Patent Application
20250213390
Embodiments relate generally to devices and methods for treating and monitoring dry eye disease. More particularly, embodiments of the disclosure relate to wearable eye masks that include heating elements to lower meibum viscosity within the Meibomian glands and ducts, and tuned harmonic resonance or non-resonance frequency stimulation vibration generators for providing vibration induced shear thinning and liquefaction of meibum, mobilization of meibum within the eyelid's Meibomian gland ducts, and for activating the lacrimal functional unit to effect neuromodulation of additional tear production including expression of shear-thinned and liquified meibum from the Meibomian glands.
Eye patch devices are known in the art. For example, U.S. Pat. No. 4,682,371 (“the '371 patent”) describes a protective eye patch. The patch described in the '371 patent includes several tabs for securing the patch to a patient's eye. U.S. Pat. No. 3,068,863 describes a patch designed to keep the eye closed. U.S. Pat. No. 3,092,103 describes a patch with a cushion material at the edge that allows the patient's eye to move underneath the eye patch. U.S. Pat. No. 3,908,645 describes an ophthalmic therapeutic pressure bandage with a conformable, permeable carrier tape.
U.S. Pat. No. 6,409,746 describes an eye pillow that releases steam from its surface applied to the eyes and the area around the eyes. The temperature described in the '746 patent is 50° C. or lower and has a total weight of 50 g or more.
Several conditions exist for which medical and cosmetic therapy is appropriate. For example, Meibomian gland dysfunction, blepharitis, meibomitis, chalazia, and/or styes are common disorders of the eyelids that cause chronic inflammation in the peri-orbita and are often associated with ocular tear film abnormalities resulting in dry eye disease and symptoms. Symptoms of dry eye disease and blepharitis include burning, itching, light sensitivity, blurred vision, poor vision quality, tearing, and foreign body sensation. Signs include tear film instability, eyelash crusting, ocular discharge, eyelid scaling and swelling, corneal epithelial cell damage as evidenced by vital dye staining, and eyelid margin and conjunctival redness. For example, staphylcoccal blepharatis is often associated with scaling and crusting along the eye lashes. There is no cure for dry eyes, and long-term treatment is required to keep it under control.
The predominant cause of dry eye is an insufficient or abnormal lipid layer of the surface of the tear film. In a healthy eye, this oily layer inhibits the evaporation of the water-based sub layer of the tear film, thereby maintaining a stable tear film. These lipids are produced in the Meibomian gland ducts located in the eyelids. From about 24 to about 40 Meibomian gland ducts exist in each eyelid. For those suffering evaporative dry eye disease, the likely root cause is Meibomian gland ducts that have become filled with viscous lipids, and occasionally clogged, resulting in a reduced quantity and abnormal quality of lipids flowing out onto the tear film. Meibomitis, also known as Meibomian Gland Dysfunction (MGD), is a dysfunction of the Meibomian gland ducts and limits the gland's ability to provide a normal lipid-based oily layer as a critical component of the eye's natural tear film.
Currently available treatments for dry eye disease and related conditions include warm compresses for 5-15 minutes, such as a warm washcloth or an Eyedetec Medical EyeGiene® Insta-Warmth heater, that heats the debris and crust on the lid, and lowers the viscosity of the lipids in the Meibomian gland ducts. After the lid has been warmed, occasionally a lid scrub is performed by using a suitable soap, such as Neutrogena® or Johnson's Baby Shampoo®. Commercially available cleansing pads are available to assist in performing the lid scrub, for example OCuSOFT® Lid Scrubs or Novartis Ophthalmics Eye Scrub®. Following the eye scrub, antibiotics, such as polysporin, tobramycin, or erythromycin, can be applied to alleviate patient discomfort and reinforce the treatment.
Warm compress therapy applied to the skin of the closed eyelids increases tear-film lipid layer thickness for subjects with MGD by more than 80% after 5 minutes of initiating treatment and an additional 20% after 15 minutes of treatment. The transition temperature from a solid to a liquid for Meibomian lipids is a range from 28° C. to 32° C. because of differences between an individual's mixture of lipids. The temperature of the eyelids will therefore affect the liquidity of Meibomian lipids and hence their viscosity. The non-Newtonian lipid mixture is known to undergo shear thinning when exposed to shear forces. Further it is known that oscillations enhance the flow rate of a shear-thinning fluid.
Conventional ocular heating devices, such as warm compresses, typically require an external power source. These sources include electricity, a stove top boiling preparation, or a microwave appliance, and are consequently difficult to provide a controlled temperature to the eyelids, are labor intensive, cumbersome, and inconvenient, and therefore historically result in poor patient compliance and persistence with the recommended therapy. Some success is realized with in-office, doctor-assisted visits.
What is needed is a convenient, accurate, and effective, easily used hand moldable heating source that patients or their doctors apply via a coupling mechanism to a patient's eyelids, and which delivers a therapeutic temperature to the entire eyelid surface independent of the individual's orbital anatomy, for a sufficient length of time to be effective. There is also a need for a device or component of the system that incorporates a moldable material to serve as a coupling element, able to sequentially and alternately deliver heat and tuned harmonic resonance or non-resonance frequency stimulation vibration to the target tissue across the entire surface of the user's eyelid and periorbital structures, as well as to optionally detect a positive eyelid resonant response from a broad range of generated harmonic frequencies, thus allowing a personalized or custom approach to each individual user. There is also a need for a device or component of the system incorporating a neurostimulation unit to deliver tuned harmonic resonance or non-resonance frequency stimulation vibration to the sensory nerves in the nasal area to induce neuromodulation of the tear production reflex including Meibomian gland expression.
Embodiments provide a moldable warming device, including: a heating disc; a pair of stimulation vibration generators; a coupling device; and an ocular and periocular treatment platform, the ocular and periocular treatment platform being head mounted and forehead stabilized. The moldable warming device is configured to sequentially and alternately apply therapeutic warmth to meibum within each Meibomian gland duct in all four eyelids and, and further configured to simultaneously apply tuned harmonic resonance or non-resonance frequency stimulation vibration according to the determined tuning parameters across the contour of the entire surface of the user's four eyelids and periorbital structures and across the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, to induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film. The pair of stimulation vibration generators is configured to generate the tuned harmonic resonance or non-resonance frequency stimulation vibration including a longitudinal vibrational wave across the contour of the entire surface of the user's four eyelids and periorbital structures, wherein a primary axis of the vibrational wave is in a medial-lateral direction tangential to the depth of each user's Meibomian gland duct, to induce shear thinning and liquefaction of meibum within each Meibomian gland duct in all four eyelids, improving the lipid layer of the surface of both of the user's eyes' tear film upon expression. The heating disc is configured to deliver 40-45° C. of heat to the meibum within each Meibomian gland duct, an amplitude of the tuned harmonic resonance or non-resonance frequency stimulation vibration delivered in the medial-lateral direction tangential to the depth of each user's Meibomian gland duct is between 10-30 microns, a frequency spectrum of the tuned harmonic resonance or non-resonance frequency stimulation vibration generated by the pair of stimulation vibration generators is set between 50 Hz to 300 Hz, and a waveform of the tuned harmonic resonance or non-resonance frequency stimulation vibration generated by the pair of stimulation vibration generators is selected from one of a square wave, a sinusoidal wave, or a triangular wave.
According to an embodiment, the moldable warming device further includes a sensor array, the sensor array configured to determine tuning parameters of a vibration and heating profile of a user's individual eyelid, periorbital, and nasal three-dimensional anatomy and surface topography. The moldable warming device is configured to sequentially and alternately apply the therapeutic warmth to meibum within each Meibomian gland duct in all four eyelids, and further configured to simultaneously apply the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures, according to the determined tuning parameters. The moldable warming device is further configured to simultaneously apply the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, based on the determined tuning parameters, to stimulate the trigeminal nerve to induce tear production reflex in the user's lacrimal functional unit to thereby induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film.
According to an embodiment, the moldable warming device further includes a pair of removable and reusable eye pads, each eye pad including a miniaturized optical coherence tomography device configured to generate cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, even at the back of a user's eye; and determine a frequency-domain measurement of spectral interference which allows for greater acquisition speed and greater contrast in the resulting images of the periocular surface of the user's eyes.
According to an embodiment, the moldable warming device further includes feedback controlled mechanical gearing configured to locate a position for each eye pad based on the structural imaging of the user's periocular surface.
According to an embodiment, the moldable warming device further includes a plurality of manual adjustment wheels, each manual adjustment wheel configured to produce tactile feedback to the user of the moldable warming device allowing the user to manually adjust each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids.
According to an embodiment, each eye pad includes a module insert configured to perform advanced diagnostic enabled imaging, the module insert including one of: a corneal staining pad, the corneal staining pad being one of a corneal fluorescein staining pad or a corneal rose bengal staining pad with illumination of selectable variable wavelengths, the corneal staining pad configured to detect dry eye syndrome, a tear interferometer configured to measure a tear meniscus in the user's eyes, a conjunctival redness measurement pad configured to diagnose and assess a level of conjunctival redness in the user's eyes, a tear breakup time measurement pad configured to measure tear breakup time in the user's eyes, a blink rate measurement pad configured to assess blink rate and completeness of blink cycle of the user's eyes for maintaining tear film stability and for sustaining tear film homeostasis, an intraocular cell and flare measurement pad configured to measure intraocular cell and flare in the user's eyes, and an intraocular pressure measurement pad configured to measure intraocular pressure in the user's eyes.
According to an embodiment, the pair of eye pads are configured to provide cold compress for inflammation reduction.
According to an embodiment, the pair of eye pads further include a surface available to hold hydrogel sheets or moisturized cotton pads, the hydrogel sheets or the moisturized cotton pads containing one of water moisture alone, impregnated anti-inflammatory agents including steroids or non-steroidal anti-inflammatories, or therapeutic agents for treating conditions including blepharitis, demodex, or eyelid wrinkles.
According to another embodiment, there is provided a method for ophthalmic eyelid therapy. The method includes the step of applying a moldable warming device to a user's individual eyelid, periorbital, and nasal three-dimensional anatomy and surface topography. The moldable warming device includes a heating disc, a pair of stimulation vibration generators, a coupling device, and an ocular and periocular treatment platform configured to hold the heating disc, the pair of stimulation vibration generators, and the coupling device for use in parallel utility, whereby the ocular and periocular treatment platform being head mounted and forehead stabilized. The method further includes the steps of: sequentially and alternately applying, using the heating disc, therapeutic warmth to meibum within each Meibomian gland duct in all four eyelids, and further simultaneously applying, using the pair of stimulation vibration generators, tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures to induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film; and simultaneously applying the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, to stimulate the trigeminal nerve to induce tear production reflex in the user's lacrimal functional unit to thereby induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film. The pair of stimulation vibration generators is configured to generate the tuned harmonic resonance or non-resonance frequency stimulation vibration including a longitudinal vibrational wave across the contour of the entire surface of the user's four eyelids and periorbital structures, whereby a primary axis of the vibrational wave is in a medial-lateral direction tangential to the depth of each user's Meibomian gland duct, to induce shear thinning and liquefaction of meibum within each Meibomian gland duct in all four eyelids, improving the lipid layer of the surface of both of the user's eyes' tear film upon expression. The heating disc is configured to deliver 40-45° C. of heat to the meibum within each Meibomian gland duct, an amplitude of the tuned harmonic resonance or non-resonance frequency stimulation vibration delivered in the medial-lateral direction tangential to the depth of each user's Meibomian gland duct is between 10-30 microns, a frequency spectrum of the tuned harmonic resonance or non-resonance frequency stimulation vibration generated by the pair of stimulation vibration generators is set between 50 Hz to 300 Hz, and a waveform of the tuned harmonic resonance or non-resonance frequency stimulation vibration generated by the pair of stimulation vibration generators is selected from one of a square wave, a sinusoidal wave, or a triangular wave.
According to an embodiment, the moldable warming device further includes a sensor, the method further including the step of determining, via the sensor, tuning parameters of a vibration and heating profile of the user's individual eyelid, periorbital, and nasal three-dimensional anatomy and surface topography, whereby the steps of sequentially and alternately applying the therapeutic warmth to meibum within each Meibomian gland duct in all four eyelids, and further simultaneously applying the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures is according to the determined tuning parameters, and whereby the step of simultaneously applying the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, is based on the determined tuning parameters, to stimulate the trigeminal nerve to induce tear production reflex in the user's lacrimal functional unit to thereby induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film.
According to an embodiment, each eye pad includes a miniaturized optical coherence tomography device. The method further includes the steps of, using the miniaturized optical coherence tomography device, generating cross-sectional images with high axial resolution for tissue diagnosis, thereby imaging a user's retina, in real-time, even at the back of a user's eye; and determining a frequency-domain measurement of spectral interference which allows for greater acquisition speed and greater contrast in the resulting images of the periocular surface of the user's eyes.
According to an embodiment, the moldable warming device further includes a plurality of manual adjustment wheels. The method further includes the step of manually adjusting, using each manual adjustment wheel configured to produce tactile feedback to the user of the moldable warming device, each eye pad to conform the pair of eye pads to the periocular surface of the user's eyelids.
According to an embodiment, each eye pad includes a module insert. The method further includes the steps of: performing, using the module insert, advanced diagnostic enabled imaging, whereby the performing step includes: detecting, using a corneal staining pad, the corneal staining pad being one of a corneal fluorescein staining pad or a corneal rose bengal staining pad with illumination of selectable variable wavelengths, dry eye syndrome, measuring, using a tear interferometer, a tear meniscus in the user's eyes, diagnosing and assessing, using a conjunctival redness measurement pad, a level of conjunctival redness in the user's eyes, measuring, using a tear breakup time measurement pad, tear breakup time in the user's eyes, assessing, using a blink rate measurement pad, blink rate and completeness of blink cycle of the user's eyes for maintaining tear film stability and for sustaining tear film homeostasis, measuring, using an intraocular cell and flare measurement pad, intraocular cell and flare in the user's eyes, and measuring, using an intraocular pressure measurement pad, intraocular pressure in the user's eyes.
According to an embodiment, the pair of eye pads are configured to provide cold compress for inflammation reduction.
According to an embodiment, the pair of eye pads further includes a surface available to hold hydrogel sheets or moisturized cotton pads, the hydrogel sheets or the moisturized cotton pads containing one of water moisture alone, impregnated anti-inflammatory agents including steroids or non-steroidal anti-inflammatories, or therapeutic agents for treating conditions including blepharitis, demodex, or eyelid wrinkles.
According to another embodiment, there is provided a method for ophthalmic eyelid therapy. The method includes the step of applying a moldable warming device to a user's individual eyelid, periorbital, and nasal three-dimensional anatomy and surface topography. The moldable warming device includes a heating disc, a pair of stimulation vibration generators, a coupling device, and an ocular and periocular treatment platform configured to hold the heating disc, the pair of stimulation vibration generators, and the coupling device for use in parallel utility, whereby the ocular and periocular treatment platform being head mounted and forehead stabilized. The method further includes the steps of: sequentially and alternately applying, using the heating disc, therapeutic warmth to meibum within each Meibomian gland duct in all four eyelids, and further simultaneously applying, using the pair of stimulation vibration generators, tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures to induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film; and simultaneously applying the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, to stimulate the trigeminal nerve to induce tear production reflex in the user's lacrimal functional unit to thereby induce expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film. The pair of stimulation vibration generators is configured to generate the tuned harmonic resonance or non-resonance frequency stimulation vibration including a longitudinal vibrational wave across the contour of the entire surface of the user's four eyelids and periorbital structures, whereby a primary axis of the vibrational wave is in a medial-lateral direction tangential to the depth of each user's Meibomian gland duct, to induce shear thinning and liquefaction of meibum within each Meibomian gland duct in all four eyelids, improving the lipid layer of the surface of both of the user's eyes' tear film upon expression. The therapeutic warmth is applied to meibum within each Meibomian gland duct in all four eyelids for 2 minutes at 43° C.+/−2° C., followed by the applying of the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures, and the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, for 30 seconds at 140 Hz to 169 Hz, followed by applying the therapeutic warmth again for 2 minutes at 43° C.+/−2° C., followed by applying the tuned harmonic resonance or non-resonance frequency stimulation vibration again for 30 seconds at 170 Hz to 200 Hz, and repeating this sequential and alternating application of the therapeutic warmth and the tuned harmonic resonance or non-resonance frequency stimulation vibration two more iterations, resulting in a total treatment of 15 minutes.
So that the manner in which the recited features, aspects, and advantages of the disclosure, as well as others that will become apparent, are attained and can be understood in detail, a more particular description of certain embodiments briefly summarized above can be had by reference to the embodiments that are illustrated in the drawings that form a part of this specification. It is to be noted, however, that the appended drawings illustrate only exemplary embodiments and are, therefore, not to be considered limiting of the disclosure's scope, for the disclosure can admit to other equally effective embodiments. Like numbers refer to like elements throughout, and the prime notation, if used, indicates similar elements in alternative embodiments or positions.
While the scope of the system and method will be described with several embodiments, it is understood that one of ordinary skill in the relevant art will appreciate that many examples, variations and alterations to the systems and methods described here are within the scope and spirit of the embodiments.
Accordingly, the embodiments described are set forth without any loss of generality, and without imposing limitations, on the embodiments. Those of skill in the art understand that the scope includes all possible combinations and uses of particular features described in the specification.
As used throughout, one of ordinary skill in the relevant art would understand that the following terms can all be used interchangeably: dry eyes, dry eye disease, dry eye syndrome, evaporative dry eye, lipid deficiency dry eyes, blepharitis, Meibomian gland disease, Meibomian gland dysfunction, and MGD.
Referring now to the disclosed devices in more detail, in
In further detail, still referring to the devices disclosed in
The desired heating disc integrity and heating duration are achieved by controlling disc thickness, formulation of the heating material, and porosity that allows controlled air flow to the heating material. Ideal time for application of heat is in a range from about 5 to 30 minutes, preferably from about 5 to 15 minutes and temperature at the surface of the eyelid should be between about 40 and 46° C. Example polyethylene (PE) based materials with a usable 25-60 μm pore size (PE25 through PE60) are shown in Table 1.
A nominal pore volume of 50% will allow the heating disc 100 to be reshaped or molded by the patient. The porous and moldable PE based material can have nominal pore sizes of 7-150 μm and are manufactured up to 300 μm in pore size. Another polyolefin material, polypropylene (PP), (PP-100 and PP150), shown in Table 1, is a heating disc material with 100-150 μm pore size with a smaller 45% pore volume, and can be infused with larger heater material particles for a longer disc heating time of 20-25 minutes.
The heating disc 100 may be made of a broad combination of the ingredients resulting in a sufficiently rigid and strong molded material that can hold its shape, yet is easily hand moldable to the closed eyelid surface for optimal therapeutic effect. The material porosity allows a heating material to reside in the pathways with access to air at between 10-90 ft/min @1.2″ H2O ΔP, where the material is between 0.125″ (3.175 mm) and 0.250″ (6.35 mm) thick with enough porosity space to adhere sufficient heating material to the support surface and internal sites. Further, the various ingredients of the disc can be substituted for different materials by shape and size to control the heating rate, total thermal energy converted and delivered, and longevity of the heat conversion.
The construction details of the heating disc 100 shown in
Still referring to
In more detail, still referring to the heating disc 100, the disc shown in
In further detail, referring to the heating disc 100 of
According to at least one embodiment, there is provided a heating disc 100 with tuned harmonic resonance or non-resonance frequency stimulation vibration which is designed for use or reuse in a treating physician's office. Referring to
According to at least one embodiment, there is provided a heating mask 140, as shown in
The details of the heating mask 140 in
According to at least one embodiment, power supply to the resistance heater can be accomplished for example through the USB connection 134 to a micro drive or mobile control device. Alternate power sources include disposable and rechargeable batteries. These batteries could be placed into the reusable mask if desired to eliminate cords extending from the reusable mask. A micro drive control board controlling the heater and resonator functions could be powered from a single supply voltage of 8-48 VDC, offering up to 100 W of peak power without any additional heat-sink.
According to at least one embodiment, the miniature RFVGs 130 induces a vibration through the coupling device to the surface of the eyelid. The control of vibration may include amplitude, a width, frequency, and where one or more of these parameters may be varied over the treatment period. The resonant vibration may have a frequency stimulation between about 2 Hz to about 270 Hz, between about 15 Hz to about 40 Hz, or between about 30 Hz to about 60 Hz. The resonant vibration may include a current having a pulse width or duty cycle between about 20% to about 80%. Vibration having the above-mentioned parameters may be used to treat one or more conditions, such as dry eye. Ideally in the physician's office, the controller would run through a range of pre-established frequencies and patterns. This range is to determine an individual patient's best response of the tuned harmonic resonance or non-resonance frequency stimulation to the applied vibration. This the tuned harmonic resonance or non-resonance frequency stimulation vibration is the condition best suited to excite and mobilize an individual's flow of the Meibum lipids from the Meibomian gland ducts. In some embodiments, anthropomorphic features and other characteristics of the patient, for example, eyelid laxity helps in the determination of the patient's personalized resonant vibration frequency. Non-limiting examples of anthropomorphic features and other patient characteristics include eyelid laxity, eyelid dimensions, eyelid mass, eyelid thickness, patient's race, patient's age, patient's sex, and any history of eyelid surgery. Non-limiting examples of anthropomorphic features and other patient characteristics also include MGD status, such as the percentage of clogged or plugged Meibomian gland ducts, the degree of truncated Meibomian gland ducts, and the quality of the Meibum lipid (i.e., thickness, turbidity, and clarity).
According to at least one embodiment, the tunable RFVGs 130 for the heating mask 140 may be provided by several different sources including sonic generators, electrodynamic or mechanical (such as cell phone vibrators) vibration generators. In some embodiments, the source is relatively quiet and able to deliver the vibrational energy through the disposable patient contacting coupling device to the underlying tissue. According to the concept of finding or non-resonance to the patient's Meibomian gland ducts and blocked oil glands, the frequency stimulation may be adjustable and tunable. There are several miniature vibration devices, such as Adafruit, shown in
According to at least one embodiment, direct heating of the eyelids and adjacent areas may be achieved by weaving a resistance NiChrome heater wire as the heater element 142 into the heating mask 140 as shown in
Referring to
According to at least one embodiment, the far infrared front end spot heater 150 is constructed to radiate heat from the far infrared end seal 152 made of heat transmitting material (thin metal face or substitute). Heat is transferred to the far infrared end seal 152 by a conducting plug 154. This plug 154 is in contact with the end seal 152 and is a designed mass of conducting material for storing and releasing the heat converted by a heating element wire 156. The exterior or sides of the spot heater 150 are comprised of heat resistant insulation material 158 allowing a user to comfortably hold the spot heater 150 without risk of uncomfortable temperature exposure. A thermocouple (not shown) might also be employed with this device and integrated into the spot heater 150 properly. The interior of the spot heater 150 includes a conducting packing material 160 all the way to the tip or the plug 154 through a ceramic cap 162. The heating element wire 156 is supported in the spot heater 150 by ceramic element supports 164 that function in a stability capacity providing little movement and adding longevity to the spot heater device 150. The electrical leads 166 are fed through the ceramic cap 162 providing support for the electrical leads 166 and temperature barrier characteristics. The insulated electrical leads 166 are comprised of insulated electrical wire with lead lengths ending in a USB connector 134 for operating the spot heater 150 in the physician's office.
According to at least one embodiment, the heating mask 140 is comprised of soft, comfortable fabric like materials with an adjustable band to help the heating mask 140 reside in the appropriate location on the eyes. A moldable coupling device is a component for the heating mask 140 to provide a sanitary, possibly sterile, skin contacting surface for individual patient use. This single use, disposable coupling device will transfer the generated thermal and vibration energy generated by the heating mask 140 effectively to the eyelid surface. In some embodiments, the coupling device is composed of hydrogel, similar to a hydrogel dressing, possibly contained in a support structure or quilted construction to assure even distribution and intimate contact across the skin contacting regions. The hydrogel composition and water are controlled to best achieve this transfer and add a controlled amount of moisture to the eyelids and lashes, with the added benefit of loosening debris on the eye lashes. According to at least one embodiment, the hydrogel layer makes direct skin contact. In alternate embodiments, the hydrogel could be constrained behind a thin moisture permeable barrier layer. In other embodiments, the coupling device is composed of a hydrogel sheet, and more particularly includes tea tree oil for treatment of, for example, demodex (i.e., mites) infestation of the eyelashes, which is common in blepharitis, Meibomian gland dysfunction, and dry eye disease.
Construction of the coupling device would allow hand molding to an individual's face, periorbita, and features or gentle reforming could be applied from pressure by the eye heating mask 140. The disposable coupling device would be easily replaceable in the heating mask 140 for use by a new patient. The coupling device would be prepared for long term storage using the barrier layer technologies described for the heating disk 100 and could be sterilized to a 10−3 or higher sterility assurance level (SAL).
As explained with the heating disk 100 above, this hydrogel layer could incorporate a mixture of particles to facilitate well dispersed heat transfer, heat sinking and bi-directional vibration energy transfer.
Alternatively, the coupling device could be made from thin layers of natural materials and fibers to create a comfortable and breathable surface against the skin. The heating mask 140 could be any number of fiber materials known to be breathable, such as cotton, linen, bamboo, or hemp. Other cloth fabrics from synthetic materials are also breathable and moisture transportable. Non-limiting examples include base layer clothing made from polyester and polypropylene. Filler materials inside the coupling device could be also made of breathable, natural fillers. The filler material may allow the heat to pass to the contact surface but also the vibration energy. Possible natural fillers, in small chunks or fibers, include bamboo fiber, small, dried beans, quinoa, rice, and hemp. Size and size distribution of the filler material can be optimized to determine the best options for transmitting the vibration energy. Also possible are quilted fabric layers using various fillers to provide the loft in the quilt and non-woven felt materials.
According to another embodiment, the coupling device would apply moist heat to the surface. A source for the moist water vapor could be the hydrogel. As heat energy from the heating mask 140 transfers to the coupling device, water in the hydrogel or natural filler turns to vapor and crosses a moisture permeable barrier to the contact surface.
Alternately, reservoirs of water could be constructed into the coupling device to interact with the heat source.
According to at least one embodiment, a microfluidic enabled sensor shown in
According to at least one embodiment, one form of the chemical sensor 170, shown in
Referring to
According to at least one embodiment, a single element version of the miniature integrated chemical sensor 190 with potentiometric detection, shown in
Referring now to the disclosed devices in more detail, in
In further detail, referring to the devices disclosed in
According to at least one embodiment, referring to
According to at least one embodiment, referring to
Temperature sensors 260 used in embodiments of this disclosure is depicted in
Referring now to
Referring now to
Referring to
According to at least one embodiment, vibration and temperature are controlled by pulse width modulation (PWM). Switching-voltage regulators employ PWM control for the switching elements. The PWM signal is either generated from a control voltage (derived from subtracting the output voltage from a reference voltage) combined with a saw tooth waveform running at the clock frequency for the voltage-mode regulator, or by adding a second loop feeding back an inductor current for current-mode control. Devices employ techniques such as voltage feed-forward for voltage-control designs and slope compensation for current-mode units.
In some embodiments, both types of topologies are employed in the system. In other embodiments, component parts are linked together in the system. Voltage-mode control switching regulators are used in some embodiments when wide-input line or output-load variations are desired, under light loads (when a current-mode control-ramp slope would be too shallow for stable PWM operation), in noisy applications (when noise from the power stage would find its way into the current-mode control feedback loop), and when multiple-output voltages are needed with good cross regulation.
In some embodiments, current-mode control devices are used for applications where the supply output is high current or very-high voltage; the fastest dynamic response is sought at a particular frequency, input-voltage variations are constrained, and in applications where cost and number of components must be minimized as in the innovations stated here within.
According to at least one embodiment, the reusable mask 140 and even the entire system is suitable for mobile control, in which the device is easily handheld and carried for patient use. Control may also be driven by a smartphone or smart device using operating systems such as iOS, Android or Windows mobile, or other similar interfaces. Mobile medical interfaces are used in products such as a Zebra MC40 Mobile Computer. Similar platforms, or other Wi-Fi, cell phone or Bluetooth connected interfaces can be used to control the patient's first in-office use of the system. In some embodiments, a range of frequencies are tested and output data from the sensors is stored. The data storage and its associated algorithm may determine the best treatment mode for following office visits or transfer an optimal program to an at-home unit. These mobile interfaces further create efficiencies for the office staff by automatically storing patient records to the electronic medical records (EMR) of the first and subsequent uses. These records include patient name, time and date of use, frequencies explored, and sensor output during that time. The at-home unit would also serve as a record of patient compliance to prescribed therapy.
According to at least one embodiment, the tuned harmonic resonance or non-resonance frequency stimulation vibration heating mask 140 is preferentially supplied as a kit. Kits include one or more devices, and varying numbers of replacement heaters depending on kit size. Kits may include both elements of the one-time use components and reusable components. In some embodiments, for example, a kit might include the one-time use heating element 100, the reusable miniature the tuned harmonic resonance or non-resonance frequency stimulation vibration generator pair 130 that fit into the eye patch component and plug into a USB 134 port and the one-time use coupling device. Kits may be provided to a patient during an office visit as the equipment used to define the correct the tuned harmonic resonance or non-resonance frequency stimulation would be available in the practitioner's office. Commercial kits may also be provided with very specific frequencies and then purchased directly by an informed customer.
According to at least one embodiment, as mentioned in describing the mobile controller, after a patient's first use of the system in the physician's office, the patient may be prescribed to continue therapy on a more frequent basis at home. As an alternate embodiment, this system could be simplified for the home user. This system would have a reusable mask 140 with single use disposable, or reusable built-in heating elements 100 and the tuned harmonic resonance or non-resonance frequency stimulation vibration generator pair 130, accommodate an optional disposable coupling device and come with appropriate power supply and control, including a mobile and wirelessly connected controller. The at-home monitoring system would not require a full range of vibration frequencies as the optimal frequency stimulation and pattern was determined in the original office use and that pattern is programmed into the individual user's system. Similarly, the full sensing capability is not needed for home use. A cell phone, Wi-Fi or Bluetooth connected controller may also create a record of use for the patient's EMR. In some embodiments, patterns of noncompliance or misuse may create an alert to go directly to the patient and/or back to the treating physician.
A further alternate embodiment may include a system that employs single use heating discs 100. This could be used for either the office based or home use products. The disposable heating disc 100, being hand moldable to conform to an individual's anatomy, would fit into the pocket in the heating mask 140. This heating disc 100 element could also be built into and supplied as part of the coupling device that contacts the skin and comprises a combined single disposable item. As shown in
According to at least one embodiment, there is provided a method of treating dry eye disease or MGD. These methods include the initial physician's office-based use where optimal treatment parameters are determined and then stored for later use either in subsequent office visits or home use.
The advantages of the devices disclosed include, without limitation, that it is portable, easy to transport, reliably functions as intended, and is simple and convenient to activate and use. Another advantage is that it is easy to integrate these devices into a reusable face mask or eye patch because they are relatively small and lightweight, showing the parallel utility of the device components stated herein.
A further alternate embodiment may include an integrated real-time imaging device to detect optimal tuning of the RFVGs 130 to the particular patient eyelid and Meibomian gland ducts. In some embodiments, for example, optoacoustic imaging or photoacoustic imaging is insensitive to photon scattering within biological tissue and, unlike conventional optical imaging methods, makes high-resolution optical visualization deep within tissue possible. A key empowering feature is the development of video-rate multispectral imaging in two and three dimensions, which offers fast spectral differentiation of distinct photo-absorbing moieties. In some embodiments, the imaging device provides a real-time-image-based assessment of the optimal settings for the miniature RFVGs 130 at which there is maximal movement of the eyelids, Meibomian gland ducts, and lipid fluid within the Meibomian gland ducts.
According to at least one embodiment, there is provided means for providing a physician and a patient with a metric related to the state of the dry eye disease being treated. This metric will correlate to the severity of disease and may be measured and provided both before and after treatment. Increased sensitivity to light is a well-known proxy for severity of dry eye disease. According to at least one embodiment, there is provided a light sensor configured to measure light sensitivity of the eye being treated and to provide a subjective light sensitivity score as a diagnostic indicator.
According to at least one embodiment, there is provided a method in which prior to initiating a treatment, the patient looks at a target in the mask 140 or at a distance. A light-emitting diode (LED) with a controllable spectrum is mounted to a head-mounted mask. The LED in the mask will turn on at an adjustable initial setting. The patient adjusts the intensity to the maximum comfortable level, with a physical rheostat or other controller. Right and left eyes may be tested sequentially, or both eyes may be tested simultaneously. The light intensity setting is recorded electronically. At the end of the treatment, the patient is exposed to light and the light sensitivity measurement is performed again. Each time the patient uses the device, their pre-treatment and post-treatment light sensitivity is recorded electronically, and comparison made with the previous light sensitivity scores. The comparison provides an indicator of treatment success, as well as dry eye disease stability, improvement, or worsening. According to at least one embodiment, the system can include a feature to automatically increase or decrease the treatment duration and/or intensity based on the light sensitivity measure, and relative change from the previous light sensitivity value.
According to at least one embodiment, the heating mask 140 can be configured to fit a single eye. The single-eyed heating mask 140 can be configured to fit either the patient's right or left eye. In some embodiments, the heating mask 140 can include two single-eyed heating masks, one configured to the right eye and the other configured to the left eye.
According to at least one embodiment, the tuned harmonic resonance or non-resonance frequency stimulation vibration is a vector force. The tuned harmonic resonance or non-resonance frequency stimulation vibration exhibits traits substantially like a longitudinal wave. In some embodiments, the tuned harmonic resonance or non-resonance frequency stimulation vibration exhibits traits substantially like a longitudinal standing wave.
According to at least one embodiment, the primary axis of vibration is substantially parallel to the medial-lateral axis, as shown in
According to at least one embodiment, the primary axis of vibration can be substantially parallel to the superior-inferior axis, as shown in
According to at least one embodiment, the tuned harmonic resonance or non-resonance frequency stimulation vibration can be a superposition of two or more longitudinal vibrational waves. In some embodiments, the tuned harmonic resonance or non-resonance frequency stimulation vibration is a superposition of two longitudinal vibrational waves, where the primary axis of the first vibration can be substantially parallel to the superior-inferior axis while the primary axis of the second vibration can be substantially parallel to the medial-lateral axis, both axes as shown in
According to at least one embodiment, the direction of the tuned harmonic resonance or non-resonance frequency stimulation vibration vector force can be selected by the device operator based on the degree of MGD (i.e., truncated gland ducts, clogged or plugged gland orifices versus open gland orifices).
According to at least one embodiment, the tuned harmonic resonance or non-resonance frequency stimulation vibration liquifies and mobilizes the Meibum lipids within the Meibomian glands. The mobilization is achieved by inducing shear forces using vibration at the resonance frequency or frequencies of the patient's eyelid and Meibomian gland complex. As shown in
According to at least one embodiment, the reusable mask can include a bladder-type coupling device to provide substantially full contact to the patient's individual eyelid and periorbital three-dimensional anatomy and surface topography. The bladder-type coupling device can be filled with gaseous or fluidic medium, or foam. Hydraulics or pneumatics can be applied to control the coupling device. In some embodiments, a hydraulic medium is used in the bladder-type coupling device, where the hydraulic medium has a viscosity suitable for conforming to the patient's individual eyelid and periorbital three-dimensional anatomy and surface topography. The hydraulic medium is suitable for transmitting the tuned harmonic resonance or non-resonance frequency stimulation vibration generated by the RFVGs 130 to the patient's Meibomian gland ducts. The hydraulic medium is suitable for transmitting the vibration in any direction. In some embodiments, the bladder-type coupling device includes channels to provide direction control of the vibration. In some embodiments, temperature and pressure control of the reusable mask can be achieved by hydraulically inserting the hydraulic medium into the bladder-type coupling device.
According to at least one embodiment, the heating mask 140 is operable to change configuration of applying heat and the tuned harmonic resonance or non-resonance frequency stimulation vibration. In some embodiments, the heating mask 140 is operated such that heat (for example, provided by the heating disc 100) and the tuned harmonic resonance or non-resonance frequency stimulation vibration (for example, provided by the RFVGs 130) are applied to the patient's eyelid area sequentially and alternately, but not simultaneously. The heating mask 140 can be internally or externally programmed to achieve this sequence. In some embodiments, the medical practitioner cannot override the programmed sequence. In other embodiments, explicit instructions, such as an instruction manual, can be given to the medical practitioner to operate the heating mask 140 by applying heat and the tuned harmonic resonance or non-resonance frequency stimulation vibration sequentially and alternately.
The most common cause of dry eye disease is an abnormal lipid layer of the tear film. The lipid layer is responsible for preventing tear film evaporation. The lipid layer is composed of a lipid called meibum that is produced by the Meibomian glands. There are 25-40 Meibomian gland ducts per eyelid, oriented in a vertical direction. The meibum is produced in these glands, is excreted via ducts onto the eyelid margin and then onto the external surface of the tear film. In dry eye disease, the meibum becomes thickened and does not function normally, as well as becomes clogged within the ducts of the Meibomian glands. Embodiments of the subject application uniquely solve the problem of dry eye disease, left unresolved by conventional devices and methods for treating dry eye disease, by integrating three mechanisms to decrease viscosity of the meibum (i.e., using heat), liquify the meibum (i.e., using vibration induced shear thinning), and then neuromodulation to express the liquefied meibum out of the ducts of the Meibomian glands. In this manner, a normal tear film is reestablished in a manner that is rapid, effective, safe, and comfortable for the patient. Embodiments of the invention depend on the fact that meibum is a shear-thinning non-Newtonian fluid.
According to various embodiments, the vibration is designed to maximize transfer of shear stress to the meibum within the ducts of the Meibomian glands. The vibration does not result in a net pressure on the lids. Rather, the vibrational direction, amplitude, waveform, and frequencies have all been optimized to liquify the meibum through shear stress that results in shear thinning and liquefaction of the non-Newtonian meibum contained within the ducts of the Meibomian glands. Lastly, the activation of the lacrimal function unit is utilized to naturally cause excretion of the liquified meibum from the Meibomian glands. As a result of heating and then shear thinning, the meibum is liquified within the Meibomian gland ducts which then enables the 3rd element of the lacrimal function unit to actively express meibum from the Meibomian gland ducts. Mechanical stimulation of the 5th cranial nerve and resulting neuromodulation also produces improved mucin and aqueous layers of the tear film.
According to various embodiments, the parameters of sequential heating, vibration, and neuromodulation are all optimized to result in a normalized tear film, particularly the lipid layer of the tear film. The heating of the eyelid externally is controlled to deliver 40-45° C. to the meibum within the Meibomian gland ducts, resulting in a reduction in viscosity. The temperature delivered can be constant or modulated to optimize viscosity reduction and last for varying amounts of time based on disease severity to optimize meibum viscosity reduction. After the heating cycle is complete, the vibration parameters are optimized for maximum shear thinning of the meibum. To ensure that the linear vibrational pulse energy is transferred to the meibum within the Meibomian gland ducts, the direction, amplitude, frequency, and waveform are all optimized and accurately controlled.
The thickness of the Meibomian gland duct ranges from 100 to 225 microns. Therefore, according to various embodiments, the optimized amplitude of vibrational energy delivered orthogonal to the long axis of the Meibomian gland duct is between 10-30 microns, i.e., optimized to be 5-25% of the diameter of a Meibomian gland duct. The direction of the vibrational energy is optimized to be medial-lateral in order to safely impart shear stress to the meibum within the Meibomian gland ducts. This medial-lateral direction of vibration ensures that shear thinning is equally induced in the Meibomian gland ducts in both the upper and lower eyelids simultaneously. Vibration parallel to the duct axis is avoided since this direction is less effective at imparting shear stress to the meibum. It is critical to limit vibrational energy in the direction of the cornea to avoid risk of vitreous and retinal detachment. The frequency spectrum of linear vibration is optimized based on a range of parameters of the human eyelid to ensure maximal transmission of the energy to the Meibomian gland ducts and internal meibum, including eyelid fat content, tension, thickness, width, and degree of mild, moderate, severe, or extreme entropian or ectropian. According to an embodiment, the frequency spectrum of linear vibration is set between 50 Hz to 300 Hz, and more preferably between 140 Hz to 200 Hz to optimize transfer of the vibrational energy through the eyelids and into the meibum of the Meibomian gland ducts. Finally, the waveform of the linear vibration can be varied from sinusoidal, square, or triangular wave to optimize desired liquefaction of meibum. According to an embodiment, the vibration waveform is optimized to be a square wave for severe disease, while sinusoidal and/or triangular waveforms will be chosen for moderate disease.
According to at least one embodiment, the RFVGs 130 transfer vibrational mechanical stimulatory energy to the nasal bridge area located between the eyes (optimally centered at the junction of the bone and cartilage area of the nasal bridge). Resonant frequency or non-resonant frequency stimulation vibration is delivered, based on determined tuning parameters, across the contour of the nasal bridge area through the nasal bone and to the sensory nerve branch of the 5th cranial nerve (such as the anterior ethmoidal nerve in the nasal septum) to induce neuromodulation of the tear production reflex in the lacrimal functional unit (LFU), which encompasses the goblet cells located primarily in the epithelium of the conjunctiva to produce the mucin layer of the tear film, the main and accessory (Wolfring and Krause) lacrimal glands to produce the aqueous layer of the tear film, and activate expression of meibum from the Meibomian gland ducts. The expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids produces the lipid layer of the surface of the user's eyes tear film. Without being bound by any theory, stimulation in the nasal sensory nerves serves as an alternate afferent pathway for tear production reflex stimulation in addition to stimulation in the sensory nerves on the ocular surface. Stimulation is received in the sensory receptors located at the nasal mucosal epithelium, and travels to the superior salivatory nucleus through the anterior ethmoidal nerves, which is a branch of the ophthalmic division of the trigeminal nerve (i.e., the 5th cranial nerve). The stimulation continues to travel through the pre-ganglionic fibers along the nervus intermedius to the pterygopalatine ganglion, and innervate the lacrimal glands, goblet cells, and the Meibomian gland ducts. Such stimulation in the lacrimal gland results in an increase of the aqueous component of the tear, which is the middle layer component of the tear film. Such stimulation in the goblet cells on the conjunctiva results in the production of mucin, which is the innermost component of the tear film. Such stimulation in the Meibomian gland duct induces expression of shear thinned and liquified meibum from each Meibomian gland duct in all four eyelids to improve the lipid layer of the surface of the user's eye tear film.
Certain parameters of the resonant frequency stimulation vibration can be adjusted for optimal neurostimulation. For example, frequency can be adjusted such that the resonant frequency or non-resonant frequency stimulation vibration is optimized for bone conduction around the nasal bridge. Amplitude can be adjusted for optimal comfort and effectiveness. The primary axis of vibration can be substantially parallel to the medial-lateral axis, as shown in
Certain parameters of the dry eye treatment device can be adjusted for optimal neurostimulation. For example, thickness and Shore Durometer material hardness can be adjusted to optimize the coupling between the external vibratory stimulus and the junction of the bone and cartilage of the nasal bridge. Vibratory conductance of the material around the nasal bridge can be adjusted to optimize the transmission of external vibration resulting in bone conduction.
In alternate embodiments, the pair of stimulation vibration generators 130 includes an ultrasonic transducer (not shown) to transfer ultrasound directly to the sensory nerves (such as the anterior ethmoidal nerve in the nasal septum) to induce tear production reflex in the LFU. The ultrasonic transducer can be any ultrasonic transducer known in the art that is capable of neurostimulation and has a size suitable to be included as a component of the heating mask 140. The ultrasonic transducer can include an array of ultrasonic transducers that enable dispersed or focused ultrasound energy to maximally control the induced neuromodulation of the tear production reflex.
In alternate embodiments, the sequence and timing of the heating and vibration stimulation can be adjusted to obtain optimal tear film therapy. Specifically, the eyelid heating that reduces meibum viscosity may be applied first, while the resonant frequency stimulation vibration next imparts shear stress in the meibum resulting in shear thinning of the meibum within the Meibomian gland ducts, followed by neurostimulation that, in addition to increasing mucin and aqueous production, induces expression of the liquified meibum from the Meibomian gland ducts. The initial heating that decreases meibum viscosity also increases the effectiveness of vibration induced shear stress that results in shear thinning and liquefaction. This sequence, and length of time of each element of the sequence, as well as repetitions of all elements of the sequence, and total time of therapy, can all be adjusted to obtain an optimal therapeutic result.
The therapeutic warmth is applied to meibum within each Meibomian gland duct in all four eyelids for 2 minutes at 43° C.+/−2° C., followed by the applying of the tuned harmonic resonance or non-resonance frequency stimulation vibration across the contour of the entire surface of the user's four eyelids and periorbital structures, and the contour surface of the user's nasal bridge area through the user's nasal bone, after the heating disc has lowered the lipid viscosity within each Meibomian gland duct, for 30 seconds at 140 Hz to 169 Hz, followed by applying the therapeutic warmth again for 2 minutes at 43° C.+/−2° C., followed by applying the tuned harmonic resonance or non-resonance frequency stimulation vibration again for 30 seconds at 170 Hz to 200 Hz, and repeating this sequential and alternating application of the therapeutic warmth and the tuned harmonic resonance or non-resonance frequency stimulation vibration two more iterations, resulting in a total treatment of 15 minutes.
According to an embodiment, as further shown in
According to an embodiment, the real-time mapping of the periocular surface will also be used to quantify the position of the right and left eye pads 302 and automatically correlate the adjustment of both eye pads 302 together, so that both eye pads 302, in concert, expand or contract their lateral position based on the measurement of corneal apex relative to the lateral canthus. This automated module is achieved through feedback controlled mechanical gearing setup inside the mask 300 utilizing the topography data provided to the software by a replaceable topography mapping diagnostic pad 308 and the OCT device 304 and algorithms locating the optimal position for the eye pads 302, depending on the patient's periocular topography. This additional adjustment of the eye pads 302 is performed in concert with the initial adjustment of the eye pads 302 to optimize the location of the eye pads 302. This adjustment can be achieved manually by the available manual adjustment wheels, right and left eye pad adjustment wheels 306, but relies on the data provided by the mapping module to guide the manual adjustment. According to an embodiment, the software can be configured to allow manual adjustment, but provides a visual rendering of the patient's periocular topography on an external screen responding to any misalignment with audible and visual feedback notifying the adjusting personnel of the potential approaching misalignment of the eye pads 302.
As shown in
According to an embodiment, the real-time mapping of the eyes and periocular surface of the user's eyes will be used to automatically adjust the topography of the eye pads 302 to optimally conform to the periocular surface of the user's eyes. This automated module is achieved through feedback controlled mechanical gearing setup inside the mask 300, responding to the topography data provided to the software and algorithm of the OCT 304, thereby locating the optimal position for each the eye pads 302, based on the patient's periocular topography. The moldable and conforming properties of the eye pads 302 along with the real-time mapping module of the mask 300 allow the surface of the eye pads 302 to be formed into the correct geometry to conform to the specific topography of the periocular surface of the user's eyes strictly adhering to the pressure parameters detailed in this application.
Embodiments provide the real-time mapping of the eyes and periocular surface will be used to manually adjust the eye pad 302 topographies to optimally conform to the periocular surface. This manual module is achieved through feedback controlled mechanical gearing setup inside the mask 300 responding to the topography data provided to the software and algorithm locating the optimal position for the eye-pads 302 depending on the patient's periocular topography. The moldable and conforming properties of the eye-pads 302 along with the mechanical features inside allow the surface of the eye-pads 302 to be formed into the correct geometry and conform to the specific topography of the periocular surface. The use of tactile sensors (e.g., 260, 262, 264, 266) in the sensor array can include piezoresistive, piezoelectric, optical, capacitive and or elastoresistive sensors. These embedded sensors 230 in the smart eye-pad 302 can produce tactile feedback allowing precise manual adjustment of the smart eye-pad 302 to the periocular surface assuring optimal performance by the mask 300. A manual status will be available to override the automated program allowing manual control with manual adjustment wheels 306 connected to the internal gearing of the smart eye-pad 302.
According to an embodiment, each of the replaceable, adjustable, moldable eye pads of the mask may include a cold compress for inflammation reduction. According to another embodiment, each of the replaceable, adjustable, moldable eye pads of the mask may include a surface available to hold hydrogel sheets or moisturized cotton pads, the hydrogel sheets or the moisturized cotton pads containing one of moisture alone, impregnated anti-inflammatory agents including steroids or non-steroidal anti-inflammatories, or therapeutic agents for treating conditions including blepharitis, demodex, or eyelid wrinkles.
Referring now to
Still referring to
Still referring to
Referring now to
Still referring to
Still referring to
Referring now to
Still referring to
Still referring to
Referring now to
Still referring to
According to at least one embodiment, the data stream is suitable for interpreting patient compliance with respect to treatment. The cloud database 600 is compliant with the Health Insurance Portability and Accountability Act (HIPAA), available through an electronic medical record system, where the medical record system includes subjective patient-entered data and is available to the patient.
According to at least one embodiment, there is provided a cloud-based, dry eye disease database 600 that includes patient demographics, treatments, and outcomes. The cloud-based database 600 is HIPAA compliant. Values of the database 600 is derived through application of pattern recognition, artificial intelligence, and big-data analytics to improve treatments and outcomes for dry eye disease and MGD patients.
According to at least one embodiment, sensors 516, 526 are imbedded in the mask 512, 522 for optimization of dry eye disease treatment. Artificial intelligence and big-data pattern recognition may be utilized to accomplish new insights into optimal treatment based on individual patient characteristics.
According to at least one embodiment, the mask 512, 522 including its imbedded components generates data to be transferred wirelessly to a smartphone or smart device with a Smart Application running while monitoring usage. Data is stored in a cloud database 600, which is HIPAA compliant.
According to at least one embodiment, various sources of data 610, 620, 630 are incorporated into the cloud database 600. Data is recorded for each use of the mask 512, 522, including usages at home and in the physician's office.
According to at least one embodiment, data input 610 includes data derived from the embedded sensors 516, 526 of the mask 512, 522. Embedded sensors 516, 526 may collect data relating to the total thermal energy delivered to the patient's eyelid, including data relating to the length of treatment and temperature curves. Embedded sensors may collect data relating to the total tuned harmonic resonance or non-resonance frequency stimulation vibration (RFS) energy delivered to the patient's eyelid and periorbital three-dimensional anatomy and surface topography, including data relating to the vibratory mechanical energy curve derived throughout treatment. Embedded sensors 516, 526 may collect data relating to the RFS frequency delivered to the patient's eyelid and periorbital three-dimensional anatomy and surface topography, including data relating to the frequency stimulation curve derived throughout treatment. Embedded sensors 516, 526 may also collect data relating to the external wind or air movement, data relating to the blink rate of the patient, and data related to the patient's length of sleep time.
According to at least one embodiment, data input 610 includes data derived from integrated light sensitivity metric. This metric is a measure of subjective sensitivity to light, which correlates to the severity of the disease, and optionally may be measured and be provided to the medical practitioner and patient both before and after treatment. Increased sensitivity to light is a well-known proxy for the severity of dry eye disease. A light sensitivity measurement includes a subjective light sensitivity score as a diagnostic indicator.
According to at least one embodiment, data input 630 includes data derived from patient questionnaires. Questionnaires may be related to patient demographics, including identity, age, and sex. Data derived from questionnaires may be related to patient responses to standardized and validated dry eye symptom questionnaires such as Ocular Surface Disease (OSD) and Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaires. Questionnaires may be related to other dry eye treatments received in the past such as drops, intense pulsed light, and thermal pulsation. Questionnaires may be related to the patient's current or past medications, vitamins, and nutraceuticals.
According to at least one embodiment, data input 620 includes data derived from recorded metadata. Metadata may include information related to date, time of day, location, humidity, and ambient temperature.
According to at least one embodiment, data input 630 includes data derived from a smart phone or a smart device. As a non-limiting example, information related to the patient's eyes may be derived from a patient's facial photograph stored in the smart phone or smart device.
According to at least one embodiment, there is provided applications of artificial intelligence and big-data pattern recognition. Utilizing artificial intelligence and big-data pattern recognition provides optimization of thermal energy treatment to improve symptoms by generating an optimized temperature profile. Utilizing artificial intelligence and big-data pattern recognition provides optimization of RFS with respect to frequency stimulation and magnitude by analyzing the patient's demographics, photographs, and outcomes. According to at least one embodiment, optimal vibration frequency(ies), amplitude, direction, and waveform stimulation is predicted for stimulation of the Meibomian gland ducts. According to at least one embodiment, optimal vibration stimulation is predicted for neuro-stimulation of the Trigeminal cranial nerve, and optionally the ophthalmic branch of the Trigeminal cranial nerve, to disrupt central pain syndrome mediated through the Trigeminal Ganglion and/or hypothalamus in patients with a central pain component, which is a well-known feature of the disease in patients with dry eye disease.
According to at least one embodiment, utilizing artificial intelligence and big-data pattern recognition provides predictive algorithms based on photographic anatomic features of eyelids and the face to personalize treatment parameters, including frequency stimulation and magnitude of RFS, and thermal energy delivered. Utilizing artificial intelligence and big-data pattern recognition provides predictive algorithms to recommend optimal time and number of treatments. Utilizing artificial intelligence and big-data pattern recognition provides identification of trends indicative of when a patient requires more intensive intervention available in their physician's office. Utilizing artificial intelligence and big-data pattern recognition provides automatic notifications sent to the physician and the patient. A dashboard view of database is provided to extract insights into patient demographics and optimized treatments.
According to at least one embodiment, end point monitors may include ultrasound techniques. The ultrasound techniques may have an ultrahigh resolution. Utilizing ultrasound imaging and analyzing images produced by ultrasound imaging provides non-invasive assessment of the viscosity of the lipids within the Meibomian gland ducts. Other modalities may be utilized to achieve the same end. The measurement of the lipid viscosity may serve as an input to optimize treatment parameters, as well as a determinant of treatment endpoint.
According to at least one embodiment, there is provided a monitoring system to manage dry eyes. A dry eye therapy ecosystem is built by utilizing both office treatment and home maintenance treatment. In the physician's office, medical practitioners may utilize an integrated in-office ophthalmic eyelid treatment monitoring system. At home, the patient may utilize an integrated, moldable warming device. The patient may use the device pursuant to the prescribed heat and vibration (at a tuned harmonic resonance or non-resonance frequency stimulation vibration) levels determined in the medical practitioner's office.
According to at least one embodiment, the monitoring system provides eyelid tuned harmonic resonance or non-resonance frequency stimulation vibration analysis including mechanisms to deliver eyelid tuned harmonic resonance or non-resonance frequency stimulation vibration. Tuned harmonic resonance or non-resonance frequency stimulation vibration may be delivered to the patient's eyelid incorporating microfluidics with vibratory motion, mechanical motor motion, and piezoelectric ultrasound vibration. The eyelid tuned harmonic resonance or non-resonance frequency stimulation vibration analysis also includes detection technology for customization of treatment. Various detection technologies may enable the system to monitor tissue response by sweeping a range of frequencies. In some embodiments, a piezoelectric crystal in receiving mode may detect a maximal or a multiple of maximal tissue vibratory responses.
According to at least one embodiment, the monitoring system provides various mechanisms of eyelid warming. Mechanisms include a warm liquid bath incorporating microfluidic devices accompanied with electrical resistive heating or other heating means so to heat the liquid in the microfluidic channels. Various liquids having various viscosities may be used in the microfluidic channels that conform to the eyelid and surrounding tissue of the patient's three-dimensional anatomy. Mechanisms include direct warming such as heating means utilizing electrical resistive heating circuits, radiofrequency, microwave, and ultrasound.
According to at least one embodiment, the monitoring system provides a coupling agent that molds to the patient's eyelid and periorbital three-dimensional anatomy and surface topography. The coupling agent may be a consumable component. The coupling agent transmits both warmth and vibration.
According to at least one embodiment, the coupling agent may include a microfluidic liquid interface having various viscosities, such as using hydrogel or an air- or gas-filled bladder. The coupling agent may be of single use. The coupling agent conforms to the patient's eyelid and periorbital three-dimensional anatomy and surface topography, transmits thermal energy, and transmits bi-directionally vibratory energy.
According to at least one embodiment, the monitoring system 510, 520 includes a mask 512, 522. The mask 512, 522 adjusts to facial features such as the eyelid and periorbital three-dimensional anatomy and surface topography. The mask 512, 522 is large enough to allow neural stimulation of the periorbital facial cranial nerves involved in the afferent component of dry eyes experienced as a central pain syndrome. The neural stimulation serves to disrupt the central pain syndrome. The mask 512, 522 is large enough to increase vascular perfusion to the periorbital region, thereby reinforcing the device's warming effect with natural warmth of tissue blood flow. The mask 512, 522 includes a conforming element over the patient's nose to enhance three-dimensional contact with the patient's eyelids, to ensure adequate conductive heating is achieved and all Meibomian gland ducts, whether nasally, centrally, or temporally located, are warmed adequately. The mask 512, 522 reduces air gaps to avoid convective heating, which is less efficient and inaccurate. In some embodiments, shape-memory materials such as Nitinol or other suitable polymers are integrated into a nose piece, customized to the individually unique three-dimensional anatomy of the patient's nasal bridge.
According to at least one embodiment, the monitoring system 510, 520 provides a controller software. The software may be controlled or programmed by the medical practitioner in the office directly, or via a smartphone or smart device app. The software may be controlled or programmed by the medical practitioner remotely via a smartphone or smart device app.
According to at least one embodiment, the monitoring system 510, 520 provides electronic components. The electronic components control thermal energy that is transmitted to the patient and sense the patient's eyelid surface temperature. The electronic components control vibratory energy that is transmitted to the patient and sense eyelid responses to the transmitted vibration.
According to at least one embodiment, the monitoring system 510, 520 provides remote connectivity via a smartphone or smart device app. The app is configured to track symptoms and treatments. The app detects and senses remotely the time and date when treatments are delivered and the length of the treatments. The app is compatible with in-office treatments, home maintenance treatments, and other home prescribed treatments. The app is configured to inform and educate both the medical practitioner and the patient. The app is configured to communicate remotely with the medical practitioner. The app is configured to provide patient access and authorized medical practitioner access. The app maintains HIPAA compliant aggregated cloud-based database 600.
According to at least one embodiment, the mask 512, 522 is provided with embedded sensors 516, 526 and energy sources 518, 528 that communicate directly and remotely with the app, receive programming from the medical practitioner through the app using authorized medical practitioner access, record all uses through the app, and set, adjust, and power the heat source and vibration source 518, 528 in the mask 512, 522.
While preferred embodiments have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Various alternatives to the embodiments described herein may be employed in practicing the invention. It is intended that any claims presented define the scope of the various embodiments and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Embodiments described herein, therefore, are well adapted to carry out the objects and attain the ends and advantages mentioned, as well as others inherent therein. While a presently preferred embodiment has been given for purposes of disclosure, numerous changes exist in the details of procedures for accomplishing the desired results. These and other similar modifications will readily suggest themselves to those skilled in the art and are intended to be encompassed within the spirit of the various embodiments disclosed herein and the scope of the appended claims.
Although the various embodiments have been described in detail, various changes, substitutions, and alterations can be made hereupon without departing from the principle and scope of the various embodiments. Accordingly, the scope of the various embodiments should be determined by the following claims and their appropriate legal equivalents.
The singular forms “a,” “an,” and “the” include plural referents, unless the context clearly dictates otherwise.
Optional or optionally means that the subsequently described event or circumstances can or may not occur. The description includes instances where the event or circumstance occurs and instances where it does not occur.
Ranges can be expressed herein as from about one particular value, and/or to about another particular value. When such a range is expressed, it is to be understood that another embodiment is from the one particular value and/or to the other particular value, along with all combinations within said range.
As used herein and in the appended claims, the words “comprise,” “has,” and “include” and all grammatical variations thereof are each intended to have an open, non-limiting meaning that does not exclude additional elements or steps.
As used herein, terms such as “first” and “second” are arbitrarily assigned and are merely intended to differentiate between two or more components of an apparatus. It is to be understood that the words “first” and “second” serve no other purpose and are not part of the name or description of the component, nor do they necessarily define a relative location or position of the component. Furthermore, it is to be understood that the mere use of the term “first” and “second” does not require that there be any “third” component, although that possibility is contemplated under the scope of the various embodiments.
While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art considering the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications, and variations as fall within the spirit and broad scope of the appended claims. The embodiments can suitably comprise, consist or consist essentially of the elements disclosed and can be practiced in the absence of an element not disclosed.
This application is a continuation-in-part application of U.S. patent application Ser. No. 18/522,857, filed on Nov. 29, 2023; U.S. patent application Ser. No. 16/739,958, filed on Jan. 10, 2020; U.S. patent application Ser. No. 16/739,958 is a continuation-in-part application of U.S. patent application Ser. No. 16/244,820, filed on Jan. 10, 2019, which claims priority to U.S. Provisional Patent Application Ser. No. 62/615,741, filed on Jan. 10, 2018; U.S. patent application Ser. No. 16/244,820 is a continuation-in-part application of U.S. patent application Ser. No. 16/146,396, filed on Sep. 28, 2018, which claims priority to U.S. Provisional Patent Application Ser. No. 62/565,818, filed on Sep. 29, 2017; U.S. patent application Ser. No. 16/146,396 is a continuation-in-part application of U.S. patent application Ser. No. 15/187,457, filed on Jun. 20, 2016, which claims priority to U.S. Provisional Patent Application Ser. No. 62/230,843, filed on Jun. 18, 2015, all of the above-referenced applications are hereby incorporated by reference in their entireties into this application.
| Number | Date | Country | |
|---|---|---|---|
| 62615741 | Jan 2018 | US | |
| 62565818 | Sep 2017 | US | |
| 62230843 | Jun 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18522857 | Nov 2023 | US |
| Child | 19083212 | US | |
| Parent | 16739958 | Jan 2020 | US |
| Child | 18522857 | US | |
| Parent | 16244820 | Jan 2019 | US |
| Child | 16739958 | US | |
| Parent | 16146396 | Sep 2018 | US |
| Child | 16244820 | US | |
| Parent | 15187457 | Jun 2016 | US |
| Child | 16146396 | US |
