiments, elongated shaft 102 (e.g., elongated shaft 102 shown in Figs. 1A-E) is not completely linear and has a curvature (e.g., deviation of the body from a straight position). This curved elongated shaft has the potential advantage of easing the insertion of the guide device as the curve may follow the anatomy of the airway. Additionally, the curvature potentially minimizes the risk of damaging the soft tissue of the airway.

[0274] In some embodiments, control 108 is located on elongated shaft 102 such that the physician can grip and / or operate the control while inserting guide device 100 with the curvature thereof corresponding to the shape of the airway. In some embodiments, control 108 is located on elongated shaft 102 so that control 108 is accessible to the physician while the guide device is inserted.

[0275] In some embodiments, the curvature is pre-set. Optionally the pre-set curvature is shaped according to a statistical characterization of a human airway. In some embodiments, the elongated shaft is formed from a rigid material (such as ABS polymers) so that the shape thereof is fixed. The fixed shape has the potential advantage of minimizing distortion of the pre-set curvature. In some embodiments, guide device 100 is formed from a material with a certain degree of deformability (such as stainless steel) which allows elongated shaft 102 to be shaped, having the potential advantage of increasing the fit between the curvature of the elongated shaft to a patientspecific airway shape. In some embodiments, the guide device is provided straight and shaped if and / or when needed, optionally, according to the specific airway shape of the patient. Alternatively or additionally, guide device 100 is provided with a pre-set curve that can be adjusted and / or reshaped, optionally, according to the specific airway shape of the patient. For example, the elongated shaft can be bent manually by the physician.

[0276] In some embodiments, control 108 and / or the control mechanism 109 (shown in Fig IE) allow to bend elongated shaft 102 without impairing the function thereof. In some embodiments, the relatively small dimensions of control 108 (examples described below, inter alia in Fig. 6B) allow thereof to be incorporated within curved elongated shaft 102.

[0277] Referring to Fig. 2, showing a simplified flow chart of an endotracheal intubation procedure using a guide device, in accordance with some exemplary embodiments of the invention.

[0278] At 202, the patient's mouth is opened and the tongue depressed using a classical laryngoscope blade or a specific mouth opener and / or tongue depressor. In some embodiments, the physician selects whether to insert a guide device pre-loaded with an endotracheal tube, or whether to insert a guide device bare of an endotracheal tube.

[0279] In some embodiments, the endotracheal tube is selected in advance, and loaded on the guide device prior to insertion thereof to the patient’s mouth. The selection is based on an assessment that considers a predicted tracheal geometry and statistics. For example, consider the patient’s sex (women's trachea is generally narrower than men's, men generally have lower vocal cords In another example, the assessment considers obesity and / or medical conditions of the patient. A potential advantage of using a pre-loaded guide device is reducing the duration of the procedure. An additional potential advantage of using a pre-loaded guide device is minimizing the requirement for assistance to the physician for loading the endotracheal tube after reaching the trachea.

[0280] In some embodiments, the endotracheal tube is selected after tracheal placement of a bare guide device. The selection can be based on a patient’s specific airway as visualized during the insertion, having the potential advantage of reducing errors of selecting unsuitable endotracheal tube size, and potentially preventing prolongation and / or complications of the procedure due to replacement of an un-suitable endotracheal tube. In some embodiments, the guide device comprises a camera at and / or near the tip thereof potentially improving the view of tracheal obstructions, and potentially further reducing errors of selecting unsuitable endotracheal tube size. Since the crosssection of the guide device is smaller than the opening of the endotracheal tube, the insertion of a bare guide device has the potential advantage of facilitating the insertion thereof through the vocal cords.

[0281] In some embodiments, the insertion of a bare guide device 100 allows applying the Seidinger technique, having the potential advantage of easing the insertion of guide device 100 into a “difficult airway”.

[0282] At 204, guide device 100 is griped, optionally by a physician, alternatively or additionally, by a robotic arm.

[0283] In some embodiments guide device 100 is griped by a physician approximately to control 108 for allowing relatively quick access thereto. Alternatively, or additionally, the guide device is griped, so that there is at least partial contact of the physician’s palm and / or at least one finger with control 108.

[0284] At 206, in some embodiments, guide device 100 is inserted into the patient's mouth, optionally by a physician, alternatively, or additionally by a robotic arm and directed toward the trachea through the vocal cords.

[0285] Although, in this document, description is generally with referent to the insertion of guide device 100 through a patient's mouth, insertion of guide device 100 through the nose, and / or tracheotomy is encompassed as well.

[0286] At 208, in some embodiments, control 108 is actuated, for moving movable tip 112 (shown in Fig. 1A). In some embodiments, movable tip 112 is bent to overcome tracheal obstructions maneuvered and guide device 100 is advanced toward the trachea.

[0287] At 210, after reaching tracheal placement, the endotracheal tube is unloaded into the trachea.

[0288] At 212, Optionally, a record of tracheal placement is obtained, for example by video recording and / or by screen- shooting at least one image of the guide device within the trachea, and / or by then screen- shooting at least one image of the endotracheal tube within the trachea. This record is documented and can be used to verify tracheal placement, for example in cases where a patient's medical condition (such as out-of-hospital trauma, difficult intubation, cerebral anoxia or other complications) raises medicolegal claims about the timing, and / or possible misplacement, of the endotracheal tube.

[0289] Referring now to Fig. 3, illustrating a guide device as used by a physician (Pl) performing endotracheal intubation on a patient (P2), in accordance with some exemplary embodiments of the invention.

[0290] In some embodiments, the control (e.g., control 108 shown in Figs. 1A-F) delineates the location on the guide device at which a physician (Pl) holds thereof. In some embodiments, physician (Pl) holds the guide device’s elongated shaft (e.g., elongated shaft 102 shown in Figs. 1A-F) such that at least one finger and / or the palm thereof at least partially contacts the control of the device. Alternatively or additionally, the physician holds the guide device in proximity to the control, optionally in the distance between the control and the proximal end of the guide device (e.g., distance 110 shown in Fig. 1A).

[0291] In some embodiments, the control is positioned on the guide device at a point that enables the physician, gripping the guide device at and / or near the control, to grip the guide device sufficiently steady to push thereof into the patient’s mouth with sufficient force to insert thereof toward and / or into the trachea.

[0292] In some embodiments, the control is located at a distance from the proximal end of the guide device (e.g., distance 110 shown in Fig. 1A) which is sufficiently long to accommodate a palm of the physician holding the guide device at a steady insertion position. In some embodiments, the distance is at least 5 mm. In some embodiments, the distance is about 15-30 cm for elongated shaft 102 having a length of about 70 mm long. For example, 10-20 mm, or 15-25 mm, or 25-35 mm, or about 20 mm, or about 30 mm, or lower or higher or intermediate numbers of lengths.

[0293] In some embodiments the control is located at a proximal portion of the guide device, optionally, extending over a third of the length of the elongated shaft (e.g., elongated shaft 102), optionally, where the elongated shaft is about 70 cm long. In some embodiments, the control is located at the distal end of this proximal portion.

[0294] In some embodiments, the distance of the control from the distal end of the guide device allows the physician to grip the elongated body at the control (and / or near the control) such that the physician’s elbows are close to the physician’s body and at abending angle of about 90 degrees. This position has the potential advantage of increasing the stability of the grip. Increasing the stability of the grip potentially allows the physician to apply less force compared to other positions.

[0295] In some embodiments, the control can be actuated by physician (Pl) with reduced and / or without altering a current steady gripping position. This has the potential advantage of reducing time consumption during intubation and / or facilitating the use of the guide device.

[0296] A steady insertion position refers to any position of at least one finger and / or a palm of the physician holding the guide device which allows the physician to apply the required force to push the guide device into and / or toward the trachea. In some embodiments, a steady insertion position is a pencil grip (e.g., one of the known pencil grips), as shown for example in Fig. 3, and / or any other position that is comfortable for physician (Pl). In some embodiments, physician (Pl) can perform the insertion of guide device 100 into the trachea one-handed, optionally, by actuating the control with the same hand that holds and / or pushes the guide device’s elongated shaft. In some embodiments, the control is configured to be operated with a single finger, optionally one of the fingers holding guide device 100, for example, with the thumb of the palm holding elongated shaft 102, optionally, in a steady insertion position.

[0297] In some embodiments, physician (Pl) can insert guide device 100 while griping the elongated shaft whereas a single finger is positioned on the control and actuates thereof when needed. Alternatively, or additionally, physician (Pl) can insert the guide device while griping the elongated shaft where one finger is adjacent to the control, reaching thereof when needed.

[0298] In some embodiments, actuating the control required from physician (Pl) to apply relatively low forces (as described in more detail below), which potentially allows physician (Pl) to use no more than a single finger, and / or to use any of finger(s) thereof. In addition, this relatively low required force allows to grip the guide device in various positions. For example, as shown in Fig 3. (e.g., a pencil grip), and / or an upside-down position compared to the position of Fig. 3, and / or a side way position compared to the position of Fig. 3. In some embodiments, the relatively low forces required to actuate the control allow a higher level of flexibility and / or softness to the elongated shaft, having the potential advantage of reducing the risk of injuring the tissue by the elongated shaft.

[0299] In some embodiments, the guide device comprises an imaging system (shown inter alia, in Fig. IB), which comprises a camera that video images the progress of the guide device’s tip (e.g., movable tip 112, shown in Fig. 1A) through the airway of the patient (as shown for example in Figs. 4C-F). The imaging system transmits signals from the camera to a screen and / or a monitor positioned externally to the patient's body. Transmitting from the movable tip (or near it) improves the view of the larynx and / or vocal cords, and potentially facilitates visualization of the tracheal cartilaginous rings after the tip is passed through the vocal cords. These features have the potential advantage of simplifying the intubation process, especially for inexperienced physicians, paramedics and / or other caregivers. By contrast, with a direct laryngoscope, there is no camera and with a video laryngoscope, the camera is fixed to the laryngoscope blade.

[0300] In the lack of an imaging system, the physician is typically required to bend and / or lean in order to directly view the patient’ s vocal cords. The physician maintains the view of the vocal cords while inserting the guide device (e.g., guide device 100 shown in Figs. 1A-D). This view requires the insertion of the guide device in an inclined manner into the patient's mouth. In this inclined position, the proximal end of the guide device might reach and / or contact the face of the physician, potentially causing discomfort during the intubation procedure and may distract the physician while performing the intubation. Furthermore, this contact may obstruct the physician's vision if the guide device comes into contact with the physician’s eye. The physician may move to avoid the touch of the guide device with the face thereof, which might result in deviation from a stable insertion position and potentially impair the control of the physician on the guide device. In addition, these disturbances to the physician performing the intubation might result in undesired misplacement of the endotracheal tube. In the case of an anterior larynx or other anatomical aberrations, the absence of a camera at the introducer tip may prevent any visualization of the vocal cords.

[0301] It is noted that a guide device intended to be inserted into the trachea bare of an endotracheal tube is relatively long (e.g., compared to pre-loaded stylets, usually having a length of about 35 cm). In some embodiments, the length of the guide device intended to be inserted into the trachea bare of an endotracheal is about twice the length of the endotracheal tube. In some embodiments, the length of the guide device intended to be inserted into the trachea bare of an endotracheal is about 70 cm long, for example, 60-80 cm, 50-90 cm, 75-85 cm, or 70 mm, or lower or higher or intermediate ranges or lengths. The relatively long guide device allows loading an endotracheal tube thereon, after tracheal placement, where a substantial portion of the guide device is deployed within the patient’ s airway. As a result, the physician’ s discomfort might increase when performing the procedure using a relatively long guide device (inserted bare of an endotracheal tube).

[0302] In other embodiments, the guide device can be inserted pre-loaded with an endotracheal tube, optionally having a shorter length compared to a guide device intended to be inserted bare of an endotracheal tube. The guide device is sufficiently long for the endotracheal tube to be loaded thereon (the distale end of the endotracheal tube is aligned with the distal end of the elongated shaft, and / or guide device’s tip) while the control is not covered thereby, and while the control remains exterior to the patient’s mouth upon tracheal placement of the guide device. In some embodiments, the length of a pre-loaded guide device is at least 45-50 cm long, for example, 45- 65 cm, 55-70 cm, 50-90 cm, or 60 mm, or lower or higher or intermediate ranges or lengths.

[0303] Using an imaging system reduces (e.g., an imaging system incorporated into the guide device and / or video-laryngoscope) the need for the physician to directly visualize the patient’s vocal cords since the camera video images the vocal cords which are presented on an external screen. Optionally, the external screen can be positioned according to the convenience of the physician.

[0304] In addition, viewing the vocal cords via an external screen allows the physician to insert the guide device into the mouth of the patient perpendicularly and / or substantially perpendicularly relative to a patient lying on his back (e.g., the guide device is substantially parallel to the body of an upright physician's). While applying this vertical insertion approach, the proximal end (e,g, proximal end 106 shown in Fig. 1A) typically does not reach the face of a standing straight physician. This has the potential advantage of reducing distractions while performing the intubation procedure in addition to potentially simplifying the insertion of the guide device

[0305] Furthermore, an upright standing position (which is possible in the vertical approach) potentially reduces the physician’s discomfort and / or enhances the physician's ergonomics.

[0306] In some embodiments, the imaging system at and / or near the movable tip allows performing intubation without requiring any laryngoscope blade. Since the vocal cords are video-imaged by the imaging system of the guide device there is potentially less and / or no need to directly view the vocal cords using a laryngoscope and / or video-image the vocal cords by a video-laryngoscope. Performing intubation without requiring a laryngoscope can be useful in situations where a laryngoscope is not available and / or cannot be disinfected before use, for example in emergencies.

[0307] In some embodiments, the guide device having an imaging system has a relatively low production cost, allowing a single use thereof. The guide device being disposable has the potential advantage of reducing and / or potentially avoiding the need for sterilization.

[0308] In some embodiments, the guide device is provided as a part of a kit which includes a tongue depressor , for potentially avoiding the need to depress and / or displace the tongue using a laryngoscope blade. In some embodiments the tongue depressor further functions as a mouth opener that can be stabilized in the patient’s oral cavity, having the potential advantage of freeing a physician’s hand from holding the tongue depressoran / or laryngoscope blade (as shown in Fig. 4B).

[0309] Referring now to Fig. 4A, showing a side view of a guide device, having a bendable tip, in accordance with some exemplary embodiments of the invention.

[0310] In some embodiments, movable tip 112 can be bent laterally relative to the longitudinal axis 103 of the elongated shaft 102, defining a bending angle a, between the bent position and a straight position, in line with axis 103. Optionally, the straight position is the retracted position of movable tip 112. In some embodiments, bending angle a ranges between about 0-120 degrees. For example, 0-90 degrees, 0-120 degrees, 0-140 degrees, or lower or higher or intermediate ranges or angles.

[0311] In some embodiments, movable tip 112, can be bent toward more than one radial direction. In some embodiments, movable tip 112 can be bent toward two radial directions, defining an additional bending angle p. In some embodiments, bending angle has a motion range as bending angle a, for example, 0-90 degrees, 0-120 degrees, 0-140 degrees, or lower or higher or intermediate ranges or angles. In other embodiments, bending angle p bends away from axis 103 toward the inner wall of the airway and has a relatively limited range of motion, for potentially reducing and / or avoiding injuring the airway wall’s tissue.

[0312] In some embodiments, the two bending directions are at an angular distance of 180 degrees, defining the movement of movable tip 112 along a single movement plane. This has the potential advantage of facilitating the guide device’s operation and / or improving the operator's sense of control over the guide device's movements.

[0313] In some embodiments, each bending angle a, p ranges from 0-90, such that movable tip 112 has a movement range of 0-180 degrees, relative to an axis perpendicular to axis 103 (e.g., the longitudinal axis of elongated shaft 102). In other embodiments, each bending angle a, ranges from 0-120, such that movable tip 112 has a movement range of about 0-240 degrees, relative to an axis perpendicular to axis 103. In some embodiments, the two radial bending directions are at an angular distance other than 180 degrees, defining bending angles a and p to move along separate movement planes.

[0314] In some embodiments, movable tip 112 can be bent along more than one movement plane, having the potential advantage of improving the guide device ability to pass obstructions along the airway. In some embodiments, movable tip 112 can be bent toward four radial directions. In some embodiments, each bending angle as the same movement range. In other embodiments, at least one of the bending angles has a relatively limited bending range, for potentially reducing and / or avoiding from injuring the inner walls of the airway.

[0315] In some embodiments, the four bending directions are at an angular distance of 90 degrees from each other, defining the movement of movable tip 112 along two orthogonal movement planes. In some embodiments, the movement range of each bending angle is about 0-90 degrees, defining movable tip 112 to bend from 0-180 degrees along each movement plane, relative to an axis perpendicular to axis 103. In other embodiments, the movement range of each bending angle is about 0-120 degrees, defining movable tip 112 to bend from 0-240 degrees along each movement plane, relative to an axis perpendicular to axis 103

[0316] In some embodiments, at least one of the angular distances between the radial bending directions is different than 90 degrees, defining movement along unorthogonal movement planes and / or along more than two movement planes.

[0317] In some embodiments, movable tip 112 can be bent continuously toward any radial direction, having the potential advantage of further improving the guide device ability to overcome obstructions along the airway. Referring to Fig. 4B, showing is a cross-sectional schematic view of endotracheal intubation performed on a patient, using a guide device, where the guide device’s tip is positioned in front of the patient’s vocal cords, in accordance with some exemplary embodiments of the invention.

[0318] Referring also to Fig. 4C, showing a cross-sectional schematic view of endotracheal intubation performed on a patient, using a guide device, where a mouth opener and / or tongue depressor is positioned within the patient’s mouth, in accordance with some exemplary embodiments of the invention;

[0319] Referring also to Figs. 4D-G sowing cross-sectional schematic views of an endotracheal intubation performed on a patient, using a guide device, showing the visual field of a camera located at the guide device’s tip, during the guide device insertion, in accordance with some exemplary embodiments of the invention.

[0320] In some embodiments, the guide device (e.g., guide device 100 shown in Fig 1A) is designed for placing an endotracheal tube in a patient’s trachea. The guide device is inserted into the patient's mouth, and directed along the airway toward the trachea. For achieving tracheal placement, the guide device directs the endotracheal tube to insert into the larynx and through the opening between the vocal cords.

[0321] In some embodiments, a patient’s airway is defined as a “difficult airway”, which involves challenges in viewing the vocal cords and / or challenges in reaching the trachea. For example, a patient might have an anterior larynx and / or sharply curved pathway toward the trachea. A "difficult airway" might result in difficult intubation and / or misplacement of the guide device and / or endotracheal tube in the esophagus.

[0322] In some embodiments, the movable tip (e.g., movable tip 112 shown in Fig. 1A) is moved to reach the trachea. In some embodiments, movable tip 112 can be manipulated, to modify the shape and / or orientation thereof to fit to the pathway toward the trachea. In some embodiments, movable tip 112 is bendable and can be bent and / or retracted to fit to the shape of the airway. In some embodiments, movable tip 112 can be bent to a range of angles, so that the level of bending can be adjusted to the curvature of the airway. For example, the tip can be bent to fit to the angle of approach in the oropharynx, to successfully pass the vocal cords. Movable tip 112 can further be bent to conform to the shape of the trachea, preventing the distal end from being stopped by and / or injuring the walls of the trachea.

[0323] In some embodiments, the guide device is introduced into the patient’s mouth while applying the vertical approach (shown in Fig. 3). The perpendicular position of the guide device typically requires the tip to be bent to an enhanced angle relative to the classic approach, to compensate for the change in the tip orientation relative to the vocal cords. In some embodiments, the movable tip can be bent to an angle of about 0-120, degrees, (between a straight and bent position). This potentially enables the insertion of the guide device into the vocal cords in a perpendicular position (relative to the patient’s mouth). As noted previously the perpendicular position has the potential advantage of enhancing the convenience of a physician performing an intubation procedure which may improve the time to perform the procedure and / or the probability of the procedure's success (e.g., tracheal placement).

[0324] In some embodiments, as previously mentioned, the guide device comprises a camera at and / or near the movable tip thereof (e.g., movable tip 112, shown in Fig. 1A). The camera transmits the images / video to an external screen and visualizes the progress of the guide device’s tip through the airway of the patient (as shown for example in Figs. 4C-F). The view from the camera changes as the guide device is inserted into the oral cavity and advanced through the airway (as shown for example in Figs 4C-F), potentially allowing a view of the vocal cords and / or the glottis of patients. This advancement may be considerably significant for viewing the vocal cords and / or the glottis of patients with a “difficult airway”.

[0325] In addition, the field of view from the camera can be adjusted by moving (e.g., bending) the movable tip, having the potential advantage of further improving the view on the vocal cords and / or the glottis of patients. A particular use case is adjusting the bending angle of the moveable tip to allow a view of the vocal cords and / or glottis of a patient with a “difficult airway”.

[0326] Figs. 4C-F illustrates the view from the camera at and / or near the guide device’s movable tip. In some embodiments, as the guide device is inserted into the patient’s mouth, the camera views the patient’s oral cavity, as shown for example in Fig. 4C. As the guide device advances through the airway, the camera can view the posterior pharyngeal wall and at least partially view the vocal cords, as shown for example in Fig. 4D. In some embodiments, as the guide device further advances, the movable tip is then bent, for example to an angle of about 40 degrees (e.g., from a retracted position, inline with the longitudinal axis of the guide device), potentially to view the vocal cords and the trachea at a distance from the tip, as shown for example in Fig. 4E. In some embodiments, as the guide device further advances, the movable tip is further bent, for example to an angle of about 90 degrees, potentially to view the vocal cords and tracheal ring, optionally where the tip is positioned in front of the vocal cords and can be inserted through the glottis, as shown for example in Fig. 4F. In some embodiments, an angle of about 90-120 degrees may be required to view and / or approach the vocal cords and / or glottis of a patient having a “difficuly airway”. For example, the presence of a cancerous tumor and / or an injury in the airway. In another example, to compensate for an insertion angle into the aurway. Referring to Fig. 5A, showing a schematic cross-sectional side view of a guide device, in a natural position, in accordance with some exemplary embodiments of the invention.

[0327] Referring also to Fig. 5B, showing a schematic cross-sectional side view of a guide device, in a first working position, in accordance with some exemplary embodiments of the invention.

[0328] Referring also to Fig. 5C, showing a schematic cross-sectional side view of a guide device, in a second working position in accordance with some exemplary embodiments of the invention.

[0329] Referring also to Fig. 7A, showing a schematic side view of a spring of a guide device’s movable tip, in accordance with some exemplary embodiments of the invention.

[0330] Referring also to Fig. 7B, showing a front view of a spring connected to an elongated shaft and a movable tip’s head, in accordance with some exemplary embodiments of the invention

[0331] In some embodiments, a guide device 500 is a detail of an embodiment of guide device 100, shown in Figs. 1A-D. The same reference numerals have been used to denote parts that are similar to those described for guide device 100, with the prefix 5 replacing the prefix 1.

[0332] In some embodiments, guide device 500 comprises an elongated shaft 502, a control 508 and a movable tip 512. In some embodiments, control 508 is a slide button (e.g., a linear slide button), operated by moving thereof along the longitudinal axis of elongated shaft 502. Alternatively or additionally control 508 can be a spherical slide button and / or a twist button at least partially surrounding elongated shaft 502.

[0333] In some embodiments elongated shaft 502 is formed from a wall 514 having a proximal end 504 and a distal end 506. In some embodiments, wall 514 defines an inner lumen 516. In some embodiments, elongated shaft 502 includes a groove 532 shaped and / or sized to accommodate slide button 508 and / or to allow back and forth movements of slide button 508 therewithin. In some embodiments, slide button 520 is at least partially incorporated within inner lumen 516 through groove 532.

[0334] In some embodiments, slide button 508 comprises two sections. In some embodiments, a first section 528 is incorporated mainly within wall 514, and / or protruding thereof. In some embodiments, a second section 530 is incorporated mainly within lumen 516 of elongated shaft 502.

[0335] In some embodiments, movable tip 512 comprises a flexure, such as a spring 518 and a head 520. Alternatively or additionally to spring 518, the flexure can be a flexible rod and / or a band.

[0336] In some embodiments, spring 518 is connected to head 520, at one end thereof, and to distal end 506 of elongated shaft 502 at the other end thereof, as can also shown in Fig. 7B. In some embodiments, head 520 is configured to come in contact with the inner walls of the airway. In some embodiments, head 520 is rounded, and / or smooth and / or formed of relativity soft material, such as plastic, having the potential advantage of reducing the risk of trachea perforation.

[0337] In some embodiments, guide device 500 comprises a control mechanism (e.g., control mechanism 109 shown in Fig. IE) that couples slide button 508 to movable tip 512. In some embodiments, the control comprises at least one filament 522 linking slide button 508 and movable tip 512. In some embodiments, filament 522 is connected to control 508, extends along elongated shaft 502, optionally within inner lumen 516, extends, along spring 518, optionally within spring 518, and is connected to head 520 in at least one connection point 534 or 536. In some embodiments, upon moving slide button 508 the filament applied tension which together with the axial contrast of spring 518 causes movable tip 512 to bend (e.g., to radially protrude from the longitudinal axis thereof), as shown in Fig. 7A.

[0338] In some embodiments, filament 522 is rigid enough to be pushed against movable tip 512. For example, filament 522 is a wire, optionally formed from a metal. Alternatively or additionally, filament 522 is a plastic and / or polymeric strand. In some embodiments, upon moving slide button 508 in one direction, at least one filament applied tension which together with the axial contrast of spring 518 causes movable tip 512 to bend in a first axial direction, and upon moving slide button 508 in the opposite direction, filament 512 applied compression which together with the axial contrast of spring 518 causes movable tip 512 to bend in an opposite axial direction.

[0339] In some embodiments, spring 518 confers flexibility to movable tip 512. In some embodiments, the spring’s flexibility allows the spring to be bent to a relatively large degree, for example, to angles range of about 0-120 degrees between the bent position and the natural retracted position thereof (e.g., where movable tip 512 is in line with the longitudinal axis of the guide device 500). In some particular embodiments, the movable tip can be bent to an angle of about 0-90 (or more) degrees, allowing the placement of the guide device within the trachea. For example, 30-90 degrees, or 20-100 degrees, or 0-120 degrees, or lower or higher or intermediate ranges of angles.

[0340] In some embodiments, the symmetric shape of the spring allows the movable tip to be bent in more than one direction (For example, in two opposite directions and / or to be steered to a plurality of directions), potentially, with less and / or without the need to exert increased force in one direction compared to the others.

[0341] In some embodiments, the spring’s flexibility allows some level of counter movement in response to contacting the walls of the trachea. A potential advantage of this counter-movement is further reducing the risk of injuring the trachea. For example, if movable tip 512 impacts the wall of the airway, spring 518 can shrink and potentially reduce and / or avoid injuring the tissue.

[0342] In some embodiments, the at least one connection point is a pair of connection points 534, 536. In some embodiments, points 534, 536 are at an angular distance of 180 degrees, defining two radial bending directions, at an annular distance of 180 degrees (two opposite bending directions on a single movement plane). In other embodiments, points 534, 536 are at an angular distance different from 180 degrees, defining two radial bending directions at an annular distance different than 180 degrees (each bending direction is along a different movement plane).

[0343] In some embodiments, the control mechanism further comprises a pin 524. In some embodiments, at least one filament 522 is a single filament which both the extremities thereof are connected to head 520. In some embodiments, one extremity of filament 522 is connected to head 520 at a first connection point for example connection point 534. Filament 522 extends from connection point 534 through spring 514, and into inner lumen 516 through distal end 506 of elongated shaft 502. Alternatively, or additionally, filament 522 extends exterior to elongated shaft 502. In some embodiments, filament 522 reaches pin 524 and folds over thereof to extend toward section 530 of slide button 508. In some embodiments, at least one filament 522 is anchored to section 530 of slide button 508 (for example at point 538) and continues extending toward distal end 506 of elongated shaft 502. In some embodiments, at least one filament 522 departs inner lumen 516 of elongated shaft 505, continues to extend through spring 518, and reaches head 520. The second extremity of filament 522 is connected to head 516 at a second connection point, for example, connection point 536.

[0344] In some embodiments, slide button 508 is placed at the center of groove 532, in the retracted position, as shown in Fig. 5A. In some embodiments, the retracted position, the tension at connection point 534 and connection point 536 are equivalent and / or approximately equivalent so movable tip 512 is held in line along the longitudinal axis of elongated shaft 502.

[0345] In some embodiments, when slide button 508 is moved along groove 532 the filament is moving along therewith, so the tension balance at connection points 534 and 536 is disturbed, as shown in Figs. 5B-C. In some embodiments, the increased tension at the filament causes spring 518 to bend away from the natural position, as shown in Fig. 7.

[0346] In some embodiments, the spring’s flexibility (and / or other flexure) requires relatively gentle tension in order to be bent, such that a physician operating the control is required to apply relatively reduced force on slide button 508 to bend movable tip 512. This has the potential advantage of easing the use of the guide device 500 and / or reducing the finger(s) fatigue. In some embodiments, the maximum force applied by a physician’s palm and / or finger on slide button 508 to bend movable tip 512 to an angle of 0 -90 degrees (relative to the retracted position, in line with the longitudinal axis of the guide device), is no more than 2-3 Newton (e.g., 200-300 gram force).

[0347] In some embodiments, when the force applied on slide button 508 is released, the slide button returns to the retracted position thereof, for example, the tension balance at connection points 534 and 536 is restored (e.g., the tension on the spring is released), and the spring (i.e., the movable tip) is retracted to the natural position thereof. In some embodiments, since the spring’s flexibility (and / or other flexure) requires relatively gentle tension in order to be bent (as previously noted) the continuous force applied on slide button 508 for maintaining the movable tip in a bent position is no more than 2-3 Newton (e.g., 200-300 gram force).

[0348] In some embodiments, the natural position is in line with the longitudinal axis of guide device 500. Alternatively or additionally, the natural position can be set to a bent position. For example, when slide button 508 is at a retracted position there is a tension disequilibrium at the two connection points 534, 536 defining a bent retracted position of movable tip 112. In another example, movable tip 512 can be shaped to have a retracted bent position.

[0349] In some embodiments, when sliding button 520 is moved toward proximal end 504 enhanced tension is applied at proximity to one of the connection points, for example, connection point 536, and spring 518 is bent so that movable tip 512 is bent relatively to the longitudinal axis of elongated shaft 502. In some embodiments, when sliding button 520 is moved toward distal end 506, enhanced tension is applied in proximity to the other connection point, for example, connection point 537, and movable tip 512 is bent in a radial opposite direction.

[0350] In some embodiments, when the tension on the spring is released (e.g., slid button 508 is returned to the retracted position) the spring’s flexibility allows thereof to return to the natural position relatively quick, having a potential advantage of reducing time waste during intubation, for example, if the force is released since the natural position is required.

[0351] In some embodiments, when a grip and / or a force applied on slide button 508 is released, slide button 508 returns to a retracted position. Alternatively or additionally, when a grip and / or a force applied on slid button 508 is released, the position of slide button 508 remains set, and the spring (e.g. movable tip 512) is locked at a bent position. This allows the physician to set the movable tip to a desired angle with potentially less and / or without requiring applying force. This has the potential advantage of reducing potential finger and / or palm fatigue of the physician. In addition, setting the movable tip to a desired angle has the potential advantage of reducing undesired movements of the movable tip. In some embodiments, slide button 508 comprises a locking mechanism in the form of markings spread along its longitudinal axis, and causing resistance to spontaneous retraction of slide button 508 by friction and / or by geometric interference. For example, slide button 508 can comprise at least one notch and / or groove, while the inner surface of wall 514 incorporates at least one corresponding protrusion. When the slide button 508 is moved back and / or forth, the at least one notch and / or groove aligns with the at least one protrusion. This alignment allows the at least one notch and / or groove and the at least one protrusion to interact, for example by fitting into each other. This interaction can consequently lock movable tip 512 at a specific bent position, defined by the location of the at least one notch and / or groove and the at least one protrusion. Alternatively or additionally, slide button 508 comprises at least one protrusion where the inner surface of wall 514 incorporates at least one corresponding notch and / or groove.

[0352] In some embodiments, the motion of slide button 508 is stepped. In some embodiments, each step defines a level of bending of movable tip 512. In some embodiments, a tactile feeling of the stepped motion allows the physician to evaluate the bending level of movable tip 512.

[0353] In some embodiments, each step defines a bent locking position of movable tip 512.

[0354] In some embodiments, guide device 500 comprises an imaging system, incorporated at movable tip 512, or positioned near thereof, as as will be described later.

[0355] In some embodiments, Elongated shaft 502 is formed from a relatively rigid material, which will not be deformed under the loads to be encountered while pushed into a patient's mouth and into a patient's trachea. The material elongated shaft 502 is formed of, also retains some degree of pliability, which allows the elongated shaft to adapt in a certain level to the shape of the airway when passed through. In some embodiments, elongated shaft 502 is formed from a material that imparts sufficient deformability for the elongated shaft 502 to be re- shaped, for example, to give elongated shaft 502 a curved form.

[0356] In some embodiments, elongated shaft 502 is formed for example from a relatively hard plastic, such as ABS polymers. Alternatively or additionally, elongated shaft 502 is formed for example from a metal, such as stainless steel.

[0357] In some embodiments, elongated shaft 502 is sufficiently long so that distal end 506 reaches the trachea, and for distance 510 to protrude from the patient's mouth. In some embodiments, elongated shaft 502 is about 70 cm long, from proximal end 504 to distal end 506 and / or to movable tip 512, but other dimensions can be used, for example, 40-70 cm, or 50-80 cm, or 70-100 cm, or lower or higher or intermediate numbers of lengths.

[0358] In some embodiments, elongated shaft 502 is a tubular rod having a circular cross-section, alternatively or additionally, a non-circular cross-section can be used, such as a rectangular and / or square and / or oval cross-section. A potential advantage of a circular cross-section is uniform flexibility toward radial directions. In some embodiments, the diameter of elongated shaft 502 cross section is about 6-8 mm diameter, but other dimensions can be used, for example, 5-6 mm, or 7-10 mm, or 4-10 mm, or about 5 mm or about 5.5 mm, or about 6, or about 6.5 mm or lower or higher or intermediate numbers of lengths. In some embodiments, the cross-section of elongated shaft 502 together with slide button 508 is less than 6.5 mm, having the potential advantage of fitting within an endotracheal tube with 6.5 mm opening.

[0359] Referring to Fig. 6A, showing a perspective view of an embodiment of a slide button, in accordance with some exemplary embodiments of the invention.

[0360] Slide button 608 is a detailed embodiment of slide button 508. The same reference numerals have been used to denote parts that are similar to those described for guide device 500, with the prefix 6 replacing the prefix 5.

[0361] In some embodiments, slide button 608 comprises two sections, inner section 630 and outer section 628. In some embodiments, inner section 630 is positioned within inner lumen 616 through groove 632. In some embodiments, inner section 630 comprises one or more protrusions 642 shaped and sized to fit within at least one channel 644 which extends along the inner surface of wall 614.

[0362] In some embodiments, outer section 628 is positioned between wall 614 (e.g., within groove 632) and / or protruding therefrom. In some embodiments, outer section 628 is wider than inner section 630. In some embodiments the upper surface of outer section 628 is concave, having the potential advantage of enhancing the grip and / or the comfort of a finger placed thereon. In some embodiments, the upper surface comprises at least a portion of rough surface and / or bulges thereon, having the potential advantage of reducing slippage of a finger actuated thereof.

[0363] In some embodiments, the positioning of one or more protrusions 642 within at least one channel 644, obstructs slide button 608 from departing from elongated shaft 602. In some embodiments, a geometric interference to the movement of one or more protrusions 642 out of at least one channel 644 prevents slide button 608 from separating from guide device 600. In addition, there is friction in the movement of one or more protrusions 642 within at least one channel 644 which optionally prevents one or more protrusions 642 from moving within at least one channel 644 and / or to exiting at least one channel 644. In some embodiments, the friction between one or more protrusions 642 and at least one channel 644 allows a controlled back-and-forth movement of slide button 608. In some embodiments, if no force and / or insufficient force is applied on slide button 600, the friction between one or more protrusions 642 and at least one channel 644 maintains slide button 600 from moving within groove 632. Upon applying sufficient axial force, one or more protrusions 642 move along channel 644 allowing the movement of slide button 608 within groove 632 (and the operation of slide button 608).

[0364] Referring to Fig. 6B, showing a slide button incorporated within the elongated shaft of the guide device, in accordance with some exemplary embodiments of the invention.

[0365] In some embodiments, the control (e.g., control 108) such as slide button 608 is incorporated within elongated shaft 608 such that slide button 608 does not extend out of the diameter of elongated shaft 608, potentially allowing to load thereon an endotracheal tube with relatively small opening. In some embodiments, the upper surface of slide button 608 comprises at least a portion of a rough surface and / or bumps and / or bulges thereon for reducing finger slippage as previously described in Fig. 6A. In some embodiments, slide button 608, including the bumps and / or bulges of the surface thereon, does not extend out of the diameter of elongated shaft 608. In some embodiments, the forces to be applied for moving slide button 608 are relatively low (as previously described in this document), such that no bumps and / or bulges and / or relatively low bumps and / or bulges are required for reducing and / or avoiding finger slippage while actuating slide button 608.

[0366] In some embodiments, the width of slide button 608 is substantially equivalent to the diameter of elongated shaft 602.

[0367] In some embodiments, a control, such as slide button 608, which does not extend and / or extends minimally radially from elongated shaft 602, has the potential advantage of reducing disruption to and / or discomfort for the physician gripping guide device 600 at and / or near slide button 608. In addition, as previously noted, an endotracheal tube can be loaded onto guide device 600, from the proximal end, over slide button 608, and into the trachea, without requiring to previously disassembled guide device 600 (for disconnecting slide button 608). This has the potential advantage of reducing the duration of the procedure and / or the need for an assistant, which may be crucial when a patient is not breathing and / or when assistance is not available, for example in emergencies.

[0368] In some embodiments, the length of slide button 608 is about 5 cm, for example, 4 cm, 5.5 cm, 6 cm, or 4-6 mm, or 2-10 mm, or lower or higher or intermediate ranges or lengths. In some embodiments, this length allows operating slide button 608 with a single finger, for example by moving slide button 608 back and / or forth using the thumb and / or the index finger.

[0369] In some embodiments, the control can be other than a slide button (e.g., slide button 608). In some embodiments, the control is a rotational control (e.g., rotational control 2208 shown in Fig. 22B), as further described in this document. In some embodiments, the rotational control does not extend out of the diameter of elongated shaft 2208. In some embodiments, the outer surface of rotational control 2208 comprises at least a portion of a rough surface and / or bumps and / or bulges thereon for reducing finger slippage. In some embodiments, rotational control 2208, including the bumps and / or bulges of the surface thereon, does not extend out of the diameter of elongated shaft 2208.

[0370] Referring to Fig. 8A, showing a schematic cross-sectional side view of an embodiment of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention.

[0371] Referring also to Fig. 8B, showing a partial cross-sectional upper view of an embodiment of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention.

[0372] Referring also to Fig. 8C, showing a schematic cross-sectional side view of an embodiment of a slide button, in accordance with some exemplary embodiments of the invention.

[0373] Referring also to Fig. 8D, showing a schematic cross-sectional side view of an embodiment of a moveable tip, in accordance with some exemplary embodiments of the invention.

[0374] Referring also to Fig. 8E, showing a schematic cross-sectional side view of an embodiment of a guide device with an imaging system and a moveable tip in a bent position, in accordance with some exemplary embodiments of the invention.

[0375] Referring also to Fig. 8F, showing an example of an imaging device, in accordance with some exemplary embodiments of the invention.

[0376] Referring also to Fig. 8G, showing a schematic cross-sectional side view of an inner section of a control, in accordance with some exemplary embodiments of the invention.

[0377] Referring also to Fig. 8H, showing a schematic cross-sectional side view of a tube connector for connecting a movable tip to a guide device, in accordance with some exemplary embodiments of the invention.

[0378] Referring also to Fig. 81, showing a perspective view of a guide device, having an imaging system, in accordance with some exemplary embodiments of the invention.

[0379] Guide device 800 is a detailed embodiment of guide device 500. The same reference numerals have been used to denote parts that are similar to those described for guide device 500, with the prefix 8 replacing the prefix 5.

[0380] In some embodiments, slide button 808 comprises two sections, inner section 830 and outer section 828. In some embodiments, outer section 828 is located outside inner lumen 816 whereas inner section 830 is positioned within inner lumen 816. In some embodiments, at least a portion of inner section 846 (shown in Fig 8C) is shaped and / or sized to come in closer contact with the inner surface of wall 814. In some embodiments, this close contact results in resistance to the movement of slide button 808 within elongated shaft 802. In some embodiments, if no force and / or insufficient force is applied, the friction between the surface of at least a portion of inner section 846 and the inner surface of wall 814 prevents slide button 808 from separating from guide device 800 and / or from moving freely within groove 832. In some embodiments, upon applying sufficient axial force to overcome the friction, slide button 808 can be moved back and / or forth within groove 832.

[0381] In some embodiments, guide device 800 comprises a base 833 for slide button 808 (shown in Fig 81). base 833 is sized and / or shaped to be deployed within inner lumen 816 and to accommodate inner section 830. In some embodiments, the at least a portion of inner section 846 comes in close contact with the inner surface of base 833. In some embodiments base 833 is formed from a material with a higher level of rigidity compared to elongated shaft 802, which potentially stabilized the movement of slide button 808 therebetween. In addition, the material of base 833 and / or the surface of the inner walls thereof can be selected to receive a desired friction with slide button 808. For example, a base 833 with a rough surface can be used to potentially increase the friction when moving at least a portion of inner section 846 therewithin.

[0382] In some embodiments, inner section 830 comprises a gap 838 (shown in Fig. 8G) sized and / or shaped to allow passage of wiring from movable tip 812 to a proximal portion of the guide device, for example, wiring of an imaging device 852 at and / or near movable tip to optionally, the distal end and / or portion of elongated shaft 802.

[0383] In some embodiments, inner section 846 may comprise an additional gap (not shown) to grip at least one filament 822 (e.g., at anchoring point 538 shown in Fig. 5A). In some embodiments, this gap is sized and / or shaped to anchor at least one filament 822 to slide button 808 such that upon moving slide button 808 tension is applied on filament 822, which results in bending movable tip 112.

[0384] In some embodiments, outer section 828 comprises alternating radially prominent sections, which form a jagged surface. This jagged surface of slide button 808 has the potential advantage of reducing slippage of a finger actuated thereof. In some embodiments, inner section 830 of control 808 comprises at least one radially prominent section 846 which at least partially occupies a portion of inner lumen 816 and comes in close contact with the inner surface of wall 814.

[0385] In some embodiments, guide device 800 comprises an imaging system 850. In some embodiments imaging system 850 comprises an imaging device 852, which comprises a camera and / or a light source. In some embodiments, imaging device 852 is incorporated at movable tip 812, or positioned near thereof, optionally, positioned at and / or near head 820. In some embodiments, the camera and optionally the light source are located at a distal portion 848 of head 820 (shown in Figs. 8A, 8D and 8F). An example of imaging device 852 which can be incorporated within distal portion 848 is shown in Fig. 8F, having, for example, a length of 2 mm and an outer diameter of 5 mm.

[0386] In some embodiments, the imaging system comprises a wire 854 (also shown in Fig. 8A) which couple imaging device 852 with a control system 856 (also shown in Fig. 8A). In some embodiments, control system 856 comprises a control 858 for operating imaging device 852 and an energy source and / or a connection to an energy source, for example, a battery 860. In some embodiments, control system 856 comprises a transmitting unit 859 for transmitting signals from the camera to a screen or a monitor, for example by WIFI and / or Bluetooth.

[0387] In some embodiments, control system 856 is located distally from movable tip 812. In some embodiments, the distance between movable tip 812 and control system 856 is sufficiently long such that the control system 856 remains outside the patient's mouth while movable tip 812 is placed within the trachea.

[0388] In some embodiments, battery 860 is placed within inner lumen 816 and wire 854 extends along elongated shaft 806 from imaging device 852 at head 820 to battery 860 and / or control 858, optionally, within inner lumen 816, alternatively or additionally, exterior to inner lumen 816, for example within an additional adjacent channel.

[0389] In some embodiments, a tube connector 819 (shown in Fig. 8E, 8H and 81) is used for connecting head 820 to distal end 806 of elongated shaft 802. In some embodiments, tube connecter 819 comprises a slit 821 that extends along the longitudinal axis thereof. In some embodiments, slits 821 is shaped and / or sized for passing wire(s) coupling imaging device 852 incorporated in head 820 with control system 856 located exterior to head 820, optionally within inner lumen 816 of the elongated shaft.

[0390] In some embodiments, wire 854 extends within the spring (e.g., spring 518 and / or 818). In some embodiments, the tension of the filament (e.g., filament 522 and / or 822) causes thereof to adjoin to an inner side of the spring, such that there is sufficient space for wire 854 to pass within the spring, as shown for example in Fig. 7B.

[0391] In some embodiments control 858 is located at proximal end 804 of elongated shaft 802. Alternatively or additionally, control 858 can be located adjacent to at least one control 808, having the potential advantage of reducing the need to alter the gripping position to operate control 858.

[0392] In some embodiments, wire 854 extends from elongated shaft 802, for example through an opening at proximal end 804, and couple imaging device 852 to an external control system, which may comprise an AC power source and / or a computer.

[0393] In some embodiments, movable tip 812 comprises a coupler 813 for coupling movable tip 812 to the proximal end of elongated shaft 802. In some embodiments, movable tip 812 (which is substantially equivalent to movable tip 112) comprises a cover 860 (shown in Fig. 8B) that encases spring 818 and head 820. Cover 860 has the potential advantage of minimizing pinching and / or irritation of the soft tissue of the airway by spring 818. An additional potential advantage of cover 860 is protecting a camera and / or a light source of imaging system 850 located at head 820.

[0394] In some embodiments cover 860 is made from a flexible material and / or a thin covering which potentially reduces interference with the spring's motion and / or flexibility. For example, a silicon cover with a thickness of about 0.1-0.2 mm. for example, 0.15-0.25 mm, or 0.18-0.25 mm, or 0.12-0.18 mm, or about 0.15 mm or or lower or higher or intermediate numbers of thicknesses.

[0395] In some embodiments, cover 860 or a portion thereof, which covers the camera is transparent for video imaging therethrough. Alternatively or additionally, the camera is exposed from cover 860, such that cover 860 can be opaque and / or semi-opaque.

[0396] Referring to Fig. 8J, showing a schematic cross-sectional view of a guide device, having at least one filament within the walls of an elongated shaft, in accordance with some exemplary embodiments of the invention.

[0397] In some embodiments, the at least one filament 822 of guide device 800 is incorporated within wall 814 of elongated shaft 802. This has the potential advantage of increasing the space in inner lumen 816 for wire 854 to pass therethrough. An additional potential advantage is reducing and / or avoiding contact between wire 854 and filament 802 which might result in disconnecting the imaging system and the control system and / or might interfere with the operation of the filament. In some embodiments, elongated shaft 502 is formed from an inner wall concentric within an outer wall, where the radial distance therebetween accommodates at least one filament 802.

[0398] Referring to Fig. 9A, showing a schematic cross-sectional side view of a guide device, having a movable tip that can be bent in more than one plane, in a natural position, in accordance with some exemplary embodiments of the invention.

[0399] Referring also to Fig. 9B, showing a schematic cross-sectional side view of a guide device, having a movable tip that can be bent in more than one plane in a first working position, in accordance with some exemplary embodiments of the invention.

[0400] Referring also to Fig. 9C, showing a schematic cross-sectional side view of the control mechanism of a guide device, having a movable tip that can be bent in more than one plane, in accordance with some exemplary embodiments of the invention.

[0401] Referring also to Fig. 9D, showing a fractional back view of a guide device having two controls, in accordance with some exemplary embodiments of the invention. Referring also to Fig. 9E, showing a fractional cross-section side view of a guide device having two controls, in accordance with some exemplary embodiments of the invention.

[0402] Referring also to Fig. 9F, showing a fractional front view of a guide device having two controls, in accordance with some exemplary embodiments of the invention.

[0403] Guide device 900 is a variant of guide device 500. The same reference numerals have been used to denote parts that are similar to those described for guide device 500, with the prefix 9 replacing the prefix 5.

[0404] In some embodiments, guide device 900 comprises a movable tip 912, that can be moved along more than one surface of movement. An additional movement surface potentially further improves the ability to view the vocal cords, to pass between the vocal cords and / or to adapt to the shape of the airway.

[0405] In some embodiments, movable tip 912 can be bent along two or more movement planes, for example in two orthogonal planes. In some embodiments, elongated shaft 802 may have a curvature, so rotating the guide device within the airway can result in a misalignment between the curved elongated shaft and the shape of the airway. Two or more movement planes allow the adjustment of the position of the movable tip radially without requiring to rotate elongated shaft 902.

[0406] In some embodiments, guide device 900 comprises at least one control 908, located on a portion of the circumference of the elongated shaft 902. Two or more movement planes allow to adjust the position of the movable tip radially within the airway without compromising access to the control and / or without compromising the convenience of using thereof.

[0407] In some embodiments of the invention, at least one control 908 is a pair of controls. In some embodiments, the pair of controls comprises two controls of the same type, such as two slide buttons. Alternatively or additionally, the two controls can be different by type and / or by function. For example, a first slide button is configured to move in steps, and a second slide button is configured to move continuously.

[0408] In some embodiments, guide device 900 comprises a first slide button 908 and a second slide button 940. The first slide button when manipulated, bends movable tip 912 toward two radial directions. In some embodiments, the two radial directions are at an angular distance of 180 degrees defining a motion of movable tip 912 along a first movement plane (movement in two opposite directions). The second slide button when manipulated bends movable tip 912 toward other two radial directions. In some embodiments, the two other radial directions are at an angular distance of 180 degrees defining a motion of movable tip 912 along a second movement plane (movement in two opposite directions). In some embodiments the two movement planes are orthogonal. In some embodiments, each of the slide buttons 908, 940 can bent movable tip 912 to a relatively large angle. For example a bending angle of about 0-90 and / or 0-120 degrees and more, between a retracted position (where movable tip 912 is in line with the longitudinal axis of guide device 900) and the bent position of the movable tip.

[0409] In some embodiments, the first and the second slide buttons 908, 940 are positioned in proximity to each other (as shown in Figs. 8E-G) potentially allowing the physician to toggle between manipulating the first and second buttons with less and / or without changing the position of the hand thereof.

[0410] In some embodiments, the position of the pair of slide buttons along elongated shaft 802 is as described in Fig. 3. For example, the pair of slide buttons 908, 940 is positioned on the elongated shaft 902 at an axial location allowing insertion of the guide device into the trachea while the pair of slide buttons 908, 940 remains exterior to the patient’s mouth. Another example is, the pair of slide buttons 908, 904 is positioned on the elongated shaft 902 at an axial location allowing the physician to push guide device 900 into the patient's airway with sufficient force, optionally, while the elbows of the physician are at about 90 degrees and / or adjacent to the physician’s body.

[0411] In some embodiments, guide device 900 comprises a first control mechanism as described for guide device 500 (shown in Fig. 5A) and a second control mechanism which includes a second filament 942 for coupling second slide button 940 to movable tip 912 . In some embodiments, first filament 922 and second filament 942 are connected to head 920 with a single connection point each, for example at connection points 934 and / or 936 respectively. Optionally, at an angular distance of 180 from each other. In some embodiments, first filament 902 and second filament 942 are connected to head 920 each with two connection points, optionally, at an angular distance of 180 from each other. Alternatively or additionally, the two connection points are at an angular distance different than 180.

[0412] Alternatively or additionally to a pair of slide buttons, other controls can be used. For example in some embodiments, a control in the form of a joystick and / or a spherical scroll button can be used for directing the movable tip in more than one movement plane. Using a single control (joystick and / or a spherical scroll button) has the potential advantage of simplifying the operation of the guide device by potentially avoiding toggling between more than one control.

[0413] In some embodiments, the at least one control, when manipulated, can move movable tip 912 in more than two movement planes. In some embodiments, movable tip 812 can be bent radially to any point, defining a circular motion. In some embodiments, a joystick and / or a spherical scroll button can be used for rotating and / or bending the movable tip, optionally, in a continuous manner. In some embodiments, guide device 900 comprises an imaging system 850 as previously described.

[0414] Referring to Figs. 10A-C, showing a flow chart of a method for performing an intubation procedure using a guide device bare of an endotracheal tube, in accordance with some exemplary embodiments of the invention.

[0415] Initially, at 1002, the patient’s tongue is manipulated using a tongue depressor and / or a laryngoscope (direct and / or video-assisted) blade which is inserted into the patient’s mouth. The tongue is shifted to facilitate viewing the patient’s vocal cords and / or glottis.

[0416] In some embodiments, a guide device that includes an imaging system with an imaging device at and / or near the tip thereof is used. In some embodiments, the imaging system visualizes the patient’s vocal cords on a screen viewed by the physician so that a laryngoscope is less and / or not required. Reducing the requirement for a laryngoscope blade has the potential advantage of decreasing dependency on laryngoscope blades and / or video-assisted laryngoscopy technology. An additional potential advantage is reducing dependency on sterilization cycles of the laryngoscope blade. An additional potential advantage of performing intubation using a tongue depressor but not a laryngoscope blade is reducing the risk of tissue damage and / or teeth dislodgment and / or damage that might be caused by the blade. In addition, reducing and / or avoiding the need to insert a laryngoscope blade into the patient's mouth has the potential advantage of making the intubation procedure physiologically and / or mentally less stressful for the patient. In addition, side effects (such as increased heart rate and / or blood pressure) resulting from the insertion of a laryngoscope blade into a patient’ s oral cavity can potentially be avoided. In some embodiments, the guide device is provided with a tongue depressor, optionally a disposable tongue depressor. The tongue depressor is inserted into the patient’s mouth and used to depress and move the patient's tongue.

[0417] At 1004, a physician is holding the guide device. The physician is gripping the elongated shaft of the guide device at the control thereof and / or such that the control is within reach of a physician’s finger.

[0418] The physician is holding the guide device one-handed, optionally, in a steady insertion position. A steady insertion position refers to a position that allows the physician to apply sufficient force to advance the guide device toward the trachea. In addition, a steady insertion position allows the physician to aim the progress of the guide device during insertion. For example, a steady insertion position can be a pencil grip position (e.g., one of the known pencil grip positions).

[0419] In some embodiments, the position of the control along the elongated shaft allows the physician to hold the guide device such that the physician’s arm is close to the body thereof, and the elbows are at an angle of about 90 degrees. In some embodiments, the other hand of the physician is free from holding the guide device, optionally, the other hand can be used to hold the laryngoscope, aid the hand holding the guide device and / or perform any other required function.

[0420] At 1006, the guide device is introduced, optionally, by the physician into the patient's oral cavity.

[0421] In some embodiments, the guide device comprises an imaging system, having the potential advantage of reducing, and / or potentially eliminating the need for the physician to directly view the patient’s vocal cords. The physician is standing in an upright posture, and inserting the guide device in a vertical approach (e.g., the guide device is perpendicular or substantially perpendicular relative to the patient). The upright posture potentially improves the physician's ergonomics. The vertical approach has the potential advantage of minimizing undesired contact of the guide device with the physician's face which might distract the physician during the intubation. In some embodiments, the imaging system transmits the progress of the guide device’s tip to a monitor or a screen, optionally, located for the convenience of the physicians.

[0422] In some embodiments, the guide device is introduced into the patient while the movable tip is relaxed, and aligned with the elongated shaft. Alternatively, the guide device can be introduced into the patient while the movable tip is bent away from the longitudinal axis of the shaft, optionally, the tip is bent to a pre-set angle. For example, the tip can be pre-set to an angle of 0-90 degrees and more (between a retracted position and a bent position, where a retracted position is in line with the longitudinal axis of the guide device).

[0423] At 1008, the guide device is advanced within the airway, at the initially selected orientation. The guide device is advanced toward the trachea optionally, by a physician, holding the elongated shaft, optionally, one-handed.

[0424] In some embodiments, the advancement of the guide device is under observation on the patient’ s airway on an external monitor.

[0425] At 1010, the physician may encounter challenges in reaching the trachea. In some embodiments, the initial angle of the movable tip may encounter difficulty in passing through the vocal cords (e.g., through the glottis), for example in patients with a "difficult airway".

[0426] In some embodiments, when the vertical approach is applied, the deviation from the orientation of the classic approach may result in difficulty in passing through the vocal cords (for patients with normal airways as well as for patients with anatomically "difficult airways" (e.g., anterior larynx, abscess or tumor)).

[0427] In some embodiments, a "difficult airway" is characterized by a curved path to the trachea. The initial orientation of the movable tip might not fit with the shape of the airway and the distal end of the guide device may be detained by the walls of the airway so that tracheal placement cannot be achieved.

[0428] At 1012, the movable tip is adjusted to conform to the shape of the airway. In some embodiments, the control is actuated to bend the movable tip. In some embodiments, the physician actuates the control while remaining in the insertion position. Optionally, the tip angle is adjusted under visualization, using the imaging system.

[0429] In some embodiments, the tip is bent to pass through the vocal cords. In some embodiments, the vertical approach is applied, and the tip is bent to compensate for the vertical position of the guide device. In some embodiments, this compensation includes bending the tip to an angle of 0- 60 degrees for a patient with a normal airway and / or to an angle of 60-90 degrees, or 90 - 120 degrees for a patient with a difficult airway.

[0430] At 1014, the guide device is further advanced toward the trachea. In some embodiments, the tip’s angle can be adjusted during the progress of the guide device.

[0431] The tip bending can be further adjusted at any point during the insertion of the guide device for example if encountering another anatomical obstacle within the airway. A potential advantage of bending the tip while moving the guide device toward the trachea is improving the time efficiency of the intubation process.

[0432] Alternatively or additionally, the tip’s angle adjustment and the guide device advancement can be intermittent. A potential advantage of progressing in steps and adjusting the tip in a static state is minimizing the risk of soft tissue or teeth trauma.

[0433] At 1016, tracheal placement of the guide device is achieved. The distal end of the guide device is placed within the trachea. In some embodiments, the tip of the guide device reaches the glottis, in some embodiments, the guide device has a length longer than the length of an endotracheal tube, to enable the insertion of the endotracheal tube into the trachea when the guide device’s tip reaches the glottis without inserting therethrough. Alternatively or additionally, the distal end of the guide device passes through the glottis.

[0434] At 1018, tracheal placement is confirmed. In some embodiments, tracheal placement can be confirmed by lung auscultation, chest wall movement and / or monitoring end tidal carbon dioxide. Alternatively or additionally, the trachea may be identified by the tactile feel of the anterior cartilaginous tracheal rings, which can be recognized in the absence of an imaging system. The movable tip which is smooth round and pliable can come in contact with the inner surface of the trachea with minimum risk to the trachea integrity. The interaction of the pliable tip with the cartilaginous rings produces a counter-movement of the tip that can be felt by the physician. Alternatively, or additionally, if the guide device comprises an imaging system, tracheal placement can be confirmed visually, by imaging the anterior cartilaginous rings of the trachea using the source light and camera at the distal end.

[0435] Confirming tracheal placement using the guide device has the potential advantage of reducing and / or avoiding the need for additional equipment for confirmation (such as a stethoscope and / or capnograph), which might not be available during the intubation.

[0436] At 1020, the physician selects an endotracheal tube. A potential advantage of selecting an endotracheal tube after tracheal placement of the guide device is that the selection can be based on the patient pathway as visualized during the intubation process. An additional potential advantage of selecting an endotracheal tube after the tracheal placement of the guide device is that the presence of the guide device along the airway facilitates the insertion of the endotracheal tube.

[0437] At 1022, the selected endotracheal tube is loaded on the guide device. The endotracheal tube is passed over the guide device from the proximal end, over the control, and maneuvered into the patient’s oral cavity and trachea.

[0438] In some embodiments, the selected endotracheal tube is loaded on the guide device, by the physician, using the hand thereof free from holding the guide device. This has the potential advantage of reducing the need for assistance to load the endotracheal tube and / or to increase the ability to perform the intubation process by a single caregiver, an ability which may be needed in emergency cases.

[0439] At 1024, the endotracheal tube is further inserted along the elongated shaft into the airway of the patient. The guide device directs the endotracheal tube through the vocal cords and along the shape of the airway.

[0440] At 1026, the distal end of the endotracheal tube reaches the distal end of the guide device at the trachea.

[0441] At 1028, the trachea can be identified by visualizing the cartilaginous tracheal rings using the imaging system. It is to be noted that a guide device having an imaging system has the potential advantage of facilitating this visual confirmation.

[0442] In some embodiments, visualizing endotracheal tube placement using the camera located at and / or near the movable tip can reduce and potentially eliminate the need for other confirmation processes (chest wall movement, lung auscultation or end tidal carbon dioxide monitoring), having the potential advantage of saving valuable time during intubation and / or reducing the risk of misplacing the endotracheal tube. At 1030, in some embodiments, the placement of the endotracheal tube can be documented by recording a video and / or by taking at least one screen shot of the endotracheal tube within the tracheal lumen.

[0443] At 1032, the guide device is withdrawn from the patient’s airway. In some embodiments, the movable tip is retracted to the retracted state thereof before pulling out the guide device. This has the potential advantage of reducing the risk of injuring the trachea.

[0444] At 1034, the endotracheal tube is connected to a respiratory machine.

[0445] In some embodiments, the connection to the respiratory machine is performed prior to withdrawing the guide device from the patient’ s trachea, potentially reducing the time for starting ventilation. In some embodiments, the endotracheal tube is connected to a respiratory machine, while the guide device, typically longer than the endotracheal tube, is therewithin, using a connector. In some embodiments, the connector is a two-way connector with an additional opening. In some embodiments, the two-way connector comprises a first opening configured to connect to the endotracheal tube, a second opening configured to connect to the respiratory machine, and an additional opening, configured to allow the guide device to emerge and protrude through. In some embodiments, the first and the additional opening are in line to allow the guide device to pass through the connector. In some embodiments, the additional opening comprises a sealing, such as a septum and / or lid for potentially reducing and / or preventing gas flow therethrough.

[0446] In some embodiments, the guide device has a diameter sufficiently smaller than the diameter of the endotracheal tube, such that the space between the guide device and the endotracheal tube allows a flow of air and / or oxygen. Alternatively or additionally, the inner lumen (e.g., inner lumen 116) of the guide device enables air and / or oxygen therethrough. In some embodiments, the guide device comprises an opening at and / or near the distal end of the elongated shaft and at the proximal end thereof, allowing fluid flow (e.g., air / oxygen) through the guide device (e.g., through the inner lumen of the elongated shaft). In some embodiments, ventilation can be performed while the guide device remains within the endotracheal tube, potentially allowing repositioning of the endotracheal tube. This repositioning has the potential advantage of simplifying positioning within the trachea in case of misplacement and / or displacement of the endotracheal tube. In some embodiments, the guide device remains within the endotracheal tube throughout the initial period of respiration and is withdrawn after confirming that the patient is ventilated. Referring to Figs. 11A-B showing a flow chart of a method for performing an intubation procedure using a guide device pre-loaded with an endotracheal tube, in accordance with some exemplary embodiments of the invention.

[0447] Initially, at 1102, the laryngoscope is inserted through the mouth of a patient, and positioned to view the vocal cords and / or the glottis of the patient, as described in act 1002 of Fig 10A.

[0448] At 1104, the physician selects an endotracheal tube. The selection is based on assessment according to the patient’s conditions and statistical guidelines (such as sex, obesity, weight, sex, and / or the patient’s medical condition).

[0449] At 1106, the endotracheal tube is mounted on the guide device. The endotracheal tube can be mounted by loading the distal end of the endotracheal tube over the proximal end of the guide device over the control. Alternatively or additionally, the endotracheal tube can be mounted by loading the proximal end of the endotracheal tube over the tip and / or the distal end of the guide device.

[0450] In some embodiments, the guide device is provided with an endotracheal tube, loaded thereon. In some embodiments, a kit is provided, including a plurality of endotracheal tubes of several sizes, each loaded on a guide device. A guide device provided with a loaded endotracheal tube has the potential advantage of reducing the time for intubation performance, which may be of great significance when a patient is not breathing and needs to be ventilated.

[0451] In some embodiments, the distal end of the endotracheal tube is aligned with the distal end of the elongated shaft, such that the movable tip of the guide device is bare of the endotracheal tube, and / or projecting therefrom. In some embodiments, the projected moveable tip is free to bend in response to control operation. The free tip allows navigation of the guide device into the trachea. Since inserting a pre-loaded guide device might pose a greater challenge in viewing the vocal cords and / or passing through the glottis, arising from the relatively large diameter of the endotracheal tube, this adjustment of the tip’s angle has the potential advantage of assisting in reaching tracheal placement.

[0452] In some embodiments, the free movable tip comprises an imaging system that visualizes the patient's vocal cords and airway, having the potential advantage of improving the view, which might be obstructed by the pre-loaded guide device when using direct vision and / or videolaryngoscope.

[0453] Alternatively, or additionally, the endotracheal tube can cover the movable tip of the guide device, so that the guide device can be used as a traditional stylet. A potential advantage of the guide device over a common stylet is that the movable tip can be bent to pre-set the angle thereof and to shape the tip of the endotracheal tube accordingly. In some embodiments, the tip’s angle can be set prior and / or after loading the endotracheal tube thereon.

[0454] In addition, commonly used stylets typically have a rigid edge concealed within the endotracheal tube. If the edge of the stylet is erroneously exposed, the contact thereof with the walls of the trachea may result in tracheal perforation. An additional potential advantage of using the pre-loaded guide device is that the moveable tip poses a reduced risk to the trachea integrity.

[0455] At 1108, a physician is holding the guide device, as Act 1004 of Fig 10A describes.

[0456] At 1110, the guide device loaded with the endotracheal tube is inserted into the mouth of the patient.

[0457] In some embodiments, the guide device is inserted while applying the vertical approach (e.g. perpendicular or substantially perpendicular to the patient's mouth).

[0458] At 1112, the guide device and the endotracheal tube are advanced simultaneously into the trachea. In some embodiments, the progress of the guide device is visualized by an imaging system in and / or near the tip thereof.

[0459] At 1114, the physician may encounter challenges in reaching the trachea, as described in act 1010 of Fig. 10A describes. In some embodiments, since the endotracheal tube is larger than a bare guide device, these challenges might be more significant.

[0460] Acts 1116-1120 are as described by acts 1012-1016 in Figs. lOA-B.At 1122, tracheal placement is confirmed, as described in act 1018 in Fig. 10B. Since the guide device is loaded with the endotracheal tube, a single conformation is required to ensure tracheal placement of the guide device and the endotracheal tube.

[0461] Acts 1124-1126 are as described by Acts 1030-1032 in Fig. 10C.

[0462] Referring to Fig. 12A, showing a schematic cross-sectional side view of a guide device with a control in the form of at least one loop, in a natural position, in accordance with some exemplary embodiments of the invention.

[0463] Referring also to Fig. 12B showing a schematic cross-sectional side view of a guide device with a control in the form of at least one loop, in a first working position, in accordance with some exemplary embodiments of the invention.

[0464] Referring also to Fig. 12C showing a schematic cross-sectional side view of the control mechanism of a guide device with a control in the form of at least one loop, in a second working position, in accordance with some exemplary embodiments of the invention.

[0465] Guide device 1200 is a detail of an embodiment of guide device 100, shown in Figs.lA- D. In some embodiments, guide device 1200 shares the same general functional elements as guide device 500 with the exception of some variances. The same reference numerals have been used to denote parts which are the same as or correspond to those of the previous embodiment, having a prefix of 12.

[0466] In some embodiments, the control is in the form of at least one loop 1208, having an opening sized to accommodate a finger of a physician.

[0467] In some embodiments loop 1208 is attached to at least one end of filament 1222. In some embodiments, elongated shaft 1202 comprises at least one opening 1232 shape and / or is sized for at least one end of filament 1222 to emerge therethrough, and loop 1208 is connected to the end of filament 1222, exterior to the elongated shaft.

[0468] In some embodiments, at least one loop 1208 is configured to be pulled and thereby bend movable tip 1212.

[0469] In some embodiments, when pulled, control 1208 is configured to be pulled and thereby manipulate movable tip 1212. In some embodiments, filament 1222 has some level of rigidity so that at least one loop 1208 can additionally be pushed, thereby bending movable to 1222 toward another radial direction (relative to the longitudinal axis of the guide device).

[0470] In some embodiments, at least one loop 1208 is a pair of loops, as shown in Figs. 12A-B. In some embodiments, when the pair of loop 1208 is un-pulled, there is tension balanced between points 1234 and 1236, such that movable tip 1212 is aligned with the longitudinal axis of guide device 1200, as shown in Fig 12A. In some embodiments, when at least one loop 1208 is pulled, the the tension balance at connection points 1234 and 1236 is disturbed, as shown in Figs. 12B-C. pulling at least one loop 1208 results in enhanced tension at one of points 1234 or 1236 which results in bending spring 1218, such that the pair of loops 1208, provides a first working position (shown in Fig. 12B) and a second, optionally, opposite working position (shown in Fig. 12C). Alternatively or additionally to a pair of loops, additional loops can be added to achieve additional working positions.

[0471] In some embodiments, a control in the form of at least one loop 1208 can be utilized for manipulating a movable tip of relatively thin guide devices (e.g., having an elongated shaft with a relatively small cross-section). A relatively thin guide may be used for tracheal placement of a relatively small endotracheal tube, for example having an inner lumen with a diameter of 6.5 mm and less, intended for insertion into the trachea of infants, kids, and / or patients with severe cases of “difficult airway”. For example, in some embodiments, since the cross-section of filament 1202 can have a diameter of 2 mm or less, the width of the elongated shaft 1202 can be less than 3 mm.

[0472] Alternatively or additionally, a control in the form of at least one loop 1208 occupies relatively less space within inner lumen 1216, having the potential advantage of increasing the free space within inner lumen 1216 for wiring an imaging device (not shown) at and / or near head 1220 with distally located control system 856.

[0473] In some embodiments, the size and / or shape and / or material of at least one loop 1208, allows thereof to fit together with elongated shaft 1202 within an endotracheal tube. In some embodiments, at least one loop 1208 is formed from an end section of filament 1222, optionally by tying an end portion of filament 1222. Optionally or additionally, at least one loop 1208 is coated with a stiffening substance, for stabilizing the shape thereof. This stabilization has the potential advantage of easing the insertion of a physician’s finger into at least one loop 1208. In some embodiments, the stiffening is limited to allow at least one loop 1208 sufficient deformability to pass within an endotracheal tube.

[0474] Alternatively or additionally, at least one loop 1208 is a pull ring connected to the end of filament 1202. In some embodiments, at least one loop 1208 is formed from a material(s) sufficiently rigid to stabilize the structure thereof, and sufficiently deformable to allow at least one loop 1208 to deform and to pass within an endotracheal tube.

[0475] In some embodiments, the control is located along elongated shaft 1202 as described in Fig. 3, optionally, at a distance of at least 5 mm from proximal end 1206. In some embodiments, at least one opening 1232 is located along elongated shaft 1222 at a sufficient distance from distal end 1206 to allow tracheal placement of guide device 1200 while at least one loop 1208 remains exterior to the patient's mouth. In some embodiments, at least one opening 1232 is located between distal end 1206 and proximal end 1204 at a point that allows the physician to grip the elongated body at the control (and / or near the control) where the physician’s elbows are close to the physician’s body, a position which allows a bending angle of 90 degrees at the elbows, as described in Fig. 3.

[0476] In some embodiments, filament 1222 comprises a plurality of bumps adjacent to at least one loop 1208. The bumps define stepped movements of filament emerging through at least one opening 1232 which results in stepped bending of movable top 1212. In some embodiments, the stepped movement defines tactile filing for bending movable tip 1212.

[0477] In some embodiments, the bump allows locking a bent position of movable tip 1112, optionally, at a desired angle, having the potential advantage of allowing the physician to work with a desired tip angle without and / or with less requirement to pull at least one loop 1208 and or to maintain a tension of filament 1222.

[0478] Referring to Fig. 13A, showing a partial schematic cross-sectional side view of a guide device a gear, in accordance with some exemplary embodiments of the invention. Referring also to Fig. 13B showing a partial schematic cross-sectional upper view of a guide device 1300, in accordance with some exemplary embodiments of the invention.

[0479] Guide device 1300 is a detail of an embodiment of guide device 100, shown in Figs.lA- D. In some embodiments, guide device 1300 shares the same general functional elements as guide device 500 with the exception of some variances. The same reference numerals have been used to denote parts which are the same as or correspond to those of the previous embodiments, having a prefix of 13.

[0480] In some embodiments, the control is in the form of a gear 1308, having a round and / or annular- shaped body (such as a disc) and optionally, a jagged edge. In some embodiments, gear 1308 is at least partially positioned within inner lumen 1316 of elongated saft 1302. Elongated shaft 1302 comprises an opening for allowing to at least a portion of gear 1308 to be exposed and / or to emerge from elongated shaft 1302.

[0481] In some embodiments, when rotating gear 1308 optionally, by axial moving a finger thereon movable tip 1312 is bent. In some embodiments, the teeth of the jagged edge define a stepped movement of gear 1308, which results in a stepped bending of the movable tip 1312.

[0482] In some embodiments, when gear 1308 is released, guide device 1300 retracts to a natural position, where movable tip 1312 is at the initial position thereof, optionally, aligned with the longitudinal axis of elongated shaft 1302. In other embodiments, when gear 1308 is released, the position thereof defines a locking position, and the bent angle of the movable tip 1312 is maintained. This has the potential advantage of minimizing the physician’s effort to maintain a desired angle of movable tip 1312.

[0483] In some embodiments, at least one filament 1312 is attached to gear 1308. In some embodiment, at least one filament 1312 at least partially surrounding a portion of gear 1308. In some embodiments, gear 1308 comprises a pin 1301, optionally attached to a side of the round and / or annular- shaped body. At least one filament 1312 at least partially surrounding a portion of pin 1301.

[0484] Referring to Fig. 14, showing a partial schematic cross-sectional side view of a guide device with a variant of a slide button, in accordance with some exemplary embodiments of the invention.

[0485] Guide device 1400 is a detail of an embodiment of guide device 100, shown in Figs.lA-D.

[0486] In some embodiments, guide device 1400 shares the same general functional elements as guide device 500 with the exception of some variances. The same reference numerals have been used to denote parts which are the same as or correspond to those of the previous embodiments, having a prefix of 14.

[0487] In some embodiments, control 1408 is a variant of slide button 508. In some embodiments, slide button 1408 is at least partially surrounding elongated shaft 1402, and manipulates movable tip 1412 by axially moving thereof over elongated shaft 1402. In some embodiments, slide button 1408 can be utilized for operating relatively thin guide devices (e.g., having a relatively small cross-section), optionally, intended for intubation of infants, kids, and / or adults with severe “difficult airways”.

[0488] In some embodiments, slide button 1408 comprises of two sections. In some embodiments, a first section 1428 is mainly incorporated and / or protruding into wall 1414, and / or inner lumen 1416. At least one filament 1412 is attached to first section 1428. In some embodiments, a second section 1430 is mainly surrounding elongated shaft 1402. In the example shown in Fig. 14, control 1408 is substantially cylindrical, but other shapes can be used, such as a quadrangle.

[0489] Referring to Fig. 15A, showing a partial schematic cross-sectional side view of a guide device a variant of a movable tip, in a natural position, in accordance with some exemplary embodiments of the invention.

[0490] Reffering also to Fig. 15B showing a partial schematic cross-sectional front view of a guide device 1500, in a working position, in accordance with some exemplary embodiments of the invention.

[0491] Guide device 1500 is a detail of an embodiment of guide device 100, shown in Figs.lA- D. In some embodiments, guide device 1500 shares the same general functional elements as guide device 500 with the exception of some variances. The same reference numerals have been used to denote parts which are the same as or correspond to those of the previous embodiment, having a prefix of 15.

[0492] In some embodiments, guide device 1500 comprises movable tip, 1512. In some embodiments, movable tip 1512 is a variant of movable tip 512. In some embodiments, movable tip 1512 comprises a tubular wall 1518 and a head 1520. In some embodiments, tubular wall 1518 comprises a flexible material (such as poly siloxane and / or other polymers). A potential advantage of the tubular wall 1518 is reducing the device manufacturing costs. It is noted that since guide device 1500 is a disposable device, used for a single intubation, reducing the costs thereof may be of considerable significance.

[0493] An additional potential advantage of the tubular wall is reducing the risk of pinching and / or irritating the tissue, and / or potentially reducing the need for a protective cover encasing movable tip 112.

[0494] In some embodiments, when control 1508 is actuated, at least one filament 1512 pulls and / or pushes head 1520 at a connection point between filament 1512 and head 1520, for example at connection point 1534. The increased tension of at least one filament 1512 causes tubular wall 1518 to bend, resulting in bending the moveable tip to a working position, as shown in Fig 15B. Referring to Fig. 16A, showing a partial schematic cross-sectional side view of a guide device with a variant of a movable tip, in a natural position, in accordance with some exemplary embodiments of the invention.

[0495] Referring also to Fig. 16B, showing a partial schematic cross-sectional front view of a guide device with a variant of a movable tip, in a bent position, in accordance with some exemplary embodiments of the invention.

[0496] Guide device 1600 is a detail of an embodiment of guide device 100, shown in Figs.lA- D. In some embodiments, guide device 1600 shares the same general functional elements as guide device 500 with the exception of some variances. The same reference numerals have been used to denote parts which are the same as or correspond to those of the previous embodiment, having a prefix of 16.

[0497] In some embodiments, guide device 1600 comprises movable tip, 1612. In some embodiments, movable tip 1612 is a variant of movable tip 1512.

[0498] In some embodiments, the movable tip comprises an accordion- shaped tubular wall 1618, having the potential advantage of reducing the required force to bend the movable tip 1612 with respect to tubular wall 1518.

[0499] Referring to Figs. 17A-B, showing an embodiment of a movable tip in a natural position (Fig. 17A) and in a bent position (Fig. 17B), in accordance with some exemplary embodiments of the invention.

[0500] In some embodiments, movable tip 1712 comprises a head 1720 and a body 1718, comprised of a plurality of interconnected segments 1770. Each segment can be bent relative to a neighboring segment, such that when tension is applied, the plurality of segments bent in the same direction to bend movable tip 1712. In some embodiments the linkage between the plurality of interconnected segments defines the bending direction, having the potential advantage of reducing deviation of bending toward an undesired direction.

[0501] Referring to Fig. 18, showing an embodiment of a movable tip in a natural position, in accordance with some exemplary embodiments of the invention.

[0502] In some embodiments, movable tip 1812 comprises a head 1820 and a flaxure 1818, having a plurality of spaced segments 1870 mounted on a band 1872. The space between the segments allows to bend each segment relative to a neighboring segment such that when tension is applied, the plurality of segments bent in the same direction to bend movable tip 1812. In some embodiments the spaces between the segments are equal and / or substantially equal, alternatively or additionally, the spaces between the segments are different. The spaces can be set to define a desired shape of movable tip 1812 in a bent position. In some embodiments, movable tip 1812 can be bent to compress the segments that define a bending in one direction and / or to stretch the segments to define a bending in an opposite direction. In some embodiments bending in the opposite direction allows an angle different than the bending in the first direction.

[0503] In some embodiments, the band is flexible, having the potential advantage of reducing the force required for bending movable tip 1812.

[0504] Referring to Fig. 19, showing a control for motorized operation, in accordance with some exemplary embodiments of the invention.

[0505] In some embodiments, a control 1900 comprises an actuator 1980 for operating thereof. In some embodiments, actuator 1980 is a linear actuator that converts a rotational motion of a motor to an axial linear motion which moves the slide button back and / or forth.

[0506] In some embodiments, actuator 1980 is attached to control 1908. In some embodiments, actuator 1980 comprises at least one protrusion 1982 configured to be inserted into a slot on the surface of slide button 1908 for connecting therebetween. For example, in some embodiments, slide button 1908 comprises a jagged surface and at least one protrusion 1982 fits between the edges thereof, such that when a rider of actuator 1980 is moved, slide button 1908 moves along.

[0507] In some embodiments, actuator 1980 can be detached from slide button 1908, optionally, for loading an endotracheal tube over the guide device, loading thereof over the control, and into the patient’s trachea. In some embodiments, actuator 1980 can be detached from control 1908 by gently pulling thereof, having the potential advantage of simplifying the process and / or reducing the time during the intubation procedure.

[0508] In some embodiments, the actuator is activated automatically. Alternatively or additionally, actuator 1980 can be activated by a physician. In some embodiments, the guide device further comprises an imaging system which together with actuator 1980 allows the physician to perform the intubation procedure remotely. The remote operation which potentially reduces the need for physical presence has the potential advantage of increasing the physician's availability. An additional potential advantage of the remote operation is reducing the risk of physicians getting infected by patients.

[0509] In some embodiments, alternatively or additionally to actuator 1980, control 1980 can be operated by a robotic arm. In some embodiments, a finger of the robotic arm can manipulate the slide button 1980 by moving thereof back and / or forward. Using a robotic arm potentially reduces the need for disconnecting an actuator (e.g., actuator 1980) from slide button 1908 prior to loading an endotracheal tube, having the potential advantage of further simplifying the process and / or reducing the time during the intubation procedure. Referring now to Fig. 20 showing a side view of a guide device, having more than one bending joint, in accordance with some exemplary embodiments of the invention.

[0510] Guide device 2000 is a detail of an embodiment of guide device 100, shown in Figs.lA- D. In some embodiments, guide device 2000 shares the same general functional elements as guide device 500 with the exception of some variances.

[0511] In some embodiments, guide device 2000 comprises more than one bending joint, having the potential advantage of enhancing the adjustability of the guide device’s shape (e.g., the tip’s shape). In some embodiments, the more than one bending joint is a pair of bending joints 2026, 2028, as shown for example in Fig. 20.

[0512] In some embodiments, a first bending joint 2026 is located distally, at movable tip 2012 as previously described in this document, and a second bending joint 2028 is located proximally to first bending joint 2026. In some embodiments, second bending joint 2028 is located about 0.8- 1.2 cm from first bending joint 2026. For example, second bending joint 2028 is distanced from first bending joint 2026 in about 0.5-1.5 cm, about 1-3 cm, 0.9-1.1 cm, or 1 cm, or lower or higher or intermediate ranges or distances.

[0513] In some embodiments, second bending joint 2028 is located on a proximal portion of movable tip 2012. In other embodiments, second bending joint 2028 is located along elongated shaft 2002.

[0514] In some embodiments, each bending joint 2026, 2028, can be bent separately, allowing the physician to obtain a single bent position at first or second bending joint 2026, 2028 and / or to simultaneously bend both bending joints 2026,2028 which results in movable tip 2012 having a double bend shape.

[0515] In some embodiments, guide device 2000 comprises a separate control (e.g., control 108) and / or control mechanism (e.g., control mechanism 109) for manipulating each bending joint, such that each bending joint 2026, 2028 can be bent to a different bending angle (relative to the longitudinal axis of the elongated shaft 2002) and / or toward a different radial direction.

[0516] Alternatively or additionally, bending first and second bending joints 2026, 2028 is synchronized, having the potential advantage of simplifying the operation of guide device 2000 for obtaining a desired double bend shape. In some embodiments, a single control (and / or control mechanism) can be used for bending more than one bending joint, for example, bending a pair of bending joints 2026, 2028. In some embodiments, the single control actively and / or simultaneously bends bending points 2026, 2028.

[0517] In some embodiments, first bending joint 2026 can be bent as previously described in this document for movable tip 112, (for example, with reference to Fig, 4A). In some embodiments, second bending joint 2028 has a motion range (e.g., range of bending angles and / or range of movement planes) as first bending joint 2026. Alternatively or additionally, the motion range of second bending joint 2028 can be relatively limited, potentially reducing and / or avoiding injuring the inner walls of the airway.

[0518] In some embodiments, an imaging device (e.g. imaging device 150) is located at and / or near first bending joint 2026, as previously described in this document. Alternatively or additionally, an imaging device can be located at and / or near second bending joint 2026.

[0519] Referring now to Figs. 21A-B showing cross-sectional side views of a guide device, having more than one bending joint, within a patient’s airway, in accordance with some exemplary embodiments of the invention.

[0520] In some embodiments, guide device 2000, having more than one bending joint, potentially facilitates the placement of the guide device within the trachea by improving the ability thereof to adjust to the shape of the patient’s airway.

[0521] For example, in some embodiments, second bending joint 2028 can be bent, as needed, to potentially avoid guide device 200 from being obstructed by the anterior and / or posterior wall of the airway. This bending can allow the advancement of tip 2012 toward the vocal cords and / or to allow the positioning thereof facing the vocal cords. Then, first bending joint 2026 can be bent, as needed, to pass through the glottis. The additional bending joint (e.g., second bending joint 2028) may be of considerable significance for intubating patients with “difficult airway”, for example, patients with an anterior larynx and / or a space-occupying lesion that makes visualizing the vocal cords difficult, having a relatively sharp approach angle to the vocal cords.

[0522] In some embodiments, the motion of second bending joint 2028 can be restricted to be bent toward a single radial direction and / or toward a range of radial directions, potentially avoiding bending toward radial directions which might injure the trachea’s anterior wall.

[0523] In some embodiments, the additional bending joint (e.g., bending joint 2028) allows elongated shaft 2002 to be more straight and / or more rigid while allowing movable tip 2012 to reach the vocal cords, having the potential advantage of improving the pushability of guide device 2000.

[0524] Referring now to Figs. 22A-B showing perspective views of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention.

[0525] Referring also to Fig. 22C showing a perspective view of a guide device having a pair of rotational buttons, in accordance with some exemplary embodiments of the invention.

[0526] Guide device 2200 is a detail of an embodiment of guide device 100 and / or 2000. The same reference numerals have been used to denote parts that are similar to those described for guide device 2000, with the prefix 22 replacing the prefix 20.

[0527] In some embodiments, guide device 2200 comprises a control (e.g., control 108) in the form of a rotational button 2208. In some embodiments, rotational button 2208 at least partially circumferentially surrounds elongated shaft 2002. In some embodiments, rotational button 2208 when rotated (around the longitudinal axis of elongated shaft 2002) manipulates (e.g., bends) movable tip 2012. In some embodiments, rotational button 2208 is configured to be rotated by a physician using the thumb and / or forefinger gripping guide device 2200.

[0528] In some embodiments, rotational button 2208 is located on a proximal portion of elongated shaft 2202, optionally, at a point along a proximal portion that extends from the proximal end to one-third of the elongated shaft’ s length, optionally this point is at the distal end of this proximal portion.

[0529] In some embodiments, rotational button 2208 does not extend radially from the crosssection elongated shaft 2022. In other embodiments, rotational button 2208 extends radially from the cross-section elongated shaft 2022, such that guide device 2200 fits within an endotracheal tube (orientated with the direction of the guide device)

[0530] In some embodiments, rotating rotational button 2208 from a retracted position in one circular direction (for example, clockwise), bends movable tip 2012 toward a first radial direction relative to the longitudinal axis of elongated shaft 2002, and optionally, rotating rotational button 2208 from a retracted position in the opposite circular direction (for example, counterclockwise) bends movable tip 2012 toward a second radial direction.

[0531] In some embodiments, when a grip and / or a force applied on rotational button 2208 is released, rotational button 2208 returns to a retracted position. Alternatively or additionally, when a grip and / or a force applied on rotational button 2208 is released, the position of rotational button 2208 remains set, and movable tip 2012 is set at a bent position. This allows the physician to set the movable tip to a desired angle with potentially less and / or without requiring applying force.

[0532] In some embodiments, the motion of rotational button 2208 is continuous, defining a continuous bending of movable tip 2012. Alternatively or additionally, the motion of rotational button 2208 is stepped, defining a stepped bending of movable tip 2012 wherein each step defines a different bending level

[0533] In some embodiments, at least one rotational button 2208 is distal from proximal end 106 of elongated shaft 2202. In some embodiments, at least one rotational button 2208 is rotated relative to elongated shaft 2022. In other embodiments, rotational button 2208 extends from proximal end 106 to a point along elongated shaft 2212 such that a proximal portion of guide device 2200 is rotated relative to a distal portion thereof.

[0534] In some embodiments, rotational button 2208 can further move axially, for example for manipulating the movable tip to bend toward an additional radial direction(s) and / or for manipulating an additional bending point joint.

[0535] In some embodiments, at least one rotational button 2208 comprises protrusions, bumps, and / or roughness for potentially reducing and / or preventing slippage of the physician’s finger(s). alternatively or additionally, rotational button 2208 comprises a high-friction material, such as rubber, which allows the surface to be smooth and / or substantially smooth together while potentially reducing and / or preventing slippage of the physician’ s finger(s). In some embodiments, the lack of protrusions, bumps, and / or roughness potentially improves the touch sensation of the finger that comes in contact with the surface of control 2208. In addition, the high-friction material can have some degree of softness, having the potential advantage of improving the comfort of a physician gripping rotational button 2208

[0536] In some embodiments, guide device 2200 comprises more than one rotational button 2208. In some embodiments, guide device 2200 comprises a first and second rotational control 2208, 2240 where first rotational button 2208 manipulates a first bending joint and second rotational button 2240 bends second bending joint 2028.

[0537] In other embodiments, second bending joint 2028 bends tip 2212 toward additional radial directions, such that first rotational button 2208 can manipulate movable tip 2212 toward two radial directions, and second rotational button 2240 can manipulate movable tip 2212 toward two other radial directions

[0538] In some embodiments, the pair of rotational buttons 2208,2240 potentially occupy relatively less longitudinal space over elongated shaft 2002, having the potential advantage of increasing the ease of operating guide devices having more than one control.

[0539] Referring now to Fig. 23A showing a side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention.

[0540] Referring also to Figs. 23B-E showing a cross-sectional side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention.

[0541] Referring also to Fig. 23F showing an exploded side view of a guide device having at least one rotational button, in accordance with some exemplary embodiments of the invention.

[0542] Guide device 2300 is a detailed embodiment of guide device 2200. The same reference numerals have been used to denote parts that are similar to those described for guide device 2200, with the prefix 23 replacing the prefix 20. In some embodiments, guide device 2300 comprises at least one actuator 2330, which converts rotational motion into axial motion, such as a screw and / or a threaded rod. Using actuator 2330 (e.g., screw) has the potential advantage of further reducing the force required for actuating at least one rotational control 2308, since the mechanical gain of the screw amplifies the axial forces applied on movable tip 2312. In some embodiments, the relatively low forces required to actuate at least one rotational control 2308, have the potential advantage of reducing the risk of finger slippage during actuation. This potentially reduces and / or avoids the need for roughness and / or bumps on the surface thereon, and / or requires relatively less prominent roughness and / or bumps.

[0543] In some embodiments, guide device 2300 comprises a pair of rotational buttons 2308,2340 and a pair of actuators 2330, 2331, each for every rotational button. In some embodiments, each of actuators 2330, 2331 is connected to a filament 2322, 2323, optionally at connection points 2332, 2334, as shown for example in Figs. 23C-D.

[0544] In some embodiments, inner lumen 2316 comprises grooves that match the shape of the screw’s thread. In some embodiments, the friction between the grooves and the screw’s thread can lock guide device 2300 in a working position as the grip and / or the force on rotatable control 2308 is released, such that movable tip 2308 is set in a bend position.

[0545] In some embodiments, the design of actuator 2330, such as the screwing angle and / or level of friction, is configured to prevent back driving. In some embodiments, lack of back driving reduces the need to provide force and / or friction to prevent the screw from moving due to pressure on movable tip 2312 and / or prevents movable tip 2312 from reverting to an unbent position. For example, the lack of back driving potentially prevents movements of screw 2330 as a result of movable tip 2312 countering the airway walls.

[0546] In other embodiments, the design of actuator 2330, such as the screwing angle and / or level of friction, is configured to allow back driving. In some embodiments, back driving has the potential advantage of reducing risk to the airway. In some embodiments, the back driving indicates resistance to the motion of movable tip 2023 within the patient's airway, so that optionally, the physician can adjust the bending level of movable tip 2023 and / or the level of applied force, having the potential advantage of may further reduce risk to the airway.

[0547] In some embodiments, guide device 2300 comprises movable tip 2012 having a first bending joint 2326 and a second bending joint 2328. In some embodiments, a first rotational button 2308 manipulates first 2326 bending joint and a second rotational button 2340 manipulates second 2328 bending joint. In some embodiments, each filament 2322, 2323 is connected to actuator 2330, 2331 at the proximal end thereof, and to a flexure 2318 of movable tip 2312 at the distal end thereof. In some embodiments, flexure 2318 comprises a notched structure, such as a tubular wall (e.g., tube) 2321 having radial notches 2315 that define a backbone along its length for potentially allowing the bending thereof. In some embodiments, flexure 2318 is a spring (e.g., spring 518, as previously described in this document, shown for example in Figs. 7A and 8D.

[0548] In some embodiments, the connection point of each filament 2322, 2323 to the flexure defines a bending joint.

[0549] In some embodiments, actuating rotational button 2308, 2340 move filament 2322, 2323 axially back and / or forth and apply tension and / or compression on the flexure of the movable tip. The tension and / or compression causes the flexure to bend, at the bending joint 2326, 2328.

[0550] In some embodiments, the pair of filaments 2322, 2323 extend along and within inner lumen 2316 optionally, in addition to a wiring of an imaging system. In some embodiments, the diameter of inner lumen 2316 allows comprising the pair of filaments and optionally, additional wiring while the diameter of elongated shaft 2302 can be fit within an endotracheal tube.

[0551] Exemplary lockable control

[0552] In some embodiments, the control is lockable. Herein, a lockable control may be referred to as a control that automatically remains in an actuated (e.g., non-retracted) position and / or does not return automatically to a retracted position when released.

[0553] In some embodiments, once released, the lockable control resists further movement and / or is locked in place. In some embodiments, the lockable control can be moved to another position, for example, returned to a retracted position, by applying sufficient force to overcome the resistance to movement and / or by releasing the lock. In some embodiments, once the lock is released the control can be moved while requiring low force, potentially reducing finger strain and / or fatigue, as described herein.

[0554] In some embodiments, the control also resists movement while being actuated (e.g., moved), requiring the operator (e.g., physician) to apply sufficient force to move it. Once released, the resistance to movement holds the control in place, potentially preventing it from moving.

[0555] The lockable control potentially reduces the need for continuous force (e.g., applied by the operator) to hold the guide device’s movable tip in place, having the potential advantage of reducing user fatigue during use, optionally, prolonged use. In addition, this lock potentially reduces and / or prevents unintended slipping and / or movements of the user’s finger(s), having the potential advantage of reducing and / or avoiding undesired movement of the movable tip during operation.

[0556] Referring to Figs. 24A-C, showing schematic fractional cross-sectional side views of a guide device 2400 having at least one lockable control 2408, in accordance with some exemplary embodiments of the invention.

[0557] Guide device 2400 may be a detailed embodiment of guide device 500. The same reference numerals have been used to denote parts that are similar to those described for guide device 500, with the prefix 24 replacing the prefix 5.

[0558] In some embodiments, guide device 2400 comprises at least one control 2408, optionally, more than one control 2408, optionally, two controls 2408 and 2440. More than one control 2408 may be configured for bending bendable tip 2412 in more than one radial direction and / or for bending more than one bending joint (e.g., 2026, 2028), as described herein in this document.

[0559] In some embodiments, at least one control 2408 can be locked in an unretracted position, such that the tip 2412 remains fixed in a bent position. Optionally, in some embodiments, when a grip and / or force applied to at least one control 2408 is released, the position of the control 2408 remains set, thereby locking the bendable tip 2412 in its bent position.

[0560] In some embodiments, guide device 2400 comprises at least one lock 2490. Optionally, guide device 2400 comprises a lock 2490 for each control of at least one control 2408. Alternatively or additionally, guide device 2400 comprises lock 2490 shared to more than one control 2408, for example to a pair of controls 2408, 2440.

[0561] In some embodiments, guide device 2400 and / or lock 2490 comprises a release button 2492 and / or any other release mechanism, optionally, for releasing at least one control 2408 back to a retracted position, thereby releasing the fixed bent position of bendable tip 2412. Alternatively or additionally, release button 2492 may be configured to release at least one control 2408 to move to another actuated position.

[0562] In some embodiments, guide device 2400 comprises a single release button 2492, configured to release lock 2490 of at least one control 2408. In some embodiments, at least one control 2408 comprises more than one control (e.g., controls 2408 and 2440), all of which can be released by actuating release button 2492, thereby allowing the bendable tip 2412 to return to its unbent configuration. A potential advantage of a single release button is the simplification of the release operation, and / or allowing for a quick and / or efficient resetting of the bendable tip 2412 to its natural (e.g., non-retracted) configuration.

[0563] In some embodiments, guiding device 2400 may comprise more than one release button 2492, optionally a separate release button 2492 for each control 2408. More than one release button potentially allows for independent control of each bending joint and / or bending direction, allowing the operator to selectively release only the desired control without affecting the others.

[0564] In some embodiments, release button 2492 is positioned at a distance from at least one control 2408, this distance potentially reduces the risk of accidental contact and / or unintentional release of the fixed bent position of the bendable tip 2412. In other embodiments, release button 2492 is positioned near at least one control 2408, potentially allowing the operator to easily access and actuate the release mechanism 2492 during operation.

[0565] In some embodiments, as shown for example in Figs. 24A-D, at least one control 2408 is in the form of a slide button, optionally, two slide buttons 2408, 2440. In some embodiments, lock 2490 comprises an elongated element 2494 (such as a rod) that interacts with second section 2430 (e.g., the section of the slide button 2408 which is incorporated mainly within lumen 2416 of elongated shaft 2402). In some embodiments, elongated element 2494 comes into contact with second section 2430 and generates friction between them, which, potentially prevents the slide buttons 2408, and / or 2440 from moving and / or potentially holding them in place. In some embodiments, the surface of the elongated element 2494 facing slide buttons 2408, 2440 may include protrusions and / or a textured (e.g., rough) surface designed to create the required friction.

[0566] In some embodiments, lock 2490 and / or second section 2430 are designed such that the friction generated by their contact acts in both directions of movement of slide buttons 2408, and / or 2440. Alternatively or additionally, in some embodiments, the friction acts only in one direction, for example, allowing (continued) movement in a forward direction (e.g., bending distal tip 2412) but resisting movement in the reverse direction (e.g., releasing distal tip 2412).

[0567] In some embodiments, pressing release button 2492 disengages the locking by separating elongated element 2494 from second section 2430 of slide buttons 2408, and 2440, removing the contact and / or friction therebetween, which potentially allows the buttons to move freely again.

[0568] In some embodiments, lock 2490 comprises a linear ratchet system configured to secure the position of at least one control 2408 in a fixed state. In some embodiments, the linear ratchet mechanism comprises a linear component (e.g., rack) having spaced teeth along its length, optionally, uniformly spaced teeth. When a force is applied on slide button 2408, second section 2430 slides over the rack’s teeth in the forward direction. Once the forward motion stops, second section 2430 locks into place between the teeth. The shape of the teeth potentially prevents second section 2430 from moving backward, potentially locking the lock in its current position. In some embodiments, a release button and / or any other release mechanism disengages the second section 2430 from the teeth, potentially allowing backward motion and / or free movement. In some embodiments, the release mechanism may be incorporated within the operation of at least one control 2408, optionally, such that guide device 2400 lacks a release button, as shown for example in Fig. 24C. In some embodiments, at least one control 2408 may be a slide button and / or a rotational button (e.g., 2208) as described herein. In some embodiments, lock 2490 is configured to allow at least one control 2408 to be moved, optionally freely, when pressure is applied thereon (for example by pushing down on the control). In some embodiments, when the pressure is released, the lock 2490 automatically locks the at least one control 2408 in place. In some embodiments, lock 2490 is configured to obstruct second section 2430 from moving and lock it in place when the least one control 2408 is released. For example, in some embodiments, lock 2490 may comprise a spring-loaded latch, friction element (e.g., rough surface), and / or detent that engages at least a portion of second section 2430, thereby potentially preventing movement of slide button 2408.

[0569] In some embodiments, when the physician pushes down on at least one control 2408 (with sufficient force), second section 2430 and the lock 2490 are disengaged, allowing the at least one control to be actuated. For example, in the case of a slide button, the physician pushes the button to slide it. In another example, in the case of a rotational button (e.g., rotational control 2208 shown in Fig. 22B), the user presses the button to rotate it freely to the desired angle. Once the user releases the downward pressure, lock 2490 re-engages, optionally, automatically. This re-engagement locks movable tip 2412 in its current position, potentially preventing further movement until control 2408 is pushed again.

[0570] Referring to Fig. 24D, showing a schematic cross-sectional side view of a movable tip 2412 having two bending joints 2426 and 2428, in accordance with some exemplary embodiments of the invention.

[0571] In some embodiments, movable tip 2412 comprises a flexure 2418, for example, similar and / or as flexure 2318.

[0572] In some embodiments, flexure 2418 comprises a notched structure, such as a tube 2421 having a plurality of radial notches 2415 positioned along its length. In some embodiments, notches 2415 are relatively large to potentially reduce the tip resistance to bending, and potentially require relatively little force to achieve a desired bent position. In some embodiments, notches 2415 are rounded, having the potential advantage of reducing the risk of flexure breakage during bending.

[0573] In some embodiments, the notched structure forms a backbone 2417 along the longitudinal axis of movable tip 2412. In some embodiments, backbone 2417 is structured for potentially reducing resistance to bending. For example, backbone 2417 may be relatively thin and / or positioned at the center of flexure 2418, thereby potentially enhancing the flexibility of movable tip 2412. Alternatively or additionally, backbone 2417 may be positioned on one side of the flexure, thereby potentially increasing resistance to bending in the radial direction on that side. In some embodiments, backbone 2417 is shaped with and / or comprises a thin and wide structure, potentially facilitating bending flexure 2418 in the thinner direction compared to the wider direction.

[0574] In some embodiments, the notches 2415 extend along the entire circumference of flexure 2418, potentially allowing bending in any radial direction. In other embodiments, the notches 2415 are located only on one side and / or specific portions of flexure 2418, potentially allowing bending primarily in the direction of the notches.

[0575] In some embodiments, at least one filament 2422, 2423 is attached to flexure 2418, such that applying tension to at least one filament 2422, 2423 bends movable tip 2412. In some embodiments, a first filament 2422 is connected to flexure 2418 and defining distal bending joint 2426. In some embodiments, a second filament 2423 is connected to flexure 2418 at a more proximal location and defining proximal bending joint 2428. Optionally, sections of flexure where a filament connects (between two segments) are more robust.

[0576] In some embodiments, each bending joint 2426 and 2428 defines a different bending direction. In some embodiments, notches 2415 are located and / or oriented differently for each bending joint 2426 and 2428, thereby defining a desired bending direction for each specific joint. In some embodiments, the notches defining bending joints 2426 are positioned in an opposite angular direction to the notches defining bending joints 2428, such that movable tip 2412 (and / or flexure 2418) is shaped into an overall "S" shape when both joints are flexed (e.g., bent).

[0577] In some embodiments, flexure 2418 comprises a helical structure such as a spring, optionally, lacking a backbone. In some embodiments, filaments 2422, and 2423 are connected to the helical structure at two different locations. In some embodiments, the lack of backbone potentially reduces the resistance of flexure 2418 to bending, having the potential advantage of requiring relatively reduced force for bending movable tip 2412.

[0578] Referring to Figs. 25A-B, showing schematic cross-sectional side views of a distal portion of a guide device 2500 having a bent natural position, in accordance with some exemplary embodiments of the invention.

[0579] Referring also to Fig. 25C, showing a schematic side view of a guide device 2600 having a bent natural position, in accordance with some exemplary embodiments of the invention. Referring also to Figs. 26A-B, showing schematic cross-sectional side views of a distal portion of a guide device 2600 having a straight natural position, in accordance with some exemplary embodiments of the invention.

[0580] In some embodiments, the guide device (e.g., guide device 2700) comprises a straight elongated shaft 2602. Optionally, when movable tip 2612 is in a natural position it is in line with the straight elongated shaft 2602, as shown for example in Figure 27 A.

[0581] In some embodiments, elongated shaft 2502 comprises a bent natural position by comprising a fixed angle y, located proximally to movable tip 2612. In some embodiments, fixed angle y is located about 2.5-5 cm from the distal end of elongated shaft 2502. For example, 1-3 cm, or 1-5 cm, or 2-10 cm, or 2.5, or 5, or lower or higher or intermediate numbers of lengths.

[0582] In some embodiments, fixed angle y is about 120 degrees. For example, 90-120 degrees, 120-150 degrees, 110-130 degrees, 120 degrees, 140 degrees, or 100 degrees or lower or higher or intermediate ranges or angles.

[0583] In some embodiments, fixed angle y is configured to direct movable tip 2512 toward the trachea. In some embodiments, fixed angle y shapes the guide device such that elongated shaft 2502 matches and / or conforms to the anatomical orientation of the path leading to the trachea. This potentially facilitates directing movable tip 2512 toward the trachea and / or reducing and / or avoiding the risk of tip 2512 entering the posterior pharynx and / or getting stuck against soft tissues. In some embodiments, fixed angle y facilitates reaching near the vocal cords. Once positioned near the vocal cords, movable tip 2512 may be bent to navigate through the vocal cords into the trachea. Movable tip 2512 potentially facilitates overcoming challenging and / or complex airway anatomies.

[0584] In some embodiments, elongated shaft 2502 comprises a deformable material, potentially allowing the formation of fixed angle y. In some embodiments, guide device 2500 is provided straight, as shown for example in figures 26A-B, and fixed angle y is shaped by the physician according to specific needs. Alternatively or additionally, guide device 2500 is provided with fixed angle y, and optionally the deformability allows the physician to adjust the degrees of fixed angle y as needed.

[0585] In some embodiments, elongated shaft 2502 comprises a material with some level of rigidity for potentially reducing and / or avoiding the risk of undesired change in fixed angle y during the procedure. In some embodiments, elongated shaft 2502 comprises and / or is formed of medicalgrade polymers.

[0586] In some embodiments, the control mechanism (e.g., control mechanism 109 shown in Figure IE) applies relatively low force on the inner walls of the elongated shaft 2502, potentially allowing elongated shaft 2502 to maintain a fixed angle y without straightening. In some embodiments, elongated shaft 2502 comprises at least a deformable portion such that fixed angle Y may be formed by bending elongated shaft 2502, optionally manually. In some embodiments, the force applied by the control mechanism on the inner walls of the elongated shaft 2502 is sufficiently low to potentially avoid straightening of the bent deformable portion.

[0587] In some embodiments, movable tip 2512 comprises two bending joints 2526, 2528, located distally to fixed angle In some embodiments, bending one of joints 2526, 2528 shapes movable tip 2512 to comprise an additional angle, distal to fixed angle \-

[0588] In some embodiments, two bending joints 2526, 2528 can bent to shape movable tip 2512 to comprise two additional bending angles a, 9, distal to fixed angle \-

[0589] In some embodiments, two bending joints 2526, 2528 can be manipulated to form movable tip 2512 into an "S" shape. This configuration is achieved by bending the first joint (distal) in one direction and the second joint (proximal) in the opposite direction, optionally creating a smooth, double-curved structure resembling the letter "S". The "S" shape potentially allows movable tip 2512 to better navigate through complex airway anatomies for example by maneuvering around obstructions or anatomical variations, such as a sharp angle in the airway or a challenging laryngeal entry.

[0590] Referring now to Fig. 27 A, showing a top view of a guide device 2700 having a tip 2712 with two bending joints controlled by slide buttons, in a retracted position, in accordance with some exemplary embodiments of the invention.

[0591] Referring also to Fig. 27B, showing a side view of a guide device 2700, having a tip 2712 with two bending joints controlled by slide buttons, in a bent position, in accordance with some exemplary embodiments of the invention.

[0592] Referring also to Fig. 27C, showing a cross-sectional side view of a movable tip 2712 having a tip with two bending joints, in a retracted position, in accordance with some exemplary embodiments of the invention.

[0593] Referring also to Fig. 27D, showing a cross-sectional side view of a portion of a slide button, in accordance with some exemplary embodiments of the invention.

[0594] Referring also to Fig. 27E, showing a cross-sectional view of a portion of a slide button, in accordance with some exemplary embodiments of the invention.

[0595] Referring also to Fig. 27F, showing a fractional side view of a guide device 2700, having a tip with two bending joints 2712 controlled by slide buttons, in a bent position, in accordance with some exemplary embodiments of the invention.

[0596] The same reference numerals have been used to denote parts that are similar to those previously described in this document, with the prefix 27 replacing any other prefix. In some embodiments, movable tip 2712 comprises a flexure 2718 comprising at least one hinged connection. In some embodiments, flexure 2718 comprises a plurality of hinged connections, optionally two hinged connections. In some embodiments, each hinged connection serves as a pivot point and defines a bending joint 2726 and 2728 of movable tip 2712. In some embodiments, each hinged connection (e.g., bending joints) is defined by two rigid elongated elements 2798 (e.g., rods). In some embodiments, rigid elongated elements 2798 comprise and / or are formed of rigid materials such as metals, rigid polymers, and / or composite materials. connected at their ends (for example via a pin). In some embodiments, for example, as shown in figure 27F, flexure 2718 comprises a distal elongated element 2798a, a proximal elongated element2798c, and one or more intermediate elongated element s2798b therebetween, such that the hinged connection of distal elongated element 2798a and intermediate elongated element2798b defines first (e.g., distal) bending joint 2726 while the hinged connection of intermediate elongated element 2798b and proximal elongated element 2798c defines second (e.g., proximal) bending joint 2728.

[0597] In some embodiments, movable tip 2712 comprises a soft, flexible, and / or shrinkable outer cover, potentially sufficient to allow movement of bending joints 2726 and 2728.

[0598] Alternatively or additionally, movable tip 2712 comprises a segmented outer cover, as shown for example in Fig. 27F. In some embodiments, an interface between two adjacent segments is aligned with a hinged connection, thereby allowing the movement of the corresponding bending joint. In some embodiments, the segmented outer cover comprises a distal segment 2799a, a proximal segment 2799c, and an intermediate segment 2799b therebetween, where optionally, distal 2799a segment comprises head 2720 which may comprise imaging device 2750.

[0599] In some embodiments, the outer cover of movable tip 2712 comprises at least one portion of a shrinkable cover 2791 between two adjacent segments, potentially allowing the movement of the bending joints. In some embodiments, segment 2799 comprises a rigid material, such that shrinkable cover portions 2791 potentially allows the bending motion of movable tip 2712. Alternatively or additionally, segments 2791 comprises a soft and / or flexible material, potentially allowing them to bend as well.

[0600] In some embodiments, bending joints 2726 and 2728 are actuated by at least one filament 2722, optionally, a separate filament for each bending joint. In some embodiments, each filament is routed through the plurality of elongated elements 2798 and connected to at least one rigid elongated element 2798. In some embodiments, bending joint 2726 is defined by the connection of a filament to distal elongated element 2798a, and bending joint 2728 is defined by the connection of a filament to intermediate elongated element 2798b. In some embodiments, when tension is applied to at least one filament 2722, it bends the hinge connection which results in the movement of the segments relative to each other.

[0601] Alternatively or additionally, in some embodiments, each filament is routed between flexure 2722 and the outer cover, and optionally connected to one or more segments of the outer cover. In some embodiments, when tension is applied to the filament 2722, it pulls one segment relative to the other, thereby causing the corresponding hinged connection to articulate. In some embodiments, bending joint 2726 is defined by the connection of a filament to distal segment 2799a, and bending joint 2728 is defined by the connection of a filament to intermediate segment 2799b.

[0602] In some embodiments, the movement of the at least one filament 2722 can be actuated via at least one slide button 2708 and 2740, for example, as described herein in this document. In some embodiments, each bending joint is actuated by a separate, slide button 2708 and 2740 and / or filament 2722.

[0603] In some embodiments, the at least one slide button 2708 and 2740 is actuated by moving thereof forward and / or backward, for example as described herein in this document. In some embodiments, once released, the at least one slide button 2708 and 2740 returned to a retracted position, leading to the bending joint controlled by it to return to its unbent position. In some embodiments, at least one sliding button 2708 and 2740 is lockable, for example, as described herein in this document. In some embodiments, guide device 2700 comprises more than one sliding button, optionally a pair of slide buttons 2708 and 2740. In some embodiments, at least one of the more than one sliding buttons is a lockable slide button. For example, in some embodiments, slide button 2740 which controls proximal bending joint 2728 may be actuated while navigating through the airway and locked in a bent position once positioning movable tip 2712 facing the vocal cords. Then, the distal bending joint may be bent by actuating slide button 2708 for passing through the vocal cords.

[0604] In some embodiments, lumen 2716 of elongated shaft 2702 comprises a leaf spring 2797 and / or any other flexure, aligned with at least one slide button 2708 and / or 2740. When the slide button is not under external force, the leaf spring 2797 applies pressure (vertical force) against it, optionally contacting second section 2730, creating friction that potentially prevents the button's movement. When sufficient force is applied to the slide button, for example, by pressing it with a finger, the applied force overcomes the friction, allowing the button to move along its designated path (e.g., groove 2732). Once the external force is released, the pressure from leaf spring 2797 and / or the friction between the leaf spring and the button locks the button into its position, potentially maintaining its unretracted position. In some embodiments, second section 2730 of slide button 2708 comprises at least one protrusion 2795, shaped and sized to be placed within at least one recess 2793 in the inner surface of elongated shaft 2702. In some embodiments, recess 2793 comprises a matching geometry to the geometry of the at least one protrusion 2795. The matching geometry between the protrusion and the recess holds the button in place when no force is applied to at least one slide button.

[0605] In some embodiments, when slide button 2708 is pressed, second section 2730 of the button moves downward, disengaging the protrusion 2795 from the recess 2793 and allowing slide button 2708, 2740 to move. Once the slide button is released, protrusion 2795 returns into recess 2793, thereby locking the slide button in place (e.g., new position).

[0606] In some embodiments, the protrusion and recess are continuous along the longitudinal axis of elongated shaft 2702. Alternatively or additionally, the protrusion comprises a plurality of protrusions arranged along the longitudinal axis, which engage with a corresponding series of recesses.

[0607] General

[0608] It is expected that during the life of a patent maturing from this application many relevant controls will be developed; the scope of the term controls is intended to include all such new technologies a priori.

[0609] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0610] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0611] The term “consisting of’ means “including and limited to”.

[0612] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0613] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0614] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0615] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0616] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0617] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0618] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0619] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A guide device for endotracheal intubation, comprising:(a) an elongate body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;(b) a controllable bendable tip at the distal end of the body, bendable over a range of at least 120 degrees; and(c) at least one human-finger manipulatable control which:(i) located along said elongated body, at a distance of at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and(ii) when manipulated, bend said tip, wherein bending said tip to 90 degrees is achieved by applying a force of no more than 3 Newton by the at least one human finger, wherein all of the device fits within a lumen of an endotracheal tube.

2. The guide device according to claim 1, wherein the elongated body comprises a fixed angle proximal to the bendable tip.

3. The guide device according to claim 2, wherein the fixed angle comprises an angle of 120 degrees.

4. The guide device according to claim 1, wherein the bendable tip comprises a bending joint.

5. The guide device according to claim 4, wherein the bendable tip comprises an additional bending joint proximal to the bending joint.

6. The guide device according to claim 1, wherein the at least one control comprises a pair of controls.

7. The guide device according to claim 6, wherein a first control of the pair of controls bends the bending joint and a second control of the pair of controls bends the additional bending joint.

8. The guide device according to claim 6, wherein each control of the pair of controls bent the tip toward two radial directions, wherein the pair of controls define four radial directions.

9. The guide device according to claim 8, wherein the four radial directions are along two movement planes.

10. The guide device according to claim 9, wherein the two movement planes are orthogonal.

11. The guide device according to claim 9, wherein the two movements planes are not orthogonal.

12. The guide device according to claim 1, wherein the control can be locked in an unretracted position.

13. The guide device according to claim 12, comprising a release button for unlocking the control.

14. The guide device according to claim 12, wherein the control is configured to be locked once the bendable tip is released.

15. The guide device according to claim 1, wherein the at least one control comprises a rotational button.

16. The guide device according to claim 1, wherein the at least one control comprises a linear slide button.

17. The guide device according to claim 1, wherein said control does not extend out of said maximum diameter.

18. The guide device according to claim 1, wherein the elongated body is at least 70 cm long and the control is distanced 15-30 cm from the proximal end of the elongated body.

19. The guide device according to claim 1, wherein the at least one control is located at a proximal portion of the elongated body, wherein a length of the proximal portion is a third of a length of the elongated body.

20. The guide device according to claim 1, , wherein at least 90 degrees of the range of at least 120 degrees are at one side of a longitudinal axis of the elongated body.

21. The guide device according to claim 1, wherein the tip comprises a flexure and a head, wherein the flexure is connected to the head at one end thereof and to the distal end of the elongated body at the other end thereof.

22. The guide device according to claim 21, wherein the flexure comprises a spring.

23. The guide device according to claim 21, comprises at least one filament coupling the control with the tip, and whereby manipulating the control the at least one filament applied tension on the tip which together with the axial contrast of the flexure causes the tip to bend.

24. The guide device according to claim 1, wherein the control is configured to move continuously defining a continuously bending motion of the tip.

25. The guide device according to claim 1, wherein the control is configured to move in steps defining a stepped motion of the tip.

26. The guide device according to claim 1, comprises an imaging system, wherein the imaging system comprises a video camera at or near the tip.

27. The guide device according to claim 26, wherein the imaging system comprises a control for operating the video camera.

28. The guide device according to claim 23, wherein the elongated body comprises a wall defining an inner lumen, and wherein the at least one filament extends within the inner lumen.

29. The guide device according to claim 28, wherein the at least one filament is incorporated within the wall of the elongated body, wherein the inner lumen can comprise a battery and a wiring of an imaging system.

30. The guide device according to claim 1, wherein the tip is in line with the longitudinal axis of the elongated body in a retracted position.

31. A guide device for endotracheal intubation, comprising:(a) an elongated body, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;(b) a controllable first bending joint at a tip at the distal end of the body;(c) at least one additional bending joint located proximally from said first bending joint, at a distance of at least 0.8 mm;(d) at least one human-finger manipulatable control which:(i) located along said elongated body, distance at least 5 mm from said proximal end, sufficient to grip the guide device at or near the control; and(ii) when manipulated, bend said tip, by the at least one human finger.

32. A guide device for endotracheal intubation, comprising:(a) an elongated body at least 50 cm long, having a proximal end, a distal end, and a maximum diameter smaller than 8 mm;(b) a controllable bendable tip at the distal end of the body,;(c) at least one human-finger manipulable control which:(i) located along said elongated body, distance at least 5 mm from said proximal end,(ii) when manipulated, bend said tip,(iii) can be locked in an unretracted position, thereby fixing the bendable tip in a bent position.

33. A method for inserting a guide device with a movable tip into a patient's trachea through the vocal cords of the patient, comprising: inserting the guide device into the patient's mouth; viewing the vocal cords of the patient using a guide device with an imaging device at and / or near the movable tip; manipulating a control of the guide device while gripping the guide device in an insertion position; bending the movable tip of the guide device to overcome obstructions toward the trachea; advancing the guide device toward the trachea; and passing an endotracheal tube the over the control; and inserting the endotracheal tube into the trachea over the guide device.

34. The method according to claim 33, wherein the inserting the guide device comprises inserting the guide device into the patient’s mouth perpendicular relative to a lying patient.

35. The method according to claim 33, wherein the inserting the guide device comprises positioning the physician’s elbows adjacent to the body thereof, wherein the elbows are at an angle of 90 degrees.

36. The method according to claim 33, wherein the method comprises standing in an upright posture.

37. The method according to claim 33, wherein the viewing comprises viewing the vocal cords on a screen or a monitor positioned according to the operator's convenience.

38. The method according to claim 33, wherein the manipulating comprises applying a force of no more than 3 Newton for bending the movable tip to an angle of 0-120 degrees.

39. The method according to claim 33, wherein the manipulating comprises bending more than one bending joint of the movable tip.

40. The method according to claim 39, wherein the bending more than one bending joint comprises bending a proximal bending joint for advancing the movable tip toward the vocal cords of the patient.

41. The method according to claim 39, wherein the bending more than one bending joint comprises bending a distal bending joint for passing through the glottis of the patient.

42. The method according to claim 39, wherein the bending more than one bending joint comprises manipulating the movable tip into an “s” shape by bending two bending joints.

43. The method according to claim 33, wherein the bending comprises bending the movable tip along more than one movement plane.

44. The method according to claim 33, comprising allowing the movable tip to be fixed in a bent position by locking the control in an unretracted position.

45. The method according to claim 44, comprising unlocking the control.

46. The method according to calim 33, comprising documenting placement of the endotracheal tube within the trachea, by recording a video or by taking at least one screenshot.

47. The method according to claim 33, comprising depressing and moving the patient's tongue before inserting the guide device, using a tongue depressor.

48. The method according to claim 33, comprising selecting if to insert the guide device pre-loaded with an endotracheal tube or bare of endotracheal.

49. The method according to claim 48, comprising loading the endotracheal tube over the proximal end of the guide device, passing the endotracheal tube over the control, into the patient's mouth toward the movable tip at the distal end.

50. The method according to claim 49, wherein the loading comprises loading the endotracheal tube such that the control is not covered or partially covered by the endotracheal tube.

Images