Ophthalmic drug applicator with optical alignment and targeting - Patents.com

Abstract

[Solution] The fluid dispensing device includes a light source and a nozzle spaced from the light source, the device also including a membrane disposed in a beam path of the light source and configured to pass a portion of light from the light source to the nozzle, the device also including a fluid chamber disposed between the membrane and the nozzle, the nozzle configured to allow the portion of the beam of light to pass along the beam path, the nozzle further configured to shape a stream of fluid emitted from the fluid chamber along the beam path.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 024,373, filed May 13, 2020, which is incorporated by reference in its entirety.

[0002] The subject matter described herein relates to devices, methods, and systems for delivering a fluid flow to a patient's eye. The ophthalmic drug applicator is particularly, but not exclusively, useful for administering drugs to the eye in ophthalmology. [Background technology]

[0003] There are several challenges in delivering medication to a patient's eye. Medications can be delivered by eye droppers or sprayers. In either case, blinking, improper applicator placement, or mis-angled applicator can cause some or all of the medication to miss the eyeball and instead be delivered to the patient's eyelids or face, which may provide little or no therapeutic value or require irrigation. Furthermore, many eye dropper and sprayer devices cannot deliver a dose if the device is held horizontally, and a substantially different dose may be delivered depending on whether the device is vertical or at an intermediate angle between vertical and horizontal (e.g., 45 degrees from vertical). Some eye sprayers include a mirror adjacent to the mist nozzle to assist the user in aligning and aiming the eye sprayer to the eye. However, there may still be some degree of error or discrepancy (such as parallax) between the view in the mirror and the actual trajectory of the mist. Thus, standard eye droppers and sprayers are prone to incorrect and / or inaccurate dosing. Also, such eye dropper and spray devices can be difficult or uncomfortable to operate while standing or sitting, especially for patients with arthritis, back pain, or other conditions.

[0004] Many sprayer devices can only aerosolize liquids with a viscosity similar to water (e.g., about 3 centipoise), whereas liquids with higher viscosities (e.g., 50 centipoise) must be delivered by eyedropper. However, high-viscosity eye drops have many advantages. They may provide increased ocular hydration, extended drug residence time, enhanced mucoadhesion, and the potential for lipid encapsulation, and increased drug loading. Unfortunately, compared to low-viscosity liquids, high-viscosity liquids delivered may take longer to spread evenly, may cause blurred vision, a sticky feeling, and may be more difficult to cleanse the eyelashes after missing the target. Therefore, it is desirable to deliver high-viscosity medications as a fine mist, fine sheet, or microstream that is delivered precisely to the eye with little or no material on the eyelids or eyelashes.

[0005] Thus, it should be understood that current ophthalmic drug delivery systems have many shortcomings, such as difficulty in delivering accurate or consistent doses, uncertainty in the dose delivered, and difficulty in cleaning.Therefore, there is a long-standing need for an improved ophthalmic drug delivery system that addresses the above and other concerns.The information contained in the background section of this specification, including the references cited herein and their descriptions or discussions, is included for technical reference purposes only and should not be considered as a binding subject matter for the scope of this disclosure. The prior art documents relevant to the invention of this application are as follows (including documents cited during the international phase after the international filing date and documents cited when the application entered the national phase in other countries). (Prior art document) (Patent Documents) (Patent Document 1) U.S. Patent Application Publication No. 2010 / 022971 (Patent Document 2) U.S. Patent No. 10,583,038 (Patent Document 3) U.S. Patent Application Publication No. 2017 / 156927 Summary of the Invention [Means for solving the problem]

[0006] The present disclosure provides an actuated ophthalmic medication applicator with alignment features that aid the user in directing the fluid stream to the eye. Focusing the medication delivery device on the eye may include emitting a narrow beam from a light source through an applicator nozzle along the axis of the applicator that directs the stream. In some embodiments, the narrow beam is visible to the user only in a small range of positions and orientations relative to the user's eye to allow the user to determine if the applicator nozzle is aimed at an acceptable area of ​​the user's eye for medication administration. In other embodiments, the alignment features described herein allow the user to aim the nozzle at the eye without parallax. Additionally, a sensor in the applicator can detect the correct aiming range and position relative to the eye, and can communicate such information as feedback to the user by changing the color or flash pattern of the light source. Thus, the ophthalmic medication applicator improves the user's experience and aids in the treatment of eye disorders such as glaucoma, dry eye, and red eye (allergic conjunctivitis).

[0007] The ophthalmic drug applicators disclosed herein are particularly, but not exclusively, useful for the treatment of ocular disorders such as glaucoma, dry eye, and conjunctivitis.

[0008] One embodiment of the present disclosure includes a fluid dispensing device, the fluid dispensing device including a light source and a nozzle spaced apart from the light source, the device also including a membrane disposed in a beam path of the light source, the membrane configured to pass a portion of light from the light source to the nozzle, the device also including a fluid chamber disposed between the membrane and the nozzle, the nozzle configured to allow the portion of the beam of light to pass along the beam path, the nozzle further configured to shape a stream of fluid emitted from the fluid chamber along the beam path.

[0009] In some embodiments, the light source may include an aligned baffle having a first slit width and the nozzle has a second slit width, the first slit width and the second slit width being less than 400 micrometers (μm). In some embodiments, the beam of light is visible to a human eye when the nozzle is aligned to within a rotational accuracy of ±8.5 degrees or less at the human eye when the device is positioned about 15 mm from the eye for fluid delivery. In some embodiments, the nozzle may include two adjacent slits spaced less than 1 mm apart, the slits positioned and aligned to transmit light to a user such that the intensity of light through both slits is perceived to be equal when the nozzle is aligned to the human eye. In some embodiments, the light source may include a first light emitting diode (LED). In some embodiments, the light source may include an integrated LED surface mount package with two or more monochromatic LED dies aligned in a row, the LED surface mount package may be configured to change from a first color to a second color without affecting the angle of light along the beam path. The processor is configured to use information from the distance sensor to determine whether the distance between the nozzle and the human eye is greater than a threshold amount, and in response to the distance being determined to be greater than the threshold amount, change the visual characteristic of the light source to a first value, and in response to the distance being determined to be less than the threshold amount, change the visual characteristic of the light source to a second value.

[0010] The device may further include an applicator body having an actuator, the light source, and an opening aligned with the nozzle. The actuator may be configured to depress the membrane into the fluid chamber, thereby causing fluid to be expelled from the fluid chamber through the nozzle. The device may further include a cartridge removably disposed within the applicator body. In some embodiments, the cartridge includes a fluid reservoir in fluid communication with the fluid chamber, the nozzle, and the membrane.

[0011] The cartridge may include a fluid reservoir in fluid communication with the fluid chamber, the nozzle, and the membrane. The applicator body may further include at least one brow stop configured to contact a user's brow arch and at least one cheekbone stop configured to contact a user's cheekbone, and the light source may be visible to the user through the nozzle when the brow stop is in contact with the user's brow arch and the cheekbone stop is in contact with the user's cheekbone. The actuator may include a piston and a head coupled to a distal end of the piston, the head may be configured to contact the membrane in an actuated position, and the head may include an inclined reflective surface disposed relative to the light source such that a beam from the light source is reflected to the nozzle. The head may include a first opening adjacent the light source and a second opening at a distal end of the head, and the angled reflective surface may be in the head such that a portion of the light enters through the first opening, reflects off the angled reflective surface, and propagates out of the second opening. The applicator body may further include one or more photodetectors configured to detect the presence of the cartridge based on internal reflection of light from the light source in the head or cartridge. The applicator body may include an actuation control, the light source, and the actuator. The cartridge may include the fluid reservoir, the membrane, the nozzle, and the fluid chamber. The device may include an actuable nozzle cover coupled to the applicator body and configured to cover the nozzle.

[0012] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of the features, details, utilities, and advantages of the ophthalmic drug applicator defined in the claims is provided in the following description of various embodiments of the disclosure and illustrated in the accompanying drawings. [Brief description of the drawings]

[0013] Exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a photograph of an exemplary ocular drug applicator for delivering a drug to a patient's eye in accordance with at least one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram depicting an exemplary drug delivery zone in the human eye. [Diagram 3] FIG. 3 is a side cross-sectional view of an exemplary ocular drug applicator according to at least one embodiment of the present disclosure. [Figure 4] FIG. 4 is a schematic diagram of an exemplary drug delivery mechanism of an ophthalmic drug applicator according to at least one embodiment of the present disclosure. [Diagram 5] FIG. 5 illustrates a front view of an exemplary nozzle having an LED shining through the nozzle in accordance with at least one embodiment of the present disclosure. [Figure 6A] FIG. 6A is a perspective view of a blink detection and proximity sensing assembly in accordance with at least one embodiment of the present disclosure. [Figure 6B] FIG. 6B is an elevational view of a blink detection and proximity sensing assembly in accordance with at least one embodiment of the present disclosure. [Figure 7A] FIG. 7A illustrates an LED configuration for use in an ophthalmic drug applicator in accordance with at least one embodiment of the present disclosure. [Figure 7B]FIG. 7B illustrates an LED configuration for use in an ophthalmic drug applicator in at least one embodiment of the present disclosure. [Figure 8] FIG. 8 is a perspective view of a reusable, replaceable ocular drug applicator cartridge in accordance with at least one embodiment of the present disclosure. [Figure 9] FIG. 9 is a perspective view of a dispensing portion of the ophthalmic drug applicator of FIG. 10 in an actuated position in accordance with at least one embodiment of the present disclosure. [Figure 10] FIG. 10 is a perspective view of a portion of the ophthalmic drug applicator of FIG. 10 in a capped and refilling position in accordance with at least one embodiment of the present disclosure. [Figure 11] FIG. 11 is a cross-sectional view of an exemplary ocular drug applicator according to at least one embodiment of the present disclosure. [Figure 12] FIG. 12 is a perspective view of a portion of the ophthalmic drug applicator of FIG. 11 in accordance with at least one embodiment of the present disclosure. [Figure 13A] FIG. 13A is a perspective view of a light-guiding component of an ophthalmic drug applicator in accordance with at least one embodiment of the present disclosure. [Figure 13B] FIG. 13B is a cross-sectional view of the light-guiding component of FIG. 13A in accordance with at least one embodiment of the present disclosure. [Figure 14] FIG. 14 is a schematic diagram of an exemplary ocular drug applicator according to at least one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] According to at least one embodiment of the present disclosure, an ocular drug applicator is provided that brings a non-gravity, orientation-independent ocular drug delivery system closer to a patient's eye. The present disclosure provides visual and other cues to help a user align the device toward his or her eye with greater precision in both location and orientation than is possible with conventional sprayers or eyedroppers. In an exemplary embodiment, the device incorporates one or more nozzles with horizontal slit shapes that are directly aligned (e.g., aligned without parallax) with a light source such as an LED, such that the user can only see the light from the light source if the nozzle is properly aligned toward the eye within a range of positions and orientations. The ocular drug applicator may not require gravity to function and therefore may function regardless of orientation. The ocular drug applicator may include multiple "smart" features such as distance detection and blink detection, as well as passive features intended to latch onto the user's forehead or cheekbones to aid in proper alignment of the device. Ophthalmic drug applicators are useful in treating eye disorders such as, for example, glaucoma, dry eye, and red eye (allergic conjunctivitis).

[0015] The ophthalmic drug applicator is uniquely designed to direct the light source through the same nozzle that dispenses the drug, i.e., through the injection nozzle, into the direct line of sight. In one embodiment, the fluid input chamber of the ophthalmic drug applicator can be transparent, so that a single-color or multi-color LED can be placed directly behind the nozzle of the applicator, which allows the nozzle to be aimed directly at the eye. A suitable aperture of the light beam can restrict the beam to a small angular range that can pass directly through the slit nozzle, so that the beam from the light source is only visible when it is properly aligned with the eye. The user can only see the colored LED light with high visibility in the color-receptive area of ​​the fovea of ​​the eye within a narrow aiming range, such as ±10 degrees, which helps the user to accurately aim the device with the eye by appropriately selecting the brightness of the LED.

[0016] In some embodiments, an optical proximity sensor is used so that the distance to the eye can be estimated. If the applicator is too far away (e.g., more than 20 mm from the eye), the light source can be controlled to change color or lighting pattern (e.g., blink, strobe, pulse, solid, etc.). Additionally, if the applicator is close enough and within a predefined range, the first color can be changed to a second color. For example, blue and orange can be a common color range for color blind people. However, any suitable color and color combination can be used. RGB LEDs can be used, allowing a wide color gamut by adjusting the relative current to each LED. Also, the intensity of the LEDs can be optionally blinked or strobed, similar to the use of a blink disable signal in a flash camera. In this way, color-changing and time-domain changing signals can communicate distance, alignment, and targeting to the user while the user is holding the device, greatly improving the usability of the device.

[0017] The present disclosure substantially aids in ophthalmic drug delivery by improving the ability of even inexperienced users to place the device in the desired location, range, and orientation to deliver drug to their own eye. This improved self-aiming capability transforms an imprecise and unreliable manual procedure into a reliable and repeatable machine-assisted procedure that does not require lying down, multiple attempts, or having another person administer the drug as is normal routine. This non-conventional approach improves the functionality of ophthalmic drug delivery systems by allowing users to self-administer ophthalmic drugs with a high success rate.

[0018] These descriptions are provided for illustrative purposes only and should not be considered as limiting the scope of the ocular drug applicator, as specific features may be added, deleted, or modified without departing from the spirit of the claimed subject matter.

[0019] For the purpose of facilitating the understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings, and the same will be described using specific terms. However, it will be understood that no limitation of the scope of the present disclosure is intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple repetitions of these combinations will not be described separately. The examples described herein are provided for illustrative purposes and are not intended to be limiting.

[0020] FIG. 1 is a side view of an exemplary ocular drug applicator 100 for delivering a drug to a patient's eye 50 in accordance with at least one embodiment of the present disclosure. As discussed above, in some embodiments, the ocular drug applicator 100 is configured to provide a flow of eye drops so that the applicator 100 can be used in a horizontal configuration. In some aspects, the flow of fluid is also referred to as a microstream. Thus, a user can apply the fluid without having to lean back to allow gravity to direct the fluid toward the patient's eye 50. To deliver the proper dose, it is useful for the ocular drug dispenser or ocular drug applicator 100 to be held in the proper position and orientation relative to the target eye 50. The ocular drug applicator 100 provides several configurations that ease the burden of this aiming process, which is otherwise difficult even for experienced users, as described below.

[0021] FIG. 2 is a schematic diagram showing an exemplary drug delivery zone of a human eye 50. MRD1 and MRD2 are the "margin reflex distances" between the pupil and eyelids (upper 52 and lower 54, respectively) when the patient is looking directly at a light source. MRD1 and MRD2 are typically about 4 mm. PBD is the pupil-to-brow distance between the center of the pupil 56 and the eyebrow 58. The eyelids 52, 54 form a shape with a long horizontal dimension and a short vertical dimension, which allows more room for error in placing the drug horizontally than vertically. Also, for comfort and visual reasons, it is desirable to administer the drug as evenly as possible across the eye 50. Thus, in some embodiments, the nozzle of the eye drug applicator is a horizontal slit that aims the drug at a horizontal line across the horizontal dimension of the eye 50 to maximize spread across the surface of the eye while at the same time reducing the amount of material that misses the eyeball 50 and contacts the eyelids 52, 54 or skin.

[0022] 3 is a side cross-sectional view of an exemplary ophthalmic drug applicator 100 according to at least one embodiment of the present disclosure. The ophthalmic drug applicator 100 includes an applicator body 110 having an activation button 112, a slide actuation mechanism 114, a light source 116, and an actuation hammer 118. The ophthalmic drug applicator 100 also includes a replaceable cartridge 120 having a drug reservoir 122, a transparent, elastically deformable wall or membrane 124, a fluid chamber 126, and a nozzle 128. In one example, with the removable cartridge 120 in place and a power switch turned on, the light source 116 draws power from a power source (e.g., a battery) and emits a light beam 125 through the membrane 124 and nozzle 128 such that the light beam 125 is visible to the human eye when the nozzle 128 is properly aimed at the eye. When the activation button 112 is pressed, the sliding actuation mechanism 114 descends and the actuation hammer 118 is cocked and then released, causing the actuation hammer 118 to strike the membrane 124 and forcing the fluid in the fluid chamber 126 out through the nozzle 128. When the actuation button 112 is released, the hammer 118 releases the membrane 124 and creates a negative pressure in the fluid chamber 126, which draws an additional dose of fluid from the drug reservoir 122 into the fluid chamber 126.

[0023] In one example, the nozzle 128 has a slit narrow enough that surface tension holds the liquid in place against gravity, vibration, etc., but still allows for a sufficient burst of drug to be delivered to the eye at the required dose. In one example, the light source 116 has an LED aligned with and spaced apart from the nozzle 128 dispensing axis. In the embodiment shown in FIG. 3, the light source 116 can also be described as being behind the nozzle 128.

[0024] 4 is a schematic diagram of an exemplary drug delivery mechanism 200 of an ophthalmic drug applicator in at least one embodiment of the present disclosure. The mechanism includes a baffle / collimator 217, a nozzle 228, a transparent, elastically deformable wall or membrane 224, a fluid chamber 226, a refresh channel 229, and a light source 216 configured to emit a light beam 225 through a rotating strike arm 218 or actuation hammer. In one example, the light source 216 is an SMD RGB LED package. To ensure accurate alignment of the ophthalmic drug applicator, it is advantageous to mount the LED 216 behind the fluid chamber 226 and membrane 224 and outside the range of motion of the striker 218 used to actuate the fluid through the nozzle 228, but in line with the nozzle 228, i.e., with a direct line of sight to the nozzle jet.

[0025] The angular range or spread of the light beam 225 is determined in part by the aperture slit width and thickness W and the offset distance Dl of the nozzle 228 to the LED aperture slit. This range may be desirable to be narrower than the acceptance angle for aiming the ocular medication applicator at the orbit and the natural acceptance angle of the myopic ray relative to the fovea.

[0026] As long as the LED signal is not directly over the color vision centers (cones) of the eye, the light intensity can be adjusted so that under normal conditions the ambient light dominates the signal received at the fovea, which has an acceptance angle of about ±2 degrees at maximum visibility, instead of black and white (rods) which have a much larger acceptance angle (~120 degrees). In practice, this can mean that the current used to power the light source can be very low, in the range of 10-20 mA, and function at millicandela level output.

[0027] In one example, with a typical fovea (nearly circular) with a radius of about 2.5 mm and a focal length of the human eye of about 17 mm, the angular acceptance range of light hitting the fovea (for device rotation, shown as rotation angle θ in FIG. 4) is approximately ±8.36 degrees. This value is for illustration purposes only, and the exact value of the angular tolerance may depend on several additional parameters. If the light is placed on the opposite side of the applicator (opposite the side closest to the eye) and the applicator is placed about 15 mm wide and 15 mm from the surface of the eye, the total distance from the LED to the eye is 30 mm. Since the nozzle is only 15 mm from the eye, this 8.36 degree angle results in a strike distance of only ±2.2 mm off-center for the human eye. Since MRD1 and MRD2 are typically about 4 mm for adult humans, there is a margin of about 2 mm for aiming error. An angle of ±8.5 degrees may be tolerated. By placing a defined aperture of a metal laser pattern on the SMD RGB LED package, the natural angle tolerance of the RGB LED can be significantly less than ±8.3 degrees. With a nozzle slit width of 300 micrometers (μm), a baffle / collimator slit width of 300 μm, and a distance Dl of about 10 millimeters (mm) or more, the natural angular range of the LED light passing through the nozzle is about ±0.03 radians or ±1.7 degrees, and thus the tolerance of angular deviation when aiming the nozzle at the eye is limited only by the diameter of the human fovea. Other larger and smaller width alignment slits may be used, including values ​​between about 100 μm and about 500 μm, for example.

[0028] In reality, a user's perception of light source alignment may be even more sensitive than these calculations suggest. For example, a user may perceive increased brightness and sharper visibility when the light source is correctly aimed, allowing the user to more accurately orient and aim the applicator toward the center of the eye. Thus, an LED placed an appropriate distance behind and aimed directly through the nozzle provides a reliable targeted user interface for ocular drug applicators.

[0029] 5 is a front view of an exemplary nozzle 328 with an LED 316 showing the LED 316 emitting light through the nozzle in accordance with at least one embodiment of the present disclosure. The light is buffled so that it is only visible through a slit in the nozzle 328. In some embodiments, the LED 316 is in line with the slit. In other embodiments, the LED 316 may be positioned above or below the plane of the slit, and an angled mirror in line with the slit may reflect the light into the nozzle 228.

[0030] Further, an optical proximity sensor can be used to estimate the distance to the eye. In this regard, FIGS. 6A and 6B show an embodiment of the nozzle 37 of the drug delivery mechanism including blink detection and proximity sensing. In this regard, the proximity sensor can be used to measure the distance to the eye, detect blinks, or both. The blink detector 295 includes two reflective proximity sensors 350 and 355 in a paired arrangement to verify proper eye targeting and also detect blinks. In some embodiments, the sensors 350 and 355 are located on either side of the nozzle 37. In some embodiments, each sensor 355 and 350 includes an LED and a photodiode (as shown in FIG. 5C as 355a and 355b). In some embodiments, the two sensors 350 and 355 are optical proximity infrared sensors configured to detect the presence of a figure and determine whether a blink has occurred. In some embodiments, the sensors 350 and 355 are reflective proximity sensors with lens focusing and surface mount technology packaging. In some embodiments, the sensors 350 and 355 are OPB733TR sensors manufactured by TT Electronics, Carrollton, Texas, USA, or HSDL-9100 sensors manufactured by Avago Technologies, San Jose, California, USA, although the sensors 350 and 355 may be any LED and photodiode detector. In some embodiments, the sensors have a molded package surface over the top surface of the microlens to provide a convenient surface onto which the microprism 365 can be attached at an angle of about 30 degrees. Typically, the sensors 350 and 255 register a balanced threshold signal indicative of alignment to the eye 127 and the distance to be within the target range to the eye 127. In some embodiments, the target range to the eye is between about 10 mm and about 30 mm. In some embodiments, L is between about 15 mm and 20 mm.

[0031] Although reflections from the eye 127 can be detected at a range of 15-25 mm, predicted spatial orientation and alignment will often be inaccurate when based on information from only one optical proximity pair (i.e., LED and photodiode combination). Therefore, placing the two sensors 350 and 355 at equal distances from the nozzle 37 will result in comparable off-axis reflection signals. Typically, a user can point the device horizontally very accurately and align it horizontally, but will have poor judgment when it comes to vertical angle and vertical spatial targeting. Furthermore, the eye 127 typically has only an 8-9 mm gap between the eyelids, while the eye 127 has an 18 mm gap in the horizontal sclera. Therefore, the horizontal scleral gap is much larger than the gap between the eyelids. Furthermore, due to the natural curvature of the eye (typically 11.5-12.5 mm radius), it would be difficult and costly to direct most of the light perpendicular to the eye 127 to optimize the reflected signal strength without mounting an optical proximity sensor on an inclined or curved substrate. Therefore, the blink detector 295 also includes microprisms 360 and 365 that direct the light perpendicular to the scleral and corneal surfaces of the eye 127, greatly increasing the reflection of the interrogation beam when the eye 127 is at an optimal distance and position perpendicular to those two paths. Thus, the sensors 350 and 355 and the microprisms 360 and 365 can be used as electronic means to detect optimal alignment of the nozzle 37 relative to the eye and blink detection.

[0032] When the nozzle 37 includes multiple apertures, for example 8-10 apertures of about 300 μm diameter, and is appropriately spaced to allow for the nozzle cone angle and low hydraulic losses, the array dimension 120a is about 14 mm. Thus, in some embodiments, the sensors 350 and 355 and their respective microprisms 360 and 365 are about 18 mm apart. However, the spacing of the sensors 350 and 355 may be based on the size of the cartridge and nozzle 37. For example, a single horizontal slit nozzle may allow for a separation of 16 mm. In some embodiments, the arrangement allows for an optimal microprism angle α for the glass (n=1.5) that maximizes the scattering of the reflected light back to the photodiode detectors of the sensors 350 and 355. The associated calculated optimal prism angle is close to 30 degrees, which is a commonly available low-cost angled prism. Because the prism angle is perpendicular to the arrangement of the photodiode detectors, there is no risk of back reflections from the prism surface returning from the LEDs to the photodiode detectors. In some embodiments, microprisms 360 and 365 are omitted.

[0033] In the vertical direction, as long as the LED light beam divergence is within the very typical ±20 degree range, a sufficient signal is obtained if the light is not pointed high or towards the upper or lower eyelid as shown in Figure 5C.

[0034] If the applicator is too far away (e.g., greater than 20 mm), the color of the light source may change, for example to flashing red or yellow, and may change to green or blue when the device is close enough to be within range. Blue / orange may be used as a color range for color blind people. Alternatively, blue / red may be used. However, any suitable color and / or color combination may be used, including green, purple, yellow, white, etc.

[0035] 7A illustrates an LED configuration 360 for use in an ocular drug applicator in at least one embodiment of the present disclosure. Many multi-color LED packages, such as monolithic SMD RGB LEDs, may include three separate LEDs, red, green, and blue, mounted in a single monolithic package. This may not meet the alignment required for an ocular drug applicator, and therefore the detailed package specifications of the desired RGB LED are further defined and refined as follows:

[0036] In the example shown in FIG. 7A, the LED package 366 includes a case 362 with a transparent or translucent cover 364 and a string of multi-color LEDs 366 (e.g., three LEDs) that create a line of illumination rather than a spot. One such example is Osram's LRTB GVTG. By changing the relative current through each LED 366, different colors can be programmed in the RGB LEDs with a simple LED driver. The intensity can be modulated by changing the on duty cycle with high frequency pulse width modulation, or the intensity can be modulated directly by programming the drop current of each of the three color LEDs mounted in a single package. In one example, the separate RGB LED chips are arranged in the package along a single line, and the transparent cover 364 is a diffuse white package with a flat top surface to optimize uniformity across the line. Advantageously, all three individual LEDs may be mounted in a single row or column (rather than in two dimensions) with the long dimension of the row aligned with the long dimension of the nozzle's slit, so that a single slit aperture placed on the package will affect the amplitude of the light evenly, with a horizontal slit collimating each color of light along the same line as shown in the example of FIG. 4.

[0037] It may also be desirable to have a diffuse planar lens package style that provides a uniform light source, providing a planar black aperture that can be easily mounted directly above the LED package. Additionally, a white backscattering reflector surface is optimal to diffuse the light uniformly across the package. In one example, the length of the package along the direction in which all three LED chiplets are aligned is greater than 2 mm.

[0038] Figure 7B illustrates another LED configuration 460 for use in an ocular medication applicator in at least one embodiment of the present disclosure. The LED 460 includes a plurality of monochromatic LEDs 466 arranged in a two-dimensional array and a curved transparent lens 464, all mounted in a case 462. It will be appreciated that the configuration illustrated in Figure 7B may result in differences in the angular range of the beams formed by the different colored LEDs into the slit of the horizontal nozzle, and therefore the packaging in Figure 7A.

[0039] In some embodiments, the light source of the applicator device described herein can have a brightness of 20cd*(3E-2)^2 to 18mcd or more. Examples of low-cost RGB LED packages that can be incorporated include, for example, Osram's LRTB GVTG.

[0040] In other embodiments, the exterior parts of the applicator body that come into contact with the patient's skin are made of polycarbonate, silicone, or polyurethane that is overmolded with medical grade TPSIV.

[0041] 8 is a perspective view of a reusable and replaceable ophthalmic drug applicator cartridge according to at least one embodiment of the present disclosure. The ophthalmic drug applicator cartridge is configured to be placed in an ophthalmic drug applicator having one or more components for discharging fluid from the cartridge. The cartridge includes a transparent or translucent membrane 404, a nozzle 408, a nozzle cover 406, a fluid chamber, a drug reservoir 402, and a label area 410. The drug reservoir 402 is in fluid communication with the fluid chamber, which may be partially defined by the nozzle 408 and the membrane 404, as described above. The size of the opening of the nozzle 408 may be small enough such that the surface tension of the pharmaceutical fluid to be dispensed retains the fluid within the fluid chamber 402 without substantially leaking through the nozzle 408.

[0042] In one example, the nozzle 408 and nozzle chamber are made of molded gamma-safe polypropylene, and the drug reservoir is made of blow-fill-seal polypropylene and includes one or more medical grade sterile polypropylene filters with pore sizes of 0.1-0.2 μm. However, any suitable material may be used. Functional coatings on the drug contact areas may include silver coatings, other antimicrobial coatings, hydrophilic surfaces, and antimicrobial properties, while the nozzle may include a fluoropolymer hydrophobic medical device coating. The exterior film may be non-functionalized or may include cartridge pull tabs, cartridge flap seals (shipping seals), labels, bar codes, and data matrices made from 3M medical grade LSE tape. The transparent flexible membrane may be made of, for example, PETE, PTFE, or polypropylene. The interior surfaces of the cartridge that come into contact with the drug, including the membrane, may include a medical grade hydrophilic coating.

[0043] Some embodiments do not include a replaceable cartridge, and all components of the replaceable cartridge are incorporated into the applicator body. In other embodiments, some, but not all, components of the cartridge shown in FIG. 8 are incorporated into the applicator body. For example, in some embodiments, the nozzle, fluid chamber, and elastomeric cover are part of the applicator body, while the drug reservoir is part of the removable cartridge.

[0044] 9 and 10 show the dispensing portion of an ocular drug applicator at various stages of use. In some embodiments, the ocular drug applicator shown in FIG. 9 and 10 may have a removable ocular drug applicator cartridge disposed within the applicator body.

[0045] 9 is a perspective view of a portion of an ophthalmic drug applicator in an actuation stage according to at least one embodiment of the present disclosure. The cap or cover is open and a transparent, elastically deformable wall or membrane 412 is depressed (e.g., by the actuation hammer of FIG. 4) to force fluid out of the nozzle chamber 414 into a stream. In this state, the hammer blocks the light source, which may be turned off to conserve power. Note that the aiming LED light source also provides a convenient way to measure the presence of the hammer in this activated state by tracking the internal reflection of light within the applicator and placing a photodiode there. Thus, the presence or absence of a cartridge or the presence or absence of a hammer placement may also be sensed utilizing the aiming LED.

[0046] 10 is a perspective view of a portion of an ophthalmic drug applicator in a capped and refilling position according to at least one embodiment of the present disclosure, where the cap is replaced and negative pressure against the elastically deformable wall or membrane 412 (e.g., by pulling down on the actuation hammer of FIG. 4) draws fluid into the nozzle chamber 414 (e.g., from a drug reservoir via a refresh flow path).

[0047] The spray profile provided by the devices described herein may have various geometric or spatial characteristics that are beneficial for ophthalmic treatment applications. In one example, such a close-range spray profile is substantially elliptical with a width smaller than the width of the eye, thereby allowing the spray to cover the eye as a thin coating. In some embodiments, the range between the nozzle and the eye is desirably, for example, 10 mm to 20 mm. In that regard, the nozzle may be sized, shaped, and structurally configured to form a wide spray pattern of a fluid having a particular viscosity within a particular application range or distance.

[0048] 11 is a schematic diagram of an ocular drug applicator in one embodiment of the present disclosure. As with the above-described embodiments, the applicator includes a housing or enclosure 510 that contains a reservoir 522 containing a drug solution, an actuator 520, a battery 535, and a circuit assembly 511 having a connector 513 and a light source 516 mounted on a board. In the illustrated embodiment, the actuator 520 has a solenoid 529 configured to actuate the piston head 518, also referred to as a light guide, to strike or strike a membrane 524 to expel fluid in a chamber 526 through a nozzle or slit 528. As above, the chamber 526 can be filled with drug solution from the drug reservoir 522. In some embodiments, the drug reservoir 522 includes a replaceable cartridge or bottle that includes a chamber 526, a membrane 524, and a nozzle 528. The solenoid head 518 is sized and shaped to deform the membrane 524 into the chamber 526. It will be appreciated that in the embodiment of FIG. 11, the solenoid 529 is aligned with the flow axis of the nozzle 528. Thus, the light source 516 is disposed on the head 518 and configured to direct a beam of light onto a diagonal surface 519 of the head 518. The diagonal surface 519 is reflective and angled such that the beam of light is reflected along the beam path to the slit 528. Light emitted from the light element 516 is reflected downward toward the reflective surface 519 by a light directing element, described below. In the illustrated embodiment, the diagonal surface 519 is oriented at an angle of 45 degrees relative to the dispense axis 515 of the slit 528, with the light source 516 disposed directly below the diagonal surface 519. However, other configurations are contemplated. For example, the diagonal surface 519 may be oriented at an angle other than 45 degrees, and may be greater or less than 45 degrees. Additionally or alternatively, the light source 516 may be offset from the head 518 of the solenoid 529 such that the axis of the light source 516 is oblique to the dispense axis of the nozzle 528 .

[0049] Figure 12 is a perspective view of a portion of the medication applicator 500 shown in Figure 11. As shown in Figure 12, the light directing element 523 may include a diagonal mirror or other optical component configured to direct light from a light element 516 mounted on the substrate of the circuit assembly 511 downward toward an opening in the solenoid head 518. The light from the light element 516 may then pass through the membrane 524 and nozzle 528 as described above with respect to Figure 11.

[0050] 13A and 13B show a piston head 518 that includes a sloped reflective surface 519 that directs light from a light element (e.g., 516 in FIG. 12) along a flow axis 515 and out a distal opening 534. In some embodiments, the piston head 518 is also referred to as a light directing element. The light directing element 518 includes a first opening 532 on a top side of the element 518 and a second or distal opening 534 on a distal side of the element 518. FIG. 13B is a cross-sectional view of the element 518 showing that the element 518 includes a sloped reflective surface 519 therein. The element may include a polymer and may be injection molded such that the surface 519 is smooth and shiny, providing coherent reflection for light exiting the distal opening 534. As explained above, element 518 is configured to reflect light along an axis 515 that is parallel or coextensive with the flow axis of the nozzle (eg, 528 in FIG. 12).

[0051] FIG. 14 is a schematic diagram of an ocular drug applicator 600 in one embodiment of the present disclosure. Similar to the embodiment of FIG. 11, the applicator 600 includes a housing or enclosure 610 that contains a reservoir 622 containing a drug fluid, an actuator 620, and a light source 616. In the illustrated embodiment, the actuator 620 is configured to directly impact or strike a membrane 624 to expel fluid in a chamber 626 through a nozzle or slit 628. As also described above, the chamber 626 can be filled with pharmaceutical fluid from the drug reservoir 622. In some embodiments, the drug reservoir 622 includes a replaceable cartridge or bottle that includes the chamber 626, the membrane 624, and the nozzle 628. In an exemplary embodiment, the actuator 620 includes a solenoid, and the head 618 of the solenoid piston is sized and shaped to deform the membrane 624 into the chamber 626. In the embodiment of FIG. 14, a reflective diagonal surface 619 is disposed on the outer angled surface of the head 618. In the illustrated embodiment, the diagonal surface 619 is oriented at an angle of 45 degrees relative to the dispensing axis of the slit 628. However, other configurations are contemplated. For example, the diagonal surface 619 may be oriented at an angle other than 45 degrees, or may be greater or less than 45 degrees. Additionally or alternatively, the light source 616 may be offset from the piston head 618 such that the axis of the light source 616 is oblique to the dispensing axis of the nozzle 628.

[0052] In some embodiments, the light source 620 includes focusing optics, baffles, or other optical components configured to limit the angular divergence of the beam of light generated by the light source 620. In the illustrated embodiment, the beam 615 is configured to reflect off the reflective surface 619 when the actuator 620 is in a retracted state. In other embodiments, the light source 620 can be configured to direct the beam of light 615 toward the reflected light when the actuator 620 is in other actuation stages. In some embodiments, the shape of the chamber 626 matches the shape or profile of the head 618 such that the membrane 624 deforms to contact the opposing inner surface of the chamber 626 and pass a majority of the fluid in the chamber 626 to the nozzle 62.

[0053] The devices described herein may include additional or alternative components, form factors, or subassemblies. For example, an ophthalmic medication applicator may include a form factor as described in U.S. Patent Application Publication No. 2020 / 0360180, entitled "Non-Gravity Fluid Delivery Device for Ophthalmic Applications," filed May 13, 2020, the entirety of which is incorporated herein by reference.

[0054] As will be readily appreciated by those skilled in the art after becoming familiar with the teachings herein, the ophthalmic drug applicator allows even inexperienced users to apply ophthalmic drugs directly to the eye with high accuracy, repeatability, and success rate. It is thus seen that the ophthalmic drug applicator fulfills a long-standing need in the art by overcoming the shortcomings of existing eye drop delivery systems.

[0055] In embodiments that include a processor, the processor may include any combination of general purpose computing devices, reduced instruction set computing (RISC) devices, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers. In some embodiments, the processor includes memory that stores instructions or information on which the processor operates. The memory may be located on the same board or chip as the processing elements, or may be external to the board or chip that includes the processing elements. The memory may include any combination of read only memory (ROM), programmable read only memory (PROM), electrically erasable read only memory (EEPROM), magnetic or electronic random access memory (RAM), flash memory, removable media, or other related memory types.

[0056] In embodiments involving external communication, including but not limited to software updates, firmware updates, or reads from the device, communication to and from the device can be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as USB, micro USB, Lightning, or a FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax, or 5G. For example, a Bluetooth Low Energy (BLE) radio can be used to establish a connection with a cloud service to transmit data and receive software patches. The controller may be configured to communicate with a remote server or a local device such as a laptop, tablet, or handheld device, or may include a display capable of displaying status variables and other information.

[0057] Communication, if any, within or between the internal electronic components of the ophthalmic drug applicator may be by a number of methods or protocols. Serial communication protocols include, but are not limited to, SPI, I2C, SPI 2.0, SPI 3.0, SPI 4.0, SPI 5.0, SPI 6.0, SPI 7.0, SPI 8.0, SPI 9.0, SPI 10.0, SPI 11.0, SPI 12.0, SPI 13.0, SPI 14.0, SPI 15.0, SPI 16.0, SPI 17.0, SPI 18.0, SPI 19.0, SPI 20.0, SPI 21.0, SPI 22.0, SPI 23.0, SPI 24.0, SPI 25.0, SPI 26.0, SPI 27.0, SPI 28.0, SPI 29.0, SPI 30.0, SPI 31.0, SPI 32.0, SPI 33.0, SPI 29 ... 2 Serial protocols may include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Serial and parallel communications may be bridged as desired by UART, USART, or other suitable subsystems.

[0058] Many variations are possible to the above examples and embodiments. For example, the ocular drug applicator may include an eye blink detection system, color changing LEDs, or dimmable LEDs. This system may be used to deliver drugs to other systems or other orifices of the body, including the nose, mouth, and ears. This device may be used in veterinary medicine or to deliver precise amounts of aerosolized substances for non-medical uses, including, but not limited to, adhesives, lubricants, paints, and dyes.

[0059] Accordingly, the logical operations making up the embodiments of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules, and should be understood to occur or be performed in any order unless expressly claimed or a particular order is inherently required by the language of the claims.

[0060] All directions such as top, bottom, in, out, upward, downward, left, right, side, front, back, top, bottom, upper, lower, vertical, horizontal, clockwise, counterclockwise, proximal, distal, etc. are referenced for the specific purpose of aiding the reader in understanding the subject matter of the claims, and are not intended to be limiting with respect to the position, orientation, or use of the ocular drug applicator specifically. References to connections, such as attached, coupled, connected, and coupled, should be interpreted broadly and may include intermediate members between groups of elements and relative movement between elements, unless otherwise indicated. Thus, references to connections do not necessarily mean that two elements are directly connected and in a fixed relationship to each other. The term "or" should be interpreted to mean "and / or" and not "exclusive or". Unless otherwise stated in the claims, the values ​​listed should be interpreted as merely exemplary and not limiting.

[0061] Generally, any creation, storage, processing, and / or exchange of user data in connection with the methods, devices, and / or systems disclosed herein is configured to comply with various privacy settings, security protocols, and common data regulations, consistent with the handling of confidentiality and integrity of user data as a matter of priority. For example, the devices and / or systems may include modules that implement information security controls to comply with a number of standards and / or other agreements. In some embodiments, the modules receive a selection of privacy settings from the user and implement controls that comply with the selected privacy settings. In other embodiments, the modules identify data that is deemed sensitive, encrypt the data according to any suitable method known in the art, replace sensitive data with code to pseudonymize the data, and otherwise ensure compliance with selected privacy settings and data security requirements and regulations.

[0062] The above specification, examples, and data provide a full description of the structure and use of exemplary embodiments of the ocular drug applicator defined in the claims. Although various embodiments of the claimed subject matter have been described above with a certain degree of particularity or with reference to one or more individual embodiments, those skilled in the art may make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter. For example, various types of power sources may be used to power the electronics, such as batteries, solar cells, springs, external "wall currents," etc.

[0063] Further embodiments are contemplated. All matter contained in the above description and shown in the accompanying drawings is to be interpreted as merely illustrative of particular embodiments and is not intended to be limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter defined in the claims.

Claims

1. 1. A fluid dispensing device comprising: A light source; a nozzle spaced from the light source; a membrane disposed in a beam path of the light source, the membrane configured to pass a portion of the light from the light source to the nozzle; a fluid chamber disposed between the membrane and the nozzle; having the nozzle is configured to allow a portion of the beam of light to pass along the beam path; the nozzle is further configured to form a stream of fluid emitted from the fluid chamber along the beam path. Fluid dosing device.

2. 10. The device of claim 1, wherein the light source has an aligned baffle, the baffle having a first slit width and the nozzle having a second slit width, the first slit width and the second slit width being less than 400 micrometers (μm).

3. 2. The device of claim 1, wherein the beam of light is visible to the human eye when the nozzle is aimed at the human eye within a rotational accuracy of ±8.5 degrees or less when the device is positioned approximately 15 mm from the eye for fluid delivery.

4. 2. The device of claim 1, wherein the nozzle has two adjacent slits spaced less than 1 mm apart, the slits positioned and aligned to transmit light to a user such that when the nozzle is aligned with the human eye, the intensity of light through both slits is perceived as equal.

5. 10. The device of claim 1, wherein the light source comprises a first light emitting diode (LED).

6. 10. The device of claim 1, wherein the light source comprises an integrated LED surface mount package having two or more monochromatic LED dies arranged in an array, the LED surface mount package configured to change from a first color to a second color without affecting the angle of the light along the beam path.

7. 10. The device of claim 1 further comprising: A distance sensor; a processor in communication with the distance sensor; and The processor, Using information from the distance sensor to determine if the distance between the nozzle and a human eye is greater than a threshold amount; in response to determining that the distance is greater than the threshold amount, modifying a visual characteristic of the light source to a first value; In response to determining that the distance is less than the threshold amount, modifying the visual characteristic of the light source to a second value. The device is configured to:

8. 10. The device of claim 1 further comprising: An applicator body, an actuator configured to depress the membrane into the fluid chamber, thereby causing fluid to be expelled from the fluid chamber through the nozzle; The light source; an opening aligned with the nozzle; The applicator body having a cartridge removably disposed within the applicator body, the cartridge comprising: a fluid reservoir in fluid communication with the fluid chamber; The nozzle; The film and The cartridge, The device has:

9. 9. The device of claim 8, wherein the applicator body further comprises: At least one brow engagement portion configured to contact a user's brow arch; at least one cheekbone stop configured to contact a cheekbone of a user; having wherein the light source is visible to a user through the nozzle when the brow stop is in contact with the user's brow arch and the cheekbone stop is in contact with the user's cheekbone.

10. 9. The device of claim 8, wherein the actuator comprises a piston and a head coupled to a distal end of the piston, the head configured to contact the membrane in an actuated position, and the head has an inclined reflective surface positioned relative to the light source such that a beam from the light source is reflected towards the nozzle.

11. 11. The device of claim 10, wherein the head has a first opening adjacent the light source and a second opening at a distal end of the head, and the angled reflective surface is within the head such that a portion of the light enters through the first opening, reflects off the angled reflective surface, and propagates out the second opening.

12. 9. The device of claim 8, wherein the applicator body further comprises one or more optical detectors configured to detect the presence of the cartridge based on internal reflection of light from the light source at the actuator or cartridge.

13. The device of claim 8 , wherein the applicator body includes an activation control, the light source, and the actuator.

14. The device of claim 8 , wherein the cartridge comprises the fluid reservoir, the membrane, the nozzle, and the fluid chamber.

15. The device of claim 8, further comprising an operable nozzle cover coupled to the applicator body and configured to cover the nozzle.

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