ULTRASOUND EYE SCANNING DEVICE

Abstract

The present disclosure is directed to an apparatus for an improved ultrasound eye scanning device wherein the size of the scan head is reduced significantly and the entire instrument can be placed on a desktop. The improved ultrasound eye scanning device also utilizes imaging goggles to enable better coupling between the patient and the instrument. The imaging goggles also allow both eyes of the patient to be scanned without the patient moving. Another innovation of the ultrasound imaging system according to the present disclosure is the use of the contralateral (opposite) eye for fixation and focusing during scanning.

Claims

1-9. (canceled)

10. An ultrasound imaging system comprising: a scan head having an arcuate guide track and a carriage movable along the guide track; imaging goggles configured to maintain the eyes of the patient in a fixed location relative to the arcuate guide track; an ultrasound transducer operatively connected to the carriage, wherein ultrasound pulses are emitted into the eye of the patient to generate an image of an ocular structure in the eye, and a fixation light, wherein: in a first operating mode in which a first eye of the patient is imaged by the ultrasound imaging system, the fixation light is viewable by a second eye of the patient, but not the first eye during imaging; and in a different second operating mode in which the second eye of the patient is imaged by the ultrasound imaging system, the fixation light is viewable by the first eye, but not the second eye, of the patient during imaging.

11. The ultrasound imaging system of claim 10, wherein, in the first operating mode, a visual field of the first eye is maintained in darkness and, in the second operating mode, the visual field of the second eye is maintained in darkness.

12. The ultrasound imaging system of claim 11, wherein, in the first and second operating modes, the imaging system provides no viewable object to the visual field of the eye being imaged.

13. The ultrasound imaging system of claim 10, wherein the imaging goggles comprises one of a ridge and slot that is received by the other of the one of the ridge and slot of the instrument.

14. The ultrasound imaging system of claim 10, wherein the imaging goggles and ultrasound transducer are positioned relative to each other such that, at a plurality of positions of the carriage along the arcuate guide track, a focal plane of the ultrasound transducer is positioned outside of an anterior segment of the eye.

15. The ultrasound imaging system of claim 14, wherein the focal plane of the ultrasound transducer is positioned in a lens of the eye as the carriage moves along at least most of the arcuate guide track.

16. The ultrasound imaging system of claim 14, wherein the focal plane of the ultrasound transducer is positioned in a cornea of the eye as the carriage moves along at least most of the arcuate guide track.

17. The ultrasound imaging system of claim 14, wherein a focal point of the ultrasound transducer is positioned in a lens of the eye as the carriage moves along at least about 75% of a length of the arcuate guide track.

18. The ultrasound imaging system of claim 14, wherein a focal point of the ultrasound transducer is positioned in a cornea of the eye as the carriage moves along at least about 75% of a length of the arcuate guide track.

19. The ultrasound imaging system of claim 14, wherein a center of curvature of the arcuate guide track is positioned between the posterior surface of the lens and the retina of the eye of the patient the eye of the patient.

20-26. (canceled)

27. A method comprising: imaging, by an ultrasound transducer of an ultrasound imaging system, an ocular structure of a first eye of a patient, wherein a fixation light is viewable by a second eye of the patient, but not the first eye during imaging; and imaging, by the ultrasound transducer, the ocular structure of the second eye of the patient, wherein the fixation light is viewable by the first eye, but not the second eye, of the patient during imaging.

28. The method of claim 27, wherein, while imaging the ocular structure of the first eye, a visual field of the first eye is maintained in darkness and, while imaging the ocular structure of the second eye, the visual field of the second eye is maintained in darkness.

29. The ultrasound imaging system of claim 28, wherein no viewable object is provided in the visual field of the eye being imaged.

30-38. (canceled)

39. An ultrasound imaging system comprising: a scan head having an arcuate guide track and a carriage movable along the guide track; imaging goggles configured to maintain the eye of the patient in a fixed location relative to the arcuate guide track; an ultrasound transducer operatively connected to the carriage, wherein ultrasound pulses are emitted into the eye of the patient to generate an image of an ocular structure in the eye, and a fixation light, wherein: in a first operating mode in which a first eye of the patient is imaged by the ultrasound imaging system, the fixation light is viewable by a second eye of the patient, but not the first eye during imaging; and in a different second operating mode in which the second eye of the patient is imaged by the ultrasound imaging system, the fixation light is viewable by the first eye, but not the second eye, of the patient during imaging.

40. The ultrasound imaging system of claim 39, wherein, in the first operating mode, a visual field of the first eye is maintained in darkness and, in the second operating mode, the visual field of the second eye is maintained in darkness.

41. The ultrasound imaging system of claim 40, wherein, in the first and second operating modes, the imaging system provides no viewable object to the visual field of the eye being imaged.

42. The ultrasound imaging system of claim 39, wherein the imaging goggles comprises one of a ridge and slot that is received by the other of the one of the ridge and slot of the instrument.

43. The ultrasound imaging system of claim 39, wherein a radius of curvature of the arcuate guide track is less than about 100 mm, wherein the imaging goggles and ultrasound transducer are positioned relative to each other such that, at a plurality of positions of the carriage along the arcuate guide track, a focal plane of the ultrasound transducer is positioned within one or more of a cornea, anterior chamber, and lens of the eye.

44. The ultrasound imaging system of claim 43, wherein a radius of curvature of the arcuate guide track is less than about 95 mm.

45. The ultrasound imaging system of claim 43, wherein a radius of curvature of the arcuate guide track is less than about 75 mm.

46. The ultrasound imaging system of claim 43, wherein a radius of curvature of the arcuate guide track is less than about 50 mm.

47-53. (canceled)

54. An ultrasound imaging method comprising: generating, by the ultrasound imaging system, a first image of a first eye of a patient, a fixation light being viewable by a second eye of the patient, but not the first eye during the generation of the first image; and thereafter, generating, by the ultrasound imaging system, a different second image of the second eye of the patient, the fixation light being viewable by the first eye, but not the second eye, of the patient during generation of the second image.

55. The method of claim 54, further comprising: providing an enclosure on a support surface, the enclosure having a window portion positioned in the side wall of the enclosure, wherein the window portion is substantially acoustically and optically transparent, and the enclosure is filled with a first fluid to a level above the window portion; providing imaging goggles wherein the goggle lenses are substantially acoustically and optically transparent and a second fluid is disposed in the volume of the imaging goggles between an interior surface of the imaging goggles and the eye of the patient; providing an ultrasound transducer imaging system in the first fluid, the ultrasound transducer imaging system having an ultrasound transducer operably interconnected to an arcuate track; positioning the patient wearing the imaging goggles at the window portion of the enclosure with the imaging goggles being engaged with a border of the window portion ; scanning the first and second eyes of the patent using the ultrasound transducer imaging system, wherein the ultrasound transducer records first and second sets of A-scan images of the first and second eyes of the patient, respectively; and combining, by a computer, a plurality of A-scan images in the first set to form a B-scan image of the first eye and a plurality of A-scan images in the second set to form a B-scan image of the second eye, wherein a radius of curvature of the arcuate guide track is no more than about 95 mm.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0115] 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.

[0116] FIG. 1 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.

[0117] FIG. 2 illustrates a compact scan head positioning mechanism which has been disclosed previously in U.S. Pat. No. 8,758,252.

[0118] FIG. 3 illustrates a compact scan head mechanism which has been disclosed previously in U.S. Pat. No. 8,758,252.

[0119] FIG. 4 shows another view of a prior art Insight 100™ Ultrasound Scanner in Use.

[0120] FIG. 5 is a cut-away of a prior art Insight 100™ with a patient in position for imaging.

[0121] FIG. 6 is a schematic showing the relationship between the ultrasound transducer, the eye seal and the patients eye during imaging.

[0122] FIG. 7 is a schematic of a prior art eye piece used on the Insight 100™.

[0123] FIG. 8 is a schematic of a speculum that fits inside the eye piece of FIG. 7.

[0124] FIG. 9 is a schematic of an Insight 100™ arcuate track, a transducer holder and transducer in relation to an eye in position for scanning.

[0125] FIG. 10 is a schematic of an arcuate track, a transducer holder and transducer in relation to an eye in position for scanning as proposed for an ultrasound imaging system according to the present disclosure.

[0126] FIG. 11 is a schematic of a sector scanner mechanism showing a transducer holder and transducer in relation to an eye in position for scanning as an alternate proposed for an ultrasound imaging system according to the present disclosure.

[0127] FIG. 12 is a rendering of an ultrasound imaging system according to the present disclosure with a patient in position to be scanned.

[0128] FIG. 13 is a rendering of eye imaging goggles for an ultrasound imaging system according to the present disclosure.

[0129] FIG. 14 is another rendering for an ultrasound imaging system with a patient in position to be scanned, according to the present disclosure.

[0130] FIG. 15 is another rendering of an ultrasound imaging system according to the present disclosure.

[0131] FIG. 16 illustrates the saline flow path for the imaging goggles.

[0132] FIG. 17 illustrates the main functional elements of the Insight 200 ultrasonic imaging system.

DETAILED DESCRIPTION OF THE DRAWINGS

Ultrasound Eye Scanning Apparatus

[0133] FIG. 1 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” which is incorporated herein by reference. The scanning device 101 of this example is comprised of a disposable eyepiece 107, a scan head assembly 108 and a positioning mechanism 109. The scan head assembly 108 is comprised of an arcuate guide 102 with a scanning transducer 104 on a transducer carriage which moves back and forth along the arcuate guide track 102, and a linear guide track 103 which moves the arcuate guide track 102 back and forth (as described further in FIG. 3). The positioning mechanism 109 is comprised of an x-y-z and beta mechanisms 105 (described in FIG. 4) mounted on a base 106. The base 106 is rigidly attached to the scanning device 101. A longitudinal axis 110 passes generally through a center of the head assembly 108 and is substantially perpendicular to a face of the eyepiece 107. A video camera (not shown) may be positioned within the scanning device 101 and aligned with the longitudinal axis 110 to provide an image of a patient's eye through the eyepiece 107. The scanning device 101 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 107 may be disposable as described in FIG. 5.

[0134] The positioner assembly 109 and scan head assembly 108 are both fully immersed in water (typically distilled water) which fills the chamber from base plate 106 to the top of the chamber on which the eyepiece 107 is attached.

[0135] A patient is seated at the scanning device 101 with one eye engaged with the disposable eyepiece 107. 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 101 by a headrest system such as shown, for example, in FIG. 4, and by the eyepiece 107.

[0136] 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 110. 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 108 and the scanning transducer 104 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 104 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 104 on the selected feature of the selected eye component; (4) rotating the scan head assembly 108 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 101 during the above operations when scanning is being carried out, which in a modern ultrasound scanning machine, can take several tens of seconds.

[0137] 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 107 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 107 in the direction of the longitudinal axis 110. Finally, the eyepiece provides an additional steady rest for the patient and helps the patient's head to remain steady during a scan procedure.

Mechanisms for General Ultrasound Scanning

[0138] FIG. 2 illustrates a compact scan head positioning mechanism which has been disclosed previously in U.S. Pat. No. 8,758,252 entitled “Innovative Components for an Ultrasonic Arc Scanning Apparatus” which is incorporated herein by reference. FIG. 2 shows a prior art scan head assembly comprised of scan head mount structure 210 and an arcuate guide track 209. The arcuate guide track 209 is comprised of an ultrasonic transducer 208 mounted on a transducer carriage 212. The transducer carriage 212 can be moved back and forth along arcuate guide track 209 to perform an arc scan. The scan head assembly is attached to a main positioner arm 215 (shown in a sectional view).

[0139] The scan head mount structure 210, arcuate guide track 209, transducer carriage 212, and ultrasonic transducer 208, while immersed in water, are sealed from the rear portion of the positioning mechanism by a translational seal 206 and a combined z-axis and rotational seal 207. The translational seal 206 is typically formed by a large rubber membrane that can flex with the small x and y motions required by the scanning head positioner, although alternate sealing mechanisms may be employed. The combined z-axis seal and rotational seal 207 seal against the main positioner arm 215 which can both rotate and move in and out in the z-direction which lies substantially parallel to a longitudinal axis of an axial piston 203. Translational seal 206 is attached to a stationary plate 201 which, in turn, is affixed to the main arc scanner chamber (not shown) which, in turn, is fixed with respect to the patient being scanned. The combined z-axis and rotational seal 207, which is shown in close-up view 211, is typically formed by a circumferential groove type sealing mechanism with the groove facing into the water, although alternate sealing mechanisms may be employed. Available seals allow both rotation and axial translation of the main positioner arm 215 while maintaining a watertight seal. Plate 202 forms a platform for the x- and y-positioning mechanisms. Plate 202 is fixed relative to stationary plate 201. The scanning head assembly can be moved back and forth axially (the z-direction) by axial piston 203 or another suitable mechanism. The scanning head assembly can be rotated (the beta-direction) about the z-axis by a rotary stepping motor (not shown) or another suitable device. The scanning head assembly can be moved up and down (the y-direction) by piston 205 or another suitable mechanism. The scanning head assembly can be moved from side to side (the x-direction) by piston 204 or another suitable mechanism. The components to the left or rear of stationary plate 201 remain in ambient air while the components to the right or front of stationary plate 201 are in immersed in water when the arc scanner is operational.

[0140] Typically, the scan head assembly is moved in the x-, y-, z- and beta directions to position the scan head assembly with respect to an eye component of interest. Although these motions are typically made rapidly under computer control, scans of the eye are typically not made during positioning. Once the scan head assembly is positioned with respect to the eye component of interest, scans are made by the transducer carriage 212 moving back and forth along the arcuate guide track 209. As described in U.S. Pat. No. 8,758,252 which is incorporated herein by reference, the transducer carriage 212 moves along arcuate guide track 209 on a fluid bearing for smooth operation.

[0141] As described above, the scanning head assembly can be moved back and forth axially (the z-direction); rotated (the beta-direction) about the z-axis; moved up and down (the y-direction); and moved from side to side (the x-direction). It is therefore possible to move the entire scan head assembly in more complex motions by coordinating these movements to obtain scans that cannot be obtained by a simple arc scan. However, the mechanisms of the apparatus of FIG. 2, while suitable for rapid positioning movements, are not well-suited for rapid scanning motions necessary, for example, to obtain multiple images of an eye accommodating in real time. A more advanced device is illustrated in FIG. 3.

[0142] FIG. 3 illustrates a prior art scan head capable of linear motion, arcuate motion, and combined linear and arcuate motion. This scan head was disclosed previously U.S. Pat. No. 8,317,709 which is incorporated herein by reference. A scan head plate 301 replaces scan head mount structure 210 of FIG. 2. Scan head plate 301 serves as the platform for a computer controlled linear carriage 302 and an arcuate carriage 303. Linear carriage 302 moves back and forth along a linear guide track 304. Arcuate carriage 303 moves back and forth along arcuate guide track 305. Typically, one of more transducers 306 or probes are mounted on the arcuate carriage 303. In this view, arc carriage 303 is at the rightmost limit of its travel along arcuate guide track 305 and linear carriage 302 is also at the rightmost limit of its travel on linear guide track 304. As can be appreciated, the motions of arcuate carriage 303 and linear carriage 302 can be controlled independently. For example, arcuate carriage 303 can move along arcuate guide track 305 or be parked anywhere along arcuate guide track 305 while linear carriage 302 moves along linear guide track 304. As another example, linear carriage 302 can be stationary while arcuate carriage 303 moves back and forth along arcuate guide track 305 to execute a pure arc scan. When arcuate carriage 303 is stationary and linear carriage 302 is moved, this is referred to as a linear scan. When both arcuate carriage 303 and linear carriage 302 are moved, this is referred to as combined scan. In this configuration, arcuate carriage 303 is moved along arcuate guide track 305 by an induction motor as described in U.S. Pat. No. 8,758,252, carriage 303 moves along arcuate guide track 305 on a fluid bearing which is also described in U.S. Pat. No. 8,758,252. In the example of FIG. 3, an ultrasound scanning transducer 306 is mounted on the arcuate carriage 303. A longitudinal axis which passes generally through a center of the ultrasound scanning transducer 306 is aligned substantially parallel to a radius of curvature of arcuate guide track 305. Linear carriage 302 is moved along linear guide track 304 by a drive motor (not shown) housed in linear drive motor housing 307. This drive motor moves linear carriage 302 by a belt and pulley system (not shown except for typical pulley housing 308). Linear carriage 302 moves along linear guide track 304 on a fluid bearing similar to that used between arcuate carriage 303 and arcuate guide track 305. In operation, the scan head assembly of FIG. 3 is under water and is sealed from the x, y, z, beta positioner by a sealing means behind the scan head plate 301. Thus the entire scanning mechanism is positioned with respect to an eye for scanning by the x, y, z, beta positioner shown in FIG. 2, while the actual acoustic imaging scan motion is implemented by one or both of the linear and arcuate carriages 302 and 303. The scan head assembly of FIG. 3 allows rapid independent linear and arcuate motion combinations of the ultrasound scanning transducer such that various scan geometries can be implemented to image not only the cornea, iris and anterior lens surface, but also the posterior lens surface, the sulcus, the ciliary body, the suprachoroidal space and the zonules that attach the lens to the ciliary body.

[0143] The scan head assembly of FIG. 3 may also perform a controlled combined motion where the linear and arcuate motions are coordinated to produce a resultant pure arcuate motion of the arcuate probe carriage wherein the effective radius of curvature of the arcuate track is larger or smaller than the radius of curvature of the arcuate guide track. This combined motion is more completely is described in U.S. Pat. No. 8,317,709.

[0144] FIG. 4 shows a prior art Insight 100™ ultrasound scanner in use. The Insight 100™ shown in FIG. 4 includes the instrument itself 400, a large display monitor 401 and a custom table 402 on which the instrument 400 and monitor 401 are mounted. A computer and fluidics module are mounted under the table. A saline bag (not shown) is mounted on a pole 403 which extends above the patient's head 404. The saline bag provides saline for the eyepiece which separates the water in which the patient's eye is immersed from the water in the chamber in which the positioner and scan head assemblies are immersed. The eye piece is fully described in FIG. 7.

[0145] FIG. 5 is a schematic cutaway drawing of a prior art Insight 100™ instrument 500. The scan head 504 is immersed in distilled water within a distilled water chamber 508 (shown in cut away view). The distilled water chamber 508 is attached to and separated from a housing which contains the instrument electronics and the positioner mechanism 512. The housing is open to ambient air. A telescoping shaft 516 of the positioner mechanism 512 passes through a large, flexible sealing membrane 520 into the distilled water chamber 508 and the scan head 504 is attached to the immersed end of this shaft 516. The scan head 504 comprises a linear track 524 on which is mounted an arcuate track 528. An ultrasound transducer 532 is mounted on a carriage 536 which can move along the arcuate track 528. In FIG. 5, a patient 540 is shown with one eye pushed against an eye piece such as described in more detail below in FIG. 6.

[0146] FIG. 6 is a cutaway view of the arc scanner 612 with patient 610 in position for scanning. The patient's eye socket is pressed against the soft flexible sealing ring 600 of the eye piece 604 which is now attached to the mounting ring 608 which, in turn, is attached to the main scanner housing 612 as described in FIG. 5. An ultrasound probe 625 is shown at the top end of the arcuate guide track 628 and is aimed at the patient's eye. As the probe 625 moves back and forth along the arcuate guide track 628, it's long axis remains approximately perpendicular to the surfaces of the cornea and anterior lens of the patient's eye. The tip of the ultrasound transducer comes very close to the membrane that separates the distilled water in the instrument bucket from the saline solution in the eye piece. The transducer is attached to the transducer carriage 613 by small magnets which will release the probe 625 if it contacts the membrane 624 of the eye piece 604 with enough force to endanger the patient's eye.

[0147] FIG. 7 is a schematic of a prior art eye seal first disclosed in U.S. Pat. No. 8,758,252 entitled “Innovative Components for an Ultrasonic Arc Scanning Apparatus”. An eyepiece serves to complete a continuous (substantially constant acoustic impedance) acoustic path for ultrasonic scanning, that path extending from the transducer to the surface of the patient's eye. The eyepiece also separates the water in which the patient's eye is immersed from the water in the chamber in which the positioner and scan head assemblies are immersed. Finally, when the patient is in position for a scan with his or her head firmly against the eye piece, the eyepiece provides a reference frame for the patient and helps the patient's head to remain steady during a scan. The eyepiece also must be able to pass optical wavelengths of light so that fixation targets can be used to focus the patient's eye in a desired focal state and alignment with respect to the eye's visual or optical axis.

[0148] Eye piece 701 is comprised of a plastic base 702 molded from a plastic such as ABS and a soft rubber conformable face seal 703 formed from a silicone thermo-plastic elastomer. The conformable face seal 703 is over-molded onto the plastic base 702 by a heat process typically applied to the conformable face seal 703. Plastic base 702 also includes attaching mechanisms 705 which attach the eye piece to the mounting ring (not shown) which is typically attached to the main scanner housing; thumb and finger protrusions 706 used to rotate the eye piece into the mounting ring; indexing ridge 707 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 708, vent port 710 and drain port 709. Ports 708, 709 and 710 allow fluid flow through the eye piece base 701.

[0149] The eye piece is attached and sealed to a mounting ring which is, in turn, attached to the main scanner housing by a groove molded as part of the eye piece base 702 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.

[0150] 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 703 is connected to the eye piece base 701. This membrane is typically attached onto the plastic eye piece base 702 by an adhesive backing commonly used in medical disposable components. The thickness of the membrane is designed for transmission of light (such as the fixation targets shown in FIG. 3) 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.

[0151] The fill, drain and vent ports shown in FIG. 7 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.

[0152] FIG. 8 is a schematic of the speculum of an embodiment as it would fit inside an eye piece 801. The speculum fits on the inner side of the sealed hygienic barrier membrane 802 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 803a and 803b optionally comprising an adhesive to adhere to skin of a patient and a flexible eyelid retraction member 804a and 804b engaging the opposing pads 803a and 803b. FIG. 8 illustrates how the speculum would rest on the hygienic barrier membrane 802 of the eyepiece 801. The length of this speculum is about 1.70 inches, the width is about 1.05 inches and the height is about 0.7 inches. The speculum shown is typically fabricated from a thermoplastic plastic by a process such as, for example, injection molding.

[0153] FIG. 9 is a schematic of an Insight 100™ arcuate track 900, a transducer holder 904 and transducer 908 in relation to an eye 920 in position for scanning. The arcuate track 900 allows the transducer 908 to be moved through an angle of 70 degrees. The arcuate track 900 has a radius of curvature of 100 mm. The transducer 908 is attached to a transducer holder 904. The face 912 of the transducer 908 is 21 mm from the center of curvature 916. The focal length of the transducer is typically 17 mm but can be changed, by changing the transducer, to any focal length between about 12 mm to about 21 mm. In FIG. 10, the focal point or plane 932 of the transducer 908 is shown as being located in the anterior chamber about halfway between the posterior surface of the cornea 924 and the anterior surface of the lens 928.

[0154] FIG. 10 is a schematic of an arcuate track 1000, a transducer holder 1004 and transducer 1008 in relation to an eye in position for scanning as proposed for an ultrasound imaging system according to the present disclosure. The arcuate track 1000 allows the transducer 1008 to be moved through an angle of 80 degrees. The arcuate track 1000 has a radius of curvature of 32 mm. The transducer 1008 is attached to a transducer holder 1004. The face 1012 of the transducer 1008 remains at 21 mm from the center of curvature 1016. The focal length of the transducer shown as 12.7 mm but can be changed, by changing the transducer, to any focal length between about 10 mm to about 21 mm. In FIG. 10, the focal point or plane 1020 of the transducer 1008 is shown as being located at about the midpoint of the cornea 924.

[0155] The geometry of the arcuate track 1000 of FIG. 10 is based on shrinking the arcuate track 1000, the transducer 1008, and/or transducer holder 1004 to about ⅓ of its former size. The range of motion of the transducer 1008 is preserved and even increased from a 70 degree included angle to an 80 degree included angle. The obvious benefit is a reduction in size of the entire scan head. A less obvious benefit is that an arcuate sweep can be made in about a third of the time as the original geometry of FIG. 9. This reduction of sweep time does not require a change in the velocity of the transducer carriage along the arcuate track.

Present Disclosure

[0156] FIG. 11 is a schematic of a scanner mechanism showing a transducer holder 1104 and transducer 1108 in relation to an eye 1130 in position for scanning as an alternate proposed for an ultrasound imaging system according to the present disclosure. The arcuate track 1112 allows the transducer 1108 to be moved through an angle of 40 degrees. The arcuate track 1112 has a radius of curvature such that the center of curvature is at the center point of the transducer face 1116. This emulates the action of a sector scanner. The transducer 1108 is attached to a short transducer holder 1104. The face 1116 of the transducer remains at 21 mm from the center of curvature 1100 of the arcuate track. The focal length of the transducer is shown as 12.7 mm but can be changed, by changing the transducer, to any focal length between about 10 mm to about 21 mm. In FIG. 11, the focal point or plane 1120 of the transducer 1108 is shown as being located inside the lens.

[0157] The geometry of the mechanism of FIG. 11 is based on shrinking the arcuate track and transducer holder to about ⅓ of its former size. The range of imaging of the transducer is such that coverage of the distal end of the lens is increased and does not require the patient to move or rotate their eye to obtain coverage of the ends of the lens, the ciliary sulcus and the zonules. The obvious benefit is a reduction in size of the entire scan head. Another benefit is that an arcuate sweep can be made in about a third of the time as the original geometry of FIG. 9. This reduction of sweep time does not require a change in the velocity of the transducer carriage along the arcuate track. The velocity of the transducer carriage is limited by cavitation in the distilled water in which the scan head is immersed.

[0158] The scan head configurations described in FIGS. 10 and 11 can lead to a substantial reduction in size and weight of the positioning and scan head mechanisms over those of the Insight 100™. The proposed positioning and scan head mechanisms are approximately one third the size of those of the Insight 100™ with no loss of functionality. Each can yield a slightly wider angle coverage of the eye compared with the Insight 100™ configuration described in FIG. 9.

[0159] The linear and arcuate track mechanisms that move the transducer carriage under computer control can move on either fluid bearings as used on the Insight 100™ or solid-surface bearing plates made from materials such as Teflon. The use of solid bearings eliminates the maintenance associated with the small orifices that are used in the fluid bearing system.

[0160] FIG. 12 is a rendering of an ultrasound imaging system 1200 according to the present disclosure with a patient 1240 in position to be scanned. The ultrasound imaging system 1200 is now a self-contained desktop device with only a moveable monitor 1204 being separate. It is similar in size and weight to other ophthalmic imaging instruments such as the IOL Master™, the Optivue™ and Topcon OCT™ systems.

[0161] As can be seen, the Insight 100™ such as shown in FIG. 4, is comprised of the instrument which is built into its own custom designed table. The imaging and control computer as well as the fluidics module are mounted under the table. The Insight 100™ therefore takes up considerable space in a clinic and must be disassembled to be moved.

[0162] With the ultrasound imaging system 1200 shown in FIGS. 12, the body of the instrument 1208 is filled with distilled water in which the scan head moves. The control and image processing computer and memory (not shown) are now on a circuit board situated within the electronics section of the desktop device which is internal to the instrument housing. The computer monitor 1204 is now decoupled from the instrument and can be a stand-alone monitor, a tablet or a cell phone which communicates with the on-board computer via short-range wireless connection. The user interface of the ultrasound imaging system 1200 is improved and can display more control and imaging information than the interface developed for the Insight 100™.

[0163] The distilled water system and its reservoir are also contained inside the rear of the device 1208 housing as shown in FIG. 14. A saline bag (not shown) can be placed in a compartment inside the instrument housing as shown in FIG. 15. The saline solution can be warmed to body temperature for patient comfort. Any saline that leaks out of the imaging goggles 1300 is captured by a used saline catch bin within the lower portion of the housing as shown in FIG. 14.

[0164] The distilled water in the instrument can be treated for biological contaminants as it is circulated within the instrument by passing the distilled water through an ultraviolet light source.

[0165] In another embodiment, the ultrasound imaging system 1200 uses the contralateral (opposite or second) eye for fixation and possibly focusing while a first eye of the patient is being scanned. Basically, the eye being scanned is kept in the dark as there is no flashing when the scan head moves in front of the fixation light to reduce dilation/constriction of the eye being imaged) while the opposite eye that is not currently being imaged is used to look at a fixation light and possibly even a small screen to allow for focusing.

[0166] The chin rest 1210 on the ultrasound imaging system according to the present disclosure is adjustable. There are small buttons on the side of the device for the patient to adjust the chin rest.

[0167] FIG. 13 is a rendering of imaging goggles 1300 for an ultrasound imaging system. The imaging goggles are shown attached to an ultrasound imaging system with a patient in position for scanning in FIGS. 12 and 14. These imaging goggles replace the Insight 100™ eye piece. The imaging goggles are constructed using the materials and assembly techniques used in the eye piece design of the Insight 100™. The imaging goggles enable better coupling between the patient and the instrument and can allow both eyes of the patient to be scanned without the patient moving.

[0168] With continuing reference to FIG. 13, the disposable imaging goggles comprise left and right eye pieces 1304a and 1304b having a water impermeable membrane 1308a and 1308b positioned in the viewing area of each eye piece to cause water to be maintained in contact with the patent's eye during imaging to provide an optically transparent and continuous acoustic transmission path for ultrasound energy. The saline water flows from the saline reservoir, through one or more input ports in each of the eye pieces 1308a and 1308b into a sealed volume defined by the membrane 1308a and 1308b, the interior walls 1324 and 1328 of each eye piece and the patient's left eye and surrounding eye socket. Saline can be drained, when scanning is completed, from either eye piece 1304a and 1308b through a tube 1312 and 1320, respectively, to a saline catch bin.

[0169] The materials and construction of the imaging goggles are based on similar materials and construction techniques developed for the Insight 100™ eye piece described in FIG. 7. The ridge 1332 on the front plastic frames of each eye piece of the imaging goggles slides into a corresponding matching slot on a mounting ring for each eye piece on the ultrasound imaging system 1200. This design allows a patient to engage with the instrument and be in position to 1) have one eye scanned by ultrasound while the other is imaged optically to follow eye motion during scanning and 2) allow the ultrasound and optical scans to be reversed so that both eyes can be scanned without the patient having to move.

[0170] When attached to the patient and the instrument, the imaging goggles contain the saline solution that completes the acoustic path from the patient's eye to the water in the interior of the instrument in which the scan head and positioner are immersed. The imaging goggles also separate the distilled water in which the scan head mechanism is immersed from the saline solution in which the patient's eyes are immersed.

[0171] The imaging goggles serve to complete a continuous (substantially constant acoustic impedance) acoustic path for ultrasonic scanning, that path extending from the transducer to the surface of the patient's eye. As noted above, the goggle membranes are also optically transparent.

[0172] FIG. 14 is another rendering for an ultrasound imaging system with a patient in position to be scanned, according to the present disclosure. As can be seen, the slanted styling of the front face of the instrument allows any saline leakage from the imaging goggles to drip into a saline catchment tray 1405 or saline catch bin located on the bottom front of the instrument. This figure illustrates the location of the distilled water reservoir 1407 and its circulation system; and the electronics housing. The control and image processing computer and memory are now on a circuit board situated within the electronics section 1406 of the desktop device which is internal to the instrument housing. The electronics housing which contains the system computer board has easy access compared to that of the Insight 100™.

[0173] FIG. 15 is another rendering of an ultrasound imaging system 1500 showing additional elements of the system. The imaging goggles 1510 described in FIG. 13 are shown attached to the instrument. The ridges 1506 on the front plastic frames of the imaging goggles slide into a matching slots on the ultrasound imaging system 1500. This figure shows the section of the instrument housing 1508 that contains the scan head 1509. There is also a compartment in the top of the instrument in which as saline bag is inserted. There is a heating plate in the bottom of the compartment that warms the saline prior to introducing the saline into the imaging goggles after the patient is in place for scanning. The body temperature saline avoids the discomfort of introducing cold saline onto the patient's eyes. Alternatively, infrared heating lamps can be used to heat the saline as well.

[0174] A moveable monitor 1504 is also shown. The monitor 1504 receives status and imaging information from the ultrasound imaging system instrument 1500 by short range wireless communications.

[0175] FIG. 16 illustrates the saline flow path for the imaging goggles. A bag containing the saline solution 1601 is located inside the compartment in the top of the device such that the saline bag is above the scan patient's head. Alternatively a controlled weight or pump can be used to create the pressure to create sufficient flow. A flow tube 1602 connects the saline bag 1601 to the imaging goggles 1605. A hand operated or electronically controlled valve 1603 is used to open the flow tube 1602 to fill the imaging goggles 1605 with saline solution. When scanning is done the saline can be drained into the saline drip tray through drain tubes which can be manually or automatically be opened or closed. Saline leakage from the imaging goggles 1605 flows to a saline drip tray 1606 (also called a saline catch bin). As can be seen in FIG. 14, the Insight 200 instrument front face is sloped so that any saline leakage from the imaging goggles 1605 flows into the saline drip tray 1606.

[0176] FIG. 17 illustrates the main functional elements of the Insight 200 ultrasonic imaging system. An operator interacts with the main Insight 200 instrument body 1701 using a computer monitor, a tablet or a cell phone 1703 that communicates to the instrument computer 1702 via a wireless connection 1704. The computer 1702 is comprised of a CPU and internal memory and is located on a circuit board situated within the electronics section which, in turn, is located inside instrument body 1701.

[0177] An ultrasonic transducer is mounted on a carriage which is moved along an arcuate track which in turns is moved along a linear track (see FIG. 3 for example) during scanning. The arcuate track and linear track form the scan head which, in turn is mounted on a positioner mechanism as shown in FIG. 2, for example. The positioner, scan head and transducer 1705 provide transducer position data to the computer 1702 so that the computer 1702 can prescribe the appropriate positioner and scan head motions to generate the desired scan.

[0178] The fluidics module 1708 includes the filling and draining of the distilled water that fills instrument body 1701 and in which the positioner, scan head and transducer 1705 move. The fluidics module 1708 also includes a saline fluid circuit 1709 which fills and drains the saline fluid in the imaging goggles as described in FIG. 16.

[0179] The mechanics module 1707 includes the motors and belts that drive the positioner and linear track motors. Movement of the transducer carriage along the arcuate guide track is controlled by a series of embedded electromagnetic coils. The motion of the transducer carriage along the arcuate track and the motion of the arcuate track along the linear track are detected by a location sensing device which includes a position encoder mounted on the carriage. The encoder senses a position of the carriage by reading a series of magnetic strips along the length of the arcuate track and linear tracks. The aforementioned position encoder system is described in U.S. Pat. No. 8,758,252 “Innovative Components for an Ultrasonic Arc Scanning Apparatus” which is incorporated herein by reference.

[0180] The electronics module 1708 includes the ultrasound pulser and receiver circuit board and the A/D circuit board.

The typical firing rate of the ultrasound pulser is about 1pulse every 250 microseconds. A 16 bit A/D board samples at about 250 million samples per second (about a sample every 4 nanoseconds). A Model 277 Quad 16-bit/250 MHz ADC Digitizer from Red Rapids in Plano Texas is an example of such a commercially available A/D board.

[0181] The sensor array comprises linear or angular position sensors that, among other things, track the relative and/or absolute positions of the various movable components and the alignment of various stationary and moveable components, such as, but not limited to, the one or more position tracking sensors, the positioning arms and probe carriage assembly, the fixation lights, the optical video camera, the arcuate guide assembly, the ultrasound transducer probe, the probe carriage, the linear guide track, the motors to move the position arms, motors to move the arcuate guide assembly, and motors to move the probe carriage. The sensor array may comprise any suitable type of positional sensors, including inductive non-contact position sensors, string potentiometers, linear variable differential transformers, potentiometers, capacitive transducers, eddy-current sensors, Hall effect sensors, proximity sensors (optical), grating sensors, optical encoders (rotary or linear), and photodiode arrays. Candidate sensor types are discussed in U.S. Pat. No. 8,758,252.

[0182] The controlled device is any device having an operation or feature controlled by a computer. Controlled devices include the various movable or activatable components, such as, but not limited to, the one or more position tracking sensors, the positioning arms and the transducer carriage assembly, the fixation lights, the optical video camera, the arcuate guide assembly, the ultrasound transducer probes and the probe carriage, the linear guide track, the motors to move the position arms, motors to move the arcuate guide assembly, and motors to move the probe carriage.

[0183] The computer may comprise a software-controlled device that includes, in memory, a number of modules executable by a processor. The executable modules include a controller to receive and process positioning signals from the sensor array and generate and transmit appropriate commands to the monitored controlled device, an imaging module to receive and process A- and B-scan images to produce two-, three-, or four-dimensional images of selected ocular components or features, and a measurement module 2040 to determine, as discussed above, the dimensions and/or volumes of selected ocular components and/or features. The imaging algorithm used by the imaging module is further discussed U.S. Pat. No. 8,496,588.

[0184] In one embodiment, the controller determines an adjustment to the position of the transducer based on receiving a control measurement input from the sensor array. In another embodiment, the controller provides a control input to the drive mechanism of the probe carriage, the positioning arm, the arcuate guide assembly, and/or the linear guide track. In yet another embodiment, the controller provides a control input to comprise controlling the power, frequency, signal/noise ratio, pulse rate, gain schedule, saturation thresholds, and sensitivity of the optical and/or ultrasound transducers. In still another embodiment, the controller utilizes control algorithms comprising at least one of on/off control, proportional control, differential control, integral control, state estimation, adaptive control and stochastic signal processing. Controller may also monitor and determine if any faults or diagnostic flags have been identified in one or more elements, such as the optical and/or ultrasound transducers and/or carriage.

[0185] In yet another embodiment, the disclosed systems and methods may be partially implemented in software that can be stored on a storage medium to include a computer-readable medium, executed on programmed general-purpose computer with the cooperation of a controller and memory, a special purpose computer, a microprocessor, or the like. In these instances, the systems and methods of this disclosure can be implemented as program embedded on personal computer such as an applet, JAVA® or CGI script, as a resource residing on a server or computer workstation, as a routine embedded in a dedicated measurement system, system component, or the like. The system can also be implemented by physically incorporating the system and/or method into a software and/or hardware system.

[0186] In one embodiment, one or more computers are used to control, among other things, the combined UHFU and OCT imaging system, the scan head assembly, the OCT sample arm probe, OCT reference arm, and/or the ultrasound transducer and/or the position sensor(s). In one embodiment, the user interacts with the computer through any means known to those skilled in the art, to include a keyboard and/or display to include a touch-screen display. The term “computer-readable medium” as used herein refers to any tangible storage and/or transmission medium that participate in providing instructions to a processor for execution. Such a medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, NVRAM, or magnetic or optical disks. Volatile media includes dynamic memory, such as main memory. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, or any other magnetic medium, magneto-optical medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, a solid state medium like a memory card, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read. A digital file attachment to e-mail or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. When the computer-readable media is configured as a database, it is to be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and/or the like. Accordingly, the disclosure is considered to include a tangible storage medium or distribution medium and prior art-recognized equivalents and successor media, in which the software implementations of the present disclosure are stored.

[0187] 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 disclosure without providing others.

[0188] 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.

[0189] 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.

[0190] 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.