Patent Description:
Macular degeneration is the leading cause of vision loss in the United States of America. In macular degeneration, the central portion of the retina (a. , the macula) deteriorates. When healthy, the macula collects and sends highly detailed images to the brain via the optic nerve. In early stages, macular degeneration typically does not significantly affect vision. If macular degeneration progresses beyond the early stages, vision becomes wavy and/or blurred. If macular degeneration continues to progress to advanced stages, central vision may be lost.

Although macular degeneration is currently considered to be incurable, treatments do exist that may slow the progression of the disease so as to prevent severe loss of vision. Treatment options include injection of an anti-angiogenic drug into the eye, laser therapy to destroy an actively growing abnormal blood vessel(s), and photodynamic laser therapy, which employs a light-sensitive drug to damage an abnormal blood vessel(s). Early detection of macular degeneration is of paramount importance in preventing advanced progression of macular degeneration prior to treatment to inhibit progression of the disease.

Early detection of macular degeneration can be accomplished using a suitable retinal imaging system. For example, Optical Coherence Tomography (OCT) is a non-invasive imaging technique relying on low coherence interferometry that can be used to generate a cross-sectional image of the macula. The cross-sectional image of the macula shows if the layers of the macula are distorted and can be used to monitor whether distortion of the layers of the macula has increased or decreased relative to an earlier cross-sectional image to assess the impact of treatment of the macular degeneration.

<CIT> describes Optical Coherence Tomography (OCT) Imaging Systems for use in pediatric ophthalmic applications. The OCT imaging systems described include a source having an associated source arm path and a reference arm having an associated reference arm path coupled to the source path, the reference arm path having an associated reference arm path length. A sample having an associated sample arm path is coupled to the source arm and reference arm paths. A reference arm path length adjustment module is coupled to the reference arm. The reference arm path length adjustment module is configured to automatically adjust the reference arm path length such that the reference arm path length is based on an eye length of the subject.

A paper by<NPL> discusses optical coherence tomography systems in which adaptive ranging is used as a feedback technique where image data is utilized to adjust the coherence gate offset and range.

The present invention is set out in the appending claims. The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding of the invention. This summary is not an extensive overview. It is not intended to identify key/critical elements or to delineate the scope of the invention. Its sole purpose is to present some embodiments in a simplified form as a prelude to the more detailed description that is presented later.

Ophthalmic imaging systems and related methods employ a viewer assembly to restrain a user's head in a substantially fixed position and orientation relative to an optical coherence tomography (OCT) imaging device and a user specific approach for controlling the reference arm length in the (OCT) imaging device to image the user's retina. In many embodiments, the OCT imaging device includes a reference arm length adjustment module that is controlled to vary the reference arm length. In many embodiments, the user engages the user's head with the viewer assembly, thereby restraining the position of the user's retina relative to the OCT imaging device. Due to variation between users in the position of a user's retina relative to the user's facial features (e.g., forehead, cheek) engaged with the viewer assembly, as well as possible variation in the relative position between a user's head and the viewer assembly, the sample arm length to any particular user's retina can be within a relatively large range. A user specific range of reference arm lengths is used during imagining of a user's retina. The user specific range of reference arm lengths is substantially smaller than a reference arm adjustment range of the reference arm length adjustment module. The use of the smaller user specific range of reference arm lengths during imaging of the user's retina substantially reduces the amount of time expended scanning of the reference arm length to find the reference arm length at which the OCT image detector generates the OCT signal for the user's retina, thereby substantially reducing the total amount of time required to image the user's retina. Also, by employing a user specific range of reference arm lengths, the OCT imaging system can be simplified relative to more complex OCT imaging systems that include a positioning system to adjust the distance between the OCT imaging device and the user's retina.

Thus, in one aspect, an ophthalmic imaging system for imaging a retina includes an optical coherence tomography (OCT) imaging device, a housing to which the OCT imaging device is attached, a viewer assembly coupled with the housing, and a control unit. The OCT imaging device includes a sample arm optical path, an OCT image detector, a reference arm optical path, and a reference arm length adjustment module. The reference arm optical path has a reference arm length. The reference arm length adjustment module is controllable to vary the reference arm length over a reference arm length adjustment range. The viewer assembly is configured to engage a user's head to restrain the user's head relative to the housing so that the sample arm optical path extends to the user's retina. The control unit is operatively connected to the OCT image detector and the reference arm length adjustment module. The control unit is configured to store a user specific range of reference arm lengths that covers a smaller range of reference arm lengths than the reference arm length adjustment range. The control unit is configured to control the reference arm length adjustment module to vary the reference arm length to search within the user specific range of reference arm lengths to identify a reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina.

The present invention provides a suitable approach that can be used to determine a suitable user specific range of reference arm lengths for a particular user for use in the ophthalmic imaging system. A larger reference arm length adjustment range of the adjustable reference arm module can be searched during an initial imaging of the user's retina to identify a reference arm length for which the OCT image detector <NUM> produces an OCT signal corresponding to the user's retina. The identified reference arm length for the initial imaging of the user's retina can then be used to formulate a suitable user specific range of reference arm lengths for use in subsequent imaging sessions of the specific user's retina. Alternatively, although not covered by the present claims, a suitable user specific range of reference arm lengths for any particular user can be predetermined. For example, the user specific range of reference arm lengths can be based on spatial information about one or more facial features of the user. In some examples, the one or more facial features of the user upon which the user specific range of reference arm lengths can be based include one or more of a forehead of the user, one or more cheeks of the user, a cornea of an eye of the user including the retina of the user, and a lateral orbital rim of the user. The spatial information about one or more facial features of the user is generated via one or more of: (a) three-dimensional scanning of the one or more facial features of the user, (b) caliper measurement of the one or more facial features of the user relative to an eye of the user that includes the retina of the user, (c) a cast mask of the one or more facial features of the user, (d) an axial length of the eye of the user that includes the retina of the user, (e) ultrasound measurement of the axial length of the eye of the user that includes the retina of the user, and (f) OCT measurement of the axial length of the eye of the user that includes the retina of the user.

In many embodiments, the ophthalmic imaging system lacks a mechanism to adjust the length of the sample arm optical path. For example, in many embodiments the ophthalmic imaging system includes an objective lens assembly and does not include an adjustment mechanism configured to adjust a distance between the user's retina and the objective lens assembly.

The lack of an adjust mechanism configured to adjust a distance between the user's retina and the objective lens assembly results in a reduced field of view on some user's retinas. To account for such a reduced field of view, in some embodiments, the ophthalmic imaging system is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to any length within the reference arm length adjustment range. In some embodiments, the ophthalmic imaging system is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to any length within the reference arm length adjustment range.

The OCT imaging device can have a relatively small image depth. For example, in some embodiments, the OCT imaging device has an image depth of no more than <NUM>.

The OCT imaging device can have a relatively large sensitivity roll-off. For example, in some embodiments, the OCT imaging device has a sensitivity roll off of not better than -3db at <NUM>.

The user specific range of reference arm lengths can be substantially smaller than the reference arm length adjustment range of the reference arm length adjustment module. For example, in many embodiments, the user specific range of reference arm lengths is less than half of the reference arm length adjustment range. In some embodiments, the user specific range of reference arm lengths is less than one-quarter of the reference arm length adjustment range.

The control unit can have any suitable configuration. For example, in many embodiments, the control unit is configured to receive input of the user specific range of reference arm lengths and store the user specific range of reference arm lengths in a memory device. According to the invention, the control unit is configured to determine the user specific range of reference arm lengths by controlling the reference arm length adjustment module during an imaging of the user's retina to vary the reference arm length to search within the reference arm length adjustment range to identify a user specific imaging reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina. In some embodiments, the control unit determines the user specific range of reference arm lengths based on the user specific imaging reference arm length.

The reference arm length adjustment range can encompass a relatively large range of reference arm lengths. For example, in many embodiments, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths. The reference arm length adjustment range can encompass at least a <NUM> range of reference arm lengths. In some embodiments, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths.

The user specific range of reference arm lengths can encompass a relatively small range of reference arm lengths. For example, in many embodiments, the user specific range of reference arm lengths encompasses less than a <NUM> range of reference arm lengths. The user specific range of reference arm lengths can encompass less than a <NUM> range of reference arm lengths. In some embodiments, the user specific range of reference arm lengths encompasses less than a <NUM> range of reference arm lengths.

In some embodiments, the ophthalmic imaging system includes a sensor that generates a signal indicative of a position of a feature of the user's head relative to the housing. In such examples, not covered by the claims, the control unit can be configured to determine the user specific range of reference arm lengths based on the signal indicative of the position of the feature of the user's head relative to the housing.

In some embodiments, the ophthalmic imaging system includes a sensor that generates a signal indicative of a position of a feature of the user's forehead relative to the housing. In such examples, not covered by the claims, the control unit can be configured to determine the user specific range of reference arm lengths based on the signal indicative of the position of the feature of the user's forehead relative to the housing.

In some embodiments, the ophthalmic imaging system includes a sensor that generates a signal indicative of a position of a feature of an eye of the user relative to the housing, wherein the eye includes the user's retina. In such examples, not covered by the claims, the control unit can be configured to determine the user specific range of reference arm lengths based on the signal indicative of a position of a feature of the eye of the user relative to the housing.

In many embodiments, the viewer assembly includes a compliant member that accommodates an amount of relative movement between the user head and the OCT device. For example, in many embodiments, the viewer assembly includes a compliant member having a thickness that can change up to <NUM> in response to change in pressure applied to the viewer assembly by the user's head. In some embodiments, the viewer assembly includes a compliant member having a thickness that can change up to <NUM> in response to change in pressure applied to the viewer assembly by the user's head.

In many embodiments, the ophthalmic imaging system includes a focusing module that is controlled by the control unit to focus sample light transmitted over the sample arm optical path onto the user's retina. A focus setting of the focusing module corresponding to the user specific imaging reference arm length can be employed during imaging of the user's retina.

In many embodiments of the ophthalmic imaging system, the sample arm length for a particular user is substantially the same over imaging sessions of the user's retina. For example, in many embodiments, the viewer assembly is configured to engage the user's head to restrain the user's head relative to the housing so that the sample arm length is substantially the same for imaging instances of the retina of the user.

In another aspect of the present disclosure, a method of imaging a retina is provided. The method includes restraining, via a viewer assembly coupled with a housing and engaged with a user's head, the user's head relative to the housing so that a sample arm optical path of an optical coherence tomography (OCT) imaging device attached to the housing extends to the user's retina. The method includes controlling, by a control unit, a reference arm length adjustment module of the OCT imaging device to vary a reference arm length of a reference arm optical path of the OCT imaging device to search a user specific range of reference arm lengths to identify a reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina. The reference arm length adjustment module is controllable to vary the reference arm length over a reference arm length adjustment range. The user specific range of reference arm lengths covers a smaller range of reference arm lengths than the reference arm length adjustment range. The method includes imaging, by the OCT imaging device, the user's retina.

Any suitable approach, such as those described herein, can be used to determine a suitable user specific range of reference arm lengths for a particular user for use in the method of imaging the retina. For example, as described herein, a larger reference arm length adjustment range of the adjustable reference arm module can be searched during an initial imaging of the user's retina to identify a reference arm length for which the OCT image detector <NUM> produces an OCT signal corresponding to the user's retina. The identified reference arm length for the initial imaging of the user's retina can then be used to formulate a suitable user specific range of reference arm lengths for use in subsequent imaging sessions of the specific user's retina. Alternatively, a suitable user specific range of reference arm lengths for any particular user can be predetermined. For example, the user specific range of reference arm lengths can be based on spatial information about one or more facial features of the user. In some embodiments, the one or more facial features of the user upon which the user specific range of reference arm lengths can be based include one or more of a forehead of the user, one or more cheeks of the user, a cornea of an eye of the user including the retina of the user, and a lateral orbital rim of the user. The spatial information about one or more facial features of the user is generated via one or more of: (a) three-dimensional scanning of the one or more facial features of the user, (b) caliper measurement of the one or more facial features of the user relative to an eye of the user that includes the retina of the user, (c) a cast mask of the one or more facial features of the user, (d) an axial length of the eye of the user that includes the retina of the user, (e) ultrasound measurement of the axial length of the eye of the user that includes the retina of the user, and (f) OCT measurement of the axial length of the eye of the user that includes the retina of the user.

In many embodiments, the method does not include adjustment of the length of the sample arm optical path. For example, in many embodiments, the viewer assembly includes an objective lens assembly, and the method does not include adjusting a distance between the user's retina and the objective lens assembly.

The lack of adjusting a distance between the user's retina and the objective lens assembly results in a reduced field of view on some user's retinas. To account for such a reduced field of view, in some embodiments, the imaging of the user's retina is limited to a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to each of all lengths within the reference arm length adjustment range. In some embodiments, the imaging of the user's retina is limited to a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to each of all lengths within the reference arm length adjustment range.

In some embodiments of the method, the OCT imaging device has a relatively small image depth. For example, the OCT imaging device can have an image depth of no more than <NUM>.

In some embodiments of the method, the OCT imaging device has a relatively large sensitivity roll-off. For example, the OCT imaging device can have a sensitivity roll off of not better than -3db at <NUM>.

In many embodiments of the method, the user specific range of reference arm lengths is substantially smaller than the reference arm length adjustment range. For example, the user specific range of reference arm lengths can be less than half of the reference arm length adjustment range. In some embodiments of the method, the user specific range of reference arm lengths is less than one-quarter of the reference arm length adjustment range.

The method can be practiced using any suitable control unit. For example, in many embodiments, the method includes (a) receiving, by the control unit, input of the user specific range of reference arm lengths, and (b) storing, by the control unit, the user specific range of reference arm lengths in a tangible memory device. In many embodiments, the method includes (a) controlling, by the control unit, the reference arm length adjustment module during an imaging of the user's retina to vary the reference arm length to search within the reference arm length adjustment range to identify a user specific imaging reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina, (b) determining, by the control unit, the user specific range of reference arm lengths based on the user specific imaging reference arm length, (c) storing, by the control unit, the user specific range of reference arm lengths in a tangible memory device.

The reference arm length adjustment range can encompass a relatively large range of reference arm lengths. For example, in many embodiments of the method, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths. The reference arm length adjustment range can encompass at least a <NUM> range of reference arm lengths. In some embodiments of the method, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths.

The user specific range of reference arm lengths can encompass a relatively small range of reference arm lengths. For example, in many embodiments of the method, the user specific range of reference arm lengths encompasses less than a <NUM> range of reference arm lengths. The user specific range of reference arm lengths can encompass less than a <NUM> range of reference arm lengths. In some embodiments of the method, the user specific range of reference arm lengths encompasses less than a <NUM> range of reference arm lengths.

The user specific range of reference arm lengths can be determined using any suitable approach. For example, in some embodiments, the method includes (a) receiving, by the control unit, input of the user specific range of reference arm lengths, and (b) storing, by the control unit, the user specific range of reference arm lengths in a tangible memory device. In some embodiments, the method includes (a) controlling, by the control unit, the reference arm length adjustment module during an imaging of the user's retina to vary the reference arm length to search within the reference arm length adjustment range to identify a user specific imaging reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina, (b) determining, by the control unit, the user specific range of reference arm lengths based on the user specific imaging reference arm length, and (c) storing, by the control unit, the user specific range of reference arm lengths in a tangible memory device.

In some embodiments of the method, a sensor is used to measure a position of the user relative to the housing. For example, in some embodiments, the method includes (a) generating, by a sensor, a signal indicative of a position of a feature of the user's head relative to the housing, and (b) determining, by the control unit, the user specific range of reference arm lengths based on the signal indicative of a position of a feature of the user's head relative to the housing. In some embodiments, the method includes (a) generating, by a sensor, a signal indicative of a position of a feature of the user's forehead relative to the housing, and (b) determining, by the control unit, the user specific range of reference arm lengths based on the signal indicative of the position of the feature of the user's forehead relative to the housing. In some embodiments, the method includes (a) generating, by a sensor, a signal indicative of a position of a feature an eye of the user relative to the housing, the eye including the user's retina, and (b) determining, by the control unit, the user specific range of reference arm lengths based on the signal indicative of the position of the feature of the eye of the user relative to the housing.

In many embodiments of the method, the viewer assembly includes a compliant member that accommodates an amount of relative movement between the user and the OCT device. For example, in many embodiments of the method, the viewer assembly includes a compliant member having a thickness that can change up to <NUM> in response to change in pressure applied to the viewer assembly by the user's head. In some embodiments of the method, the viewer assembly includes a compliant member having a thickness that can change up to <NUM> in response to change in pressure applied to the viewer assembly by the user's head.

In many embodiments of the method, the ophthalmic imaging system includes a focusing module that is controllable to focus sample light transmitted over the sample arm optical path onto the retina. The method can include: (a) storing, by the control unit, a focus setting of a focusing module of the OCT imaging device corresponding to the user specific range of reference arm lengths, and (b) employing the focus setting during imaging of the user's retina.

In many embodiments of the method, the sample arm length for a particular user is substantially the same over imaging sessions of the user's retina. For example, in many embodiments, the viewer assembly is configured to engage the user's head to restrain the user's head relative to the housing so that the sample arm length is substantially the same for imaging instances of the retina of the user.

In another aspect of the present disclosure, an ophthalmic imaging system for imaging a user's retina includes an optical coherence tomography (OCT) imaging device, a housing to which the OCT imaging device is attached, a viewer assembly coupled with the housing, an objective lens assembly, and a control unit. The OCT imaging device includes a sample arm optical path, an OCT image detector, a reference arm optical path having a reference arm length, and a reference arm length adjustment module controllable to vary the reference arm length over a reference arm length adjustment range. The viewer assembly is configured to engage a user's head to restrain the user's head relative to the housing so that the sample arm optical path extends to the user's retina. The ophthalmic imaging system does not include an adjustment mechanism configured to adjust a distance between the user's retina and the objective lens assembly. The control unit is operatively connected to the OCT image detector and the reference arm length adjustment module. The control unit is configured to control the reference arm length adjustment module to vary the reference arm length to identify a reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina.

In many embodiments, the ophthalmic imaging system images a reduced field of view on the user's retina. For example, in many embodiments, the ophthalmic imaging system is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to each of all lengths within the reference arm length adjustment range. In some embodiments, the ophthalmic imaging system is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to each of all lengths within the reference arm length adjustment range.

For a fuller understanding of the nature and advantages of the claimed invention, reference should be made to the ensuing detailed description and accompanying drawings.

However, it will also be apparent to one skilled in the art that the claimed invention may be practiced without the specific details.

Referring now to the drawings, in which like reference numerals represent like parts throughout the several views, <FIG> shows a user <NUM> looking into a view port <NUM> of a viewer assembly <NUM> of an ophthalmic imaging system <NUM>, in accordance with many embodiments. The ophthalmic imaging system <NUM> includes an optical coherence tomography (OCT) imaging device <NUM> to which the viewer assembly <NUM> is coupled. The viewer assembly <NUM> is configured to be engaged by the user's head to restrain the user's head relative to the OCT imaging device <NUM> to approximately position one eye of the user <NUM> on an optical axis of the OCT imaging device <NUM>. For example, in the configuration shown in <FIG>, the viewer assembly <NUM> is configured to approximately position the right eye of the user <NUM> on the optical axis of the OCT imaging device <NUM>. In the illustrated embodiment, the viewer assembly <NUM> can be rotated, relative to the OCT imaging device <NUM>, <NUM> degrees around a pivot axis <NUM> so as to reconfigure the viewer assembly <NUM> to approximately position the left eye of the user <NUM> on the optical axis of the OCT imaging device <NUM>. Accordingly, each of the right and the left eye of the user <NUM> can be selectively approximately positioned on the optical axis of the OCT imaging device <NUM> for imaging of the respective eye by the OCT imaging device <NUM>. In many embodiments, final positioning and alignment of the optical axis of the respective eye of the user <NUM> with the optical axis of the OCT imaging device <NUM> is accomplished by the user <NUM> adjusting the position of the user's head relative to the view port <NUM> in response to feedback provided to the user <NUM> by the ophthalmic imaging device <NUM>.

The OCT imaging device <NUM> automatically adjusts the reference arm path length as described herein during imaging session in which an OCT image is generated for a user's retina. The OCT imaging device <NUM> can have any suitable configuration that accommodates automatic adjustment of reference arm path length. For example, <FIG> shows a simplified schematic illustration of components and associated optical paths of an embodiment of the OCT imaging device <NUM>. The components of the OCT imaging device <NUM> illustrated in <FIG> include a broadband light source <NUM>, a dual mirror scanner <NUM>, focusing lenses <NUM>, <NUM>, dichroic mirrors <NUM>, <NUM>, <NUM>, an adjustable reference arm module <NUM>, an OCT image detector <NUM>, an eye illuminator <NUM>, an eye camera <NUM>, and a display device <NUM>. In the illustrated embodiment, the OCT imaging device <NUM> is a spectral domain OCT imaging device that operates in a wavelength range of <NUM> to <NUM>. The eye illuminator <NUM> illuminates an eye <NUM> of the user <NUM> using a suitable wavelength of light (e.g., a wavelength of light above <NUM>). The display device <NUM> can project light between any suitable wavelength (e.g., from <NUM> to <NUM>). The dichroic mirror <NUM> transmits the OCT wavelength and the display wavelength range (<NUM> to <NUM>) and reflects the illumination wavelength (e.g., greater than <NUM>) to the eye camera <NUM>. The dichroic mirror <NUM> transmits the display wavelength range and reflects the OCT wavelength.

In operation, the broadband light source <NUM> generates the OCT wavelength light. The OCT wavelength light propagates from the light source <NUM> to the dichroic mirror <NUM>. A sample arm portion of the OCT wavelength light passes through the dichroic mirror <NUM> and proceeds to propagate along a sample arm optical path <NUM> to the eye <NUM>. A reference arm portion of the OCT wavelength light is reflected by the dichroic mirror <NUM> so as to propagate along a reference arm optical path that extends into the adjustable reference arm module <NUM>. The sample arm portion of the OCT wavelength light is focused on the retina of the eye <NUM>. The OCT wavelength light focused on the retina is scattered by the retina so that a backscattered portion of the OCT wavelength light propagates back along the sample arm optical path <NUM>. The backscattered portion of the OCT wavelength light passes through the dichroic mirror <NUM>, is reflected by the dichroic mirror <NUM> and the dual scanning mirror <NUM> back to the dichroic mirror <NUM>, which reflects the backscattered potion of the OCT wavelength light to the OCT image detector <NUM>. The adjustable reference arm module <NUM> includes a reference arm mirror <NUM> that reflects the reference arm portion of the OCT wavelength light back to the dichroic mirror <NUM>. The returning portion of the reference arm portion of the OCT wavelength light passes through the dichroic mirror <NUM> to the OCT image detector <NUM>. In response to the combined incidence of the returning sample arm OCT light and the returning reference arm OCT light onto the OCT image detector <NUM>, the OCT image detector <NUM> generates and outputs an OCT image signal that is processed using known techniques to build up a three-dimensional OCT image of layers of the retina. In many embodiments, the OCT image detector <NUM> detects interference between the returning sample arm light and the reference arm light only if the time travelled by light in the reference and sample arms is nearly equal. In many embodiments, the reference arm mirror <NUM> is mounted to a motorized mechanism that is controllable to vary the position of the reference arm mirror <NUM>, thereby controllably varying the reference arm optical path length. The ability to vary the reference arm path length enables the OCT imaging device <NUM> to be used to generate OCT images of any user's retina of a desired population of users even though each user's retina can be at a different distance from the OCT imaging device <NUM> when the user's head is engaged with the viewer assembly <NUM> due to corresponding anatomical variations between user's heads, as well as variation in the relative position between the user's head and the viewer assembly <NUM>.

In many embodiments, the eye illuminator <NUM>, the eye camera <NUM>, and the display device <NUM> are used to provide feedback to the user <NUM> by which the user <NUM> self-aligns the eye <NUM> with the optical axis of the OCT imaging device <NUM>. The display device <NUM> displays a fixation target that is viewed by the user so as to align the eye <NUM>. The eye camera <NUM> measures the current position of the eye relative to the optical axis of the OCT imaging device <NUM> via illumination of the eye <NUM> by the eye illuminator <NUM>. Based on the measured position of the eye relative to the optical axis of the OCT imaging device <NUM>, the display device <NUM> further displays feedback to the user <NUM> by which the user adjusts the position of the user's head relative to the viewer assembly <NUM> to position the user's eye <NUM> within an acceptable distance of the optical axis of the OCT imaging device <NUM> for the generation of an OCT image of the user's retina.

As illustrated in <FIG>, positioning the pupil at the focal length of the ophthalmic lens <NUM> maximizes the area on the retina that can be imaged by minimizing the amount of sample arm portion of the OCT wavelength light that is obscured by the iris. In contrast, as illustrated in <FIG>, positioning the pupil away from the focal length of the ophthalmic lens <NUM> reduces the area on the retina that can be imaged. Accordingly, in order to image a visual field of the entire macula (about <NUM> degrees), existing ophthalmic OCT systems include a means to adjust the distance between the pupil and the ophthalmic lens of the OCT system. In some existing ophthalmic OCT systems, the distance between the entire ophthalmic OCT system and the user's pupil is adjustable. In some other existing ophthalmic OCT systems, the position of the ophthalmic lens relative to the rest of the ophthalmic OCT system is adjustable so as to adjust the distance between the ophthalmic lens and the user's pupil. In some other existing ophthalmic OCT systems, the position of the user's head is moved relative to the ophthalmic OCT system to adjust the distance between the ophthalmic lens and the user's pupil.

In existing ophthalmic OCT systems, elimination of the ability to reposition the pupil relative to the ophthalmic lens would seriously degrade performance. For example, in existing ophthalmic OCT systems, elimination of the ability to reposition the pupil relative to the ophthalmic lens can result in: (a) a large reduction in the field of view on the retina due to obstruction by the iris, and/or (b) inability to adjust the reference arm path length to a length required for imaging the retina where the existing ophthalmic OCT system lacks sufficient adjustment range for the reference arm path length.

In contrast to existing ophthalmic OCT systems, in many embodiments of the ophthalmic OCT systems described herein, the distance between the user's pupil and the ophthalmic lens is substantially fixed and the ophthalmic OCT system does not include an adjustment mechanism configured to adjust the distance between the user's pupil and the objective lens assembly. To accommodate the lack of an adjustment mechanism configured to adjust the distance between the user's pupil and the objective lens assembly, the adjustable reference arm module <NUM> is configured to be controllable to vary the reference arm path length over a reference arm path length adjustment range that is significantly larger than in current ophthalmic OCT systems. For existing ophthalmic OCT imaging systems, adjustment of the reference arm path length only needs to accommodate variation in the axial length of the eye for different users. Typical axial length of the eye can vary by +/- <NUM> for (+/- <NUM> Diopter). As a result, adjustment to the reference arm path length in existing OCT imaging systems does not need to exceed about <NUM>. In contrast, variation in the location of facial landmarks relative to the eye are much greater. Facial land marks can vary in a range of +/- <NUM>. Accordingly, in many embodiments, the reference arm length adjustment range encompasses a relatively large range of reference arm lengths. For example, in many embodiments of the method, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths. The reference arm length adjustment range can encompass at least a <NUM> range of reference arm lengths. In some embodiments of the method, the reference arm length adjustment range encompasses at least a <NUM> range of reference arm lengths.

The larger reference arm path length adjustment range, however, by itself, would increases the time it takes to search within the larger reference arm path length adjustment range to identify a reference arm length for which the OCT image detector <NUM> produces an OCT signal corresponding to the user's retina. Increased search time significantly increases chair time resulting in fixation losses and increased technician cost. To limit the search time, in many embodiments described herein, a user specific range of reference path arm lengths is employed to limit the search to identify the reference arm length for which the OCT image detector produces an OCT signal corresponding to the user's retina to a suitably small range of reference arm lengths for the specific user.

Any suitable approach, such as those described herein, can be used to determine a suitable user specific range of reference path arm lengths for a particular user. According to the present invention, the larger reference arm path length adjustment range of the adjustable reference arm module <NUM> can be searched during an initial imaging of the user's retina to identify a reference path length for which the OCT image detector <NUM> produces an OCT signal corresponding to the user's retina. The identified reference path length for the initial imaging of the user's retina can then be used to formulate a suitable user specific range of reference path arm lengths for use in subsequent imaging sessions of the specific user's retina. Alternatively, although not covered by the present claims, a suitable user specific range of reference path arm lengths for any particular user can be predetermined based on spatial information about a user's facial features (e.g., forehead, cheeks, cornea, lateral orbital rim, and/or any other suitable facial feature) and their relations to each other. The spatial information about the user's facial features can be captured/measured in any suitable manner including, but not limited to, any suitable virtual approach, any suitable physical approach, and any suitable combination of virtual and physical approaches. For example, the spatial information about the user's facial features and/or the suitable user specific range of reference path arm lengths can be determined based on: (a) three-dimensional scanning of the user's face, (b) caliper measurement of the specific land mark on the user's face relative to the user's eye ball, (c) a cast mask of the user's face, (d) combinations of (a) through (c) with axial length of the eye (e.g., measured via ultrasound, OCT, etc.) combined with measurement of the distance to the facial land mark to determine the distance of the facial land mark to the retina, and/or (e) OCT measurement via the OCT image detector <NUM>.

Moreover, without an adjustment mechanism to adjust the distance between the user's pupil and the objective lens assembly, a reduced field of view of the user's retina can result for some users, such as users with small pupils that are positioned away from the focal length of the ophthalmic lens <NUM>. To accommodate variability in the resulting field of view for different users, in some embodiments, the ophthalmic imaging system <NUM> images a fixed reduced field of view for all users. For example, in some embodiments, the ophthalmic imaging system <NUM> is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to any length within the reference arm length adjustment range. In some embodiments, the ophthalmic imaging system <NUM> is configured to image a field of view on the user's retina equal to or less than <NUM> degrees for the reference arm length equal to any length within the reference arm length adjustment range.

In many embodiments, the OCT imaging device <NUM> is configured to automatically control components/modules of the OCT imaging device <NUM> during a imaging session during which an OCT image of a user's retina is generated. In many embodiments, the OCT imaging device <NUM> includes a suitable control unit that is operatively connected to components/modules of the OCT imaging device <NUM> and configured to communicate and/or control the components/modules. For example, <FIG> is a simplified schematic diagram illustrating components/modules of an embodiment of the OCT imaging device <NUM> that includes a control unit <NUM> operatively coupled with the components/modules. The control unit <NUM> includes a processor <NUM> and a data storage device <NUM>. The data storage device <NUM> stores program instructions executable by the processor <NUM> to accomplish the acts described herein. The data storage device <NUM> also stores user specific data as described herein that is used by the processor <NUM> to customize its control of the operation of the OCT imaging device <NUM> to the specific user as described herein.

The control unit <NUM> is operatively connected to the a user interface <NUM> to receive input from the user via the user interface <NUM> and/or to display output to the user via the user interface <NUM>. Any suitable user interface <NUM> can be employed including, but not limited to, one or more push buttons, a display, a touch display, one or more indicator lights, and/or a speaker. The user interface <NUM> can be configured to enable a user to input an identification of the user for a imaging session so that the control unit <NUM> can employ scanning parameters stored in the data storage device <NUM> when controlling the components/modules of the OCT imaging device <NUM> during a imaging session for the user.

The control unit <NUM> is operatively connected to the eye illuminator <NUM>, the eye camera <NUM>, and the display device <NUM>. The control unit <NUM> can turn the eye illuminator <NUM> on at the start of a imaging session and off at the end of a imaging session. In many embodiments, the control unit <NUM> turns the eye camera <NUM> on at the start of the imaging session, receives image data from the eye camera <NUM>, processes the image data to track the position of the optical axis of the eye <NUM> relative to the optical axis of the OCT imaging device <NUM>, and turns the eye camera <NUM> off at the end of the imaging session. In many embodiments, the control unit <NUM> turns the display device <NUM> on at the start of the imaging session, generates and displays feedback to the user on the display device <NUM> to enable the user to reposition the user's head relative to the viewer assembly <NUM> to sufficiently align the user's eye <NUM> with the optical axis of the OCT imaging device <NUM> for the generation of an OCT image of the user's retina, and turns the display device <NUM> of that the end of the imaging session.

The control unit <NUM> is operatively connected to the broadband light source <NUM>, the dual mirror scanner <NUM>, the reference arm length adjustment module <NUM>, the OCT image detector <NUM>, and a focusing module <NUM> to control operation of these components/modules during an OCT imaging portion of a imaging session. The control unit <NUM> can turn the broadband light source <NUM> on to begin transmission of the OCT wavelength light over the sample and reference arms at the beginning of the OCT scanning portion of the imaging session, and can turn the light source <NUM> off to at the end of the imaging session. The control unit <NUM> is configured to
control the reference arm length adjustment module <NUM> to vary the reference arm length to search for a user specific reference arm length(s) as described herein for the respective user for which the OCT image detector <NUM> generates a suitable OCT signal for use in generating an OCT image of the user's retina. The control unit <NUM> can control the reference arm length adjustment module <NUM> to vary the reference arm length to search within a previously determined user specific range of reference arm lengths for the respective user to identify a reference arm length for which the OCT image detector <NUM> generates a suitable OCT signal for use in generating an OCT image of the user's retina. The control unit <NUM> can also control the reference arm length adjustment module <NUM> so as to optimize the OCT signal generated by the OCT image detector <NUM> and/or to adjust the reference arm length in response to movement of the eye <NUM> relative to the OCT imaging device <NUM>. In many embodiments, the control unit <NUM> stores, in the data storage device <NUM>, one or more reference arm lengths and/or one or more settings of the reference arm length adjustment module <NUM> for which the OCT image detector <NUM> is found to generate a suitable OCT signal during a imaging session for a user for use in conjunction with control of the reference arm length adjustment module <NUM> during a subsequent imaging session of the user as described herein. In many embodiments, the control unit <NUM> stores, in the data storage device <NUM>, a previously determined user specific range of reference arm lengths, for the respective user, that is searched during imaging of the user's retina to identify a reference arm length for which the OCT image detector <NUM> generates a suitable OCT signal for use in generating an OCT image of the user's retina. The control unit <NUM> can control the focusing module <NUM> to vary a setting of the focusing module <NUM> to focus the sample arm OCT wavelength light onto a target surface of the retina of the eye <NUM>. The control unit <NUM> can store, in the data storage device <NUM>, a suitable setting of the focusing module <NUM> used during a imaging session for a user for use as the setting of the focusing module <NUM> during a subsequent imaging session of the user as described herein. In many embodiments, the control unit <NUM> turns the OCT image detector <NUM> on at the start of the OCT scanning portion of the imaging session, receives an OCT detector output signal generated by the OCT image detector <NUM>, processes the OCT detector output signal to generate an OCT image of the retina and to determine how to control the reference arm length adjustment module <NUM> and the focusing module <NUM> during a imaging session, and turns the OCT image detector <NUM> off at the end of the imaging session. In many embodiments, the control unit <NUM> controls the operation of the dual mirror scanner <NUM> during a imaging session. During an initial portion of a imaging session, the control unit <NUM> can control the dual mirror scanner <NUM> to perform a limited two-dimensional scan of the sample arm OCT wavelength light suitable for searching for suitable settings of the reference arm length adjustment module <NUM> and/or the focusing module <NUM> for which the OCT image detector <NUM> generates a suitable OCT detector output signal for the generation of an OCT image of the retina. Once suitable settings of the reference arm length adjustment module <NUM> and/or the focusing module <NUM> are determined by the control unit <NUM>, the control unit <NUM> can control operation of the dual mirror scanner <NUM> to perform a two-dimensional scan of the sample arm OCT wavelength light suitable for the generation of an OCT image of the retina.

<FIG> is a simplified schematic block diagrams of acts of a method <NUM> of imaging a retina by an ophthalmic imaging system during an imaging session, in accordance with embodiments of the present disclosure. Any suitable ophthalmic imaging system, such as the ophthalmic imaging system <NUM> described herein, can be used to practice the method <NUM>.

In act <NUM>, an identification of a user of the ophthalmic imaging system is input to the ophthalmic imaging system for use in controlling an OCT imaging device of the ophthalmic imaging system during an imaging session. For example, the identification of the user can be used to retrieve user specific reference arm length data and/or user specific focus data for use in controlling the OCT imaging device during the imaging session. The identification of the user can also be used to store user specific reference arm length data and/or user specific focus data determined during the imaging session for use in one or more subsequent imaging sessions for the identified user.

In act <NUM>, the identification of the user for the imaging session can be used to determine a suitable reference arm search range for the imaging session. If no reference arm length data is stored for the identified user, according to the invention, the reference arm search range for the imaging session can be set to a default initial search range suitable for a target population of users that includes the identified user. For example, <FIG> illustrates example search ranges for the reference arm path length of the OCT imaging device for an initial imaging of a user's retina and a subsequent imaging of the user's retina. The search range for the reference arm path length for a subsequent imaging of a user's retina will typically be smaller than the search range for the reference arm path length for the initial imaging of the user's retina because the search range for the subsequent imaging is determined based on the reference arm path lengths used to generate an OCT image of the user's retina during an earlier imaging session(s). During an initial imaging session of the identified user's retina, the reference arm search range for the imaging session can be defined between an initial search range maximum reference arm length <NUM> and an initial search range minimum reference arm length <NUM> suitable for the target population of users. During a subsequent imaging session of the identified user's retina, the reference arm search range for the imaging session can be defined between a user specific maximum reference arm length <NUM> and a user specific minimum reference arm length <NUM> based on reference arm lengths used to image the user's retina during one or more previous imaging sessions. For example, the user specific maximum reference arm length <NUM> can be set by adding a suitable path length increment to an initial imaging maximum reference arm length <NUM> employed to generate an OCT image of the user's retina during an initial imaging session for the identified user. Likewise, the user specific minimum reference arm length <NUM> can be set by subtracting a suitable path length increment to an initial imaging minimum reference arm length <NUM> employed to generate an OCT image of the user's retina during an initial imaging session for the identified user.

In act <NUM>, the user's head is engaged with a viewer assembly so as to restrain the position of the user's head relative to the OCT imaging device during the imaging session. In many embodiments, the OCT imaging device provides feedback to the user to enable the user to reposition the user's head to position the user's eye to be imaged within a suitable distance from the optical axis of the OCT imaging device and in suitable alignment with the optical axis of the OCT imaging device for the generation of an OCT image of the user's retina.

In act <NUM>, with the user's eye suitably restrained relative to the optical axis of the OCT imaging device, the reference arm length of the OCT imaging device is varied to search within the reference arm search range for the imaging session to identify a suitable reference arm length for use in generating an OCT image of the user's retina. For example, in the OCT imaging device <NUM>, the position of the reference arm mirror <NUM> is controlled by the control unit <NUM> to vary the reference arm length within the reference arm search range for the imaging session. The OCT image detector output signal is monitored by the control unit <NUM> to identify a reference arm length for which the OCT image detector output signal indicates that the reference arm length matches the sample arm length close enough for the generation of an OCT image for the user's retina. To speed the search for a suitable reference arm length for the imaging session, the extent to which the sample arm OCT light is scanned in two dimensions during the search for the suitable reference arm length can be limited as compared to the two-dimensional scanning used to generate the OCT image of the retina. When the reference arm search range for the imaging session is based on the reference arm length(s) used to generate an OCT image for the user during one or more previous imaging sessions, the time required to search the resulting user specific reference arm search range may be substantially reduced relative to the time required to search the larger reference arm search range for an initial imaging session for the user.

In act <NUM>, the sample arm OCT wavelength light is focused on the retina and the reference arm length is adjusted, if necessary, to optimize the OCT image detector output signal. For example, in the OCT imaging device <NUM>, the control unit <NUM> can control the focusing module <NUM> to vary the optical power of the focusing module <NUM> to vary the focus of the sample arm OCT wavelength light over a target surface of the retina while monitoring the OCT image detector output signal to identify a setting for the focusing module <NUM> that optimizes the OCT image detector output signal for suitable locations on the target surface of the retina. Once an optimum setting for the focusing module <NUM> is identified, the control unit <NUM> can control the reference arm length adjustment module <NUM> to finely vary the reference arm length while monitoring the OCT image detector output signal to identify a setting for the reference arm length adjustment module <NUM> that optimizes the OCT image detector output signal for the optimal setting of the focusing module <NUM>.

In act <NUM>, the identified reference path length and the identified focus setting are used during generation of an OCT image for the user's retina. In some embodiments, the reference path length is controlled during the generation of the OCT image to optimize the OCT image detector output signal throughout the generation of the OCT image.

In act <NUM>, the reference arm length(s) used to generate the OCT image during the imaging session is stored in a memory device (e.g., the data storage device <NUM> of the control unit <NUM>) so as to be associated with the identified user for use in determining the reference arm search range for a subsequent imaging session for the identified user. If the reference arm path length was varied during the generation of the OCT image to optimize the OCT image detector output signal throughout the generation of the OCT image and/or in response to movement of the eye relative to the OCT imaging device, a maximum reference arm length and a minimum reference arm length used during the generation of the OCT image can be stored in memory device so as to be associated with the identified user for use in determining the reference arm search range for a subsequent imaging session for the identified user.

In act <NUM>, a focus setting used during the generation of the OCT image can be stored in a memory device so as to be associated with the identified user for use in a subsequent imaging session for the identified user. For example, in the OCT imaging device <NUM>, the control unit <NUM> can store a setting of the focusing module <NUM> in the data storage device <NUM> so as to be associated with the identified user for use as the setting of the focusing module <NUM> in a subsequent imaging session for the identified user.

<FIG> is a simplified schematic block diagrams of additional acts that can be accomplished in the method <NUM> to determine the reference arm search range for a subsequent imaging session for the identified user. In act <NUM>, a sensor generates a signal indicative of a position of a feature of the user's head relative to the OCT imaging device. For example, in the ophthalmic imaging system <NUM>, the sensor can be mounted to the viewer assembly <NUM> and generate a signal indicative of a position of a feature of the user's head relative to the OCT imaging device <NUM>. In act <NUM>, the measured position of the feature of the user's head relative to the OCT imaging device is used by a control unit to determine the reference arm search range for the imaging session. For example, in embodiments in which the viewer assembly <NUM> includes a compliant member that deforms by different amounts in response to different interface force magnitudes applied to the viewer assembly <NUM> by the user's head, the measured position of the feature of the user's head relative to the OCT imaging device can be used to determine the reference arm search range for the imaging session so as to account for the actual gross position of the user's head relative to the OCT imaging device. By accounting for the actual gross position of the user's head relative to the OCT imaging device, the reference arm search range for the imaging session can cover a smaller range of reference arm lengths as compared to when the actual gross position of the user's head relative to the OCT imaging device is unknown. For example, <FIG> illustrates an example non-feature based initial reference arm search range <NUM> suitable for an initial imaging session for a user for which the gross position of the user's head relative to the OCT imaging device is unknown, an example feature based initial reference arm search range <NUM> suitable for an initial imaging session for a user for which the gross position of the user's head has been measured via a sensor that generates a signal indicative of the position of a feature of the user's head relative to the OCT imaging device, and an example feature based user specific reference arm search range <NUM> suitable for a subsequent imaging session for a user for which the gross position of the user's head has been measured via a sensor that generates a signal indicative of the position of a feature of the user's head relative to the OCT imaging device. The non-feature based initial reference arm search range <NUM> can be selected suitable for a target population of users and for a suitable range of expected gross positions between the head of each of the target population of users and the OCT imaging device. The feature based initial reference arm search range <NUM> can be selected based on a measured gross position of a user's head and the target population of users. By measuring the actual gross position of a user's head relative to the OCT imaging device, the feature based initial reference arm search range <NUM> covers a smaller range of reference arm lengths that the non-feature based initial reference arm search range <NUM>, which accommodates variation in the possible gross position between the user's head and the OCT imaging device. The feature based user specific reference arm search range <NUM> covers a smaller range of reference arm lengths that the feature base initial reference arm search range <NUM> because the feature based user specific reference arm search range <NUM> is based on both the measured gross position of a specific user's head relative to the OCT imaging device and the reference arm lengths used during the generation of an OCT image of the specific user's retina during one or more previous imaging sessions. In act <NUM>, data defining a relationship between the reference arm length suitable for the generation of an OCT image of the user's retina and the position of the feature of the user's head during the generation of the OCT image of the user' retina is stored in memory for use during a subsequent imaging of the user's retina. In act <NUM>, the signal generated by the sensor during a subsequent imaging session for the user and the data defining the relationship between the reference arm length suitable for the generation of an OCT image of the user's retina and the position of the feature of the user's head during the prior generation of the OCT image of the user' retina are used to determine the feature based user specific reference arm search range <NUM> for the imaging session.

Other variations are within the scope of the claimed invention. Thus, while the claimed invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention, as defined in the appended claims.

The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The term "connected" is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed.

Claim 1:
An ophthalmic imaging system for imaging a retina of a user, the ophthalmic imaging system comprising:
an optical coherence tomography,OCT, imaging device (<NUM>) including a sample arm optical path (<NUM>), an OCT image detector (<NUM>), a reference arm optical path (<NUM>) having a reference arm length, and a reference arm length adjustment module controllable to vary the reference arm length over a reference arm length adjustment range;
a housing to which the OCT imaging device (<NUM>) is attached;
a viewer assembly (<NUM>) coupled with the housing, the viewer assembly being configured to engage a user's head to restrain the user's head relative to the housing so that the sample arm optical path (<NUM>) extends to the retina of the user;
characterized in that it further comprises
a control unit (<NUM>) operatively connected to the OCT image detector (<NUM>) and the reference arm length adjustment module (<NUM>), the control unit (<NUM>) being configured to:
control the reference arm length adjustment module (<NUM>) during an initial imaging of the retina of the user to vary the reference arm length within the reference arm length adjustment range to identify an initial imaging reference arm length (<NUM>, <NUM>) for which the OCT image detector (<NUM>) produces an OCT signal corresponding to the retina of the user;
determine a user specific range of reference arm lengths (<NUM>, <NUM>), based on the initial imaging reference arm length (<NUM>, <NUM>), that covers a smaller range of reference arm lengths than the reference arm length adjustment range; and
control the reference arm length adjustment module during an imaging of the retina of the user subsequent to the initial imaging of the retina of the user to vary the reference arm length to search within the user specific range of reference arm lengths (<NUM>, <NUM>) to identify a subsequent imaging reference arm length for which the OCT image detector (<NUM>) produces an OCT signal corresponding to the retina of the user.