Systems, devices, and methods for visualization during medical procedures

Abstract

Visualization during a medical procedure using a visualization system is provided, the visualization system comprising: a control device defining an upper surface and a lower surface; a display visible through the upper surface of the control device; a handle coupled to and extending away from the lower surface; a knob coupled to the control device, the knob configured to rotate about a rotation axis; an imaging assembly mechanically coupled to the knob and communicatively coupled to the control device, the imaging assembly configured to rotate about the rotation axis based on rotation of the knob; and the control device configured to display an image on the display, the image captured by the imaging assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 875,298, filed on July 17, 2019, entitled “Systems, Devices, And Methods For Visualization Of Orifices During Medical Procedures,” and is incorporated herein by reference as if reproduced in its entirety below. Technical Field

[0003] Various example embodiments relate to systems, devices, and methods for tissue visualization, and more particularly, to visualization of the ear canal and structures therein during otologic diagnoses and procedures. Background Art

[0004] Otological procedures, or procedures involving the ear, involve inserting medical instruments into a patient's ear. During otological procedures, it can be difficult for a clinician to see inside the ear. Otological procedures can be performed using a surgical microscope, which provides visualization of the ear, but requires a line-of-sight view of the target treatment area. However, when manipulating instruments within the ear canal, the instrument's entry path often overlaps or blocks the line of sight between the microscope and the target treatment area. Consequently, the clinician may be limited in their manipulation of the instrument or must operate with an incomplete view of the target treatment area. Additionally, the view provided by the microscope may be sensitive to patient movement. Therefore, it would be desirable to have a system for otological procedures that allows instruments to approach the target treatment area while providing a clear view that does not become out of focus due to patient movement. Summary of the Invention

[0005] At least one example embodiment is a visualization system comprising: a control device defining an upper surface and a lower surface; a display visible through the upper surface of the control device; a handle coupled to and extending away from the lower surface; a knob coupled to the control device, the knob configured to rotate about a rotation axis; an imaging assembly mechanically coupled to the knob and communicatively coupled to the control device, the imaging assembly configured to rotate about the rotation axis based on rotation of the knob; and the control device configured to display an image on the display, the image captured by the imaging assembly.

[0006] The example visualization may further include: a rotation sensor in operative relationship with the knob and communicatively coupled to the control device, the rotation sensor configured to sense rotation of the knob and the imaging assembly; wherein the control device is configured to rotate an image on the display in response to rotation of the knob such that the image maintains a consistent orientation despite rotation of the imaging assembly. The rotation sensor may further include: a first conductive pattern; a second conductive pattern, the second conductive pattern being distinct from and electrically isolated from the first conductive pattern; a conductive member coupled to the knob; a measurement circuit electrically coupled to the first conductive pattern, the second conductive pattern, and the conductive member; the measurement circuit configured to sense rotation of the knob based on a capacitance measurement between the conductive member, the first conductive pattern, and the second conductive pattern. In some cases, the first conductive pattern may also include a wide end having a first width and a narrow end having a second width smaller than the first width, and the first conductive pattern extends in a circular pattern; the second conductive pattern may also include a wide end having a third width and a narrow end having a fourth width smaller than the third width, and the second conductive pattern extends in a circular pattern next to the first conductive pattern; and the width of the first conductive pattern decreases with the circular distance around the circular pattern in the first direction, and the width of the second conductive pattern increases around the circular pattern in the first direction.

[0007] The example visualization system may further include: a column defining a proximal end and a distal end, the proximal end of the column being coupled to the lower surface of the control device and the column extending away from the lower surface; a base coupled to the distal end of the column, the base defining an upper surface, a lower surface, and an orifice; the knob being disposed on the upper surface of the base; and the imaging assembly passing through the orifice and extending below the lower surface of the base. The column may further include: a first recess disposed inwardly on a first side of the column, the first recess defining a closed bottom, an open top, and a channel; and a second recess disposed inwardly on a second side of the column opposite the first side, the second recess defining a closed bottom, an open top, and a channel. The example visualization system may further include the channel of the first recess being parallel to the channel of the second recess.

[0008] In an exemplary visualization, the imaging assembly can further include: an elongated shaft defining a proximal end and a distal end, the proximal end being rigidly coupled to the rotation knob; an optical sensor disposed within the elongated shaft, the optical sensor defining an optical axis, and the optical sensor being communicatively coupled to the control device; and an illumination source disposed within the elongated shaft, wherein the optical axis forms a non-zero angle with the rotation axis of the rotation knob. The example visualization system can further include: a distal optical lens disposed at the distal end of the elongated shaft, the imaging assembly having a field of view extending through the distal optical lens along the optical axis; and an illumination window disposed at the distal end of the elongated shaft, the illumination window having an illumination light path at least partially coextensive with the field of view. In some cases, the optical axis of the optical sensor intersects the rotation axis of the rotation knob.

[0009] The example visualization system may further include a communication cable coupled between the imaging assembly and the control device, the communication cable remaining coupled between the control device and the imaging assembly as the rotational orientation of the knob changes. The example system may also include: a base rigidly coupled to the control device, the base defining an orifice; a fixed circular rack rigidly coupled to the orifice and at least partially defining the orifice; a rotatable circular rack rigidly coupled to the knob and at least partially defining an axis of rotation of the knob; a pinion disposed between the fixed circular rack and the rotatable circular rack, the pinion configured to translate along the fixed circular rack in response to relative rotational movement of the rotatable circular rack; a disk having an annular channel defined on an outer diameter of the disk, the disk coupled to the pinion and configured to translate with the pinion; and the communication cable at least partially confining the disk within the annular channel.

[0010] The example visualization system may further include: a speculum defining a longitudinal axis and a distal tip, the speculum being coupled to the rotation knob such that the longitudinal axis is coaxial with the rotation axis of the rotation knob and the speculum rotates when the rotation knob is rotated; an imaging cavity disposed on an inner surface of the speculum, the imaging cavity defining a closed bottom, the imaging assembly being disposed within the imaging cavity; and a working channel defined by the speculum, the working channel being different from the imaging cavity.

[0011] In an exemplary visualization system, the distal end of the imaging lumen can define a setback distance from the distal tip such that a field of view of the imaging assembly overlaps a portion of an inner diameter of the speculum at the distal tip. In some cases, the speculum defines a shape of an inverted conical frustum.

[0012] Other exemplary embodiments are a speculum for use with a surgical otoscope, the speculum comprising: an outer wall defining a frustum having a longitudinal central axis;

[0013] a proximal end defining a first orifice; a distal tip defining a second orifice, the second orifice being smaller than the first orifice; an interior volume defined by the interior surface of the outer wall; an imaging cavity disposed on the interior surface, the imaging cavity having an open proximal end and a distal end; a working channel defined by the remainder of the interior volume not occupied by the imaging cavity; and a window disposed at the distal end of the imaging cavity, the window fluidically isolating the imaging cavity from the working channel.

[0014] In an example speculum, the second aperture can define a plane perpendicular to the longitudinal center axis. In some cases, the distal end of the imaging lumen is disposed at an axial position relative to the longitudinal center axis that is different from the axial position of the distal tip. In some cases, the axial position of the distal end of the imaging lumen is between 9 mm and 13 mm, inclusive.

[0015] The example may further include: a proximal portion defining a first orifice for fluidly coupling to the working channel and a second opening for fluidly coupling to the imaging cavity; and a distal portion defining an inverted frustum. The example speculum may further include means for coupling the speculum to a surgical otoscope, the means for coupling being disposed at the intersection of the proximal and distal portions. The means for coupling may further include an annular surface that defines the speculum at the intersection of the proximal and distal portions. The means for coupling may further include: a leaf spring that partially defines the speculum at the intersection of the proximal and distal portions, the leaf spring defining an annular groove; and an engagement member disposed inboard on an outer surface of the leaf spring; wherein in a non-compressed orientation of the leaf spring, the means for coupling defines a first diameter, and in a compressed orientation, the means for coupling defines a second diameter that is smaller than the first diameter.

[0016] The example speculum may further include an optical axis defined by the imaging cavity and a window disposed at a distal end of the imaging cavity, the optical axis intersecting the longitudinal central axis at a location beyond the distal tip of the speculum. In some cases, the angle between the optical axis and the longitudinal central axis is approximately 7.5 degrees.

[0017] Another example embodiment is a method of performing an otologic procedure comprising: displaying an image of an ear canal on a display device of an otoscope, the image being captured by an imaging assembly in operative relationship with a speculum within the ear canal, the image being in a first rotational orientation; sensing a rotation of the speculum and the imaging assembly; and in response to the sensing, rotating the image on the display device by the otoscope so that the image remains in the first rotational orientation.

[0018] The example method may further include, prior to inserting the speculum into the ear canal, coupling the speculum to the otoscope such that the imaging assembly is disposed within an imaging cavity of the speculum. The example method may further include: inserting an instrument through a working channel of the speculum; displaying on the display device a physical relationship between a distal end of the instrument and anatomical structures within the ear canal; and performing an otologic procedure using the instrument.

[0019] An example otologic procedure may also include performing at least one of: a myringotomy; a myringostomy tube delivery; wax removal; and foreign body removal.

[0020] In an example method, displaying an image may further include displaying in the image at least a portion of a distal end of the speculum in the image.

[0021] The example method may also include: coupling the speculum to the otoscope such that the imaging assembly is disposed within an imaging cavity of the speculum; holding the otoscope by a clinician, the otoscope residing in a plane defined by a thumb and index finger of the clinician's hand; placing the speculum and the imaging assembly into the ear canal; and stabilizing the otoscope by placing a lower portion of the clinician's hand on the patient's head. In some cases, the first rotational orientation corresponds to a viewing angle of the clinician relative to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] For a detailed description of exemplary embodiments, reference will now be made to the accompanying drawings, in which:

[0023] Figure 1 is a block diagram of a visualization system according to at least some embodiments;

[0024] Figure 2 is a perspective view of a visualization system according to at least some embodiments;

[0025] Figure 3A is a cross-sectional perspective view of a speculum according to at least some embodiments;

[0026] Figure 3B is a bottom plan view of a speculum according to at least some embodiments;

[0027] Figure 4 is a cross-sectional elevational view of a speculum and imaging assembly according to at least some embodiments;

[0028] Figure 5 illustrates, in block diagram form, considerations regarding the thickness of an illumination source, an optical sensor, and an optical tip, according to at least some embodiments;

[0029] Figure 6A and 6B shows side elevation views of two example specula according to at least some embodiments;

[0030] Figure 7 shows a cross-sectional view of a speculum according to at least some embodiments, wherein an instrument is extended through the speculum to illustrate the range of motion of the instrument;

[0031] Figure 8 is a top view of a speculum according to at least some embodiments, wherein an instrument is extended through the speculum to illustrate a range of motion of the instrument at a proximal end to produce the range of motion at a distal end;

[0032] Figure 9 is a perspective diagram illustrating the relationship of an imaging field of view to a range of motion of an instrument, according to at least some embodiments;

[0033] Figure 10A and 10B is a cross-sectional view of a speculum according to at least some embodiments to illustrate the placement of the imaging lumen relative to the speculum tip;

[0034] Figure 11 shows a perspective view of an imaging assembly according to at least some embodiments;

[0035] Figure 12A is a bottom plan view of an imaging assembly having an optical sensor in the form of a circular camera, according to at least some embodiments;

[0036] Figure 12B is a bottom plan view of an imaging assembly having an optical sensor in the form of a cube camera, according to at least some embodiments;

[0037] Figure 13 A set of schematic diagrams illustrating an optical lens assembly configuration 1300 of an imaging assembly that may include a passive or active focusing mechanism according to at least some embodiments;

[0038] Figure 14 is a schematic diagram of image data 1400 generated by an imaging component of a visualization system, according to at least some embodiments;

[0039] Figure 15 is an example image of the tympanic membrane and adjacent tissue generated by an imaging component of a visualization system according to at least some embodiments;

[0040] Figure 16A is a perspective view of an image rotation assembly according to at least some embodiments;

[0041] Figure 16B is an exploded perspective view of an example image rotation assembly according to at least some embodiments;

[0042] Figure 17 is an exploded side view of a visualization device according to at least some embodiments;

[0043] Figure 18 is a cross-sectional side view of a visualization device according to at least some embodiments;

[0044] Figure 19 is a cross-sectional perspective view of a visualization device having a rotary position encoder according to at least some embodiments;

[0045] Figure 20 is a simplified schematic diagram of an image rotation assembly with a position encoder according to at least some embodiments;

[0046] Figure 21 is a schematic diagram of an image rotation assembly having a position encoder according to at least some embodiments;

[0047] Figure 22A and 22B is a schematic diagram of an image rotation assembly having a position encoder according to at least some embodiments;

[0048] Figure 23 is a schematic diagram of an image rotation assembly having a position encoder according to at least some embodiments;

[0049] Figure 24 is a schematic diagram of a sensor of an image rotation assembly according to at least some embodiments;

[0050] Figure 25A is a schematic diagram of a sensor of an image rotation assembly according to at least some embodiments;

[0051] Figure 25B is a schematic diagram of a sensor of an image rotation assembly according to at least some embodiments;

[0052] Figure 26Ais a graph of an area A1 of a first conductive pattern according to a displacement along the first conductive pattern according to at least some embodiments;

[0053] Figure 26B is a graph of an area A2 of the second conductive pattern according to a displacement along the second conductive pattern according to at least some embodiments;

[0054] Figure 26C is a graph of capacitance of a first conductive pattern according to displacement along the first conductive pattern according to at least some embodiments;

[0055] Figure 26D is a graph of capacitance of the second conductive pattern as a function of displacement along the second conductive pattern according to at least some embodiments;

[0056] Figure 26E is a graph of a ratio of a first conductive pattern capacitance to a second conductive pattern capacitance according to displacement along the pattern according to at least some embodiments;

[0057] Figure 26F is a pattern of series capacitance corresponding to a first conductive pattern and a second conductive pattern according to at least some embodiments;

[0058] Figure 26G is a graph of a voltage v(x) developed across a first conductive pattern and a second conductive pattern operating as a voltage divider according to at least some embodiments;

[0059] Figure 27A is a graph of capacitance C1 of the first conductive pattern according to displacement along the first conductive pattern according to at least some embodiments;

[0060] Figure 27B is a graph of capacitance C2 of the second conductive pattern according to displacement along the second conductive pattern according to at least some embodiments;

[0061] Figure 27C is a graph of a ratio of a first conductive pattern capacitance to a second conductive pattern capacitance according to displacement along the pattern according to at least some embodiments;

[0062] Figure 27D is a pattern of series capacitance corresponding to a first conductive pattern and a second conductive pattern according to at least some embodiments;

[0063] Figure 27E is a pattern of a voltage developed across a first conductive pattern and a second conductive pattern operating as a voltage divider according to at least some embodiments;

[0064] Figure 28A a block diagram illustrating various relationships of a visualization system according to at least some embodiments;

[0065] Figure 28B is a graph illustrating the relationship of fields of view of two types of optical sensors according to at least some embodiments;

[0066] Figure 28C is a diagram illustrating the tilt angle according to at least some embodiments. A graph of the distance from the central field of view;

[0067] Figure 29 is an example method of organizing visualization according to at least some embodiments;

[0068] Figure 30 is an example method of image processing for visualization of a target treatment area according to at least some embodiments;

[0069] Figure 31A is a bottom perspective view of a visualization device with an attachment mechanism in a closed configuration according to at least some embodiments;

[0070] Figure 31B is a bottom perspective view of a visualization device with an attachment mechanism in an open configuration according to at least some embodiments;

[0071] Figure 32A is a side cross-sectional view of a speculum locked within a visualization device according to at least some embodiments;

[0072] Figure 32B is a side cross-sectional view of a speculum within a visualization device with an engagement member retracted, according to at least some embodiments;

[0073] Figure 33A is a perspective view of a speculum having an attachment mechanism carried by the speculum, according to at least some embodiments;

[0074] Figure 33B is a bottom view of a speculum having an attachment mechanism carried by the speculum, according to at least some embodiments;

[0075] Figure 34 shows a side cross-sectional view of a speculum within a visualization device according to at least some embodiments;

[0076] Figure 35A is a perspective view of a visualization device according to at least some embodiments;

[0077] Figure 35B is a partial perspective view of a visualization device with a knob removed to reveal a line management system according to at least some embodiments;

[0078] Figure 35C is a partial perspective view of a visualization device with a knob removed to reveal a line management system according to at least some embodiments;

[0079] Figure 35D is a partial perspective view of a visualization device with a knob removed to reveal a line management system according to at least some embodiments;

[0080] Figure 36A is a schematic plan view of an alternative line management assembly according to at least some embodiments;

[0081] Figure 36B is a schematic side view of a wire management component of a visualization system according to at least some embodiments; and

[0082] Figure 37 is a plan view of a visualization system including a base and a wired connection in the form of a flexible circuit coil in a spiral configuration, according to at least some embodiments.

[0083] definition

[0084] Various terms are used to refer to specific system components. Different companies may refer to a component by different names—this document is not intended to distinguish between components that differ in name but function identically. In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended manner and should, therefore, be interpreted to mean "including, but not limited to..." Furthermore, the terms "couple" or "coupled" are intended to represent either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections.

[0085] The terms "transparent," "transparency," and variations thereof shall mean a transmission of light at a predetermined wavelength and / or wavelength range of about 10% or greater through the object, while the terms "opaque," "opacity," "opacity," and variations thereof shall mean a transmission of light at a predetermined wavelength and / or wavelength range of about 10% or less through the object. For example, acrylic may be considered transparent because it provides approximately 90% transmission of wavelengths from UV to infrared.

[0086] When used in conjunction with numerical values ​​and / or ranges, the terms "about" and / or "approximately" refer to those numerical values ​​and / or ranges that are close to the stated numerical values ​​and / or ranges. The terms "about" and "approximately" shall mean within ±10% of the recited value. For example, in some cases, "about 100 [units]" may mean within ±10% of 100 (e.g., from 90 to 110). The terms "about" and "approximately" may be used interchangeably. DETAILED DESCRIPTION

[0087] The following discussion relates to various embodiments of the present invention. Although one or more of these embodiments may be preferred, the disclosed embodiments should not be interpreted or otherwise used to limit the scope of the present disclosure, including the claims. In addition, those skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is intended only as an example of that embodiment and is not intended to imply that the scope of the present disclosure, including the claims, is limited to that embodiment.

[0088] Some medical procedures, such as those in the ear canal, can be challenging to perform and visualize due to sensitive tissue, constrained anatomy, and the size of the devices placed therein. Consequently, one or more of image resolution, field of view (FOV), device access, and device range of motion (ROM) are conventionally limited. Additionally, the views provided by conventional systems can be susceptible to patient motion (e.g., movement in response to patient motion), which can further limit the clinician's ability to consistently view the patient's anatomy and / or track the movement of medical devices relative to the patient's anatomy.

[0089] Various example embodiments are directional systems, devices, and methods for visualizing a patient's orifice. The systems, devices, and methods can be used to visualize the ear canal at a region of interest during otologic diagnostic and therapeutic procedures. An example visualization system may include a speculum configured to be advanced into the patient's ear canal. The speculum can be removably coupled to a surgical otoscope (hereinafter simply a "scope") comprising an imaging assembly (e.g., a camera), a display, and a rotation mechanism. When the speculum is attached to the scope, at least a portion of the imaging assembly can be disposed within an imaging cavity of the speculum. The speculum can be advanced into the ear canal so that the imaging assembly can visualize the ear canal. An instrument can be advanced into the ear canal through an instrument cavity (e.g., a "working channel") of the speculum. A clinician can manipulate the instrument and speculum while performing a procedure. For example, a clinician can rotate the speculum relative to the scope to modify the entry of the instrument into the ear canal.

[0090] As described in more detail below, the systems, devices, and methods can improve one or more of field of view, range of motion, image resolution, and ease of use. For example, image data output to the clinician can be processed to compensate for rotation of the speculum so that a consistent orientation is provided to the clinician. Furthermore, in some embodiments, the speculum can be separated from the scope so that the scope can be reusable and the speculum can be a single-use, disposable component.

[0091] The instructions are arranged as outlined below:

[0092] I. Visualization system block diagram

[0093] II. Example Visualization System

[0094] A. Guide device or speculum

[0095] i. Indentation and Field of View

[0096] ii. Optical axis angle

[0097] B. Visualization device

[0098] i. Imaging Components

[0099] ii. Attachment mechanism

[0100] iii. Image rotation component

[0101] iii. Line Management Component

[0102] C.Control device

[0103] i.Display

[0104] ii. Processor

[0105] iii. Memory

[0106] iv.Power supply circuit

[0107] v.Communication device

[0108] III. Methods

[0109] The description first turns to a high-level overview of an example system.

[0110] I. Visualization system block diagram

[0111] Figure 1 is a block diagram of a visualization system 100 according to at least some embodiments. Specifically, Figure 1 A control device 110, a visualization device 120 (e.g., the scope portion of a handheld device), and a guide device 130 (e.g., a speculum) are shown. In some embodiments, the control device 110 can be coupled to and / or integrated with the visualization device 120. In some embodiments, portions of the visualization system 100, such as the control device 110 and the visualization device 120, are designed to be reusable (e.g., used multiple times and with one or more patients). In some cases, the guide device 130 is designed to be reusable, while in other embodiments, the guide device 130 is designed to be a single-use item.

[0112] The guide device 130, hereinafter referred to as the speculum 130, can include a distal portion sized and shaped to be placed into an orifice of a patient (e.g., an ear canal). The speculum 130 can include one or more lumens, such as an instrument lumen 132 and an imaging lumen 134. The instrument lumen 132 can serve as a working channel, which enables one or more instruments to be passed through the working channel for accessing a space distal to the open end (tip) of the speculum 130. For example, tympanostomy tube delivery devices (e.g., as described in the following patents: U.S. Patent No. 8,052,693, entitled “System and Method for the Simultaneous Automated Bilateral Delivery of Pressure Equalization Tubes,” issued on November 8, 2011; U.S. Patent No. 8,864,774, entitled “Tympanic Membrane Pressure Equalization Tube Delivery System,” issued on October 21, 2014; U.S. Patent No. 9,320,652, entitled “Features to Improve and Sense Tympanic Membrane Apposition by Tympanostomy Tube Delivery Instrument,” issued on April 26, 2016; U.S. Patent No. 9,320,652, entitled “Features to Improve and Sense Tympanic Membrane Apposition by Tympanostomy Tube Delivery Instrument,” issued on June 20, 2017; U.S. Patent No. 9,320,652, entitled “Tympanostomy Tube Delivery Device with Cutting Edge Attachment,” issued on June 20, 2017 Dilator (Tympanostomy Tube Delivery Device with Cutting Dilator); U.S. Patent Application Publication No. 2016 / 0038342, published on February 11, 2016, entitled "Tympanostomy Tube Delivery Device with Rotatable Flexible Shaft; U.S. Patent No. 9,833,360, published on December 5, 2017, entitled "Tympanostomy Tube Delivery Device with Replaceable Shaft Portion" can be inserted into a portion of the ear canal adjacent to the tympanic membrane through the instrument cavity (132).In some embodiments, a visualization device 120 including an imaging assembly 122 may be disposed in the imaging cavity 134 and configured to generate image data corresponding to one or more tissues and anatomical structures during a procedure.

[0113] In some embodiments, the visualization device 120 can be configured to output image data and further configured to enable the speculum 130 to rotate relative to a portion of the visualization device 120. In some embodiments, the visualization device 120 can include an imaging assembly 122, an image rotation assembly 124, an attachment mechanism 126, and a line management assembly 128. The imaging assembly 122 can be configured to generate image data for output, for example, on a user interface of the control device 110. In some embodiments, the visualization device 120 can be attached to, operably coupled to, and / or integrated with the body of the control device 110.

[0114] In some embodiments, control device 110 may include processor 112, memory 113, power circuitry 114, and display 111 or communication device 115. In other embodiments, visualization device 120 may transmit information (e.g., via communication device 115) to a remote computing device that includes a display or other user interface.

[0115] As described in more detail below, portions of the imaging assembly 122 can be configured to be advanced into the imaging cavity 134 of the speculum 130. The imaging assembly 122 can include a sensor (e.g., an optical sensor, an imaging sensor, etc.) and an illumination source (e.g., a light emitter). The image rotation assembly 124 can be configured to enable an operator to rotate portions of the visualization device 120 and the speculum 130 relative to the rest of the visualization device 120. For example, the image rotation assembly 124 can (e.g., using a rotatable knob) enable the speculum 130 and the imaging assembly 122 to rotate relative to the rest of the visualization device 120. In some embodiments, the image rotation assembly 124 includes a sensor configured to generate data including, for example, position data, rotation data, and / or orientation data of the speculum 130 and / or the imaging assembly 122. The data generated by the image rotation assembly 124 can be used (e.g., by the processor 112) to process image data received from the visualization device 120 to provide a view of a portion of the ear canal having a predetermined (e.g., consistent) image orientation. In some embodiments, the attachment mechanism 126 couples the speculum 130 to the visualization device 120 in a selectively releasable manner.

[0116] In an example, the visualization device 120 includes a wiring management component 128. The example wiring management component 128 is configured to provide a wired connection between the imaging component 122 and one or more components of the control device 110 (e.g., the display 111, the processor 112, the power circuit 114), while enabling the imaging component 122 to rotate relative to the visualization device 120. In other embodiments, different components of the visualization device 120 can be configured to exchange information via a wireless connection (e.g., Bluetooth, WiFi, etc.). For example, the imaging component 122 can include a communication device (e.g., a transmitter or transceiver) that can transmit information (e.g., imaging data, position data, and / or other sensor data) to one or more components of the control device 110 (e.g., the display 111, the processor 112, the power circuit 114).

[0117] The processor 112 and the memory 113 can be configured to perform a number of tasks. For example, the processor 112 and the memory 113 can control the visualization device 120 and process data received from the sensors of the visualization device 120. The processor 112 and the memory 113 can transmit information (e.g., via the communication device 115) to other computing devices including remote computing devices. An example power supply circuit 114 provides power to the visualization device 120. In some embodiments, the visualization device 120 may include an onboard power supply operably coupled to the power supply circuit 114. In other cases, the visualization device 120 is connected to an external power source (e.g., via a wired connection). The communication device 115 can be configured to transmit and receive data from one or more computing devices. For example, the communication device 115 can transmit imaging data about a patient to a computing device for storage, analysis, and / or future viewing (e.g., in cases involving training).

[0118] II. Example Visualization System

[0119] Figure 2 2 is a perspective view of a visualization system 200 including a control device 205, a visualization device 210, and a speculum 240. The visualization device 210 includes a base 211 (e.g., a hub) coupled to an imaging assembly 212 and an image rotation assembly 216. The base 211 can include a movable or adjustable linkage (e.g., a flexible linkage) between the image rotation assembly 216 and a display 214 disposed within a housing 218. The imaging assembly 212 can be coupled to the image rotation assembly 216 to enable the imaging assembly 212 to rotate relative to the base 211. The example imaging assembly 212 can include an elongated portion (e.g., an optical sensor support arm) configured to extend components of the imaging assembly 212 into the speculum 240. More specifically, the elongated portion can be designed and constructed to fit within an imaging cavity 244 of the speculum 240.

[0120] The processor ( Figure 2 The image rotation assembly 216 and the base 211 may be communicatively coupled to the image rotation assembly 216. The image rotation assembly 216 and the base 211 may define an opening 213 (e.g., an orifice, a through hole, a working channel) configured to allow an instrument to pass through the instrument lumen 242 of the speculum 240. In the example system, the opening 213 is configured to receive a proximal portion of the instrument lumen 242 of the speculum 240 such that the opening 213 and the imaging lumen 244 are protected from contact with instruments (not shown for clarity) or from ingress of fluids (e.g., solid, liquid particles) that may enter the speculum 240 (e.g., to protect against biological contamination).

[0121] In the example shown, the base 211 is coupled to a housing 218 that encloses and / or supports the display 214 and other electronic components of the visualization system 200, such as similar to those described above with respect to FIG. Figure 1 The processor, memory, power supply circuit, battery and communication device of those components described. In some embodiments, the handle, handle, handpiece or palm support 215 can extend from the housing 218 in a direction opposite to the display 214. The exemplary palm support 215 is configured to hold the visualization system 200 for the clinician and position the visualization system 200 relative to the patient. The palm support 215 can be adjustable (e.g., extendable, slidable, rotatable, etc.) relative to the housing 218. In some embodiments, the clinician can use a single hand to hold and operate the visualization system 100. For example, the clinician can hold the palm support 215 with one hand and manipulate the instrument (not shown) with the other hand. Additionally or alternatively, the clinician can hold the palm support 215 while using one or more of the fingers and thumb to rotate the image rotation component 216.

[0122] Specifically, the example housing 218 defines a post 203. The post 203 defines a proximal end coupled to the underside of the housing 218, and the post 203 extends parallel to the palm support 215. Figure 2 In the example, the post 203 defines two finger recesses, one on each side, so that the example post 203 defines an inverted "T" shape. In use, the visualization system 200 is placed on the clinician's hand, and more specifically, the bottom side of the housing 218 rests on a plane defined by the clinician's index finger and thumb. The palm support 215 resides at the intersection of the index finger and thumb. The index finger extends through one finger recess of the post 203 to contact the image rotation assembly 216, and the thumb extends through the other finger recess of the post 203 to also contact the image rotation assembly 216. Thus, the clinician can rotate the image rotation assembly 216 while viewing the display 214 and manipulating the instrument. In some cases, when the speculum and imaging assembly are disposed in the patient's ear canal, the lower portion of the clinician's hand rests on or adjacent to the patient's head.

[0123] The example speculum 240 defines an instrument lumen 242 and an imaging lumen 244. The lower portion of the example speculum 240 has the shape of an inverted frustum, such that the speculum tapers in diameter from a larger proximal end to a distal open end (e.g., at a tip 246). In some cases, the lower portion of the example speculum 240 has the shape of an inverted cone, where the walls of the cone have a diameter that is a function of F(x) = -1 / x. 2 The larger proximal open end of the speculum 240 can be attached to the distal end of the speculum 240 via a speculum attachment mechanism ( Figure 2 , but discussed more below) is selectively coupled to and decoupled from the image rotation assembly 216.

[0124] In some embodiments, the visualization system 200 can be a durable component that can be used for multiple patients and / or procedures. When used with the speculum 240, the visualization system 200 can be designed to avoid contacting any part of the patient's anatomy, while the speculum 240 is designed to contact the patient's anatomy. Therefore, after the procedure, the speculum 240 can be cleaned and / or disinfected, while the visualization system 200 may not need to be disinfected. In some embodiments, the speculum 240 is a disposable component (e.g., a disposable consumable) that is replaced for each patient and / or procedure. The speculum 240 can be configured to contact the patient during use while shielding the visualization device 210 from contacting the patient.

[0125] The speculum 240 can be made of any suitable material. In the case where the speculum 240 is a disposable consumable, the outer wall of the speculum can be a transparent or opaque plastic material. In the case where the speculum 240 is reusable, any material suitable for cleaning (e.g., autoclave) such as metal and some plastics can be used to construct the speculum.

[0126] The speculum 240 can be sized to fit within a predetermined orifice, such as an ear canal. As shown and described in greater detail below, the tip 246 of the speculum 240 can be angled. That is, in the angled tip embodiment, the plane defined by the tip 246 is not perpendicular to the longitudinal center axis of the speculum 240. The angled tip 246 of the speculum 240 modifies the field of view of the imaging assembly 212 disposed within the imaging cavity 244 of the speculum 240.

[0127] A. Guide device or speculum

[0128] Figure 3A is a cross-sectional perspective view of a speculum 300 according to an example embodiment. Specifically, Figure 3AThe instrument cavity 310 (e.g., working channel), imaging cavity 320, speculum tip 340, and attachment portion 350 are shown. In some embodiments, the speculum 300 is supplied as preassembled components, and in some cases, the entire speculum 300 is disposable. In other embodiments, the speculum 300 is provided as multiple components (e.g., components designed to contact the patient's anatomy and components that do not contact the patient's anatomy), so that certain components of the speculum 300 can be discarded while other components can be retained for reuse. For example, the truncated lower portion 351 can be a disposable component, while the attachment portion 350 can be a reusable component.

[0129] Different portions and / or components of the speculum 300 may be formed of different materials depending on the functions of these portions. For example, a portion designed to contact the patient's anatomy (e.g., the lower portion 351) may be formed of a softer material, while a portion designed to couple to a visualization device (e.g., the attachment portion 350) may be formed of a more rigid material.

[0130] The speculum tip 340 disposed at the distal end of the speculum 300 defines an orifice or exit for instruments advanced through the speculum 300. The instrument lumen 310 may define an orifice or entrance configured to receive an instrument. The attachment portion 350 may be configured to attach to an attachment mechanism of a scope (e.g., Figure 1 Attachment mechanism 126). In the example shown, attachment portion 350 includes an alignment feature (352) configured to releasably couple speculum 300 to a scope.

[0131] In particular, the example speculum 300 includes an outer wall 313 defining a frustum having a longitudinal central axis. The outer wall 313 defines a first orifice at the tip 340 and a second orifice at the proximal end of the speculum 300. The orifice at the tip 340 is smaller than the orifice at the proximal end of the speculum 300. The outer wall 313 defines an inner diameter and an internal volume. An imaging lumen 310 is disposed on the inner diameter of the outer wall 313. The imaging lumen 310 has a proximal end and a distal end. The distal end includes a lens or optical tip 332. The example speculum further defines an instrument lumen 310 by the remainder of the internal volume not occupied by the imaging lumen 320.

[0132] In an exemplary embodiment, the speculum 300 is substantially opaque, except for an optical portion 330 which may be transparent, for example, to allow light transmission. For example, the imaging cavity 320 may include an optical portion 330 having an optical tip 332 at the distal end of the imaging cavity 320. The optical portion 330 enables the imaging assembly to provide illumination through the tip 340 and to generate an image of the target treatment area by transmitting and receiving light entirely through the optical tip 332. In the illustrated example, the optical tip 332 obscures, blocks, or surrounds the distal end of the imaging cavity 320 to provide a barrier between the imaging cavity 320 and the instrument cavity 310. The fluidly separated instrument cavity 310 and imaging cavity 320 enable the imaging assembly located within the imaging cavity 320 to be protected from contact with instruments in the instrument cavity 310 and / or from ingress of fluid that may enter the speculum 300 from the ear canal.

[0133] In an exemplary embodiment, imaging cavity 320 is designed and constructed to increase the cross-sectional area and / or usable volume of instrument cavity 310. In the illustrated example, imaging cavity 320 is positioned along the sidewall of speculum 300, allowing instrument cavity 310 to have a larger size and more usable space. In particular, because the size of an orifice such as a patient's ear canal is limited (e.g., approximately 0.5 cm to approximately 0.8 cm for an adult and smaller for a child), the distal end of speculum 300, including instrument cavity 310 and imaging cavity 320, is constrained to these dimensions. Thus, the size of imaging cavity 320 and / or its positioning relative to instrument cavity 310 provides a working channel for receiving instruments through speculum 300. Furthermore, imaging cavity 320 is sized to accommodate the size of the imaging assembly.

[0134] In some embodiments, and as Figure 3A , the optical tip 332 can be positioned within the speculum such that the imaging lumen 320 does not extend all the way to the tip 340 of the speculum 300 (e.g., does not extend the full length of the speculum 300). In other words, the distal end of the imaging lumen 320 is disposed at a first axial position relative to the longitudinal center axis, and the tip 340 is disposed at a second axial position that is different from the distal end of the imaging lumen 320. The position, depth, and orientation of the imaging lumen 320 are described in more detail below.

[0135] Figure 3B is a bottom plan view of an example speculum 300. Figure 3B According to an example embodiment, the axial position of the optical tip 332 is retracted from the tip 340 so that in use, the tip 340 of the speculum is visible to the imaging assembly, thereby providing a line of sight outward from the tip 340.

[0136] Figure 44 is an elevational, partial cross-sectional view of the distal end of a speculum 400 having an imaging assembly 440 disposed therein. The speculum 400 can be an example of any of the specula previously discussed. The example speculum 400 includes an instrument lumen 410 and an imaging lumen 420. The example imaging lumen 420 includes an optical portion 430 having a lens or optical tip 432. The imaging assembly 440 can be configured to irradiate illumination 442 (schematically shown as a light ray) from an end of the imaging assembly 440, through the optical tip 432, and through the tip 402 to illuminate a target treatment area (e.g., a portion of the ear canal adjacent the tympanic membrane). Figure 4 It is shown that in some cases, the light path of the illumination 442 can be wider than the inner diameter of the distal end of the speculum 400 at the tip 402. Making the light path of the illumination 442 wider than the diameter at the tip 402 provides illumination of the inner surface of the speculum 400 at the tip 402 to assist the imaging assembly 440 in visualizing the tip 402. Thus, although Figure 4 Some rays are shown passing through the outer wall of the speculum, but in reality these rays are intended to illuminate the inner surface and do not pass through the opaque speculum. However, illumination 442 is configured to illuminate a target treatment area (not shown) external to and distal to the tip 402, and as shown, may optionally illuminate portions of the speculum 400 to aid in visualizing the distal end of the instrument during initial insertion into the speculum 400. However, based on the angle of attack of illumination 442, reflections of illumination 442 directed toward the tip 402 back into the speculum are reduced.

[0137] According to some embodiments, imaging cavity 420 has a length that enables imaging assembly 440 to be telescoped into imaging cavity 420 and to contact or abut the inner surface of optical tip 432. However, due to manufacturing variations, imaging assembly 440 may not always fit completely into imaging cavity 420 such that the imaging assembly abuts the inner surface of optical tip 432. In other cases, to avoid damaging imaging assembly 440, the length of imaging cavity 420 and the length of imaging assembly 440 are designed and constructed such that when imaging assembly 440 is fully inserted into imaging cavity 420, a small gap may exist between the distal end of imaging assembly 440 and the inner surface of optical tip 432. However, this gap between the distal end of imaging assembly 440 and the inner surface of optical tip 432 may affect the quality of image data generated by imaging assembly 440 due to reflections caused by internal refraction and surface refraction of optical tip 432.

[0138] Still refer to Figure 4In some embodiments, the optical portion 430 of the imaging cavity 420 can include a dome and / or Fresnel features configured to redirect light toward the tip 402 and thereby reduce light scattering within the speculum. Additionally, in some embodiments, the imaging assembly 440 can include one or more baffles between the optical sensor and the illumination source(s) and configured to block light scattering within the optical tip 432.

[0139] In embodiments where imaging assembly 440 is designed and configured to abut the inner surface of optical tip 432, imaging assembly 440 can include a spring (not shown) configured to apply a force such that the imaging assembly can be biased toward optical tip 432. For example, the elongated portion of imaging assembly 440 can include a spring having a predetermined k value that enables the distal end of imaging assembly 440 to be aligned with and in flush contact with the inner surface of optical tip 432 without requiring adjustment by the clinician. In some embodiments, the spring can have a short stroke and be configured to reduce the gap between imaging assembly 440 and optical tip 432 to no more than about 0.3 mm.

[0140] Additionally or alternatively, an optical gel can be disposed between the imaging assembly 440 and the optical tip 432. For example, the optical gel can have a refractive index that substantially matches that of the optical tip 432 to reduce refraction and reflection (e.g., caused by any air gaps). In some embodiments, the speculum 400 can be preassembled with the optical gel applied to at least the inner surface of the optical tip 432. The imaging assembly 440 can be inserted into the imaging cavity 420 and optically coupled to the optical tip 432 via the optical gel. In other cases, the optical gel is applied to the distal tip of the imaging assembly 440 prior to insertion into the imaging cavity 420. After use, when the speculum 400 is separated from the imaging assembly 440, the distal end of the imaging assembly 440 can be cleaned (e.g., wiped) to remove any remaining gel on the imaging assembly 440.

[0141] In the event that there is a gap between the distal end of the imaging assembly 440 and the inner surface of the optical tip, the distance between the distal end of the imaging assembly 440 and the inner surface of the optical tip 432 can be selected to improve image quality while reducing the size of the imaging assembly and the speculum. In some embodiments, the illumination 442 output by the illumination source of the imaging assembly 440 can be focused at the center of the target treatment area and away from the inner surface of the speculum 400 to reduce reflections. In some embodiments, the sidewalls of the speculum 400 are formed of a light absorbing material to reduce the amount of reflected light. In addition, the thickness of the optical tip 432 can be selected to reduce interference (e.g., refractive loss, image blur, crosstalk) between the (multiple) illumination sources and the optical lenses of the imaging assembly 440, while being of sufficient thickness to be durable and facilitate manufacturing. For example, the configuration and size of the imaging cavity and imaging assembly can depend on the numerical aperture (NA) of the illumination source and the field of view of the optical lens imaging assembly.

[0142] Figure 5 Considerations regarding the illumination source, placement of the optical sensor, and thickness of the optical tip are shown in block diagram form. Specifically, Figure 5 An imaging assembly 500 and an optical tip 530 are shown. The imaging assembly 500 includes a lens system 510 (e.g., a camera, an optical sensor) and one or more illumination sources 520 (e.g., light and / or optical fibers; a single optical fiber is shown for clarity). The lens system 510 and the illumination source 520 define a center-to-center spacing X. The optical tip 530 defines a thickness T. The lens system 510 and the illumination source 520 define a gap or separation from the inner surface of the optical tip 530, the separation being shown as a distance D. The distance D may be given by equation (1):

[0143]

[0144] Among them C r is the radius of the exposed portion of the lens system entrance element, F r is the radius of the illumination source, α1 is half the acceptance angle of the illumination source 520 by the optical tip, and β1 is half the observation angle (half field of view (SFOV)) of the lens system.

[0145] The remaining parameters of equation (1) can be given by the following equations:

[0146]

[0147] where n ac is the refractive index of the light exit material of the illumination source (e.g., the optical tip material),

[0148]

[0149] X1(D)=D·tan(α1) (4)

[0150] X2=T·tann(α2) (5)

[0151] X3=T·tan(β2) (6)

[0152] X4(D)=D·tan(β1). (7)

[0153] In the example case where the optical tip is constructed of acrylic with a numerical aperture of 0.51, the optical window has a thickness T of 0.5 mm, the optical sensor has a field of view of 50 degrees, and has a distance X of approximately 1.5 mm, the imaging assembly 500 can be designed to have a maximum distance D of approximately 0.09 mm to reduce or prevent reflections. In some embodiments, the optical tip 530 can be constructed of a material with a low refractive index, such as polycarbonate and acrylic. For example, the polycarbonate can be injection molded and ultrasonically welded to form the speculum.

[0154] Figure 6A and 6B A side elevation view of two example specula is shown. Specifically, the tip of the speculum can be configured to enable an instrument to enter a patient's orifice, such as the ear canal, and also to enable visualization of the target treatment area and / or instrument (e.g., located near the target treatment area). The first speculum 600 has a symmetrical tip 610. That is, the longitudinal center axis of the speculum 600 is orthogonal to the plane defined by the tip 610. The second speculum 620 has an inclined tip 630. That is, the longitudinal center axis of the speculum 620 is not orthogonal to the plane defined by the tip 630, but forms a non-right angle with the plane defined by the tip. The tip 630 of the speculum 620 can improve the entry of the instrument into the ear canal (e.g., increase the range of motion of the instrument) and can increase the field of view of the imaging assembly disposed within the speculum. Specifically, because the imaging cavity and the imaging assembly are biased toward one side of the speculum, the inclined tip 630 reduces the amount of the interior of the speculum visible to the imaging assembly, thereby increasing the amount of light reaching the tympanic membrane and the number of pixels used to image the tympanic membrane. In some embodiments, the tip 630 forms an angle of less than about 30 degrees relative to a plane normal to the longitudinal center axis.

[0155] In some embodiments, the tip of the speculum can be atraumatic. For example, the tip can be formed by a silicone material or can include thermoplastic elastomer overmolding. In some embodiments, the speculum can be a size 4 speculum, wherein the inner diameter of the tip is between about 4mm and about 4.2mm, including end values. The speculum of size 4 can accommodate instruments with an outer diameter of about 3.5mm. Although a size 4 speculum is envisioned, the size of the speculum can vary (for example, from children to adults). Example speculum can also include a size 5 speculum (for example, the inner diameter of the tip between about 5mm and about 5.2mm, including end values), a size 6 speculum (for example, the inner diameter between about 6mm and about 6.2mm, including end values), and all ranges and subvalues ​​therebetween.

[0156] Figure 7 A cross-sectional view of a speculum is shown with an instrument extending through the speculum to illustrate the instrument's range of motion. In particular, Figure 7 Speculum 700 and instrument 730 extending through speculum 700 are shown. Instrument 730 is shown in multiple positions to illustrate the range of motion 732 of the distal tip of instrument 730. In one example embodiment, instrument 730 is a myringostomy tube delivery system. Example speculum 700 includes instrument cavity 710, and example imaging assembly 740 is disposed within instrument cavity 720, wherein the distal end of imaging assembly 740 is adjacent to optical tip 722. Imaging assembly 740 can be configured to generate image data from a field of view 742 sufficient to visualize a target treatment area (e.g., the tympanic membrane).

[0157] The field of view 742 is shown overlapping the distal end of the speculum 700. In an example embodiment, the outer wall of the speculum 700 is opaque, and therefore the imaging assembly 740 will not be able to "see through" the speculum 700. Instead, Figure 7 It is shown that in the example embodiment, the field of view 742 includes the ability to visualize the tip 702, which is why the example field of view 742 overlaps with the outer wall of the speculum 700. Although Figure 7 It is not specifically shown in FIG, but the width of the effective field of view at the target treatment site will be less than Figure 7 Field of view 742 shown in .

[0158] The field of view 742 of the imaging assembly 740 and the range of motion 732 of the instrument 730 depend on the internal dimensions of the speculum 700, the axial positioning and size of the imaging cavity 720, the angle of the speculum tip 702, and the imaging characteristics of the imaging assembly 740. Figure 7 In the example shown, instrument 730 does not have a range of motion as wide as field of view 742. The relationship between imaging assembly position and optical imaging properties is described in more detail below.

[0159] Figure 8is a top view of a partial cross-section of a speculum with an instrument extending through the speculum to illustrate the range of motion of the instrument at the proximal end of the speculum. Figure 8 Speculum 800 and instrument 830 are visible in the example system. Speculum 800 includes an instrument lumen 810 configured to accommodate advancement and manipulation of instrument 830. Also shown in partial cross-section are an imaging lumen 820 and an imaging assembly 840. Instrument 830 is shown in multiple positions to illustrate a range of motion 832 of instrument 830 once advanced through speculum 800. The range of motion 832 of instrument 830 may depend on the size of speculum 800, and / or the location and size of imaging lumen 820. In the example system, instrument 830 does not have a full 360-degree range of motion because imaging lumen 820 and imaging assembly 840 obstruct instrument 830 along a portion of the full 360 degrees.

[0160] Figure 9 is a perspective view showing the relationship between the imaging field of view and the range of motion of the instrument. Specifically, Figure 9 The distal end of the instrument 930 is shown after insertion through the speculum 400, and an imaging field of view 942 relative to the speculum 910 and the instrument 930 is also shown. The imaging field of view 942 overlaps with an example target treatment area 950 (e.g., the diameter of the target treatment area 950 is between about 9 mm and about 10 mm). The target treatment area 950 can be the eardrum (illustrated as a plane perpendicular to the central axis of the speculum for clarity). For example, the speculum 910 can be aimed directly over the center of the target treatment area 950. In the example shown, the imaging field of view 942 encompasses the entire target treatment area 950, but is offset from the target treatment area 950 (i.e., not concentric with respect to the target treatment area 950) due to the placement of the imaging assembly along the sidewall of the speculum 910. In example embodiments, it is desirable to increase the overlap between the imaging field of view 942 and the area covering the instrument's range of motion so that the instrument 930 can reach a larger visible portion of the target treatment area 950.

[0161] The visualization system 900 can be configured to enable the instrument 930 to interact with any portion of the target treatment area 950, while limiting repositioning (e.g., rotation, translation, etc.) of the speculum 910. The example instrument 930 can be advanced through the speculum 910 and manipulated through the speculum 910 to have a range of motion 932. In the illustrated example, the range of motion 932 of the instrument 930 is not circular due to the geometric constraints of the speculum 910 and the instrument lumen (not shown), such as the space within the speculum 910 occupied by the imaging lumen. The range of motion 932 of the instrument 930 covers, for example, approximately 90% of the target treatment area 950, with the remaining portion of the target treatment area 950 defining a coverage gap 960. In some embodiments, rotation of the speculum 910 (e.g., approximately 20 degrees) modifies the range of motion 932 of the instrument 930 to overlap the coverage gap 960 and provide the operator with access to the entire target treatment area 950. Thus, in some embodiments, the visualization system 900 enables rotation of the speculum 910 and / or the imaging assembly. Additionally or alternatively, the speculum 910 can be manipulated (eg, tilted, pivoted, advanced, retracted, laterally moved) to modify the range of motion 932 of the instrument 930 relative to the target treatment area 950 .

[0162] An example visualization system may include an imaging assembly that can be positioned at a predetermined depth, position, and angle relative to the distal end or tip of the speculum to enhance visualization of the procedure. Consider that when positioned at the speculum tip, the imaging assembly may not be able to visualize the instrument until the instrument extends beyond the speculum tip. Therefore, by positioning the imaging assembly proximal to the speculum tip, the imaging assembly can visualize the instrument as it advances beyond the speculum tip toward the target treatment area. This visualization capability can increase the clinician's spatial and depth perception, thereby improving patient safety and patient outcomes.

[0163] Figure 10A and 10B is a cross-sectional view of the speculum to illustrate considerations regarding placement of the imaging cavity relative to the speculum tip and field of view. Figure 10A , Figure 10AA retractor 1000 is shown having an instrument lumen 1010, an imaging lumen 1020, and an imaging assembly 1040 disposed within the imaging lumen 1020. The example imaging lumen 1020 has a distal end disposed a first setback distance 1030 proximal to the tip 1001. The setback distance can be measured as the distance along the optical axis 1051 of the imaging assembly from the distal end of the imaging lumen 1020 to a line intersecting the intersection of the field of view with the inner wall of the retractor at or near the distal-most point of the tip 1001, and the line being perpendicular to the optical axis 1051. In other words, the example imaging lumen 1020 has a distal end disposed at a first axial position along the longitudinal axis of 1050, and the distal tip 1001 is disposed at a second axial position along the longitudinal axis 1050, and at a second axial position along the longitudinal axis 1050. Figure 10A The imaging assembly 1040 generates image data having a first field of view 1042 and a target depth of focus 1060.

[0164] Similarly, Figure 10B The speculum 1002 is shown having an instrument lumen 1012, an imaging lumen 1024, and an imaging assembly 1044 disposed within the imaging lumen 1024. The exemplary imaging lumen 1024 has a second setback distance 1032 (e.g., 13 mm, greater than the tip 1003) disposed proximal to the tip 1003. Figure 10A The distal tip 1003 is disposed at a first axial position along the longitudinal axis 1050 and at a second axial position along the longitudinal axis 1050. Figure 10B The imaging assembly 1044 generates image data having a second field of view 1046 and a target depth of focus 1062.

[0165] In an example system, the first retraction distance 1030 can be approximately 9 mm, and the second retraction distance 1032 can be approximately 13 mm. The first field of view 1042 can be approximately 36.8 degrees, and the second field of view 1046 can be approximately 25.5 degrees. Thus, as the retraction distance between the tip of the speculum and the distal end of the imaging assembly increases, the effective field of view of the visualization system decreases (e.g., due to the size of the opening at the tip of the speculum).

[0166] In some embodiments, the imaging assembly can have a resolution between about 15 micrometers (μm) and about 120 μm, depending on the distance of the object being visualized from the imaging assembly. For example, consider an imaging assembly 1040 having a depth of focus (DOF) between about 9 mm and about 28 mm, inclusive. A far field focus of about 28 mm measured from the distal end of the imaging assembly 1040 along the optical axis 1051 results in a far field focus of about 19 mm away from the speculum tip 1001. From about 9 mm to about 20 mm from the distal end of the imaging assembly 1040, the focus resolution is less than the resolution at the target depth of focus 1060; however, the reduced resolution in the range of 9 mm to about 20 mm can be at least about 150 μm, so that objects can be identified and visualized even if fine details are not fully visible. As the design of the speculum further retracts the imaging assembly backward, the target depth of focus relative to the speculum tip can be reduced. For example, in Figure 10B In the embodiment depicted in FIG1044 with a 13 mm retraction distance, the depth of focus of the imaging assembly 1044 can be between about 13 mm and about 32 mm, with a target depth of focus 1062 between about 24 mm and about 32 mm, inclusive. For other camera systems (e.g., a camera sensor disposed at the distal tip of the imaging assembly), the camera sensor can have a depth of focus between 0 mm and 50 mm, in which case the retraction distance is primarily governed by the desired range of motion.

[0167] i. Indentation and Field of View

[0168] According to example embodiments, the retraction distance between the speculum tip and the distal end of the imaging cavity (measured along the optical axis) can be between about 4 mm and about 24 mm, inclusive. The retraction distance controls the effective field of view of the imaging assembly, and in some embodiments, the inner edge of the orifice of the speculum tip is within the field of view. In example embodiments, a retraction distance of about 8 mm corresponds to an effective field of view of about 40 degrees, and a retraction distance of 24 mm corresponds to an effective field of view of about 12 degrees.

[0169] Figure 10A and Figure 10B Also shown are the trade-offs or balances that must be considered during the design phase of the speculum and associated imaging components. Figure 10A In the example of , the field of view 1042 is an example 36.80 degrees. At an example retraction distance 1030 of 9 mm and an example depth of focus of 16 mm from the distal tip 1001 (a point within the depth of focus 1060), the tympanic membrane (e.g., 10 mm in diameter) occupies a certain amount (less than the entire) of the field of view within the depth of focus. On the other hand, at Figure 10B In the example, the field of view 1046 is the example 25.53 degrees. At the example retraction distance 1032 of 13 mm and the example depth of focus, the eardrum (e.g., 10 mm in diameter) occupies less than the entire field of view at the depth of focus, but occupies more than Figure 10AMore fields of view. Figure 10B In comparison, Figure 10A In other words, for the same size eardrum, Figure 10B The resolution of the image of the tympanic membrane in Figure 10A In some example cases, the eardrum residing at the depth of focus (e.g., 1060, 1062) occupies at least 50% of the visible area at the depth of focus, in some cases at least 60% of the visible area at the depth of focus, and in other cases at least 80% of the visible area at the depth of focus.

[0170] ii. Optical axis angle

[0171] Given the inverted frustum shape of the example speculum, the optical axis of the imaging assembly can be angled relative to the speculum longitudinal axis, where the magnitude of the angle is based on the retraction distance. For example, the first speculum 1000 defines a first longitudinal axis 1050, and a retraction distance 1030 of approximately 9 mm results in a tilt angle of approximately 7.5 degrees measured between the longitudinal axis 1050 and the optical axis 1051. As the retraction distance of the design increases, the tilt angle between the speculum's longitudinal axis and the optical axis also increases. In other words, the optical axis 1051 can also be defined solely based on the imaging cavity 1020. For example, the optical axis 1051 can be equivalently defined as a line perpendicular to the optical window at the distal end of the imaging cavity 1020, and in some cases, the line perpendicular to the optical window is parallel to a line tangential to the inner surface of the speculum at the distal end of the imaging cavity. However, the tilt angle between the optical axis (however defined) and the longitudinal axis can increase as the retraction distance of the speculum design increases.

[0172] According to example embodiments, the speculum is designed and constructed to compensate for the offset of the imaging cavity from the longitudinal axis, with the compensation taking the form of a tilt angle. That is, during the design of the speculum, the tilt angle is selected such that the optical axis intersects the longitudinal axis of the speculum near or within the target treatment area. In other words, during the design of the speculum, the tilt angle is selected such that the optical axis intersects the longitudinal axis of the speculum at the designed focal depth of the imaging assembly. Figures 28A-28C The relationship of the optical axis and the tilt angle of the target treatment area relative to the field of view of the imaging assembly is shown.

[0173] Figure 28A A block diagram illustrating various relationships of an example visualization system 2800 is shown. In particular, Figure 28AA camera or optical sensor 2810 is shown positioned within an ear canal 2820. The optical sensor 2810 can be a predetermined distance X from a target treatment area 2802 (e.g., the eardrum) having a diameter Y. The optical sensor 2810 is positioned a distance W from the sidewall of the example ear canal 2820. The example optical sensor 2810 has a field of view centered around the optical axis of the optical sensor 2810 with a diameter Z. In one example embodiment, the distance X can be 16 mm, the diameter Y can be 9 mm, and the distance W can be 0.75 mm.

[0174] exist Figure 28A In the example case of FIG, the optical axis of the optical sensor does not intersect the center of target treatment area 2802. In order for the optical axis of optical sensor 2810 to intersect the center of target treatment area 2802 or pass within a predetermined distance from the center of the target treatment area, the optical axis of optical sensor 2810 needs to be placed at an oblique angle (e.g., relative to the longitudinal axis of the not-shown speculum).

[0175] Figure 28B is a graph illustrating the relationship of the fields of view of two types of optical sensors that may be provided within an imaging assembly of various embodiments. Figure 28B The Y axis is the distance from zero in the first direction, where zero is centered along the axis. Figure 28B The X axis of is the distance from zero in a second direction orthogonal to the first direction, where zero is centered along the axis. Specifically, Figure 28B Observation areas 2832 and 2834 (at uniform distances) are shown for both types of optical sensors. Specifically, an optical sensor implemented as a cube camera may have observation area 2832 as shown, while an optical sensor implemented as a circular camera may have observation area 2834. The difference in observation area can be attributed to the half-angle of view of each optical sensor type. An exemplary circular camera may have a half-angle of view of 35 degrees, while a cube optical sensor may have a half-angle of view of 45 degrees.

[0176] Figure 28C is a diagram showing the tilt angle according to at least some embodiments A graph showing the relationship as a function of distance from the center of the field of view. Figure 28C The Y axis shows the tilt angle in degrees (eg, the tilt angle of the optical axis relative to the longitudinal axis of the speculum). Figure 28C The X-axis shows the distance from the optical sensor to the target processing area (e.g., Figure 28A Specifically, Figure 28C The graph shows the tilt angle An example relationship between and distance X to center the field of view of the optical sensor. In other words, Figure 28C The graph shows the tilt angle The relationship between the distance X and the optical axis of the optical sensor can be used to intersect the center of the target processing area or pass within a predetermined distance of the center of the target processing area. Figure 28C shows the tilt angle of the optical sensor As the distance X between the optical sensor and the target processing area decreases, it increases. In terms of the retraction distance of the imaging assembly, and assuming that the tilt angle increases with the increase of the retraction distance, Figure 28C shows the tilt angle of the optical sensor It increases as the designed target treatment area moves closer to the speculum tip.

[0177] B. Visualization device

[0178] The visualization system described herein can be coupled to a speculum and enable visualization of the ear canal and tympanic membrane using one or more instruments (e.g., a myringostomy tube delivery device) during a procedure. For example, a scope attached to a speculum can be configured to capture image data while enabling rotation of portions of the scope and / or speculum. Figure 1 As mentioned, the visualization system 100 may include an imaging assembly, a speculum attachment mechanism, an image rotation assembly, and a circuit management system, all of which are described in greater detail below, beginning with the imaging assembly.

[0179] i. Imaging Components

[0180] An example imaging assembly can include a sensor (e.g., an optical sensor, such as a camera, a serializer) and an illumination source (e.g., a light emitter and / or a light guide). The imaging assembly can include an elongated portion configured to position various components of the imaging assembly within an imaging cavity of the speculum so that those components can image a target treatment area (e.g., a tympanic membrane). For example, the elongated portion can be a shaft or arm that includes a housing configured to support and / or enclose at least a portion of the optical sensor and the illumination source.

[0181] Figure 11A perspective view of an imaging assembly 1100 is shown according to at least some embodiments. The example imaging assembly 1100 represents any of the imaging assemblies previously discussed. The imaging assembly includes a proximal end 1102, a distal end 1104, and an elongated shaft or elongated portion 1130. The proximal end 1102 of the imaging assembly 1100 is configured to be coupled to a base of a visualization system (the entire visualization system is not shown for clarity). The distal end 1104 of the imaging assembly 1100 is configured to telescope within an imaging cavity of a speculum and is further configured to provide illumination and image sensing within a speculum (e.g., any of the example specula previously discussed). Accordingly, the elongated portion 1130 is designed and constructed to fit within the imaging cavity of a speculum. In some embodiments, the elongated portion can be a sealed housing configured to enable routine cleaning and maintenance of the imaging assembly.

[0182] The exemplary imaging assembly 1100 includes a distal optical lens 1110 disposed on a distal end face of an elongated shaft. The distal optical lens 1110 is operably disposed between a first illumination source 1120 and a second illumination source 1122. In some embodiments, an optical sensor (not specifically shown) may physically reside at the distal end of the imaging assembly; however, in other embodiments, the optical sensor may reside within the elongated portion 1130 of the imaging assembly 1100 and be optically coupled to the distal optical lens 1110 via a rod lens system. Figure 11 , but discussed in more detail below).

[0183] Figure 12A is a bottom plan view of an imaging assembly having a distal optical lens adapted for use with an optical sensor in the form of a circular camera, according to at least some embodiments. The example imaging assembly 1200 includes a housing 1230 enclosing a distal optical lens 1210 disposed between a first illumination source 1220 and a second illumination source 1222. In the example system, the center-to-center spacing between the first illumination source 1220 and the second illumination source 1222 is approximately 2.92 mm. In the example system, the thickness of the overall imaging assembly 1200 (measured at the apex of the curved surface to the flat bottom) can be approximately 1.6 mm. The distal optical lens 1210 is schematically shown as circular to accommodate a circular camera having a circular cross-sectional shape (at Figure 12A ). The imaging assembly 1200 is designed and constructed to telescope with the imaging cavity of the speculum and is disposed in operative relationship with a lens or window defining a distal end of the imaging cavity of the speculum.

[0184] Figure 12Bis a bottom plan view of an imaging assembly having a distal optical lens adapted for use with an optical sensor in the form of a cube camera, according to at least some embodiments. The example imaging assembly 1250 includes a housing 1280 enclosing a distal optical lens 1260 disposed between a first illumination source 1270 and a second illumination source 1272. In the example system, the center-to-center spacing between the first illumination source 1270 and the second illumination source 1272 is approximately 2.2 mm. In the example system, the thickness of the overall imaging assembly 1250 (measured at the apex of the curved surface to the flat bottom) can be approximately 1.32 mm. The distal optical lens 1260 is schematically shown as a square to accommodate an optical sensor having a rectangular cross-sectional shape (at Figure 12B The imaging assembly 1250 is designed and constructed to telescope with the imaging cavity of the speculum and to be disposed in operative relationship with a lens or window defining the distal end of the imaging cavity of the speculum.

[0185] The circular or cubic optical sensor may take any suitable form. For example, the optical sensor may include a photodiode, a charge coupled device (CCD), or a complementary metal oxide semiconductor (CMOS) optical sensor, and in some cases, an optical lens assembly. In some embodiments, the optical sensor may have a resolution between about 1 megapixel and about 5 megapixels, inclusive. The optical sensor may have a pixel size between about 1.12 μm and about 2 μm, inclusive. The optical sensor may have a pixel size between about 6 mm and about 1.2 μm, inclusive. 2 About 12mm 2 The optical sensor may have a sensor image area between about 600 mV / Lux-sec and about 700 mV / Lux-sec, inclusive. The optical sensor may have a chief ray angle of up to about 29.1 degrees. The optical sensor may have a frame rate of up to about 30 frames per second. In some embodiments, the optical sensor may be recessed into the tip of the speculum by a distance between about 2 mm and about 24 mm, inclusive, and have a focus-optimized working distance (e.g., target depth of focus) from the tip of the speculum between about 11 mm and about 19 mm, inclusive, corresponding to a focus tolerance between about +3 mm and about -5 mm, inclusive. The optical sensor may have a detail resolution target at a working distance between about 12 μm and about 40 μm, inclusive. In some embodiments, the full depth of focus of the optical system may be between about 2 mm and about 43 mm, and the field of view may be between about 12 degrees and about 50 degrees, inclusive (depending on the distance the optical system is recessed into the tip of the speculum and other factors).

[0186] Figure 13A set of schematic diagrams illustrates an optical lens assembly configuration 1300 for an imaging assembly that may include a passive or active focusing mechanism. Specifically, the optical lens assembly may include an objective lens element 1320 and a relay lens element 1330. In some embodiments, the optical lens assembly may include two or more elements (four elements are shown for purposes of example). The optical lens assembly may be configured to balance feature resolution and depth of field to accommodate variations in patient anatomy (e.g., ear structure, ear canal shape, ear canal size). For example, the focus of the optical lens system may be configured to provide a working distance of approximately 16 mm for a total working depth of focus between approximately 19 mm and 22 mm (inclusive), with a tolerance between approximately +3 mm and approximately -5 mm. Resolution over the working depth range may vary. For example, an imaging assembly having an optical lens assembly that is recessed approximately 9 mm from the tip of the speculum may have a focus-optimized working distance between approximately 20 mm and approximately 28 mm. Resolution may degrade rapidly outside this working distance range (e.g., in the near-field direction). The full depth of focus range accounts for the recessed distance from the end of the working distance. For example, for an optical lens assembly recessed about 9 mm from the speculum tip, the full depth of focus will be between about 9 mm and about 28 mm. In the near field range of the full depth of focus, between about 9 mm and about 20 mm, inclusive, the resolution can be about 150 μm.

[0187] In some embodiments, the imaging assembly may include a focusing assembly configured to modify the working depth of focus to improve resolution when the desired focus is outside the current working depth of focus range. For example, the working depth of focus may be modified by moving one or more of the optical sensor 1310, the objective lens element 1320, and the relay lens element 1330 relative to each other. The objective lens element 1320 may include a first lens A and a second lens B. The relay lens element 1330 may include a third lens C and a fourth lens D. Although Figure 13 Two objective lens elements 1320 and two relay lens elements 1330 are shown, but it will be appreciated that any number of objective lens elements and two relay lens elements may be used, including, for example, a single objective lens element and a single relay lens element.

[0188] A first focusing configuration 1340 may include a set of objective lens elements 1320, a set of relay lens elements 1330, and an optical sensor 1310, each of which is fixed relative to one another so that the working focal depth is set within a fixed range. A second focusing configuration 1350 and a third focusing configuration 1360 may include a set of relay lens elements 1330 and an optical sensor 1310 configured to move relative to the set of objective lens elements 1320. In the second focusing configuration 1350, the third lens C and the fourth lens D may move together. In the third focusing configuration 1350, at least one of the relay lens elements 1330 (e.g., lens D) may move relative to a fixed relay lens (e.g., lens C). A fourth focusing configuration 1370 may include an optical sensor 1310 configured to move relative to the fixed set of objective lens elements 1320 and the fixed set of relay lens elements 1330.

[0189] In some embodiments, a voice coil mechanism (VCM) and / or an elastic membrane mechanism (MEM) can be configured to move at least one of lens elements 1320, 1330 and optical sensor 1310 relative to the other components. In some embodiments, a mechanical actuator (e.g., a knob, a dial, a slider) can enable a clinician to manually modify the focus of the imaging assembly. In some embodiments, the clinician can modify the focus of the imaging assembly using an input device operably coupled to and / or integrated into the scope, such as a user interface (e.g., including a touch screen, a keyboard, a display, an audio device, etc.).

[0190] In some embodiments, each illumination source may include a light emitter and / or an optical waveguide. Non-limiting examples of light emitters include incandescent, discharge (e.g., excimer lamps, fluorescent lamps, discharge lamps, plasma lamps, etc.), electroluminescent (e.g., light emitting diodes, organic light emitting diodes, lasers, etc.), and induction lighting. For example, a light emitting diode (LED) can be disposed at the proximal end of the imaging assembly and coupled to an optical waveguide extending along the length of the imaging assembly. The optical waveguide can receive light having a predetermined combination of light output parameters (e.g., wavelength, frequency, intensity) from the light emitter and transmit and emit the light to the area being imaged (e.g., the ear canal). Additionally or alternatively, the distal end of the imaging assembly may directly include a light emitter (e.g., an LED).

[0191] An optical waveguide may refer to a physical structure that guides electromagnetic waves, such as waves in the visible light spectrum, to passively propagate and distribute the received electromagnetic waves. Non-limiting examples of optical waveguides include optical fibers, rectangular waveguides, light pipes, light conduits, combinations thereof, and the like. For example, a light conduit may include a hollow structure having a reflective lining or a transparent solid configured to propagate light by total internal reflection. The optical waveguides described herein may be made of any suitable material or combination of materials. For example, in some embodiments, the optical waveguides may be made of optical grade polycarbonate or glass. In some embodiments, the housings described herein may be co-injection molded to form the optical waveguides. In other embodiments, the optical waveguides may be formed separately and coupled to respective housings. In some embodiments, the optical waveguides described herein may include one or more portions configured to transmit light therethrough.

[0192] In some embodiments, the illumination source may include an optical fiber configured to direct light output through the aperture tip toward a predetermined target treatment area (e.g., the tympanic membrane). That is, given the relative position of the imaging assembly (and therefore the illumination source) relative to the target treatment area and / or the distal aperture of the speculum, the illumination source may be designed and constructed so that the light emitted by the optical fiber can be directed toward the target treatment area. For example, the tip of an optical fiber with a diameter of 0.75 mm may have an angled tip (e.g., a cutting angle, a bevel) between about 40 degrees and about 50 degrees, inclusive. The tip of the fiber may be angled up to about 0 degrees to about 15 degrees relative to the longitudinal axis of the speculum to direct the emitted light from the speculum tip to the target treatment area. In some embodiments, light emitted from one or more symmetrical illumination sources can be directed to the target treatment area within a nominal working distance range of about 16 mm, with a tolerance of about +3 mm and about -5 mm. The light emitted by the one or more illumination sources can be adjusted, for example, by angling or shaping the tip of the fiber or by using a lens element molded into the optical tip.

[0193] Figure 14 is a schematic diagram of image data 1400 generated by an imaging component of a visualization system. The image data 1400 may include a square image corresponding to an image of a target treatment area 1410 and an image 1420 of a portion of a speculum (i.e., the portion of the distal end of the speculum visible in the frame). The lens system of the imaging component may map incident light (e.g., light received from the target treatment area) to an imaging area of ​​an optical sensor, such as Figure 14By mapping the incident light to the short dimension of the optical sensor, the image data is not cropped or lost before it is sent to the processor for further post-processing. As the retractor design uses a larger retraction distance, the size or total area of ​​the retractor image 1420 can be increased. In some of these embodiments, the field of view can be reduced to avoid losing pixels from image cropping. Due to the higher pixel density over the total area of ​​the image data 1400, reducing the field of view can achieve an increase in image resolution (see, e.g., Figure 10A 、 10B and the related discussion above).

[0194] Figure 15 1 is an example image 1500 of a tympanic membrane 1530 and adjacent tissue 1510 generated by an imaging component of a visualization system. Image 1500 depicts a portion of tissue 1510 (e.g., ear canal tissue) adjacent to the tympanic membrane 1530, a target treatment area 1540, and an image 1520 of a speculum (e.g., the tip of the speculum). In some cases, the tympanic membrane 1530 may have a diameter between about 9 mm and about 10 mm. The imaging component can be configured to increase illumination and improve resolution within the target treatment area 1540.

[0195] ii. Attachment mechanism

[0196] In some embodiments, an attachment mechanism (e.g., attachment mechanism 126) is configured to couple the speculum to the visualization system, which enables a disposable (e.g., single-use) speculum to be used with a durable and reusable visualization system. The image rotation assembly is coupled to the speculum via the attachment mechanism so that the imaging assembly and the speculum can be rotated about the longitudinal axis of the speculum, the rotation being relative to the base of the visualization system.

[0197] In an example embodiment, the attachment mechanism is configured to provide an attachment interface for a speculum. In some embodiments, the attachment mechanism fixes the longitudinal position of the speculum relative to the base while enabling the speculum to be rotated a predetermined number of degrees (e.g., 360 degrees) relative to the base and about the longitudinal axis of the speculum by rotation of the image rotation assembly.

[0198] In an example embodiment, the attachment mechanism includes a fastener (e.g., a latch, a clip, a screw, a strap) or any other mechanical structure configured to engage the speculum. For example, the attachment mechanism may include a spring-loaded latch or an interface with an internal thread. As another example, the speculum may include a snap arm configured to engage with a corresponding feature provided on the image rotation assembly and / or the imaging assembly.

[0199] In some embodiments, the attachment mechanism may include a release mechanism configured to release the speculum from the visualization system. For example, an operator can actuate a release mechanism that enables a clinician to manually remove or remove by gravity to separate the speculum from the visualization system. In some embodiments, the attachment mechanism may include a mechanical attachment mechanism, a pressure-based attachment mechanism, a magnetic attachment mechanism, and / or an electrical attachment mechanism. For example, the attachment mechanism may include a magnet that is configured to attract a corresponding magnet or group of magnets disposed on the speculum. That is, a sidewall of the speculum may include a first magnet that is configured to attract a second magnet disposed within the elongated portion of the imaging assembly. In some embodiments, the magnetic engagement may form a rotational coupling between the speculum and the rotation mechanism.

[0200] In some embodiments, the attachment mechanism may include an iris mechanism configured to transition from a closed configuration to an open configuration based on the position of the actuator. The iris mechanism may include a set of elongated portions configured to retain the speculum to or release the speculum from the visualization system. The following discussion and figures provide examples of attachment mechanisms.

[0201] Figure 31A 31 is a bottom perspective view of a visualization device 3100 having an attachment mechanism in a closed configuration. Specifically, the visualization device 3100 includes a base 3110, an imaging assembly 3120, and an attachment mechanism 3130. The example attachment mechanism 3130 includes an attachment base 3134 defining an orifice or lumen through which the imaging assembly 3120 protrudes, and an annular ring 3136 defining an actuator or tab 3150 extending therefrom. A set of springs biases the annular ring 3136 toward a first rotational orientation relative to the attachment base 3134. For example, the spring 3132 is coupled between the attachment base 3134 and the annular ring 3136 and rotates counterclockwise (in a direction opposite to the rotational orientation of the annular ring). Figure 31A ) offset annular ring. Although Figure 31A Three springs are shown to bias the annular ring 3136 relative to the attachment base 3134, but one or more springs may be used.

[0202] The example annular ring 3136 defines a plurality of elongated orifices or slots, and in the example case, defines three slots corresponding to three engaging members. For example, the slot 3138 representing all the slots is in an operational relationship with the cylinder or pin 3140. The pin 3140 is disposed in the slot so that when the annular ring 3136 rotates relative to the attachment base 3134, the pin 3140 slides in the slot 3138. The movement of the pin 3140 in the slot 3138 causes the movement of the associated engaging member 3142. Two additional engaging members 3144 and 3146 can be seen, and each engaging member is associated with a slot and a pin (not specifically numbered). Although three engaging members 3142, 3144 and 3146 are shown, two or more engaging members operating as an iris mechanism can be used.

[0203] Figure 31B is a bottom perspective view of a visualization device with an attachment mechanism in an open configuration. Figure 31B , the annular ring 3136 has been rotated relative to the attachment base 3134, both loading the spring (e.g., spring 3132) and translating the pins within the slots (e.g., pin 3140 within slot 3138). Translation of the pins along and within their respective slots causes the respective engagement members to retract into the apertures defined in the annular ring 3136 and the attachment base 3134. Thus, in Figure 31B In the orientation shown, no engagement members are visible within the aperture through which the imaging assembly 3120 protrudes.

[0204] Also refer to Figure 31A and 31B In operation, the clinician rotates the annular ring 3136 relative to the attachment base 3134, for example by interacting with the tab 3150. Figure 31B , the proximal end of the speculum (not shown so as not to unduly complicate the drawing) is placed within the orifice. Once the speculum is placed, the clinician releases the tab 3150. Upon releasing the tab 3150, the annular ring 3136 is biased back to the first orientation by a spring (e.g., spring 3132), and movement to the first orientation causes the engagement members 3142, 3144, and 3146 to extend, as shown. Figure 31A , such that engagement members 3142 , 3144 , and 3146 maintain the speculum and visualization device 3100 in an operative relationship.

[0205] Although Figure 31A and 31BThe example shown in FIG. 3 shows the tab 3150 and the annular ring 3136 moving in a clockwise direction to retract the engagement members 3142, 3144, and 3146, and moving or allowing the tab 3150 and the annular ring 3136 to move in a counterclockwise direction to deploy or extend the engagement members 3142, 3144, and 3146, but the visualization assembly can be designed and constructed to operate with the opposite rotational movement as well. In further embodiments, the tab 315 can be designed and constructed to move radially to engage and release the engagement members.

[0206] Figure 32A is a side cross-sectional view of the speculum locked within the visualization device 3200. In particular, Figure 32A 32. Visible in the figure is a base 3210, a knob 3220 configured to rotate about the base 3210, a speculum 3230, and an attachment mechanism 3240. The example attachment mechanism 3240 includes a spring 3244 and an engagement member 3242 configured to be advanced and retracted to engage and disengage the speculum 3230, respectively.

[0207] Figure 32A An example attachment mechanism 3240 is shown in a closed configuration, wherein an engagement member 3242 engages an engagement portion 3232 (e.g., lip, shoulder) of a speculum 3230 to retain the speculum 3230 within the base 3210. When engaged, the speculum 3230 can rotate relative to the base 3210, for example, around the longitudinal axis 3250 of the speculum 3230, and when the clinician turns the knob 3220. The example engagement portion 3232 and engagement member 3242 have mating surfaces with matching angles to assist rotation, friction reduction, and releasable attachment. The engagement portion 3232 can act as (or include a functional sub-portion) a channel or guide in which the engagement member 3242 can move, such that the speculum 3230 can rotate relative to the base 3210.

[0208] Figure 32B is a side cross-sectional view of the speculum within the visualization device, but with the engagement member retracted. Specifically, Figure 32B The attachment mechanism 3240 is shown in an open configuration, wherein the engagement member 3242 is retracted away from the engagement portion 3232 of the speculum 3230 so that the speculum 3230 can be released (eg, detached) from the base 3210. Figure 32B In the configuration shown, the speculum 3230 can be dropped from the base 3210 due to gravity, or pulled away by the clinician.

[0209] Also refer to Figure 32A and 32B The base 3210 is fixed relative to the rest of the body. The knob 3220 is coupled to the base 3210 so that the knob 3220 can rotate relative to the base 3210. Figure 32A and 32B Although not shown, the knob 3220 is coupled to the imaging assembly. When the speculum 3230 is attached as shown, the imaging assembly telescopes within the imaging cavity of the speculum 3230. When the clinician turns the knob 3220, the speculum 3230 rotates about the longitudinal axis 3250 based on the rotational force imparted to the speculum 3230 by the knob 3220. In some cases, the rotational force is imparted to the speculum 3230 by the imaging unit.

[0210] exist Figure 32A and 32B In one embodiment, the attachment mechanism is coupled to a visualization device (e.g., visualization device 120) and is part of the visualization device. In other embodiments, the attachment mechanism can be disposed on or integrated with the speculum. The speculum-based attachment mechanism can include a movable portion (e.g., an elastic or plastic portion) and / or a movable spring. For example, the speculum-based attachment mechanism can be configured to transition from a first configuration (e.g., an expanded configuration) to a second configuration (a compressed configuration) based on a compression force applied to one or more elastic portions. In the expanded configuration, the speculum-based attachment mechanism can be engaged to a corresponding feature of the rotation mechanism. In the compressed configuration, the diameter of the speculum attachment mechanism is reduced by compression so that the speculum can be released (e.g., detached) from the rotation mechanism.

[0211] Figure 33A is a perspective view of an example speculum 3300 having an attachment mechanism carried by the speculum. Figure 33A 33. The tip 3310 and an example speculum-based attachment mechanism 3320 are shown. The speculum-based attachment mechanism 3320 includes a set of actuators (e.g., 3330), an engagement member (e.g., engagement member 3324), and a spring (e.g., spring 3332). While the actuators 3330 and spring 3332 are representative, the springs 3332 are rigidly coupled to the inner portion of the speculum 3300 at each end. The springs 3332 can take any suitable form, such as a leaf spring or a living spring. The spring 3332, which can be integrally formed with the speculum, defines an annular groove 3333 between the inner surface of the spring 3332 and the inner portion of the speculum 3300, wherein the annular groove 3333 partially defines the speculum. The example actuator 3330 is disposed on the outer surface of the spring 3332 opposite the groove 3333, and as shown, in some cases, the actuator 3330 is disposed inwardly between the ends of the spring 3332. In operative relationship with the actuator 3330 , the engagement member 3324 is schematically illustrated as an angled ridge wherein the slope of the ridge increases with increasing distal distance along the speculum 3300 .

[0212] According to these example embodiments, the actuator 3330 and the spring 3332 form a compression tab. That is, the actuator 3330 (and the unnumbered actuator on the opposite side) can be configured to move inwardly (e.g., compress) toward the longitudinal axis of the speculum 3300. For example, a clinician can hold a set of actuators (e.g., actuator 3330) with a thumb and finger, apply a compressive force to squeeze the actuators together, and reduce the diameter of the speculum 3300 to place the speculum 3300 on the scope or release it from the scope (e.g., separate). Specifically, in the compressed configuration, the engagement member (e.g., engagement member 3324) slides out of an operational relationship with an attachment member on a visualization device (not shown), enabling the speculum 3300 to be slid on or removed from the scope.

[0213] Figure 33B yes Figure 33A Bottom view of the speculum 3300. Also refer to Figure 33A and 33B , the speculum 3300 is shown in a first (e.g., rest or expanded) configuration. To couple the speculum 3300 to the scope (e.g., to couple the engagement member 3324 with a corresponding engagement portion of the scope), the clinician applies a compressive force to an actuator (e.g., actuator 3330) to move the engagement portion inward (e.g., to change the speculum 3300 to a second or compressed configuration). The clinician can then telescope the speculum 3300 into a mating relationship with the scope, and more specifically engage the imaging cavity with the imaging assembly, and telescope the proximal end of the speculum into an orifice formed by a rotation mechanism (e.g., a knob). Once in place, the clinician releases the actuator to enable the speculum 3300 to return to its rest or expanded configuration, thereby placing the engagement portion in a mating relationship with the corresponding feature of the scope.

[0214] In other embodiments, the force used to compress the spring and thereby create a compressed orientation can be provided simply by pushing the speculum 3300 into position on the scope. That is, the speculum 3300 is telescoped onto the scope in an extended configuration, and the force of the spring 3322 can be overcome by the inclined surface of the engagement portion (e.g., engagement member 3324) that interacts with a corresponding feature of the speculum 3300 to move into a compressed configuration and engage with the scope. For example, when the speculum 3300 is pressed against the scope, the spring can be compressed, causing the movable portion of the speculum 3300 that carries the engagement portion to move inward and enable the speculum 3300 to slide into engagement with the scope, and then the spring returns to its extended configuration to maintain its engagement with the scope. Reference Figure 34 Such engagement is further described.

[0215] Figure 34 A side cross-sectional view of a speculum coupled to a visualization device 3400 is shown. Figure 34 Visible therein is a base 3410 , a knob 3440 configured to rotate about the base 3410 , a speculum 3420 , and a speculum-based attachment mechanism 3430 . Figure 34 The visualization device 3400 may include components structurally and / or functionally similar to other visualization systems described herein, particularly with reference to Figure 33A and 33B The example speculum 3420 includes a latch or engagement portion 3422 configured to engage a corresponding engagement portion 3412 of the base 3410 to retain the speculum 3420 relative to the base 3410. However, the speculum 3420 can be configured to rotate relative to the base 3410 about a longitudinal axis 3450 of the speculum 3420. The speculum attachment mechanism 3430 in a first configuration is biased to be in an expanded configuration (as shown) such that the speculum 3420 can engage the base 3410.

[0216] The speculum-based attachment mechanism 3430 can include an actuator 3432 configured to press toward the longitudinal axis 3450. When the attachment mechanism 3430 is compressed, the diameter of the attachment mechanism 3430 decreases, and the engagement portion 3412 disengages from the engagement portion 3412 of the base 3410. The reduced diameter and disengagement enable the speculum to be released (e.g., detached) from the base 3410. For example, a clinician can push the actuator 3432 inward and then move (e.g., pull) the speculum 3420 away from the base 3410 to release the speculum 3420 from the base 3410.

[0217] iii. Image rotation component

[0218] An endoscope can be configured to generate images having a rotational orientation that is consistent with the rotational orientation of the endoscope itself. For example, rotating the endoscope relative to a reference position can generate images that are rotated, for example, up to 180 degrees clockwise or counterclockwise, depending on the amount of rotation of the endoscope. Unless a reference position is provided, an observer of the image data may become disoriented. In some cases, symbols, such as chevrons, are overlaid on the image data to indicate the relative rotational orientation of the endoscope. However, symbol-based indications can be a suboptimal solution because the clinician may need to manually operate surgical instruments relative to the rotating endoscope rather than relative to the clinician's own perspective. In this case, if the clinician fails to perform the procedure consistently from the perspective of the rotating endoscope, the clinician may make errors and may cause injury and / or discomfort to the patient.

[0219] The example visualization systems described herein may include an image rotation assembly (e.g., image rotation assembly 124) that includes a rotation mechanism and one or more sensors configured to generate rotation data and orientation data that can be used by a processor (e.g., processor 112) to process image data and present the image data to an operator in a predetermined (e.g., consistent) orientation. For example, the image rotation assembly may include a rotatable knob configured to enable a clinician to rotate a speculum and imaging assembly within the ear canal while holding the scope in position outside the patient's ear.

[0220] Figure 16A A perspective view of the image rotation assembly is shown. Figure 16B Shown Figure 16A An exploded perspective view of the Rotation component of the example image. Also see Figure 16A and 16B , a portion of the visualization device 1600 includes a knob 1610, a base 1620, and an attachment mechanism 1630. The knob 1610 and the attachment mechanism 1630 can each be rotatably coupled to the base 1620 and rotated a predetermined number of angles (e.g., 360 degrees). As discussed above, the attachment mechanism 1630 can be configured to selectively engage and release the speculum. The example knob 1610 can be coupled so that rotation of the knob 1610 causes rotation of the imaging assembly (not shown for clarity) and the attached speculum. In other words, rotation of the knob 1610 and the speculum enables the imaging assembly to rotate relative to the patient's target treatment area (e.g., the tympanic membrane). Thus, the clinician can turn the knob to adjust the field of view of the imaging assembly and the rotational orientation of the attached speculum.

[0221] Figure 17 is an exploded side view of the visualization device 1700. Specifically, Figure 17 Shown are a rotation knob 1710, a base 1720, an attachment mechanism 1730, an imaging assembly 1750, and a speculum 1740. The speculum 1740 itself is divided into a proximal portion 1742 and a distal portion 1744 to expose the relationship of the imaging assembly 1750 relative to the proximal portion 1742. The rotation knob 1710, the attachment mechanism 1730, and the speculum 1740 can each be configured to be rotatably coupled to the base 1720. For example, the proximal portion 1742 of the speculum 1740 can be advanced through an opening in the base 1720 and the rotation knob 1710.

[0222] Figure 18 is a cross-sectional side view of the visualization device 1800. Specifically, Figure 1818. A rotation knob 1810, a base 1820, an attachment mechanism 1830, and a speculum 1840 are shown. Details of the attachment mechanism 1830 are omitted to avoid unduly complicating the drawing. The rotation knob 1810, the attachment mechanism 1830, and the speculum 1840 can each be configured to be rotatably coupled to the base 1820. An exemplary base 1820 is disposed between the rotation knob 1810 and the speculum 1840. A proximal portion 1842 of the speculum 1840 can be configured to rotate relative to a sidewall 1822 that is part of or rigidly coupled to the base 1820. An imaging assembly can be rotatably coupled to the rotation knob 1810 and disposed within an imaging cavity 1844 of the speculum 1840, but the imaging assembly is not shown to avoid unduly complicating the drawing. When the rotation knob 1810 is rotated relative to the base 1820, the imaging assembly and the speculum 1840 rotate along with the rotation knob 1810. In one example embodiment, the knob 1810 and the speculum 1840 can rotate around a full 360 degrees. In another embodiment, the knob 1810 and the speculum 1840 can rotate at least about 180 degrees, and in another embodiment at least about 90 degrees.

[0223] In an example embodiment, the processor and image rotation assembly can be configured to measure the rotation of the knob, imaging assembly and / or speculum. The image data generated by the imaging assembly can be processed to correspondingly rotate the image data by the amount of rotational change measured, for example, in the opposite direction. Thus, the orientation of the image data viewed by the clinician on a screen or display (e.g., display 111) maintains substantially the same rotational orientation throughout the procedure, regardless of the rotation state of the speculum and imaging assembly. That is, regardless of the rotational state of the imaging assembly and speculum, the viewing angle of the image can substantially match the viewing angle of the clinician throughout the procedure. Although the imaging assembly rotates about the longitudinal axis of the speculum, offsetting the rotation of the image can reduce the cognitive burden on the clinician and can improve procedural efficiency as well as patient outcomes.

[0224] To determine the amount of rotation applied to the knob and, therefore, the speculum, in some example embodiments, the image rotation assembly includes a sensor configured to generate orientation data that can be used by a processor to process the image data (e.g., rotate the image data) to achieve a predetermined (e.g., consistent) image orientation.

[0225] In some embodiments, the sensor for determining the rotational position of the imaging assembly may include a position sensor, such as an encoder configured to generate rotation data (e.g., a rotary encoder). In some embodiments, the rotation data may include absolute position data and angular position data. The encoder may be configured to generate the absolute position data in real time. The processor may be configured to process (e.g., rotate) the image data based on the rotation data and the orientation data to reflect a predetermined orientation.

[0226] In some embodiments, the encoder can be configured to measure a predetermined number (e.g., 16) of discrete rotational positions and provide a resolution of approximately 22.5 degrees to ensure smooth rotation of the image data. Each position of the sixteen-bit encoder can be separated by an angle of approximately 22.5 degrees. Therefore, the image rotation component rotates through one of these positions corresponding to a rotation of approximately 22.5 degrees of the image data. In some cases, the encoder can include approximately 16 to 90 discrete positions, including end values. The 90-position encoder can provide a resolution of approximately 4 degrees and can enable the image on the display to rotate more smoothly.

[0227] Figure 19 is a cross-sectional perspective view of a visualization device 1900 having a rotary position encoder. Figure 19 Visible therein are base 1910, imaging assembly 1920, image rotation assembly 1940, annular channel 1950, and line management system 1960. Figure 19 An example visualization device is configured to be coupled to a carrier-based speculum attachment mechanism (e.g., Figure 33A 、 33B 34 ). The exemplary image rotation assembly 1940 includes a magnet 1944 and a knob 1930. As before, the imaging assembly 1920, the image rotation assembly 1940, and the speculum attachment mechanism in the form of an annular channel 1950 can each be configured to be rotatably coupled to the base 1910. In one exemplary embodiment, the base 1910 includes and / or supports a magnetic encoder sensor 1942 configured to measure the magnetic field of the magnet 1944. The magnetic encoder sensor 1942 can be fixed relative to the magnet 1944. In other words, the magnetic encoder sensor 1942 can be fixed relative to the base 1910. The exemplary magnet 1944 is in the form of an annular ring with a set of alternating magnetic poles radially spaced around the annular ring 1944. The exemplary magnetic encoder sensor 1942 is configured to generate rotational data regarding changes in the angular position of the image rotation assembly 1940 and, in some cases, may be able to determine the absolute angular position. For example, rotation of the knob 1930 rotates the magnet 1944, and the rotation of the magnet causes a change in the magnetic field measured by the magnetic encoder sensor 1942, thereby generating rotation data. The rotation data generated by the magnetic encoder sensor 1942 can be sent to a processor (e.g., processor 112) and used to process image data generated by the imaging assembly 1920 to rotate the image data to account for the rotation of the imaging assembly 1920.

[0228] Figure 20 is a simplified schematic diagram of the image rotation assembly of the visualization device 2000 with a mechanical position encoder. Specifically, Figure 20A knob 2010, a sprocket or gear 2012 coupled to the knob 2010, an intermediate sprocket or gear 2020, and a mechanical encoder 2034 including a sprocket or gear 2030 are shown. The example mechanical encoder 2034 is configured to generate rotation data. In the example shown, the gear 2012 is part of an image rotation assembly (e.g., the knob 2010), and more specifically, the gear 2012 is integrally formed with the knob 2010 or rigidly coupled to the knob. In some cases, the gear 2012 has a rotation axis 2014 that is coaxial with the longitudinal axis of the speculum (when attached). The gear 2020 is an intermediate gear that transmits rotation from the gear 2012 to the gear 2030 of the mechanical encoder 2034. Thus, the intermediate gear 2020 has a rotation axis 2022 that is parallel to the rotation axis 2014 and spaced apart from the rotation axis. Gear 2030 is coupled to the shaft of a mechanical encoder 2034 and defines a rotation axis 2032 that is parallel to and offset from the rotation axes 2014 and 2022. The example encoder 2034 is configured to measure rotational changes of the image rotation assembly via gear 2012, intermediate gear 2020, and gear 2030, and the example mechanical encoder 2034 generates rotational data. The rotational data generated by the mechanical encoder 2034 can be sent to a processor (e.g., processor 112) and used to process image data generated by the imaging assembly to rotate the image data to account for the rotation of the imaging assembly.

[0229] Figure 21 is a schematic diagram of an image rotation component of a visualization device 2100 having another example position encoder. Specifically, Figure 21 Shown are a knob 2110, a sprocket or gear 2112, a sprocket or gear 2122, and a mechanical encoder 2124. The example mechanical encoder 2124 is configured to generate rotation data. In the example shown, the gear 2112 is part of the image rotation assembly, and more specifically, the gear 2112 is integrally formed with the knob 2110 or rigidly coupled to the knob. The gear 2122 can be rotationally coupled to the gear 2122. As shown, the gear 2112 and the gear 2122 can be bevel gears. The knob 2110 and the gear 2112 can be configured to rotate about the rotation axis 2014, and the gear 2122 can be configured to rotate about an axis perpendicular to the rotation axis 2014. The mechanical encoder 2124 can be configured to measure the rotation of the knob 2110 via the gear 2112 and the gear 2122. As an alternative to gear 2112, gear 2122, and mechanical encoder 2124, the image rotation assembly can include a second gear 2112, a cable 2130 (e.g., a torque cable), and an encoder 2132. Cable 2130 can be configured to couple second gear 2122 to encoder 2132 to increase the distance X between knob 2110 and encoder 2132.

[0230] Figure 22A and 22B is a schematic diagram of an image rotation component of a visualization system 2200 with another example position encoder. Specifically, Figure 22A and 22B Shown are a base 2220, a speculum 2240, an image rotation mechanism 2230, and an optical rotation sensor assembly. The optical rotation sensor assembly includes an optical encoder 2250 disposed within the rotation mechanism 2230 and fixed relative to the base 2220. The optical encoder 2250 is configured to read an optically readable pattern 2210 on a portion of the speculum 2240. The image rotation mechanism 2230 and the speculum 2240 can be configured to rotate about a rotation axis 2232. The optical encoder 2250 can be configured to measure the rotation of the speculum 2240 by optically measuring a first pattern 2212 and a second pattern 2214. The optically readable pattern 2210 can include absolute position data 2214 and dynamic position data 2212 (e.g., angular position data). The absolute position data 2214 can include, for example, unique marks and / or patterns at each position, and the dynamic position data 2212 can include, for example, marks of the same type (e.g., lines or dots) and / or repeating marks or patterns. In some embodiments, when dynamic position data 2212 is used instead of absolute position data 2214, the clinician may need to calibrate the visualization device before use, for example to indicate where a starting or zero position is and / or to indicate the current position of the device. Alternatively, the visualization device (or a control device operably coupled to the visualization device) can be equipped with a memory to store its last known position and / or be configured to operate in a lower power state so that the image rotation assembly can track its movement when not in use. The optical encoder 2250 can be configured to generate rotation data. The rotation data generated by the optical encoder 2250 can be sent to a processor (e.g., processor 112) and used to process image data generated by the imaging assembly to rotate the image data to account for the rotation of the imaging assembly.

[0231] In some embodiments, the optical encoder 2250 may include an optical sensor, which may include a photodiode, a charge coupled device (CCD), or a complementary metal oxide semiconductor (CMOS) optical sensor. In some embodiments, the optical encoder 2250 may be mounted on a portion of the base 2220 within the rotation mechanism 2230, and the optical encoder may be fixed relative to the base 2220.

[0232] In some embodiments, the optical pattern 2210 may be printed on a predetermined portion (e.g., a flange) of the speculum 2240 or applied to a predetermined surface of the speculum 2240 using an adhesive. For example, the optical pattern 2210 may be provided on a radial sticker applied to the speculum 2240.

[0233] Figure 23 is a schematic diagram of an image rotation component of a visualization system 2300 with another example position encoder. Specifically, Figure 23 Shown are a base 2320, an image rotation mechanism 2310, and an optical rotation sensor assembly 2330. The optical rotation sensor assembly 2330 may include a set of optical encoders (e.g., "break" encoders), such as optical encoder 2332 and optical encoder 2334, each disposed on a portion of the base 2320. A portion of the image rotation assembly (shown as portion 2310) is rotationally coupled to a speculum (not shown) such that portion 2310 and the speculum rotate relative to the optical encoders 2332, 2334 and the base 2320. Portion 2310 (e.g., a knob) may be configured to rotate a rotation axis 2312. Portion 2310 may include a set of optical patterns or tabs 2340, 2342 configured to pass within respective channels of the optical encoders 2332, 2334 to generate a "break" signal by blocking the respective optical encoders 2332, 2334. The set of tabs 2340, 2342 may include a set of features, such as protrusions, arranged in a predetermined order.

[0234] In some embodiments, the optical encoders 2332 and 2334 can be configured to measure the rotation of the portion 2310 of the image rotation assembly via optical measurement of an optical pattern caused by the tabs 2340 of the optical encoder 2332 and by the tabs 2342 of the optical encoder 2334. The optical pattern created by the tabs 2340 and 2342 can correspond to absolute position data (e.g., a unique mark or pattern indicating an absolute angular position) and dynamic position data (e.g., a repeating or identical mark or pattern indicating incremental movement). The optical encoders 2332 and 2334 can be configured to generate rotation data. In some embodiments, the optical encoders 2332 and 2334 can include an optical sensor that can include a photodiode, a charge-coupled device (CCD), or a complementary metal oxide semiconductor (CMOS) optical sensor. The rotation data generated by the optical encoders 2332 and 2334 can be sent to a processor (e.g., processor 112) and used to process image data generated by the imaging assembly to rotate the image data to account for the rotation of the imaging assembly.

[0235] Figure 24 FIG is a schematic diagram of a rotation sensor of an image rotation component. Specifically, Figure 24A visualization system 2400 is shown, which includes a capacitance measurement circuit 2410, a plurality of conductive pads or conductive patterns 2420 disposed on a base (not shown), and a rotatable conductive portion 2430 coupled to an image rotation mechanism (not shown). In some embodiments, the conductive pattern 2420 may include a set of spaced-apart conductive segments (e.g., copper pads). Specifically, the conductive pattern 2420 may include a plurality of conductive pads, each at a specific radial position (e.g., relative to the rotation axis of the image rotation assembly). Each conductive pad is electrically isolated from the other conductive pads, and each conductive pad is individually electrically coupled to the capacitance measurement circuit 2410. In the example shown, eight conductive pads are implemented; however, any suitable number (e.g., 16, 32) may be used. The greater the number of conductive pads, the higher the angular resolution of the system.

[0236] The conductive portion 2430 can be configured to rotate relative to the base so as to overlap with at least one conductive pad at any given point within the circular rotation path of the conductive portion 2430. In some cases, and as shown, the conductive portion overlaps with at least two conductive pads at any given point within the circular rotation path of the conductive portion 2430. The conductive portion 2430 is carried by a rotatable element of the image rotation assembly, such as a knob of the image rotation assembly.

[0237] The example capacitance measurement circuit 2410 is configured to measure the capacitance between each segment of the conductive pattern 2420 and the conductive portion 2430. A higher capacitance between the conductive portion 2430 and any of the conductive pads of the conductive pattern 2420 indicates that the conductive portion is close to or above the conductive pad. Conversely, a lower capacitance between the conductive portion 2430 and any of the conductive pads of the conductive pattern 2420 indicates that the conductive portion is not close to or above the conductive pad. Therefore, in the example system, the capacitance measurement circuit 2410 is configured to generate rotational data, wherein the rotational position of the rotation mechanism corresponds to the measured capacitance value of the conductive pattern 2420. For example, the change in capacitance of each conductive pad measured by the capacitance measurement circuit 2410 corresponds to the rotation of the conductive portion 2430 on the conductive pattern 2420. In some embodiments, the conductive pattern 2420 and the conductive portion 2430 may be separated by air (or any other suitable dielectric material) by approximately 0.1 mm or more.

[0238] Figure 25A is a schematic diagram of the sensor of the image rotation component. Specifically, Figure 25AAn image rotation assembly 2500 is shown, which includes a capacitance measurement circuit 2510, a first conductive pattern 2520, a second conductive pattern 2522, a third conductive pattern 2532, and a rotatable conductive portion 2530. The rotatable conductive portion 2530 can be configured to rotate relative to a base so as to overlap the conductive patterns 2520, 2522, 2530 at any given point within the circular rotation path of the rotatable conductive portion 2530. The rotatable conductive portion 2530 is carried by a rotatable element of the image rotation assembly, such as a knob of the image rotation assembly. The first conductive pattern 2520, the second conductive pattern 2522, and the third conductive pattern 2532 are each disposed on a base (not shown). The example first conductive pattern 2520 and the second conductive pattern 2532 each have a width that continuously varies according to the distance along the respective conductive pattern, although the width varies in opposite circular directions of the two patterns. For example, the first conductive pattern 2520 has a wide end 2534 with a wide width (measured radially from the axis of rotation of the image rotation assembly), and the width decreases with the circular distance around the pattern (counterclockwise in the view of FIG. 25 ). The first conductive pattern 2520 has a narrow end 2536 with a second width that is narrower than the width at the wide end 2534. Similarly, the conductive pattern 2522 has a wide end 2538 (also measured in the radial direction) with a wide width that decreases with the circular distance around the pattern (clockwise in the view of FIG. 25 ). The second conductive pattern 2522 has a narrow end 2540 with a narrow width that is narrower than the width of the wide end 2538. In other words, the conductive patterns have widths that continuously change according to the circular position around the corresponding conductive pattern, but the widths change in opposite circular directions on the two patterns.

[0239] In the example system, the conductive portion 2530 is configured to rotate relative to the base along a circular path on the conductive patterns 2520, 2522, and 2532. At any given point along the circular path, the capacitance measurement circuit 2510 measures an electrical parameter between the conductive portion 2530 and the conductive patterns 2520, 2522, and 2532. For example, the capacitance measurement circuit 2510 can measure the capacitance between any of the following combinations: conductive pattern 2520 and conductive pattern 2532; conductive pattern 2522 and conductive pattern 2532; and conductive pattern 2520 and conductive pattern 2522. The example capacitance measurement circuit 2510 generates rotational data, where the rotational position of the rotating mechanism corresponds to the measured value. As described herein, the rotational data can include absolute position data and angular position data. The generated rotational data can be sent to a processor (e.g., processor 112) and used to process image data generated by the imaging assembly to rotate the image data to account for the rotation of the imaging assembly.

[0240] In the example system, the conductive portion 2530 may have a width of approximately 1 mm (measured tangentially to the circular direction), sufficient to cover or reside on the length of all three conductive patterns (measured parallel to the radial axis of rotation of the image rotation component). In the example system, if assumed to be unfolded or untied into a straight line, the first conductive pattern 2520 may have a length of approximately 100 mm. The width of the example first conductive pattern 2520 varies continuously along its length. Similarly, if assumed to be unfolded or untied into a straight line, the second conductive pattern 2522 may have a length of approximately 100 mm, and the width of the example second conductive pattern 2522 varies continuously along its length. The continuously varying width creates a straight linear relationship between the distance along the conductive pattern and the area of ​​the conductive pattern that resides under the conductive portion 2530. In other words, and considering the example Figure 25A The continuously varying width of the conductive pattern wrapped in the middle creates a straight linear relationship between the circular position of the conductive portion 2530 and the area of ​​the conductive pattern below the conductive portion 2530.

[0241] Figure 26A is the area A1 (in mm) of the first conductive pattern 2520 below the rotatable conductive portion (eg, the rotatable conductive portion 2530) according to the displacement (eg, length) x along the first conductive pattern. 2 In other words, Figure 26A is a graph of the area A1 of the first conductive pattern 2520 below the rotatable conductive portion according to the circular position relative to a predetermined starting point (eg, narrow end). Similarly, Figure 26B is the area A2 (in mm) of the second conductive pattern 2522 below the rotatable conductive portion according to the displacement x along the second conductive pattern 2522. 2 In other words, Figure 26B is a graph of the area A2 of the second conductive pattern 2522 below the rotatable conductive portion relative to a predetermined circular position (e.g., the wide end). As shown, areas A1 and A2 are linear functions with opposite slopes. For example, when the rotatable conductive portion (e.g., rotatable conductive portion 2530) is located at the widest portion of the first conductive pattern 2520 (and therefore has the largest area A1), the rotatable conductive portion 2530 can also be located at the narrowest portion of the second conductive pattern 2522.

[0242] Figure 26C is a graph 2620 of the capacitance per picofarad (pF) of the first conductive pattern 2520 according to the displacement x. In other words, Figure 26C is a graph of the capacitance C1 of the first conductive pattern 2520 under the rotatable conductive portion according to a circular position relative to a predetermined starting point (eg, a narrow end). Figure 26Dis a graph 2630 of the capacitance of the second conductive pattern 2522 according to displacement x. In other words, Figure 26D is a graph of the capacitance A2 of the second conductive pattern 2522 under the rotatable conductive portion according to the circular position relative to a predetermined starting point (eg, the wide end).

[0243] In some embodiments, the measured capacitances (C1(x), C2(x)) of the first conductive pattern 2520 and the second conductive pattern 2522 may be given by equations (8) and (9), respectively:

[0244]

[0245]

[0246] where C, C1(x), and C2(x) correspond to the capacitive contributions from the rotatable conductive portion 2530, the first conductive pattern 2520, and the second conductive pattern 2530, respectively. The equations for C, C1(x), and C2(x) are given by equations (10), (11), and (12):

[0247]

[0248]

[0249]

[0250] where ε0 is the dielectric constant or permittivity of air, ε r is the relative dielectric constant of the material between the capacitor plates, A1(x) is the area of ​​conductive pattern strip 1 at displacement x, A2(x) is the area of ​​strip 2 at displacement x, and d is the distance between the conductive pattern and the covering pattern (e.g., conductive portion 2530).

[0251] Figure 26E Graph 2640 shows the ratio of the capacitance of the first conductive pattern to the capacitance of the second conductive pattern (C1(x) / C2(x)) according to a displacement x along the pattern. By taking the ratio of the capacitance of the first conductive pattern to the capacitance of the second conductive pattern, the variation due to the distance d between the conductive pattern and the conductive portion is canceled out in the ratio calculation because these distances are equal for each conductive pattern.

[0252] In some embodiments, the first conductive pattern 2520 and the second conductive pattern 2522 act as series capacitors due to their proximity. Figure 26F is a graph 2650 corresponding to the series capacitance of the first conductive pattern 2520 and the second conductive pattern 2522 and can be given by Equation 13:

[0253]

[0254] Where C(x) is the series capacitance.Thus, the capacitance measurement circuit 2510 generates rotation data that can provide the absolute position of the rotation mechanism (eg, knob) of the image rotation assembly, and thus the absolute position of the imaging assembly of the visualization device.

[0255] The various embodiments of capacitive sensing of the rotational orientation of an image rotation assembly discussed so far have assumed capacitance-based determination of the rotational position of the image rotation assembly. Figure 25A In the embodiment of the present invention, the rotational position can be determined based on the magnitude of the AC voltage formed using the capacitors as a voltage divider. Specifically, capacitors C1 and C2 are used as the voltage divider, and for a given interrogation frequency, the magnitude of the AC voltage formed across the voltage divider indicates the position of the conductive portion 2530 relative to the conductive patterns 2520 and 2522.

[0256] Figure 26G 2660 is a graph of the voltage v(x) developed across the first conductive pattern 2520 and the second conductive pattern 2522 operating as a voltage divider. The exemplary voltage v(x) represents a nonlinear function in the sense that it is not a straight line function, but nonetheless has a direct and distinct relationship between the voltage and the distance x (either circular or rotational position). The voltage v(x) can be given by Equation 14:

[0257]

[0258] wherein C1(x) and C2(x) are as defined above.

[0259] Figure 27A is a graph 2700 of capacitance C1 (in pF) of the first conductive pattern 2520 beneath a rotatable conductive portion (eg, rotatable conductive portion 2530) according to displacement x along the first conductive pattern. In other words, Figure 27A is a graph of the capacitance C1 of the first conductive pattern 2520 under the rotatable conductive portion according to the circular position relative to a predetermined starting point (eg, narrow end). Similarly, Figure 27B is a graph 2710 of the capacitance C2 (in pF) of the second conductive pattern 2522 beneath the rotatable conductive portion according to the displacement x along the second conductive pattern 2522. In other words, Figure 27BGraph 2522 shows the capacitance C2 of the second conductive pattern 2522 below the rotatable conductive portion according to its circular position relative to a predetermined starting point (e.g., the wide end). As shown, capacitances C1 and C2 are linear functions with opposite slopes. For example, when the rotatable conductive portion (e.g., rotatable conductive portion 2530) is at the widest portion of the first conductive pattern 2520 (and therefore has the maximum capacitance C1), the rotatable conductive portion 2530 can also be at the narrowest portion of the second conductive pattern 2522.

[0260] Figure 27C Graph 2720 shows the ratio of the capacitance of the first conductive pattern to the capacitance of the second conductive pattern (C1(x) / C2(x)) according to a displacement x along the pattern. By taking the ratio of the capacitance of the first conductive pattern to the capacitance of the second conductive pattern, the change due to the distance d between the conductive pattern and the conductive portion is offset in the ratio calculation. Figure 27D is a graph 2730 corresponding to the series capacitance of the first conductive pattern 2520 and the second conductive pattern 2522 and can be given by Equation 13 above. Figure 27E is a graph 2740 of the voltage v(x) formed across the first conductive pattern 2520 and the second conductive pattern 2522 operating as a voltage divider. Specifically, Figure 27E In the example of , the relative widths of the underlying conductive patterns 2520, 2540 are designed and constructed to provide a linear (eg, straight line in this case) relationship in the voltage developed across capacitors C1 and C2 operating as a voltage divider. In other words, Figure 27E In the example of FIG. 2 , the relative capacitances of the underlying conductive patterns 2520 and 2540 are designed and constructed to provide a linear relationship of the voltages developed across capacitors C1 and C2 operating as a voltage divider.

[0261] return Figure 25A In some cases, capacitance measurement circuit 2510 measures the capacitance of each conductive pattern individually through circular conductive pattern 2532 and conductive portion 2530. For example, consider applying an AC signal to circular conductive pattern 2532. The signal passes through the capacitance formed between conductive pattern 2532 and conductive portion 2530, then passes through the capacitance formed between conductive portion 2530 and the conductive pattern being measured, and then returns to capacitance measurement circuit 2510. Based on the electrical characteristics (e.g., voltage, current, phase angle) of the signal returned to capacitance measurement circuit 2510, and the fact that the capacitance formed between conductive pattern 2532 and conductive portion 2530 is constant for any rotational position of conductive portion 2530, the capacitance formed between conductive portion 2530 and the conductive pattern being measured can be determined.

[0262] However, for series capacitors, the net capacitance is largely controlled by the smallest link in the series connection. Figure 25A, at some rotational positions (e.g., the conductive portion at the position of the lead of reference numeral 2534), the capacitance formed between the conductive portion 2530 and the conductive pattern being measured is greater than the capacitance formed between the conductive pattern 2532 and the conductive portion 2530. In the given example scenario, in some cases, when the constant capacitance associated with the conductive pattern 2532 and the conductive portion 2530 is small, it may be difficult for the capacitance measurement circuit 2510 to accurately measure the capacitance formed between the conductive portion 2530 and the conductive pattern.

[0263] Figure 25B A schematic diagram of the sensor showing the image rotation assembly. Figure 25B In FIG, the rotating portion includes not only the conductive portion 2530, but also an additional electrically integral circular conductive pattern 2490 coupled to a knob (not shown). The conductive pattern 2490 resides just above the conductive pattern that surrounds the conductive patterns 2520 and 2522 (not shown, but see FIG. Figure 25A 2532). In this way, the capacitance associated with the rotating portion of the sensor (e.g., a knob) is greater than the capacitance formed between conductive portion 2530 and the conductive pattern being measured at all measured positions / rotations. Capacitance measurement circuit 2510 can more easily and accurately determine the expected capacitance.

[0264] Although the conductive patterns and portions (e.g., conductive patterns 2520, 2522, 2530) in the above examples are described as having particular dimensions, it will be understood that other dimensions may be used, for example, to accommodate image rotation assembly components of different sizes (e.g., knob diameters of different sizes) to adjust linearity and / or sensitivity.

[0265] iv. Line management components

[0266] Brief return Figure 1In some embodiments, a wire management assembly 128 can be used and configured to provide a wired connection between the imaging assembly 122 and one or more components of the device (e.g., a base, a display, a processor, a power supply circuit) while enabling the imaging assembly 122 to rotate relative to the device. Due to the rotation of the imaging assembly 122, the wired connection described herein can be configured for dynamic and controlled movement to ensure electrical and / or communication connection between the imaging assembly 122 and the control device 110. The wire management assembly 128 can enable a loop of communication conductors (e.g., electrical conductors, optical conductors) to service the rotation of the image rotation assembly 124 and control parameters such as tension, friction, and translation of the communication conductors. For example, as the wired connection translates along its predetermined path, a predetermined amount of tension can be maintained to reduce kinking and wear while providing predictability in the movement of the wired connection. In some embodiments, the wire management assembly 128 can include a rotating pinion service ring mechanism.

[0267] Figure 35A is a perspective view of a visualization device 3500 according to at least some embodiments. Specifically, Figure 35A A base 3510, an imaging assembly 3520, and a rotation mechanism or knob 3530 are shown. The imaging assembly 3520 and the knob 3530 are rotatably coupled to the base 3510. For example, the imaging assembly 3520 can be rigidly coupled to the knob 3530 so that when the knob 3530 is turned, the imaging assembly moves or translates about the axis of rotation of the knob 3530. In an example embodiment, the knob 3530 surrounds the line management system (in Figure 35A not visible in the ).

[0268] Figure 35B is a partial perspective view of the visualization device with the knob removed to reveal the line management system 3540. Specifically, the example line management system 3540 can be disposed between the knob and the base 3510. In an example embodiment, the knob surrounds the line management system 3540 such that the line management system 3540 is not visible to the clinician during use.

[0269] The example line management system 3540 includes a fixed circular rack 3512 rigidly coupled to the base 3510, and a rotatable circular rack 3532 rigidly coupled to the knob and imaging assembly 3520. Thus, when the knob is rotated relative to the base 3510, the rotatable circular rack 3532 rotates relative to the fixed circular rack 3512. The fixed circular rack 3512 defines a plurality of upwardly pointing teeth 3513 forming a gear or rack. The rotatable circular rack 3532 defines a plurality of downwardly pointing teeth 3533 forming a gear or rack.

[0270] The example line management assembly 3540 also includes a pinion gear 3542 disposed between the fixed circular rack 3512 and the rotatable circular rack 3532. Specifically, the teeth of the pinion gear 3542 interact with the teeth 3513 of the fixed circular rack 3512 and with the teeth 3533 of the rotatable circular rack 3532. In use, the pinion gear 3542 is configured to translate between the fixed circular rack 3512 and the rotatable circular rack 3532 along a circular path defined by the racks 3512 and 3532. In the example system shown, the pinion gear 3542 abuts the stop 3514, which prevents the knob from being rotated further in the clockwise direction (in the example system). Figure 35B ). From Figure 35B When the knob is turned counterclockwise (in Figure 35B ), the pinion 3542 translates in a counterclockwise direction along the fixed circular rack 3512.

[0271] The example wiring management system 3540 also includes a service ring, gear flange, or wire trough 3544 that is coupled to the pinion gear 3542 and configured to translate along a circular path with the pinion gear 3542. In the example case, the wire trough 3544 is in the form of a circular disk having an annular channel defined on the outer diameter of the disk. The annular channel is designed and constructed to accommodate and translate the communication cable or cable bundle 3550 as the knob and imaging assembly 3520 is rotated by the clinician. In some cases, the wire trough 3544 is rigidly coupled to the pinion gear 3542 such that as the pinion gear 3542 rotates and translates about the circular path, the wire trough 3544 rotates about a common rotational axis. In other cases, the wire trough 3544 is coupled (e.g., via a bearing) such that relative rotational motion between the wire trough 3544 and the pinion gear 3542 along the common rotational axis is possible. In such cases, movement of the cable bundle 3550 causes the wire trough 3544 to rotate about the common rotational axis.

[0272] Also refer to Figure 35A and 35B In the example system, the pinion 3542 translates along a 180 degree circular path as the knob 3530 and the rotatable circular rack 3532 are turned. As mentioned above, Figure 35B The pinion 3542 is shown adjacent to the stop 3514, so Figure 35B An example system is shown with the knob 3530 and rotatable circular rack 3532 in a maximum clockwise orientation.

[0273] Figure 35C is a perspective view of a portion of the visualization device 3500, with the knob again removed to reveal the line management system 3540, and the line management system 3540 rotated so that the pinion gear is relative to Figure 35B Translate 180 degrees. Specifically, Figure 35C In the embodiment, the pinion (not visible) abuts a second stop (not visible) which prevents the knob from turning in the counterclockwise direction (in Figure 35C In the example system shown, and from Figure 35C , when the knob and rotatable circular rack 3532 are turned in a clockwise direction, the pinion translates in a clockwise direction along the fixed circular rack 3512.

[0274] Back to Figure 35A and 35B Regardless of the direction of travel of the pinion 3542, the tension of the cable bundle 3550 on the wire groove 3544 can be maintained at approximately zero throughout the translation path of the pinion 3542. For example, when the rotating mechanism rotates, the cable bundle 3550 maintains a "U" shape around the wire groove 3544.

[0275] The example wire management assembly 3540 is configured to translate a predetermined length of a cable bundle 3550 about a pinion 3542 and a wire groove 3544. A first portion of the cable bundle 3550 is secured to a first predetermined position in the base 3510 (e.g., such as by pressing on a Figure 35B , extending along the unnumbered slots). A second portion of the cable bundle 3550 can be secured in a second predetermined position 3552 in one or more rotating components. For example, the second portion of the cable bundle 3550 can be secured to a proximal portion of the imaging assembly 3520 as shown. Although the cable bundle 3550 translates with the movement of the pinion 3542, the overall length of the cable bundle 3550 remains the same and makes the wear of the cable bundle 3550 more consistent and predictable. In other words, the overall length of the cable bundle 3550 remains constant, but the length of the cable bundle 3550 on either side of the pinion 3542 (e.g., above, below) changes based on the position of the knob and the rotatable circular rack 3532.

[0276] In an example system, the diameter of the wire trough 3544 can be based on the minimum bend radius of the cable bundle 3550. The cable bundle 3550 can have a diameter of approximately 1 mm to approximately 2.5 mm. The wire trough 3544 can have a diameter of approximately 5 mm to approximately 20 mm. The pinion gear 3542 can have a diameter of approximately 5 mm to approximately 15 mm. In some embodiments, the pinion gear 3542 can have a gear ratio that translates the pinion gear 3542 to a smaller degree relative to rotation of the knob 3530. For example, the pinion gear 3542 can be configured such that for every degree of rotation of the knob 3530 and the rotatable circular rack 3532, the pinion gear 3542 translates approximately 0.5 degrees along its circular path. This configuration reduces the predetermined length of the translated cable bundle 3550 relative to the travel path of the knob 3530, thereby creating a compact cable management assembly 3540 and reducing wear over time. Furthermore, the reduced length of the cable bundle 3550 can reduce signal noise generated, for example, by manipulating the cable bundle 3550.

[0277] Figure 35D is a partial perspective view of a more detailed, again removed knob to reveal a visualization device for a line management system, according to at least some embodiments. In particular, Figure 35D 35. A portion of the fixed circular rack 3512, a portion of the rotatable circular rack 3532, and the pinion 3542 disposed between the racks are better shown in FIG. Also visible is a wire duct 3544 having a cable bundle 3550 that partially defines the wire duct 3544. Figure 35D Pinion 3542 is shown abutting stop 3514, thereby limiting rotational travel in the clockwise direction (in Figure 35D In the example embodiment, the pinion 3542 has an axis of rotation. Although the axis of rotation of the pinion 3542 changes position relative to the base 3510 as the pinion 3542 translates along the circular path, in the example system, the axis of rotation always intersects the axis of rotation of the rotatable circular rack 3532 and the knob. In some cases, the axis of rotation of the rotatable circular rack 3532 and the knob 3530 is coaxial with the longitudinal axis of the speculum ( Figure 35D not shown).

[0278] Figure 36A is a schematic plan view of an alternative line management assembly 3600 that includes a wired connection, such as a communication cable in the form of a flexible circuit 3610. Figure 36B is a schematic side view of a line management component of a visualization system according to at least some embodiments. Figure 36A and 36B, the flexible circuit 3610 can be looped around the pinion 3620. A first end 3630 of the flexible circuit 3610 can be secured to the base (not shown for clarity), and a second end 3640 of the flexible circuit 3610 can be secured to the imaging assembly (not shown for clarity). The diameter of the pinion can be based on the minimum bend radius of the flexible circuit 3610, which can depend on the number of layers of the flexible circuit.

[0279] Figure 37 37 is a plan view of a visualization system 3700 comprising a base 3710 and a communication cable in the form of a flexible circuit coil 3720 in a spiral configuration oriented perpendicular to the base 3710. From a zero position, the flexible circuit coil 3720 can be configured to tighten as the rotation mechanism rotates toward a fully rotated orientation (e.g., 360 degrees of rotation of the knob). A physical stop can act as a barrier to rotation at the end of the circular travel. Additionally, the flexible circuit coil 3720 can be configured such that when the flexible circuit coil 3720 is tensioned, the tensile load is below a predetermined threshold (e.g., before the flexible circuit coil 3720 is damaged).

[0280] C.Control device

[0281] Reference again Figure 1 , an example control device 110 can be coupled to a speculum 130 and / or visualization device 120 and provide processing and / or communication capabilities to facilitate visualization of the ear canal and tympanic membrane using one or more instruments (e.g., a myringostomy tube delivery device) during a procedure. For example, the control device 110 operably coupled to the speculum 130 can be configured to process image data and output the image data on a display. The control device 110 can be removably coupled to other components of the visualization system and be reusable. The control device 110 of the visualization system 100 may include a display 111, a processor 112, a memory 113, a power supply circuit 114, and a communication device 115. Each aspect will be described in turn.

[0282] i.Display

[0283] The image data generated by the imaging component 122 may be output on the display 111. In some embodiments, the display 111 may be implemented as a light emitting diode (LED), a liquid crystal display (LCD), an electroluminescent display (ELD), a plasma display panel (PDP), a thin film transistor (TFT), an organic light emitting diode (OLED), an electronic paper / electronic ink display, a laser display, and / or a holographic display.

[0284] In some embodiments, the display 111 may include and / or be operably coupled to an input device (e.g., a touch screen) that is configured to receive input data from a clinician. For example, the input of an input device (e.g., a keyboard, a button, a touch screen) may be received and processed by the processor 112 and the memory 113 of the visualization system 100. The input device may include at least one switch configured to generate a control signal. For example, the input device may include a touch surface for providing an input corresponding to a control signal to the clinician (e.g., a finger contacts the touch surface). The input device including the touch surface may be configured to detect contact and movement on the touch surface using any one of a variety of touch-sensitive technologies, including capacitive, resistive, infrared, optical imaging, scattered signals, acoustic pulse recognition, and surface acoustic wave technology. In the example case of an input device including at least one switch, the switch may have, for example, at least one of a button (e.g., hard key, soft key), a touch surface, a keyboard, an analog stick (e.g., a joystick), a directional pad, a mouse, a trackball, a jog wheel, a stepping switch, a rocker switch, a pointer device (e.g., a stylus), a motion sensor, an image, and a microphone. The motion sensor can receive user movement data from the optical sensor and classify user gestures as control signals. The microphone can receive audio data and recognize user voice as control signals.

[0285] In some embodiments, in addition to the display 111, the visualization system may optionally include one or more output devices, such as an audio device and a tactile device. The audio device can audibly output any patient data, sensor data, system data, alarms, and / or notifications. For example, when a fault in an imaging component is detected, the audio device can output an audible alarm. In some embodiments, the audio device can be implanted as a speaker, a piezoelectric audio device, a magnetostrictive speaker, and / or a digital speaker. In some embodiments, a clinician can use the audio device and a communication channel to communicate with other users. For example, an operator can form an audio communication channel (e.g., a VoIP call).

[0286] Additionally or alternatively, the system may include a haptic device configured to provide additional sensory output (e.g., force feedback) to the operator. For example, the haptic device may generate a tactile response (e.g., vibration) to confirm an operator input to an input device (e.g., a touch surface). As another example, tactile feedback may notify the operator that the input has been overridden by the processor.

[0287] ii. Processor

[0288] The processor 112 described herein can process data and / or other signals to control one or more components of the system (e.g., imaging assembly 122). The processor 112 can be configured to receive, process, compile, calculate, store, access, read, write, and / or transmit data and / or other signals. Additionally or alternatively, the processor can be configured to control one or more components of the device (e.g., display 111).

[0289] In some embodiments, image processing of the image data may include applying a nonlinear two-dimensional filter configured to reduce brightness at the edges of the image. This can reduce glare due to reflections from tissue (e.g., the ear canal) and increase visibility of the target treatment area (e.g., the tympanic membrane). In one example scenario, the gain of the image brightness plane can decrease toward the periphery of the image data, with higher gain centered within the image brightness plane and lower gain as the distance from the center of the image brightness plane increases. In other scenarios, the image brightness plane can be conceptually divided into a higher gain inner region and a lower gain outer region.

[0290] In some embodiments, the processor 112 can be configured to access or receive data and / or other signals from the imaging component and storage media (e.g., memory 113, flash drive, memory card). In some embodiments, the processor 112 can be any suitable processing device configured to run and / or execute a set of instructions or codes, and can include one or more processors, image processors, graphics processing units (GPUs), physical processing units, digital signal processors (DSPs), analog signal processors, mixed signal processors, machine learning processors, deep learning processors, finite state machines (FSMs), compression processors (e.g., data compression to reduce data rate and / or memory requirements), encryption processors (e.g., for secure wireless data transmission), and / or central processing units (CPUs). The processor 112 can be, for example, a general-purpose processor, a field programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a processor board, etc. The processor 112 can be configured to run and / or execute application processes and / or other modules, processes, and / or functions associated with the system. The underlying device technology can be provided in various component types (e.g., metal oxide semiconductor field effect transistor (MOSFET) technology, such as complementary metal oxide semiconductor (CMOS), bipolar technology such as emitter coupled logic (ECL), polymer technology (e.g., silicon conjugated polymer and metal conjugated polymer metal structures), mixed analog and digital, etc.

[0291] The systems, devices, and / or methods described herein may be implemented by software (implemented on hardware), hardware, or a combination thereof. Hardware modules may include, for example, a general-purpose processor (or microprocessor or microcontroller), a field programmable gate array (FPGA), and / or an application-specific integrated circuit (ASIC). Software modules (implemented on hardware) may be expressed in a variety of software languages ​​(e.g., computer code), including C, C++, Python, Ruby, Visual and / or other object-oriented procedural languages ​​or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions, such as those generated by a compiler, code for generating web services, and files containing high-level instructions executed by a computer using an interpreter. Other examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0292] iii. Memory

[0293] The visualization system described herein may include a memory 113 configured to store data and / or information. In some embodiments, the memory 113 may include one or more of the following: random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), a memory buffer, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, and the like. In some embodiments, the memory may store instructions for the processor 112 to execute modules, processes, and / or functions associated with the device, such as image processing, image display, data and / or signal transmission, data and / or signal reception, and / or communication. Some embodiments described herein may involve computer storage products having a non-transitory computer-readable medium (also referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. Computer-readable media (or processor-readable media) is non-transitory because it does not include transitory propagating signals themselves (e.g., electromagnetic waves that propagate information across a transmission medium such as space or a cable). The media and computer code (which may also be referred to as code or algorithm) may be those designed and constructed for a specific purpose or purposes.

[0294] In some embodiments, the memory 113 can be configured to store any data received and / or generated by the device. In some embodiments, the device can be configured to store one or more of image data and patient data (e.g., diagnostic information, surgical or procedural data, etc.), combinations thereof, etc. In some embodiments, the memory 113 can be configured to store image data, including 2D and 3D data, as well as any other data generated from imaging of a patient. In some embodiments, the memory 113 can be configured to store data temporarily or permanently.

[0295] iv.Power supply circuit

[0296] The example power supply circuit 114 can be configured to receive wired or wireless power. For example, the power supply circuit 114 can be configured to receive wireless power and convert the received power into energy that can be used to power the device. In some embodiments, the power supply circuit 114 may include one or more energy storage elements (e.g., batteries, capacitors) configured to store energy. The power supply circuit 114 can also be configured to control (e.g., regulate, limit) the power provided to one or more components (e.g., circuit blocks) of the device.

[0297] In some embodiments, the power supply circuit 114 may convert the AC voltage at the terminals of the converter into a DC voltage. In some embodiments, the power supply circuit 114 may include a rectifier configured to generate a DC voltage rail. The rectifier may include a passive rectifier, an active rectifier, a passive voltage doubler, and / or a combination thereof. In some embodiments, the power supply circuit 114 may include a DC-DC converter configured to generate one or more DC voltage rails from the rectifier DC voltage rail. In some embodiments, the power supply circuit 114 may include a voltage regulator (e.g., a low dropout regulator (LDO) circuit, a voltage clamp circuit) configured to generate a regulated or constant DC voltage rail. In some embodiments, the power supply circuit 114 may include one or more reference generation circuits, such as a current reference circuit, a bandgap reference circuit, a voltage reference circuit, and / or a combination thereof.

[0298] In some embodiments, power circuit 114 may include an energy storage device comprising one or more of a capacitor, a supercapacitor, a rechargeable battery, and / or a combination thereof. In some embodiments, power circuit 114 may not include or omit an energy storage device, and visualization system 100 may be continuously powered by another device. In some embodiments, power may be supplied to the device until it completes its function, and the device may remain inactive until it is powered again. A power circuit 114 without an energy storage device may reduce the size of power circuit 114 and the overall device.

[0299] v.Communication device

[0300] In some embodiments, the control device 100 may include a communication device 115 configured to communicate with other devices. The communication device 115 may be configured to connect to the control device 100 via a wired or wireless connection, thereby connecting the visualization system 100 to another system (e.g., the Internet, a remote server, a database). In some embodiments, the visualization system 100 may communicate with other devices via one or more wired and / or wireless networks. In some embodiments, the communication device 115 may include a radio frequency (RF) receiver, transmitter, and / or optical (e.g., infrared) receiver and transmitter configured to communicate with one or more devices and / or networks. The communication device 115 may communicate via wires and / or wirelessly.

[0301] The communication device 115 may include RF circuitry configured to receive and transmit RF signals. The RF circuitry may convert electrical signals into / from electromagnetic signals and communicate with a communication network and other communication devices via the electromagnetic signals. The RF circuitry may include well-known circuitry for performing these functions, including but not limited to an antenna system, an RF transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor, a CODEC chipset, a subscriber identity module (SIM) card, memory, and the like.

[0302] Wireless communication by any of the devices may use any of a number of communication standards, protocols and technologies, including, but not limited to, Global System for Mobile Communications (GSM), Enhanced Data GSM Environment (EDGE), High Speed ​​Downlink Packet Access (HSDPA), High Speed ​​Uplink Packet Access (HSUPA), Evolution-Data Only (EV-DO), HSPA, HSPA+, Dual Cell HSPA (DC-HSPDA), Long Term Evolution (LTE), Near Field Communication (NFC), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth, Wireless Fidelity (WiFi) (e.g., IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11d), IEEE 802.11e, IEEE 802.11f, IEEE 802.11f, IEEE 802.11g, IEEE 802.11f ... 802.11n, etc.), Voice over Internet Protocol (VoIP), Wi-MAX, email protocols (e.g., Internet Message Access Protocol (IMAP) and / or Post Office Protocol (POP), instant messaging (e.g., Extensible Messaging and Presence Protocol (XMPP), Session Initiation Protocol with Extensions for Instant Messaging and Presence (SIMPLE), Instant Messaging and Presence Service (IMPS), and / or Short Message Service (SMS), or any other suitable communication protocol. In some embodiments, the devices herein can communicate directly with each other without transmitting data through a network (e.g., through NFC, Bluetooth, WiFi, RFID, etc.).

[0303] In some embodiments, the systems, devices, and methods described herein can communicate with other wireless devices via, for example, one or more networks, each of which can be any type of network (e.g., a wired network, a wireless network). Communications can be encrypted or unencrypted. A wireless network can refer to any type of digital network that is not connected by any type of cable. Examples of wireless communications in a wireless network include, but are not limited to, cellular, radio, satellite, and microwave communications. However, a wireless network can be connected to a wired network to connect to the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are typically provided by copper twisted pair, coaxial cable, and / or fiber optic cable. There are many different types of wired networks, including wide area networks (WANs), metropolitan area networks (MANs), local area networks (LANs), internet area networks (IANs), campus area networks (CANs), global area networks (GANs) such as the Internet, and virtual private networks (VPNs). Hereinafter, a network refers to any combination of wireless, wired, public, and private data networks, which are typically interconnected via the Internet to provide a unified network and information access system.

[0304] Cellular communications may include technologies such as GSM, PCS, CDMA or GPRS, W-CDMA, EDGE or CDMA2000, LTE, WiMAX, and 5G network standards. Some wireless network deployments combine networks from multiple cellular networks, or use a mix of cellular, Wi-Fi, and satellite communications.

[0305] II. Methods

[0306] Also described are methods for visualizing tissue using the described systems and devices. Specifically, the systems, devices, and methods described herein can be used to visualize instruments and the ear canal when a clinician performs an otology procedure (e.g., myringostomy tube delivery, myringotomy, wax removal, foreign body removal, etc.). The methods described herein may include, for example, attaching a speculum 130 to an observation instrument (e.g., a visualization device 120 and a control device 110), inserting the speculum 130 into the ear canal, and irradiating and / or visualizing the ear canal and / or tympanic membrane. The instrument can be inserted into the ear canal through the speculum, for example, through an instrument cavity as described above. The clinician can perform the procedure using the instrument and rotate the speculum when image data is displayed on the display 111. Regardless of how the image rotation assembly 124 rotates the speculum 130, the image data can be rotated so as to be presented in a predetermined orientation.

[0307] Figure 2929. Example method 2900 for tissue visualization. Example method 2900 optionally includes assembling a speculum to a visualization device (block 2902). For example, the speculum can be assembled with an observation instrument such that an imaging component of the observation instrument extends into an imaging cavity of the speculum. In some embodiments, the speculum and visualization device can be provided pre-assembled. The speculum can be advanced into the ear canal (block 2904). Imaging parameters can optionally be adjusted (block 2910). For example, a clinician can provide input (e.g., input from a touch screen or other input device) to control focus, resolution, brightness, etc. The speculum (and therefore the imaging component of the visualization device) can optionally be rotated relative to other parts of the visualization device, for example, to change the field of view of the ear canal (block 2906). The device can generate image data for a display (block 2908). An instrument (e.g., a myringostomy tube delivery device, a suction device, and / or other type of device for performing an otologic procedure, e.g., placing a myringostomy tube, removing fluid, cerumen, or foreign matter, or delivering a therapeutic substance) can be advanced into the ear canal through the visualization device and the speculum (block 2912). The procedure can be performed using the instrument while image data is displayed (block 2914). The speculum can optionally be rotated while the instrument is in use, e.g., to adjust the instrument's range of motion (block 2916). The instrument and speculum can be retracted from the ear canal (block 2918). The speculum can be removed from the visualization device (block 2920). Optionally, if the speculum is a disposable component, it can be discarded (block 2922). Alternatively, the speculum can be sterilized for another use using known sterilization procedures.

[0308] Figure 30 3000 is an example method for image processing for visualization of a target treatment area. Method 3000 includes rotating a speculum relative to a visualization system (block 3002). The visualization system may generate image data (block 3004). The image data may be generated by, for example, an imaging assembly as described herein. The visualization system may also generate rotation data corresponding to the speculum (block 3006) and / or generate orientation data corresponding to a clinician (block 3008). The rotation data and / or orientation data may be generated by, for example, an image rotation assembly as described herein. The image data may be processed based on one or more of the rotation data and the orientation data (block 3010). In this way, the image data may have a consistent, predetermined orientation (e.g., from a clinician's perspective) that may facilitate visualization. The image data may be output (block 3012), for example, on a display of the visualization system.

[0309] Although various inventive embodiments have been described and illustrated herein, a person of ordinary skill in the art will readily devise various other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, a person of ordinary skill in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications in which the teachings of the present invention are used. A person of ordinary skill in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Therefore, it should be understood that the foregoing embodiments are presented by way of example only and, within the scope of the appended claims and their equivalents, the inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, provided such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

[0310] Furthermore, various inventive concepts can be embodied as one or more methods, examples of which have been provided. The actions performed as part of the methods can be ordered in any suitable manner. Thus, embodiments can be constructed in which the actions are performed in an order different from that illustrated, which can include performing some actions simultaneously, even though shown as sequential actions in the illustrative embodiments.

[0311] The above discussion is intended to illustrate the principles and various embodiments of the present invention. Once the above disclosure is fully understood, many changes and modifications will become apparent to those skilled in the art.

[0312] It is intended that the following claims be interpreted as encompassing all such variations and modifications.

Claims

1. A visualization system comprising: Controls defining the upper and lower surfaces; a display, the display being visible through an upper surface of the control device; a handle coupled to the lower surface and extending away from the lower surface; a knob coupled to the control device, the knob configured to rotate about a rotation axis; an imaging assembly mechanically coupled to the knob and communicatively coupled to the control device, the imaging assembly configured to rotate about the rotation axis based on rotation of the knob; as well as a rotation sensor in operative relationship with the knob and communicatively coupled to the control device, the rotation sensor configured to sense rotation of the knob and the imaging assembly and generate rotation data of the imaging assembly; wherein the control device is configured to display an image on the display, the image being captured by the imaging assembly; and wherein the control device is configured to rotate the image on the display in response to rotation of the knob based on the rotation data such that the image maintains a consistent orientation despite rotation of the imaging assembly, wherein the rotation sensor further comprises: a first conductive pattern; a second conductive pattern, the second conductive pattern being different from and electrically isolated from the first conductive pattern; a conductive member coupled to the knob; a measurement circuit electrically coupled to the first conductive pattern, the second conductive pattern, and the conductive member; The measurement circuit is configured to sense rotation of the knob based on capacitance measurements between the conductive member, the first conductive pattern, and the second conductive pattern.

2. The visualization system according to claim 1: wherein the first conductive pattern further comprises a wide end having a first width and a narrow end having a second width smaller than the first width, and the first conductive pattern extends in a circular pattern; wherein the second conductive pattern further comprises a wide end having a third width and a narrow end having a fourth width smaller than the third width, the second conductive pattern extending in a circular pattern beside the first conductive pattern; and The width of the first conductive pattern decreases with a circular distance around the circular pattern in a first direction, and the width of the second conductive pattern increases around the circular pattern in the first direction.

3. The visualization system according to claim 1, further comprising: a post defining a proximal end and a distal end, the proximal end of the post being coupled to the lower surface of the control device and the post extending away from the lower surface; a base coupled to the distal end of the post, the base defining an upper surface, a lower surface, and an orifice; The knob is disposed on the upper surface of the base; as well as The imaging assembly extends through the aperture and below the lower surface of the base.

4. The visualization system of claim 3, wherein the column further comprises: a first recess disposed inboard on a first side of the post, the first recess defining a closed bottom, an open top, and a passage; as well as A second recess is disposed inboard on a second side of the post opposite the first side, the second recess defining a closed bottom, an open top, and a channel. 5 . The visualization system of claim 4 , further comprising a channel of the first recess being parallel to a channel of the second recess.

6. The visualization system of claim 1 , wherein the imaging assembly further comprises: an elongated shaft defining a proximal end and a distal end, the proximal end rigidly coupled to the knob; an optical sensor disposed within the elongated shaft, the optical sensor defining an optical axis, and the optical sensor communicatively coupled to the control device; as well as an illumination source disposed within the elongated shaft; The optical axis forms a non-zero angle with the rotation axis of the knob.

7. The visualization system according to claim 6, further comprising: a distal optical lens disposed on a distal end of the elongated shaft, the imaging assembly having a field of view along the optical axis through the distal optical lens; as well as An illumination window is disposed on the distal end of the elongated shaft, the illumination window having an illumination ray path at least partially coextensive with the field of view. 8 . The visualization system of claim 6 , further comprising an optical axis of the optical sensor intersecting a rotation axis of the knob.

9. The visualization system of claim 1, further comprising a communication cable coupled between the imaging assembly and the control device, the communication cable remaining coupled between the control device and the imaging assembly as the rotational orientation of the knob changes.

10. The visualization system according to claim 9, further comprising: a base rigidly coupled to the control device, the base defining an orifice; a fixed circular rack rigidly coupled to and at least partially defining the aperture; a rotatable circular rack rigidly coupled to the knob and at least partially defining an axis of rotation of the knob; a pinion gear disposed between the stationary circular rack and the rotatable circular rack, the pinion gear being configured to translate along the stationary circular rack in response to relative rotational movement of the rotatable circular rack; a disc having an annular channel defined on an outer diameter of the disc, the disc coupled to the pinion and configured to translate with the pinion; as well as The communication cable at least partially defines the disc within the annular channel.

11. The visualization system according to claim 1 , further comprising: a speculum defining a longitudinal axis and a distal tip, the speculum coupled to the rotation knob such that the longitudinal axis is coaxial with the rotation axis of the rotation knob and the speculum rotates when the rotation knob is rotated; an imaging cavity disposed on an inner surface of the speculum, the imaging cavity defining a closed bottom, the imaging assembly disposed within the imaging cavity; as well as A working channel is defined through the speculum, the working channel being distinct from the imaging lumen.

12. The visualization system of claim 11, wherein the distal end of the imaging lumen defines a setback distance from the distal tip such that a field of view of the imaging assembly overlaps a portion of an inner diameter of the speculum at the distal tip.

13. The visualization system of claim 11, wherein the speculum defines a shape of an inverted conical frustum.

Images