Adjustable irradiation device and method for photomechanical therapy and diagnosis

By using panels with varying widths and nested hinges to minimize optical dead spaces, the adjustable irradiation device achieves enhanced light uniformity and effectiveness for photodynamic therapy.

JP7696967B2Active Publication Date: 2025-06-23SUN PHARMACEUTICAL IND INC
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Patent Information

Application Number
JP2023146114
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2017-04-14
Filing Date
2023-09-08
Publication Date
2025-06-23
Estimated Expiration
2038-04-11

AI Technical Summary

Technical Problem

Conventional adjustable irradiation devices for photodynamic therapy (PDT) suffer from optical 'dead spaces' due to the arrangement of panels and hinges, leading to reduced light uniformity and effectiveness in treatments requiring high intensity and specific wavelength light.

Method used

The device incorporates a plurality of panels with varying widths, where narrower panels act as 'lighting hinges' to fill in gaps and reduce optical dead spaces. The panels are connected by nested hinges to minimize non-light emitting areas, and the light sources are individually configurable to ensure uniform power distribution.

Benefits of technology

This configuration significantly enhances light uniformity across the treatment site, reducing the optical dead space and ensuring a more effective PDT by delivering consistent intensity and wavelength of light, thereby improving treatment outcomes.

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Abstract

To deliver uniform light to a targeted treatment area regardless of the shape and location of a patient's body.SOLUTION: An illuminator for photodynamically diagnosing or treating a surface includes a plurality of panels 10a-10e. The illuminator further includes a plurality of light sources, each mounted on one of the panels. The light sources are configured to irradiate the surface with substantially uniform intensity visible light. The illuminator also includes a heat source 160 configured to emit heat to a patient. The heat increases the generation of a photoactivatable agent and thus shortens the time needed to complete photodynamic therapy.SELECTED DRAWING: Figure 9A
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Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Patent Application No. 15 / 487,991, filed on Apr. 14, 2017, the entire contents of which are incorporated herein by reference.

[0002] This disclosure generally relates to adjustable irradiation devices and a plurality of methods including the operation of adjustable irradiation devices that provide a uniform distribution of visible light in various structures and are suitable for use in photodynamic therapy and diagnosis.

Background Art

[0003] Photodynamic therapy (PDT), photodynamic diagnosis (PD), or photochemotherapy is generally used to treat and / or diagnose various diseases in or near other tissues such as the skin or body cavities. For example, PDT or PD can be used to treat or diagnose actinic keratosis in the scalp or facial region of a patient. Also, PDT or PD may be used for the treatment and diagnosis of other indications (e.g., acne, warts, psoriasis, photo - damaged skin, cancer), and other parts of the patient's body (e.g., arms and legs).

[0004] In one form of PDT or PD, first, a photosensitizer or a precursor of a photosensitizer that accumulates in the tissue to be treated or diagnosed is administered to a patient. The photosensitizer or precursor may be administered, for example, to treat skin diseases. Next, the site where the photosensitizer has been administered is exposed to visible light, thereby causing chemical and / or biological changes in the photosensitizer. These changes can selectively localize, destroy, or denature the drug in the target tissue while keeping the damage to other tissues within the treatment site mild and reversible. An example of a precursor of a photosensitizer is 5 - aminolevulinic acid (“ALA”), which is commonly used in PDT for actinic keratosis. As used herein, the term ALA or 5 - aminolevulinic acid refers to ALA itself, its precursors, and their pharmaceutically acceptable salts.

[0005] For effective treatment, it is desirable to have an output with uniform intensity and color. Regarding the technologies, methods, compositions, and devices related to PDT and PD, which are all incorporated by reference in their entirety, the irradiation devices (luminaires, illuminators) disclosed in U.S. Patent Nos. 8,758,418, 8,216,289, 8,030,836, 7,723,910, 7,190,109, 6,709,446, and 6,223,071 are typically used to provide the appropriate uniformity of light for treatment purposes. Generally, these devices include a light source (e.g., a fluorescent tube), a coupling element that directs, filters, or guides the light to reach the intended target in a usable shape, and a control system that starts and stops the generation of light as needed.

Summary of the Invention

Problems to be Solved by the Invention

[0006] Since PDT can be used for the treatment of various treatment sites, some irradiation devices use two or more panels each having a light source that emits light to the intended target site. These panels are rotatably connected to each other. By having a plurality of rotatable panels, the dimensions and shape of the entire area irradiated with light can be changed according to the intended treatment site.

[0007] In conventional adjustable irradiation devices, multiple panels have the same width and length and are usually driven at the same power level. Also, the multiple panels are connected by hinges at their ends and are configured to be rotatable to a desired shape. However, due to the ends of the multiple panels and the multiple hinges, the light source(s) of one panel cannot be located directly adjacent to the light source(s) of an adjacent panel. As a result, no light is emitted from the "gaps" between the multiple light sources. When supplying uniform power to the multiple panels, since no light is emitted from such regions, there is a possibility of an optical "dead space" occurring in specific parts of the treatment target site. Therefore, the total amount of light received by these parts is reduced, and as a result, the treatment dose is lowered. In some cases, the treatment dose can drop to one-fifth compared to the site that receives the optimal amount of light.

[0008] Generally, these conventional irradiation devices are used for acne phototherapy, in which case the administration of a photosensitizer is usually not necessary for effective treatment. Therefore, irradiation with light alone generally suffices for treatment. Also, since multiple treatment sessions can be utilized to effectively treat a disease, there may be little concern about the uniformity of the light irradiated over the entire target site during treatment. However, in certain treatments involving PDT, such as using ALA to treat actinic keratosis, light of a specific and high uniformity in intensity and color is required to obtain an effect. In these examples, the success of PDT depends on the targeted delivery of both an appropriate amount of photosensitizer and an appropriate amount (i.e., output and wavelength) of light to produce the desired photochemical reaction in the target cells. Thus, to achieve this, the light source must irradiate the target site, and both the wavelength and output of this light irradiation must be uniform. In conventional adjustable irradiation devices, the optical dead space that can occur at or near the hinge reduces the uniformity of the light along the treatment site, thus reducing the effectiveness of PDT in a particular treatment. Furthermore, these irradiation devices are also configured to be adjustable within a limited range so as to treat only limited portions of the patient's body surface, such as the patient's face or scalp. Also, since the outer shape of the patient's body is diverse, the uniformity of the light delivered by these conventional irradiation devices can vary greatly depending on the patient's treatment site.

[0009] Accordingly, some embodiments of the present invention aim to reduce or eliminate these dead spaces and achieve a more uniform light distribution in an adjustable irradiation device designed for PDT and / or PD of various target sites. Further, some embodiments of the present disclosure aim to provide an infinitely adjustable irradiation device that can effectively deliver uniform light to various parts of the patient's body, such as the patient's limbs (e.g., arms and legs) and torso, in addition to the patient's face and scalp. Thus, uniform light can be delivered to the treatment target site regardless of the outer shape and position of the patient's body.

Means for Solving the Problems

[0010] One embodiment of the present disclosure includes a plurality of panels, and the width of at least one panel is different from that of other panels. This panel is disposed between two other panels and functions as a "lighting hinge" that emits sufficient "fill-in light" to reduce or eliminate optical dead space when the panel is bent into a specific shape. Preferably, a total of five panels may be provided to optimally increase the total area of the treatable range. Two of the panels preferably have a smaller width than the other three larger panels. The panels are alternately arranged such that each of the panels with a smaller width is located between two of the three larger panels, thereby being adjustable and enhancing uniformity. Further, in order to further reduce or eliminate the optical dead space, it is preferable to connect the panels by a nested hinge to reduce the area where there is no light source in the irradiation device. In order to further reduce or eliminate the optical dead space, the plurality of light sources of each panel are preferably individually configurable to supply specific power to a specific range of the plurality of light sources of the plurality of panels to compensate for the reduced uniformity. For example, the power output to each diode of a light-emitting diode (LED) array may be adjusted individually.

[0011] One embodiment of the present disclosure relates to an irradiation device for photodynamic diagnosis or treatment of a surface, comprising a plurality of panels, a plurality of light sources each attached to one of the plurality of panels and configured to irradiate a surface with visible light of substantially uniform intensity, and a heat source configured to radiate heat toward a patient between the outer panels of the plurality of panels.

[0012] Another embodiment of the present disclosure relates to a method for performing photodynamic diagnosis or treatment on a patient, including controlling a heat source to apply heat to a patient's skin during a first time period, and irradiating the patient with light during a second time period after the first time period by an irradiation device for treating skin diseases, the irradiation device having a plurality of panels and at least one light source provided on at least one of the plurality of panels.

[0013] A further embodiment of the present disclosure includes irradiating a patient with light by an irradiation device having a plurality of light sources, and heating the patient's skin by radiating heat from a heat source during the light irradiation, and starting the irradiation of light from the plurality of light sources substantially simultaneously with the radiation of heat from the heat source to the patient, and relates to a method for performing photodynamic diagnosis or treatment on a patient.

[0014] A further embodiment of the present disclosure relates to a system including an irradiation device for photodynamically diagnosing or treating a surface, the irradiation device including a plurality of panels, a plurality of light sources each attached to one of the plurality of panels and configured to irradiate visible light onto the surface, and at least one sensor configured to detect the orientation of at least one of the plurality of panels. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The features, aspects, and advantages of the present disclosure will become apparent from the following description and the exemplary embodiments shown in the accompanying drawings, which are easily described below.

[0016]

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DETAILED DESCRIPTION OF THE INVENTION

[0017] Various embodiments are described below. Note that the specific embodiments are not intended as an exhaustive description or as a limitation to the broader aspects discussed herein. One aspect described in connection with a particular embodiment is not necessarily limited to that embodiment and can be practiced with one or more other embodiments.

[0018] As will be understood by those skilled in the art, all ranges disclosed herein, for all purposes, especially with respect to providing a written description, also include any and all possible subranges and combinations thereof. Each of the recited ranges can be readily recognized as being capable of fully describing the same range divided into at least halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be easily subdivided into lower thirds, middle thirds, and upper thirds, etc. Also, as will be understood by those skilled in the art, all terms such as "up to", "at least", "greater than", "less than", etc. include the recited numbers and refer to ranges that can be subsequently divided into subranges as described above. Finally, as will be understood by those skilled in the art, ranges include each individual element.

[0019] Unless otherwise specified, all numbers representing quantities of properties, parameters, conditions, etc. used in the specification and claims should be understood to be modified in all cases by the term "about". Accordingly, unless indicated otherwise, the numerical parameters set forth in the following specification and the appended claims are approximations. Any numerical parameter should at least be construed in light of the reported significant digits and by applying ordinary rounding techniques. The term "about", when used prior to a numerical designation, including ranges of temperature, time, quantity, and concentration, indicates an approximation that can vary by (+) or (-) 10%, 5%, or 1%.

[0020] Figures 1A and 1B, Figures 2A and 2B show embodiments of a configurable irradiation device (lighting fixture, illuminator) according to the present disclosure. The main body 100 of the irradiation device preferably has five individual panels 10a to 10e, and each panel is rotatably connected via a nested hinge 50. Each panel includes a light emitting diode (LED) array 60, and the array may be configured in an equally spaced pattern across the surface of the panel. The number of individual LEDs arranged in any array is not particularly limited. Alternatively, other types of light sources such as fluorescent lamps and halogen lamps may be used.

[0021] Preferably, each LED array 60 extends to as many ends as possible. Further, the LED array 60 preferably has dimensions that provide an overall irradiation area for any treatment site based on the range from the 5th percentile of the size corresponding to a female subject to the 95th percentile of the size corresponding to a male subject. The plurality of LED arrays 60 emit light having a wavelength appropriate for the intended treatment or a wavelength appropriate for activating a specific photoactivator used for treatment or diagnosis. For example, when ALA is used as a precursor of a photoactivator for the treatment of actinic keratosis, the plurality of LED arrays 60 preferably emit blue light having a wavelength of 400 nanometers (nm) or more, such as about 430 nm, about 420 nm, and, as an example, 417 nm. However, the LED array 60 may emit visible light in the green and / or red regions between 400 and 700 nm, such as about 625 nm to 640 nm, or, as an example, 635 nm, etc. Further, for example, the LED array 60 may emit light having a wavelength of 510 nm, 540 nm, 575 nm, 630 nm, or 635 nm. Also, the plurality of LED arrays 60 may be configured to emit light continuously, or the plurality of LED arrays 60 may be configured such that the diodes emit light in an on / off manner at predetermined intervals. Furthermore, the LED array 60 may be configured such that only light of one wavelength (e.g., blue) is emitted. Alternatively, the plurality of LED arrays 60 may be configured such that light of two or more wavelengths is emitted from the array. For example, the plurality of LED arrays 60 may be configured to alternately emit blue light and red light for treatment purposes.

[0022] As shown in FIGS. 1A and 1B, and FIGS. 2A and 2B, the five panels 10a to 10e have different widths from each other. Specifically, in a particular embodiment, three panels 10a, 10c, 10e are wide, and two panels 10b, 10d are narrow and configured to become smaller. The widths of the two narrow panels 10b, 10d are each smaller than the widths of the three wide panels 10a, 10c, 10e. In some embodiments, the widths of the three wide panels 10a, 10c, 10e are approximately equal. In other embodiments, the widths of the three wide panels 10a, 10c, 10e are different from each other. Also, the widths of the two narrow panels 10b, 10d may be approximately equal or different from each other. Further, the panels are in an alternating arrangement where a narrow panel (e.g., 10b) is located between two wide panels (e.g., 10a, 10c). As shown in FIG. 6, in some embodiments, the narrow panels 10b, 10d are configured to have a width that is about 30% to 60% smaller than the widths of the wide panels 10a, 10c, 10e. In other embodiments, the narrow panels 10b, 10d are configured to have a width that is about 30% to 50% smaller than the widths of the wide panels 10a, 10c, 10e.

[0023] As shown in FIGS. 1A and 1B, FIGS. 2A and 2B, panels 10a to 10e are rotatably connected by a hinge 50. The hinge 50 may be in the form of a nested hinge, including a hinge that significantly reduces or eliminates an optical dead space. As shown in FIGS. 2A and 2B, on at least one side of the panel, tabs 23 may extend from both the upper and lower portions of the panel. As shown in FIG. 2A, a plurality of tabs 23 are configured such that one side surface of an adjacent panel is received between the plurality of tabs 23. Thus, as shown in FIGS. 2A, 2B, and 6, the height of an adjacent panel (e.g., panel 10a) is slightly lower than the height of the tabbed panel (e.g., panel 10b) that receives it. As shown in FIG. 6, the central panel (i.e., panel 10c) preferably has the maximum height so that it has tabs on both sides and can receive the side surfaces of the adjacent panels on each side. As shown in FIGS. 1A and 1B, each tab 23 further includes an opening for inserting a bolt for connecting adjacent panels.

[0024] Panels 10a to 10e may be arranged such that the side panels are movable so that the total cover area or range of panels 10a to 10e expands, or may be configured to extend to a site such as a patient's chest or abdomen. In at least one embodiment, at least one of panels 10a to 10e may be arranged such that at least one is in a flat or folded (e.g., bent or angled) arrangement. The panels may be moved such that the shape changes continuously. In at least one embodiment, one or more return mechanisms are provided on one or more panels to hold the one or more panels in a desired position. One or more return mechanisms may be provided on one or more panels to suppress the movement of the panels by the return mechanism in order to realize a plurality of different panel configurations for treatment in which the panels are maintained in a specific position during the treatment of the patient. The panels may be arranged relative to each other such that the irradiation device has one or more specific shapes. In at least one embodiment, the panels may be arranged relative to each other such that the irradiation device has at least one of, for example, a curved, flat, or folded shape.

[0025] As shown in more detail in FIGS. 3A and 3B, a nested hinge 50 is provided between a plurality of tabs 23 and is attached to the inner side surfaces of a plurality of adjacent panels (e.g., 10a, 10b), whereby the plurality of panels are rotatable. The flange 51 of the hinge 50 is attached to the inner side surface of the panel via a plurality of bolts 53. The inner side surface of the panel may include a recess in which the flange 51 is disposed. Further, the inner side surface of the panel may include a further recess that houses the joint portion of the hinge 50 such that the joint portion of the hinge 50 is flush with the outer surface of the panel. With such a configuration, the outer vertical ends of adjacent panels can be arranged closer to each other. By reducing the distance between the vertical ends of adjacent panels, the optical dead space can be further reduced or eliminated. Further, by providing a plurality of tabs 23 together with a plurality of hinges 50, the number of pinch points present in the system can be reduced.

[0026] As shown in FIGS. 1A and 1B, the main body 100 of the irradiation device may include a mounting head 40. By having the mounting head 40, the main body 100 can be attached to the movable stand 80 shown in FIG. 4, so that the user can easily move the main body 100 to an appropriate treatment position. The stand 80 includes a base 81 and a vertical support 82. The base 81 may further include a plurality of wheels 87 at the bottom so that the user can horizontally move the irradiation device to an appropriate position. The plurality of wheels 87 may include a plurality of locks so that the stand 80, once properly positioned, does not move horizontally any further. Also, the vertical support 82 may be attached to the base 81 at a pivot point 83. The pivot point 83 enables the vertical support 82 to rotate, expanding the position adjustment range of the irradiation device. The vertical support 82 includes a connection arm 85 at its upper end that can function as a mounting structure for the main body 100. The connection arm 85 includes a hinge point 86 so that the main body 100 can move vertically with respect to the stand 80. Also, the vertical support 82 may be configured as a telescopic structure so that the user can change the height of the vertical support 82. Thereby, the vertical movement range of the main body 100 is expanded, and the user can place the main body 100 at a treatment site at a low position such as the patient's leg or foot. The stand 80 may include a stabilizing arm 84. After the stand 80 and the main body 100 are arranged, the stabilizing arm 84 can be attached to the main body 100 to prevent unwanted movement of the main body 100 during treatment. Further, as shown in FIG. 4, a control device and a power source 90 are attached to the stand 80 to supply power to the main body 100 and enable the user to control the main body 100 for treatment purposes. Alternatively, the control device and the power source 90 may be directly attached to the main body 100. As a cooling system for the LED array 60, one or more fans 70 may be attached to each panel as shown in FIG. 4.

[0027] Further, at least one control device (also referred to as a control unit) is connected to the panel in order to adjust the supply power so that a plurality of lights achieve the uniformity and intensity required for the intended treatment. Also, in at least one embodiment, the control device may control the output of the heat source 160, which will be described in more detail later. In at least one embodiment, a plurality of control devices may be provided to control at least one dynamic process, for example, to control the outputs of one or more light sources, one or more heat sources, and / or one or more air sources (such as fans) in any combination. For example, a plurality of control devices may be provided separately or integrally to control the outputs of a plurality of LED arrays 60 and the heat source 160, respectively. In at least one embodiment, as an example, the first control device may control both the light source and the heat source, and the second control device may control the air source.

[0028] The control device may be realized as hardware, software, or a combination thereof, such as a combination of a storage device storing a computer program and a processor executing the program. Alternatively, a dedicated control device may be provided for each panel, and the power supplied to one LED array of an arbitrary panel may be adjusted to perform calibration specified by the irradiation device, thereby further enhancing uniformity and efficiency. For example, according to Lambert's cosine law, the light intensity at any point on a "Lambertian" surface (such as the skin) is directly proportional to the cosine of the angle between the incident light and the normal to the surface. Therefore, the light rays directed towards the front of a curved surface (e.g., the patient's head) reach the area almost perpendicularly, so the absorbance is 100%. However, the light rays reaching the side ends of the curved surface reach almost parallel. According to Lambert's cosine law, since the light intensity and absorption are approximately zero at the side ends, there is no effect on the treatment of that part. Thus, the "fall off" of the exposure dose tends to occur at the ends of the curved surface. Also, the longer the distance between the light source and a point on the surface, the greater the "fall off".

[0029] The shape of the irradiation device that conforms to the curved surface (for example, a U-shaped design that "wraps around" the curve of the surface) helps to reduce this effect and enhances the overall uniformity. However, to sufficiently enhance the uniformity, the light source must be larger than the treatment target site so that the body part to be treated is completely surrounded and light hits any target position in the treatment site from all angles. To enhance the exposure uniformity of the treatment site while keeping the irradiation device at a practical size, multiple LED arrays 60 may be individually configured so that the intensity of the light emitted by specific diodes is increased to compensate for the fall-off phenomenon.

[0030] An example of multiple individually configurable LED arrays 60 is shown in FIG. 5. Here, the multiple LED arrays 60 are divided into three regions, which may be "addressable strings" (a string of multiple LEDs connected in a string, where each LED is individually controllable). Regions 1, 3, and 5 correspond to the addressable string configuration, which may be included in the wide panels 10a, 10c, and 10e. On the other hand, regions 2, 4, and 6 correspond to the addressable string configuration, which may be included in the narrow panels 10b and 10d. The current to each region is adjusted to regulate the intensity of the light emitted from each region. For example, a higher current may be supplied to regions 1 and 2 than the current supplied to regions 3 and 4 so that regions 1 and 2 emit light at a higher intensity than regions 3 and 4. Similarly, a higher current may be supplied to regions 3 and 4 than the current supplied to regions 5 and 6. By doing so, the intensity of the light emitted from the ends becomes overall higher, and the fall-off phenomenon can be reduced. Alternatively, the irradiation device may be configured to individually adjust each diode included in any LED array 60 so that a greater calibration effect (i.e., fine-tuning is possible) can be obtained.

[0031] Furthermore, a plurality of pre-programmed settings or a plurality of sensors for detecting the curvature of the surface to be treated may be used to individually configure the plurality of LED arrays 60 so as to emit stronger light only in areas where it is needed. Also, the plurality of pre-programmed sensors may be used to detect the orientation of one or more panels (e.g., whether the panel is curved or folded flat), and may also be used to configure the plurality of LED arrays 60 to emit stronger or weaker light in areas where it is needed. Specifically, in at least one embodiment, at least one sensor detects the orientation of at least one panel and provides detection information (detection results) to the control device. The plurality of sensors may include one or more encoders provided at one or more locations on the panel, for example, one or more angular encoders. In at least one embodiment, at least one sensor is a microswitch configured to detect the position of at least one panel. In some embodiments, the plurality of sensors may include encoders, microswitches, or a combination thereof. The sensors are configured to communicate with the control device and provide information regarding the orientation of the panel, such as the angle at which the panel is disposed, to the control device. Then, the control device controls the intensity of the light according to the detection results. In at least one embodiment, information is provided from the plurality of sensors to the control device so that the control device can determine whether the shape of the irradiation device is one of a plurality of pre-set structures. For example, the control device may store information regarding one or more pre-set structures (e.g., a curved irradiation device, a flat irradiation device, etc.) in the memory.

[0032] When the control device receives information transmitted from a plurality of sensors, the control device may compare the detected information with a preset structure and determine the match between the detected information and one or more preset structures. Further, the control device may store a protocol for changing the intensity, which is executed when it is determined that the detected information matches one or more preset structures. For example, when it is detected that the irradiation device is a curved irradiation device, the control device executes a light intensity output associated with a protocol preset for the curved irradiation device. The control device may further compare the current intensity with the intensity associated with a specific structure and determine whether the intensity should be adjusted. Thereby, the output and / or the light intensity are increased only with specific diodes as necessary, and the uniformity of the exposure is efficiently enhanced. In at least one embodiment, for example, a plurality of structures may be presented to a clinician or a medical practitioner on a touch screen so that a preset structure corresponding to the physical arrangement of the irradiation device in a clinical environment can be selected.

[0033] Also, the plurality of addressable strings of the LED array 60 may include various numbers of individual diodes attached to specific regions. For example, in the case of the wide panels 10a, 10c, and 10e, twelve diodes are attached to each region 1, nine diodes are attached to each region 3, and forty-one diodes are attached to region 5, such that each of the wide panels 10a, 10c, and 10e includes a total of eighty-three individual diodes. In the case of the narrow panels 10b and 10d, eight diodes are attached to each region 2, nine diodes are attached to each region 4, and twenty-three diodes are attached to region 6, such that each of the narrow panels 10b and 10d includes a total of fifty-seven individual diodes. However, the number and arrangement of the diodes included in each LED array 60 are not particularly limited. For example, the wide panels 10a, 10c, and 10e may each include diodes in a total range of from about eighty to about three hundred and fifty. Similarly, the narrow panels 10b and 10d may each include diodes in a total range of from about fifty to about two hundred and fifty. By varying the arrangement of the diodes in each addressable string of the LED array 60, the output and / or intensity of the light emitted from any array may be more appropriately controlled and finely adjusted.

[0034] Also, by individually adjusting the power supplied to the plurality of LED arrays 60, it is also possible to contribute to reducing or eliminating optical dead spaces that may occur at a plurality of hinge points when not adjusted. Specifically, near the end of the array closest to the nested hinge, the output and / or emission intensity may be increased to compensate for the lack of light emitted from the contact point between the panels. Also, the narrow panels 10b, 10d are preferably operated at a higher power level and / or higher emission intensity than the wide panels 10a, 10c, 10e in order to add fill-in light. Further, the individual power adjustment may be used to compensate for manufacturing errors in each diode. Finally, since each array can be individually configured to meet the lighting needs of a specific application, by finely adjusting each array 60, the panels can be easily arranged for use in other applications.

[0035] The irradiation device may further include a timer that can indicate to the user the length of the exposure time appropriate for a specific treatment. Also, the irradiation device may be programmed with pre-stored radiation dose parameters so that the user can select the type of treatment desired. The pre-stored parameters may include, for example, settings regarding pre-stored exposure time, light intensity, and output wavelength. Based on the selected treatment, the irradiation device is automatically configured such that appropriate power is supplied to achieve an accurate radiation dose and the uniformity required for the treatment is obtained. Alternatively, the irradiation device can be provided with sensors that detect the size of the treatment site located in front of the irradiation device. These sensors then determine the accurate radiation dose parameters based on the detected treatment site. Further, the irradiation device may also include an actuator and may be programmed to move automatically according to the selected treatment. After the treatment is selected, the irradiation device may be automatically arranged in an appropriate configuration by the actuator without the user manually moving the system. Also, the sensors may detect the adjustment position of the irradiation device manually set by the user. Subsequently, the detected position of the irradiation device may be used to indicate the intended treatment site. And accurate radiation dose parameters regarding a specific treatment site may be provided based on the detection position set by the user.

[0036] In the irradiation device of the present disclosure, there are infinitely many structures that can be adapted to the treatment target site. These structures vary from a flat emitter (shown in FIGS. 1B and 2B) to a substantially U-shaped structure (shown in FIGS. 1A and 2A). Further, the adjustable irradiation device may be configured to pull the two panels 10a and 10e at both ends backward with respect to the three intermediate panels 10b, 10c, and 10d, and form a smaller U-shaped structure by these intermediate panels. Thus, with the adjustable irradiation device, other parts of the patient's body can be additionally treated. That is, the adjustable irradiation device can not only effectively send light of uniform intensity to the conventionally targeted surfaces such as the face and scalp, but can also be easily configured as a device for treating other parts of the patient's body, particularly parts with small curved surfaces such as the arms and legs. Further, the adjustable irradiation device can also be easily arranged at a position to send light of uniform intensity to a larger treatment site such as the back or chest.

[0037] As described above, the narrow panels 10b and 10d are sized such that these panels function as "lighting hinges". Therefore, when the wide panels 10a, 10c, and 10e are in a desired shape, while in the conventional case "bending" occurred substantially at the hinge itself, in this irradiation device, "bending" occurs at the narrow panels 10b and 10d. Thus, instead of the non-lighting "bending" part in the conventional irradiation device, this irradiation device is provided with a "bending" part configured to also emit light, whereby the optical dead space can be reduced without requiring a large difference in the power supply amount between the light sources of each panel to provide the necessary fill-in light. The effect of this configuration can be best understood by comparing FIGS. 7 and 8. FIG. 7 shows the light uniformity by a conventional irradiation device, which was measured at a distance of 2 inches using a cosine sensitivity detector that mimics the reaction of the patient's skin to the incident light described above. The total light dose represented in units of J / cm 2 is represented by the irradiance (W / cm 2) Based on this, it was measured over time (in seconds). The illustrated treatment target site is the patient's head, with the height on the y-axis and the rotation angle from the center of the radiation plane on the x-axis. As can be understood from FIG. 7, at the center of the face near the patient's nose (for example, region A), the radiation dose is about 10 J / cm 2 and is high. At this location, the patient is closest to the central panel and is substantially perpendicular to it. The total radiation dose decreases as it moves away from the center of the face, and more of the cosine "fall-off" phenomenon and optical dead space can be seen. For example, the radiation dose is reduced by about 20% in the patient's cheek region (for example, region B) and is reduced by up to about 80% towards the outer boundaries of the patient's face such as the ears and forehead (for example, region E). Therefore, as shown in FIG. 7, in a conventional adjustable irradiation device using panels of the same size operating at the same output level, irradiation fields with different light uniformities are generated, which is not desirable and ineffective especially in treatments that require particularly high light uniformity.

[0038] The above-described specific embodiments relate to an irradiation device including a plurality of panels, but other embodiments may include an arch-shaped irradiation device without individual linear panels. For example, in at least one embodiment, the irradiation device may be composed of at least one curved member. Further, the arch-shaped irradiation device may be configured such that a plurality of substantially curved portions extend from a substantially flat portion provided therebetween. The patient's face may be arranged to face the substantially flat portion so that the patient's head is surrounded from at least three sides by the irradiation device. For example, the patient's face may face the first portion of the irradiation device, and the left and right sides of the patient's head may face the second and third portions, respectively.

[0039] On the one hand, FIG. 8 shows the light uniformity resulting from an embodiment of the present disclosure. The treatment target site is the same as the site measured in FIG. 7. However, compared with FIG. 7, the uniformity of the light output generated by this irradiation device is significantly higher across the entire face of the patient, with little or no variation from the light output measured at the center of the patient's face to the light output measured at the edge of the patient's face. For example, as shown in FIG. 8, across all regions of the face, including the center of the face (e.g., the patient's nose), the patient's cheek region, and the boundary regions outside the patient's cheek region such as the ears and forehead, the total light dose is about 10 J / cm 2 (e.g., region A'). Furthermore, the decrease in the total light dose at the outermost boundary of the patient's face is minimal (e.g., region B'). In one embodiment, the measured output in the entire effective emission region (in the entire effective emission region) is 60% or more of the maximum measured value (in the entire effective emission region) measured by a cosine-sensitive detector at any operating distance. More preferably, the measured output of the entire emission region is 70% or more of the maximum measured value at a distance from 2 inches to 4 inches. Even more preferably, the measured output of the entire emission region is 80% or more of the maximum measured value at a distance from 2 inches to 4 inches.

[0040] An example of a treatment method for precancerous lesions such as actinic keratosis by PDT using the above-described adjustable irradiation device in combination with ALA will be described below.

[0041] Basically, anhydrous ALA is mixed with a liquid diluent immediately before use. The ALA mixture is topically applied to the lesion using a point applicator to suppress dispersion of the ALA mixture. The mixture may be applied by the technique disclosed in U.S. Patent Application No. 15 / 371,363, filed December 7, 2016, the entire description of the background, apparatus, and method of which is incorporated herein by reference. After the initially applied ALA mixture has dried, one or more successive applications may be made in the same manner. An ALA solution of about 10-20% is administered. The formation of photosensitive porphyrin and the photosensitization reaction of the treatment lesion occur 30 minutes to 18 hours later. Exposure to direct sunlight or other bright light sources during this period must be minimized. Irradiation of the lesion is performed with the adjustable irradiation device according to the present disclosure between 30 minutes and 18 hours after administration of ALA. The irradiation device irradiates the lesion with uniform blue light over a predetermined period of time. In a preferred treatment, the visible light has a nominal wavelength of 417 nm.

[0042] Thus, such an embodiment provides a method for photodynamic diagnosis or treatment of a patient's undulating surface, the method comprising providing the adjustable irradiation device, positioning the patient relative to the irradiation device, and irradiating the patient with light to diagnose or treat the patient. The patient may be irradiated with light to treat actinic keratosis, acne, photo-damaged skin, cancer, warts, psoriasis, or other skin diseases. Such a method may also be used for hair removal and for the diagnosis and treatment of cancer.

[0043] Total light dose (J / cm 2 ) = irradiance (W / cm 2 ) × time (seconds), so one of the parameters that requires control to deliver the correct treatment light dose is the exposure time. This may be achieved by the timer described above. This timer can appropriately control the power supplied to the plurality of LED arrays 60, and the timer can be set by a physician. The data is the irradiance density of 10 mW / cm 2 or an irradiance density of about 9.3 to about 10.7 mW / cm 2 and 10 J / cm 2shows that clinically acceptable results are produced in a desired treatment site (e.g., face, scalp, limbs). According to the above formula, an exposure time of 1000 seconds (16 minutes and 40 seconds) is required for this light dose. Also, since the adjustable irradiation device has individually controllable characteristics, in order to shorten the time required for effective treatment, the patient's treatment may be performed using a higher output irradiation device. For example, the adjustable irradiation device emits light at an exposure time of 500 seconds (8 minutes and 20 seconds) and a irradiance density of 20 mW / cm 2 and may emit light with a clinically acceptable light dose of 10 J / cm 2 . Alternatively, the adjustable irradiation device may operate in a higher output range, e.g., 30 mW / cm 2 during the exposure time so as to result in a light dose of 10 J / cm 2 . Also, within the treatment period, the selected light dose may be executed by additionally or alternatively changing the irradiance density. In at least one embodiment, the parameter to be controlled is the temperature at which the irradiation device warms up, as described below.

[0044] According to one embodiment, the treatment method includes warming up the irradiation device to release heat from the irradiation device and exposing the patient's skin to the irradiation device. The heat promotes the conversion of ALA to porphyrin (e.g., photosensitive porphyrin or protoporphyrin). The relationship between temperature exposure and ALA conversion is non-linear, and the enzymatic pathway involved in the conversion is very sensitive to temperature. In at least one embodiment, increasing the temperature by about 2°C can, for example, double the production rate of protoporphyrin IX (PpIX). In at least one embodiment, by increasing the heat output of the irradiation device by, for example, about 2°C, the effect can be obtained approximately 20 minutes after treatment. This is comparable to the effect achieved in a course of treatment that takes 1 to 3 hours without increasing the temperature.

[0045] Specifically, the method according to one embodiment includes activating a light source such as a plurality of LEDs 60 and activating a heating element of the irradiation device. Such a method may include simultaneously activating both the plurality of LEDs 60 and the heating element so that both light and heat are applied during the treatment period. Further, such a method may further include activating the plurality of LEDs 60 after heater heating (for example, a 5-minute preparatory warming). When the treatment period is about 20 minutes, the total allowable light dose delivered to the patient may be about 10 - 20 J / cm 2 It may be. The treatment period in an exemplary embodiment may be from about 10 minutes to about 1 hour. The total allowable light dose in an exemplary embodiment may be about 10 - 40 J / cm 2 It may be. In at least one embodiment, depending on the clinical situation, the treatment period may be more than 1 hour or less than 10 minutes, and the total allowable light dose may be less than 10 J / cm 2 Or more than 40 J / cm 2 It may be.

[0046] In at least one embodiment, the plurality of LEDs 60 and the heating element (heat source) 160 may operate sequentially rather than simultaneously. For example, first, ALA may be applied. Next, the heating element can be activated to apply heat to the patient's skin during a first treatment period, for example, for a heat soak that may be 20 - 30 minutes. It has been found that the surface temperature of the face stabilizes in about 5 minutes. Following the first treatment period, a second treatment period, for example, light can be applied for about 8 - 15 minutes. The total light dose delivered to the patient may be about 10 - 20 J / cm 2 It may be. In some embodiments, at least a portion of the heat may be delivered via one or more heating pads placed on the patient's skin. In at least one embodiment, such a process is performed, for example, to treat a skin disease of the patient. The treatment period in an exemplary embodiment may be from about 10 minutes to about 1 hour. The total allowable light dose in an exemplary embodiment may be about 10 - 40 J / cm 2 It may be. In at least one embodiment, depending on the clinical situation, the treatment period may be more than 1 hour or less than 10 minutes, and the total allowable light dose may be less than 10 J / cm 2Less than or 40 J / cm 2 or may be more than.

[0047] Also, in at least one embodiment, the treatment method further includes recording data indicating the temperature of at least one node of the volume and recording data indicating the temperature of at least one additional node of the volume. The volume may be a cubic or other shaped control volume that at least partially corresponds to a portion of the patient's skin exposed to the irradiation device.

[0048] Figures 9A and 9B show an apparatus according to an embodiment of the present disclosure. The apparatus is, for example, an irradiation device including the specific components shown in FIGS. 2A-2B. The irradiation device includes a frame 150 to which panels 10a-10e are attached. In addition to the panels 10a-10e, a heat source (heating element) 160 is attached to the frame 150. For example, as shown in FIG. 9B, the heat source 160 may be sandwiched between the panels 10b and 10d and at least partially disposed on the rear side of the panel 10c. The heat source 160 may include a plurality of curved end portions 162, 164 that protrude beyond a plurality of panels, and at least a portion of the heat source may be directly exposed to the patient without being blocked by the plurality of panels. In at least one embodiment, the heat source 160 may be an infrared quartz heater. By combining the panels 10a-10e, the frame 150, and the end portions 162, 164, a partially enclosed space is formed, which serves as a warm air bath that can warm a part of the patient (e.g., the patient's head).

[0049] In at least one embodiment, the heat source 160 may be constituted by a frame-mounted resistive tape heater. In at least one embodiment, the heat source 160 may be constituted by a plurality of heaters including at least one selected from the group including infrared LEDs, electric resistance cartridge heaters, PTC (positive temperature coefficient) heaters, or the above-described infrared quartz heaters. In at least one embodiment, the infrared quartz heater has high responsiveness and outputs sufficient heat. Further, the infrared quartz heater can be easily controlled by a control device 77 which may be, for example, a PID (proportional-integral-derivative) controller. Furthermore, since the infrared quartz heater is small, it can be integrated into the frame 150 without increasing the size of the frame 150.

[0050] The heat source 160 may include at least one control device (control unit) such as the control device 77 for the heat output of the target treatment. The control unit may be a control device realized as hardware, software, or a combination thereof, for example, a combination of a storage device storing a computer program and a processor executing the program. In at least one embodiment, the heat source 160 is controlled by a PID controller that performs monitoring and over-temperature / over-cooling control. In some embodiments, the control device may further include one or more of an input / output (I / O) expansion module, a data logging and field communication access module. The control device may be a microprocessor control regulator having a software framework driver programmed to control the input set temperature to a specified allowable value based on feedback from a reference / contrast thermistor 170 described later. In at least one embodiment, the heat source is configured to output sufficient heat to reach a predetermined target temperature of the skin or tissue, for example, 40°C ± 2°C.

[0051] FIG. 9C shows an irradiation device according to an embodiment. In at least one embodiment, the irradiation device further includes one or more thermistors. The thermistor may be integrated with the irradiation device or provided as one of a set of kits including a set of diagnostic tools. In at least one embodiment, a negative temperature coefficient thermistor or a positive temperature coefficient thermistor may be provided as a reference control thermistor 170 disposed near the heat source 160 or in its vicinity. In at least one embodiment, the thermistor 170 may be disposed in a part of the heat source 160 near the upper part of the panel 10c. The temperature measured by the reference control thermistor 170 may be compared with the temperature measured on the exposed skin of the patient by a temperature probe such as a contact thermocouple set on the patient's forehead. In some embodiments, one or more thermocouples may be used to understand the relationship between the skin temperature (thermocouple temperature) and the temperature detected by the thermistor 170 (reference temperature or thermistor temperature).

[0052] Specifically, one or more thermocouples may be used to understand the relationship between the skin temperature and the reference temperature at the initial stage when the irradiation device is manufactured or when the first diagnosis is performed. For example, the reference temperature or the reference temperature may be set based on experimental data, and the reference temperature or the reference temperature compared with the thermocouple temperature may be a temperature value obtained from a table stored in the memory of the control unit connected to the irradiation device. In at least one embodiment, the thermistor may be a programmable thermistor in which one or more temperature values are stored, and the thermistor may be used to adjust the heat output of the heat source 160 after being programmed. The temperature comparison may be performed at one or more locations on the exposed skin of the patient. For example, a temperature map of the patient's face may be created by measuring the temperature at multiple locations on the patient's face. Temperature mapping may be performed before and after treatment. Further, the result of the temperature mapping may be compared with, for example, the needs of the user specified in the treatment plan or the clinical plan. The result of the patient's temperature mapping may be compared with the temperature mapping data of one or more other patients.

[0053] In at least one embodiment, the heat source 160 may be used in combination with the fan 70. For example, the fan 70 may be operated to circulate cooling air within the system. Further, cold or room temperature air moving along the path indicated by arrow "C" in FIG. 9C may be directed towards the heat exchanger within the heat source 160. The heat exchanger heats the cold air. The heated air moving along the path indicated by arrow "H" in FIG. 9C may be blown at a gentle flow rate. In at least one embodiment, the fan 70 is controlled by a control device such that the air velocity is about 3 to 6 knots and the volumetric flow rate is 14 cubic feet per minute (CFM). In some embodiments, the speed of the fan may be constant or variable. In at least one embodiment, a control device (which may be a control device that controls at least one of the plurality of LEDs 60 and the heat source 160) controls the fan 70. The control device may control the output of one or more fans 70, for example, by varying the number of revolutions per minute (RPM) of the fan 70. The heated air may be blown by the fan 70, for example, onto the patient's face from the upper and lower parts of the heat source 160. This air flow forms, for example, a warm air trough or a warm air pocket that substantially surrounds the patient's skin so as to wrap the patient's face with warm air. Due to the thermodynamic behavior of the system, control can be achieved such that the difference between the temperature of the patient's skin (measured by a contact thermocouple) and the temperature measured by the thermistor is, for example, within about 15°C. In at least one embodiment, the surface of the patient's skin (e.g., the facial skin) reaches a stable temperature within 5 minutes from the heat radiation from the heat source 160.

[0054] By controlling the thermodynamic transfer behavior, the air to be blown and the heat output from the heat source can be adjusted according to the desired skin heating effect. In at least one embodiment, by determining the temperature rise of the air and the corresponding time, a desired temperature rise of the skin temperature (e.g., 2 °C) can be achieved. That is, the control device may be programmed to determine the temperature rise and time required to heat the patient's skin to the desired temperature. Further, in at least one embodiment, the control device may also make such a determination with respect to the air velocity and / or the volumetric flow rate. Such a determination by the control device may be made with reference to one or more maps stored in the memory of the control device. For example, one such map is a map that associates the temperature of the thermistor 170 with the rise in skin temperature. Another map is a map that associates the thermistor temperature with the air velocity and the volumetric flow rate of the air. The air velocity and the volumetric flow rate themselves vary at least in part based on the configuration of the heat source 160, more specifically, the configuration and the shape of the arrangement of the curved portions (plenum spaces) 162, 164. In at least one embodiment, one or more maps stored in the memory may associate one or more of the thermistor temperature, the desired skin temperature, the volumetric flow rate, the air velocity, and the air temperature with each other. The control device may refer to the information from one or more maps for accurate control of the skin temperature. The system may include a plurality of sensors for detecting the temperature at a plurality of locations, and the control device may refer to the aforementioned maps including the data from these sensors to control the heat source 160 at one or more locations. Further, the heating of the skin at a plurality of points may be controlled in accordance with the treatment plan in consideration of the information from the temperature - heat map. In one embodiment, by using such a map, for example, the desired skin temperature can be obtained without directly measuring the skin temperature by arranging one or more temperature sensors on the skin.

[0055] FIG. 9D shows an irradiation device according to an embodiment in which heat is radiated to a control volume, for example, a cubic volume. In at least one embodiment, the heat source 160 may radiate heat towards a treatment target, for example, a target inside the cubic volume 172 as shown in FIG. 9D. The cubic volume 172 may have an overall height of 6 inches, and the temperature may be measured at multiple points in the x, y, and z directions of the cubic volume 172. For example, the temperature may be detected at a position 3 inches from the central panel 10c, where a predetermined treatment target is located at the center of the cubic volume 172. FIG. 9E shows the cubic volume 172 when the treatment target is the nose of a patient at the center of the cubic volume. FIG. 9F is a perspective view showing an example of the positioning of the patient with respect to the heat source 160 and the irradiation device.

[0056] FIG. 10 shows a volume (a specific three-dimensional space) in which nodes 1 to 12 are defined, node 10 is the node at the very center of the volume, and node 12 is a node outside the volume (for example, at a distance from the volume). To create a temperature map, the temperature can be measured at any or all of the multiple nodes. In at least one embodiment, the data recording may be performed every minute or at different predetermined time intervals. In at least one embodiment, the cubic volume 172 is provided as a measurement framework. The measurement of the temperature (and the measurement of the distance from one or more panels 10) is performed at one or more nodes and can be compared, for example, with the temperature measured by the thermistor 170. Thus, the positioning of the patient with respect to the irradiation device may be controlled so that the total allowable radiation dose is surely achieved.

[0057] Figures 11A-11B show a temperature map according to one embodiment. Figure 11A shows a temperature map of a patient's skin before heating. The average skin temperature before heating was 93.6°F. In at least one embodiment, after preheating the heat source 160 for 5 minutes, the patient can be exposed to the light from the light source 60 and the heat from the heat source 160 for about 10 minutes. Figure 11B shows the temperature map after 5 minutes of preheating the heat source 160 and 10 minutes of heat immersion. The average skin temperature after the preheating time and 10 minutes of heat immersion was 102°F. In at least one embodiment, forced convection with low instability and small variation in the temperature of the entire heated target can be selected and used. Further, in at least one embodiment, indirect heating may be used so that the patient's skin does not directly contact the heat source 160. Rather, the heat is radiated at a distance from the patient's skin, and the control device determines the radiation pattern plan based on the comparison result between the plurality of temperature measurement values obtained at the plurality of nodes of the control volume 172 and the temperature measurement value obtained by the thermistor 170.

[0058] In at least one embodiment, the control device may receive temperature feedback from the thermistor 170 and turn the heat source 160 on and off via firmware having a firmware setting of ±1 degree. In at least one further embodiment, a non-contact infrared (IR) sensor such as an infrared laser sensor may be used to detect the skin temperature and provide the detected skin temperature data to the control device. The input from the non-contact IR sensor may be shown in one or more maps stored in the control device as additional data indicating the skin temperature. In at least one embodiment, during the initial warm-up time (e.g., 5 minutes), the heat source 160 starts the warm-up, but the system is not in a steady state where it can be controlled to send the desired output and is in a transient state. The non-contact IR sensor may be used to detect the patient's skin temperature so that the detection result can be compared with the skin temperature values of multiple patients. Such skin temperature data may be data obtained from a sample population and stored in a map in the control device. If a patient's skin temperature is lower than the average skin temperature, the control device may increase the heating rate of the heat source 160 to more efficiently promote the warming of the patient's skin. Alternatively, if the patient's skin temperature is above the average skin temperature, it may continue as it is without increasing the speed during the warming process.

[0059] In at least one embodiment, when the temperature of the skin or tissue is high, it is about 40.3 to 42.6 °C, and the average skin temperature is 41.3 °C. The heat test was carried out at 10 mW / cm 2 and 20 mW / cm 2 with only light or only heat, or both light and heat added. In the heat test, it was shown that when heat was applied, the light itself was considered not to affect the skin temperature of the patient's face.

[0060] Figures 12A to 12D show temperature data when no light is applied. Specifically, FIG. 12A shows a temperature map of the skin or tissue temperature of a patient before heating, and FIG. 12B shows a temperature map after heating by thermal immersion for 10 minutes. FIG. 12C shows skin temperature (thermocouple temperature) and thermistor temperature data at nodes 1 to 12. FIG. 12D shows a plot of the thermocouple temperature and thermistor temperature over time at the central node 10 during thermal immersion.

[0061] Figures 13A to 13D show temperature data when no heat is applied. Specifically, FIG. 13A shows a temperature map of the skin or tissue of a patient without applying heat. FIG. 13B shows a temperature map after phototherapy. FIG. 13C shows temperature data (data of thermocouple and thermistor) at the central node 10. FIG. 13D shows a plot of the thermocouple and thermistor data over time in a treatment protocol where the heat source 160 is not turned on. Specifically, FIG. 13D reflects "light only" treatment, and a predetermined time may have elapsed between when the light source is first activated and when the skin temperature of the patient is measured. For example, 5 minutes may have elapsed between when the light source is first activated and when the skin temperature of the patient is measured, and then the patient may receive an additional 10 minutes of light-only treatment.

[0062] Figures 14A to 14D show node-based temperature data according to an embodiment. Specifically, FIGS. 14A to 14D show data according to an embodiment in which the patient is exposed to both light and heat during treatment. FIG. 14A shows a temperature map of the skin or tissue temperature of a patient before heat treatment. FIG. 14B shows a temperature map of the skin or tissue temperature of the patient after heat treatment. FIG. 14C shows temperature data including the thermocouple temperature (skin temperature) and thermistor temperature (control temperature, reference temperature) at node 10 when the irradiance density is 20 mW / cm 2 and shows temperature data including the thermocouple temperature (skin temperature) and thermistor temperature (control temperature, reference temperature) at node 10 when the irradiance density is 20 mW / cm. FIG. 14D shows a plot of the temperature data over time during 10 minutes of thermal immersion at a position 3 inches from the front panel (for example, panel 10c) when the control temperature setting is 57°C.

[0063] Those skilled in the art will readily conceive of further advantages and modifications. Therefore, the present invention is not limited to the specific details, representative devices, and methods shown and described herein. Thus, various modifications can be made without departing from the spirit and scope of the general inventive concept as defined by the appended claims and their equivalents.

Description of Reference Numerals

[0064] Regions 1 to 6 Nodes 1 to 12 Panels 10a to 10e 23 tabs Mounting head 40 Hinge 50 Flange 51 Bolt 53 LED array 60 Fan 70 Control device 77 Stand 80 Base 81 Vertical support 82 Pivot point 83 Stabilizing arm 84 Connecting arm 85 Hinge point 86 Wheel 87 Control device and power supply 90 Body 100 Frame 150 Heat source 160 Tip 162 Tip 164 Reference / control thermistor 170 Cubic volume 172

Claims

A lighting device comprising a plurality of panels including five panels, each of the five panels being connected by a hinge in the width direction to an adjacent panel of the five panels, the hinge being provided on a side surface of each panel of the five panels, and the side surface of each panel of the five panels being connected facing the side surface of the adjacent panel in the width direction. A lighting device, A light source disposed on the surface of the panel, the lighting device being configured to uniformly illuminate a treatment surface of a patient through the light source, one of the plurality of panels being disposed as a central panel configured to face the treatment surface, and two or more of the plurality of panels being configured to have an angle with respect to the central panel so as to be disposed in a bent configuration. And a heat source configured to radiate heat toward the patient between the panels located on the outermost sides in the width direction among the plurality of panels. Each of the plurality of panels has two first ends and two second ends shorter than the two first ends, and the light source is disposed such that a higher emission intensity is irradiated at a position adjacent to the second end compared to a position not adjacent to the second end in each panel. In the two left and right panels of the central panel, the light source is disposed such that the higher emission intensity is irradiated at a position adjacent to the first end in the width direction to suppress a decrease in exposure amount, and the higher emission intensity is irradiated at a position adjacent to the hinge to compensate for insufficient light amount at a portion where the panels are in contact with each other. A system for optically diagnosing or treating the patient. Claim 2 The system according to claim 1, wherein the lighting device is configured to uniformly illuminate the treatment surface when the treatment surface is at a distance of 5.08 to 10.16 cm from the lighting device. Claim 3 The lighting device is 10 mW / cm 2 to 30 mW / cm 2The system according to claim 1, configured to output light with an irradiance density of.

4. The system according to claim 1, wherein the plurality of light sources are configured to emit light having a wavelength in the range of 400 nm to 700 nm.

5. The lighting device is configured to irradiate a light dose of 10 J / cm 2 of, The system according to claim 1.

6. The lighting device is configured to irradiate a light dose of 20 J / cm 2 of, The system according to claim 1.

7. The lighting device is configured to irradiate light having an irradiation irradiance density of 20 mW / cm 2 of, The system according to claim 1.

8. The lighting device is configured to irradiate blue light, The system according to claim 1.

9. The lighting device is configured to irradiate red light, The system according to claim 1.

10. The heat source is a heating pad, The system according to claim 1.

11. The heat source is an infrared heat source, The system according to claim 1.

12. The heat source is configured to heat the skin of the patient to a temperature of 40°C ± 2°C, The system according to claim 1.

13. The hinge is received in a recess disposed in each of the sides. The system according to claim 1.

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