Disposable Speculum for Digital Otoscope

Abstract

A disposable speculum for an otoscope provides a sheath adapted to cover an elongated otoscope probe and provides an inwardly extending tab adapted to bend outwardly to engage a corresponding groove of the otoscope when the speculum is inserted onto the otoscope. The inwardly extending tab provides precise alignment of the speculum with the elongated otoscope probe along the insertion axis to protect the length of the probe.

Description

Background of the Invention

[0002] The present invention relates to a speculum for an otoscope, and more particularly to a speculum that can be inserted into an ear canal and surrounds an electronic camera of the otoscope extending along an axis of the speculum to retrieve an image of the ear canal.

[0003] An otoscope is a medical device that allows a healthcare professional to examine the ear canal and tympanic membrane (ear drum). A simple otoscope is provided with a hollow funnel-shaped speculum, the smaller end of which is inserted into the ear canal. The purpose of the funnel shape of the speculum is to provide a visual path to the tympanic membrane and to help control the insertion depth of the speculum. The speculum also provides a clean barrier between the otoscope and the patient.

[0004] Modern otoscopes include an internal illumination source directed along the axis of the speculum from an included battery powered light, and a magnifying lens supported on the outside of the ear and aligned with the axis of the speculum may be provided to provide a magnified image of the ear structure being viewed. The speculum may ideally be disposable and typically includes a threaded attachment provided by a short helical groove that attaches to a receiving portion of the otoscope.

[0005] More recently, otoscopes have incorporated digital cameras with displays directly on the otoscope to view the camera image. Examples of these otoscopes can be found in U.S. Patent 9,326,668, U.S. Patent Publication 2016 / 0374546, and U.S. Patent Publication 2018 / 0125345, all of which are incorporated herein by reference. In such otoscopes, a digital camera can be positioned at the end of a probe that is inserted into the ear. Summary of the invention

[0006] The inventors have recognized that conventional spiral groove threads used to attach disposable specula to otoscopes may not be optimal for digital otoscopes, where the axial tip of the speculum must be precisely positioned to protect the camera without unduly limiting its field of view. The helical engagement of the thread system may also hinder the use of a probe or tool attached to the speculum where precise rotational position and torque resistance are important.

[0007] The present invention provides a disposable speculum for an otoscope, which provides a sheath adapted to cover an elongated otoscope probe and provided with an inwardly extending tab adapted to bend outwardly to releasably engage a corresponding groove of the otoscope when the speculum is inserted onto the otoscope.

[0008] Specifically, therefore, in one embodiment, the present invention provides a disposable speculum for an otoscope, the speculum comprising a funnel-shaped sheath having a central hole sized to receive an elongated cylindrical probe element of the otoscope therein along an axis and having a distal end and a proximal end, the distal end being sized to fit within the ear canal, the proximal end providing radially inwardly extending teeth that are capable of bending outwardly to allow the inwardly extending teeth to releasably engage corresponding grooves of the elongated probe element of the otoscope by outward movement of the teeth.

[0009] It is therefore a feature of at least one embodiment of the invention to provide an attachment mechanism that facilitates precise rotational positioning and axial extension of the axial tip of the speculum to protect an axially extending camera therein. The snap on attachment mechanism provides an intuitive sense of rotational positioning compared to a spiral-type speculum where rotational position may be important, such as where the speculum includes a scraper tool.

[0010] Axial notches are provided on the sides of the teeth to enable the portion of the proximal end retaining the teeth to flex outwardly.

[0011] It is therefore a feature of at least one embodiment of the invention to provide an engagement mechanism that does not require rotation of the speculum during attachment.

[0012] The teeth may have front faces facing the distal end, with the front faces extending inwardly perpendicular to the axis or inclined toward the distal end as the teeth proceed inwardly along the front faces.

[0013] It is therefore a feature of at least one embodiment of the invention to provide teeth that resist axial displacement after the teeth engage the corresponding grooves.

[0014] The three teeth may be equally spaced 120° apart around the axis.

[0015] It is therefore a feature of at least one embodiment of the invention to provide an attachment mechanism that better resists torsion in two dimensions across the axis of insertion and perpendicular to the probe axis.

[0016] Circumferentially opposite ends of the tooth may provide at least one wall that slopes inwardly as the tooth progresses radially inwardly along the tooth.

[0017] It is therefore a feature of at least one embodiment of the invention that the contact pressure between the teeth and the inclined walls of the recess of the otoscope is reduced when the speculum is rotated for release and disposal.

[0018] The proximal end may provide a rounded rim and the axial slot extends through the rim.

[0019] It is therefore a feature of at least one embodiment of the invention to provide good outward curvature of the teeth using simple injection molding techniques.

[0020] The proximal end may include a cylindrical portion that abuts and supports the cylindrical probe element.The speculum may include a tapered portion in addition to the cylindrical portion.

[0021] It is thus a feature of at least one embodiment of the invention to maximize camera support while reducing the tip width required for insertion into the inner ear.

[0022] The speculum may further include radially outwardly extending fins rotationally aligned with the teeth.

[0023] It is therefore a feature of at least one embodiment of the invention to apply a rotational force directly over the teeth to improve release of the teeth during speculum rotation and to provide controlled bending stiffness independent of the thickness of the speculum wall.

[0024] The sheath may be a thermoplastic material.

[0025] It is therefore a feature of at least one embodiment of the invention to provide a speculum that is easy to manufacture and thus inexpensive to be disposable for increased safety.

[0026] The sheath may be light absorbing.

[0027] It is thus a feature of at least one embodiment of the invention to prevent unwanted light leakage into the sheath that could affect the camera image.

[0028] The sheath may also include an otoscope shell suitable for being supported by the hand of a medical professional, the shell being in an examination position near the patient's outer ear, wherein an elongated cylindrical probe element has a proximal end supported by the shell so that the distal end of the elongated cylindrical probe element can extend into the ear canal along an axis; and an otoscope electronic camera supported by the distal end of the elongated cylindrical probe element for observing the ear canal when the distal end of the elongated cylindrical probe element is positioned in the ear canal of the outer ear.

[0029] It is therefore a feature of at least one embodiment of the invention to mount the speculum on an otoscope where it is desired to extend the camera tip into the ear canal.

[0030] The corresponding grooves may be radially spaced 120° apart around the axis.

[0031] It is thus a feature of at least one embodiment of the invention that the teeth are aligned with the grooves by a slight (less than a quarter turn) rotation of the speculum.

[0032] The corresponding groove may include a ramp surface.

[0033] It is thus a feature of at least one embodiment of the invention to allow for detachment of the speculum by rotating the speculum and then separating the speculum and otoscope along an axis.

[0034] The corresponding groove may include a front vertical surface.

[0035] It is therefore a feature of at least one embodiment of the invention to provide an abutment of the teeth against the front face of the groove to prevent displacement of the speculum.

[0036] The distance between the distal end of the sheath and the distal end of the elongate probe element may be approximately 1 mm to 2 mm.

[0037] It is thus a feature of at least one embodiment of the invention to provide fixed axial alignment of a speculum extending over a fragile axially extending camera head.

[0038] In an alternative embodiment, the present invention provides a method for using a disposable speculum for an otoscope, the method comprising the following steps: providing a funnel-shaped sheath having a central hole, a distal end, and a proximal end, the central hole being sized to receive an elongated cylindrical probe element of the otoscope therein along an axis, the distal end being sized to fit within the ear canal, the proximal end providing radially inwardly extending teeth that are capable of bending outwardly to allow the inwardly extending teeth to releasably engage corresponding grooves of the elongated probe element of the otoscope by outward movement of the teeth; and inserting the sheath into the ear canal.

[0039] These particular objects and advantages may apply to only some embodiments falling within the scope of the claims, thus not limiting the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 is a side view of a disposable speculum constructed according to the present invention inserted into an otoscope along an insertion axis;

[0041] Figure 2 yes Figure 1 A perspective view of the exterior of a disposable speculum of , which provides a sheath presenting a curved collar tapering to a cylindrical tube;

[0042] Figure 3 yes Figure 2 A perspective view of the interior of a disposable speculum showing a plurality of teeth that bend outwardly with a curved collar;

[0043] Figure 4 It is along the Figure 1 The vertical plane of line 4-4 passes through Figure 1 a cross-sectional view of a speculum and an assembled otoscope;

[0044] Figure 5 is similar to Figure 4, showing a tooth having substantially vertical side walls received in a recess of an otoscope; and

[0045] Figure 6 It is along the Figure 4 An enlarged cross-sectional view of a vertical plane along line 6-6, which is perpendicular to the insertion axis of the otoscope and shows a tooth having at least one inclined side wall received in a recess of the otoscope. DETAILED DESCRIPTION

[0046] First refer to Figure 1 , the removable speculum 10 of the present invention may provide a protective sheath 12 that fits over a cylindrical probe 14 of an otoscope 16 that extends along an insertion axis 20 that is aligned with the ear canal when the otoscope 16 is in use. The otoscope 16 may support a forward-facing electronic camera 18 on its probe distal tip 17 for acquiring a multi-pixel, three-color image in a field of view oriented along the speculum axis 22. Otoscopes 16 suitable for use with the present invention are described in U.S. Patent 9,326,668, U.S. Patent Publication 2016 / 0374546, and U.S. Patent Publication 2018 / 0125345, each of which is incorporated herein by reference.

[0047] As described further below, the removable speculum 10 is attached to the otoscope 16 via a snap-lock engagement between the protective sheath 12 and the otoscope 16 supporting the cylindrical probe 14 and the electronic camera 18 .

[0048] Now refer to Figure 2 , the protective sheath 12 of the removable speculum 10 can be in the form of a hollow trumpet with a central hole extending along the speculum axis 22 and surrounded by the outer sheath 12. The outer sheath 12 is generally radially symmetrical over a rotation angle of 120 degrees, and the amount of eversion gradually increases along the speculum axis 22 as the sheath 12 opens upward from the speculum distal tip 11 to the rounded proximal outer edge 13 attached to the otoscope 16. The outer diameter of the outer sheath 12 can gradually increase from about 2-3 mm at the speculum distal tip 11 to about 18-19 mm at the proximal outer edge 13, or gradually increase by 6 to 10 times its minimum diameter.

[0049] The outer sheath 12 may be constructed of a non-elastic thermoplastic by injection molding. The rigid material of the protective sheath 12 allows the speculum 10 to slide easily over the cylindrical probe 14 without the resistance that might be expected, for example, if the material is an elastomer. The rigid material of the protective sheath 12 also serves to support and protect the relatively fragile cylindrical probe 14 and electronic camera 18. The speculum 10 may be opaque and may be light absorbing, such as black in color, to minimize light leakage into the sheath 12.

[0050] The distal portion 33 of the protective sheath 12 extending into the ear canal may provide an elongated tube 34 having a central hole extending along the speculum axis 22, the inner diameter of the central hole being about 2-3 mm and less than 3 mm and ideally less than 2.3 mm measured in a plane perpendicular to the speculum axis 22. It is intended that the tube 34 be sized to have an outer diameter smaller than the ear canal so that it can be comfortably inserted into the ear canal, for example, about 2-3 mm and less than 3 mm and ideally less than 2.4 mm. The outer diameter of the tube 34 may be minimized to allow the tube 34 to be inserted into smaller sized ear canals, such as the ear canals of toddlers and infants, which may be as small as 3 to 4 mm in diameter. The length of the tube 34 may be about 8-12 mm and at least 8 mm to allow the protective sheath 12 to extend through smaller obstructions, such as ear wax that is typically present, but to allow the passage of the electronic camera 18 to be maintained close to the ear drum to allow imaging of the ear drum of the ear.

[0051] In some embodiments, the tube 34 can be cylindrical, with a constant inner diameter that closely matches the outer diameter of the cylindrical probe 14 for good support, although the tube 34 can also taper slightly over the length, for example, toward the narrowed distal speculum tip 11.

[0052] The tube 34 opens at the speculum distal tip 11 to allow exposure of the held electronic camera 18 along the speculum axis 22. The speculum distal tip 11 can support a probe or tool, such as a spoon 31 to assist in removing ear wax. The spoon 31 extends from the speculum distal tip 11 along the axis 22 and is concave upward toward the axis 22.

[0053] The proximal portion 36 of the protective sheath 12 may take the form of a funnel 37 having a central hole that flares outwardly from the tube 34 and extends to a gradually flaring, integrally molded collar 38 coupled to the otoscope 16. The diameter of the distal end of the funnel 37 measured in a plane perpendicular to the speculum axis 22 may be approximately 2-3 mm, and the diameter of the proximal end of the funnel 37 extending at least 12 mm along the speculum axis 22 from the distal end of the funnel 37 may be 9-10 mm. The funnel 37 may flare outwardly toward the integrally molded collar 38 of the protective sheath 12 at approximately 15-20 degrees relative to the speculum axis 22 and at approximately 18 degrees relative to the speculum axis 22. The increased diameter of the funnel 37 compared to the narrow tube 34 can help control the insertion depth of the speculum 10 so that the proximal portion 36 can only partially extend into the ear canal 21 to prevent the distal tube 34 from extending too deeply into the ear canal 21, which could risk damaging or puncturing the ear drum.

[0054] The funnel 37 expands outwardly to a flaring, integrally molded collar 38 that can be engaged over the head 24 of the otoscope 16 to be secured thereto. The collar 38 can take a similar conical shape, flaring outwardly toward the proximal end of the protective sheath 12 at about 40-45 degrees relative to the speculum axis 22 in the unbent state and at about 45 degrees relative to the speculum axis 22, thereby providing a larger diameter hole for receiving the head 24 of the otoscope 16. The diameter of the distal end of the collar 38 measured in a plane perpendicular to the speculum axis 22 can be about 9-10 mm, and the diameter of the proximal end of the collar 38 extending at least 3 mm from the distal end of the collar 38 along the speculum axis 22 can be 18-19 mm.

[0055] The proximal portion 36 of the protective sheath 12 may provide a curved section 40 formed by axial slots 46 extending along the speculum axis 22 and dividing the proximal portion 36 into cantilevered sections that may be deformed outwardly and / or inwardly by a distance of about 0.1-0.5 mm, and at least 0.1 mm, away from and / or toward the speculum axis 22 at the proximal edge 13 of the proximal portion 36. The longitudinally extending slots 46 may be about 0.5-1 mm wide, and at least 0.5 mm wide, and may extend through the proximal edge 13 toward the distal portion 34 for a length of at least 8 mm, or at least one third of the length of the protective sheath 12.

[0056] In one embodiment, the collar 38 may include three equally spaced notches 46 positioned approximately 120 degrees apart about the speculum axis 22 of the proximal portion 36 and forming three cantilevered segments 40a, 40b, 40c supported at the distal end by the protective sheath 12 and separated on the left and right sides at the proximal edge 13 by the notches 46 to allow the segments 40a, 40b, 40c to flex outwardly and / or inwardly away from and / or toward the speculum axis 22. Each of the segments 40a, 40b, 40c may flex independently, however, equal outward / inward forces on the segments 40a, 40b, 40c generally result in substantially equal outward / inward flexion of each segment 40a, 40b, 40c.

[0057] The outer surface 49 of the proximal portion 36 of the protective sheath 12 can support at least one outwardly projecting fin 50 extending from the protective sheath 12. The at least one outwardly projecting fin 50 can generally span between the funnel 37 and the collar 38 to form a generally triangular tab for twisting the protective sheath 12 by the fingers of a medical professional without the need for additional tools. In one embodiment, the proximal portion 36 can carry three equally spaced fins 50 that are spaced approximately 120 degrees apart about the speculum axis 22 and are generally radially centered between the three equally spaced notches 46.

[0058] Reference Figure 3 , the inner surface 51 of the proximal portion 36 may support at least one radially inwardly projecting tooth 52 that engages the inserted head 24 of the fully installed otoscope 16. The tooth 52 may be in the shape of an elliptical, oblong, or rectangular protrusion extending from the inner surface 51 toward the speculum axis 22 and have a generally circular outer edge to allow the tooth 52 to slide or roll into or out of a corresponding groove 58 of the otoscope 16. The tooth 52 may be at least 1 mm wide, 3 mm long, and 0.1 mm deep. The tooth 52 may be oriented so that the longest dimension of the tooth 52 extends along the circumference of the protective sheath 12 and the shortest dimension of the tooth 52 extends along the speculum axis 22.

[0059] Briefly turn to Figure 5 and Figure 6 Each tooth 52 may have a front face 53 facing the distal end of the protective sheath 12 that is substantially perpendicular to the speculum axis 22 (axis 22' extends parallel to axis 22) as shown, or may be inclined toward the speculum axis 22 as the tooth moves inwardly along the front face 53, and thus be oriented to abut the front wall of the groove 58 to prevent the tooth 52 from being removed from the groove 58 in the forward direction. The back face 54 of the tooth 52 may be substantially perpendicular to the speculum axis 22 as shown, or may be inclined toward the speculum axis 22 as the tooth moves outwardly along the front face 53, and thus be oriented to abut the rear wall of the groove 58 to prevent the tooth 52 from being removed from the groove 58 in the rearward direction. The side faces 55, 56 of the tooth 52 may be inclined away from the speculum axis 22 as the tooth moves inwardly along the front face 53, as shown, but may also be inclined toward the speculum axis 22 as the tooth moves inwardly along the front face 53, or may be substantially perpendicular to the speculum axis 22, and thus be oriented to assist the tooth 52 in moving along the slope of the groove 58. In one embodiment, the inner surface 51 of each segment 40a, 40b, 40c can support a single tooth 52. The tooth 52 can be generally centrally located between three equally spaced notches 46 within each segment 40a, 40b, 40c and positioned toward the proximal end of the funnel 37. The tooth 52 can be rotationally aligned with the outwardly extending fin 50.

[0060] Now refer to Figure 1 and Figure 4 , the removable speculum 10 can be slid over the otoscope 16, which generally provides a housing having a head 24 supported by a removable grip portion 72. The grip portion 72 is sized to be grasped by the hand of a healthcare professional in the manner that conventional otoscopes have a grip portion 72 that extends generally upward from the hand of the healthcare professional to the head 24.

[0061] The head 24 of the otoscope 16 can take the shape of a cone that tapers to a front end defined by a rounded tip that supports a frustoconical mounting boss 74. A distal end 77 of the frustoconical mounting boss 74 of the head 24 of the otoscope 16 supports an extension of a cylindrical probe 14 having a proximal end 78 supported by the head 24 and a distal end or tip 17 that extends along the axis 20 of the ear canal 21. The cylindrical probe 14 can extend a length of approximately 8-10 mm and at least 8 mm to allow a forward-facing electronic camera 18 at the probe distal tip 17 to reach a desired depth within the ear canal 21. The distal tip 17 of the cylindrical probe 14 supports the electronic camera 18, which is used to view the interior of the ear canal 21 and communicate with an electronic display that displays an otoscope image from the electronic camera 18, and is located at the distal tip 17 of the cylindrical probe 14 along the axis 20 and centered along the axis 20 as understood in the art. The electronic camera 18 may be, for example, a stand-alone charge coupled device (CCD) camera, such as commercially available, providing, for example, a measuring area of ​​1.4 mm diagonal and 62,500 pixels.

[0062] The outer edge of the frustoconical mounting boss 74 may have grooves 58 disposed therein and corresponding to the teeth 52 of the removable speculum 10. The grooves 58 of the otoscope 16 may be generally rectangular holes approximately 1 mm to 2 mm wide, 3 mm to 4 mm long, and 0.1 mm to 0.5 mm deep. In one embodiment, the cylindrical mounting boss 74 may support three equally spaced grooves 58 spaced approximately 120 degrees apart about the axis 20, whereby the largest dimension of the rectangle extends along the circumference of the cylindrical mounting boss 74 and the shortest dimension of the rectangle extends along the axis 20.

[0063] Now refer to Figure 5 , the rectangular groove 58 can provide substantially vertical front and rear side walls 80, 82, respectively (relative to the axis 20' which is parallel to the axis 20), thereby preventing the teeth 52 from being removed from the groove 58 in the anterior-posterior direction along the axis 20. In this way, the removable speculum 10 cannot be easily removed by a medical professional and is fixed to the otoscope 16 once installed.

[0064] Now refer to Figure 6, the rectangular groove 58 can provide lateral sidewalls 84, 86, whereby at least one of the sidewalls 84, 86 is angled to provide a ramp in which the teeth 52 can slide or travel along the angled sidewalls 84, 86 and become disengaged from the groove 58 when the removable speculum 10 is rotated in at least one of a clockwise or counterclockwise direction. The angle of at least one of the sidewalls 84, 86 can be at least 45 degrees relative to vertical and at least 45 degrees. It should be understood that one or both of the lateral sidewalls 84, 86 can be angled to provide an exit ramp for the teeth 52. In one embodiment, one lateral sidewall 84 is angled, while the opposing sidewall 86 extends substantially perpendicular to the bottom of the groove 58. In this regard, twisting motion in one direction (toward the angled sidewall 84) will allow the removable speculum 10 to be removed from the head 24 of the otoscope 16, while twisting motion in the opposite direction will be blocked by the generally vertical sidewall 86. In an alternative embodiment, both lateral sidewalls 84 , 86 are angled such that twisting in either a clockwise or counterclockwise direction will allow the removable speculum 10 to be removed from the head 24 of the otoscope 16 .

[0065] Refer again Figure 1 , Figure 4 and Figure 5 As shown, the removable speculum 10 can be inserted onto the cylindrical probe 16 by sliding the speculum 10 backward along the insertion axis 20 over the cylindrical probe 16, whereby the central hole of the tube 34 holds the cylindrical probe 14, which carries the electronic camera 18 facing forward at its tip 17. The sections 40a, 40b, 40c of the removable speculum 10 can be bent outward to accommodate the head 24 as it is inserted into the speculum 10. The speculum 10 is inserted along the axis 20 until the collar 38 extends over the boss 74 of the removable speculum 10. If the teeth 52 are aligned with the grooves 58 during insertion along the axis 20, the speculum 10 may not need to be rotated, but in some cases a slight rotation (less than a quarter turn) may be required until the teeth 52 are aligned with the grooves 58 and the removable speculum 10 snaps into place.

[0066] Once installed, the axial position of the distal tip 11 of the removable speculum 10 is set so that the distal tip 17 of the cylindrical probe 14 can terminate before the distal tip 11 of the removable speculum 10. In one embodiment, the distance between the distal tip 17 of the cylindrical probe 14 and the distal tip 11 of the removable speculum 10 can be approximately 1-2 mm, or less than 2 mm. The distance between the distal tip 17 of the cylindrical probe 14 and the distal tip 11 of the removable speculum 10 can be set to minimize blinding internal reflections and narrowed field of view of the electronic camera 18, while still protecting the fragile electronic camera 18 from contamination and damage.

[0067] Reference again Figure 6 , approximately a quarter turn twisting of the removable speculum 10 causes the teeth 52 to slide along one of the inclined side walls 84, 86, while the sections 40a, 40b, 40c of the removable speculum 10 flex outwardly (at least 0.1 mm) to accommodate the outward movement of the teeth 52. Once the teeth 52 are displaced from the grooves 58, forward movement of the removable speculum 10 along the axis 20 allows the removable speculum 10 to be separated from the head 24 of the otoscope 16.

[0068] As is generally understood, the external ear of a human patient includes an auricle that provides a sound collecting structure. The auricle surrounds an ear canal 21 that leads to and terminates at the tympanic membrane or ear drum. The length of the ear canal 21 of an average adult is about 25 mm, and the average diameter of the ear canal 21 is about 7 mm. The length of the ear canal 21 of an average infant is about 5, and the average diameter of the ear canal 21 is about 3-4 mm.

[0069] Certain terms are used herein for reference purposes only and are therefore not intended to be limiting. For example, terms such as "upper," "lower," "above," and "below" refer to directions in the drawings to which reference is made. Terms such as "forward," "backward," "back," "bottom," and "side" describe the orientation of parts of a component within a consistent but arbitrary frame of reference, which is clarified by reference to the relevant drawings and text describing the component in question. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning. Similarly, the terms "first," "second," and other such numerical terms referring to structures do not imply a sequence or order unless the context clearly indicates.

[0070] When introducing elements or features of the present disclosure and exemplary embodiments, the articles "a," "an," "the," and "said" are intended to indicate the presence of one or more such elements or features. The terms "comprising," "including," and "having" are intended to be open ended and mean that there may be additional elements or features in addition to those specifically noted. It should also be understood that the method steps, processes, and operations described herein should not be interpreted as necessarily requiring them to be performed in the particular order discussed or illustrated, unless explicitly identified as an order of execution. It should also be understood that additional or alternative steps may be employed.

[0071] In particular, the present invention is not limited to the embodiments and illustrations contained herein, and the claims should be understood to include modifications of those embodiments including combinations of parts of the embodiments and elements of different embodiments that fall within the scope of the claims of the present invention. All disclosures described herein, including patents and non-patent disclosures, are incorporated herein by reference in their entirety in their entirety.

Claims

1. A disposable speculum for an otoscope, comprising: A funnel-shaped sheath having a central hole sized to receive an elongated cylindrical probe element of the otoscope therein along an axis, and having: a distal end sized to fit within the ear canal, and a proximal end portion providing radially inwardly extending teeth which are capable of flexing outwardly to allow the inwardly extending teeth to releasably engage corresponding recesses of the elongated probe element of the otoscope by outward movement of the teeth; Wherein, an axial notch is arranged on the side of the tooth so that the portion of the proximal end portion holding the tooth can be bent outward.

2. The speculum according to claim 1, wherein: The tooth has a front face facing the distal end, and the front face extends inwardly perpendicular to the axis or slopes toward the distal end as the tooth progresses inwardly along the front face.

3. The speculum according to claim 1, wherein: The three teeth are equally spaced 120° around the axis.

4. The speculum according to claim 1, wherein: Circumferentially opposite ends of the tooth are provided with at least one wall which slopes inwardly as the tooth progresses radially inwardly along the tooth.

5. The speculum according to claim 1, wherein: The proximal end provides a circular rim and the axial slot extends through the rim.

6. The speculum according to claim 1, wherein: The proximal end includes a cylindrical portion that abuts and supports the cylindrical probe element.

7. The speculum according to claim 6, further comprising a tapered portion in addition to the cylindrical portion.

8. The speculum of claim 1 further comprising radially outwardly extending fins rotationally aligned with the teeth.

9. The speculum according to claim 1, wherein: The sheath is a thermoplastic material.

10. The speculum according to claim 1, wherein: The sheath is light absorbing.

11. The speculum according to claim 1, further comprising An otoscope housing adapted to be supported by a hand of a healthcare professional, wherein: The housing is in an examination position close to the patient's external ear, wherein the elongated cylindrical probe element has a proximal end supported by the housing such that a distal end of the elongated probe element can extend into the ear canal along the axis; and An otoscope electronic camera is supported by the distal end of the elongated cylindrical probe element for viewing the ear canal when the distal end of the probe element is positioned in the ear canal of the external ear.

12. The speculum according to claim 11, wherein: The corresponding grooves are radially spaced 120° apart about the axis.

13. The speculum according to claim 11, wherein: The corresponding groove includes a ramp surface.

14. The speculum according to claim 11, wherein: The corresponding groove includes a front vertical surface.

15. The speculum according to claim 11, wherein: The distance between the distal end of the sheath and the distal end of the elongated probe element is 1 mm to 2 mm.

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