Adjustable illuminators and methods for photodynamic therapy and diagnosis

Abstract

To provide adjustable illuminators which provide a uniform distribution of visible light and are suitable for use in photodynamic therapy and diagnosis.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 promotes formation of a photoactivatable agent and thus shortens the time needed to complete photodynamic therapy.SELECTED DRAWING: Figure 9A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. patent application Ser. No. 15 / 487,991, filed Apr. 14, 2017, the entire contents of which are incorporated by reference.

[0002] The present disclosure generally relates to adjustable illumination devices and methods of operating adjustable illumination devices that provide a uniform distribution of visible light in a variety of configurations and are suitable for use in photodynamic therapy and diagnostics. [Background technology]

[0003] Photodynamic therapy (PDT), photodynamic diagnosis (PD), or photochemotherapy are commonly used to treat and / or diagnose various diseases in or near the skin or other tissues, such as within body cavities. For example, PDT or PD can be used to treat or diagnose actinic keratosis on the scalp or facial area of ​​a patient. PDT or PD may also be used to treat and diagnose other indications (e.g., acne, warts, psoriasis, photodamaged skin, cancer) and other areas of a patient (e.g., arms and legs).

[0004] In one form of PDT or PD, a patient is first administered a photoactivatable agent or a precursor of a photoactivatable agent that accumulates in the tissue to be treated or diagnosed. The photoactivatable agent or precursor may be administered, for example, to treat a skin disorder. The area where the photoactivatable agent has been administered is then exposed to visible light, which induces chemical and / or biological changes in the photoactivatable agent. These changes allow the agent to selectively locate, destroy, or modify the target tissue while minimizing and reversing damage to other tissues within the treatment area. One example of a photoactivatable agent precursor is 5-aminolevulinic acid ("ALA"), which is commonly used in PDT for actinic keratosis. As used herein, the terms ALA or 5-aminolevulinic acid refer to ALA itself, its precursors, and their pharmaceutically acceptable salts.

[0005] For effective treatment, a uniform output of intensity and color is desirable. Illuminators, such as those 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, which are incorporated by reference in their entireties for their use in PDT and PD-related techniques, methods, compositions, and devices, are typically used to provide adequate uniformity of light for therapeutic purposes. Generally, these devices include a light source (e.g., a fluorescent tube), coupling elements that direct, filter, or guide the emitted light to reach the intended target in a usable form, and a control system that starts and stops light production as needed. Summary of the Invention [Problem to be solved by the invention]

[0006] Because PDT can be used to treat a variety of treatment areas, some delivery devices use two or more panels, each with a light source that directs light toward the intended target area. These panels are pivotally connected to one another. By having multiple pivotable panels, the overall size and shape of the light-irradiated area can be varied depending on the intended treatment area.

[0007] In conventional adjustable irradiation devices, multiple panels have the same width and length and are typically driven at the same power level. Furthermore, the multiple panels are connected at their edges by hinges, allowing them to rotate to a desired shape. However, due to the edges of the multiple panels and the multiple hinges, the light source(s) on one panel cannot be positioned directly adjacent to the light source(s) on an adjacent panel. As a result, light does not exit from the "gaps" between the multiple light sources. When applying uniform power to multiple panels, optical "dead space" can occur in certain areas of the treatment target region because light is not emitted from these areas. This reduces the overall amount of light received by these areas, resulting in a lower treatment dose. In some cases, the treatment dose can be as low as one-fifth of that received by areas receiving the optimal amount of light.

[0008] These conventional irradiation devices are typically used for phototherapy of acne, where the administration of a photoactivatable agent is not typically required for effective treatment. Therefore, light alone is generally sufficient for treatment. Furthermore, because multiple treatment sessions can be used to effectively treat a disease, uniformity of light delivered across a target area during treatment may be less of a concern. However, certain treatments involving PDT, such as the use of ALA to treat actinic keratosis, require light of a specific and highly uniform intensity and color to be effective. In these instances, successful PDT relies on the targeted delivery of both the appropriate amount of photoactivatable agent and the appropriate amount (i.e., power and wavelength) of light to produce the desired photochemical reaction in the target cells. Therefore, to achieve this, the light source must deliver light to the target area, and both the wavelength and power of this light delivery must be uniform. In conventional adjustable irradiation devices, optical dead spaces that can occur at or near the hinge reduce the uniformity of light along the treatment area, thereby reducing the effectiveness of PDT in certain treatments. Furthermore, these illumination devices are also configured to be adjusted within a limited range to treat only limited portions of a patient's body surface, such as the patient's face, scalp, etc. Also, because patient body contours vary widely, the uniformity of light delivered by these conventional illumination devices can vary significantly depending on the treatment area on the patient.

[0009] Accordingly, some embodiments of the present disclosure aim to reduce or eliminate these dead spaces and provide more uniform light distribution in adjustable illumination devices designed for PDT and / or PD of various target regions. Furthermore, some embodiments of the present disclosure aim to provide an infinitely adjustable illumination device that can effectively deliver uniform light across various regions of a patient's body, such as the patient's face and scalp, as well as the patient's extremities (e.g., arms and legs) and torso. Thus, uniform light can be delivered to treatment target regions regardless of the patient's body shape or location. [Means for solving the problem]

[0010] One embodiment of the present disclosure includes multiple panels, with at least one panel having a different width than the other panels. This panel is positioned between two other panels and functions as a "lighting hinge" that provides 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 are provided to optimally increase the total treatable area. Two of the panels are preferably narrower than the other three larger panels. The panels are staggered so that each narrow panel is positioned between two of the three larger panels, thereby providing adjustability and improving uniformity. To further reduce or eliminate optical dead space, the panels are preferably connected by nested hinges to reduce areas of the illumination device where no light source is present. To further reduce or eliminate optical dead space, the multiple light sources in each panel are preferably individually configurable to provide specific power to specific regions of the multiple light sources in the panels to compensate for reduced uniformity. For example, the power delivered to each diode in a light emitting diode (LED) array may be individually adjusted.

[0011] One embodiment of the present disclosure relates to an illumination device for photodynamically diagnosing or treating a surface, the illumination device comprising a plurality of panels, a plurality of light sources each attached to one of the plurality of panels and configured to illuminate the surface with visible light of a substantially uniform intensity, and a heat source configured to radiate heat towards a patient between 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, comprising controlling a heat source to apply heat to the patient's skin during a first time period, and irradiating the patient with light during a second time period after the first time period with an irradiation device for treating a skin disorder, the irradiation device having a plurality of panels, at least one of the plurality of panels being provided with at least one light source.

[0013] A further embodiment of the present disclosure relates to a method for performing photodynamic diagnosis or therapy on a patient, comprising irradiating the patient with light using an irradiation device having multiple light sources, and, during the irradiation of light, radiating heat from a heat source to warm the patient's skin, wherein the irradiation of light from the multiple light sources begins approximately simultaneously with the radiation of heat from the heat source to the patient.

[0014] A further embodiment of the present disclosure relates to a system including an illumination device for photodynamically diagnosing or treating a surface, the illumination device comprising a plurality of panels, a plurality of light sources each attached to one of the plurality of panels and configured to illuminate the surface with visible light, and at least one sensor configured to detect an orientation of at least one of the plurality of panels. [Brief explanation of the drawings]

[0015] Features, aspects, and advantages of the present disclosure will become apparent from the following description and from the exemplary embodiments illustrated in the accompanying drawings, which are briefly described below.

[0016] [Figure 1A-1B] 1A and 1B are top views showing the main body of an illumination device according to an exemplary embodiment. [Figure 2A-2B] 2A and 2B are perspective views showing the main body of the irradiation device of FIGS. 1A and 1B. [Figure 3A] FIG. 3A is a detailed view showing the telescopic hinge of the body of the illumination device of FIGS. 1A and 1B. [Figure 3B] FIG. 3B is a detailed view showing the telescopic hinge of the body of the illumination device of FIGS. 1A and 1B. [Figure 4] FIG. 4 is a perspective view showing the irradiation device in a state where the main body of FIG. 1A and FIG. 1B is attached to a stand. [Figure 5] FIG. 5 is a schematic diagram showing the addressable configuration of the LEDs attached to the main body of the illumination device of FIGS. 1A and 1B. [Figure 6] FIG. 6 is a schematic diagram showing the width and length of each panel of the main body of the illumination device of FIGS. 1A and 1B. [Figure 7] FIG. 7 is a graph showing the light dose over the entire treatment area using a conventional panel-type irradiation device. [Figure 8] FIG. 8 is a graph showing the amount of light in the entire treatment area when the same area as in FIG. 7 is treated using an irradiation device according to one embodiment. [Figure 9A] FIG. 9A shows an illumination device according to one embodiment. [Figure 9B] FIG. 9B shows an illumination device according to one embodiment. [Figure 9C] FIG. 9C shows an illumination device according to one embodiment. [Figure 9D] FIG. 9D shows an irradiation device according to an embodiment in which heat is radiated into a control volume, for example a cubic volume. [Figure 9E] FIG. 9E shows a control volume according to one embodiment. [Figure 9F] FIG. 9F is a perspective view showing a configuration according to one embodiment. [Figure 10] FIG. 10 shows a cubic volume with multiple nodes. [Figures 11A-11B] 11A and 11B show temperature data according to one embodiment. [Figures 12A-12B] 12A and 12B show the temperature data without light. [Figure 12C] FIG. 12C shows the temperature data without light. [Figure 12D] FIG. 12D shows the temperature data without light. [Figures 13A-13B] 13A and 13B show the temperature data without the application of heat. [Figure 13C] FIG. 13C shows the temperature data without the application of heat. [Figure 13D] FIG. 13D shows the temperature data without the application of heat. [Figures 14A-14B] 14A and 14B illustrate node-based temperature data according to one embodiment. [Figure 14C]FIG. 14C illustrates node-based temperature data according to one embodiment. [Figure 14D] FIG. 14D illustrates node-based temperature data according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0017] Various embodiments are described below. It should be noted that a particular embodiment is not intended as an exhaustive description or as a limitation on the broader aspects discussed herein. An aspect described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in conjunction with one or more other embodiments.

[0018] As will be understood by those skilled in the art, for any and all purposes, particularly with respect to providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of those subranges. Any recited range can be readily recognized as fully describing and allowing for the same range to be divided into at least one half, one third, one quarter, one fifth, one tenth, etc. As a non-limiting example, each range discussed herein can be readily subdivided into a lower third, middle third, and upper third, 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., are inclusive of 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, a range includes each individual element.

[0019] Unless otherwise noted, all numbers expressing quantities of properties, parameters, conditions, and the like used in the specification and claims should be understood to be modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the following specification and appended claims are approximations. Any numerical parameters should be construed, at least in light of the number of reported significant digits and by applying ordinary rounding techniques. The term "about," when used before numerical designations, such as temperature, time, amounts, and concentrations, including ranges, indicates approximations that may vary by (+) or (-) 10%, 5%, or 1%.

[0020] 1A and 1B and 2A and 2B illustrate an embodiment of a configurable illumination device (illuminator) according to the present disclosure. The illumination device body 100 preferably includes five individual panels 10a-10e, each pivotally connected via a telescoping hinge 50. Each panel includes a light-emitting diode (LED) array 60, which may be arranged in an evenly spaced pattern across the panel's surface. The number of individual LEDs arranged in any array is not particularly limited. Alternatively, other types of light sources, such as fluorescent or halogen lamps, may be used.

[0021] Preferably, each LED array 60 extends to as many edges as possible. Furthermore, the LED array 60 is preferably sized to provide a full irradiated area for any treatment area based on a range from the 5th percentile for female subjects to the 95th percentile for male subjects. The LED arrays 60 emit light at wavelengths appropriate for the intended treatment or for activating the specific photoactivatable agent used for treatment or diagnosis. For example, if ALA is used as a precursor for the photoactivatable agent for the treatment of actinic keratosis, the LED arrays 60 preferably emit blue light at wavelengths of 400 nanometers (nm) or greater, such as approximately 430 nm or 420 nm, or, for example, 417 nm. However, the LED arrays 60 may also emit visible light in other spectral regions, such as the green and / or red regions between 400 and 700 nm, such as approximately 625 nm to 640 nm, or, for example, 635 nm. For example, the LED array 60 may emit light having a wavelength of 510 nm, 540 nm, 575 nm, 630 nm, or 635 nm. The LED arrays 60 may be configured to emit light continuously, or may be configured so that the diodes turn on and off at predetermined intervals. The LED array 60 may be configured to emit only one wavelength of light (e.g., blue). Alternatively, the LED arrays 60 may be configured to emit light of two or more wavelengths. For example, the LED arrays 60 may be configured to alternately emit blue and red light for therapeutic purposes.

[0022] As shown in FIGS. 1A and 1B and 2A and 2B, the five panels 10a-10e have different widths. Specifically, in certain embodiments, three panels 10a, 10c, and 10e are wide, and two panels 10b and 10d are narrow and small, with the two narrower panels 10b and 10d each having a smaller width than the three wider panels 10a, 10c, and 10e. In some embodiments, the widths of the three wide panels 10a, 10c, and 10e are approximately equal. In other embodiments, the widths of the three wide panels 10a, 10c, and 10e are different. Furthermore, the widths of the two narrower panels 10b and 10d may be approximately equal or different. Furthermore, the panels are arranged in an alternating manner, with a narrower panel (e.g., 10b) positioned between two wider panels (e.g., 10a and 10c). 6, in some embodiments, narrow panels 10b, 10d are configured to have widths that are approximately 30% to 60% smaller than the widths of wide panels 10a, 10c, 10e. In other embodiments, narrow panels 10b, 10d are configured to have widths that are approximately 30% to 50% smaller than the widths of wide panels 10a, 10c, 10e.

[0023] As shown in FIGS. 1A and 1B and 2A and 2B, panels 10a-10e are pivotally connected by hinges 50. Hinge 50 may be in the form of a nested hinge, including a hinge that significantly reduces or eliminates optical dead space. As shown in FIGS. 2A and 2B, tabs 23 may extend from both the top and bottom of at least one side of the panel. As shown in FIG. 2A, the tabs 23 are configured so that one side of an adjacent panel is received between the tabs 23. Thus, as shown in FIGS. 2A, 2B, and 6, the height of an adjacent panel (e.g., panel 10a) is slightly shorter than the height of the tabbed panel (e.g., panel 10b) that receives it. As shown in FIG. 6, the middle panel (i.e., panel 10c) preferably has tabs on both sides and is configured to have the greatest height so that it can receive the sides of adjacent panels on each side. As shown in FIGS. 1A and 1B, each tab 23 further includes an opening for inserting a bolt to connect adjacent panels.

[0024] The panels 10a-10e may be arranged such that the lateral panels are movable to increase the total coverage area or range of the panels 10a-10e, and may be configured to extend to areas of the patient, such as the chest or abdomen. In at least one embodiment, at least one of the panels 10a-10e may be arranged such that at least one is in a flat or folded (e.g., bent or angled) configuration. The panels may be moved to continuously change shape. In at least one embodiment, one or more panels may be provided with one or more detent mechanisms to hold the one or more panels in a desired position. One or more detent mechanisms may be provided on one or more panels to inhibit movement of the panels to achieve multiple different panel configurations for treatment, where the panels are maintained in specific positions during treatment of the patient. The panels may be arranged relative to one another to allow the irradiation device to assume one or more specific shapes. In at least one embodiment, the panels may be positioned relative to one another such that the illumination device assumes at least one of a curved, flat, or folded configuration, for example.

[0025] As shown in more detail in FIGS. 3A and 3B , nested hinges 50 are provided between multiple tabs 23 and attached to the inner sides of multiple adjacent panels (e.g., 10a, 10b), allowing the panels to pivot. A flange 51 of the hinge 50 is attached to the inner side of the panel via multiple bolts 53. The inner side of the panel may include a recess into which the flange 51 is positioned. The inner side of the panel may also include an additional recess to accommodate the joint of the hinge 50 so that the joint is substantially flush with the outer surface of the panel. This configuration allows the outer vertical edges of adjacent panels to be positioned closer together. By positioning the vertical edges of adjacent panels closer together, optical dead space can be further reduced or eliminated. Additionally, providing multiple tabs 23 along with multiple hinges 50 reduces the number of pinch points present in the system.

[0026] As shown in FIGS. 1A and 1B, the main body 100 of the irradiation device may include a mounting head 40. The mounting head 40 allows the main body 100 to be attached to a movable stand 80, as shown in FIG. 4, so that a user can easily move the main body 100 to the 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 on its bottom to allow a user to horizontally move the irradiation device to the appropriate position. The plurality of wheels 87 may include a plurality of locks to prevent further horizontal movement of the stand 80 once it is properly positioned. The vertical support 82 may also be attached to the base 81 at a pivot point 83. The pivot point 83 allows the vertical support 82 to rotate, thereby increasing the range of position adjustment for the irradiation device. The vertical support 82 includes a connecting arm 85 at its upper end, which can serve as a mounting structure for the main body 100. The connecting arm 85 includes a hinge point 86 to allow the main body 100 to move vertically relative to the stand 80. Additionally, the vertical support 82 may be configured as a telescoping structure to allow the user to change the height of the vertical support 82. This increases the vertical movement range of the main body 100, allowing the user to position the main body 100 for treatment on lower areas, such as the patient's legs or feet. The stand 80 may also include a stabilizing arm 84. After the stand 80 and main body 100 are positioned, the stabilizing arm 84 can be attached to the main body 100 to prevent undesired movement of the main body 100 during treatment. Furthermore, as shown in FIG. 4, a controller and power supply 90 is attached to the stand 80 to provide power to the main body 100 and allow the user to control the main body 100 for treatment purposes. Alternatively, the controller and power supply 90 may be attached directly 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] At least one controller (also referred to as a control unit) is connected to the panel to adjust the power delivered so that the lights achieve the uniformity and intensity required for the intended treatment. In at least one embodiment, the controller may also control the output of the heat source 160, which will be described in more detail below. In at least one embodiment, at least one Multiple controllers may be provided to control the dynamic process of, for example, controlling the output of one or more light sources, one or more heat sources, and / or one or more air sources (e.g., fans) in any combination. For example, multiple controllers may be provided, either separately or integrated, to control the output of the multiple LED arrays 60 and the output of the heat source 160, respectively. In at least one embodiment, as an example, a first controller may control both the light sources and the heat sources, and a second controller may control the air source.

[0028] The controller may be implemented as hardware, software, or a combination thereof, such as a combination of a memory device storing a computer program and a processor executing the program. Alternatively, each panel may have its own dedicated controller that adjusts the power supplied to one LED array on any panel to achieve specific calibrations for the illumination device, further enhancing uniformity and efficiency. For example, Lambert's cosine law states that the light intensity at any point on a "Lambertian" surface (such as skin) is directly proportional to the cosine of the angle between the incident light and the normal to the surface. Thus, a light beam directed toward the front of a curved surface (e.g., a patient's head) will arrive nearly perpendicular to the area, resulting in 100% absorbance. However, light beams reaching the side edges of the curved surface will arrive nearly parallel. According to Lambert's cosine law, light intensity and absorption at the side edges approach zero, making the treatment ineffective at that area. Thus, a "fall off" in exposure dose tends to occur at the edges of the curved surface. Furthermore, the greater the distance between the light source and the point on the surface, the greater the "fall off."

[0029] An illumination device shape that conforms to curved surfaces (e.g., a U-shape designed to "wrap" around the surface curve) helps mitigate this effect and improve overall uniformity. However, to achieve sufficient uniformity, the light source must be larger than the treatment target area so that the body part being treated is completely surrounded and any target location on the treatment area is illuminated from all angles. To improve the uniformity of exposure at the treatment area while maintaining a practical illumination device size, multiple LED arrays 60 may be individually configured to increase the intensity of light emitted by specific diodes to compensate for the dip phenomenon.

[0030] An example of an individually configurable LED array 60 is shown in FIG. 5. Here, the LED array 60 is divided into three regions, which may be "addressable strings" (multiple LEDs connected in a string-like fashion, each 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. 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 control the intensity of light emitted from each region. For example, a higher current may be supplied to regions 1 and 2 than to regions 3 and 4, causing regions 1 and 2 to emit light with a higher intensity than regions 3 and 4. Similarly, a higher current may be supplied to regions 3 and 4 than to regions 5 and 6. This increases the overall intensity of light emitted from the edges, reducing the dip phenomenon. Alternatively, the illumination system may be configured to individually adjust each diode in any LED array 60, allowing for even greater calibration (ie, finer adjustment).

[0031] Additionally, pre-programmed settings or sensors that detect the curvature of the surface to be treated may be used to individually configure the LED arrays 60 to emit more intense light only in the required areas. Pre-programmed sensors may also be used to detect the orientation of one or more panels (e.g., whether the panel is curved or folded flat) and configure the LED arrays 60 to emit more or less intense light in the required areas. Specifically, in at least one embodiment, at least one sensor detects the orientation of at least one panel and provides the detection information to a controller. The sensors may include one or more encoders, such as one or more angle encoders, located on one or more of the panels. In at least one embodiment, the at least one sensor is a microswitch configured to detect the position of at least one panel. In some embodiments, the sensors may include encoders, microswitches, or a combination thereof. The sensor is configured to communicate with the controller and provide information regarding the orientation of the panel, such as the angle at which the panel is positioned, to the controller. The controller then controls the intensity of the light in response to the detection. In at least one embodiment, the plurality of sensors provide information to the controller so that the controller can determine whether the shape of the illumination device is one of a plurality of pre-defined configurations. For example, the controller may store information in a memory regarding one or more pre-defined configurations (e.g., curved illumination device, flat illumination device, etc.).

[0032] When the controller receives information transmitted from the multiple sensors, the controller may compare the sensed information with preset configurations and determine a match between the sensed information and one or more preset configurations. The controller may further store protocols for modifying intensity that are executed when the sensed information is determined to match one or more preset configurations. For example, if the irradiator is detected as a curved irradiator, the controller executes a light intensity output correlated with a preset protocol for curved irradiators. The controller may further compare the current intensity with the intensity associated with a particular configuration to determine whether the intensity should be adjusted. This may increase the output and / or light intensity of only certain diodes as needed, effectively improving exposure uniformity. In at least one embodiment, multiple configurations may be presented to the clinician or practitioner, for example, via a touchscreen, allowing the clinician to select a preset configuration that corresponds to the physical placement of the irradiator in the clinical environment.

[0033] Additionally, the multiple addressable strings of the LED array 60 may include various numbers of individual diodes mounted in specific regions. For example, in the case of the wide panels 10a, 10c, and 10e, 12 diodes may be mounted in each region 1, 9 diodes in each region 3, and 41 diodes in region 5, so that each of the wide panels 10a, 10c, and 10e includes a total of 83 individual diodes. In the case of the narrow panels 10b and 10d, 8 diodes may be mounted in each region 2, 9 diodes in each region 4, and 23 diodes in region 6, so that each of the narrow panels 10b and 10d includes a total of 57 individual diodes. However, the number and arrangement of diodes included in each LED array 60 are not particularly limited. For example, each of the wide panels 10a, 10c, and 10e may include a total of approximately 80 to approximately 350 diodes. Similarly, narrow panels 10b and 10d may each include a total of between about 50 and about 250 diodes. By varying the arrangement of diodes in each of the addressable strings of LED array 60, the power and / or intensity of the light emitted from any array may be better controlled and fine-tuned.

[0034] Independent adjustment of the power supplied to the multiple LED arrays 60 can also help reduce or eliminate optical dead space that might otherwise occur at the hinge points. Specifically, increased power and / or luminous intensity may be provided near the ends of the arrays closest to the nested hinges to compensate for the lack of light emitted from the panel-to-panel contact points. Additionally, the narrower panels 10b, 10d are preferably operated at higher power levels and / or higher luminous intensities than the wider panels 10a, 10c, and 10e to provide additional fill-in light. Furthermore, independent power adjustments may help compensate for manufacturing variations in the individual diodes. Finally, because each array can be individually configured to meet the lighting needs of a specific application, fine-tuning each array 60 can facilitate easy deployment of the panels for use in different applications.

[0035] The delivery device may further include a timer that can indicate to the user the appropriate exposure time length for a particular treatment. The delivery device may also be programmed with pre-stored light dose parameters to allow the user to select the desired treatment type. Pre-stored parameters may include, for example, pre-stored settings for exposure time, light intensity, and output wavelength. Based on the selected treatment, the delivery device is automatically configured to deliver the appropriate power to achieve the correct light dose and uniformity required for the treatment. Alternatively, the delivery device may include sensors located in front of the delivery device to detect the size of the treatment area. These sensors then determine the correct light dose parameters based on the detected treatment area. The delivery device may also include an actuator and be programmed to automatically move in response to the selected treatment. After a treatment is selected, the actuator may automatically position the delivery device in the appropriate configuration without the user having to manually move the system. The sensor may also detect the user's manually adjusted position for the delivery device. The detected position of the delivery device may then be used to indicate the intended treatment area. Accurate light dose parameters for the specific treatment area may then be provided based on the detected position set by the user.

[0036] The illumination device of the present disclosure has an infinite number of configurations that can be adapted to the treatment target area. These configurations range from a flat emitter (as shown in FIGS. 1B and 2B) to a roughly U-shaped configuration (as shown in FIGS. 1A and 2A). The adjustable illumination device may also be configured so that the two end panels 10a, 10e are pulled back relative to the three middle panels 10b, 10c, and 10d, forming a smaller U-shaped configuration with the middle panels. In this manner, the adjustable illumination device can additionally treat other areas of the patient's body. That is, the adjustable illumination device not only effectively delivers uniformly intense light to traditionally targeted surfaces such as the face and scalp, but can also be easily configured to treat other parts of the patient's body, particularly areas with less curvature, such as the arms and legs. Furthermore, the adjustable illumination device can be easily positioned to deliver uniformly intense light to larger treatment areas, such as the back or chest.

[0037] As noted above, the narrow panels 10b and 10d are sized so that they function as "illuminated hinges." Thus, when the wider panels 10a, 10c, and 10e are shaped to the desired shape, the "bend" occurs at the narrow panels 10b and 10d, rather than at the hinges themselves as in the past. Thus, instead of the non-illuminating "bends" of conventional illuminators, the present illuminator includes "bends" that are also configured to emit light, thereby reducing optical dead space without requiring significant differences in power supply between the light sources of each panel to provide the necessary fill-in light. The effectiveness of this configuration can be best understood by comparing Figures 7 and 8. Figure 7 shows the light uniformity of the conventional illuminator, measured at a distance of 2 inches using a cosine-sensitive detector that mimics the response of a patient's skin to the incident light described above. J / cm 2 The total light dose expressed in units of irradiance (W / cm 2 ) over time (in seconds) ) was measured. The treatment target area shown is the patient's head, with the height indicated as the y-axis and the rotation angle from the center of the radiation surface indicated as the x-axis. As can be seen from Figure 7, at the center of the patient's face (e.g., area A), near the nose, the light dose was approximately 10 J / cm 2 At this point, the patient is closest to and nearly perpendicular to the center panel. The total light dose decreases with distance from the center of the face, with the cosine "dip" phenomenon and optical dead space becoming more prevalent. For example, the light dose decreases by approximately 20% in the patient's cheek area (e.g., area B) and decreases to approximately 80% toward the outer edges of the patient's face, such as the ears and forehead (e.g., area E). Thus, as shown in Figure 7, conventional adjustable illumination devices using identically sized panels operating at the same power level will result in illumination fields with different light uniformities, which is undesirable and ineffective, especially for treatments requiring high light uniformity.

[0038] While certain embodiments described above relate to irradiators including multiple panels, other embodiments may include arch-shaped irradiators without individual linear panels. For example, in at least one embodiment, the irradiator may be comprised of at least one curved member. Furthermore, the arch-shaped irradiator may be configured with multiple generally curved sections extending from a generally flat section disposed therebetween. The patient's face may be positioned facing the generally flat section such that the irradiator surrounds the patient's head on at least three sides. For example, the patient's face may face a first section of the irradiator, and the left and right sides of the patient's head may face a second and third section, respectively.

[0039] In contrast, Figure 8 illustrates the uniformity of light produced by an embodiment of the present disclosure. The treatment target area is the same as the area measured in Figure 7. However, compared to Figure 7, the uniformity of light output produced by this illumination device is significantly higher across the patient's face, with little to 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 Figure 8, a total light dose of approximately 10 J / cm was measured across all areas of the face, including the center of the face (e.g., the patient's nose), the patient's cheek area, and the outer boundaries of the patient's cheek area, such as the ears and forehead. 2 (e.g., area A'). Additionally, there is minimal drop-off in total light dose at the outermost boundaries of the patient's face (e.g., area B'). In one embodiment, the measured output (across the entire effective light-emitting area) is 60% or greater of the maximum measured value (across the entire effective light-emitting area) measured by a cosine-sensitive detector at all operating distances. More preferably, the measured output (across the entire effective light-emitting area) is 70% or greater of the maximum measured value at a distance of 2 inches to 4 inches. Even more preferably, the measured output (across the entire light-emitting area) is 80% or greater of the maximum measured value at a distance of 2 inches to 4 inches.

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

[0041] Typically, anhydrous ALA is mixed with a liquid diluent immediately before use. The ALA mixture is applied topically to the lesion using a point applicator to prevent dispersion of the ALA mixture. The mixture may be applied using the techniques disclosed in U.S. Patent Application No. 15 / 371,363, filed December 7, 2016, the entire description of which, including the background, devices, and methods, is incorporated herein by reference. After the initial application of the ALA mixture has dried, one or more subsequent applications may be applied in the same manner. Approximately 10-20% ALA solution is administered. The formation of photosensitive porphyrins and the photosensitization reaction of the treated lesion occur 30 minutes to 18 hours later. Exposure to direct sunlight or other bright light sources during this period should be minimized. Between 30 minutes and 18 hours after ALA administration, the lesion is irradiated using an adjustable irradiator according to the present disclosure. The irradiator delivers uniform blue light to the lesion for a predetermined period of time. In a preferred treatment, the visible light has a nominal wavelength of 417 nm.

[0042] Thus, such embodiments provide a method for photodynamic diagnosis or treatment of a contoured surface of a patient, comprising providing an adjustable illumination device as described above, positioning the patient relative to the illumination device, and illuminating the patient with light to diagnose or treat the patient. The light may be irradiated onto the patient to treat actinic keratosis, acne, photodamaged skin, cancer, warts, psoriasis, or other skin disorders. Such methods may also be used for hair removal and cancer diagnosis and treatment.

[0043] Total light dose (J / cm 2 ) = irradiance (W / cm 2 ) × time (seconds), one of the parameters that needs to be controlled to deliver an accurate therapeutic light dose is the exposure time. This may be achieved by the timer mentioned above. This timer can appropriately control the power delivered to the multiple LED array 60, and the timer can be set by the physician. The data is based on an irradiance density of 10 mW / cm 2 Or irradiance density of about 9.3 to about 10.7 mW / cm 2 10J / cm delivered from the light source 2This shows that a dose of light equivalent to 1000 seconds (16 minutes 40 seconds) of exposure time is required for the desired treatment area (e.g., face, scalp, extremities). Based on the above formula, this dose of light requires an exposure time of 1000 seconds (16 minutes 40 seconds). Additionally, due to the individually controllable nature of the adjustable irradiator, patients may be treated with an irradiator at a higher power output to shorten the time required for effective treatment. For example, an adjustable irradiator may be used with an exposure time of 500 seconds (8 minutes 20 seconds) and an irradiance density of 20 mW / cm. 2 It emits light at a clinically acceptable light dose of 10 J / cm 2 Alternatively, the adjustable irradiator may emit light in a higher power range, e.g., 30 mW / cm during the exposure time. 2 It operates at a light dose of 10J / cm 2 The selected light dose may also be achieved by additionally or alternatively varying the irradiance density during the treatment period. In at least one embodiment, the controlled parameter is the temperature applied by the irradiation device, as described below.

[0044] According to one embodiment, a treatment method includes warming up an irradiation device to release heat from the irradiation device and exposing a patient's skin to the irradiation device. The heat promotes the conversion of ALA to porphyrins (e.g., photoporphyrin or protoporphyrin). The relationship between temperature exposure and ALA conversion is nonlinear, and the enzymatic pathway involved in the conversion is highly sensitive to temperature. In at least one embodiment, increasing the temperature by approximately 2°C can, for example, approximately double the rate of protoporphyrin IX (PpIX) production. In at least one embodiment, increasing the heat output of the irradiation device by, for example, approximately 2°C can provide benefits approximately 20 minutes after treatment. This is comparable to the benefits achieved with a 1-3 hour course of treatment without increasing the temperature.

[0045] Specifically, a method according to one embodiment includes activating a light source, such as a plurality of LEDs 60, and activating a heating element of an irradiation device. The 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. The method may also include activating the plurality of LEDs 60 after heating (e.g., a 5-minute warm-up). For a treatment period of approximately 20 minutes, the total allowable light dose delivered to the patient is approximately 10-20 J / cm. 2 In one exemplary embodiment, the treatment duration may be from about 10 minutes to about 1 hour. In one exemplary embodiment, the total allowable light dose may be from about 10 to 40 J / cm. 2 In at least one embodiment, depending on the clinical situation, the treatment duration may be greater than 1 hour or less than 10 minutes, with a total allowable light dose of 10 J / cm. 2 Less than or 40J / cm 2 Super is fine too.

[0046] In at least one embodiment, the LEDs 60 and the heating element (heat source) 160 may be activated sequentially rather than simultaneously. For example, ALA may be applied first. The heating element may then be activated to apply heat to the patient's skin for a first treatment period for a heat soak, which may be, for example, 20-30 minutes. It has been found that the facial surface temperature stabilizes in about 5 minutes. Following the first treatment period, the light may be applied for a second treatment period, for example, about 8-15 minutes. The total light dose delivered to the patient may be about 10-20 J / cm. 2 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 patient's skin condition. In one exemplary embodiment, the treatment duration may be from about 10 minutes to about 1 hour. In one exemplary embodiment, the total acceptable light dose may be from about 10 to 40 J / cm. 2 In at least one embodiment, depending on the clinical situation, the treatment duration may be greater than 1 hour or less than 10 minutes, with a total allowable light dose of 10 J / cm. 2Less than or 40J / cm 2 Super is fine too.

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

[0048] 9A and 9B illustrate an embodiment of a device according to the present disclosure. The device may be, 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 panels 10a-10e, a heat source (heating element) 160 is attached to frame 150. For example, as shown in FIG. 9B, heat source 160 may be sandwiched between panels 10b and 10d, with at least a portion of the heat source positioned behind panel 10c. Heat source 160 may include multiple curved end portions 162, 164 that extend beyond the multiple panels, allowing at least a portion of the heat source to be directly exposed to the patient without being obstructed by the multiple panels. In at least one embodiment, heat source 160 may be an infrared quartz heater. The combination of panels 10a-10e, frame 150, and end portions 162, 164 forms a partially enclosed space, providing a warm air bath for a portion of the patient (e.g., the patient's head) to be warmed.

[0049] In at least one embodiment, the heat source 160 may comprise a frame-mounted resistive tape heater. In at least one embodiment, the heat source 160 may comprise a plurality of heaters, including at least one selected from the group including an infrared LED, an electrical resistive cartridge heater, a PTC (positive temperature coefficient) heater, or an infrared quartz heater as described above. In at least one embodiment, the infrared quartz heater has a fast response and provides sufficient heat output. Additionally, the infrared quartz heater can be easily controlled by the controller 77, which may be, for example, a PID (proportional-integral-derivative) controller. Furthermore, the infrared quartz heater is compact, allowing it to be integrated into the frame 150 without increasing the size of the frame 150.

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

[0051] FIG. 9C illustrates an irradiator according to one embodiment. In at least one embodiment, the irradiator further includes one or more thermistors. The thermistors may be integrated with the irradiator or may be provided as part of a kit containing a set of diagnostic tools. In at least one embodiment, a negative or positive temperature coefficient thermistor may be provided as a reference control thermistor 170 located at or near the heat source 160. In at least one embodiment, the thermistor 170 may be part of the heat source 160 and located near the top of the panel 10c. The temperature measured by the reference control thermistor 170 may be compared to a temperature measured at the patient's exposed skin, for example, with a temperature probe such as a contact thermocouple placed on the patient's forehead. In some embodiments, one or more thermocouples may be used to correlate the skin temperature (thermocouple temperature) with the temperature sensed by the thermistor 170 (control or thermistor temperature).

[0052] Specifically, one or more thermocouples may be used to determine the relationship between skin temperature and a control temperature when the irradiation device is initially manufactured or during an initial diagnosis. For example, a reference or control temperature may be established based on empirical data, and the reference or control temperature to which the thermocouple temperature is compared may be a temperature value obtained from a table stored in the memory of a control unit connected to the irradiation device. In at least one embodiment, the thermistor may be a programmable thermistor having one or more temperature values ​​stored therein, which may be used to adjust the heat output of the heat source 160 after being programmed. Temperature comparisons may be performed at one or more locations on the patient's exposed skin. For example, temperature measurements may be taken at multiple locations on the patient's face to create a temperature map of the patient's face. Temperature mapping may be performed before and after treatment. Furthermore, the results of the temperature mapping may be compared to the user's needs, for example, as specified in a treatment plan or clinical plan. The results of the patient's temperature mapping may also be compared to the temperature mapping data of one or more other patients.

[0053] In at least one embodiment, the heat source 160 may be used in conjunction with a fan 70. For example, the fan 70 may be operated to circulate cooled air through the system. Additionally, cool or room temperature air traveling along the path indicated by arrow "C" in FIG. 9C may be directed toward a heat exchanger within the heat source 160. The heat exchanger heats the cool air. The heated air traveling 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 controller to provide an air velocity of approximately 3-6 knots and a volumetric flow rate of 14 cubic feet per minute (CFM). In some embodiments, the fan speed may be constant or variable. In at least one embodiment, a controller (which may also control the plurality of LEDs 60 and / or the heat source 160) controls the fan 70. The controller may control the power output of one or more fans 70, for example, by varying the revolutions per minute (RPM) of the fan 70. Heated air may be blown onto the patient's face by fans 70, for example, from above and below heat source 160. This air flow creates a warm air bath or pocket that generally surrounds the patient's skin, for example, to envelop the patient's face in warm air. The thermodynamic behavior of the system allows for control of the patient's skin temperature (measured by a contact thermocouple) to within, for example, about 15°C of the temperature measured by the thermistor. In at least one embodiment, the surface of the patient's skin (e.g., facial skin) reaches a stable temperature within five minutes of thermal radiation from heat source 160.

[0054] By controlling the thermodynamic transfer behavior, the impinging air and heat output from the heat source can be tailored to the desired skin heating effect. In at least one embodiment, a desired skin temperature increase (e.g., 2°C) can be achieved by determining the air temperature increase and corresponding time. That is, the controller may be programmed to determine the temperature increase and time required to heat the patient's skin to the desired temperature. Furthermore, in at least one embodiment, the controller may also make such a determination regarding air velocity and / or volumetric flow rate. This determination by the controller may be made with reference to one or more maps stored in the controller's memory. For example, one such map may relate the temperature of the thermistor 170 to the increase in skin temperature. Another map may relate thermistor temperature to air velocity and volumetric air flow rate. The air velocity and volumetric air flow rate themselves vary based at least in part on the configuration of the heat source 160, and more specifically, the geometry of the configuration and placement of the curved portions (plenum spaces) 162, 164. In at least one embodiment, one or more maps stored in memory may correlate one or more of thermistor temperature, desired skin temperature, volumetric flow rate, air velocity, and air temperature. The controller may reference information from the one or more maps to precisely control skin temperature. The system may include multiple sensors for sensing temperature at multiple locations, and the controller may reference such maps containing data from these sensors to control the heat source 160 at one or more locations. Information from the temperature-heat map may also be taken into account to control heating of the skin at multiple points in accordance with a treatment plan. In one embodiment, such a map may be used to achieve a desired skin temperature without, for example, placing one or more temperature sensors on the skin to directly measure skin temperature.

[0055] FIG. 9D illustrates an embodiment of the irradiation device in which heat is radiated to a control volume, e.g., a cubic volume. In at least one embodiment, the heat source 160 may radiate heat toward a treatment target, e.g., a target within the cubic volume 172 as shown in FIG. 9D. The cubic volume 172 may have a total height of 6 inches, and temperature may be measured at multiple points in the x, y, and z directions of the cubic volume 172. For example, temperature may be sensed 3 inches from the center panel 10c, with the predetermined treatment target located at the center of the cubic volume 172. FIG. 9E illustrates a cubic volume 172 in which the treatment target is the patient's nose at the center of the cubic volume. FIG. 9F is a perspective view illustrating an example of patient positioning relative to the heat source 160 and irradiation device.

[0056] FIG. 10 illustrates a volume (a particular three-dimensional space) in which nodes 1-12 are defined, with node 10 being the center-most node of the volume and node 12 being a node outside (e.g., at a distance from) the volume. To create a temperature map, temperature can be measured at any or all of the nodes. In at least one embodiment, data recording can occur every minute or at different predetermined time intervals. In at least one embodiment, a cubic volume 172 is provided as a measurement framework. Temperature measurements (and distance measurements from one or more panels 10) can be taken at one or more nodes and compared to temperatures measured by, for example, thermistor 170. In this manner, patient positioning relative to the irradiation device can be controlled to ensure that the total allowable light dose is achieved.

[0057] 11A-11B show temperature maps according to one embodiment. FIG. 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 a five-minute warm-up of the heat source 160, the patient can be exposed to light from the light source 60 and heat from the heat source 160 for approximately ten minutes. FIG. 11B shows a temperature map after five minutes of warm-up of the heat source 160 and a ten-minute heat soak. The average skin temperature after the warm-up period and the ten-minute heat soak was 102°F. In at least one embodiment, forced convection can be selected for use, as it provides less instability and temperature variation across the heated target. Additionally, in at least one embodiment, indirect heating can be used, such that the patient's skin does not come into direct contact with the heat source 160. Rather, heat is radiated at a distance from the patient's skin, and the controller determines the proposed radiation pattern based on a comparison of multiple temperature measurements taken at multiple nodes in the control volume 172 with the temperature measurements taken by the thermistor 170.

[0058] In at least one embodiment, the controller may receive temperature feedback from the thermistor 170 and turn the heat source 160 on and off via firmware with 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 skin temperature and provide the detected skin temperature data to the controller. Input from the non-contact IR sensor may be represented in one or more maps stored in the controller as additional data indicative of skin temperature. In at least one embodiment, during an initial warm-up period (e.g., 5 minutes), the heat source 160 begins warming, but the system is in a transient state rather than a steady state where it can be controlled to deliver a desired power output. The non-contact IR sensor may detect the patient's skin temperature and compare the detection results to multiple patient skin temperature values. Such skin temperature data may be obtained from a sample population and stored in a map within the controller. If a patient's skin temperature is lower than the average skin temperature, the controller may increase the heating rate of the heat source 160 to more efficiently promote warming of the patient's skin. Alternatively, if the patient's skin temperature is above the average skin temperature, the heating process may continue without increasing the rate.

[0059] In at least one embodiment, skin or tissue temperatures were as high as about 40.3-42.6°C, with an average skin temperature of 41.3°C. Thermal testing was performed at 10 mW / cm 2 and 20 mW / cm 2 The thermal tests showed that the light itself did not appear to affect the skin temperature of the patient's face when heat was also applied.

[0060] Figures 12A-12D show temperature data without light application. Specifically, Figure 12A shows a temperature map of the patient's skin or tissue temperature before heating, and Figure 12B shows a temperature map after heating with a 10-minute heat soak. Figure 12C shows skin temperature (thermocouple temperature) and thermistor temperature data at nodes 1-12. Figure 12D shows a plot of the thermocouple temperature and thermistor temperature at the center node 10 over time during the heat soak.

[0061] 13A-13D show temperature data without the application of heat. Specifically, FIG. 13A shows a temperature map of a patient's skin or tissue without the application of heat. FIG. 13B shows a temperature map after light therapy. FIG. 13C shows temperature data (thermocouple and thermistor data) at the center node 10. FIG. 13D shows plots of thermocouple and thermistor data over time for a treatment protocol in which the heat source 160 was not turned on. Specifically, FIG. 13D reflects a "light only" treatment, where the patient's skin temperature is measured from the time the light source is first activated. For example, five minutes may elapse between when the light source is first activated and when the patient's skin temperature is measured, after which the patient may receive an additional 10 minutes of light-only treatment.

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

[0063] Additional advantages and modifications will readily occur to those skilled in the art. Accordingly, the present invention is not limited to the specific details and representative apparatus and methods shown and described herein. Various modifications may be made without departing from the spirit and scope of the general inventive concept as defined by the appended claims and their equivalents. [Explanation of symbols]

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

Claims

1. 1. An illumination device for photodynamically diagnosing or treating a surface, comprising: a plurality of panels; a plurality of light sources, each attached to one of the plurality of panels and configured to illuminate the surface with visible light of a substantially uniform intensity; and a heat source configured to radiate heat towards a patient between outer panels of the plurality of panels.

2. 10. The irradiation device of claim 1, further comprising a controller programmed to control operation of the heat source.

3. The irradiation device of claim 1 , wherein the heat source comprises an infrared heater having a quartz emitter.

4. The illumination device of claim 1 , wherein the plurality of light sources are light emitting diodes.

5. The illumination device according to claim 1 , wherein the plurality of light sources are configured to emit light having a wavelength of 400 nm to 430 nm.

6. 6. The illumination device of claim 5, wherein the plurality of light sources are configured to emit light at a wavelength of 417 nm.

7. 5. The illumination device of claim 4, wherein at least a first panel of the plurality of panels comprises from about 80 to about 350 individual light emitting diodes and at least a second panel of the plurality of panels comprises from about 50 to about 250 individual light emitting diodes.

8. The illumination device of claim 1 , further comprising at least one thermistor configured to sense a temperature of the heat source.

9. 10. The illumination device of claim 1, wherein the measured output across the effective light-emitting area of ​​the illumination device is at least 60% of the maximum measured output at all operating distances.

10. The illumination device according to claim 1 , wherein the power supplied to the light sources located in the peripheral area among the plurality of light sources is greater than the power supplied to the light sources located in the central area among the plurality of light sources.

11. The irradiation device of claim 2 , wherein the control device is configured to adjust the total light dose based on a selected treatment area.

12. The illumination device of claim 2 , wherein the control device is configured to cause the illumination device to emit a fixed amount of light based on a selected treatment duration.

13. 1. A method for performing photodynamic diagnosis or treatment on a patient, comprising: controlling a heat source to apply heat to the patient's skin during a first time period; and irradiating the patient with light during a second time period after the first time period using an irradiation device for treating skin diseases, the irradiation device having a plurality of panels, at least one of the panels being provided with at least one light source.

14. 14. The method of claim 13, wherein the at least one light source is a plurality of light sources, and further comprising varying the output power of the light sources so that the measured output power over the entire effective light-emitting area is at least 60% of the maximum measured power at all operating distances.

15. 14. The method of claim 13, further comprising: measuring temperature at a plurality of locations within a set distance from at least one of the panels; and creating a temperature map showing the temperature distribution across the plurality of locations.

16. 14. The method of claim 13, further comprising: measuring temperatures at a plurality of locations within a set distance from at least one of the panels; and comparing the temperatures measured at the plurality of locations to a reference temperature measured at the heat source.

17. The method of claim 13 , wherein the at least one light source is configured to emit light having a wavelength of at least 400 nm.

18. The method of claim 13 further comprising pre-warming the heat source during the first period of time.

19. A method for performing photodynamic diagnosis or therapy on a patient, comprising: irradiating a patient with light using an irradiation device having a plurality of light sources; and warming the patient's skin by radiating heat from a heat source during the light irradiation, wherein the irradiation of light from the plurality of light sources is started approximately simultaneously with the radiation of heat from the heat source to the patient.

20. 20. The method of claim 19, further comprising varying the output power of the light source so that the measured output power over the entire effective light-emitting area is at least 60% of the maximum measured power at all operating distances.

21. 21. The method of claim 20, further comprising: measuring temperatures at a plurality of locations within a set distance from a portion of the irradiation device; and creating a temperature map showing the temperature distribution across the plurality of locations.

22. 14. The method of claim 13, wherein the irradiation device is configured to surround the patient's head on at least three sides.

23. 1. An illumination device for photodynamically diagnosing or treating a surface, comprising: a plurality of panels; a plurality of light sources, each light source attached to one of the plurality of panels and configured to illuminate the surface with visible light; and at least one sensor configured to detect an orientation of at least one of the plurality of panels.

24. 24. The illumination device of claim 23, further comprising: a heat source configured to radiate heat to the surface; and a controller programmed to adjust at least one of a light output of at least one of the plurality of light sources and a heat output of the heat source based on the detected orientation.

25. 24. The illumination device of claim 23, further comprising a controller programmed to control an output of at least one of the plurality of light sources based at least on the orientation and skin temperature detected by the sensor.

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