Deflection mechanism for ENT tools

Abstract

The present invention relates to a medical tool comprising a deflectable distal end, at least a pull wire and a deflection assembly. The at least pull wire has a first end coupled to the distal end of the medical tool and is configured to move to deflect the distal end. The deflection assembly is coupled to at least the second end of the pull wire and is configured to control the deflection of the distal end. The deflection assembly comprises a first gear having a first axis of rotation; and a second gear having a second axis of rotation and comprising a serrated surface for integration with the first gear. The serrated surface is inclined relative to the second axis of rotation, and when the first gear rotates, the second gear is configured to be rotated by the first gear, move along the second axis of rotation and deflect the distal end by moving the pull wire.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to U.S. patent application entitled “Non-circular working channel of an ear-nose-throattool” and attorney docket number ID-1758 / BIO6271USNP1 / 1002-2126. This application is also related to U.S. patent application entitled “Preventing twisting of pull wires when deflecting an ear-nose-throattool” and attorney docket number ID-1776 / BIO6273USNP1 / 1002-2129. The disclosures of these related applications are incorporated herein by reference. Technical Field

[0003] The present invention relates generally to medical devices, and particularly to methods and systems for deflecting ear, nose and throat (ENT) tools. Background Art

[0004] Some medical tools, such as ear, nose and throat (ENT) tools, may have bending capabilities.

[0005] For example, U.S. Patent Application Publication No. 2011 / 0295242 describes a device and system for controlling the movement of a working end of a surgical device by a robotic system. In one embodiment, a system and device for moving an end effector on the distal end of a surgical fastening device are provided. The movement can include rotational movement of the end effector about the axis of a shaft, articulation of the end effector relative to the shaft, and actuation of the end effector, for example, closing, firing, and / or cutting.

[0006] U.S. Patent 6,485,455 describes a catheter having an electrode tip assembly that is bendable in two different directions at the user's option. The electrode tip assembly assumes different asymmetric, predetermined curvilinear configurations when bent in the two directions and is steered by a steering wire adjustably connected tangentially to the lateral edge of a rotatable cam located in the catheter handle. Summary of the Invention

[0007] Embodiments of the invention described herein provide a medical tool comprising a rotatable hollow tube and one or more electrical wires. The rotatable hollow tube defines a working channel therein for inserting a medical device into a cavity in a patient's body. The one or more electrical wires traverse the working channel for exchanging electrical signals with one or more electronic devices located at the distal end of the rotatable hollow tube. The working channel has a non-circular cross-section for passing both the medical device and the one or more electrical wires therethrough, and for allowing the rotatable hollow tube to rotate relative to the medical device located within the working channel in the presence of the one or more electrical wires.

[0008] In some embodiments, the cavity includes a nasal cavity in the patient's head, and the medical instrument is selected from the list consisting of: (a) a balloon, (b) a guide wire, (c) a suction tube, (d) a surgical tool, (e) an ENT diagnostic tool, (f) an ENT treatment tool, and (g) any combination thereof. In other embodiments, the medical tool includes a rotatable knob configured to rotate at least one of the rotatable hollow tube and the medical instrument using a rotation mechanism. In yet other embodiments, the rotatable knob is configured to rotate in at least one of a clockwise direction and a counterclockwise direction within a rotation angle range between 0 ° and 180 °.

[0009] In an embodiment, the medical tool includes one or more pull wires, each pull wire having a first end coupled to a distal end portion and a second end coupled to a deflection mechanism, for deflecting the distal end portion by pulling the one or more pull wires. The rotatable hollow tube includes a retainer configured to be coupled between the hollow tube and the deflection mechanism to prevent the one or more pull wires from twisting around a component of the medical tool. In another embodiment, the one or more wires include a braid of wires.

[0010] According to one embodiment of the present invention, a method for producing a medical tool is further provided, the method comprising providing a rotatable hollow tube defining a working channel therein for inserting a medical device into a cavity of a patient's body. One or more electrical wires pass through the working channel for exchanging electrical signals with one or more electronic devices located at a distal end of the rotatable hollow tube. The working channel has a non-circular cross-section for passing both the medical device and the one or more electrical wires therethrough, and for allowing the rotatable hollow tube to rotate relative to the medical device located within the working channel in the presence of the one or more electrical wires.

[0011] Another embodiment of the present invention provides a medical tool comprising a deflectable distal end, at least a pull wire, and a deflection assembly. At least the pull wire has a first end coupled to the distal end of the medical tool and is configured to move to deflect the distal end. The deflection assembly is coupled to at least the second end of the pull wire and is configured to control the deflection of the distal end. The deflection assembly comprises a first gear having a first axis of rotation; and a second gear having a second axis of rotation and comprising a serrated surface for integration with the first gear. The serrated surface is inclined relative to the second axis of rotation, and when the first gear rotates, the second gear is configured to be rotated by the first gear and move along the second axis of rotation, and deflect the distal end by moving the pull wire.

[0012] In some embodiments, the second gear has a circumference comprising the following segments: (i) a first segment having (a) a first thickness along the second rotational axis and (b) a first serrated segment extending therefrom with a serrated surface, and (ii) a second segment having (a) a second thickness along the second rotational axis that is less than the first thickness, and (b) a second serrated segment extending therefrom with a serrated surface. Upon rotation of the second gear: when the first serrated segment contacts the first gear, the distal end deflects a first amount, and when the second serrated segment contacts the first gear, the distal end deflects a second amount that is less than the first amount. In other embodiments, the medical tool comprises a rotatable knob coupled to the first gear and configured to control the deflection by rotating the first gear. In yet other embodiments, the medical tool comprises a coupling element coupled to at least the second end of the pull wire and configured to be moved along the second rotational axis by the second gear.

[0013] In an embodiment, the second gear is hollow and the medical tool includes one or more rods that are parallel to the second rotation axis and transverse to the second gear so that the second gear is moved along the second rotation axis by the one or more rods. In another embodiment, the medical tool includes a hollow tube disposed between the distal end and the deflection assembly, and the hollow tube defines a working channel therein for inserting the medical instrument through the distal end into a cavity of the patient's body. In yet another embodiment, the cavity includes a nasal cavity in the patient's head, and the working channel is used to insert a medical instrument selected from the list consisting of: (a) a balloon, (b) a guidewire, (c) a suction tube, (d) a surgical tool, (e) an ENT diagnostic tool, (f) an ENT treatment tool, and (g) any combination thereof.

[0014] According to one embodiment of the present invention, there is further provided a method for producing a medical instrument, the method comprising providing a deflectable distal end portion. The distal end portion of the medical instrument is coupled to at least a first end portion of a pull wire, which is to be moved to deflect the distal end portion. At least a second end portion of the pull wire is coupled to a deflection assembly for controlling the deflection of the distal end portion. The deflection assembly comprises a first gear having a first axis of rotation; and a second gear having a second axis of rotation and comprising a serrated surface for integration with the first gear. The serrated surface is inclined relative to the second axis of rotation, and when the first gear rotates, the second gear is rotated by the first gear and moves along the second axis of rotation for deflecting the distal end portion by moving the pull wire.

[0015] Another embodiment of the present invention provides a medical tool comprising a deflectable distal end, at least a pull wire, and a coupling element. At least the pull wire has a first end coupled to the distal end of the medical tool and is configured to move to deflect the distal end. The coupling element is coupled to the second end of the pull wire and has at least two bores configured to receive at least two corresponding rods therethrough. The coupling element is configured to move along the axis of rotation of a rotatable element coupled thereto, and the bores and corresponding rods are configured to prevent rotation of the coupling element.

[0016] In some embodiments, the coupling element has at least one additional borehole, and the pull wire traverses the additional borehole. In other embodiments, the rotatable element includes a hollow gear surrounding at least a portion of the coupling element, and when the hollow gear rotates, the coupling element moves along the axis of rotation, and the rod prevents the coupling element from rotating with the hollow gear. In still other embodiments, the coupling element has a faceplate coupled to the second end of the pull wire and in physical contact with the rotatable element to facilitate movement along the axis of rotation.

[0017] In an embodiment, the coupling element has an additional bore defining a working channel therein for inserting a medical device into a cavity of the patient's body. In another embodiment, the cavity comprises a nasal cavity in the patient's head, and the medical device is selected from the list consisting of: (a) a balloon, (b) a guidewire, (c) a suction tube, (d) a surgical tool, (e) an ENT diagnostic tool, (f) an ENT therapeutic tool, and (g) any combination thereof.

[0018] According to one embodiment of the present invention, a method for producing a medical instrument is further provided, the method comprising providing a deflectable distal end portion. A first end portion of at least a pull wire to be moved for deflecting the distal end portion is coupled to the distal end portion of the medical instrument. A coupling element having at least two boreholes is coupled to the second end portion of the pull wire, and at least two corresponding rods are inserted so as to traverse the at least two boreholes. A rotatable element for moving the coupling element along the axis of rotation of the rotatable element is coupled to the coupling element so that the boreholes and the corresponding rods prevent rotation of the coupling element.

[0019] The present invention will be more fully understood through the following detailed description of embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic illustration of an ENT protocol using an ENT system according to an embodiment of the present invention;

[0021] Figure 2A is a schematic illustration of a rotatable hollow tube according to an embodiment of the present invention;

[0022] Figure 2B is a schematic illustration of a rotation mechanism of an ENT tool according to an embodiment of the present invention;

[0023] Figure 3A is a schematic illustration of a deflection mechanism of a distal tip assembly according to an embodiment of the present invention;

[0024] Figure 3B is a schematic illustration of a wire retainer according to an embodiment of the present invention; and

[0025] Figure 4 is a flow chart schematically illustrating a method for producing an ENT tool according to an embodiment of the present invention. DETAILED DESCRIPTION

[0026] Overview

[0027] Some medical procedures require inserting medical tools into a patient's ENT sinuses. For example, a sinus balloon dilation procedure involves inserting a guidewire into the patient's ear, nose, and throat (ENT) sinuses and moving a balloon on the guidewire into the sinus ostium to open a blockage. In other procedures, a physician may insert a suction tube to remove mucus from the sinuses or a surgical tool to cut tissue (e.g., cartilage, bone, or polyps) in the patient's ENT organs.

[0028] Embodiments of the present invention described below provide methods and apparatus for improving the functionality and maneuverability of ENT tools. In some embodiments, an ENT system includes an ENT tool and a console. The ENT tool includes a distal end that is inserted into a branch organ (such as a patient's sinus) by a physician. The ENT tool includes a rotatable hollow tube that defines a working channel for inserting a sinus medical device (such as, but not limited to, the aforementioned guidewire, balloon, suction tube, surgical tool, or any combination thereof).

[0029] In some embodiments, the ENT tool includes a rotation and deflection mechanism for improving manipulation of the distal end and for inserting the aforementioned instrument into the sinus. The ENT tool includes an electronic device, such as a camera and a light emitting diode (LED), which is coupled to the distal end and is configured to acquire an image of the tissue under consideration. In some embodiments, the ENT system includes one or more wires, which are typically incorporated into a braid passing through the working channel and are configured to exchange power and imaging signals between the console and the electronic device at the distal end.

[0030] During an ENT procedure, a physician rotates and / or deflects the distal end of an ENT tool having one or more of a medical device and a wire braid in a working channel. In some cases, the braid can become entangled around the medical device and can tear and / or interfere with the movement of the medical device.

[0031] In some embodiments, the working channel has a non-circular cross-section for passing both the medical device and the braid of wires therethrough, and allowing the medical device to be rotated relative to the hollow tube in the presence of the braid of wires.

[0032] In some embodiments, the ENT tool includes a rotatable knob configured to rotate at least one of the rotatable hollow tube and the medical instrument. The rotatable knob is configured to rotate clockwise and counterclockwise within a rotation angle range between 0° and 180°.

[0033] In some embodiments, the ENT tool includes one or more pull wires having (a) a distal end coupled to a distal end of the ENT tool, and (b) a proximal end coupled to a deflection mechanism (also referred to herein as a deflection assembly) of the ENT tool. In some embodiments, the deflection assembly includes (i) a first gear configured to rotate about a first rotational axis and controlled by a deflection knob operated by a physician, and (ii) a second gear that rotates about a second rotational axis and includes a serrated surface for integration with the first gear. The serrated surface is inclined relative to the second rotational axis, and when the physician rotates the deflection knob, the second gear is rotated by the first gear and moves along the second rotational axis to deflect the distal end by moving the pull wire.

[0034] In some embodiments, the ENT tool includes a wire retainer (also referred to herein as a coupling element) that is in physical contact with the second gear and is coupled to the proximal end of the one or more pull wires. In such embodiments, the wire retainer is configured to be moved by the second gear along the second rotational axis.

[0035] Physical contact between the wire retainer and the second gear can cause the wire retainer to rotate with the second gear, which may cause the pull wires to twist around each other and / or around other elements of the ENT tool. In some embodiments, the wire retainer has at least two bores configured to receive at least two corresponding rods extending therethrough. In such embodiments, the bores and rods are configured to prevent rotation of the coupling element, thereby preventing twisting of the pull wire.

[0036] In some embodiments, the pull wire may have additional bores for traversing various components of the ENT tool, such as, but not limited to, a medical device and one or more of the aforementioned pull wires.

[0037] The disclosed technology improves the functionality of medical tools by enabling a single physician to operate multiple diagnostic and / or therapeutic devices simultaneously. Furthermore, the disclosed technology improves the maneuverability of such multifunctional medical tools in various branching procedures, such as ENT, bronchoscopy, or neurology, although the configuration may need to be adjusted for specific applications.

[0038] System Description

[0039] Figure 1 is a schematic illustration of an ENT procedure using the ENT system 20 according to an embodiment of the present invention. In some embodiments, the ENT procedure may include a sinus balloon dilation procedure in which a balloon is inserted into a blocked ostium of a sinus 48 and inflated to open the ostium to enable regular flow and drainage of mucus from the sinus through the nasal cavity of the nose 26 of the patient 22. In other embodiments, the ENT procedure may include any other diagnostic or therapeutic procedure performed in the patient's ENT. In such embodiments, the ENT system 20 includes a medical catheter (in this example, an ENT tool 28) that is configured to perform one or more of the ENT procedures in one or more sinuses 48 of the patient 22.

[0040] In some embodiments, ENT tool 28 includes a rotatable hollow tube, referred to herein as tube 52, which is inserted by physician 24 into a cavity of patient 22, such as the nasal cavity of nose 26 described above. ENT tool 28 also includes a handheld device 30 that is coupled to the proximal end of tube 52 and is configured to assist physician 24 in performing an ENT procedure in head 41 of patient 22, as will be described in detail below.

[0041] Reference is now made to Figure 45. In some embodiments, the ENT tool 28 includes a distal tip assembly 77 that is coupled to the distal end of the tube 52. The distal tip assembly 77 may comprise a nickel-titanium alloy, such as nitinol TM , or any other suitable material, and is configured to deflect and rotate as will be described in detail below.

[0042] In some embodiments, the handheld device 30 includes a gripper 58 that is held by the fingers of the physician 24. In some embodiments, the handheld device 30 includes a slider 70 that is moved by the thumb of the physician 24 along the longitudinal axis of the ENT tool 28. In the example of illustration 45, the physician 24 moves the slider 70 in two directions, shown as double-headed arrows 72, to insert and / or retract a medical device, such as a balloon (not shown), into the head 41 of the patient 22.

[0043] Now see back Figure 1 In one embodiment, system 20 further includes a magnetic position tracking system configured to track the position of one or more position sensors in head 41. The magnetic position tracking system includes a magnetic field generator 44 and a position sensor 55 that generates a position signal in response to sensing an external magnetic field generated by magnetic field generator 44, thereby enabling processor 34 (described in detail below) to estimate the position of position sensor 55 within head 41 of patient 22.

[0044] This position sensing method is used in various medical applications, such as in the CARTO TM 6,332,089, PCT Patent Publication No. WO 96 / 05768, and U.S. Patent Application Publication Nos. 2002 / 0065455A1, 2003 / 0120150A1, and 2004 / 0068178A1, the disclosures of which are incorporated herein by reference in their entirety.

[0045] In some embodiments, the system 20 further includes a positioning mat 40 comprising a field generator 44 secured to a frame 46. Figure 1In the exemplary configuration shown in FIG, the pad 40 includes five field generators 44, but may alternatively include any other suitable number of field generators 44. The pad 40 also includes a pillow (not shown) that is placed under the head 41 of the patient 22 so that the field generators 44 are positioned at fixed and known locations on the outside of the head 41.

[0046] In some embodiments, system 20 includes a console 33 including a memory 49 and a driver circuit 42 configured to drive a field generator 44 with appropriate signals via a cable 37 to generate a magnetic field in a predetermined working volume in the space surrounding the head 41 .

[0047] In some embodiments, the console 33 includes a processor 34, typically a general purpose computer, having suitable front-end and interface circuitry for receiving signals from the ENT tool 28 having one or more magnetic sensors 55 coupled thereto via the cable 32, and for controlling other components of the system 20 described herein.

[0048] In some embodiments, processor 34 is configured to estimate the position of each position sensor 55. Based on the estimated position of the corresponding sensor in the coordinate system of the magnetic position tracking system, processor 34 is configured to derive the position, orientation, and radius of curvature of distal tip assembly 77.

[0049] In the context of the present invention and the claims, the terms “bend” and “deflect” are used interchangeably and refer to the manipulation of one or more segments of the ENT tool 28 .

[0050] In some embodiments, processor 34 is configured to receive, via an interface (not shown), one or more anatomical images, such as computed tomography (CT) images obtained using an external CT system (not shown) depicting respective segmented two-dimensional (2D) slices of head 41. The term "segmented" refers to the display of various types of tissue identified in each slice by measuring the respective attenuation of the tissue in the CT system.

[0051] The console 33 also includes an input device 39 for controlling the operation of the system 20 and a user display 36 configured to display data (e.g., images) received from the processor 34 and / or to display input inserted by the physician 24 or another user of the input device 39.

[0052] In some embodiments, the processor 34 is configured to select one or more slices from a CT image, such as the anatomical image 35, and display the selected slices on the user display 36. Figure 1 In the example of , anatomical image 35 depicts a cross-sectional anterior view of one or more sinuses 48 of patient 22 .

[0053] In some embodiments, processor 34 is configured to register between the coordinate system of the CT system and the magnetic position tracking system and overlay the position of distal tip assembly 77 on anatomical image 35 .

[0054] Reference is now returned to illustration 45. In some embodiments, handheld device 30 includes a deflection knob, referred to herein as knob 66, which is controlled by physician 24 and is configured to deflect distal tip assembly 77 by rotating clockwise and counterclockwise about its axis, as indicated by double-headed arrow 69.

[0055] In some embodiments, the handheld device 30 further includes a knob, referred to herein as knob 54, which is configured to be rotated clockwise and counterclockwise, as indicated by double-headed arrow 68, to rotate the tube 52, distal tip assembly 77, and the medical device within the tube 52 (hereinafter referred to as the rotation knob). Figure 2A 、 Figure 2B 、 Figure 3A and Figure 3B ) about the longitudinal axis 50. In this example, the knob 54 rotates both the tube 52 and the distal end assembly 77 about the longitudinal axis 50 without rotating the medical device. In some embodiments, the knob 54 is configured to rotate 180° clockwise and 180° counterclockwise, as will be described below. Figure 2A and Figure 2B Described in detail in.

[0056] In some embodiments, the distal tip assembly 77 includes electronics 56, such as, but not limited to, a camera and one or more light emitting diodes (LEDs). The electronics 56 are coupled to the distal end of the distal tip assembly 77 and are configured to illuminate the ENT tissue of interest and acquire anatomical images of the ENT tissue during an ENT procedure.

[0057] Now see back Figure 1 Note that for simplicity and clarity, Figure 1 Only the elements related to the technology disclosed in the present invention are shown. System 20 typically includes additional modules and elements that are not directly related to the technology disclosed in the present invention and are therefore intentionally omitted. Figure 1 and omitted from the description of system 20.

[0058] The processor 34 can be programmed with software to perform the functions used by the system and store data in the memory 49 to be processed or otherwise used by the software. For example, the software can be downloaded to the processor in electronic form over a network, or the software can be provided on non-transitory tangible media, such as optical, magnetic, or electronic storage media. Alternatively, some or all of the functions of the processor 34 can be performed by dedicated or programmable digital hardware components.

[0059] This particular configuration of an ENT tool 28 is shown by way of example in order to illustrate certain problems solved by embodiments of the present invention and to demonstrate the application of these embodiments in enhancing the performance of such systems. However, embodiments of the present invention are by no means limited to this particular class of exemplary ENT tools, and the principles described herein may be similarly applied to other classes of medical diagnostic and / or therapeutic tools and / or systems.

[0060] Rotatable hollow tube having a working channel with a non-circular cross section

[0061] Figure 2A is a schematic illustration of a rotatable hollow tube 52 according to an embodiment of the present invention. In some embodiments, the rotatable hollow tube 52 defines a working channel (WC) 62 therein for inserting a medical device 88 into the sinus 48 (or any other cavity) of the patient 22. In some embodiments, the medical device 88 may include: (a) a balloon or another device that moves along the guidewire to perform the above-described Figure 1 (b) a suction tube connected to a pump for withdrawing mucus from the patient, e.g., after opening a blocked sinus ostium, (c) any suitable type of ENT surgical tool, e.g., for cutting polyps or for removing other tissue from the patient 22, (d) an ear, nose, and throat diagnostic tool, (e) an ear, nose, and throat therapeutic tool, (f) any other suitable type of ENT medical device, or (g) any suitable combination thereof. Figure 2A , medical device 88 is shown schematically in cross-section and may have any suitable size and shape.

[0062] In some embodiments, when at least distal tip assembly 77 is inserted into the nasal cavity of nose 26 , physician 24 applies slider 70 to insert a medical device 88 (eg, the aforementioned sinuplasty balloon) into target tissue, such as sinus 48 .

[0063] In some embodiments, the system 20 includes one or more wires, in this example a braid of wires 90 , that traverse the WC 62 for exchanging electrical signals between the console 33 and the one or more electronic devices 56 .

[0064] In some embodiments, rotation of tube 52 by knob 54 is limited to 180° clockwise and 180° counterclockwise to prevent braid 90 from becoming entangled around medical device 88. Without limited rotation, entanglement could result in tearing or damage to at least one wire and / or make it difficult to move medical device 88.

[0065] In some embodiments, WC 62 has a non-circular cross-section for passing therethrough (a) one or more medical devices 88 and (b) braid 90. The non-circular shape of WC 62 allows tube 52 to rotate relative to medical device 88 (positioned within WC 62) in the presence of braid 90. In some embodiments, at least one of medical device 88 and tube 52 is configured to rotate about axis 50. In such embodiments, the non-circular cross-sectional shape of WC 62 enables relative rotation between medical device 88 and tube 52 without wrapping one or more wires of braid 90 around medical device 88.

[0066] In some embodiments, the proximal end of the WC 62 may have the aforementioned non-circular cross-sectional shape, and the distal end of the WC 62 may have any other cross-section, such as, but not limited to, a circular or non-circular cross-sectional shape.

[0067] In some embodiments, the tube 52 is coupled to the housing 53, which in the example of the system 20 is integrated as a single molded piece with the tube 52. In other configurations, the tube 52 can be coupled to the housing 53 using any suitable technique.

[0068] In some embodiments, the housing 53 has one or more retainers 60 configured to retain the housing 53 attached to the underlying Figure 2B The rotating mechanism shown in the following Figure 3A In such embodiments, when the physician 24 rotates the knob 54, the retainer 60 prevents the pull wire from rotating with the tube 52 (described below). Figure 3A and Figure 3B ).

[0069] In some embodiments, the housing 53 has one or more openings 73 configured to retain the housing 53 attached to the knob 54 and to the aforementioned rotation mechanism.

[0070] Figure 2B FIG is a schematic illustration of the rotation mechanism 89 and distal end assembly 77 of the tube 52 according to an embodiment of the present invention. Figure 2BIn the example of , for conceptual clarity, several components of the ENT tool 28, such as the knob 54, the housing 53, and the tube 52, are removed from the figure to illustrate elements of the rotation mechanism 89 that are typically hidden from the viewer when the ENT tool 28 is assembled.

[0071] In some embodiments, the rotation mechanism 89 is configured to fit tightly within the housing 53. In some embodiments, the rotation mechanism 89 includes a disk 59 having a non-circular opening surrounding the medical device 88 and the braid 90. In some embodiments, the shape of the non-circular opening is generally similar to the shape of the WC 62, but in other embodiments, the opening can have any other suitable shape.

[0072] In some embodiments, the rotation mechanism 89 has one or more openings 61, wherein each opening is configured to fit over a corresponding holder 60 (on the top). Figure 2A ) in order to keep the housing 53 attached to the rotating mechanism 89 and rotate with the rotating mechanism 89, and to keep the pull wire (below Figure 3A and Figure 3B ) rotates with the tube 52. This configuration prevents the pull wires from twisting around each other and / or around other components of the ENT tool 28 (such as the medical device 88 and / or the braid 90).

[0073] In some embodiments, the rotation mechanism 89 includes one or more protrusions 75, wherein each protrusion is configured to fit within a corresponding opening 73 to couple between the housing 53 and the rotation mechanism 89. In such embodiments, the housing 53 and tube 52 fit over the rotation mechanism 89 so that the physician 24 can insert the medical device 88 through the WC 62 defined in the tube 52 into a cavity of interest (e.g., the sinus 48) of the patient 22.

[0074] In some embodiments, a rotation mechanism 89 is coupled to the rotation knob 54 for rotating at least one of the tube 52, the distal tip assembly 77, and the medical device 88 about the longitudinal axis 50 of the ENT tool 28. In this example, the physician 24 applies the rotation knob 54 to rotate the tube 52 and the distal tip assembly 77 about the longitudinal axis 50.

[0075] The specific configurations of the rotation mechanism 89, tube 52, and housing 53 are provided by way of example to illustrate certain issues, such as enabling the physician 24 to improve control over the rotation of at least one of the tube 52, distal tip assembly 77, and medical device 88, which is typically performed during one or more of the aforementioned ENT procedures. Such issues are addressed by embodiments of the present invention, and the configurations described above demonstrate the application of these embodiments in enhancing the performance of such ENT systems. However, embodiments of the present invention are by no means limited to this particular class of exemplary systems, and the principles described herein may be similarly applied to other classes of rotatable ENT and medical systems.

[0076] Deflection mechanism for ENT tools

[0077] Figure 3A is a schematic illustration of a deflection mechanism 99 of a distal tip assembly 77 according to an embodiment of the present invention. In some embodiments, the deflection mechanism 99 is activated by a knob 66 ​​operated by a physician 24. In the context of the present disclosure and claims, the terms "deflection mechanism" and "deflection assembly" are used interchangeably.

[0078] Reference is now made to illustration 87 , which shows a perspective view of the deflection mechanism 99 as viewed from the distal end of the ENT tool 28 . In some embodiments, the deflection mechanism 99 includes a gear 96 coupled to and rotated by the knob 66 ​​. The gear 96 includes a serrated surface that is integrated with the serrated surface 112 of the gear 111 . In an exemplary configuration of the deflection mechanism 99 , the gear 111 is hollow and configured to rotate about a rotational axis 122 . In this example, the rotational axis 122 is substantially parallel to the longitudinal axis 50 of the ENT tool 28 and substantially orthogonal to the rotational axes of the knob 66 ​​and the gear 96 . In other embodiments, the rotational axes of the gears 96 and 111 may have any other suitable orientation angle therebetween that is different from the right angle in this exemplary configuration. In alternative embodiments, the rotational axis 122 may have any suitable orientation relative to the longitudinal axis 50 (e.g., non-parallel).

[0079] In some embodiments, the ENT tool 28 includes one or more pull wires 92 having a first end coupled to the distal tip assembly 77 and a second end coupled to the deflection mechanism 99, as will be described below. At least one of the pull wires 92 can have any suitable diameter between about 0.1 mm and about 0.5 mm and can include stainless steel, nanofilaments (also known as spider dragline silk), aramids (such as kevlar), and polyamides. TM), or any other suitable material having a tensile strength greater than about 10 kgf. Note that the diameter of the pull wire 92 is selected based on the tensile strength and the specified range of forces applied to the pull wire 92 to deflect the distal tip assembly 77. In some embodiments, the pull wire is configured to be moved by the deflection mechanism 99 to deflect the distal tip assembly 77.

[0080] In the context of the present disclosure and claims, the terms "about" or "substantially" for any numerical value or range indicate a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. For example, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 72% to 100%.

[0081] In some embodiments, the deflection mechanism 99 is configured to control the deflection of the distal tip assembly 77 based on the engagement between the gears 96 and 111 .

[0082] In some embodiments, the gear 111 is hollow so that the pull wire 92 and one or more rods 120 (two rods 120 in this example) pass therethrough. In some embodiments, the serrated surface 112 is inclined relative to the rotation axis 122 and defines an inclination angle 114 between the serrated surface 112 and the rotation axis 122.

[0083] In some embodiments, the tilt angle 114 can have any suitable angle to obtain movement of the gear 111 at an exemplary range of between about 1 mm and about 12 mm.

[0084] In some embodiments, the ENT tool 28 includes a wire holder 132 having a face plate 133 and a bottom surface. Figure 3B The gear 111 rotates around the wire holder 132 and can have physical contact with the face plate 133 of the wire holder 132. As will be described in detail below, the rod 120, medical device 88 and pull wire 92 all pass through the bore of the wire holder 132.

[0085] In some embodiments, the gear 111 has a circumference that can be arranged parallel to the rotation axis 122. The gear 111 has segments 116 and 118 located at different locations on the circumference of the gear 111. In such embodiments, each of the segments 116 and 118 is configured to make physical contact with the panel 133 and has a segment of the serrated surface 112. In such embodiments, the serrated segment 113 of the serrated surface 112 extends from the segment 116, and the serrated segment 115 of the serrated surface 112 extends from the segment 118. Note that in the configuration of the deflection mechanism 99, the panel 133 is non-rotatable, as described below in Figure 3BAs shown in inset 87 , due to the shape of the gear 111 , the thickness of the segment 116 along the axis of rotation 122 is greater than the thickness of the segment 118 .

[0086] In some embodiments, when physician 24 rotates gear 96 via knob 66 ​​, serrated surfaces 97 and 112 are integral with one another, and gear 111 is configured to rotate about rotational axis 122 with gear 96 rotating but not translating relative to knob 66 ​​.

[0087] In such an embodiment, when serrated segment 113 contacts serrated surface 97 of gear 96, gear 111 is configured to move along rotational axis 122 in direction 117 and deflect distal tip assembly 77 a maximum amount by moving pull wire 92, as will be described below. Similarly, when serrated segment 115 contacts serrated surface 97, gear 111 is configured to move along rotational axis 122 in direction 119 and enable straightening of distal tip assembly 77. Furthermore, physician 24 can control the amount of deflection of distal tip assembly 77 by rotating knob 66, such that any other serrated segment of gear 111 contacts serrated surface 97 of gear 96. For example, physician 24 can achieve partial deflection of distal tip assembly 77 by rotating knob 66, such that a given serrated surface located between serrated segments 113 and 115 contacts serrated surface 97 of gear 96. Note that the amount of deflection when a given serrated surface contacts serrated surface 97 is less than the amount of deflection when serrated segment 113 contacts serrated surface 97 .

[0088] As above Figure 1 As described above, the distal tip assembly 77 may include nitinol TM , which acts as a spring when deflected. In other words, when the distal end assembly 77 is deflected, the nickel-titanium alloy applies a force to the pull wire 92 in order to return to the straightened (ie, undeflected) position.

[0089] In some embodiments, when the serrated segment 113 is integrated with the serrated surface 97 of the gear 96, the pull wire 92 moves in direction 117 with the gear 111 and holds the distal end assembly 77 in the deflected position. When the serrated segment 115 (of the segment 118) is integrated with the serrated surface 97, the pull wire 92 moves in direction 119 with the gear 111 and can be loosened to allow the nitinol TM The internal force of the distal end assembly 77 is pulled straight to the non-deflected position. Note that the rod 120 serves as a track for the movement of the gear 111 along the directions 117 and 119.

[0090] Reference is now made to illustration 91 , which shows a perspective view of the deflection mechanism 99 as viewed from the proximal end of the ENT tool 28. As described above in illustration 87, the serrated surface 112 is inclined relative to the axis of rotation 122, as indicated by the inclination angle 114.

[0091] As described above in illustration 87, rod 120, medical device 88, and pull wire 92 all pass through the bore of wire holder 132. As shown in illustration 91, rod 120, medical device 88, and pull wire 92 protrude through panel 133, and one or more pull wires 92 pass through bore 94 and are coupled to the outer surface of panel 133.

[0092] In some embodiments, rod 120 serves as a track for movement of wire retainer 132 and gear 111 along rotational axis 122. When physician 24 rotates knob 66, rod 120 is configured to prevent face plate 133 of wire retainer 132 from rotating with gear 111 and also enable movement of puller wire 92 along rotational axis 122 to control deflection of distal tip assembly 77, as described above.

[0093] The configuration of the deflection mechanism 99 is shown by way of example and incorporates an interface with the rod 120, the medical device 88, and the puller wire 92 to effect deflection of the distal tip assembly 77. However, embodiments of the present invention are in no way limited to this particular class of exemplary configurations, and the principles described herein may be similarly applied to other classes of deflection mechanisms used in other types of medical tools and / or systems or other types of deflectable devices.

[0094] Prevents twisting of the pull wire when deflecting the distal tip assembly

[0095] Figure 3B is a schematic illustration of a wire retainer 132 according to an embodiment of the present invention. In some embodiments, the wire retainer 132 (also referred to herein as a coupling element) has a bore 134 for passing the rod 120 therethrough. Figure 3A and Figure 3B In the exemplary configuration of , the ENT tool 28 includes two rods 120, and therefore the wire retainer 132 has two bores 134. In other embodiments, the ENT tool 28 may have any other suitable number of one or more rods 120 and corresponding one or more bores 134.

[0096] In some embodiments, the wire holder 132 has a bore 136 defining a working channel (such as the WC 62) for passing the medical instrument 88 therethrough. In other embodiments, the wire holder 132 can include multiple bores 136 for respectively passing multiple medical instruments 88 therethrough. Additionally or alternatively, the bores can have any suitable cross-section, which can vary in size, shape, or any other parameter thereof.

[0097] As above Figure 3A As shown and described in FIG. 91 of FIG. , the wire retainer 132 has a bore 94 ( Figure 3B (not shown in FIG. 1 ). In some embodiments, a wire retainer 132 can serve as the aforementioned coupling element, which is coupled to the proximal end of the pull wire 92 and is configured to move along the rotation axis 122 via the gear 111, as described above. In some of the aforementioned embodiments, the bore 134 and corresponding rod 120 are configured to prevent rotation of the coupling element (in this example, the wire retainer 132) when the gear 111 rotates about the rotation axis 122. In such embodiments, the bore 134 and corresponding rod 120 are configured to prevent twisting of the pull wire 92 when the distal tip assembly 77 is deflected (and straightened).

[0098] Now return to the reference above Figure 2A and Figure 2B Note that when the retainer 60 is inserted into the corresponding opening 61, the pull wire 92 rotates with the rotation mechanism 89 and the tube 52 and, therefore, does not twist around each other or around any other component of the ENT tool 28. In some embodiments, when the retainer 60 is inserted into the corresponding opening 61, the rod 120 (which passes through the bore 134) and the faceplate 133 rotate with the rotation mechanism 89 when the physician 24 rotates the knob 54. In such embodiments, when the physician 24 rotates the knob 54, the entire structure of the wire retainer 132 rotates with the rotation mechanism 89.

[0099] In some embodiments, when physician 24 rotates knob 66 ​​to deflect distal end assembly 77, gear 111 rotates about rotation axis 122, however, bore 134 and corresponding rod 120 are configured to prevent rotation of wire retainer 132 to prevent the aforementioned twisting of pull wire 92.

[0100] Now return to reference Figure 3B In some embodiments, wire retainer 132 includes a generally circular surface 131 such that when physician 24 rotates knob 66 ​​, an inner surface (not shown) of hollow gear 111 fits over and rotates about surface 131 .

[0101] In some embodiments, the wire retainer 132 includes a surface 135 that is an inner surface of the panel 133 and is configured to make contact with the gear 111. In such embodiments, when the serrated segment 113 is in contact with the serrated surface 97 (as shown above), the wire retainer 132 may be configured to make contact with the gear 111. Figure 3A87 ), the gear 111 moves in direction 117 and applies force to the surface 135 to move the wire retainer 132 in direction 117 to deflect the distal tip assembly 77. Note that when the physician 24 controls the gear 111 to move in direction 119, the nitinol TM The internal force acts as a spring that moves the pull wire 92 in the direction 119 so as to straighten the distal end assembly 77 to the non-deflected position.

[0102] For clarity of concept, the configuration of the wire retainer 132 is provided by way of example and may be simplified. In other embodiments, the wire retainer 132 may include additional bores and / or may have Figure 3B Some of the boreholes shown are grouped together into a single borehole.

[0103] Figure 4 2 is a flow chart schematically illustrating a method for producing an ENT tool 28 according to an embodiment of the present invention. The method begins at a handheld device providing step 200, wherein a handheld device 30 of an ENT tool 28 is provided. At a deflection mechanism coupling step 202, a deflection mechanism 99 controlled by a knob 66 ​​is coupled to the handheld device 30. As described above Figure 3A As described in , the deflection mechanism 99 includes a gear 111 that is hollow and rotates about and moves along an axis of rotation 122 .

[0104] At the wire retainer coupling step 204, the wire retainer 132 is coupled to the gear 111, for example, by fitting the wire retainer 132 into the opening of the hollow gear 111, as described above. Figure 3A In some embodiments, the wire retainer 132 has a mechanism for moving along the axis of rotation 122 and preventing rotation about the axis of rotation 122. Figure 3B In the present example described in , the wire retainer 132 has a bore 134 for passing the rod 120 therethrough, so as to enable movement of the wire retainer 132 along the rotation axis 122 and prevent the wire retainer 132 from rotating about the rotation axis 122. In some embodiments, a method for producing the ENT tool 28 includes assembling the wire retainer 132 within a hollow portion of the gear 111 and inserting the rod 120 into the bore 134.

[0105] At a rotation mechanism coupling step 206, the rotation mechanism 89 controlled by the knob 54 is coupled to the handheld device 30. At a rotatable hollow tube coupling step 208, the rotatable hollow tube 52 is coupled to the rotation mechanism 89. In some embodiments, a housing 53 coupled to the tube 52 can be used to couple between the tube 52 and the rotation mechanism 89. In such embodiments, the rotation mechanism 89 includes one or more protrusions 75, wherein each protrusion is configured to fit into a corresponding opening 73 of the housing 53 so as to couple between the tube 52 and the rotation mechanism 89 (using the housing 53). In some embodiments, the hollow section within the tube 52 defines a working channel 62 having a non-circular cross-section, as described above. Figure 2A As stated.

[0106] At a deflectable distal end coupling step 210, the distal end assembly 77 is coupled to the distal end of the tube 52. At an electronics assembly step 212, the position sensor 55 and one or more electronic devices 56 are assembled to the distal end assembly 77. At a wire coupling step 214, one or more wires (in this example, a braid of wires 90) are passed through the working channel 62 and coupled to the position sensor 55 and to the one or more electronic devices 56. During a procedure, a user of the system 20 (e.g., the physician 24) can couple the proximal end of the braid 90 to the console 33 to enable the exchange of power and electrical signals between the console 33 and the position sensor 55 and the electronic devices 56 via the wires of the braid 90.

[0107] At the pull wire coupling step 216, one or more pull wires 92 are coupled between the distal end assembly 77 and the wire retainer 132. In the example of the system 20, the one or more pull wires 92 pass through the bore 94 of the wire retainer 132 and are coupled to the outer surface of the panel 133, as described above. Figure 3A and Figure 3B As described in.

[0108] In some embodiments, the wire coupling step 216 ends Figure 4 In other embodiments, the order of steps 202-216 may be different from Figure 4 For example, (i) the wire coupling step 214 may be performed before the electronic device assembly step 212 , or (ii) the electronic device assembly step 212 may be performed before the distal end coupling step 210 .

[0109] In addition, for the sake of conceptual clarity, Figure 4The method steps are simplified, and the overall production process of the ENT tool 28 may include additional steps, such as, but not limited to, alignment between the bore 136 and the working channel 62. The alignment may be performed and tested so that (i) the physician 24 can easily insert one or more medical devices 88 into a cavity of interest within the body of the patient 22, and (ii) the braid 90 is placed within the ENT tool 28 and its wires are connected to the position sensor 55 and to the electronics 56.

[0110] Although the embodiments described herein are primarily directed to ENT tools, the methods and systems described herein may also be used in other applications.

[0111] It should therefore be understood that the embodiments described above are cited by way of example, and that the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and subcombinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art. The documents incorporated by reference into this patent application are considered an integral part of this application, except that if any term defined in these incorporated documents conflicts with a definition explicitly or implicitly given in this specification, only the definition in this specification shall be considered.

Claims

1. A medical tool comprising: a distal end portion, the distal end portion being deflectable; at least one pull wire having a first end coupled to the distal end of the medical tool and configured to move for deflecting the distal end; as well as a deflection assembly coupled to the second end of the at least one puller wire and configured to control deflection of the distal end, the deflection assembly comprising: a first gear having a first axis of rotation; and A second gear having a second rotational axis parallel to the longitudinal axis of the medical instrument and including a serrated surface for integration with the first gear, wherein the serrated surface is inclined relative to the second rotational axis, and wherein, when the first gear rotates, the second gear is configured to be rotated by the first gear and move along the second rotational axis and deflect the distal end by moving the at least one pull wire.

2. The medical tool according to claim 1, wherein the second gear having a circumference including the following segments: a first segment having a first thickness along the second rotational axis and a first serrated segment of the serrated surface extending therefrom; and a second segment having a second thickness along the second rotational axis that is less than the first thickness and a second serrated segment of the serrated surface extending therefrom, and wherein, upon rotation of the second gear: The distal end deflects a first amount when the first serrated segment contacts the first gear; and When the second serrated segment contacts the first gear, the distal end deflects a second amount that is less than the first amount. 3 . The medical tool of claim 1 , comprising a rotatable knob coupled to the first gear and configured to control the deflection by rotating the first gear.

4. The medical tool of claim 1, comprising a coupling element coupled to the second end of the at least one puller wire and configured to be moved along the second rotational axis by the second gear.

5. The medical tool according to claim 1, wherein The second gear is hollow and includes one or more rods parallel to the second rotation axis and transverse to the second gear, the one or more rods serving as tracks for the second gear to move along the second rotation axis.

6. The medical tool of claim 5, comprising a hollow tube disposed between the distal end and the deflection assembly, wherein the hollow tube defines a working channel therein for inserting a medical device through the distal end into a cavity of a patient's body.

7. The medical tool according to claim 6, wherein The cavity includes a nasal cavity in the patient's head, and wherein the working channel is used to insert the medical device selected from the list consisting of: a balloon, a guide wire, a suction tube, a surgical tool, an ENT diagnostic tool, an ENT treatment tool, and any combination thereof.

8. A method for producing a medical tool, the method comprising: providing a distal end, said distal end being deflectable; coupling a first end of at least one pull wire to the distal end of the medical tool, the at least one pull wire to be moved for deflecting the distal end; as well as A deflection assembly is coupled to the second end of the at least one puller wire for controlling deflection of the distal end, the deflection assembly comprising: a first gear having a first axis of rotation; and a second gear having a second rotational axis parallel to the longitudinal axis of the medical instrument and including a serrated surface for integration with the first gear, wherein the serrated surface is inclined relative to the second rotational axis, and wherein, when the first gear rotates, the second gear is rotated by the first gear and moves along the second rotational axis for deflecting the distal end by moving the at least one pull wire.

9. The method according to claim 8, wherein the second gear having a circumference including the following segments: a first segment having a first thickness along the second rotational axis and a first serrated segment of the serrated surface extending therefrom; and a second segment having a second thickness along the second rotational axis that is less than the first thickness and a second serrated segment of the serrated surface extending therefrom, and wherein, upon rotation of the second gear: The distal end deflects a first amount when the first serrated segment contacts the first gear; and When the second serrated segment contacts the first gear, the distal end deflects a second amount that is less than the first amount.

10. The method of claim 8, comprising a rotatable knob coupled to the first gear and configured to control the deflection by rotating the first gear.

11. The method of claim 8, comprising coupling a coupling element to the second end of the at least one puller wire for movement along the second rotational axis by the second gear.

12. The method according to claim 8, wherein The second gear is hollow, and the method includes inserting one or more rods through the second gear, the one or more rods being parallel to the second rotational axis and transverse to the second gear, the one or more rods serving as tracks for the second gear to move along the second rotational axis.

13. The method of claim 12, comprising disposing a hollow tube between the distal end and the deflection assembly, wherein the hollow tube defines a working channel therein for inserting a medical device through the distal end into a lumen of a patient's body.

14. The method according to claim 13, wherein The cavity includes a nasal cavity in the patient's head, and wherein the working channel is used to insert the medical device selected from the list consisting of: a balloon, a guide wire, a suction tube, a surgical tool, an ENT diagnostic tool, an ENT treatment tool, and any combination thereof.

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