METHOD AND APPARATUS FOR CONTROLLING AN EYE LID DURING ULTRASOUND IMAGING

Abstract

The present disclosure is directed to a method and apparatus for holding an eyelid open and preventing involuntary blinking during an ultrasound imaging procedure while ensuring patient safety and comfort. Eyelids can be taped up to the forehead or down to the cheek with common medical tape; however, this does not provide the instrument operator with the ability to adjust or control the amount of eye lid opening very well, nor allow the patient to relax the eyelids between scanning sessions. The present disclosure includes a speculum that can be placed in an eye piece such as used in a precision ultrasound device or other imaging device wherein the optical acoustic and transmission path between the eye and instrument is formed by a fluid such as saline solution and distilled water.

Claims

1. A speculum, comprising: opposing pads comprising an adhesive to adhere to skin of a patient; and a flexible eyelid retraction member engaging the opposing pads, the retraction member comprising a plurality of curved surfaces collectively sized to surround an eye of the patient and press outwardly against the eyelids of the patient to urge the upper and lower eyelids to retract from the eye.

2. The speculum of claim 1, wherein a radius of curvature of each of opposing first and second curved surfaces of the retraction member is greater than a radius of curvature of each of opposing third and fourth curved surfaces of the retraction member.

3. The speculum of claim 2, wherein a first of the opposing pads engages the third curved surface and a second of the opposing pads engages the fourth curved surface.

4. The speculum of claim 2, wherein upper and lower surfaces of the flexible eyelid retraction member and the opposing pads curve upwardly above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces.

5. The speculum of claim 4, wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces.

6. The speculum of claim 1, wherein the speculum is received by an eye seal of an ocular imaging device.

7. The speculum of claim 1, wherein the retraction member comprises first and second arcuate surfaces, first and second ends of each connecting to the opposing pads.

8. A speculum, comprising: opposing pads contacting first portions of the eyelids of a patient; and a flexible eyelid retraction member engaging the opposing pads and contacting second portions of the patient's upper and lower eyelids, the first and second portions being discrete from each other, wherein the flexible eyelid retraction member curves outwardly to substantially contact skin surrounding an eye socket of the patient.

9. The speculum of claim 8, wherein the retraction member comprises a plurality of curved surfaces collectively sized to surround an eye of the patient and press outwardly against the eyelids of the patient to urge the upper and lower eyelids to retract from the eye.

10. The speculum of claim 9, wherein a radius of curvature of each of opposing first and second curved surfaces of the retraction member is greater than a radius of curvature of each of opposing third and fourth curved surfaces of the retraction member.

11. The speculum of claim 10, wherein a first of the opposing pads engages the third curved surface and a second of the opposing pads engages the fourth curved surface.

12. The speculum of claim 10, wherein upper and lower surfaces of the flexible eyelid retraction member and the opposing pads curve upwardly above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces.

13. The speculum of claim 12, wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces.

14. The speculum of claim 8, wherein the speculum is received by an eye seal of an ocular imaging device.

15. The speculum of claim 9, wherein the retraction member comprises first and second arcuate surfaces, first and second ends of each connecting to the opposing pads.

16. A speculum, comprising: first and second opposing pads; and a flexible eyelid retraction member engaging the first and second opposing pads, the retraction member comprising a plurality of curved surfaces collectively sized to surround an eye of the patient and press outwardly against the eyelids of the patient and urge the upper and lower eyelids to retract from the eye, wherein the first and second opposing pads engage skin adjacent to inner and outer ends of the upper and lower eyelids while the retraction member contacts the upper and lower eyelids above and below the iris, respectively, and wherein the flexible eyelid retraction member is configured to curve outwardly while in contact with the patient to substantially continuously contact skin surrounding the eye of the patient.

17. The speculum of claim 16, wherein a radius of curvature of each of opposing first and second curved surfaces of the retraction member is greater than a radius of curvature of each of opposing third and fourth curved surfaces of the retraction member.

18. The speculum of claim 17, wherein the first opposing pad engages the third curved surface and the second opposing pad engages the fourth curved surface.

19. The speculum of claim 17, wherein upper and lower surfaces of the flexible eyelid retraction member and the opposing pads curve upwardly above a line defined by lower extremities of the first and second curved surfaces and an apex of the upward curve is located on the opposing third and fourth curved surfaces.

20. The speculum of claim 19, wherein a radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces.

21. The speculum of claim 16, wherein the speculum is received by an eye seal of an ocular imaging device.

22. The speculum of claim 16, wherein the retraction member comprises first and second arcuate surfaces, first and second ends of each connecting to the opposing pads.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0102] The present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure. In the drawings, like reference numerals may refer to like or analogous components throughout the several views.

[0103] FIGS. 1a-b show various types of prior art ophthalmic speculums.

[0104] FIG. 2 shows an alternate method to hold an eyelid open during imaging (from U.S. patent application Ser. No. 17/133,233 filed Dec. 23, 2020, which is incorporated herein by reference).

[0105] FIG. 3 is a schematic of a prior art Insight 100 ultrasound imaging device for the eye.

[0106] FIG. 4 is a schematic of a prior art eye piece used on the Insight 100.

[0107] FIG. 5 is a cut-away of a prior art Insight 100 with a patient in position for imaging.

[0108] FIG. 6 is a prior art schematic showing the relationship between the scan head, the ultrasound transducer, the eye seal and the patient's eye during imaging.

[0109] FIG. 7 is a schematic of the speculum of the embodiment as it would fit inside an eye piece.

[0110] FIG. 8 is another schematic of the speculum of the embodiment as it would fit inside an eye piece.

[0111] FIG. 9 is a schematic of the speculum of the embodiment.

[0112] FIGS. 10a-f show various schematic views of the speculum of the embodiment.

[0113] FIG. 11 illustrates approximate cost versus volume for several plastic fabrication processes.

[0114] FIGS. 12a-f show schematic views of various speculum applicator tool designs of the embodiment.

[0115] FIG. 13 is a schematic of a speculum applicator tool clamping on a speculum of the embodiment.

DETAILED DESCRIPTION OF THE DRAWINGS

Prior Art

[0116] FIG. 1 shows various types of prior art ophthalmic speculums. FIG. 1a shows a number of types of eye speculums that have been used. None of these would be useful to hold open eye lids during imaging with the ultrasound scanner such as shown in FIG. 3. Adjustments of these speculums could not be made by the patient. FIG. 1b shows a molded plastic speculum taken from U.S. D601,6985 “Eye Speculum”. This speculum can be used to hold open eye lids during imaging with the ultrasound scanner such as shown in FIG. 3. This speculum causes some patient discomfort but cannot be adjusted by the instrument operator or patient once the patient is engaged with the eye piece of the scanning instrument shown in FIG. 3.

[0117] FIG. 2 shows an alternate method to hold an eyelid open during imaging. FIG. 2 is a photo of an eye strip applied to a patient prior to imaging. One assembled eye strip is attached to the upper eye lid using the short section of exposed adhesive on the one sided tape. A second assembled eye strip is attached to the lower eye lid using the short section of exposed adhesive on its one sided tape. The patient pulls their own eye lid open then positions himself at the scanning machine.

[0118] Eyelids can be taped up to the forehead or down to the cheek with common medical tape; however, this does not provide the instrument operator with the ability to adjust or control the amount of eye lid opening very well, nor to relax the eyelids, for instance between scanning, and then reapply the tension. This concept is disclosed in U.S. patent application Ser. No. 17/133,233 entitled “A Method and Apparatus for Controlling an Eye Lid During Imaging” filed Dec. 23, 2020, which is incorporated herein by reference.

Ultrasound Imaging Instrument

[0119] FIG. 3 is a prior art schematic of an Insight 100 ultrasound imaging device for the eye. FIG. 3 is a schematic of the principal elements of a prior art ultrasound eye scanning device such as described in U.S. Pat. No. 8,317,709, entitled “Alignment and Imaging of an Eye with an Ultrasonic Scanner”. The scanning device 301 of this example is comprised of a disposable eyepiece 307, a scan head assembly 308 and a positioning mechanism 309. The scan head assembly 308 is comprised of an arcuate guide 302 with a scanning transducer 304 on a transducer carriage which moves back and forth along the arcuate guide track 302, and a linear guide track 303 which moves the arcuate guide track 302 back and forth (as described further in FIG. 3). The positioning mechanism 309 is comprised of an x-y-z and beta mechanisms 305 (described in FIG. 4) mounted on a base 306. The base 306 is rigidly attached to the scanning device 301. A longitudinal axis 310 passes generally through a center of the head assembly 308 and is substantially perpendicular to a face of the eyepiece 307. A video camera (not shown) may be positioned within the scanning device 301 and aligned with the longitudinal axis 310 to provide an image of a patient's eye through the eyepiece 307. The scanning device 301 is typically connected to a computer (not shown) which includes a processor module, a memory module, a keyboard, a mouse or other pointing device, a printer, and a video monitor. One or more fixation lights (not shown) may be positioned within the scanning device at one or more locations. The eyepiece 307 may be disposable as described in FIG. 5.

[0120] The positioner assembly 309 and scan head assembly 308 are both fully immersed in water (typically distilled water) which fills the chamber from base plate 306 to the top of the chamber on which the eyepiece 307 is attached.

[0121] A patient is seated at the scanning device 301 with one eye engaged with the disposable eyepiece 307. The patient is typically directed to look downward at one of the fixation lights during a scan sequence. The patient is fixed with respect to the scanning device 301 by a headrest system such as shown, for example, in FIG. 4, and by the eyepiece 307.

[0122] An operator using a mouse and/or a keyboard and the video monitor, for example, inputs information into the computer selecting the type of scan and scan sequences as well as the desired type of output analyses. The operator using the mouse and/or the keyboard, the video camera located in the scanning machine, and the video screen, centers a reference marker such as, for example, a set of cross hairs displayed on the video screen on the desired component of the patient's eye which is also displayed on video screen. This is done by setting one of the cross hairs as the prime meridian for scanning. These steps are carried out using the positioning mechanism which can move the scan head in the x, x, z and beta space (three translational motions plus rotation about the z-axis). The z-axis is parallel to the longitudinal axis 310. Once this is accomplished, the operator instructs the computer to proceed with the scanning sequence. Now the computer processor takes over the procedure and issues instructions to the scan head 308 and the scanning transducer 304 and receives positional and imaging data. The computer processor proceeds with a sequence of operations such as, for example: (1) with the transducer carriage substantially centered on the arcuate guide track, rough focusing of the scanning transducer 304 on a selected eye component; (2) accurately centering of the arcuate guide track with respect to the selected eye component; (3) accurately focusing the scanning transducer 304 on the selected feature of the selected eye component; (4) rotating the scan head assembly 308 through a substantial angle (including orthogonal) and repeating steps (1) through (3) on a second meridian; (5) rotating the scan head back to the prime meridian; (6) initiating a set of A-scans along each of the of selected scan meridians, storing this information in the memory module; (7) utilizing the processor, converting the A-scans for each meridian into a set of B-scans and then processing the B-scans to form an image associated with each meridian; (8) performing the selected analyses on the A-scans, B-scans and images associated with each or all of the meridians scanned; and (9) outputting the data in a preselected format to an output device such as a printer. As can be appreciated, the patient's head must remain fixed with respect to the scanning device 301 during the above operations when scanning is being carried out, which in a modern ultrasound scanning machine, can take several tens of seconds.

[0123] An eyepiece serves to complete a continuous acoustic path for ultrasonic scanning, that path extending in water from the transducer to the surface of the patient's eye. The eyepiece 307 also separates the water in which the patient's eye is immersed (typically a saline solution) from the water in the chamber (typically distilled water) in which the transducer guide track assemblies are contained. The patient sits at the machine and looks down through the eyepiece 307 in the direction of the longitudinal axis 310. Finally, the eyepiece provides an additional steady rest for the patient and helps the patient's head to remain steady during a scan procedure.

Eye Piece for Ultrasound Imaging

[0124] FIG. 4 is a prior art schematic of an eye piece typically used on an ultrasound scanner such as the Insight 100. FIG. 4 is an isometric view of an advanced eye piece for a precision scanning machine. Eye piece 401 is comprised of a plastic base 402 molded from a plastic such as ABS and a soft rubber conformable face seal 403 formed from a silicone thermo-plastic elastomer. The conformable face seal 403 is over-molded onto the plastic base 402 by a heat process typically applied to the conformable face seal 403. Plastic base 402 also includes attaching mechanisms 405 which attach the eye piece to the mounting ring (not shown) which is typically attached to the main scanner housing; thumb and finger protrusions 406 used to rotate the eye piece into the mounting ring; indexing ridge 407 which prevents over-rotation of the eye piece as it is rotated into the mounting ring attached to the main scanner housing; and fill port 408, vent port 410 and drain port 409. Ports 408, 409 and 410 allow fluid flow through the eye piece base 401.

[0125] The eye piece is attached and sealed to a mounting ring which is, in turn, attached to the main scanner body by a groove molded as part of the eye piece base 402 and a matching tongue formed as part of the mounting ring. The eye piece is rotated into position with the mounting ring where the tongue and groove form a contact connection which compresses and seals as the parts are rotated into position.

[0126] A sealed hygienic barrier membrane (not shown) is formed as part of the eye piece and is typically located, where the soft rubber face seal 403 is connected to the eye piece base 401. This membrane is typically attached onto the plastic eye piece base 402 by an adhesive backing commonly used in medical disposable components. The thickness of the membrane is designed for transmission of light (such as a fixation light, and transmission of acoustic energy emitted by the transducer and reflected by a component of the eye. The membrane is hermetically sealed to prevent saline solution from contaminating the distilled water in the machine body (saline solution or tap water inside the machine body can corrode plastic, ceramic and metal components) and to prevent the distilled water in the machine body from contaminating the saline solution in the eye piece. As disclosed in U.S. Pat. No. 8,758,252, eye piece membranes have been made from materials such as, for example, polyethylene, mylar, polypropylene; vinylidene chloride; polyvinylidene chloride; or DuraSeal (made by Diversified Biotech) which is polyethylene based material free of adhesives. A preferred material is medical grade polyethylene which has an acoustic impedance slightly higher than that of water (about 2.33 million kg/m.sup.2-s compared to 1.54 million kg/m.sup.2-s for water). The thickness of the membrane is preferably in the range of about 10 to about 30 microns. This thickness is a small part of an acoustic wavelength in water which is about 150 microns at 10 MHz and about 20 microns at 80 MHz.

[0127] The fill, drain and vent ports shown in FIG. 4 are designed and sized for fast fill (to minimize the patient's time with their eye immersed in the saline solution), for venting of any bubbles that may form, for example, if the seal on the patient's head leaks or the patient pulls away from the machine, and for rapid draining of the saline solution back into the plastic saline bag after scanning is completed. As can be appreciated, the fill and vent ports are on the top of the eye piece and the drain port is on the bottom of the eye piece.

Ultrasound Imaging Instrument Operation

[0128] FIG. 5 is a prior art cut-away of an Insight 100 with a patient in position for imaging. FIG. 5 is a rendering of an ultrasound scanner and patient being imaged. In this rendering, the bucket or compartment which holds the positioner and scan head assemblies and the water used during scanning, is shown in a cutaway view. This cutaway view also shows the ultrasound transducer with the probe tip very close to one side of the eye seal membrane and with the patient's eye on the other side of the membrane.

[0129] FIG. 6 is a prior art schematic showing the relationship between the scan head, the ultrasound transducer, the eye seal and the patient's eye during imaging. In this figure, an ultrasound transducer is shown as it moves along an arcuate guide track. As noted previously, the scan head and probe are immersed in scanner fluid (water) and a membrane contained by the eye piece or eye seal separates the scanner fluid from the saline solution in the eye seal cup. The cornea of the eye is immersed in the saline solution and the eye is sealed against a soft material, formed from a silicone thermo-plastic elastomer, that is part of the eye piece assembly. Thus the saline solution, the membrane and the scanner fluid form an acoustic path that has substantially the same acoustic impedance as the anterior segment components of the eye. The acoustic path is also optically transparent and allows an optical camera to assist in centering the eye just prior to scanning.

[0130] The scan head is mounted on a positioner mechanism. The positioner mechanism is fixed to the instrument body in the lower left of FIG. 6. The positioner includes a telescoping cylinder that goes through a flexible rubber seal that separates the lower compartment from the water chamber in which the scan head is located. The scan head is immersed in scanner fluid (typically distilled water) while the fixed section of the positioner mechanism is immersed in ambient air.

Present Disclosure

[0131] FIG. 7 is a schematic of the speculum of an embodiment as it would fit inside an eye piece 401. The speculum fits on the inner side of the sealed hygienic barrier membrane 402 that separates the saline solution into which the patient's eye is immersed from the distilled water in the imaging machine. The speculum comprises opposing pads 704a and 704b optionally comprising an adhesive to adhere to skin of a patient and a flexible eyelid retraction member 708a and 708b engaging the opposing pads 704a and 704b.

[0132] FIG. 8 is another schematic of the speculum of the embodiment as it would fit inside an eye piece. The speculum fits on the inner side of the sealed hygienic barrier membrane that separates the saline solution into which the patient's eye is immersed from the distilled water in the imaging machine. The speculum comprises opposing pads 704a and 704b optionally comprising an adhesive to adhere to skin of a patient and a flexible eyelid retraction member 708a engaging the opposing pads 704a and 704b.

[0133] FIG. 9 is a schematic of the speculum of the embodiment. The long dimension of this speculum is about 1.70 inches. The speculum shown is typically fabricated from a thermoplastic plastic by a process such as injection molding. The speculum comprises opposing pads 904a and 904b optionally comprising an adhesive to adhere to skin of a patient and a flexible eyelid retraction member 908 engaging the opposing pads 904a and 904b. The retraction member 908 comprises a plurality of curved surfaces 901, 903, 905 and 906 collectively sized to surround an eye of the patient and press outwardly against the eyelids of the patient to urge the upper and lower eyelids to retract from the eye.

[0134] FIG. 10 shows various schematic views of the speculum of the embodiment. FIG. 10a is a top view of the speculum and FIG. 10f is a bottom view of the speculum. FIG. 10d is a side view of the speculum. As shown, the long dimension of the speculum is about 1.70 inches. FIG. 10b is an isometric view of the speculum and FIGS. 10c and 10e are end views of the speculum. As shown, the width dimension of the speculum is about 1.05 inches and the height dimension of the speculum is about 0.7 inches.

[0135] FIG. 10a is a top view of the speculum 1000 showing the opposing pads 1000a and 1000b. FIG. 10a also illustrates the shamrock shape of the flexible eyelid retraction member 1008 (see FIG. 9), and FIG. 10d is a side view of the speculum 1000 showing the arcuate, or vaulted, shape of the speculum 1000 with the bottom surface 1050 of the speculum engaging the patient's eyelids and skin around the eye and the upper surface 1054 of the speculum engaging the eyepiece. As shown, the long dimension of the speculum in FIG. 10d is about 1.70 inches. FIG. 10b is an isometric view of the upper surface of the speculum 1000 and FIGS. 10c and 10e are end views of the speculum 1000 taken from either opposing end of the speculum in FIG. 10d. As shown, the width dimension of the speculum (or the distance between the opposing pads 1000a,b) is about 1.05 inches and the height dimension of the speculum 1000 is about 0.7 inches taken from the lowest to the highest points 1060 and 1064, respectively, of the speculum of FIG. 10d. As can be seen from FIG. 10, the speculum comprises opposing pads that engage the patient's eyelids and interior surfaces of the eyepiece to maintain the speculum in a desired position for scanning.

[0136] A radius of curvature of each of opposing first and second curved surfaces 1020 and 1024 of the retraction member are typically substantially equivalent but each is greater than a radius of curvature of each of opposing third and fourth curved surfaces 1012 and 1016 of the retraction member. The radii of curvature of each of the third and fourth curved surfaces 1012 and 1016 are substantially equivalent. A first of the opposing pads 1004b engages the third curved surface 1012 and a second of the opposing pads 1004a engages the fourth curved surface 1016.

[0137] As shown in FIG. 10d, upper and lower surfaces 1054 and 1050 of the flexible eyelid retraction member 1008 and the opposing pads 1004a,b curve upwardly above a line defined by lower extremities 1060 of the first and second curved surfaces and an apex 1064 of the upward curve is located on the opposing third and fourth curved surfaces. The upward curve, when the flexible eyelid retraction member is in position on the patient, curves outwardly to substantially contact skin surrounding an eye socket of the patient. A radius of curvature of the upward curve is greater than the radius of curvature of each of the first, second, third and fourth curved surfaces.

[0138] FIG. 10f depicts a speculum according to another embodiment. The speculum is vaulted as in FIG. 10d but comprises only first and second curved or arcuate surfaces, each having ends coupled to the opposing pads. FIG. 8 depicts an eye seal in which the speculum is positioned in the absence of the patient to depict the relative position of the speculum with interior surfaces of the eye seal. In the speculum 700 of FIGS. 7-8 and 10f, the retraction member comprises first and second arcuate surfaces 708a, b, first and second ends of each connecting to the opposing pads 704a and 704b.

[0139] In the speculums of both FIGS. 10a-e and FIGS. 7, 8, and 10d, the flexible eyelid retraction member is sized to surround the eye of the patient and press outwardly against the eyelids of the patient and urge the upper and lower eyelids to retract from the eye. The first and second opposing pads engage skin adjacent to inner and outer ends of the upper and lower eyelids while the retraction member contacts the upper and lower eyelids above and below the iris, respectively. As noted, the flexible eyelid retraction member is configured to curve outwardly while in contact with the patient to substantially continuously contact skin surrounding the eye of the patient.

[0140] FIG. 11 illustrates approximate cost versus volume for several plastic fabrication processes. Current 3D printing technology is good for low volume prototyping whereas injection molding is appropriate for low cost, high volume production.

[0141] A thermoplastic, or thermo-softening plastic, is a plastic polymer material that becomes pliable or moldable at a certain elevated temperature and solidifies upon cooling.

Thermoplastics include: [0142] Acrylic, also known by trade names such as Lucite, Perspex and Plexiglas. [0143] ABS or acrylonitrile butadiene styrene [0144] Nylon [0145] Polylactic acid (polylactide) is one of the materials used for 3D printing. [0146] Polybenzimidazole Polybenzimidazole is a synthetic fiber with a very high melting point. [0147] Polycarbonate known under trademarks such as Lexan, Makrolon, Makroclear, and arcoPlus. [0148] Polyether sulfone (PES) or polysulfone [0149] Polyoxymethylene Polyoxymethylene (POM). [0150] Polyetherether ketone (PEEK) [0151] Polyetherimide Polyetherimide (PEI), [0152] Polyethylene as ultra-high-molecular-weight polyethylene (UHMWPE); high-density polyethylene (HDPE); medium-density polyethylene (MDPE); low-density polyethylene (LDPE); and linear low-density polyethylene (LLDPE) [0153] Polyphenylene (PPO) [0154] Polyphenylene sulfide (PPS) [0155] Polypropylene (PP) [0156] Polystyrene (PS) [0157] Polyvinyl chloride (PVC) and chlorinated polyvinyl chloride (CPVC) [0158] Polyvinylidene fluoride, PVDF [0159] Teflon (PTFE)

[0160] Manufacturing methods include: [0161] 3D printing which can include any number of specific processes such as SLA [0162] (stereolithograpy), FDM (fused deposition modeling), MSLA (liquid crystal mask) and DLP [0163] (digital light processing) [0164] polymer casting [0165] vacuum forming. [0166] rotational molding [0167] extrusion [0168] injection molding

[0169] FIG. 12 shows various schematic views of a typical speculum applicator tool 1200 used to install the speculum of the embodiment into an eye piece. As shown in FIG. 12, each of the opposing ends 1204 and 1208 of the opposing arms 1212a and 1212b of the applicator tool are bent inwardly and slotted to form opposing pairs of clamping hooks that hold the opposing pads 1000a and 1000b (see FIG. 10) of the speculum securely for proper placement around the patient's eye. The opposing arms 1212a and 1212b of the applicator tool are articulated to allow the installer of the speculum more flexibility when installing the speculum in the eye piece. The opposing arms 1212a and 1212b of the applicator tool 1200 move towards and away from one another and function like a pair of tweezers to grasp the speculum to install the speculum into an eye piece (see FIGS. 7 and 8 showing the speculum as it would be installed in an eye piece).

[0170] FIG. 13 is a schematic of a speculum applicator tool 1300 clamping on a version of the speculum of the embodiment 1301. As will be appreciated, the flexible speculum elastically deforms under inward pressure applied by the opposing arms 1303a and 1303b such that the inwardly facing corners of the speculum move towards one another as shown in FIG. 13. When the speculum is applied at the proper position on the patient's eye and the pressure released, the energy stored in elastic deformation of the speculum is released (like a spring) to enable the speculum to return to its original shape such as shown in FIG. 10a. This beneficially draws the eyelids and skin surrounding the eye back to expose the eye for scanning in the eyepiece.

[0171] The steps from applying an eye lid strip to engaging the eye seal with speculum are:

1. Attach the speculum to the applicator (see FIG. 13).
2. Remove the protective tabs from the tape on the top and bottom lid pads of the speculum.
3. Instruct the patient to close their eye and look down.
4. Squeeze the applicator to close the speculum (see FIG. 13).
5. Tilt the speculum and apply the top pad of the speculum to the upper eye lid as close to the edge of the eye lid as possible.
6. Instruct the patient to look up.
7. Push the upper eye lid upward as needed and apply the bottom pad to the lower eye lid as close to the edge of the eye lid as possible.
8. Release the speculum from the applicator.

[0172] The patient can now engage with the eye seal and scanning can proceed.

[0173] One of the approaches to applying the speculum of the present disclosure on a patient is to slightly compress the speculum so as to apply it to the patient's eyelid and to do so without bringing the hand of the operating technician or doctor too close to the patient's eye. One means to accomplish this to form a plastic applicator tool in the same process used to fabricate the speculum. For example, an injection mold could be used to mold an applicator tool and a speculum simultaneously. The plastic tool would act as a pair of tweezers to grasp and slightly compress the speculum for application while keeping the hand of the operating technician or doctor from touching the patient's eye. This would facilitate putting the speculum under the patient's eyelid prior to the patient placing his or her eye against an eyepiece attached to a precision ultrasound imaging device as shown for example in FIGS. 5 and 6.

[0174] A number of variations and modifications of the disclosure can be used. As will be appreciated, it would be possible to provide for some features of the disclosures without providing others.

[0175] The present disclosure, in various embodiments, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various embodiments, sub-combinations, and subsets thereof. Those of skill in the art will understand how to make and use the present disclosure after understanding the present disclosure. The present disclosure, in various embodiments, includes providing devices and processes in the absence of items not depicted and/or described herein or in various embodiments hereof, including in the absence of such items as may have been used in previous devices or processes, for example for improving performance, achieving ease and\or reducing cost of implementation.

[0176] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0177] Moreover though the description of the disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.