Systems and methods for treating ischemia-reperfusion and other injuries using waveguides - Patents.com

Abstract

A NIR light therapy device having at least one near infrared (NIR) light source and a waveguide having i) an NIR light input surface and ii) an NIR light emission surface. The waveguide comprises a lens mechanism forming the NIR light input surface. The lens mechanism is configured to at least substantially collimate treatment NIR light from the at least one NIR light source and convey the substantially collimated light through the waveguide in a first direction. The waveguide also comprises a plurality of extraction surfaces on a surface of the waveguide configured to reflect the substantially collimated light through the light emission surface to the subject. The plurality of extraction surfaces are also configured to generate a substantially uniform NIR light output across the light emission surface.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 223,677, filed July 20, 2021, the entire contents of which are incorporated herein by reference.

[0002] Government Licensing Rights This invention was made with Government support under NS105238 and NS120322 awarded by the National Institutes of Health. The Government has certain rights in this invention.

[0003] In general, various embodiments of the present invention relate to systems and methods for treating ischemia-reperfusion injury, and in particular to a wearable device having a light delivery unit configured to deliver light energy to an injured body region of a user (e.g., the head region). [Background technology]

[0004] Typically, treatment of body tissues (e.g., subcutaneous body tissues) requires invasive forms of treatment, including surgical and pharmaceutical interventions. Near-infrared (NIR) light has been shown to provide therapeutic treatment to body tissues affected by ischemia / reperfusion (IR) injury. Specifically, NIR light at wavelengths of about 750 nm and 940 nm has effectively treated the effects of IR injury by modulating mitochondrial activity of body tissues under oxidative stress. NIR light has been effective as a form of treatment due to the transparency of body tissues to NIR light, as well as the low absorption of body fluids of NIR light.

[0005] Although the therapeutic effects of NIR light treatment are evident, the actual delivery of NIR light to a patient's body tissues can be challenging. Conventional NIR light therapy devices can apply undesirable pressure to body areas due to their rigid form. These devices are often constructed of non-flexible materials that are not suitable for use by a wide variety of patients (e.g., adults, children, infants, etc.). Even conventional NIR light therapy devices that can avoid applying undesirable pressure to body areas are often functionally ineffective because they target superficial body tissues via low levels of light therapy. Furthermore, both types of these devices can cause discomfort and potential damage to the patient if they lack an effective system to mitigate the heat generated by the absorption of NIR light by hair and other tissues at the site of the area to be treated. As a result, patients may experience discomfort or even pain when using conventional NIR light therapy devices. Thus, there is a need for improved therapy devices that provide patients with comfortable and adaptable NIR light therapy. Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention is based, in part, on the development of a waveguide for safely and effectively directing light, such as NIR light, into the tissue of a subject.

[0007] In one aspect, an embodiment of the invention features a waveguide for delivering light, e.g., NIR light, into tissue of a subject, the waveguide including a light input portion, an extraction portion including a plurality of extraction features adapted to redirect light received from the light input portion, and an emission portion adapted to receive light from the extraction portion and emit the light at a tissue surface of the subject.

[0008] In various embodiments, the light entrance comprises an aspheric lens. The light entrance may further comprise an optical channel for dispersing light incident on the aspheric lens to pass along the optical channel to the extraction. In some embodiments, the plurality of extraction features comprises at least three extraction features. In some embodiments, at least one exterior surface of the waveguide may further comprise a reflective coating adjacent thereto. In some embodiments, the plurality of extraction features may form gaps between the reflective coatings. In some embodiments, the plurality of extraction features are adapted to redirect light received from the light entrance to a direction substantially perpendicular to the subject's skin surface. Each of the plurality of extraction features may comprise a surface oriented at an angle relative to a normal to the skin surface, the angle being within a range of ±20 degrees to 70 degrees (i.e., within a range of 20 degrees to 70 degrees in either a clockwise or counterclockwise direction relative to a normal to the skin surface).

[0009] In some embodiments, the emitting portion includes a flat shape. In some embodiments, the emitting portion includes an arc shape including a concave lower surface, the concave lower surface can be adapted to conform to the skin surface of the subject. The contour of the concave lower surface can include a radius of curvature ranging from 3 cm to 10 cm.

[0010] In some embodiments, the waveguide comprises an integrated cooling system adapted to cool a skin surface of the subject. The integrated cooling system can be disposed within the emission portion. The integrated cooling system can comprise a fluid channel molded within the emission portion and adapted to carry a coolant fluid (e.g., water). The fluid channel can comprise a serpentine shape. The serpentine shape can be defined by a plurality of substantially parallel conduits each connected by bends, the diameter of the inner surface of the substantially parallel conduits being greater than the diameter of the inner surface of the bends. The fluid channel can occupy at least 20% of the surface area of ​​the emission portion.

[0011] In some embodiments, at least a portion of the waveguide can be defined by a biocompatible material. The biocompatible material can be a silicone material (e.g., optically clear silicone), the silicone material comprising an elastic modulus in the range of 1 MPa to 50 MPa. The tissue surface can include a skin surface.

[0012] In general, in another aspect, embodiments of the invention feature a light treatment device for delivering light to a skin surface of a subject. The light treatment device can include at least one waveguide as described herein and a support member adapted to hold the at least one waveguide and position the at least one waveguide proximate to the skin surface of the subject.

[0013] In various embodiments, the support member can hold the array of waveguides. The support member can comprise at least one of a strap, a cap, a helmet, or a combination thereof. The support member can be adapted to position the at least one waveguide to avoid interaction between the emitted light and a predetermined area of ​​the subject, the predetermined area including a venous sinus. In some embodiments, the light treatment device comprises a temperature measurement system for determining a temperature of the skin surface of the subject. The temperature measurement system can comprise a first probe for measuring a temperature of a coolant fluid entering the waveguide via an inlet of the fluid channel, a second probe for measuring a temperature of a cooling fluid exiting the waveguide at an outlet of the fluid channel, and a reference probe for measuring a skin temperature at an untreated location of the subject.

[0014] In some embodiments, the light treatment device comprises a light source for generating and delivering light to at least one waveguide, the light source comprising at least one of a diode, a laser, or a laser diode. The light source can generate light having a wavelength of about 750 nm or about 940 nm. In some embodiments, the light source can generate light having a wavelength of 750 nm ± 30 nm or about 940 nm ± 30 nm.

[0015] These and other objects, together with advantages and features of the embodiments of the invention disclosed herein, will become more apparent with reference to the following description, the accompanying drawings, and the claims. Moreover, it should be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations. [Brief description of the drawings]

[0016] In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the invention are described with reference to the following drawings:

[0017] [Figure 1A] 1 is a schematic perspective exploded view of an exemplary light delivery unit (LDU) according to various embodiments.

[0018] [Figure 1B] FIG. 1B is a schematic perspective assembly diagram of the exemplary LDU of FIG.

[0019] [Figure 1C] FIG. 1B is a schematic close-up side view of the example LDU of FIG. 1A.

[0020] [Figure 1D] FIG. 1B is a schematic cross-sectional close-up side view of the exemplary LDU of FIG. 1A.

[0021] [Figure 1E] FIG. 1B is a schematic bottom view of the example LDU of FIG. 1A.

[0022] [Figure 2A] 1 is a schematic side view illustrating an example optical channel through an example waveguide in accordance with various embodiments.

[0023] [Figure 2B] 2B is a schematic bottom view illustrating an example optical channel through the example waveguide of FIG. 2A.

[0024] [Figure 2C] FIG. 2B is a perspective view of the waveguide of FIG. 2A.

[0025] [Figure 2D] FIG. 2B is a left side view of the waveguide of FIG. 2A.

[0026] [Figure 2E] FIG. 2B is a top view of the waveguide of FIG. 2A.

[0027] [Figure 2F] FIG. 2B is a bottom view of the waveguide of FIG. 2A.

[0028] [Figure 2G] FIG. 2B is a right side view of the waveguide of FIG. 2A.

[0029] [Figure 2H] FIG. 2B is a rear view of the waveguide of FIG. 2A.

[0030] [Figure 3A] FIG. 1 is a schematic diagram of an exemplary treatment system for NIR light therapy.

[0031] [Figure 3B] 1 is a schematic internal view of an exemplary wearable device of an exemplary treatment system for providing near infrared NIR light treatment.

[0032] [Figure 3C] FIG. 3C is a schematic external view of the exemplary wearable device of FIG. 3B.

[0033] [Figure 3D] FIG. 3C is a schematic side view of the exemplary wearable device of FIG. 3B.

[0034] [Figure 3E] FIG. 3C is a schematic perspective view of the exemplary wearable device of FIG. 3B in a wrapped orientation around the head of a subject to be treated.

[0035] [Figure 4A] 1 is a schematic diagram of an exemplary combiner for circulating coolant within a treatment system for providing NIR light treatment in accordance with various embodiments.

[0036] [Figure 4B] FIG. 1 is a schematic diagram of an exemplary coolant circulation system within a treatment system for providing NIR light treatment in accordance with various embodiments.

[0037] [Diagram 5] FIG. 1 is a schematic diagram of an exemplary coupling mechanism in a treatment system for providing NIR light treatment in accordance with various embodiments.

[0038] [Figure 6] FIG. 1 is a block diagram of an example computer system that can be used in implementing the techniques described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] The present invention is based in part on the development of waveguides for safely and effectively directing light, such as NIR light, into the tissue of a subject. One or more of the waveguides can be incorporated into a light delivery unit to deliver light to the tissue of a subject.

[0040] Light Delivery Unit (LDU)

[0041] FIG. 1A is an exploded view of an exemplary light delivery unit (LDU) 100. The LDU 100 may comprise one or more components. In some cases, the LDU 100 may comprise a waveguide 110. The waveguide 110 may be configured to receive a light (e.g., NIR light) input. The waveguide 110 may be configured to redirect the received light input and emit a light output via an emission surface 114. For example, the waveguide 110 may emit a redirected NIR light signal via the emission surface 114 to a tissue surface of a user. In some cases, the waveguide 110 may comprise one or more extraction mechanisms 142 configured to redirect the received light input as described herein.

[0042] In general, the waveguide 110 may be constructed of any suitable material having the properties described herein. In some cases, the waveguide 110 may be constructed of silicone. The silicone may be transparent and / or a low durometer silicone. For example, the silicone may have a durometer ranging from 20 Shore A to 80 Shore A (e.g., 50 Shore A). The silicone may be flexible and / or compressible, allowing the waveguide 110 to conform to a surface of the subject (e.g., a skin surface). In some cases, the silicone may include an elastic modulus ranging from 1 MPa to 50 MPa. In some cases, one or more faces or surfaces of the waveguide 110 may be covered with and / or otherwise bonded to a reflective material. In one embodiment, the top surface, sides, and one or more extraction features 142 of the waveguide 110 may include a reflective material. The reflective material may reflect one or more optical signals that are not redirected by the extraction features 142 (described below) so that they remain contained within the waveguide 110. The reflective material can improve the extraction efficiency for redirection of one or more optical signals by the extraction mechanism.

[0043] In certain embodiments, the waveguide 110 may include one or more channels 116 (see, e.g., FIGS. 1E and 2F). The channels 116 may be configured to circulate a coolant (e.g., water) within the waveguide 110 as described herein. For example, the channels 116 may circulate a coolant within the waveguide 110 to absorb excess heat at the emission surface 114. A first end of the channel 116 may include an inlet 118 (see, e.g., also FIGS. 1B, 1C, 1E, 2C, 2E-2G). A second end of the channel 116 may include an outlet 119 (see, e.g., FIGS. 1E and 2E-2G). The inlet 118 and the outlet 119 may each include a receiving mechanism (e.g., a female interface of a male-female coupling mechanism) configured to couple to a tube that connects to a coolant reservoir.

[0044] In certain embodiments, the LDU 100 may include a housing 120 formed from one or more parts. For example, the housing 120 may be constructed from two parts (e.g., forming a clamshell design). The parts may be coupled to one another via one or more fasteners (e.g., screws, hinges, brackets, clips, etc.). In another example, the housing 120 is comprised of a single part. In general, the housing 120 may be constructed from any suitable material having the properties described herein. For example, the housing 120 may be plastic (e.g., polyoxymethylene (POM)). In some cases, the housing 120 may be formed by injection molding or milling, although any suitable manufacturing technique may be used to form the housing 120.

[0045] In some embodiments, the housing 120 can include a cavity for receiving and / or otherwise holding the waveguide 110. The housing 120 can include an input / output (I / O) connector 124 configured to couple to an optical signal input (e.g., a fiber optic cable or other lead / tip) from a light source (e.g., a laser or energy source). The I / O connector 124 can include one or more slots (e.g., v-groove slots) configured to receive the optical signal input. In some cases, the I / O connector 124 can include one or more electrical connections for coupling to an assembly described herein. The housing 120 can hold the optical signal input and the waveguide 110 such that the optical signal input is disposed proximate to the waveguide 110. The optical signal input can be disposed proximal to the waveguide 110 at a predetermined focal distance as described herein. The housing 120 can be configured to receive the waveguide 110 such that an emission face of the waveguide 110 can be disposed proximal or adjacent to a tissue surface (e.g., a skin surface) of a subject to be treated.

[0046] In certain embodiments, one or more interior walls or surfaces of the housing 120 may be coated and / or otherwise covered with a reflective layer. The reflective layer may include a non-metallic or metallic coating. In one example, the non-metallic coating may be polyethylene. In another example, the metallic coating may be gold, aluminum, or copper. The reflective layer may reflect light (e.g., NIR light) propagating within the waveguide 110, such that light incident on one or more interior walls is contained within the housing 120. NIR light propagating from the light source may exit the waveguide 110 and be reflected off the interior walls of the housing 120 via the reflective layer.

[0047] In certain embodiments, the LDU 100 may include a cooling system 130. The cooling system 130 may include one or more conduits 132 (e.g., tubes). Each of the conduits 132 may be configured to carry a coolant to and / or from the channel 116 of the waveguide 110. For example, a first conduit 132 may carry a chilled coolant to the channel 116, and a second conduit 132 may carry a warmed coolant from the channel 116, where the warmed coolant absorbs thermal energy from the waveguide 110. In general, the coolant may be any suitable fluid, such as water. In one example, the coolant may be sterile deionized water. In some cases, a first end of each tube 132 may include a fitting 136. A second end of each tube may be coupled to a coolant chiller as described herein. Each fitting 136 may be coupled to the waveguide 110 via an inlet 118 or an outlet 119. Each fitting 136 may include a barbed fitting (e.g., a male interface of a male-female coupling mechanism) such that fitting 136 may be inserted into inlet 118 or outlet 119. Fitting 136 may remain coupled to inlet 118 or outlet 119 via the barbed fitting, as described herein.

[0048] In certain embodiments, each fitting 136 may include a temperature sensor. In some cases, the temperature sensor may be waterproof. The temperature sensor may be coupled to the interior of the fitting 136, where the temperature sensor may measure the temperature within the fitting 136. In some cases, each temperature sensor may be coupled to one or more cables 134. Each cable 134 may be configured to communicate an electrical signal (e.g., including temperature measurement information) to a controller or other external location. The cables 134 may be electrically coupled to the I / O connector 124. In certain embodiments, for fittings 136 coupled to the inlets 118 and outlets 119 of the channels 116 of the waveguide 110, the temperatures measured at the inlets 118 and outlets 119 may be compared to determine a temperature change of the coolant flowing through the channels 116.

[0049] FIG. 1B is an assembled view of an exemplary LDU 100. The LDU 100 can include a waveguide 110, as described herein. The waveguide 110 may be carried by a housing 120. The housing 120 can include an I / O connector 124 configured to couple the LDU 100 to an optical signal input of a light source, as described herein. The waveguide 110 can include channels 116 (not shown in FIG. 1B), as described herein, each of the channels 116 configured to circulate a coolant proximate an emission face 114 of the waveguide 110. A cooling system 130 can deliver and collect the coolant from the channels 116 via conduits (e.g., tubes) 132. Each of the conduits 132 can be coupled to the LDU 100 at the waveguide 110, and the fittings 136 of each conduit 132 can facilitate coupling to a corresponding inlet 118 or outlet 119 (not shown in FIG. 1B) of the waveguide 110.

[0050] FIG. 1C is a close-up view of a side of an exemplary LDU 100. As shown in FIG. 1C, the LDU 100 can include a waveguide 110 carried by a housing 120. In certain embodiments, as described herein, the waveguide 110 can include an emission surface 114. The emission surface 114 can be concave and can conform to a surface on which the LDU 100 is placed (e.g., a skin surface of a subject). In other cases, the emission surface 114 can be convex. In one example, the emission surface 114 can have a radius of curvature ranging from 3 cm to 10 cm (e.g., about 6.5 cm) in a concave or convex orientation. The radius of curvature of the emission surface 114 can be configured to conform to a tissue surface with minimal deformation, thereby reducing an air gap between the emission surface 114 and the surface on which the LDU 100 is placed. In some cases, the radius of curvature of the emission surface 114 can be selected based on a target user of the LDU 100 and / or a system including one or more LDUs 100 as described herein. In other cases, the emission surface 114 may be flat.

[0051] 1C, the waveguide 110 may be held within the housing 120 such that a gap 144 exists between the extraction feature 142 of the waveguide 110 and the exterior surface of the housing 120. Based on the waveguide 110 being flexible and / or compressible (e.g., due to being constructed of silicone) as described herein, the presence of the gap 144 may allow the waveguide 110 to conform to the surface on which the LDU 100 is placed.

[0052] FIG. 1D is a side internal cross-sectional view of an exemplary LDU 100. In some cases, the waveguide 110 can include a lens 112. The lens 112 can be constructed from silicone. In one example, the lens 112 can be molded into the waveguide 110. That is, the lens mechanism 112 can form a NIR light input surface. Additionally, the lens 112 can receive and focus an optical signal from one or more light sources. The lens 112 can be in proximity to the at least one NIR light source and configured to at least substantially collimate (e.g., see FIG. 2A ) the treatment NIR light from the at least one NIR light source and convey the substantially collimated light in a first direction through the waveguide.

[0053] The light source can emit NIR light, e.g., light having wavelengths of 750 nm and / or 940 nm, capable of treating ischemia / reperfusion or other injury as described herein. The lens 112 can direct the received light signal to one or more of the reflective extraction features 142 of the waveguide 110 as described herein. In general, the lens 112 can have any suitable shape, e.g., an aspheric or non-cylindrical shape. The I / O connector 124 can be coupled to any suitable number of light sources, e.g., in the range of 1-10 light sources, in the range of 2-8 light sources, or in the range of 4-6 light sources. In certain embodiments, the I / O connector 124 can be coupled to a range of 1-100 light sources. The waveguide 110 can receive and redirect the light signal from each light source. In certain embodiments, the waveguide 110 and / or the I / O connector 124 can be configured to separate the lens 112 and the light sources by a predetermined focal length 113, which can be any suitable distance. 1D, the focal length 113 between the light source and the lens 112 may be about 3.5 mm±2 mm. Other focal lengths 113 may be used based on the application of the LDU 100, the configuration of the waveguide 110 (e.g., the shape of the lens 112), the wavelength of the emitted optical signal, and / or the angular divergence of the optical signal.

[0054] FIG. 1E is a bottom view of an exemplary light delivery unit (LDU) 100. As described herein, the LDU 100 can include a waveguide 110 carried by a housing 120. One or more tubes 132 can each be coupled to a waveguide channel 116 at an inlet 118 or an outlet 119 via a fitting 136. As shown in FIG. 1E, the LDU 100 can include an emission surface 114. An optical signal from a light source can be emitted by the waveguide 110 via the emission surface 114. The optical signal can propagate (e.g., vertically) through the channel 116 and reach a surface (e.g., a user's skin surface).

[0055] The emission surface 114 may be any suitable area (e.g., 1 cm 2 ~200cm 2range, for example 4cm 2 ). The area of ​​the emission surface 114 can be configured based on the application of the waveguide 110. The channel 116 can comprise a subset of the area of ​​the emission surface 114. In some cases, the channel 116 can comprise at least 20% (e.g., in a range of 50-80%) of the area of ​​the emission surface. In some cases, the channel 116 can be molded into the waveguide 110. In one example, the channel 116 can comprise a single channel in a serpentine configuration, as shown in FIG. 1E. The walls of the channel 116 can be non-parallel and / or non-angled. In one example, the walls of the channel 116 can be rectangular.

[0056] In certain embodiments, the portion of the channel 116 in contact with the optical signal can have a larger diameter than the portion of the channel 116 not in contact with the optical signal. As shown in FIG. 1E, the diameter of the channel 116 may be configured to be larger in a particular area. The diameter of the channel 116 may be configured to be larger in an area where a majority (e.g., at least 50%, at least 60%, at least 70%, at least 80%, and / or at least 90%) of the optical signal propagates, slowing the flow of coolant in the portion of the channel where the channel diameter is larger (e.g., the region where the optical signal propagates to the center). In some cases, the slowdown of the flow of coolant in the portion of the channel where the channel diameter is larger can increase the efficiency of heat exchange between the coolant and the proximal region of the channel 116. In some cases, one or more vortices can form in the portion of the channel where the channel diameter is larger, causing turbulent flow of the coolant through the channel 116. The turbulent flow of the coolant in the channel 116 can increase the efficiency of heat exchange between the coolant and the proximal region of the channel 116. In some cases, the channel 116 may be coated and / or otherwise sealed with a film. The film may be an optically transparent film (e.g., transparent to NIR light) configured to enhance heat exchange efficiency and facilitate propagation of the optical signal through the waveguide 110. The film may include a refractive index that is equal to or approximately equal to the refractive index of the waveguide 110. The film may be adhered to or be a part of the emission surface 114 and seal (e.g., hermetically seal) the channel 116. In an exemplary embodiment, the film may be an ultra-thin silicone film.

[0057] In some embodiments, as described herein, the coolant can circulate through the channel 116. The coolant provided from the tube 132a can enter the channel 116 via the inlet 118. The inlet 118 can include a temperature sensor to measure the temperature of the coolant (e.g., chilled coolant) at the inlet 118. The coolant can circulate through the channel 116. In some cases, the coolant can absorb thermal energy from a region proximal to the channel 116. In one example, the coolant can absorb energy generated by NIR light emitting at the user's skin surface. The coolant can flow through the channel 116 as shown in FIG. 1E. The coolant (e.g., warmed coolant) can exit the channel 116 via the outlet 119 to the tube 132b. The coolant exiting the channel 116 of the waveguide 110 can be provided to a coolant chiller and recirculated to the LDU 100.

[0058] Waveguide Configuration

[0059] FIG. 2A is a side view of an exemplary waveguide 110 showing an exemplary optical input and optical channels through the waveguide 110. As shown, the waveguide 110 may comprise a lens 112. The lens 112 may focus a received optical input 210 (e.g., optical energy) into one or more focused optical signals 212 (e.g., light beams). In some cases, the lens 112 may diffuse or disperse a single optical input into several optical signals 212 passing through the waveguide 110. The waveguide may comprise an optical entrance portion 202, which may be an elongated portion of the waveguide 110 through which the optical signal 212 propagates after being focused and / or diffused / dispersed by the lens 112. In some cases, the waveguide 110 may comprise an extraction portion 203 comprising one or more stepped extraction features 142 that may deliver the optical signal 212 from the optical entrance portion 202. In general, any suitable number of extraction features 142 may be used, for example, at least three extraction features. The extraction features 142 may be molded into the waveguide 110, with each extraction feature 142 inclined at an angle relative to a direction perpendicular to the emission surface 114 and / or the user's skin surface. In various embodiments, each extraction feature 142 may be configured to be inclined at an angle depending on the application for which the waveguide 110 is used. For example, the inclination angle may be configured in a range of 35 degrees to 75 degrees (e.g., 55 degrees). In other words, the multiple extraction surfaces 142 on the surface of the waveguide are configured to substantially reflect light (e.g., collimated light) through the emission surface 114 to the subject. At least some of the extraction surfaces of the multiple extraction surfaces 142 may be inclined in a range of 35 degrees to 75 degrees relative to a direction approximately perpendicular to the subject. Additionally, the multiple extraction surfaces may be configured to generate a substantially uniform NIR light output across the light emission surface.

[0060] In some cases, all of the extraction features 142 may be oriented at the same angle. In other cases, different extraction features 142 may be oriented at different angles. Each extraction feature 142 (a surface from which light reflects) may be configured to redirect at least one optical signal 212 to the emission face 114 of the waveguide 110, where the at least one optical signal propagates through the emission face 114 approximately perpendicular to the emission face 114 and / or the user's skin surface. In some cases, the extraction features 142 may be configured to redirect the optical signal such that the optical signal power distribution of the waveguide 110 is substantially uniform across the emission face 114. For example, the output power distribution across the emission face 114 may be substantially uniform. In some embodiments, to determine the uniformity of the optical signal power distribution across the emission face 114 of the waveguide 110, the area of ​​the emission face 114 may be divided into one or more pixels. In some cases, the area of ​​each pixel of the multiple pixels may be equivalent. In one example, the emission face 114 may be divided into five pixels. During operation of the waveguide 110, the power density (e.g., mW / cm 2 ) can be measured for each pixel. The maximum and minimum power densities from the pixels on the emission surface 114 can be determined based on the measured power densities of the pixels. A surface power density uniformity (SPDU) metric as described by Equation 1 can be calculated based on the maximum and minimum power densities. Equation 1 can be written as follows:

[0061]

number

[0062] As explained by Equation 1, the SPDU is PD " and "Min PD " can be based on the function "Max PD " can correspond to the maximum power density of a pixel among a plurality of pixels, and "Min PD " can correspond to the minimum power density of a pixel among the pixels. In one example, 100 mW / cm 2 Equal to "Max PD" and 20 mW / cm 2 Equal to "Min PD ", the determined SPDU of the emission surface 114 may be approximately 33% according to Equation 1. In some embodiments, the SPDU through the emission surface 114 may be comprised in the range of 10-100%. In one example, the SPDU through the emission surface 114 may be 50%.

[0063] In some embodiments, the waveguide 110 can deliver the optical signal with an efficiency in the range of 20%-100%, 30%-90%, 40%-80%, or 50%-70%. As used herein, efficiency is calculated as the percentage of the optical signal 110 incident on the lens 112 that exits the emission face 114.

[0064] In some cases, as described herein, one or more faces or surfaces of the waveguide 110 may be covered with and / or otherwise coupled to a reflective material. In one example, the top, sides, and one or more extraction features of the waveguide 110 may include a reflective material. The lens 112 and the emission face 114 may not be covered with a reflective material. The reflective material may help contain one or more optical signals 210 within the waveguide 110 such that the optical signals 212 enter the waveguide 110 only through the lens 112 and exit the waveguide 110 only through the emission face 114.

[0065] The light input 210 may include one or more light signals. In one example, the light signals may include a combination of approximately 750 nm and 940 nm light emanating from one or more light sources (e.g., laser sources or energy sources). The extraction mechanism 142 may redirect the focused light signal 212 to the emission face 114. The focused light signal 212 may exit the emission face 114, for example, approximately perpendicular to the emission face 114, and may be used in therapeutic applications (e.g., treatment of IR or other damage) as described herein.

[0066] FIG. 2B is a bottom view of an exemplary waveguide 110 showing an exemplary optical input 210. As described herein, the waveguide 110 can include a lens 112, an extraction mechanism 142, and an emission face 114. The waveguide 110 can receive an optical input 210. As shown in FIG. 2B, the optical input 210 can include a plurality (e.g., 1-10 optical inputs, e.g., optical signals in the range of 6 shown). The lens 112 can focus the optical input 210 into a focused optical signal 212 that can propagate through the waveguide 110. The extraction mechanism 142 can redirect the focused optical signal 212 to the emission face 114, where the focused optical signal 212 can exit the emission face 114, e.g., approximately perpendicular to the emission face 114.

[0067] 2C-2G are further views of the exemplary waveguide 110. The dimensions shown in FIGS. 2C-2G are merely examples according to certain embodiments and are not intended to limit the present disclosure. Any suitable dimensions may be used for the waveguide 110 without departing from the scope of the present disclosure. FIG. 2C is a perspective view of the exemplary waveguide 110. FIG. 2D is a left side view of the exemplary waveguide 110. FIG. 2E is a top view of the exemplary waveguide 110. FIG. 2F is a bottom view of the exemplary waveguide 110. FIG. 2G is a front view of the exemplary waveguide 110. FIG. 2H is a rear view of the waveguide 110.

[0068] Treatment system configuration

[0069] In some embodiments, one or more LDUs 100 as described herein may be included in a treatment system. In general, the treatment system may be used to treat any suitable injury. For example, the treatment system may provide therapeutic treatment to a patient's body tissue affected by ischemia / reperfusion (IR) injury via NIR light. FIG. 3A is a schematic diagram of an exemplary treatment system 300 for providing NIR light therapy. The connections shown in FIG. 3A may include one or more of electrical connections, optical connections, or fluid connections. In some cases, the treatment system 300 may include an assembly 301, a splitter 340, and a wearable treatment device 350.

[0070] In some embodiments, the assembly 301 can include a power source 302 configured to provide power to the assembly 301. In some cases, the power source can be electrically coupled to an external power source (e.g., a wall outlet) via a connection 330. In some cases, the power source 302 can include a battery. If the power source includes a battery, the power source can be coupled to a charging station via the connection 330 to charge the battery. In some cases, the power source 302 can be electrically coupled to one or more of the one or more fans 304, the coolant chiller 306, and the control module 308 (e.g., to provide power). In some cases, the assembly 301 can include one or more fans 304. The fans 304 can operate to circulate air inside and / or outside the assembly 301. Based on the circulated air, the fans can cool the assembly 301. The fans 304 can be controlled by the control module 308 as described herein.

[0071] In certain embodiments, the assembly 301 can include a coolant chiller 306. The coolant chiller may receive power from the power source 302. The coolant chiller 306 can be fluidly coupled to the cooling system 362 of the wearable therapy device 350. The coolant chiller 306 can be electrically coupled to the control module 308. The coolant chiller 306 can cool the coolant provided to the coolant chiller 306. The coolant chiller can lower or raise the temperature of the received and / or stored coolant to a configured temperature. In an exemplary embodiment, the coolant chiller 306 can cool the coolant received from the cooling system 362. In some cases, the coolant chiller 306 can include a pump configured to circulate the coolant. In one example, the pump of the coolant chiller 306 can circulate the coolant to the cooling system 362 of the wearable therapy device 350.

[0072] In some embodiments, the assembly 301 can include a control module 308. The control module 308 can be electrically coupled to one or more of the fan 304, the coolant chiller 306, the user interface 310 (and associated components), the light source 322a, the light source 322b, and the wearable therapy device 350 (and associated components described herein). The control module 308 can include a processor, a memory, and / or a communication module (not shown in FIG. 3A). The processor can communicate with and / or otherwise control other components of the assembly 301 and / or components of the wearable therapy device 350. The memory can store one or more computer-readable instructions for carrying out functions of the assembly 301 and / or the wearable therapy device 350 as described herein.

[0073] In some embodiments, the assembly 301 can include a user interface 310. The user interface 310 can be electrically coupled to the control module 308. The user interface 310 can include one or more displays for displaying feedback and / or control information of the assembly 301 and / or the wearable therapy device 350. In some cases, the user interface 310 can include a timer 312. The timer 312 can be electrically coupled to the control module 108. The timer 312 can indicate the time and / or duration of the therapy provided by the wearable therapy device 350. In one example, the timer 312 can be displayed via a liquid crystal digital (LCD) display. Any suitable display can be used for the timer 312. In some cases, the user interface 310 can include one or more feedback indicators 314. The feedback indicators can be electrically coupled to the control module 108. The feedback indicators 314 can include audible, visual, and / or tactile feedback information corresponding to the assembly 301 and / or the wearable therapy device 350. For example, the feedback indicator 314 may be a light emitting diode (LED) indicator that lights up to indicate that the assembly 301 and the wearable therapy device 350 are on. Additionally, for example, the feedback indicator may be an audible indicator that emits a tone when therapy via the wearable therapy device 350 is complete.

[0074] In some embodiments, the user interface 310 may include one or more input devices 316. The input devices may be electrically coupled to the control module 308. The input devices 316 may be used to input information to the assembly 301 and / or the wearable therapeutic device 350. Information input via the input devices may be communicated to the control module 108. Examples of the input devices 316 may include touch-sensitive devices, push buttons, sliders, knobs, and / or microphones. The input devices 316 may be used to configure the assembly 301 and / or the wearable therapeutic device 350. In one example, the input devices 316 may be used to activate the delivery of NIR light via the wearable therapeutic device 350. In another example, the input devices 316 may be used to configure a time period for the delivery of NIR light via the wearable therapeutic device 350.

[0075] In some embodiments, the assembly 301 may include one or more light sources 322. As shown in FIG. 3A, the assembly may include light sources 322a and 322b. In some cases, the light source 322 may be a laser diode assembly. The light source 322 may be configured to emit a light signal at about 750 nm (e.g., 750 nm ± 30 nm). The light source 322b may be configured to emit a light signal at about 940 nm (e.g., 940 nm ± 30 nm). The light source 322 may be configured to emit a light signal at any suitable wavelength based on the application of the assembly 301 and / or the wearable therapeutic device 350. As described herein, the light signals at about 750 nm and 940 nm may provide treatment for IR damage by modulating mitochondrial activity of body tissues under oxidative stress.

[0076] In certain embodiments, light source 322 may be optically coupled to splitter 340. In an exemplary embodiment, light sources 322a and 322b may be coupled to splitter 340 via a pair of fiber optic cables. In some cases, as shown in FIG. 3A, the splitter may be external to assembly 301 and wearable therapy device 350. In other cases, splitter 340 may be included in assembly 301 or wearable therapy device 350. Splitter 340 may be configured to splice and / or otherwise combine the received optical signals into a combined optical signal. In one example, splitter 340 may combine a 750 nm optical signal emitted by light source 322a with a 940 nm optical signal emitted by light source 322b to form a combined optical signal including both 750 nm and 940 nm light. Splitter 340 may be optically coupled to one or more LDUs 100 of wearable therapy device 350. The splitter 340 can provide the combined optical signal to at least one LDU 100 of the wearable therapy device 350. In one example, the splitter 340 can provide a combined 750 nm and 940 nm optical signal to the LDU 100 via a fiber optic cable. The light sources 322a and 322b are split by the splitter 140 to provide a combined 750 nm and 940 nm optical signal to the LDU 100. 2 ~2W / cm 2 , for example, about 1 W / cm 2 The light source 322 of the assembly 322 may be configured to emit light at any suitable power based on the application of the assembly 301 and / or the wearable therapeutic device 350.

[0077] In some embodiments, the treatment system 300 can include a wearable treatment device 350. The wearable treatment device 350 can include a connection indicator 352, a usage module 354, and one or more LDUs 100. In some cases, the wearable treatment device 350 can include a support member, the support member configured to adhere to a body region of the patient. In general, the support member can be configured to adhere to any suitable body region, for example, a head region, a neck region, an upper torso region, a lower torso region, an upper leg region, and / or a lower leg region. The support member can be manufactured from an elastic woven material. In one example, the elastic woven material can be composed of a cotton / spandex blend woven material or a polyester / spandex blend woven material. In some cases, the support member can be any combination of a strap, a cap, or a helmet. In some cases, the support member can be disposable. The support member can be configured in one or more sizes. For example, the support member can be configured in small, medium, and large sizes to fit infants, children, and adults, respectively. The support member can hold the connection indicator 352, the usage module 354, and the LDU 100. The support member can have one or more features as described herein with respect to Figures 3B-3E.

[0078] In some embodiments, the connection indicator 152 may be electrically coupled to the control module 308 of the assembly 301. The connection indicator may be an audible, visual, and / or tactile indicator. In some cases, the connection indicator 152 may indicate whether the assembly 301 and the wearable therapeutic device 350 are connected. Upon detecting a connection between the assembly 301 and the wearable therapeutic device 350, the control module may display an indication of the connection via the connection indicator 152. In certain embodiments, the connection indicator 152 may be an LED indicator that is illuminated when the assembly 301 and the wearable therapeutic device 350 are connected.

[0079] In certain embodiments, the usage module 354 may be electrically coupled to the control module 308 of the assembly 301. The control module 308 may determine usage information stored in the usage module 354, and the control module 308 may be configured to deactivate the wearable therapeutic device 350 based on a usage threshold. Additionally or alternatively, the usage module 354 may be configured to deactivate the wearable therapeutic device 350 based on a usage threshold. In some cases, the usage module 354 may comprise a fuse, and the fuse may be configured to sever and / or otherwise break based on the usage threshold. In one example, applying an increased current to the fuse may cause the fuse to break. Based on breaking the fuse, the wearable therapeutic device 350 may be deactivated. In some cases, the usage threshold may be a number of uses threshold (e.g., one use). In other cases, the usage threshold may be a threshold amount of energy delivered to the subject being treated. Use of the wearable therapeutic device 350 may be defined as a period of use exceeding a threshold duration (e.g., within a range of 2-8 hours). In some cases, the usage module 354 may be configured to deactivate the wearable therapeutic device 350 based on received input (e.g., via the input device 316). In one example, the treatment system 300 can receive an emergency stop input via the input device 316. Based on the received emergency stop input, the usage module 354 can deactivate the wearable therapeutic device 350.

[0080] In some embodiments, the wearable therapeutic device can include a temperature sensor 356. The temperature sensor 356 may be electrically coupled to the control module 308. In some cases, the temperature sensor 356 may be external to the wearable therapeutic device 350. In some cases, the temperature sensor 356 may be adhered to a body region of a user (e.g., a patient). The control module 108 receives a reference temperature (T R ) can be measured. T Rcan indicate the user's body temperature at a location different from the location of the temperature sensor on the LDU 100.

[0081] In some embodiments, the wearable therapy device 350 can include one or more LDUs 100. In various embodiments, the wearable therapy device 350 can include a range of 1-20 LDUs, a range of 2-18 LDUs, a range of 3-16 LDUs, a range of 4-14 LDUs, a range of 5-12 LDUs, a range of 6-10 LDUs (e.g., 6 LDUs or 8 LDUs). Each LDU 100 can include a cooling system 362, a waveguide 110, and a housing (not shown). The cooling system 362 can include one or more characteristics of the cooling system 130 described herein with respect to FIGS. 1A-1E. In some cases, the cooling system 362 can be fluidly coupled to the coolant chiller 306 via one or more tubes. The cooling system 362 can be fluidly coupled to the waveguide 110 via tubes. The coolant chiller 306 can be coupled to the channels of the waveguide 110 via conduits of a cooling system 362. Each of the conduits of the cooling system 362 can be configured to carry coolant to or from the channels of the waveguide 110. In one example, a first conduit can carry chilled coolant from the coolant chiller 306 to an inlet of the channel of the waveguide 110, and a second conduit can carry warmed coolant from an outlet of the channel to the coolant chiller 306.

[0082] In certain embodiments, the cooling system 362 may include one or more temperature sensors. As described herein, a fitting for each tube of the cooling system 362 may include a temperature sensor, and the fitting may couple the tube to an inlet or outlet of the waveguide 110. Each temperature sensor of the cooling system 362 may be electrically coupled to the control module 308 via a cable. A temperature sensor may be coupled to each fitting and may measure the temperature of a proximal region of the fitting. The control module 308 may measure the temperature of the wearable therapeutic device 350 (e.g., coolant temperature) via a temperature sensor included in the cooling system 362. In some cases, a temperature sensor may be located at an inlet (e.g., inlet 118), and the temperature sensor may determine a temperature as T1. T1 may represent the temperature of the coolant entering the channel. In some cases, a temperature sensor may be located at an outlet (e.g., outlet 119), and the temperature sensor may determine a temperature as T2. T2 may represent the temperature of the coolant exiting the channel. The control module 308 can determine the temperature difference between the outlet and inlet (ΔT=T2-T1). ΔT can be used to determine the absorption of heat in the subject's skin area to which the wearable therapeutic device 350 is applied. T R and ΔT can be compared (e.g., by the control module 108) to determine whether the wearable therapeutic device 350 will operate under expected conditions and / or adjust treatment parameters as necessary. R A comparison of ΔT to ΔT can be used to determine overheating in the area where the wearable therapeutic device 350 is placed. In certain embodiments, the treatment regime can include different operating parameters at different stages of treatment, which can be informed by measurements from the temperature sensor and / or implemented by the control module 308.

[0083] In a particular embodiment, the LDU 100 may comprise a waveguide 110 as described herein. The channels of the waveguide 110 may be fluidly coupled to the coolant chiller 306 via a cooling system 362 as described herein. The waveguide 110 may be optically coupled to the splitter 340. In an exemplary embodiment, the waveguide 110 may be coupled to the splitter 340 via a fiber optic cable. The waveguide 110 may receive an optical input from the splitter 340. In an exemplary embodiment, the optical input may be a combined optical signal including both 750 nm and 940 nm light. In another exemplary embodiment, the optical input may be separate optical signals, where a first optical signal includes 750 nm light and a second optical signal includes 940 nm light. In some cases, when the optical input includes separate optical signals, the separate optical signals may be combined into a combined optical signal including both 750 nm and 940 nm light. The combined optical signal may enter and propagate through a lens of the waveguide 110. The lens can focus the composite optical signal into one or more focused optical signals. The focused optical signals can be incident on and propagate through one or more extraction features of the waveguide 110. The extraction features can redirect the focused optical signals so that the focused optical signals are approximately perpendicular to the emission face of the waveguide 110. The focused optical signals can propagate through the channels and emission face as one or more emitted optical signals. In some cases, when the wearable therapeutic device is worn on a subject (e.g., a patient), the emitted optical signals can be incident on a tissue surface (e.g., a skin surface) of the subject. The emitted optical signals can propagate through the body tissue of the subject. In some cases, the propagation of the emitted optical signals through the body tissue can provide therapy via modulation of mitochondrial activity when the body tissue is under oxidative stress.

[0084] In some embodiments, as described herein, the LDU 100 can include a housing 120. In some cases, the housing can include one or more fasteners (e.g., brackets, screws, clips, etc.) for physically coupling the LDU 100 to the wearable therapeutic device 350.

[0085] FIG. 3B is an internal view of an exemplary wearable therapeutic device 350 of an exemplary therapeutic system 300 for providing NIR light therapy. In some cases, as described herein, the wearable therapeutic device 350 can include a support member 370 configured to adhere to a body region (e.g., head region) of a patient. As shown in FIG. 3B, the support member 370 can include a first end 371 and a second end 372. The first end 371 of the support member 370 can include a strap 374. The strap 374 can be removably coupled to a strap 375 (not shown in FIG. 3B) to removably couple the second end 372 to the first end 371. The support member 370 can be constructed of an elastic woven material. In an exemplary embodiment, the wearable therapeutic device 350 can be flat, as shown in FIG. 3B. In other embodiments, the wearable therapeutic device 350 can be wrap-around, as shown in FIG. 3D. In some cases, the support member 370 can be any combination of a strap, a cap, or a helmet. In some cases, the support member 370 may be disposable. The support member 370 may be configured in one or more sizes. For example, the support member 370 may be configured in small, medium, and large sizes to fit infants, children, and adults, respectively. The support member 370 may hold the LDUs 100 (not shown in FIG. 3B) external to the wearable therapeutic device 350, as shown in FIG. 3C. In one example, the wearable therapeutic device 350 may include eight LDUs 100 held by the support member 370. In some embodiments, the wearable therapeutic device 350 may include one or more pads 386. The pads 386 may be configured to reduce and / or otherwise prevent pressure areas (e.g., pressure points) on the body area to which the wearable therapeutic device 350 is adhered. Each pad 386 may correspond to an LDU 100 on the wearable therapeutic device 350, with each pad 386 positioned in an area proximal to the LDU 100 within the wearable therapeutic device 350. The pad 386 may be constructed of a soft gel material. In one example, the pad 386 may be 2 cm to 8 cm in size by 2 cm to 8 cm in size (eg, 6 cm by 6 cm).

[0086] FIG. 3C is an exterior view of an exemplary wearable therapeutic device 350 of an exemplary therapeutic system 300 for providing NIR light therapy. In some cases, as described herein, the wearable therapeutic device 350 can include a support member 370 configured to adhere to a patient's body region (e.g., head region). As shown in FIG. 3C, the support member 370 can include a first end 371 and a second end 372. The second end 372 of the support member 370 can include a strap 375. The strap 375 can be removably coupled to a strap 374 (as shown in FIG. 3B) to removably couple the second end 372 to the first end 371. In an exemplary embodiment, as shown in FIG. 3C, the wearable therapeutic device 350 can be flattened. The support member 370 can hold the LDU 100 (not shown in FIG. 3C) external to the wearable therapeutic device 350. In one example, the wearable therapy device 350 can include eight LDUs 100 held by a support member 370.

[0087] 3D is a side view of an exemplary wearable therapeutic device 350 of an exemplary treatment system 300 for providing NIR light therapy. As shown in FIG. 3D, the wearable therapeutic device 350 may be configured in a wrap-around position. A first end 371 of the support member 370 may be coupled to a second end 372 of the support member 370 via a strap 374 (not shown in FIG. 3D) and a strap 375. Any suitable fasteners may be used in place of or in addition to the strap 374 and the strap 375. The wearable therapeutic device 350 may be configured in a wrap-around position and adhered to the head region of the user of the treatment system 300.

[0088] FIG. 3E illustrates an exemplary wearable therapy device 350 of the exemplary therapy system 300 worn on the head of a user. In some cases, the wearable therapy device can be adapted to the user 380 via a support member 370. In an exemplary embodiment, as shown in FIG. 3E, the wearable therapy device 350 can be adapted to the head region of the user 380. The wearable therapy device 350 can be adapted to the head region of the user 380 via a strap 374 and a strap 375 (not shown in FIG. 3E). The wearable therapy device 350 can be configured to strategically position the LDUs 100 (not shown in FIG. 3E) to deliver NIR light therapy to desired tissue regions and to avoid delivering NIR light therapy to undesirable anatomical structures (e.g., venous sinuses, specific blood vessels, organs, etc.). The number of LDUs 100 and / or the location of each of the LDUs 100 on the support member 370 can be selected based on the particular therapy application and / or characteristics of the subject of the wearable therapy device 350 (head size, placement of venous sinuses, etc.). In some cases, the user characteristics can be determined using medical imaging, such as an x-ray, MRI, or CT scan. In an exemplary embodiment, the wearable therapy device 350 can include eight LDUs 100, with four LDUs 100 positioned on each hemisphere of the user's 380 head. Such positioning can also avoid contact with certain anatomical structures. In another example, the wearable therapy device 350 can include six LDUs 100, with three LDUs 100 positioned on each hemisphere of the user's 380 head region. Each of the LDUs 100 can conform to the skin surface of the user 380. In some cases, each LDU 100 can be positioned such that the optical signal emitted by each LDU 100 (e.g., via the waveguide 110) is emitted approximately perpendicular to the skin surface of the user 380.

[0089] Coolant I / O Mechanism Configuration

[0090] FIG. 4A illustrates an exemplary combiner 402 for circulating coolant within a treatment system (e.g., treatment system 300) for providing NIR light treatment. In some cases, tubing of a cooling system of an LDU may be coupled to the combiner 402 as described herein. The combiner 402 may be comprised of one or more conduits (e.g., tubes) and one or more fittings to combine or distribute fluid from one or more sources. In an exemplary embodiment, the combiner 402 distributes coolant from a chiller device to one or more LDUs of a wearable treatment device. In another example, the combiner may combine coolant from one or more LDUs and deliver the combined coolant to a chiller device. The combiner 402 may include a first inlet / outlet (I / O port) 410 and one or more second I / O ports 420. In some cases, a fluid (e.g., coolant) may flow into the first I / O port 410 and be distributed to the second I / O port 420. In other cases, the fluid (e.g., coolant) may flow into the second I / O port 420 and be combined at the first I / O port 410. In one example, as shown in FIG. 4A, the combiner 402 may include eight I / O ports 420. The combiner 402 may include any suitable number of second I / O ports 420 based on the number of LDUs included in the wearable therapeutic device and / or the number of combiners included in the therapeutic system described herein.

[0091] FIG. 4B illustrates an example of coolant circulation through an exemplary combiner 402 in a treatment system (e.g., treatment system 300) for providing near-infrared (NIR) light therapy. For purposes of illustration, the example of coolant circulation illustrated in FIG. 4B is illustrated for a single LDU 100. However, any suitable number of LDUs 100 may circulate coolant as described herein. In some cases, treatment system 400 may include one or more tubes 403. The tubes 403 may combine one or more combiners 402 into a coolant chiller as described herein. As illustrated in FIG. 4B, treatment system 400 may include tubes 403a and 403b. In some cases, treatment system 400 may include one or more combiners 402, each configured to combine or distribute coolant. As illustrated in FIG. 4B, treatment system 400 may include combiners 402a and 402b. In some cases, treatment system 400 can include one or more LDUs 100 as part of the wearable treatment device described herein. LDU 100 can include a cooling system that includes one or more tubes 401 coupled to an inlet or outlet of LDU 100. As shown in FIG. 4B, treatment system 400 can include tubes 401a and 401b as part of the cooling system of LDU 100.

[0092] In some cases, the combiner 402 may be included in a wearable therapy device that includes the LDU 100. For example, the wearable therapy device may include combiners 402a and 402b, and a tube 401 connected to the inlet and outlet of the LDU 100 may be coupled to combiner 402a or combiner 402b on the wearable therapy device. In other cases, the combiner 402 may be included in an assembly (e.g., assembly 301). For example, assembly 301 may include combiners 402a and 402b for fluidly coupling the coolant chiller 306 to the LDU 100. In some cases, the combiner 402 may be included with a splitter (e.g., splitter 340), and the combiner 402 is external to the assembly and wearable therapy device described herein.

[0093] In some embodiments, the tube 403a may be coupled to the coolant chiller 306, and the tube 403a circulates the cooled coolant to the first I / O port 410a of the combiner 402a. The combiner 402a can receive the coolant and distribute the received coolant to one or more second I / O ports 420. The tube 401a may be coupled to the second I / O port 420a of the combiner 402a. The tube 401a can receive the cooled coolant from the second I / O port 420a of the combiner 402a. The tube 401a can circulate the cooled coolant to an inlet of the channel 116 (not shown in FIG. 4B) of the LDU 100. The cooled coolant can exit the LDU 100 as a warmed coolant at an outlet of the channel 116. The tube 401b may be coupled to an outlet of the channel 116. The tube 401b can receive the warmed coolant from the outlet. The tube 401b can be coupled to a second I / O port 420b of the combiner 402b, and the tube 401b circulates the warmed coolant to the second I / O port 420b of the combiner 402b. In some cases, the warmed coolant originating from one or more LDUs 100 can be supplied to the second I / O port 420 of the combiner 402b. The combiner 402b can receive the warmed coolant from the LDU 100 (and one or more other LDUs 100). The warmed coolant can converge into the combiner 402b at a first I / O port 410b of the combiner 402b. The tube 403b can be coupled to the first I / O port 410b of the combiner 402b. Tube 403b can receive warmed coolant from first I / O port 410b of combiner 402b and supply the warmed coolant to coolant chiller 306, as described herein. Thus, coolant can be circulated between LDU 100 and coolant chiller 306 via combiners 402a and 402b, LDU 100 (e.g., the discharge face of LDU 100) can be cooled by the cooled coolant, and the warmed coolant emerging from LDU 100 can be cooled by coolant chiller 306.

[0094] Photoelectric I / O mechanism configuration

[0095] FIG. 5 illustrates an exemplary coupling mechanism in a therapy system 500 for providing NIR light therapy. In some cases, a wearable therapy device 350 may be coupled to an assembly 501 as described herein. The wearable therapy device 350 may include one or more LDUs 100 (not shown in FIG. 5), each of which may include an I / O connector 124 as described herein. The wearable therapy device 350 may include a support member 370 configured to hold the LDU 100 and adhere to a body region (e.g., head region) of a user as described herein. In some cases, the wearable therapy device 350 may include one or more connectors 572. A first end of the connector 572 may be coupled to one or more I / O connectors 124 corresponding to the LDU 100. The location of the pads 386 on the interior of the wearable therapy device 350 as shown in FIG. 5 may indicate the location of the LDU 100 on the exterior of the wearable therapy device 350. In one example, as shown in FIG. 5, a first end of connector 572a can be coupled to four LDUs 100 (positioning indicated by pads 386a) and a first end of connector 572b can be coupled to four LDUs 100 (positioning indicated by pads 386b). In various embodiments, the first end of connector 572 can be coupled to any suitable number of LDUs 100. In some embodiments, splitter (not shown) or assembly 501 can include one or more connectors 574. A second end of connector 572 can be coupled to a first end of connector 574. In one example, as shown in FIG. 5, a second end of connector 572a can be coupled to a first end of connector 574a and a second end of connector 572b can be coupled to a first end of connector 574b. In some cases, connector 572 can be removably coupled to connector 574. In one example, connectors 572a and 572b can be removably coupled to connectors 574a and 574b such that the wearable therapeutic device 350 and assembly 501 can be separated.

[0096] In some embodiments, the connector 572 may be configured as an insertion connector (e.g., a male connector of a male-female coupling mechanism). In some cases, the connector 574 may be configured as a receiving connector (e.g., a female connector of a male-female coupling mechanism). In some examples, the connectors 572 and 574 may be physically coupled based on a male-female coupling mechanism. Both the connectors 572 and 574 may include one or more optical channels (e.g., fiber optic cables) and electrical wires and / or cables, and the connectors 572 and 574 may be optically and electrically coupled to transmit one or more signals. The coupled optical channels may transmit emitted optical signals (e.g., combined 750 nm and 940 nm light) from the assembly 501 to each LDU 100 of the wearable therapy device 550. The coupled electrical wires and / or cables may communicate information between a temperature sensor included in the wearable therapy device 350 and the assembly. In an exemplary embodiment, a control module of the assembly (eg, control module 308 ) can determine temperature information at the inlet and outlet of each of the LDUs 560 via coupled connectors 572 and 574 .

[0097] In some embodiments, as described herein, the assembly 501 can include a coolant chiller 306. The coolant chiller 306 can be configured to chill the coolant and circulate the coolant to the LDUs of the coupled wearable therapy device 350. In one example, as shown in FIG. 5, the assembly can include the coolant chiller 306 and a pair of combiners 402. A first combiner 402 of the pair of combiners 402 can combine the coolant received from the LDU 100 for cooling by the coolant chiller 306. A second combiner 402 of the pair of combiners 402 can distribute the coolant cooled by the coolant chiller 306 to the LDU 100. Further Description of Specific Embodiments

[0098] FIG. 6 is a block diagram of an exemplary computer system 600 that may be used in implementing the techniques described in this document (e.g., as part of the controller 308). A general purpose computer, a network appliance, a mobile device, or other electronic system may also comprise at least a portion of the system 600. The system 600 comprises a processor 610, a memory 620, a storage device 630, and an input / output device 640. Each of the components 610, 620, 630, and 640 may be interconnected, for example, using a system bus 650. The processor 610 may process instructions for execution within the system 600. In some implementations, the processor 610 is a single-threaded processor. In some implementations, the processor 610 is a multi-threaded processor. The processor 610 may process instructions stored in the memory 620 or the storage device 630.

[0099] The memory 620 stores information within the system 600. In some implementations, the memory 620 is a non-transitory computer-readable medium. In some implementations, the memory 620 is a volatile memory unit. In some implementations, the memory 620 is a non-volatile memory unit.

[0100] The storage device 630 can provide mass storage for the system 600. In some implementations, the storage device 630 is a non-transitory computer-readable medium. In various different implementations, the storage device 630 can comprise, for example, a hard disk device, an optical disk device, a solid-state drive, a flash drive, or some other mass storage device. For example, the storage device may store long-term data (e.g., database data, file system data, etc.). The input / output device 640 provides input / output operations to the system 600. In some implementations, the input / output device 640 can comprise one or more of a network interface device, such as an Ethernet card, a serial communication device, such as an RS-232 port, and / or a wireless interface device, such as an 802.11 card, a 3G wireless modem, or a 4G wireless modem. In some implementations, the input / output device can comprise a driver device configured to receive input data and send output data to other input / output devices, such as a keyboard, a printer, and a display device 660. In some examples, mobile computing devices, mobile communication devices, and other devices can be used.

[0101] In some implementations, at least some of the techniques described above may be realized by instructions that, when executed, cause one or more processing devices to perform the processes and functions described above. Such instructions may include, for example, interpreted instructions, such as script instructions, executable code, or other instructions stored on a non-transitory computer-readable medium. The storage device 630 may be implemented in a distributed manner over a network, for example as a server farm or a set of widely distributed servers, or may be implemented on a single computing device.

[0102] Although an exemplary processing system is described in FIG. 6, embodiments of the subject matter, functional operations, and processes described herein may be implemented in other types of digital electronic circuitry, in tangibly embodied computer software or firmware, in computer hardware including the structures disclosed herein and their structural equivalents, or in one or more combinations thereof. Embodiments of the subject matter described herein may be implemented as one or more computer programs, i.e., one or more modules of computer program instructions encoded on a tangible non-volatile program carrier for execution by or to control the operation of a data processing apparatus. Alternatively or additionally, the program instructions may be encoded in an artificially generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal generated to encode information for transmission to a suitable receiving device for execution by the data processing apparatus. The computer storage medium may be a machine-readable storage device, a machine-readable storage substrate, a random or serial access memory device, or a combination of one or more of the foregoing.

[0103] The term "system" may encompass any kind of apparatus, device, and machine for processing data, including, by way of example, a programmable processor, a computer, or multiple processors or computers. A processing system may comprise special purpose logic circuitry, such as, for example, a field programmable gate array (FPGA) or an application specific integrated circuit (ASIC). In addition to hardware, a processing system may comprise code that creates an execution environment for the computer program in question, such as code constituting a processor firmware, a protocol stack, a database management system, an operating system, or one or more combinations thereof.

[0104] A computer program (which may also be referred to or described as a program, software, software application, module, software module, script, or code) can be written in any form of programming language, including compiled or interpreted languages, or declarative or procedural languages, and can be deployed in any form, such as as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program may or may not correspond to a file in a file system. A program may be stored in part of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple cooperating files (e.g., files that store one or more modules, subprograms, or portions of code). A computer program can be deployed to be executed on one computer, or on multiple computers located at one site or distributed across multiple sites and interconnected by a communication network.

[0105] The processes and logic flows described herein may be performed by one or more programmable computers executing one or more computer programs to perform functions by manipulating input data to generate output. The processes and logic flows may also be performed by, and an apparatus may also be implemented as, special purpose logic circuitry, such as, for example, an FPGA or ASIC.

[0106] A computer suitable for executing a computer program may, by way of example, comprise a general-purpose or dedicated microprocessor or both, or any other type of central processing unit. Typically, the central processing unit receives instructions and data from a read-only memory or a random access memory or both. A computer typically comprises a central processing unit for performing or performing instructions, and one or more memory devices for storing instructions and data. Typically, a computer also comprises one or more mass storage devices, e.g., magnetic, magneto-optical, or optical disks, for storing data, or is operatively coupled to receive data from or transfer data to, or both. However, a computer need not have such devices. Additionally, a computer may be incorporated into another device, e.g., a mobile phone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a global positioning system (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few.

[0107] Computer-readable media suitable for storing computer program instructions and data include, by way of example, all forms of non-volatile memory, media, and memory devices, including semiconductor memory devices such as EPROM, EEPROM, and flash memory devices, magnetic disks, e.g., internal hard disks or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks. The processor and the memory may be supplemented by, or incorporated in, special purpose logic circuitry.

[0108] To provide for user interaction, embodiments of the subject matter described herein can be implemented on a computer having a display device, such as a cathode ray tube (CRT) or liquid crystal display (LCD) monitor, for displaying information to the user, and a keyboard and pointing device, such as a mouse or trackball, by which the user can provide input to the computer. Other types of devices can also be used to provide for user interaction. For example, feedback provided to the user can be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback. Input from the user can be received in any form, including acoustic, speech, or tactile input. Additionally, the computer can interact with the user by sending documents to and receiving documents from a device used by the user, for example, by sending a web page to a web browser on the user's user device in response to a request received from the web browser.

[0109] An embodiment of the subject matter described herein may be implemented in a computing system that includes back-end components, e.g., as a data server, or includes middleware components, e.g., an application server, or includes front-end components, e.g., a client computer having a graphical user interface or web browser through which a user can interact with an implementation of the subject matter described herein, or any combination of one or more such back-end, middleware, or front-end components. The components of the system may be interconnected by any form or medium of digital data communication, e.g., a communications network. Examples of communications networks include local area networks (LANs) and wide area networks (WANs), e.g., the Internet.

[0110] A computing system can include clients and servers. Clients and servers are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0111] According to one example, a waveguide for delivering light into a tissue of a subject may include a light entrance portion, an extraction portion including a plurality of extraction mechanisms adapted to redirect light received from the light entrance portion, and a NIR light emission portion adapted to receive light from the extraction portion and emit light onto a tissue surface of the subject.

[0112] The light entrance may comprise an aspheric lens. The light entrance may also comprise a light channel such that light entering the aspheric lens is dispersed and passes along the light channel to the extraction portion.

[0113] The plurality of extraction mechanisms may be at least three extraction mechanisms.

[0114] At least one exterior surface of the waveguide may have a reflective coating or housing adjacent thereto. There may be a gap between the reflective coating or housing and the plurality of extraction features.

[0115] The extraction mechanism is adapted to redirect (reflect) light received from the light input in a direction substantially perpendicular to the subject's skin surface.

[0116] Each of the plurality of extraction features may comprise a surface oriented at an angle relative to the normal to the skin surface, the angle may be in the range of 35 degrees to 75 degrees.

[0117] The NIR light emitting portion may have, for example, a plate-like or arc-like shape with a concave lower surface. The concave lower surface may be adapted to fit the skin surface of the subject. The contour of the concave lower surface may have a radius of curvature ranging from 3 cm to 10 cm.

[0118] The LDU or waveguide may include an integrated cooling system adapted to cool a skin surface of a subject. The integrated cooling system may be disposed within the emission portion. Additionally, the integrated cooling system may include a fluid channel molded into the emission portion and adapted to carry a coolant fluid (e.g., water). The fluid channel may have a serpentine shape. The serpentine shape may be defined by a plurality of substantially parallel conduits each connected by bends, the diameter of the inner surface of the substantially parallel conduits being greater than the diameter of the inner surface of the bends.

[0119] The fluid channel may occupy at least 20% of the surface area of ​​the ejection portion.

[0120] At least a portion of the waveguide may be defined by a biocompatible material (eg, silicone or optically clear silicone). The silicone material may have an elastic modulus in the range of 1 MPa to 50 MPa.

[0121] According to another example, a light treatment device for delivering light to a skin surface of a subject may include at least one support member adapted to hold at least one waveguide and position the at least one waveguide in proximity to the skin surface of the subject.

[0122] The support member can hold the array of waveguides and can be, for example, at least one of a strap, a cap, a helmet, or a combination thereof. Further, the support member can be adapted to position the at least one waveguide to avoid interaction between the emitted light and a predetermined area of ​​the subject (e.g., a venous sinus).

[0123] The treatment device may also include a temperature measurement system for determining a temperature of the subject's skin surface. The temperature measurement system may include, for example, a first probe for measuring the temperature of the coolant fluid entering the waveguide via the inlet of the fluid channel, a second probe for measuring the temperature of the coolant fluid exiting the waveguide at the outlet of the fluid channel, and a reference probe for measuring the skin temperature at an untreated location on the subject.

[0124] The light source of the treatment device can include at least one of a diode, a laser, or a laser diode. The light source can generate light having a wavelength of about 750 nm or about 940 nm, or a wavelength of 750 nm ± 30 nm and / or about 940 nm ± 30 nm.

[0125] Although this specification contains many specific implementation details, these should not be construed as limitations on the scope of the claims, but rather as descriptions of features that may be specific to certain embodiments. Certain features described in this specification in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and initially claimed as such, one or more features from the combination of the claims may, in some cases, be deleted from the combination, and the combination of the claims may be directed to a subcombination or a variation of the subcombination.

[0126] Similarly, although operations are shown in the figures in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown, or in sequential order, or that all of the operations shown be performed, to achieve desirable results. In certain situations, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the program components and systems described may generally be integrated together in a single software product or packaged in multiple software products.

[0127] Specific embodiments of the subject matter are described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. By way of example, the processes depicted in the accompanying drawings do not necessarily require the particular order depicted, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Other steps or stages may be provided, or steps or stages may be eliminated, from the processes described. Accordingly, other implementations are within the scope of the following claims.

[0128] term

[0129] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0130] The terms "approximately," "approximately equal," and other similar phrases as used herein and in the claims (e.g., "X has a value of about Y" or "X is equal to about Y") should be understood to mean that one value (X) is within a given range of another value (Y). The given range may be plus or minus 20%, 10%, 5%, 3%, 1%, 0.1%, or less than 0.1%, unless otherwise specified.

[0131] The indefinite articles "a" and "an" as used herein and in the claims should be understood to mean "at least one" unless expressly indicated otherwise. The term "and / or" as used herein and in the claims should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are sometimes present jointly and other times present separately. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and / or" clause, whether or not related to the specifically identified element. Thus, as a non-limiting example, a reference to "A and / or B", when used in conjunction with open-ended language such as "comprising", may refer in one embodiment to only A (optionally comprising elements other than B), in another embodiment to only B (optionally comprising elements other than A), and in yet another embodiment to both A and B (optionally comprising other elements).

[0132] When used in the specification and claims, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as inclusive, i.e., including at least one of, but also including more than one, and optionally including additional unlisted items, of a number or list of elements. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" when used in the claims, when preceded by a term of exclusivity, such as "either," "one of," "only one of," "exactly one of," "consisting essentially of," etc., shall be interpreted only as indicating exclusive alternatives (i.e., "one or the other, but not both") and shall have its ordinary meaning as used in the field of patent law.

[0133] As used herein and in the claims, the phrase "at least one" in connection with a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether or not related to the specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can refer in one embodiment to at least one, optionally including two or more As, with no B present (and optionally including elements other than B); in another embodiment, optionally to at least one, optionally including two or more Bs, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including two or more As, and optionally to at least one, optionally including two or more Bs (and optionally including other elements); and so forth.

[0134] The use of "including," "comprising," "having," "containing," "involving," and variations thereof are meant to encompass the items listed thereafter as well as additional items.

[0135] The use of ordinal terms such as "first," "second," "third," etc. in the claims to modify claim elements does not, by itself, imply a priority, precedence, or ordering of one claim element relative to another claim element, or the temporal order in which method operations are performed. The ordinal terms are used merely as labels (but for the purposes of the use of ordinal terms) to distinguish one claim element having a particular name from another element having the same name, and to distinguish between the claim elements.

[0136] Having thus described several aspects of at least one embodiment of this invention, it should be understood that various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

Claims

1. At least one NIR light source for providing treatment NIR light, i) an optical waveguide having a NIR light incident surface on which the treatment NIR light from the at least one NIR light source is incident, and ii) an optical waveguide having a NIR light emission surface from which the treatment NIR light is emitted from the optical waveguide, The optical waveguide is, a lens mechanism that forms the NIR light input surface and is close to the at least one NIR light source, the lens mechanism being configured to at least substantially collimate the treatment NIR light from the at least one NIR light source and carry light substantially collimated in a first direction through the optical waveguide, a plurality of extraction surfaces on the surface of the optical waveguide and configured to reflect the substantially collimated light to a subject through the light emission surface, at least some of the extraction surfaces of the plurality of extraction surfaces being inclined in a range of 35 degrees to 75 degrees with respect to a direction substantially perpendicular to the subject, and the plurality of extraction surfaces being configured to generate a substantially uniform NIR light output across the light emission surface, the plurality of extraction surfaces, a near-infrared (NIR) light treatment device.

2. The optical waveguide further comprises at least one cooling channel configured to circulate a coolant that absorbs heat in the vicinity of the NIR light emission surface, and the optical waveguide is configured to transmit at least some of the reflected NIR light through the at least one cooling channel, the NIR light treatment device according to claim 1.

3. The optical waveguide includes silicone such that the lens mechanism, the plurality of extraction surfaces, the NIR light emission surface, and the at least one cooling channel are made of silicone, and the silicone is a low durometer silicone having a durometer in the range of 20 Shore A to 80 Shore A such that the NIR light emission surface can at least partially conform to the subject, the NIR light treatment device according to claim 2.

4. Furthermore, an inlet in the optical waveguide for receiving the coolant before the coolant enters the at least one cooling channel, a first temperature sensor configured to measure a first temperature of the coolant before the coolant enters the at least one cooling channel, an outlet in the optical waveguide for carrying the coolant from the optical waveguide after the coolant has moved through the at least one cooling channel, A second temperature sensor configured to measure a second temperature of the coolant after the coolant has passed through the at least one cooling channel; A control module for determining a difference between the first temperature and the second temperature, the NIR light therapy device according to claim 2.

5. The at least one coolant channel has a varying diameter to slow the flow of the coolant and increase the heat exchange efficiency between the coolant and the region adjacent to the portion of the at least one cooling channel through which the slowed coolant flows, the NIR light therapy device according to claim 2.

6. The at least one NIR light source generates light having wavelengths of 750 nm and 940 nm, and the light emitting surface is curved to conform to the surface of the subject, the NIR light therapy device according to claim 1.

7. At least some of the extraction surfaces of the plurality of extraction surfaces are inclined at 55 degrees with respect to a direction substantially perpendicular to the subject, the NIR light therapy device according to claim 1.

8. Furthermore, At least one additional waveguide; A support member configured to be applied to the head of the subject, the support member further holding at least the waveguide and the at least one additional waveguide, The NIR light therapy device according to claim 1, configured to ensure that the treatment NIR light from each waveguide avoids the cavernous sinus region of the subject.

9. The NIR light therapy device according to claim 1, further comprising a housing for accommodating at least a portion of the waveguide, the housing comprising a reflective material for reflecting the treatment NIR light exiting the waveguide in a region other than the light emitting surface back to the waveguide.

10. A method of manufacturing a near-infrared (NIR) light therapy device for treating a subject, comprising: Forming a waveguide, Forming the waveguide comprises: Forming a lens in the waveguide, the lens being configured to receive NIR treatment light from an NIR light source and carry the NIR treatment light in a first direction; Forming an elongated portion of the waveguide through which the carried NIR treatment light propagates substantially in the first direction; Forming an extraction part on the surface of the waveguide, the extraction part being configured to reflect the NIR treatment light traveling in the first direction to generate reflected NIR treatment light propagating in a direction substantially perpendicular to the subject. Forming a NIR light emitting surface on the waveguide, the waveguide being configured to pass the reflected NIR treatment light from the waveguide through the NIR light emitting surface to the subject, and the extraction part being configured to generate a substantially uniform NIR light output across the NIR light emitting surface. A method comprising the steps of: **Claim 11** The forming of the waveguide further comprises forming at least one cooling channel configured to be proximate to the NIR light emitting surface, pass the reflected NIR light, and circulate a coolant that absorbs heat proximate to the NIR light emitting surface. The apparatus according to claim 10. **Claim 12** The waveguide is composed of optically transparent low durometer silicone, the lens is further configured to collimate the NIR treatment light in the first direction, and the optically transparent low durometer silicone has a durometer in the range of 20 Shore A to 80 Shore A such that the NIR light emitting surface can at least partially conform to the subject. The method according to claim 11. **Claim 13** Creating a first temperature sensor attachable to the NIR light therapy device, the first temperature sensor being configured to measure a first temperature of the coolant before the coolant enters the at least one cooling channel. Creating a second temperature sensor attachable to the NIR light therapy device, the second temperature sensor being configured to measure a second temperature of the coolant after the coolant passes through the at least one cooling channel. Creating a control module attachable to the NIR light therapy device, the control module being configured to determine a difference between the first temperature and the second temperature. The method according to claim 11. **Claim 14** Forming at least one additional waveguide. The method according to claim 13, further comprising positioning the waveguide and the at least one additional waveguide on the wearable support member such that, when the wearable support member is applied to the head of the subject, NIR treatment light reflected from each waveguide avoids the subject's cavernous sinus region.

15. The method according to claim 10, further comprising attaching a reflection housing to at least a portion of the waveguide, the reflection housing being configured to reflect light exiting the waveguide from a region other than the NIR light emitting surface back into the waveguide.

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