AU2021106215A4

AU2021106215A4 - Photobiomodulation apparatus and method

Info

Publication number: AU2021106215A4
Application number: AU2021106215A
Authority: AU
Inventors: Sheila Thompson; Michael Whitmore
Original assignee: Twobeseen Pty Ltd
Current assignee: Twobeseen Pty Ltd
Priority date: 2021-07-16
Filing date: 2021-08-20
Publication date: 2021-10-28
Anticipated expiration: 2029-08-20
Also published as: WO2023283699A1

Abstract

Embodiments generally relate to apparatuses and methods for delivery of photobiomodulation (PBM) therapy. An apparatus for delivering PBM therapy is disclosed. The apparatus comprises a treatment unit. The treatment unit defines an inner surface and an outer surface, wherein the treatment unit is configured to be worn by a user such that the inner surface of the treatment unit faces an eye area of the user. An array of light sources is coupled to the inner surface of the treatment unit, wherein the array is configured to emit light waves from the inner surface of the treatment unit. A controller is operably connected to the array and configured to control emission of the light waves. Each one of the light sources in the array is configured to emit the light waves outwardly from the inner surface of the treatment unit to provide photodynamic stimulation of tissue spanned by the inner surface. 1/21 OL 00 ba OOz LnI N

Description

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"Photobiomodulation apparatus and method"

Technical Field

[0001] The present disclosure relates to photobiomodulation apparatus and methods for treating the human or animal eye and its surrounding tissues using light therapy. Some disclosed embodiments relate to a wearable apparatus for providing and directing light onto treatment areas of a user's face, particularly the user's eyes and surrounding tissues.

Background

[0002] Skin aging and/or inflammation may be caused or exacerbated by exposure to irritants, pollutants, chemical agents, or other environmental factors.

[0003] Exposure to ultraviolet (UV) light and radiation may accelerate the natural aging process, and lead to undesirable outcomes such as skin damage and wrinkling. Exposure to UV light breaks down the skin's connective tissue, collagen, and elastin fibres, which lie in the deeper layer of skin (dermis). Without this supportive connective tissue, the skin loses strength and flexibility, and begins to sag and wrinkle. In addition to causing wrinkles, the breakdown of the skin's connective tissue may lead to a loss of support for other organs and systems such as the circulatory and lymphatic systems. This can lead to a loss or normal organ function causing conditions such as inflammation or poor immune response. The eyes are particularly vulnerable to UV light damage as the light penetrates all the way to the retina. Conditions such as cataracts and macular degeneration are often a result of over exposure to UV.

[0004] Blue light from computer screens and other digital devices can behave similarly to UV light, penetrating deeply into the eye and leading to eye strain. Symptoms of eye strain include dry eye disease, sore or irritated eyes and difficulty focusing. The inventors have found research by Zhao et al (2018) which indicates that high energy blue light easily passes through the comea and lens to the retina causing diseases such as dry eye, cataracts, and possibly even age-related macular degeneration.

[0005] Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that causes tear film instability with potential damage to the ocular surface. It is thought that the prevalence of dry eye disease in the world population ranges from 6% to 34%. Dry eye disease is typically more common in those aged over 50, and twice as common in women. Furthermore, it is also understood that a younger population is being impacted by dry eye symptoms, which is considered likely to be related to increasing exposure to and use of digital devices and the associated blue light emissions.

[0006] Photobiomodulation, also known as low level light therapy (LLLT), is a treatment in which a patient (human or animal) is exposed to low-level light, such as via laser or light emitting diode. Photobiomodulation can stimulate cellular function leading to beneficial clinical effects. However, an appropriate combination of wavelength, intensity, duration, and treatment interval is complex with different diseases, injuries and dysfunctions needing different treatment parameters and techniques.

[0007] It is desired to address or ameliorate one or more shortcomings of prior photobiomodulation treatment apparatus and methods, or to at least provide a useful alternative thereto.

[0008] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.

[0009] Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Summary

[0010] Some embodiments relate to an apparatus for delivery of photobiomodulation (PBM) therapy, the apparatus comprising:

a treatment unit, the treatment unit defining an inner surface and an outer surface, wherein the treatment unit is configured to be worn by a user such that the inner surface of the treatment unit faces an eye area of the user;

an array of light sources coupled to the inner surface of the treatment unit, the array configured to emit light waves from the inner surface of the treatment unit;

a controller operably connected to the array and configured to control emission of the light waves;

wherein each one of the light sources in the array is configured to emit the light waves outwardly from the inner surface of the treatment unit to provide photodynamic stimulation of tissue spanned by the inner surface.

[0011] The tissue spanned by the inner surface may comprise at least one of:

(i) the eye area of the user, including the orbital, infraorbital and supraorbital regions;

(ii) eyebrow and glabella areas;

(iii) the tear trough across the nasal region and the midsection of the face; or

(iv) the zygomatic region spanning the infratemporal, pre auricular, parotid and temporal regions on both sides of the user's head.

[0012] Further to the aforementioned tissue areas, the treatment unit may additionally cover a nose region of the user. Further to the aforementioned tissue areas, the treatment unit may additionally cover a cheek region of the user. Further to the aforementioned tissue areas, the treatment unit may additionally cover both the nose region and the cheek region of the user.

[0013] At least one of the light sources maybe configured to transmit light at a first wavelength, and at least another of the light sources may be configured to transmit light at a second wavelength different from the first wavelength.

[0014] The treatment unit maybe configured to house the array of light sources and the controller.

[0015] The treatment unit may comprise a multi-layer arrangement, comprising an outer shell, a second layer, and a third layer. The second layer may consist of the controller, a battery, a power source, and the array of light sources. The outer shell may define a recess for receiving the second layer therein. The third layer may have light diffusing qualities.

[0016] The apparatus may further comprise a frame configured to secure the apparatus to the face of the user, and the treatment unit may be removably attached to the frame.

[0017] The light sources maybe LEDs connected to a circuit board housed within the treatment unit.

[0018] At least one of the light sources may emit light having a wavelength in the range of 629 nm to 700 nm. At least one of the light sources may emits light having a wavelength of 670 nm +/- 10 nm. At least one of the light sources may emit light having a wavelength of 799 nm to 860 nm. At least one of the light sources may emit light having a wavelength of 830 nm +/- 10 nm.

[0019] Some embodiments relate to a method for improving the functionality of the tissue of and around the eyes comprising:

applying light with a predetermined set of photobiomodulating parameters to the eyes and surrounding areas tissues from a treatment apparatus; wherein the light has one or more wavelengths ranging from 630 nm +/- Onm to 900 nm +/- 10 nm.

[0020] A target irradiance delivered by the apparatus may be 0.5 - 50 mW / cm2.

[0021] A target treatment time period may be between 1 and 30 minutes.

[0022] A target total delivered energy density may be between 0.1 and 25 J / cm2.

[0023] The target total delivered energy density may be between 0.1 and 5 J / cm2.

[0024] The apparatus used in the method may be the apparatus as defined above.

Brief Description of Drawings

[0025] Embodiments are described in further detail below, by way of example, with reference to the accompanying drawings, in which:

[0026] Fig. 1A is a first perspective view of an apparatus for delivering photobiomodulation therapy to the eye and surrounding areas, according to some embodiments;

[0027] Fig. 1B is a second perspective view of an apparatus for delivering photobiomodulation therapy to the eye and surrounding areas, according to some embodiments;

[0028] Fig. 2A shows the exterior portion of the apparatus of Fig. IB, as viewed from the front of the apparatus;

[0029] Fig. 2B shows the interior portion of the apparatus of Fig. 2A, as viewed from the rear of the apparatus;

[0030] Fig. 2C is a section view of the apparatus of Fig. 2B, as taken along the line marked "Fig. 2C" therein, and showing the interior portion of the right hand side of the apparatus;

[0031] Fig. 3A shows the exterior portion of the apparatus of Fig. IB, as viewed from the right hand side of the apparatus;

[0032] Fig. 3B shows the exterior portion of the apparatus of Fig. IB, as viewed from the left hand side of the apparatus;

[0033] Fig. 4A is a top view of the apparatus of Fig. IB;

[0034] Fig. 4B is a bottom view of the apparatus of Fig. IB;

[0035] Fig. 4C is an exploded view of the apparatus of Fig. IB;

[0036] Fig. 5A shows an embodiment of the apparatus of Figs. 1A and IB, as worn by a user and as viewed from the front and left side of the apparatus;

[0037] Fig. 5B shows an outline of the apparatus of Fig. 5A, as viewed from the front and left side of the apparatus, to demonstrate positioning of the apparatus relative to the user's face;

[0038] Fig. 6 is a simplified illustration of the areas of the user's face and head to which embodiments of the apparatus are configured to deliver photobiomodulation light therapy;

[0039] Fig. 7A is a front view of the apparatus for delivering photobiomodulation therapy to the eye and surrounding areas, according to a further embodiment and shown as worn by a user;

[0040] Fig. 7B is a left hand side view of the apparatus of Fig. 7A.

[0041] Fig. 7C is a perspective view of the apparatus of Fig. 7A;

[0042] Fig. 8A shows the exterior portion of the apparatus of Fig. 7A, as viewed from the front of the apparatus;

[0043] Fig. 8B shows the interior portion of the apparatus of Fig. 7A, as viewed from the rear of the apparatus;

[0044] Fig. 9A shows the exterior portion of the apparatus of Fig. 7A, as viewed from the right hand side of the apparatus;

[0045] Fig. 9B shows the exterior portion of the apparatus of Fig. 7A, as viewed from the left hand side of the apparatus;

[0046] Fig. 1OA is a top view of the apparatus of Fig. 7A;

[0047] Fig. 1OB is a bottom view of the apparatus of Fig. 7A;

[0048] Fig. 1OC is an exploded view of the apparatus of Fig. 7A;

Detailed Description

[0049] The present disclosure relates to photobiomodulation apparatus and methods for treating the human or animal eye and its surrounding tissues using light therapy. Some disclosed embodiments relate to a wearable apparatus for providing and directing light onto treatment areas of a user's face, particularly the user's eyes and surrounding tissues.

[0050] The present disclosure relates to a wearable, hands-free apparatus that is configured to deliver photobiomodulation therapy in the form of multi wavelength, low level light therapy, directly over the eyes and surrounding tissues. Disclosed embodiments generally relate to a photobiomodulation apparatus for promoting the health and appearance of the eye and surrounding areas. Some embodiments of the apparatus provide photobiomodulation therapy across an area of the user's face which may span from the temporal area, over the eyebrow / glabella region, below the tear trough across the nose and the midsection of the face, spanning to the pre auricular area on both sides. Some embodiments of the apparatus provide photobiomodulation therapy across the aforementioned areas of the user's face, and may exclude the nose area. The apparatus comprises a photobiomodulation therapy light source, which may comprise a plurality of light emitting diodes (LED) and/or organic light emitting diodes (OLED) and circuitry.

[0051] The present disclosure includes methods directed to promoting healing, reducing inflammation, redness, alleviating symptoms of dry eye and/or reducing the appearance of skin aging surrounding the eyes of a subject. The methods involve application of red and near-infrared light therapy to the eye and the surrounding areas. The disclosed methods may use embodiments of the disclosed apparatus. Some embodiments of the apparatus are designed to deliver red and near infrared light therapy via light emitting diodes in photobiomodulating doses to the eye, including eyelids and/or the surrounding areas of the eye.

[0052] Red and near infrared light therapy is known to contribute to the improvement of cellular function through a reduction of oxidative stress, promoting ATP production, activating fibroblasts and stimulating collagen, encouraging tear breakdown, improving skin elasticity and tone, alleviating symptoms of dry eye, promoting healing and lymphatic drainage, reducing inflammation and redness in treated areas thereby promoting eye health, function, and appearance of treated areas.

[0053] In basic terms, the skin is made up of three layers, the Epidermis, the Dermis, and the Hypodermis (sometimes referred to as the subcutaneous layer). Within these layers we find the vascular system, the lymphatic system, the peripheral nerve system, sweat glands, sebaceous glands, and other miscellaneous tissues and structures. All these tissues are positively affected by photobiomodulation therapy with red and near infrared light.

[0054] The human eyelids are thin, mobile folds that cover the eyeball anteriorly. They offer protection from excessive light or injury and maintain lubrication by distributing tears over the entire surface of the eyeball. They eyelids are split into upper and lower portions, which meet at the medial and lateral canthi of the eye. The opening between the two eyelids is called the palpebral aperture or opening.

[0055] The eyelid consists of five main layers (superficial to deep): skin and subcutaneous tissue, orbicularis oculi, tarsal plates, levitator apparatus, conjunctiva.

[0056] The skin and subcutaneous tissue form the most superficial layer of the eyelid. This layer of skin is amongst the thinnest in the human body. In the subcutaneous layer, there is loose connective tissue but no subcutaneous fat. As a result, the eyelids are easily distended by oedema or blood.

[0057] The orbicularis oculi muscle has three distinct parts - palpebral, lacrimal, and orbital. The palpebral part gently closes the eyelids, the lacrimal part is involved in the drainage of tears, and the orbital part tightly closes the eyelids. All of these parts are innervated via the facial nerve (temporal and zygomatic branches).

[0058] The tarsal plates are located deep to the palpebral region of the orbicularis oculi muscle. There are two plates: the superior tarsus (upper eyelid) and inferior tarsus (lower eyelid). They act to form the scaffolding of the eyelid and are composed of dense connective tissue. The superior tarsus also acts as the attachment site of the levator palpebrae superioris.

[0059] In the tarsal plates lie the Meibomian glands, these are a specialized type of sebaceous gland that secretes an oily substance onto the eye to slow the evaporation of the eye's tear film. The oily substance also prevents the eyelid from sticking together when closed.

[0060] The levator palpebrae superioris and superior tarsal muscles both act to open the eyelid and they are both located in the upper eyelid.

[0061] The palpebral conjunctiva forms the deepest layer of the eyelid, it is a thin mucous membrane which covers the inside of the eyelid.

[0062] They eyelid has a rich arterial supply from numerous vessels including the Ophthalmic artery (lacrimal, medial palpebral, supraorbital, dorsal nasal and supratrochlear), the angular branch of the facial artery, and the transverse facial branch of the superficial temporal artery. Venous drainage is provided by a rich network around the eyelid. Medially, blood drains via the medial palpebral vein into the angular and ophthalmic veins. Laterally, blood drains into the superficial temporal vein from the lateral palpebral vein. Sensory innervation to the eyelids is supplied by branches of the trigeminal nerve. The Ophthalmic nerve is connected to the upper eyelid via the supraorbital, supratrochlear, infratrochlear, and lacrimal branches. The Maxillary nerve is connected to the lower eyelid via the infraorbital and zygomaticofacial branches. Innervation to the muscles of the eyelid is via the facial nerve (orbicularis oculi), oculomotor nerve (levator palpebrae superioris) and sympathetic fibres (superior tarsal muscle).

[0063] Many of the conditions and diseases we experience as we age are a result of exposure to ultraviolet (UV) light and other stressors. Ultraviolet radiation, which speeds the natural aging process, is considered the primary cause of wrinkling. Exposure to UV light breaks down the skin's connective tissue, collagen, and elastin fibres, which lie in the deeper layer of skin (dermis). Without this supportive connective tissue, the skin tends to lose strength and flexibility, and may begin to sag and wrinkle. Additionally, the breakdown of the skin's connective tissue may lead to a loss of support for other organs and systems, such as the circulatory and lymphatic systems. In the case of the eyelids and surrounding areas, this breakdown may be particularly impactful due to the thinness of the skin and the critical eye functionality that it supports.

[0064] Figs. 1A and 1B are simplified schematic illustrations of embodiments of an apparatus 1 configured to deliver photobiomodulation therapy to the eye and/or the surrounding areas of the eye. The apparatus 1 delivers photobiomodulation therapy by positioning a light source in fixed relation to the user's face.

[0065] The apparatus 1 comprises a treatment unit 2. The treatment unit 2 covers the user's eyes when the apparatus 1 is placed over the user's face. In some embodiments, when in use, the treatment unit 2 extends to cover the surrounding areas of the eyes. The treatment unit 2 may have a visor or spectacle/glasses shape to at least cover the eye and surrounding areas, although it is envisaged that the treatment unit 2 may extend across other areas of the face in use, such as in a full "face mask" type of configuration. With reference to Fig. 6, a full "face mask" configuration may, for example. extend across the user's face to cover most (if not all) of the forehead region 26, the sides of the face (infratemporal) 18, and most (if not all) of the jaw or cheek (mandibular/buccal) region 28. Some embodiments may also cover a mouth or chin region. Some embodiments may not cover the user's lips.

[0066] In some embodiments, the treatment unit 2 comprises at least one arcuate or curved portion 3 to facilitate the treatment unit 2 extending across the eye region of the user between the temple regions on either side of the user's head, in a similar manner to wraparound sunglasses. The treatment unit 2 may comprise left and right side portions 4, 5 which when worn, correspond to the left and right sides of the user's head, such as shown in Figs. 5A and 5B. The side portions 4, 5 may be positioned approximately around the temple regions in use. The left side portion 4 is more clearly shown in Fig. 1B, while the right side portion 5 is more clearly shown in Fig. 1A. The left and right side portions 4, 5 may be symmetrical/mirror images of each other.

[0067] As shown in Figs. 1A and IB, the treatment unit 2 comprises an upper section 6 and a lower section 7. When the apparatus 1 is in use, such as shown in Figs. 5A and B, the upper section 6 may be disposed towards an eyebrow region of the user's face. The upper section 6 may alternatively extend onto or beyond the eyebrow region. Similarly, the lower section 7 may be disposed towards a cheek region of the user's face. The lower section 7 may alternatively extend onto or beyond the cheek region, such as shown in Figs. 5A and 5B and Figs. 7A and 7B. The lower section 7 may curve or sweep upwards towards the upper section 6 to define a convex section 7A. In doing so, the convex section 7A allows the treatment unit 2 to extend towards the user's ear in use, without impinging on the ear (such as shown in Figs. 5A and 5B).

[0068] Figs. 5A and 5B are a simplified illustration of the positioning on the face and head of an embodiment of an apparatus that delivers photobiomodulation therapy to the eye(s) and surrounding areas. This illustration demonstrates both front and side profile view showing the external view (Fig. 5A) of the apparatus and positioning and the areas of the face and head that are covered. Additionally (Fig. 5B) represents a transparent view of both front and side profile view of the apparatus, demonstrating internal positioning and the areas of the face and head that are covered.

[0069] Continuing to refer to Figs. 1A and 1B, the treatment unit 2 may be removably attached to a frame 8, which allows the treatment unit 2 to be removed for repair, for example. The frame 8 may extend partly or wholly around a perimeter of the treatment unit 2. For example, in some embodiments, the frame 8 connects to the upper section 6. The frame 8 may be similar in overall shape and function to the frame of a pair of spectacles/glasses, in which the frame provides a means to securely locate the treatment unit 2 in fixed relation to the user's face in use. The frame 8 may also come in various sizes, be adjustable or deformable, or comprise modular components to allow users to adjust or customize the shape and size of the frame 8 to better suit the size and shape of their face and thereby improve user comfort.

[0070] The frame 8 may comprise an interior or inner portion 9 of the treatment unit 2. The interior portion 9 is configured to be facing the user's face when the apparatus 1 is in use. A photobiomodulation light source 15 is also disposed on the interior portion 9 so that the user's face is exposed to the light emitted from the light source 15 when the apparatus 1 is in use. The operation of the apparatus 1 and the light source 15 will be discussed in more detail later herein.

[0071] In some embodiments, the frame 8 and/or the treatment unit 2 are configured to fold or be collapsed into a more compact form, which may assist with storage and/or protection of the photobiomodulation light source 15 disposed on the interior portion 9. For example, in some embodiments the treatment unit 2 can be collapsed, so that the left side portions 4 and the right side portion 5 can be brought together. Alternatively, the upper section 6 and the lower section 7 may be collapsed and brought together. Such a collapsible arrangement may be facilitated by a hinge or hinges (to allow folding in half, for example), or by the treatment unit 2 being made of separable sub portions which are secured by a removable clip or latch mechanism, for example.

[0072] With further reference to Figs. 4A and 4B, which respectively show top and bottom views of the apparatus 1, the frame 8 may comprise padding 81 on the interior or inner portion 9. The padding 81 may bulge or extend outwardly from the interior portion 9 so that when the apparatus 1 is in use, the inner portion 9 (and the photobiomodulation light source 15) does not contact the user's face. In some embodiments, the padding 81 does not bulge out from the interior portion 9, and is instead a consistent layer of padding 81 across the interior portion 9. The thickness and location of the padding 81 may be adjusted or varied in order to maintain a fixed distance between the interior portion 9 (and the photobiomodulation light source 15) and the user's face. The padding 81 may also provide a cushioned surface to improve user comfort when the apparatus 1 is in use. The padding 81 may be deformable so as to be mouldable to suit the shape of the user's face. The padding 81 may comprise a resilient foam, a memory foam, or a plastic bumper. The padding 81 may comprise a textured or tacky surface so that when the padding 81 is in contact with the user's face, the textured or tacky surface allows the padding 81 to lightly grip the skin so as to help hold the apparatus 1 in a fixed position on the user's face.

[0073] Continuing to refer to Figs. 1A and 1B, and with further reference to Figs. 3A and 3B, the frame 8 may comprise supports or securing means 11. The securing means 11 extends outwardly from the side portions 4, 5 so that in use, the securing means 11 provides a means to hold the apparatus 1 in position on the user's face. The securing means 11 may cooperate with the textured or tacky surface of the padding 81 to help hold the apparatus 1 in a fixed position on the user's face. This may make it easier for the light source 15 to provide secure and consistent coverage of the desired areas of the user's face during a photobiomodulation therapy session.

[0074] In some embodiments, the securing means 11 comprises arms which rest on the user's ears akin to the arms of spectacles/glasses. The arms may have a curved shape which allows them to at least partially wrap around the user's ear to provide improved stability and security. In some embodiments, the securing means 11 comprises a band or strap which wraps around the user's head, akin to goggles. The securing means 11 may be elastic, resiliently deformable, and/or comprise an adjustment mechanism so as to be adjustable in length and shape to cater to different head diameters and shapes. The securing means 11 may be removable for cleaning or replacement. The securing means 11 may be foldable, collapsible, or removable to allow the apparatus 1 to have a more compact or collapsed form when not in use.

[0075] The apparatus 1 may further comprise a power button 12. The apparatus 1 may further comprise a control panel 13. The apparatus 1 may further comprise a charging port 14. The apparatus 1 may further comprise a photobiomodulation light source 15. The apparatus 1 may further comprise a power source such as a battery, and/or a controller. The charging port 14 provides a connection point for a charging cable to connect the apparatus 1 to an external power supply (such as mains electricity) to charge the power source. The power source may be a rechargeable battery. In some embodiments, the power source is able to be charged wirelessly, such as by inductive charging.

[0076] The power button 12 may be a switch or other similar type of control interface which controls the output of the photobiomodulation light source 15. In some embodiments, the power button 12 is a simple power button such as an on/off switch. The power button 12 may additionally have functions beyond "on" and "off'. In some embodiments, the power button 12 is a button, dial or slider which adjusts the output across a plurality of output levels. For example, the power button 12 may be adjustable between "on", "low power", "medium power", "high power", and "off' settings/modes.

In some embodiments, the apparatus 1 comprises an autotimer for therapy settings. The apparatus 1 may comprise a programmable component that may be programmed or utilised by the user to customise therapy settings. In some embodiments, the apparatus 1 is configured to communicate wirelessly with other devices such as a smartphone, for example. Wireless communication may be achieved by Bluetooth, NFC, or over WiFi. The apparatus 1 may communicate with other devices such as a smartphone, for example to facilitate such customisation of therapy settings via an app on the smartphone.

[0077] The control panel 13 may display operational data of the apparatus 1. For example, the control panel 13 may indicate the output level of the photobiomodulation light source 15, the charge level of the battery/power source, or whether the apparatus 1 is "on" or "off'. The control panel 13 may indicate other useful information such as the duration of use; for example, a timer displaying the duration of the current photobiomodulation therapy session, and/or the amount of time remaining in the current photobiomodulation therapy session. The control panel 13 may be an LCD or LED display, for example, and may comprise a capacitive/touch screen.

[0078] The apparatus 1 may comprise a speaker which is configured to communicate information about the apparatus 1, and/or to communicate details of the current photobiomodulation therapy session. The speaker may emit a specific sound, series of sounds, or pre-recorded voice messages to signify particular events such as the charge/power status of the battery or the amount of time remaining in the session. When the user is using the apparatus 1, they may not be allowed to open their eyes during the photobiomodulation therapy session, and the speaker provides a means to inform the user when the therapy session is completed. This may be in addition to a visual aid, such as the light source switching off when the therapy session is completed.

[0079] The power button 12, control panel 13, charging port 14, light source 15, and/or power source are connected to the controller. The controller regulates the amount of light emitted from the light source 15 in order to allow the user to control the delivery of the photobiomodulation therapy. In some embodiments, in response to a setting or mode of the power button 12, the controller regulates the amount of electrical power supplied from the power source to the light source 15. The controller may also control or communicate with the timer to control the duration of the light emitted from the light source 15, and thereby the duration of the treatment.

[0080] The controller may indicate the operational status, such as the setting/mode and the battery life, on the control panel 13. The controller may also select the type of light emitted from the light source 15. For example, the light source 15 may be configured to emit specific wavelengths of light.

[0081] The controller may communicate with memory or a data storage unit which contains instructions for specific pre-set therapy programs. Each therapy program may cause light to be emitted from the light source 15 at different durations, wavelengths, and/or intensities. The memory may also be able to store customised programs which the user can upload, for example via a smartphone app. The memory may also be updated to receive software updates from the manufacturer.

[0082] The power button 12, control panel 13, and/or charging port 14 may be positioned on the apparatus 1 to be easily accessed by the user. For example, the power button 12 and/or the control panel 13 may be disposed on an exterior portion 10 of the treatment unit 2 to allow the status of the apparatus 1 to be easily seen by the user or by a third party (such as a person administering the photobiomodulation therapy to the user). The control panel 13 and/or power button 12 features may be situated on the right and / or left side of the apparatus 1 as shown in Figs 1A and IB; however, this is illustrative and in no way limits the potential location or functionality of these components on the apparatus and merely serves as an example in this embodiment for explanatory purposes. This may be particularly useful when the apparatus 1 is in a compact or collapsed configuration, wherein the internal portion is obscured to protect the light source.

[0083] Referring again to Figs. 1A and IB, with further reference to Fig. 2A, the treatment unit 2 further comprises the exterior or outer portion 10 which defines an exterior or outer surface. In some embodiments, the exterior portion 10 comprises a firm or rigid outer casing or shell 2A. The outer casing 10 may be rigid so that it holds its shape and provides some protection of the light source 15 disposed on a reverse interior portion of the treatment unit 2.

[0084] Fig. 2B shows the reverse interior portion 9 of the treatment unit 2, which is oppositely disposed to the exterior portion 10. The interior portion 9 defines an interior or inner surface, such as shown in Fig. 2B. At least part of the interior surface may be generally concave to facilitate a wraparound configuration of the treatment unit 2. The interior portion 9 may comprise a rigid inner casing or shell. This may facilitate mounting and or protection of the light source 15. In some embodiments, the light source 15 comprises an array of light generating sources such as light emitting diodes (LEDs), organic light emitting diodes (OLED), lasers, or other suitable light sources that are adapted to emit light within a particular wavelength range correlating with the treatment of one or more specific skin-related and/or eye related conditions.

[0085] In some embodiments, the photobiomodulation is achieved using light emitting diodes as the source 15 of red to near infrared light. In comparison with lasers, LED technology generates negligible heat, is clinically proven to be safe, and has achieved non-significant risk status for human trials by the U.S. Food and Drug Administration. In some embodiments, the apparatus 1 utilizes a noncoherent light source 15 capable of irradiating the user's face, on and around the eyes.

[0086] The light source 15 may comprise an array of light sources 15 which may be distributed across the inner portion 9 to provide the desired light coverage to the areas of the user's face indicated in Fig. 5A and 5B. The distribution of the array of light sources 15 may be uniform or irregular. For example, the light source 15 may comprise an array of several LEDs which are concentrated (that is, more LEDs per unit area) in particular sections of the inner portion 9 which correspond to specific regions of the user's face when the apparatus 1 is in use. In some embodiments, the LEDs are arranged in a grid.

[0087] The light emitted by the light source 15 may vary in intensity and wavelength depending on the type of photobiomodulation therapy desired. In one aspect, the light emitted by the light source 15 has a wavelength between 630-1000 nm. The light emitted by the light source 15 may have a power intensity/target irradiance between 0.5 - 50 mW/cm2 for a time of 1 - 30 minutes (equivalent to an energy density of 0.5 - 25 J/cm2), according to Hamblin et al. "Biphasic Dose Response in Low Level Light Therapy" 2009. Exposure to light emitted by the light source 15 at these wavelengths and/or intensities may lead to improvement in dry eye conditions. Such photobiomodulation treatment may lead to an improvement in the appearance of skin. For example, this may lead to an observable improvement in healing, reduced inflammation, redness, alleviating symptoms of dry eye symptoms and reducing the appearance of skin aging of the eyelid and areas surrounding the eye. The improved tissue function may also result in increased serum melatonin levels resulting in improved sleep, more desirable tear production, and increased intradermal collagen resulting in improved skin health and appearance.

[0088] Peak wavelengths of 670nm and 830nm, with bandwidths of 25-30nm have been used in numerous experimental and clinical studies. In clinical studies of red light therapy for treatment of conditions around the eye, as well as for ocular injury or disease, 670nm LED irradiation was administered at a power intensity between 25-50 mW/cm2 between 1-3 minutes to produce an energy density of 4 J/cm2. The inventors observe that 670nm and 830nm LED irradiation administered at a power intensity between 0.5 - 50mW/cm2 between I to 30 minutes produces an energy density of 0.1 to 4.5 J/cm2 and may promote the health and appearance of the eye and surrounding areas due to the photobiomodulation effects of the light, which causes a reduction in oxidative stress. This reduction in oxidative stress allows the cells of these tissues to function more optimally, resulting in, for example, increased collagen production, increased blood and lymphatic flow, and improved tissue function. This may result in advantages including but not limited to promoting healing, reducing inflammation, redness, alleviating symptoms of dry eye and reducing the appearance of skin aging surrounding the eye.

[0089] Fig. 2C is a section view of the apparatus 1 as viewed along the line marked as such in Fig. 2B and looking at the inside of the right-hand side of the apparatus 1. In some embodiments, the interior portion 9 and the exterior portion 10 are spaced apart, and in doing so provides a structure that defines a cavity 10A therebetween. The interior portion 9 and the exterior portion 10 may be spaced apart by the frame 8, such that the frame 8 is sandwiched by the interior portion 9 and the exterior portion 10. In some embodiments the cavity 10A is sufficiently spacious to house the required circuitry to service the light source 15, the power source, the charging port 14, the control panel 13 and the power button 12. The circuitry may include at least one flexible circuit board to which the LEDs 15 are connected.

[0090] The interior portion 9 and/or the exterior portion 10 maybe attached to the frame 8 by screws to allow disassembly for repair, for example to provide access to the controller and battery/power source.

[0091] Figs. 4A and 4B respectively show top and bottom views of the apparatus 1. In these views, the shape of the curved portions 3 are more clearly shown. The frame 8 has a curved shape to generally correspond to the shape of the user's head, and thereby provide a more secure and comfortable fit. In some embodiments, the frame 8 is symmetrical about a reference centreline 40. The frame 8 extends away from centreline 40, before curving around and back towards the centreline 40 near the temple region of the user's head. The arms 11 may also extend towards the centreline 40 at the ear region of the user's head, and wrap slightly around the rear portion of the user's head to provide a secure fit.

[0092] Figs. 4A and 4B show example placement of the padding 81 and how it bulges from the inner portion 9 to space the apparatus 1 from the user's face. The padding 81 may be placed in between the LEDs 15 so as to avoid blocking the emission of light. In some embodiments, the padding 81 may cover the entirety of the inner layer 16. In some embodiments, the padding 81is transparent or translucent to allow the light emitted from the LEDs 15 to pass through and irradiate the skin. In some embodiments, the padding 81 comprises light diffusing material to allow the light emitted from the LEDs 15 to pass through and irradiate the skin.

[0093] Fig. 4C is an exploded view of the apparatus 1, according to some embodiments. In some embodiments, the apparatus 1 comprises a treatment unit 2 made from multiple layers. The treatment unit 2 may comprise the shell 2A, and a second layer 15A. The shell 2A comprises the frame 8, which may define raised edges or lips 2B and a recess 2C for receiving the second layer 15A. The lips 2B may define the perimeter of the recess 2C, and be raised so that the inner portion 9 sits approximately flush with the lips 2B when the second layer 15A is received in the recess 2C. The second layer 15A may be a body which houses the circuitry, componentry such as controller, battery, and power source, and the light source(s) 15 as previously identified. The frame 8 may additionally define a hole or socket 14A which aligns with the charging port 14 when the second layer 15A is received in the recess 2C.

[0094] In some embodiments, the apparatus 1 further comprises a third layer 16. The third layer 16 sits in closest proximity to the face. The third layer 16 may be made from a soft, comfortable material and comprise the padding 81. The third layer 16 may have a light diffusing quality, and may provide protection for the light sources 15. The third layer 16 may be moulded to match the shape of the apparatus 1 and/or be moulded to the shape of the human face/head. The multiple layers may be disassembled to allow for easier maintenance and repair. For example, the third layer 16 may require cleaning or replacement after prolonged or repeated exposure to skin oils and sweat. Similarly, if the light source 15 requires replacement, the second layer 15A can be replaced without requiring replacement of the entirety of the apparatus 1.

[0095] The user may self-administer photobiomodulation treatment by placing it on the head, similar to a pair of glasses (as exemplified by Fig. 5A and Fig. 5B), pressing the power button 12, choosing setting if required (via the control panel 13), initiating therapy and allowing the apparatus 1 to deliver the treatment which can last from any time from 1-30 minutes, depending on required dosing, programming of device and requirements of user. In some embodiments, the apparatus 1 will have an auto timer component and will automatically switch off when treatment time and programmed dose has completed. In some embodiments, the functionality of the apparatus 1 can include the ability to operate each wavelength of light at a time, both wavelengths at the same time, or each wavelength in succession. In some embodiments, the apparatus 1 can be connected to a smart phone or other device wirelessly and controlled via an application. This application could be used to select a specific treatment plan or protocol based upon the user's preference or professional advice, as well as record treatment data over a course of time. This application could also monitor other device functionality, including battery levels and possibly update firmware if appropriate.

[0096] Fig. 6 is a simplified illustration of the areas of the face and head that the apparatus will deliver photobiomodulation light therapy to. More specifically including, but not limited to the following areas of the face/head; across the entire orbital (22), infraorbital (21) and supraorbital (24) regions, including the eyebrow and glabella (23) areas, covering below the tear trough across the nasal region (25) and the midsection of the face, including the zygomatic region (20) spanning to the infratemporal (18), pre auricular (27), parotid (17) and temporal (19) regions on both sides.

[0097] Figs. 7A, 7B, and 7C show a further embodiment of the apparatus 1, denoted as apparatus 70. As with the apparatus 1, the apparatus 70 comprises a treatment unit 72 (corresponding to the treatment unit 2) which covers the user's eyes when the apparatus 1 is placed over the user's face. In some embodiments, the treatment unit 2 and the treatment unit 72 cover the cheek area. The treatment unit 2 and the treatment unit 72 may cover the same amount or regions of the cheek area. In some embodiments, the treatment unit 72 extends lower over the cheek area than treatment unit 2. The treatment unit 72 may cover a larger amount or region of the cheek area than the treatment unit 2.

[0098] In some embodiments, the treatment unit 72 covers the cheek and the nose area. In some embodiments, the treatment unit 72 extends over the cheek area but does not extend over the nose area, such as shown in Figs. 7A and 7B. In such embodiments, the treatment unit 72 comprises two halves 72A and 72B, which in use, may correspond to the left and right sides of the user's face in a similar way to the left and right side portions 4, 5.

[0099] The halves 72A and 72B of the treatment unit 72 may be connected by a bridge portion 72C. The light source 15 may extend across the bridge portion 72C between the halves 72A and 72B to provide photobiomodulation therapy to the area of skin beneath (which may generally correspond to the bridge of the nose and the area between the eyebrows). In some embodiments, the light source 15 does not extend between the halves 72A and 72B, and so the bridge portion 72C does not provide photobiomodulation therapy.

[0100] The apparatus 70 may further comprise a hinge or releasable means at the bridge portion 72C so that the two halves 72A and 72B can be separated for storage as previously disclosed.

[0101] The lower section 7 of the treatment unit 72 extends rearward so as to define a concave section 73. In embodiments where the treatment unit 72 extends to cover more of the cheek area than the treatment unit 2, the concave section 73 allows the treatment unit 72 to extend and provide coverage of the user's face below the ears, around the sides of the user's jaw bone. For example, the concave section 73 extends to cover the mandibular and/or buccal regions of the user's face, as shown on Fig. 6 (item 28).

[0102] Fig. 7C shows the apparatus 70 when not in use. Similar to the treatment unit 2, the treatment unit 72 comprises the at least one arcuate or curved portion 3 to facilitate the treatment unit 2 extending across the eye region of the user between the temple regions on either side of the user's head, in a similar manner to wraparound sunglasses. The treatment unit 72 further comprises the upper section 6 and the lower section 7.

[0103] The treatment unit 72 may be removably attached to a frame 78. The frame 78 is functionally equivalent to the frame 8 and comprises similar features such as the interior portion 9 and the exterior portion 10. The frame 78 may be collapsible or foldable in the same ways previously discussed herein in relation to the frame 8.

[0104] Fig. 8A shows a frontview of the apparatus 70 inthe same way as Fig. 2A shows the front of the apparatus 1. Fig. 8B shows a rear or inside view of the apparatus in the same way as Fig. 8B shows the rear/inside of the apparatus 1.

[0105] Fig. 9A shows a right side view of the apparatus 70 inthe same way as Fig. 3A shows the right side of the apparatus 1. Fig. 9B shows a left side view of the apparatus 70 in the same way as Fig. 8B shows the left side of the apparatus 1. The difference in shape and coverage provided by the concave section 73 compared to the convex section 7A is apparent when comparing Figs. 9A and 9B with Figs. 3A and 3B.

[0106] Fig. 10A shows a top view of the apparatus 70 in the same way as Fig. 4A shows the top of the apparatus 1. Fig. 1OB shows a bottom or underside view of the apparatus 70 in the same way as Fig. 4B shows the bottom or underside of the apparatus 1.

[0107] Fig. 1OC is an exploded view of the apparatus 70, similar to Fig 4C which shows the exploded view of the apparatus 1. In some embodiments, the apparatus 70 comprises a treatment unit 72 made from multiple layers. The treatment unit 72 may comprise the shell 2A, and a second layer 15A. The shell 2A comprises the frame 78, which similar to the frame 8 may define raised edges or lips 2B and a recess 2C for receiving the second layer 15A. The lips 2B may define the perimeter of the recess 2C, and be raised so that the inner portion 9 sites approximately flush with the lips 2B when the second layer 15A is received in the recess 2C. The second layer 15A may be a body which houses the circuitry, componentry such as controller, battery, and power source, and the light source(s) 15 as previously identified. The frame 78 may additionally define a hole or socket 14A which aligns with the charging port 14 when the second layer 15A is received in the recess 2C.

[0108] In some embodiments, the apparatus 70 further comprises the third layer 16. The third layer 16 sits in closest proximity to the face. The third layer 16 may be made from a soft, comfortable material and comprise the padding 81. The third layer 16 may have a light diffusing quality, and may provide protection for the light sources 15. The third layer 16 may be moulded to match the shape of the apparatus 70 and/or be moulded to the shape of the human face/head. The multiple layers may be disassembled to allow for easier maintenance and repair. For example, the third layer 16 may require cleaning or replacement after prolonged or repeated exposure to skin oils and sweat. Similarly, if the light source 15 requires replacement, the second layer A can be replaced without requiring replacement of the entirety of the apparatus 70.

[0109] The apparatus 1, 70 can be used to improve the functionality of the tissue of and around the eyes. An example of a method for improving the functionality of the tissue of and around the eyes may comprise applying light with a predetermined set of photobiomodulating parameters to the eyes and surrounding areas tissues using the apparatus 1, 70. The light emitted from the apparatus 1, 70 may have wavelengths in the range of 600 nm +/- 1Onm to 900 nm +/- 10 nm. Applying the light in this way may result in reduction of oxidative stress of the tissues exposed to this light, thereby improving cellular respiration and resulting in improved tissue function.

[0110] Certain wavelengths of light at certain intensities (delivered by laser, LED or other monochromatic sources) will, for example, aid tissue regeneration, resolve inflammation, relieve pain and boost the immune system. Furthermore, it is agreed that the mechanism of action is photochemical rather than heat related. Observed biological and physiological effects include changes in cell membrane permeability, and up regulation and down-regulation of adenosine triphosphate and nitric oxide.

[0111] Specific wavelengths of red and near infrared light can lead to the activation of mitochondria, the energy-producing organelles within the cell via cytochrome c oxidase.

[0112] Brendan J Quirk and Harry T Whelan's "Near-Infrared Irradiation Photobiomodulation: The Need for Basic Science" 2011, is a review that analyses a body of existing study and describes that the technique of photobiomodulation is based on the phenomenon that exposure to low-level laser light can alter cellular function. Evidence has indicated that near-IR light treatment can prevent cell death (apoptosis) in cultured neuronal cells. Irradiation at 660-680 nm has been shown to increase the activity of purified cytochrome oxidase, increase the energy production rates of isolated mitochondria, and upregulate cytochrome oxidase activity in cultured neuronal cells. Together, these data indicated that cytochrome oxidase, and thus mitochondria energy production, are cellular targets influenced by red and near-infrared light treatment.

[0113] Hamblin et al highlight that the lymphatic system plays a critical role in the process of reducing inflammation and oedema. Photobiomodulation reduces swelling, and it is likely that the lymphatic system is involved, this is likely due to the fact that nitric oxide (NO) modulates lymphatic vessel contraction and the subsequent lymph flow, and it has been established that PBM releases stores of NO and subsequently improves blood flow. (see Hamblin, M et al. Low-Level Light Therapy: Photobiomodulation. SPIE Press 2018.)

[0114] With respect to the safety of red and NIR radiation on and around the eyes, it has been demonstrated in both animal models and in clinical trials to be both safe and beneficial. Eells et al demonstrated that it protects the retina against the toxic actions of methanol-derived formic acid in a rodent model of methanol toxicity and may enhance recovery from retinal injury and other ocular diseases in which mitochondrial dysfunction is postulated to play a role (Eells J T., PNAS, 100(6):3439-44 (2003)).

[0115] Koev et al did a five-year follow up of patients that received LLLT to treat age-related macular degeneration (AMD) and found that the oedema and haemorrhage in the patients with progressive, exudative AMD significantly decreased. Furthermore, no side effects were observed during the therapy. They concluded that it is a highly effective treatment that has potential to become a long-term therapeutic option for both forms of AMD, as it is effective in improving patients' visual acuity. Finally, in their review of light therapy and the safety associated with the eyes, Brouwer et al concluded that the results suggest that light therapy is safe for the eyes in physically healthy, unmedicated persons. They also note that while the ocular safety of light therapy in persons with pre-existing ocular abnormalities or increased photosensitivity warrants further study, these theoretical considerations do not substantiate stringent ocular safety-related contraindications for light therapy.

[0116] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Bibliography

Zhao et al. Research progress about the effect and prevention of blue light on eyes. International Journal of Ophthalmology. 2018.

Brendan J Quirk and Harry T. Whelan. Near-Infrared Irradiation Photobiomodulation: The Need for Basic Science. Photomedicine and Laser Surgery. 2011.

Hamblin, M et al. Low-Level Light Therapy: Photobiomodulation. SPIE Press 2018

Eells J T. Therapeutic photobiomodulation for methanol-induced retinal toxicity. PNAS, 100(6):3439-44 (2003)

Koev et al. Five-year follow-up of low-level laser therapy (LLLT) in patients with age related macular degeneration (AMD). 2018.

Claims

CLAIMS:

1. An apparatus for delivery of photobiomodulation (PBM) therapy, the apparatus comprising: a treatment unit, the treatment unit defining an inner surface and an outer surface, wherein the treatment unit is configured to be worn by a user such that the inner surface of the treatment unit faces an eye area of the user; an array of light sources coupled to the inner surface of the treatment unit, the array configured to emit light waves from the inner surface of the treatment unit; a controller operably connected to the array and configured to control emission of the light waves; wherein each one of the light sources in the array is configured to emit the light waves outwardly from the inner surface of the treatment unit to provide photodynamic stimulation of tissue spanned by the inner surface.

2. The apparatus of claim 1, wherein at least one of the light sources is configured to transmit light at a first wavelength, and at least another of the light sources is configured to transmit light at a second wavelength different from the first wavelength.

3. The apparatus of claim 1 or claim 2, wherein the treatment unit is configured to house the array of light sources and the controller.

4. The apparatus of any one of claims 1 to 3, wherein the treatment unit comprises a multi-layer arrangement, comprising an outer shell, a second layer, and a third layer.

5. The apparatus of claim 4, wherein the second layer consists of the controller, a battery, a power source, and the array of light sources.

6. The apparatus of claim 4 or claim 5, wherein the outer shell defines a recess for receiving the second layer therein.

7. The apparatus of any one of claims 4 to 6, wherein the third layer has light diffusing qualities.

8. The apparatus of claim I to 7, wherein the tissue comprises at least one of: (i) the eye area of the user, including the orbital, infraorbital and supraorbital regions; (ii) eyebrow and glabella areas; (iii) the tear trough across the nasal region and the midsection of the face; or (iv) the zygomatic region spanning the infratemporal, pre auricular, parotid and temporal regions on both sides of the user's head.

9. The apparatus of any one of claims 1 to 8, wherein the treatment unit additionally covers a nose region of the user.

10. The apparatus of any one of claims I to 9, wherein the treatment unit additionally covers a cheek region of the user.

11. The apparatus of any one of claims 1 to 10, wherein the apparatus further comprises a frame configured to secure the apparatus to the face of the user, and the treatment unit is removably attached to the frame.

12. The apparatus of any one of claims I to 11, wherein the light sources are LEDs connected to a circuit board housed within the treatment unit.

13. The apparatus of any one of claims 1 to 12, wherein at least one of the light sources emits light having a wavelength in the range of 629 nm to 700 nm.

14. The apparatus of any one of claims 1 to 13, wherein at least one of the light sources emits light having a wavelength of 670 nm +/- 10 nm.

15. The apparatus of any one of claims 1 to 12 wherein at least one of the light sources emits light having a wavelength of 799 nm to 860 nm.

16. The apparatus of any one of claims I to 12, or the apparatus of claim 15, wherein at least one of the light sources emits light having a wavelength of 830 nm +/- 10 nm.

17. A method for improving the functionality of the tissue of and around the eyes comprising: applying light with a predetermined set of photobiomodulating parameters to the eyes and surrounding areas tissues from a treatment apparatus; wherein the light has one or more wavelengths ranging from 630 nm+/- 1Onm to 900 nm +/- 10 nm.

18. The method of claim 17, wherein a target irradiance delivered by the apparatus is 0.5 - 50 mW / cm2.

19. The method of claim 17 or claim 18, wherein a target treatment time period is between 1 and 30 minutes.

20. The method of any one of claims 17 to 19, wherein a target total delivered energy density is between 0.1 and 25 J / cm 2 .

21. The method of claim 20, wherein the target total delivered energy density is between 0.1 and 5 J / cm2 .

22. The method of any one of claims 17 to 21, wherein the apparatus is the apparatus of any one of claims I to 16.

23. The steps, features, integers, compositions and/or compounds disclosed herein or indicated in the specification of this application individually or collectively, and any and all combinations of two or more of said steps or features.

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