Nasal photobiomodulation and drug delivery device

Abstract

A nasal photobiomodulation device including an elongate body having an outer surface disposed between a proximal end and a distal end. The photobiomodulation device further includes a first lumen and a second lumen disposed along at least a portion of the length of the elongate body. The first and second lumens have a first end and a second end. The first ends are disposed adjacent the proximal end of the elongate body and the second ends open through the outer surface of the elongate body. The second end of the second lumen disposed adjacent the second end of the first lumen.

Description

NASAL PHOTOBIOMODULATION AND DRUG DELIVERY DEVICERELATED APPLICATION SECTION

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application Number 63 / 571 ,175, filed March 28, 2024, the content of which is incorporated by reference herein in its entirety and for all purposes.FIELD

[0002] The present disclosure relates to a nasal cavity therapy devices and, more particularly, to a nasal photobiomodulation and drug delivery device.BACKGROUND

[0003] Infrared, near-infrared, and other light therapies have been shown to reduce inflammation and improve cell functions. Light therapies also provide improvements when administered to a person’s brain. Infrared and near-infrared light sources, disposed on a hat or helmet, administer light therapy to a person’s brain. However, there are difficulties in getting infrared and near-infrared light therapies to penetrate deeply into the brain through a person’s skull without using higher energy which may be detrimental to the scalp and brain. These challenges exist whether delivery light for therapeutic or diagnostic purposes.

[0004] In addition to light therapy, various drugs can be preferably administered nasally instead of orally or intravenously. Nasal administration of medications can improve the efficacy of some medications. In some examples, the nasal administration of medication can more effectively penetrate the blood-brain barrier if administered at and around the cribriform plate and associated areas. For example, insulin administered nasally has been found to have increased efficacy as a brain therapy as compared to intravenously-introduced insulin.SUMMARY

[0005] Disclosed herein is a nasal photobiomodulation device including an elongate body having a proximal end and a distal end. The photobiomodulation device includes a tip disposed on the distal end of the elongate body. The photobiomodulation device further includes a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body. The photobiomodulation device further includes a securement mechanism coupled to at least one of the elongate body and the first end of the lumen.

[0006] In some variations, the elongate body of the photobiomodulation device is curved. Additionally, the tip of the photobiomodulation device may be rounded. The curve of the elongate body and the rounded tip facilitate insertion of the elongate body into a person’s nasal cavity.

[0007] In other variations, the lumen is a first lumen, and the photobiomodulation device may include a second lumen disposed adjacent to the first lumen. The second lumen may have a first end disposed adjacent to the first end of the first lumen and a second end including an opening disposed through the outer surface of the elongate body and adjacent to the second end of the first lumen. The first end of the first lumen may define a first diameter and the first end of the second lumen may define a second diameter. In some such examples, the first diameter is different from the second diameter and the first diameter may be larger than the second diameter. Furthermore, the lumen may define a narrowing taper from the first end to the second end.

[0008] In yet other variations, the photobiomodulation device includes an inflatable cuff disposed on the elongate body, between the proximal end and the distal end. The inflatable cuff may be disposed opposite the second end of the lumen.

[0009] Also disclosed herein is a nasal photobiomodulation device, including an elongate body having a proximal end and a distal end. The nasal photobiomodulation device also includes a first lumen disposed along at least a portion of the elongate body and a second lumen disposed along at least a portion of the elongate body. The nasal photobiomodulation device also includes a cuff disposed on the curved elongate body between the proximal end and the distal end.

[0010] In some variations, the cuff is inflatable. In some such variations, the photobiomodulation device may include a third lumen in fluid communication with the cuff. Pressurized air can pass through the third lumen to inflate the cuff. When the cuff is inflated, the elongate body can be brought closer to a person’s skull base, cribriform plate, olfactory nerves and increase the efficacy of any light or medication therapy administered by the photobiomodulation device. In some examples, the inflated cuff can also push through various nasal secretions or other tissues.

[0011] In other variations, a first opening through the outer surface of the elongate body is defined by the first lumen; and a second opening through the outer surface of the elongate body is defined by the second lumen. The second opening may be disposed adjacent to the first opening.

[0012] In yet other variations, the elongate body of the nasal photobiomodulation device may be curved. Additionally, the tip of the nasal photobiomodulation device is rounded. Also, the nasal photobiomodulation device can include a securement mechanism coupled with the proximal end of the elongate body.

[0013] In other variations, a first end of the first lumen may define a first diameter and a first end of the second lumen may define a second diameter. The first diameter may bedifferent from the second diameter. In some such examples, the first diameter is larger than the second diameter. Furthermore, at least one of the first lumen and the second lumen may define a narrowing taper.

[0014] In some other variations, the elongate body is a first elongate body and the photobiomodulation device may also include a second, parallel elongate body, such that the first elongate body is received in one nasal cavity of a patient and the second elongated body is simultaneously received in the patient’s other nasal cavity. In some such examples, the securement mechanism includes a first end coupled to the first elongate body and a second end coupled to the second elongate body. The second elongate body may be identical to the first elongate body but mirrored about the securement mechanism.

[0015] Also disclosed herein is nasal photobiomodulation device including an elongate body having an outer surface disposed between a proximal end and a distal end. A first lumen is disposed along at least a portion of the elongate body. The first lumen has a first end and a second end. The first end is disposed adjacent the proximal end of the elongate body and the second end opens through an outer surface of the elongate body. A second lumen is disposed along at least a portion of the elongate body. The second lumen has a first end and a second end. The first end is disposed adjacent the proximal end of the elongate body and the first end of the first lumen and the second end opens through an outer surface of the elongate body.

[0016] In some variations, the second end of the second lumen may be disposed adjacent to the second end of the of the first lumen. In such examples, the second lumen can include a cooling fluid or heat sink to maintain the photobiomodulation device at a comfortable temperature and to reduce tissue temperature of tissues receiving the energy. This may take the form of cooled air or fluids which circulate into the nasal cavity. This channel can also accommodate a thermal probe that can control surrounded temperature for the purposes of cerebral cooling. Additionally or alternatively, the first and second lumens can be used simultaneously to administer additional light, light and a medication, or only medication.

[0017] In other variations, the nasal photobiomodulation device may include a cuff disposed on the curved elongate body between the proximal end and the distal end. The nasal photobiomodulation device may also include a third lumen having a first end disposed adjacent to the proximal end of the elongate body and a second end in fluid communication with the cuff. The cuff may be disposed opposite the second end of the first lumen.

[0018] In other variations, the nasal photobiomodulation device may include a securement mechanism coupled to at least one of the elongate body and the first end of the lumen. Additionally, the elongate body may be curved.

[0019] In yet other variations, the first end of the first lumen may define a first diameter and the first end of the second lumen defines a second diameter. The first diameter may be different from the second diameter. In some examples, the first diameter is larger than the second diameter. Further, at least one of the first lumen and the second lumen may define a narrowing taper from the first end to the second end.

[0020] Also disclosed herein is a method of introducing light or medicament to a location proximate to the skull base, particularly a cribriform plate of a human. The method includes introducing into a nasal cavity of the human a nasal photobiomodulation device. The nasal photobiomodulation device includes an elongate body having a proximal end and a distal end, a tip disposed on the distal end of the elongate body, and a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body, and a securement mechanism coupled to at least one of the elongate body and the first end of the lumen. The method includes introducing at least one of a light source or source of medicament through a proximal end of the nasal photobiomodulation device. The method also includes either activating the light source or initiating a flow of the medicament from the source of medicament.

[0021] In some variations, the method includes activating the light source, which may include generating an infrared, near-infrared light, blue, near ultraviolet, visible or light wavelength. In some such examples, the method may include directing the light source at a cribriform plate of the human.

[0022] In other variations, initiating a flow of the medicament includes directing the medicament towards a cribriform plate of the human. In some such examples, the medicament is insulin. To facilitate administration of insulin, the photobiomodulation device may include a cooling fluid or heat sink (described in greater detail below).

[0023] In yet further variations, the photobiomodulation device further includes an inflatable cuff. In such examples, the method includes inflating the inflatable cuff after the photobiomodulation device has been inserted into the nasal cavity of the person. Inflating the inflatable cuff causes the second end of the lumen to move towards the cribriform plate of the person. The method also includes deflating the cuff after activating the light source or initiating a flow of the medicament for a predetermined period of time.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present disclosure is described in the following detailed description in conjunction with the drawings, wherein:

[0025] FIG. 1 is a cross sectional view of a human head with a nasal photobiomodulation device made in accordance with the present disclosure.

[0026] FIG. 2 is a perspective view of a first nasal photobiomodulation device made in accordance with the present disclosure.

[0027] FIG. 3 is a right side view of the nasal photobiomodulation device of FIG. 2.

[0028] FIG. 4 is a front side view of the nasal photobiomodulation device of FIG. 2.

[0029] FIG. 5 is a left side view of the nasal photobiomodulation device of FIG. 2.

[0030] FIG. 6 is a back side view of the nasal photobiomodulation device of FIG. 2.

[0031] FIG. 7 is a top view of the nasal photobiomodulation device of FIG. 2.

[0032] FIG. 8 is a bottom view of the nasal photobiomodulation device of FIG. 2.

[0033] FIG. 9 is a perspective view of a first nasal photobiomodulation device made in accordance with the present disclosure.

[0034] FIG. 10 is a right side view of the nasal photobiomodulation device of FIG. 9.

[0035] FIG. 11 is a front side view of the nasal photobiomodulation device of FIG. 9.

[0036] FIG. 12 is a left side view of the nasal photobiomodulation device of FIG. 9.

[0037] FIG. 13 is a back side view of the nasal photobiomodulation device of FIG. 9.

[0038] FIG. 14 is a top view of the nasal photobiomodulation device of FIG. 9.

[0039] FIG. 15 is a bottom view of the nasal photobiomodulation device of FIG. 9.

[0040] FIG. 16 is a perspective view of a third example nasal photobiomodulation device made in accordance with the present disclosure.

[0041] FIG. 17 is a perspective view of a fourth example nasal photobiomodulation device made in accordance with the present disclosure.

[0042] FIG. 18 illustrates example cross sectional shapes of any of the first, second, third, or fourth nasal photobiomodulation devices of FIGS. 1-17.

[0043] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments. It will further be appreciatedthat certain actions and / or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein.DETAILED DESCRIPTION

[0044] Although the following text discloses a detailed description of example methods, apparatus, and / or articles of manufacture. It should be understood that the legal scope of the property right is defined by the words of the claims set forth at the end of this patent. Accordingly, the following detailed description is to be construed as examples only and does not describe every possible example, as describing every possible example would be impractical, if not impossible. Numerous alternative examples could be implemented, using either current technology or technology developed after the filing date of this patent. It is envisioned that such alternative examples, would still fall within the scope of the claims.

[0045] Disclosed herein is a nasal photobiomodulation and drug delivery device configured to provide therapy to the brain. The nasal photobiomodulation and drug delivery device directs therapy to the brain through and via the cribriform plate and surrounding areas for improved therapeutic effect, as this is an optimal location through which light and / or medicaments may be introduced to the brain, as discussed further below. Light penetration in this area could also be useful for diagnostic purposes as in the case of near-infrared light to measure brain tissue oxygenation and brain blood volume.

[0046] In one example, the nasal photobiomodulation device is adapted to provide nearinfrared or infrared light treatment to the brain. Research has shown that infrared and nearinfrared light therapies decrease oxidative stress, inflammation, improve brain mitochondrial function. These therapies could be tremendously beneficial after stroke, cardiac arrest, traumatic brain injury, sepsis, Alzheimer’s disease, and many other brain conditions. Additional research is investigating the benefit of visible light, blue light, violet / near ultraviolet light, and ultraviolet light therapies.

[0047] In other examples, the nasal photobiomodulation device could administer a medication to and around the skull base, cribriform plate, olfactory nerves, and surrounding areas. For example, evidence has shown that administering insulin to the cribriform plate is more effective than other administration methods. The medication is more effective, in part because, medication passes to the brain through the olfactory bulb. The olfactory bulb, with its nerves and supporting cells, communicate with the brain through the cribriform plate. Inaddition, branches of the trigeminal nerve and its supporting cells in the lamina propria in the upper sinus near and around the cribriform plate also provide an opportunity for efficient drug delivery to the brain. As a result, using the photobiomodulation device to administer a medication to and around the cribriform plate could reduce the amount of medication delivered because of the increased effectiveness of the location of administration.

[0048] FIG. 1 illustrates a cross-section of person’s head 10 including an example photobiomodulation device 100 disposed adjacent a person’s cribriform plate 102 and extends into the posterior nasal pharyngeal area 104. The cribriform plate 102, located above the nasal cavities, is a thin portion of the anterior skull base. The cribriform plate 102 is a preferential location to administer a light-based therapy due to the thinness of the cribriform plate, and light transmissivity through the cribriform plate 102, relative to other regions of the skull.

[0049] In some examples, the photobiomodulation device 100 includes an inflatable cuff 112. As shown in FIG. 1 , the inflatable cuff 112 is uninflated. After inflating the inflatable cuff 112, the photobiomodulation device 100 curves closer to the cribriform plate 102. In such an example, an endoscopic light source 122 is closer to cribriform plate 102. Additionally, inflating the inflatable cuff 112 can laterally displace impeding tissues such as the nasal turbinates and secretions disposed in the nasal cavity.

[0050] FIGS. 2-7 illustrate a first example photobiomodulation device 200 made in accordance with the present disclosure. The photobiomodulation device 200 includes a first elongate body 202 and a second elongate body 204. In the present example, the first and second elongate bodies 202, 204 are identical, but mirrored. In other examples, the first and second elongate bodies 202, 204 may not be identical. In the present example, each of the first and second elongate bodies 202, 204 curve and form an arc. In other examples, the first and second elongate bodies 202, 204 may be straight. Additionally, the first and second elongate bodies 202, 204 are flexible (e.g., medical grade silicon, polyvinyl chloride (PVC)), but in other examples, the first and second elongate bodies 202, 204 may be semi-flexible or rigid. Furthermore, in some examples, the example photobiomodulation device 100 may be made with only one elongate body (described below in connection with FIGS. 16 and 17).

[0051] The first elongate body 202 and the second elongate body 204 each include a proximal end 212 and a distal end 214. The proximal end 212 is open and defined by an outer surface 216. Each of the first and second elongate bodies 202, 204 have a circular cross-sectional shape. In other examples, the cross-sectional shape could be elliptical (see FIG. 18), tear drop shaped (see FIG. 18), obround, or any cross-sectional shape that facilitates comfortable insertion of the first and second elongate bodies 202, 204 into aperson’s nasal cavities. Additionally, the distal end 214 includes a tip 218 formed by the outer surface 216. In the present example, the tip 218 is closed and rounded (see, for example, FIGS. 4 and 7), but in other examples, the tip 218 could be a variety of shapes. Preferably, the tip 218 facilitates insertion into a nasal passage of a user. In some examples, the outer surface 216 is transparent to allow light to pass through the outer surfaces 216. In other examples, the outer surface 216 is opaque or semi-transparent.

[0052] As illustrated in FIGS. 2, 6, and 7, the first and second elongate bodies 202, 204 includes a first lumen 222 and a second lumen 224. The first lumen 222 includes a first end 232a and a second end 232b, defining a first opening 232c and the second lumen 224 includes a first end 234a and a second end 234b defining a second opening 234c. In the present example, the first opening 232c is disposed adjacent to the second opening 234c. In the present example, both the first and second openings 232c, 234c are approximately 2 to approximately 3 centimeters (cm) from the proximal end 212. But, in other examples, the first and second openings 232c, 234c may be at any other locations on the outer surfaces 216 of the respective first and second elongate bodies 202, 204. In some examples, the first and second lumens 222, 224 are manufactured to include a reflective material. Additionally, in some examples, the openings 232c, 234c may amplify light emissions out of the openings 232c, 234c.

[0053] As illustrated in FIG. 6, the first lumen 222 defines a first diameter 602 and the second lumen defines a second diameter 604. The first diameter 602 is larger than the second diameter 604, but in some examples, the second diameter 604 is larger than the first diameter 602 or the first and second diameters 602, 604 are equal. Additionally, one or both of the first lumen 222 and the second lumen 224 define a narrowing taper from the first end 232a or 234a to the second end 232b or 234b. In such examples, the first and / or second lumens 222, 224 are larger at least at one of the first end 232a, 234a or the second end 232b, 234b. The dimensions and shape of the first and second lumens 222, 224 are sized to receive a therapy device (e.g., a drug delivery apparatus or an endoscopic light source (e.g., endoscopic light source 122)). The endoscopic light source could include a light generating element (e.g., a light emitting diode (LED)) or a light transmission element (e.g., fiber optic). In some examples, if one of the first and second lumens 222, 224 receives the endoscopic light source, the other of the first and second lumens 222, 224 can be configured to receive a cooling element (e.g., heat sink, cooling fluid flow). The cooling element could be used to cool the photobiomodulation device and potentially lower metabolic oxidative stress in tissues around the nasal and sinus cavities and the brain. In yet other variations, one of the first or second lumens could be configured to receive another therapy device such as diagnostic equipment. For example EEG, Doppler blood flow equipment, and / or nearinfrared spectroscopy could be inserted into either the first or second lumens 222, 224. Additionally, in some examples, the diagnostic equipment could be wireless to permit the patient to be ambulatory during use of the diagnostic equipment.

[0054] In the present example, the first lumen 222 and the first opening 232c are centrally disposed to inwardly transmit light from the light element (e.g., endoscopic lighting source 122). Because the opening 232c is inwardly facing, the light element will point away from a user’s optical nerve. In various examples, the opening 232c could be moved as necessary to direct the light element away from the user’s optical nerve. The second lumen 224 is smaller and capable of administering a medication to the cribriform plate (e.g., cribriform plate 102). In some examples, the first lumen 222 and / or the second lumen 224 could include a coupling to connect to a light element or a medication delivery device.

[0055] As illustrated in FIGS. 2 and 6-8, the photobiomodulation device 200 includes a securement mechanism 242 for securing the photobiomodulation device to a user’s nose. In the present example, the securement mechanism 242 is a flexible clip (similar to a nasal bridle) that secures the photobiomodulation device 100 to the septum of the user’s nose. In other examples, the photobiomodulation device 100 may include a securement mechanism 242 may engage another portion of a person’s face including a person’s lower lateral cartilage, upper lateral cartilage, cheek, lip, etc.

[0056] Additionally, as illustrated in FIGS. 2, 3, 5, and 8, the photobiomodulation device 200 includes a cuff 252 disposed on each of the first and second elongate bodies 202, 204. The cuff 252 is disposed approximately opposite the first and second openings 232c, 234c. In the present example, the cuff 252 is inflatable after passing pressurized air, saline, sterile water, or other acceptable gas or solution through a third lumen 254 disposed adjacent the proximal end 212 of the first and second elongate bodies 202, 204 and in fluid communication with the cuff 252. In preferred examples, the user inflates the cuff 252 after inserting the cuff 252 into a nasal passage of a user to bring the first opening 232c closer to the cribriform plate 102 of FIG. 1. In some examples, inflating the cuff 252 seals the nasal cavity and permits recirculation of medication administered in the nasal or sinus cavity.

[0057] As shown in FIGS. 6 and 8, the photobiomodulation device 200 further includes an open channel 612. The open channel 612 facilitates easier manufacturing methods.Additionally, disposing the third lumen 254 and the inflatable cuff 252 in the open channel 612 improves the functionality of the photobiomodulation device. The inflatable cuff 252 readily expands in the space provided by the open channel 612. For example, without the open channel 612, the inflatable cuff 612 could be constrained from expanding circumferentially by the surface of the photobiomodulation device 200. For example, the thirdlumen 254 can be partially disposed outside the elongate body 202, 204. As a result, the size of the elongate body 202, 204 can be reduced to facilitate insertion of the photobiomodulation device 200 into the nasal cavity of a person. Additionally, inflatable cuff 252 can be partially disposed in the open channel. The inflatable cuff 252 can be secured to the open channel 612 and still be inflated to move the openings 232c, 234c proximate to the cribriform plate and / or seal the nasal cavity.

[0058] FIGS. 9-15 illustrate a second example photobiomodulation device 900 made in accordance with the present disclosure. The photobiomodulation device 900 includes a first elongate body 902 and a second elongate body 904. In the present example, the first and second elongate bodies 902, 904 are substantially identical to the first and second elongate bodies 202, 204 of FIG. 2. For example, the first and second elongate bodies 902, 904 are also curved and include a proximal end 912, a distal end 914, an outer surface 916, and a rounded tip 918 similar and / or identical to the photobiomodulation device 200. In contrast to the photobiomodulation device 200, the photobiomodulation device 900 does not include a cuff (e.g., cuff 252) or a third lumen (e.g., third lumen 254).

[0059] As illustrated in FIGS. 9, 13, and 14, the first and second elongate bodies 902, 904 includes a first lumen 922 and a second lumen 924. The first and second lumens 922, 924 of the photobiomodulation device 900 are similar and / or identical to the first and second lumens 222, 224 of the photobiomodulation device 200. For example, each of the first and second lumens 922, 924 include a first end 932a, 934a, a second end 932b, 934b, and a first and second opening 932c, 934c. In various examples, the first and second lumens 922, 924 are shaped and configured similarly or identically to the first and second lumens 222, 224 of the photobiomodulation device 200.

[0060] FIG. 16 illustrates a third example photobiomodulation device 1600 made in accordance with the present disclosure. In the present example, the photobiomodulation device 1600 is similar to one of the first and second elongate bodies 202, 204 of FIG. 2. For example, the photobiomodulation device 1600 is similarly curved and made of a flexible material, but could be manufactured in any manner similar to the first and second elongate bodies 202, 204.

[0061] The photobiomodulation device includes a proximal end 1612 and a distal end 1614. The proximal end 1612 is open and defined by an outer surface 1616. Additionally, the distal end 1614 includes an open tip 1618 formed by the outer surface 1616. In the present example, the tip 1618 is open and angled opposite the curve. Preferably, the tip 1618 facilitates insertion into a nasal passage of a user. In some examples, the outer surface 1616 is transparent to allow light to pass through the outer surfaces 1616. In otherexamples, the outer surface 1616 is opaque or semi-transparent. The photobiomodulation device 1600 further includes a lumen 1622, similar to the first lumen 222, 922 of FIGS. 2 and 9. The lumen 1622 includes a first end 1632a and a second end 1632b, defining a first opening 1632c. In the present example, the opening 1632c is approximately 2 to approximately 3 centimeters (cm) from the proximal end 1612, but may be elsewhere on the photobiomodulation device 1600. In various examples, the location of the opening 1632c, 1634c is configured based on the therapy. For example, the openings 1632c, 1634c could be adjusted to direct light therapy, medication, sterilizing agents (e.g., bacteriocidal, bacteriostatic), or any other therapy anywhere in the nose, nasal cavity, sinus cavity, or throat. In some examples, the lumen 1622 is made with or lined with a reflective material. Additionally, in some examples, the opening 1632c is configured to amplify light emissions out of the opening 1632c.

[0062] The dimensions and shape of the lumen 1622 permit the lumen 1622 to receive a drug delivery apparatus or an endoscopic light source (e.g., a fiber optic endoscopic light source 122). In other examples, the endoscopic light source can be received at the proximal end 1612 and pass through the photobiomodulation device 1600 to the tip 1618 and through a second opening 1636 at the tip 1618.

[0063] The photobiomodulation device 1600 further includes a securement mechanism 1642 and an inflatable cuff 1652, inflated via lumen 1654. The securement mechanism 1642 could be similar to the securement mechanisms 242, 942 of FIGS. 2 and 9, or could be any mechanism for securing the photobiomodulation device 1600 to a person’s face. For example, in contrast to the photobiomodulation device 1600 including the inflatable cuff 1652, a photobiomodulation device 1700 is substantially similar to the photobiomodulation device 1600 but does not include the inflatable cuff.

[0064] The photobiomodulation devices 1600, 1700 include the second opening 1636, 1736. The second opening 1636 opens in a first direction opposite the curve of the photobiomodulation device 1600 but the second opening 1736 is disposed perpendicular to the curve of the photobiomodulation device 1700 and the opening 1732c. An endoscopic light source passes through the photobiomodulation devices 1600, 1700 and illuminates a posterior nasal pharyngeal area. Additionally or alternatively, a drug delivery device can administer a medication to the posterior nasal pharyngeal area.

[0065] FIG. 18 illustrates alternative cross-sectional shapes that could define the elongate bodies 202, 204, 902, 904 or the photobiomodulation devices 1600, 1700. The cross- sectional shape 1802 is a teardrop and includes a circular portion 1804 and an angled portion 1806 with a vertex 1808. In the present example the vertex 1808 comes to an edge,but in other examples, the vertex 1808 is round, for user comfort. Alternatively, the cross- sectional shape 1822 is elliptical. The cross-sectional shapes 1802, 1822 are example cross-sectional shapes. In various other examples, the cross-sectional shape could be ovular, obround, circular, or any similar shape.

[0066] Disclosed herein are several embodiments of a photobiomodulation and drug delivery device. As described herein the photobiomodulation device has several benefits.

[0067] First, the photobiomodulation devices can administer infrared or near-infrared light therapy through the skull base, particularly the cribriform plate to provide therapy to the hardest to reach portions of the brain. The proximity of the openings 232c, 234c, 932c, 934c, 1632c, and 1732c to the cribriform plate causes improved intensity of the administered light therapy to the brain through the cribriform plate. Light of a variety of wavelengths (e.g., infrared, visible, ultraviolet) can be administered through the openings 232c, 234c, 932c, 934c, 1632c, and 1732c.

[0068] Second, the photobiomodulation devices can administer medications with improved efficacy. Administering medications through the openings 232c, 234c, 932c, 934c, 1632c, and 1732c can facilitate improved administration of medications to the brain through the blood-brain barrier.

[0069] Third, the photobiomodulation devices may include secondary lumens that can accommodate heat sinks, thermal probes, or cooling fluids to reduce discomfort resulting from heat generated by any light generating or light transmitting elements as well as cool surrounding tissues including areas of the brain. In certain circumstances such as severe hypothermia, these lumens could be used to provide warming air and fluids to increase the temperature of the brain and surrounding structures.

[0070] Fourth, the photobiomodulation devices can further administer light or medication or temperature modulated air or fluids, to other portions of the nasal cavity and nasal pharyngeal area noninvasively and with improved comfort over other devices.

[0071] Fifth, the photobiomodulation devices could be used to treat various sinus and throat infections and transiently sterilize the sinuses and the secretions in the sinuses. In some examples, the location and direction of the openings on the photobiomodulation device could be positioned to direct the medication (e.g., bactericidal medication), irrigation, or sterilizing light at a specific location in the nasal cavity, sinuses, or throat.EXAMPLES

[0072] The following claims recite aspects of certain examples of the disclosed subject matter and are considered to be part of the above disclosure. These aspects may be combined with one another.

[0073] Example 1 . A nasal photobiomodulation device, comprising: an elongate body having a proximal end and a distal end; a tip disposed on the distal end of the elongate body; a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a securement mechanism coupled to at least one of the elongate body and the first end of the lumen.

[0074] Example 2. The nasal photobiomodulation device of Example 1 , wherein the elongate body is curved.

[0075] Example 3. The nasal photobiomodulation device of any one of the preceding Examples, wherein the tip is rounded.

[0076] Example 4. The nasal photobiomodulation device of any one of the preceding Examples, wherein the lumen is a first lumen, and further comprising a second lumen disposed adjacent to the first lumen, the second lumen having a first end disposed adjacent to the first end of the first lumen and a second end disposed opening through the outer surface of the elongate body and adjacent to the second end of the first lumen.

[0077] Example 5. The nasal photobiomodulation device of Example 4, wherein the first end of the first lumen defines a first diameter and the first end of the second lumen defines a second diameter, the first diameter different from the second diameter.

[0078] Example 6. The nasal photobiomodulation device of Example 5, wherein the first diameter is larger than the second diameter.

[0079] Example 7. The nasal photobiomodulation device of any one of the preceding Examples, wherein the lumen defines a narrowing taper from the first end to the second end.

[0080] Example 8. The nasal photobiomodulation device of any one of the preceding Examples, further comprising an inflatable cuff disposed on the elongate body, between the proximal end and the distal end.

[0081] Example 9. The nasal photobiomodulation device of Example 8, wherein the inflatable cuff is disposed opposite the second end of the lumen.

[0082] Example 10. A nasal photobiomodulation device, comprising: an elongate body having a proximal end and a distal end; a first lumen disposed along at least a portion of theelongate body; a second lumen disposed along at least a portion of the elongate body; and a cuff disposed on the elongate body between the proximal end and the distal end.

[0083] Example 11 . The nasal photobiomodulation device of Example 10, wherein the cuff is inflatable.

[0084] Example 12. The nasal photobiomodulation device of Example 11 , further comprising a third lumen in fluid communication with the cuff.

[0085] Example 13. The nasal photobiomodulation device of any one of Examples 10 - 12, further comprising: a first opening through an outer surface of the elongate body defined by the first lumen; and a second opening through the outer surface of the elongate body defined by the second lumen.

[0086] Example 14. The nasal photobiomodulation device of Example 13, wherein the second opening is disposed adjacent to the first opening.

[0087] Example 15. The nasal photobiomodulation device of any one of Examples 10 -14, wherein the elongate body is curved.

[0088] Example 16. The nasal photobiomodulation device of any one of Examples 10 -15, further comprising a tip disposed on the distal end of the elongate body, wherein the tip is rounded.

[0089] Example 17. The nasal photobiomodulation device of any one of Examples 10 -16, wherein a first end of the first lumen defines a first diameter and a first end of the second lumen defines a second diameter, the first diameter different from the second diameter.

[0090] Example 18. The nasal photobiomodulation device of Example 17, wherein the first diameter is larger than the second diameter.

[0091] Example 19. The nasal photobiomodulation device of Example 17, wherein at least one of the first lumen and the second lumen defines a narrowing taper.

[0092] Example 20. The nasal photobiomodulation device of any one of Examples 10 - 19, further comprising a securement mechanism coupled with the proximal end of the elongate body.

[0093] Example 21 . The nasal photobiomodulation device of Example 20, wherein the elongate body is a first elongate body, the photobiomodulation device further comprising a second elongate body; wherein the securement mechanism includes a first end coupled to the first elongate body and a second end coupled to the second elongate body, and wherein the second elongate body is identical to the first elongate body but mirrored about the securement mechanism.

[0094] Example 22. A nasal photobiomodulation device, comprising: an elongate body having an outer surface disposed between a proximal end and a distal end; a first lumen disposed along at least a portion of the elongate body having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a second lumen disposed along at least a portion of the elongate body having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the first end of the first lumen and the second end opening through an outer surface of the elongate body.

[0095] Example 23. The nasal photobiomodulation device of Example 22, wherein the second end of the second lumen is disposed adjacent to the second end of the of the first lumen.

[0096] Example 24. The nasal photobiomodulation device of any one of Examples 22 - 23, further comprising a cuff disposed on the elongate body between the proximal end and the distal end.

[0097] Example 25. The nasal photobiomodulation device of Example 24, further comprising a third lumen having a first end disposed adjacent to the proximal end of the elongate body and a second end in fluid communication with the cuff.

[0098] Example 26. The nasal photobiomodulation device of Example 24, wherein the cuff is disposed opposite the second end of the first lumen.

[0099] Example 27. The nasal photobiomodulation device of Example 26, further comprising an open channel disposed in the elongate body, at least one of the third lumen and the cuff is at least partially disposed in the open channel.

[0100] Example 28. The nasal photobiomodulation device of any one of Examples 22 -27, further comprising a securement mechanism coupled to at least one of the elongate body and the first end of the first lumen.

[0101] Example 29. The nasal photobiomodulation device of any one of Examples 22 -28, wherein the elongate body is curved.

[0102] Example 30. The nasal photobiomodulation device of any one of Examples 22 -29, wherein the first end of the first lumen defines a first diameter and the first end of the second lumen defines a second diameter, the first diameter different from the second diameter.

[0103] Example 31 . The nasal photobiomodulation device of Example 30, wherein the first diameter is larger than the second diameter.

[0104] Example 32. The nasal photobiomodulation device of any one of Examples 22 - 31 , wherein at least one of the first lumen and the second lumen defines a narrowing taper from the first end to the second end.

[0105] Example 33. A method of introducing light or medicament to a location proximate to or at the cribriform plate of a human, the method comprising: introducing into a nasal cavity of the human a nasal photobiomodulation device comprising: an elongate body having a proximal end and a distal end; a tip disposed on the distal end of the elongate body; a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a securement mechanism coupled to at least one of the elongate body and the first end of the lumen; introducing at least one of a therapy device through a proximal end of the nasal photobiomodulation device; and at least one of activating the therapy device or initiating a flow of the medicament from the source of medicament.

[0106] Example 34. The method of Example 33, wherein activating the therapy device includes activating a light source and generating an infrared or near-infrared light.

[0107] Example 35. The method of any one of Examples 33 - 34, further comprising directing the light source at the cribriform plate of the human.

[0108] Example 36. The method of any one of Examples 33 - 35, wherein initiating a flow of the medicament includes directing the medicament towards and around cribriform plate of the human.

[0109] Example 37. The method of any one of Examples 33 - 36, wherein the medicament is insulin.

[0110] Example 38. The method of any one of Examples 33 - 37, the photobiomodulation device further includes an inflatable cuff, the method further comprising: inflating the inflatable cuff after the photobiomodulation device has been inserted into the nasal cavity of the person, wherein inflating the inflatable cuff causes the second end of the lumen to move towards the cribriform plate of the person.

[0111] Example 39. The method of Example 38, further comprising deflating the cuff after activating the light source or initiating a flow of the medicament for a predetermined period of time.

[0112] Example 40. The method of any one of Examples 33 - 39, wherein the elongate body is a first elongate body inserted into a first nasal cavity and the nasal photobiomodulation device includes a second elongate body; the method further comprising inserting the second elongate body into a second nasal cavity of the human.

[0113] Example 41. The method of Example 40, and in inserting the second elongate body into the second nasal cavity of the human, the second elongate body has a proximal end and a distal end, a tip disposed on the distal end of the second elongate body, a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the second elongate body and the second end opening through an outer surface of the second elongate body.

[0114] Example 42. The method of Example 40, wherein the nasal photobiomodulation device includes a securement mechanism coupling the first elongate body and the second elongate body; the method further comprising securing the photobiomodulation device to the human’s nose by engaging the nose with the securement mechanism.

[0115] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described examples without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

WHAT IS CLAIMED IS:1 . A nasal photobiomodulation device, comprising: an elongate body having a proximal end and a distal end; a tip disposed on the distal end of the elongate body; a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a securement mechanism coupled to at least one of the elongate body and the first end of the lumen.

2. The nasal photobiomodulation device of claim 1 , wherein the elongate body is curved.

3. The nasal photobiomodulation device of claim 1 , wherein the tip is rounded.

4. The nasal photobiomodulation device of claim 1 , wherein the lumen is a first lumen, and further comprising a second lumen disposed adjacent to the first lumen, the second lumen having a first end disposed adjacent to the first end of the first lumen and a second end disposed opening through the outer surface of the elongate body and adjacent to the second end of the first lumen.

5. The nasal photobiomodulation device of claim 4, wherein the first end of the first lumen defines a first diameter and the first end of the second lumen defines a second diameter, the first diameter different from the second diameter.

6. The nasal photobiomodulation device of claim 5, wherein the first diameter is larger than the second diameter.

7. The nasal photobiomodulation device of claim 1 , wherein the lumen defines a narrowing taper from the first end to the second end.

8. The nasal photobiomodulation device of claim 1 , further comprising an inflatable cuff disposed on the elongate body, between the proximal end and the distal end.

9. The nasal photobiomodulation device of claim 8, wherein the inflatable cuff is disposed opposite the second end of the lumen.

10. A nasal photobiomodulation device, comprising: an elongate body having a proximal end and a distal end; a first lumen disposed along at least a portion of the elongate body; a second lumen disposed along at least a portion of the elongate body; and a cuff disposed on the elongate body between the proximal end and the distal end.11 . The nasal photobiomodulation device of claim 10, wherein the cuff is inflatable.

12. The nasal photobiomodulation device of claim 11 , further comprising a third lumen in fluid communication with the cuff.

13. The nasal photobiomodulation device of claim 10, further comprising: a first opening through an outer surface of the elongate body defined by the first lumen; and a second opening through the outer surface of the elongate body defined by the second lumen.

14. The nasal photobiomodulation device of claim 13, wherein the second opening is disposed adjacent to the first opening.

15. The nasal photobiomodulation device of claim 10, wherein the elongate body is curved.

16. The nasal photobiomodulation device of claim 10, further comprising a tip disposed on the distal end of the elongate body, wherein the tip is rounded.

17. The nasal photobiomodulation device of claim 10, wherein a first end of the first lumen defines a first diameter and a first end of the second lumen defines a second diameter, the first diameter different from the second diameter.

18. The nasal photobiomodulation device of claim 17, wherein the first diameter is larger than the second diameter.

19. The nasal photobiomodulation device of claim 17, wherein at least one of the first lumen and the second lumen defines a narrowing taper.

20. The nasal photobiomodulation device of claim 10, further comprising a securement mechanism coupled with the proximal end of the elongate body.21 . The nasal photobiomodulation device of claim 20, wherein the elongate body is a first elongate body, the photobiomodulation device further comprising a second elongate body; wherein the securement mechanism includes a first end coupled to the first elongate body and a second end coupled to the second elongate body, and wherein the second elongate body is identical to the first elongate body but mirrored about the securement mechanism.

22. A nasal photobiomodulation device, comprising: an elongate body having an outer surface disposed between a proximal end and a distal end; a first lumen disposed along at least a portion of the elongate body having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a second lumen disposed along at least a portion of the elongate body having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the first end of the first lumen and the second end opening through an outer surface of the elongate body.

23. The nasal photobiomodulation device of claim 22, wherein the second end of the second lumen is disposed adjacent to the second end of the of the first lumen.

24. The nasal photobiomodulation device of claim 22, further comprising a cuff disposed on the elongate body between the proximal end and the distal end.

25. The nasal photobiomodulation device of claim 24, further comprising a third lumen having a first end disposed adjacent to the proximal end of the elongate body and a second end in fluid communication with the cuff.

26. The nasal photobiomodulation device of claim 24, wherein the cuff is disposed opposite the second end of the first lumen.

27. The nasal photobiomodulation device of claim 26, further comprising an open channel disposed in the elongate body, at least one of the third lumen and the cuff is at least partially disposed in the open channel.

28. The nasal photobiomodulation device of claim 22, further comprising a securement mechanism coupled to at least one of the elongate body and the first end of the first lumen.

29. The nasal photobiomodulation device of claim 22, wherein the elongate body is curved.

30. The nasal photobiomodulation device of claim 22, wherein the first end of the first lumen defines a first diameter and the first end of the second lumen defines a second diameter, the first diameter different from the second diameter.31 . The nasal photobiomodulation device of claim 30, wherein the first diameter is larger than the second diameter.

32. The nasal photobiomodulation device of claim 22, wherein at least one of the first lumen and the second lumen defines a narrowing taper from the first end to the second end.

33. A method of introducing light or medicament to a location proximate to or at the cribriform plate of a human, the method comprising: introducing into a nasal cavity of the human a nasal photobiomodulation device comprising: an elongate body having a proximal end and a distal end; a tip disposed on the distal end of the elongate body; a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the elongate body and the second end opening through an outer surface of the elongate body; and a securement mechanism coupled to at least one of the elongate body and the first end of the lumen;introducing at least one of a therapy device through a proximal end of the nasal photobiomodulation device; and at least one of activating the therapy device or initiating a flow of the medicament from the source of medicament.

34. The method of claim 33, wherein activating the therapy device includes activating a light source and generating an infrared or near-infrared light.

35. The method of claim 33, further comprising directing the light source at the cribriform plate of the human.

36. The method of claim 33, wherein initiating a flow of the medicament includes directing the medicament towards and around cribriform plate of the human.

37. The method of claim 33, wherein the medicament is insulin.

38. The method of claim 33, the photobiomodulation device further includes an inflatable cuff, the method further comprising: inflating the inflatable cuff after the photobiomodulation device has been inserted into the nasal cavity of the person, wherein inflating the inflatable cuff causes the second end of the lumen to move towards the cribriform plate of the person.

39. The method of claim 38, further comprising deflating the cuff after activating the light source or initiating a flow of the medicament for a predetermined period of time.

40. The method of claim 33, wherein the elongate body is a first elongate body inserted into a first nasal cavity and the nasal photobiomodulation device includes a second elongate body; the method further comprising inserting the second elongate body into a second nasal cavity of the human.41 . The method of claim 40, and in inserting the second elongate body into the second nasal cavity of the human, the second elongate body has a proximal end and a distal end, a tip disposed on the distal end of the second elongate body, a lumen having a first end and a second end, the first end disposed adjacent the proximal end of the second elongate body and the second end opening through an outer surface of the second elongate body.

42. The method of claim 40, wherein the nasal photobiomodulation device includes a securement mechanism coupling the first elongate body and the second elongate body; the method further comprising securing the photobiomodulation device to the human’s nose by engaging the nose with the securement mechanism.

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