The present disclosure relates generally to light emitting apparatus and more particularly to a light emitting apparatus for treating ischemic conditions.
Acute ischemic stroke is a common cause of morbidity and mortality worldwide. Acute ischemic stroke is often treated with ischemia-reperfusion (e.g., using revascularization therapy), but this often causes additional trauma due to damage caused by the formation of cytotoxic oxygen-derived free radicals (also called reactive oxygen species (ROS)).
In the damaged ischemic area, the free radicals cause additional cell death (e.g., through protein dysfunction, DNA damage, and lipid peroxidation). Further, free radical damage may also cause hemorrhagic transformation and cerebral edema.
The majority of reactive oxygen species (ROS) (also referred to as free radicals) are generated in the mitochondria under conditions of cellular stress. For example, studies have shown that ROS are produced at high mitochondrial membrane potentials. In particular, conditions of cellular stress lead to an increase in the activity of cytochrome C oxidase (CcO) through changes in posttranslational modifications of CcO, which causes pathologically high mitochondrial membrane potentials. This in turn leads to excessive ROS production and cell death.
It is possible to reduce CcO activity using light (e.g., infrared light). Consequently, it is possible to reduce mitochondrial membrane potentials (and the associated generation of free radicals) by reducing CcO activity using phototherapy.
The present disclosure provides a method for treating ischemic stroke by illuminating a skin surface (e.g., the scalp) to reduce free radical generation in subsurface target tissues (e.g., the brain following an ischemic event). The method utilizes a waveguide that receives light from a light source. The waveguide is placed adjacent a skin surface of a patient and the waveguide emits light that passes through the skin surface and illuminates a subsurface target tissue. Because light incident on the skin surface having an angle outside of +/−25° from the perpendicular may have difficulty passing through the upper skin layer of the patient to reach the underlying subsurface target tissues, the waveguide includes light-extracting features configured to emit light at a target angle (e.g., approximately perpendicular) to the surface tissue. That is, the light-extracting features alter a trajectory of light emitted by the waveguide, such that a larger percentage of light emitted by the light guide has an angle that is +/−25 degrees off of a center line of the light guide.
In one embodiment, the present disclosure provides a deep tissue (e.g., brain, cardiac, etc.), non-invasive phototherapy treatment to aid in recovery from ischemic events (e.g., stroke, cardiac arrest) using a photobiomodulation mechanism to throttle the tissue's natural recovery mechanism of flooding the area with ROS or free radicals (this natural recovery mechanism is underdamped and is toxic to the tissues brain due to unnecessarily high oxygen levels).
While a number of features are described herein with respect to embodiments of the invention; features described with respect to a given embodiment also may be employed in connection with other embodiments. The following description and the annexed drawings set forth certain illustrative embodiments of the invention. These embodiments are indicative, however, of but a few of the various ways in which the principles of the invention may be employed. Other objects, advantages, and novel features according to aspects of the invention will become apparent from the following detailed description when considered in conjunction with the drawings.
The annexed drawings, which are not necessarily to scale, show various aspects of the invention in which similar reference numerals are used to indicate the same or similar parts in the various views.
The present invention is now described in detail with reference to the drawings. In the drawings, each element with a reference number is similar to other elements with the same reference number independent of any letter designation following the reference number. In the text, a reference number with a specific letter designation following the reference number refers to the specific element with the number and letter designation and a reference number without a specific letter designation refers to all elements with the same reference number independent of any letter designation following the reference number in the drawings.
The present invention provides a phototherapy apparatus including a wave guide for receiving light from a light source and for controlling a trajectory of light emitted by the wave guide, such that an angle of the emitted light relative to a surface falls within a predetermined angular range.
In the embodiments shown in
The light 15 from the light source 12 may be emitted omnidirectionally. As shown in the embodiments depicted in
In one embodiment, pressure is applied to the waveguides 14 to ensure that the light emitting surface 18 is adjacent the skin surface 32. This may improve light reaching the target tissue 19 by reducing index of refraction boundaries (i.e., a waveguide 14 to skin surface 32 boundary instead of both a waveguide 14 to air boundary and an air to skin surface 32 boundary). Additionally, the light emitting surface 18 being adjacent the skin surface 32 helps ensure that the light emitted in the preferred angular range from the light emitting surface 18 interacts with the skin surface 32 in the same preferred angular range. Any gaps between the light emitting surface 18 and the skin surface 32 may alter the angle that the emitted light 15 interacts with the skin surface 32. A softness of the waveguide 14 may depend on properties of the skin surface 32 and/or the target tissue 19. For example, the waveguide 14 softness may be sufficient for the waveguide 14 to conform to a contour of the skin surface 19 (e.g., a radius of curvature R may be 50 mm for a skull).
The waveguides 14 may be any suitable object for receiving light and directing light towards the subsurface target tissue 19. In one example, the waveguides 14 are made from silicone, urethane, polyethylene, or any material having a hardness of 50 shore A or softer. The waveguides 14 may be flexibly molded, rigid, machined to match the contour of the surface tissue, 3D printed, refractive, diffractive, a lens, a light guide, a fiber (e.g., circular or flat), woven fiber, Uniglo, etc. A portion of the waveguide 14 including the light emitting surface 18 may have a hardness of 50 shore A or less to mitigate tissue damage that may be caused by more rigid structures.
In another embodiment, the waveguide 14 is at least semi-rigid (having a hardness of greater than 50 shore A) and the light emitting surface 18 may have a curvature that conforms to a curvature of the surface tissue 19. In still another embodiment, the waveguide 14 includes a rigid portion (having a hardness of greater than 50 shore A) and a flexible portion (having a hardness of less than 50 shore A). The rigid portion has a curvature that conforms to a curvature of the surface tissue 19. The flexible portion is located adjacent the rigid portion, and is configured to be positioned between the rigid portion and the surface tissue 19.
In the embodiment shown in
As shown in
In the embodiment shown in
The housing 30 may be any suitable structure for pressing the waveguides 14 against the surface tissue 32. For example, the housing 30 may be an elastic band and/or may be adjustable to increase or decrease the pressure applied to the waveguides 14. In the embodiment shown in
The phototherapy system 10 shown in
The housing 30 may include radially emitting glass fiber integrated into the structure of the housing (e.g., possibly woven) to deliver light to the subsurface target tissue (also referred to as the target region). That is, the waveguide 14 may be woven into the housing 30.
In the embodiment shown in
The waveguide 14 may comprise a separate component from the light guide 12 and/or a coating or an overmolding of the light guide 12. For example, the light guide 12 may include multiple branches as shown in
The waveguide 14 may alter the trajectory of the light 15 emitted by the light guide 12 through total internal reflection. That is, the emitted light may reflect at a surface of the light directing structure 14 due to a difference in index of refraction. Alternatively or additionally, the light directing structure 14 may also include a reflective layer 50 configured to reflect the emitted light.
In the embodiments shown in
The light source 12 may be any source of light. For example, the light source 12 may be an external light box mechanically separated from the waveguides 14 and optically coupled to the waveguides via the light guide 34. In one example, the light source 12 is not physically supported by the waveguides 34, but is instead supported by an external structure such as a table. In one embodiment, the light source 12 is an external light box including a laser light emitter (e.g., externally located with an optical cable to optically couple the light source and the waveguide).
The light 15 emitted by the light source 12 may have any suitable properties. The light source 12 may include any wavelength of electromagnetic radiation (also referred to as light). For example, the light source 12 may emit light including at least one of 9040 nm or 750 nm. In one embodiment, the light source 12 is a 30 W 940 nm multi-mode fiber coupled laser system and a 20 W 750 nm multi-mode fiber coupled laser module. the light source may emit different wavelengths of light sequentially or simultaneously.
In one embodiment, the light source 12 includes a 940 nm source having a 105 μm core glass fiber and a 750 nm system having a 400 μm core glass fiber. Each light emitter is coupled to a 1-to-7 fused fiber bundle (i.e., the light guide 34) via a lens adaptor 44. All connections may be made with an industry standard connector SMA-905.
In one embodiment, the light source 12 includes multiple light emitters 46 physically attached to the waveguides 14. For example, as shown in
The light emitters 46 may be any suitable structure for emitting light. For example, the light emitters 46 may include one or more light emitting diodes (LEDs), organic LEDs (OLEDs), microLEDs, laser diodes, mini-LED, quantum dot (QD)-conversion, phosphor conversion, excimer lamps, multi-photon combination, or SLM wavefront manipulation.
In the embodiment depicted in
The volume of tissue illustrated in
The phototherapy apparatus 10 may be used in a method to treat an ischemic event. For example, the light guide 12 may be placed adjacent to a skin surface of the patient at a location close to the ischemic event. As an example, the light guide 12 may be placed such that the emitted light illuminates the scalp of a patient that has experienced a cerebral stroke. In this way, light emitted by the phototherapy apparatus 10 may reduce the production of free radicals near and in the brain, reducing the number of free radicals in the ischemic area(s) of the brain.
Turning to
In one embodiment, the phototherapy system 10 includes a sensor or user input for determining a size of a target volume. A controller 66 included in the phototherapy system 10 may modulate the optical power output by the light source 12 based on the target area size to target a specific power density. For example, the sensor may be used to measure the size of the target volume may be an electronic strain sensor, FBG optical strain sensor, machine vision system, or air pressure monitor (i.e., for performing a volumetric measurement).
The controller 66 may have various implementations. For example, the controller 66 may include any suitable device, such as a processor (e.g., CPU), programmable circuit, integrated circuit, memory and I/O circuits, an application specific integrated circuit, microcontroller, complex programmable logic device, other programmable circuits, or the like. The controller 66 may also include a non-transitory computer readable medium, such as random-access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), or any other suitable medium. Instructions for performing the method described below may be stored in the non-transitory computer readable medium and executed by the controller 66. The controller 66 may be communicatively coupled to the computer readable medium and network interface through a system bus, mother board, or using any other suitable structure known in the art.
The phototherapy system 10 may also include a sensor for sensing optical power. The sensor may be located at the skin surface 32 (e.g., the head) and/or within the light source 12. The sensor may be used as part of a closed loop system to regulate the power supplied to the light source 12, such that the optical power being delivered to the target tissue 19 falls within a predetermined range. For example, the sensor may be a photodiode, SiPM, camera, or spectrometer. The controller 66 may control the light source 12 based on the sensed optical power, such that the target tissue 19 receives a predetermined optical dose. For example, the predetermined optical dose may be an amount of light known to cause a physiological effect.
The phototherapy system 10 may also include a sensor (e.g., a thermometer) for measuring skin temperature at the tissue surface 32. The controller 66 may receive the measured skin temperature and modulate optical power output by the phototherapy system 10, such that the skin temperature stays below a threshold (i.e., to avoid overheating). The sensor may be any suitable sensor for measuring temperature, such as a thermometer, infrared camera/photodiode, spectrometer, etc. The sensor may be embedded in LDU, mounted on the target tissue, or used to measure air temperature.
The controller 66 may also be configured to pulse width modulate the light source 12. The controller 66 may also control a duty cycle of the light source 12 to improve penetration of the light 15 into the tissue and/or to modulate a temperature of the skin. The controller 66 may similarly modulate the frequency of emitted light 15 to improve tissue penetration.
An interface material may be applied to the surface tissue 32 as an interface to the body. The interface material may be thermal conductive and mediate skin temperature. The interface material may be index matching to enhance optical coupling. The interface material may be used to mechanically cushion the tissue and/or to adhere to the surface tissue.
The phototherapy system 10 may also include a mask for controlling illumination of the tissues. For example, the mask may be an elastic mesh having cutouts that fit to the target tissue 19. The mask may be thermally conductive, light reflective, light absorbing, a diffuse scatterer, and/or light tight.
The phototherapy system 10 may also include features designed to effect different human factors. For example, anything auxiliary to the actual performance of device meant to improve the human experience using it. As examples, mood affecting ambient lighting, sounds, graphics, etc.
All ranges and ratio limits disclosed in the specification and claims may be combined in any manner. Unless specifically stated otherwise, references to “a,” “an,” and/or “the” may include one or more than one, and that reference to an item in the singular may also include the item in the plural.
Although the invention has been shown and described with respect to a certain embodiment or embodiments, equivalent alterations and modifications will occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In particular regard to the various functions performed by the above described elements (components, assemblies, devices, compositions, etc.), the terms (including a reference to a “means”) used to describe such elements are intended to correspond, unless otherwise indicated, to any element which performs the specified function of the described element (i.e., that is functionally equivalent), even though not structurally equivalent to the disclosed structure which performs the function in the herein illustrated exemplary embodiment or embodiments of the invention. In addition, while a particular feature of the invention may have been described above with respect to only one or more of several illustrated embodiments, such feature may be combined with one or more other features of the other embodiments, as may be desired and advantageous for any given or particular application.
This application claims the benefit of 62/940,940 filed on Nov. 27, 2019. Which is herein incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US20/62319 | 11/25/2020 | WO |
Number | Date | Country | |
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62940940 | Nov 2019 | US |