JP7382832B2 - Adjustable irradiation device and method for photodynamic therapy and diagnosis - Google Patents

Description

[Cross reference to related applications]
This application claims the benefit of priority from U.S. patent application Ser. No. 15/487,991, filed April 14, 2017, and is incorporated by reference in its entirety.

The present disclosure generally describes multiple methods, including adjustable illumination devices and operation of 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. Regarding.

Photodynamic therapy (PDT), photodynamic diagnosis (PD), or photochemotherapy is 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 the patient (e.g., arms and legs). .

In one form of PDT or PD, a patient is first administered a photoactivating agent or a precursor of a photoactivating agent that accumulates within the tissue to be treated or diagnosed. Photoactivators and precursors may be administered, for example, to treat skin disorders. The site where the photoactivating agent is being administered is then exposed to visible light, which causes chemical and/or biological changes in the photoactivating agent. These changes allow the drug to selectively locate, destroy, or degenerate the target tissue while causing only mild and reversible damage to other tissues within the treatment area. An example of a precursor of a photoactivating agent is 5-aminolevulinic acid (“ALA”), which is commonly used in PDT for actinic keratoses. As used herein, the term ALA or 5-aminolevulinic acid refers to ALA itself, its precursors, and pharmaceutically acceptable salts thereof.

For effective treatment, uniform output in intensity and color is desirable. U.S. Patent Nos. 8,758,418, 8,216,289, and 8,030,836, all of which are incorporated by reference in their entirety, for techniques, methods, compositions, and devices related to PDT and PD. No. 7,723,910, No. 7,190,109, No. 6,709,446, and No. 6,223,071 disclose irradiation devices (illuminators, illuminators) for therapeutic purposes. Typically used to provide adequate uniformity of light. Generally, these devices include a light source (e.g., a fluorescent tube), a coupling element that directs, filters, or directs the emitted light so that it reaches the intended target in a usable shape, and optionally a coupling element for directing, filtering, or directing the light so that it reaches the intended target in a usable shape. and a control system for starting and stopping production.

Because PDT can be used to treat a variety of treatment areas, some delivery devices employ two or more panels, each with a light source that emits light to the intended target area. These panels are pivotally connected to each other. By having multiple pivotable panels, the overall size and shape of the illuminated area can be varied depending on the intended treatment area.

In conventional adjustable illumination devices, the panels have the same width and length and are typically driven at the same power level. Further, the plurality of panels are connected at the ends by hinges, and are configured to be rotatable to form a desired shape. However, due to multiple panel edges and multiple hinges, the light source(s) of one panel cannot be located directly next to the light source(s) of an adjacent panel. . As a result, no light is emitted from the "gap" between the plurality of light sources. When applying uniform power to multiple panels, optical "dead space" can occur in certain portions of the treatment target area because no light is emitted from such areas. Therefore, the overall amount of light received by these areas is reduced, resulting in a lower treatment dose. In some cases, the treatment dose may be reduced by a factor of five compared to areas that receive the optimal amount of light.

Generally, these conventional irradiation devices are used for phototherapy of acne, where the administration of photoactivating agents is usually not required for effective treatment. Therefore, irradiation with light alone is generally sufficient treatment. Also, because multiple treatment sessions can be used to effectively treat a disease, there may be less concern about the uniformity of the light delivered across the target area when administering the treatment. However, certain treatments involving PDT, such as the use of ALA to treat actinic keratoses, require specific and highly uniform intensities and colors of light to be effective. In these instances, successful PDT relies on targeted delivery of both the right amount of photoactivator and the right amount (i.e., power and wavelength) of light to produce the desired photochemical reaction in the target cells. ). Thus, to achieve this, the light source must illuminate the target area, and both the wavelength and power of this illumination must be uniform. In conventional adjustable illumination devices, optical dead space that can occur at or near the hinge reduces the uniformity of light along the treatment area, thereby reducing the effectiveness of PDT in a particular treatment. Furthermore, these radiation devices are also configured to be adjusted within a limited range so as to treat only a limited portion of the patient's body surface, such as the patient's face or scalp. . Additionally, due to the wide variety of patient body contours, the uniformity of light delivered by these conventional illumination devices can vary widely depending on the patient's treatment area.

Accordingly, some embodiments of the present invention reduce or eliminate these dead spaces and provide a more uniform light distribution in adjustable illumination devices designed for PDT and/or PD of diverse target sites. The purpose is to Additionally, some embodiments of the present disclosure provide uniform light across various parts of a patient's body, such as the patient's extremities (e.g., arms and legs) and torso, as well as the patient's face and scalp. The objective is to provide an infinitely adjustable irradiation device that can be delivered effectively. Therefore, uniform light can be sent to the treatment target area regardless of the external shape or position of the patient's body.

One embodiment of the present disclosure includes a plurality of panels, with at least one panel having a different width than the other panels. This panel is placed between two other panels and emits enough "fill-in light" to reduce or eliminate optical dead space when the panel is bent into a particular shape. It functions as a "hinge that lights up." Preferably, a total of five panels may be provided to optimally increase the total area of the treatable area. Preferably, two of the panels are smaller in width than the other three larger panels. The panels are staggered, with each smaller width panel positioned between two of the three larger panels, thereby providing adjustability and increasing uniformity. Also, to further reduce or eliminate optical dead space, it is preferable to connect the panels with each other by nested hinges to reduce the area of the illumination device where there is no light source. To further reduce or eliminate optical dead space, the light sources in each panel are configured to deliver specific power to specific ranges of the light sources in the panels to compensate for the reduced uniformity. Preferably, it is individually configurable. For example, the power output to each diode of a light emitting diode (LED) array may be individually adjusted.

One embodiment of the present disclosure includes 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 substantially uniform intensity of visible light; and a heat source configured to radiate heat towards a patient between outermost panels of the invention.

Another embodiment of the present disclosure includes controlling a heat source to apply heat to the patient's skin during a first time and having a plurality of panels, at least one of the plurality of panels having at least one irradiating the patient with light during a second time period after the first time period with an irradiation device for treating a skin disease, the radiation device being provided with two light sources; or relating to a method of providing treatment.

Further embodiments of the present disclosure include irradiating a patient with light using an irradiation device having a plurality of light sources, and radiating heat from a heat source to warm the patient's skin during the irradiation of the light, the plurality of The present invention relates to a method for performing photodynamic diagnosis or treatment on a patient, characterized in that irradiation of light from a light source starts almost simultaneously with radiation of heat from a heat source to the patient.

Further embodiments of the present disclosure include a plurality of panels, a plurality of light sources each attached to one of the plurality of panels and configured to illuminate a surface of the plurality of panels with visible light; and at least one sensor configured to detect the orientation of at least one of the surfaces.

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

1A and 1B are top views showing a main body of an irradiation device according to an exemplary embodiment. 2A and 2B are perspective views showing the main body of the irradiation device of FIGS. 1A and 1B. FIG. 3A is a detailed view of the nested hinge of the body of the illumination device of FIGS. 1A and 1B. FIG. 3B is a detailed view of the nested hinge of the body of the illumination device of FIGS. 1A and 1B. FIG. 4 is a perspective view of the irradiation device in which the main body of FIGS. 1A and 1B is attached to a stand. FIG. 5 is a schematic diagram showing the addressable configuration of the LEDs attached to the body of the illumination device of FIGS. 1A and 1B. FIG. 6 is a schematic diagram showing the width and length of each panel of the main body of the irradiation device of FIGS. 1A and 1B. FIG. 7 is a graph showing the amount of light over the entire treatment area using a conventional panel-type irradiation device. FIG. 8 is a graph showing the light dose of the entire treatment area when the same area as in FIG. 7 is treated using the irradiation device according to one embodiment. FIG. 9A shows an irradiation device according to one embodiment. FIG. 9B shows an irradiation device according to one embodiment. FIG. 9C shows an irradiation device according to one embodiment. FIG. 9D shows an irradiation device according to an embodiment in which heat is radiated into a control volume, for example a cubic volume. FIG. 9E shows a control volume according to one embodiment. FIG. 9F is a perspective view showing a configuration according to one embodiment. FIG. 10 shows a cubic volume in which a plurality of nodes (node points) are set. 11A and 11B illustrate temperature data according to one embodiment. FIGS. 12A and 12B show temperature data in the absence of light. FIG. 12C shows temperature data without light. FIG. 12D shows temperature data without light. FIGS. 13A and 13B show temperature data when no heat is applied. FIG. 13C shows temperature data without applying heat. FIG. 13D shows temperature data without applying heat. 14A and 14B illustrate node-based temperature data according to one embodiment. FIG. 14C illustrates node-based temperature data according to one embodiment. FIG. 14D illustrates node-based temperature data according to one embodiment.

Various embodiments are described below. Note that the particular embodiments are not intended as exhaustive descriptions or limitations 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.

As will be understood by those skilled in the art, all ranges disclosed herein, for any and all purposes, particularly with respect to providing a written description, also include any and all possible subranges and subranges thereof. Also includes combinations of. Any listed range is easily recognized as sufficient to describe and enable the same range to be divided into at least one-half, one-third, one-fourth, one-fifth, one-tenth, etc. can be done. As a non-limiting example, each range discussed herein can be easily subdivided into a lower third, a middle third, an upper third, and so on. Also, as will be understood by those skilled in the art, all terms such as "up to", "at least", "greater than", "less than", etc. Refers to a range that can be divided into partial ranges. Finally, as will be understood by those skilled in the art, ranges include each individual element.

Unless stated otherwise, all numbers expressing quantities of characteristics, parameters, conditions, etc. used in the specification and claims are to be understood as modified in all cases by the term "about" . Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and appended claims are approximations. Any numeric parameters should at least be interpreted by considering the reported number of significant digits and applying normal rounding techniques. The term "about" when used before a numerical designation, such as a range of temperatures, times, amounts, and concentrations, refers to an approximate value that may vary by (+) or (-) 10%, 5%, or 1%. shows.

1A and 1B and 2A and 2B illustrate embodiments of configurable illumination devices (illuminators, illuminators) according to the present disclosure. The body 100 of the illumination device preferably has five individual panels 10a-10e, each panel being pivotally connected via a nested hinge 50. Each panel includes a light emitting diode (LED) array 60, which may be arranged in an evenly 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 or halogen lamps may be used.

Preferably, each LED array 60 extends to as many ends as possible. Further, the LED array 60 can be sized to provide a total area of illumination for any treatment area based on a range from the 5th percentile of size corresponding to a female subject to the 95th percentile of size corresponding to a male subject. preferable. The plurality of LED arrays 60 emit light at wavelengths appropriate for the intended treatment or for activating a particular photoactivating agent used in treatment or diagnosis. For example, if ALA is used as a precursor of a photoactivating agent for actinic keratosis treatment, the plurality of LED arrays 60 may have a wavelength of 400 nanometers (nm) or greater, such as about 430 nm or about 420 nm, as an example. , 417 nm blue light is preferably emitted. However, the LED array 60 may emit visible light in other spectral regions, such as in the green and/or red region between 400 and 700 nm, for example about 625 nm to 640 nm, or, by way of example, 635 nm. 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. Further, 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 diodes turn on and off to emit light at predetermined intervals. Additionally, LED array 60 may be configured to emit only one wavelength of light (eg, blue). Alternatively, multiple LED arrays 60 may be configured such that two or more wavelengths of light are emitted from the array. For example, the plurality of LED arrays 60 may be configured to alternately emit blue and red light for therapeutic purposes.

As shown in FIGS. 1A and 1B, and 2A and 2B, the five panels 10a to 10e have different widths. Specifically, in certain embodiments, three panels 10a, 10c, 10e are wide and two panels 10b, 10d are narrow and configured to be small. The widths of the two panels 10b and 10d are smaller than the widths of the three wider panels 10a, 10c and 10e, respectively. In some embodiments, the widths of the three widely configured panels 10a, 10c, 10e are approximately equal. In other embodiments, the three widely configured panels 10a, 10c, 10e have different widths. Further, the widths of the two narrow panels 10b and 10d may be approximately equal or may be different from each other. Furthermore, the panels are arranged in an alternating arrangement with a narrow panel (eg, 10b) located between two wide panels (eg, 10a, 10c). As shown in FIG. 6, in some embodiments, narrow panels 10b, 10d are configured with a width that is approximately 30% to 60% less than the width of wide panels 10a, 10c, 10e. In other embodiments, the narrow panels 10b, 10d are configured with a width that is approximately 30% to 50% less than the width of the wide panels 10a, 10c, 10e.

As shown in FIGS. 1A and 1B and 2A and 2B, the panels 10a to 10e are rotatably connected by hinges 50. As shown in FIGS. The hinge 50 may be in the form of a nested hinge, including hinges that significantly reduce or eliminate optical dead space. As shown in Figures 2A and 2B, on at least one side of the panel, tabs 23 may extend from both the top and bottom of the panel. As shown in FIG. 2A, the plurality of tabs 23 are configured such that one side of adjacent panels is accommodated between the plurality of tabs 23. Thus, as shown in FIGS. 2A, 2B, and 6, the height of an adjacent panel (eg, panel 10a) is slightly less than the height of the tabbed panel (eg, panel 10b) that it accommodates. As shown in FIG. 6, the central panel (i.e., panel 10c) is configured with tabs on both sides to maximize its height so that it can accommodate the sides of adjacent panels on each side. It is preferable that As shown in FIGS. 1A and 1B, each tab 23 further includes an opening for inserting a bolt for connecting adjacent panels.

The panels 10a-10e may be arranged in such a way that the laterally located panels can be moved so that the total coverage area or range of the panels 10a-10e is increased, and may extend to areas such as the patient's chest or abdomen. It may be configured as follows. 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 (eg, bent or angled) arrangement. The panel may be moved to continuously change shape. In at least one embodiment, one or more detent mechanisms are provided on one or more panels to hold the one or more panels in a desired position. one or more detent mechanisms to inhibit movement of the panel by the detent mechanism to achieve a plurality of different panel configurations for treatment in which the panel is maintained in a particular position during patient treatment; may be provided on one or more panels. The panels may be arranged relative to each other such that the illumination device has one or more particular shapes. In at least one embodiment, the panels may be arranged relative to each other such that the illumination device is, for example, at least one of a curved, flat, or folded configuration.

As shown in more detail in FIGS. 3A and 3B, nested hinges 50 are provided between a plurality of tabs 23 and attached to the inner sides of a plurality of adjacent panels (e.g., 10a, 10b). , multiple 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 of the panel may include a recess in which the flange 51 is placed. The inner side of the panel may also include a further recess to accommodate the joint of the hinge 50 such that the joint of the hinge 50 is substantially flush with the outer surface of the panel. Such a configuration allows the outer vertical ends of adjacent panels to be placed close to each other. Optical dead space can be further reduced or eliminated by closer spacing between the vertical edges of adjacent panels. Also, by providing multiple tabs 23 along with multiple hinges 50, the number of pinch points present in the system can be reduced.

As shown in FIGS. 1A and 1B, the main body 100 of the irradiation device may include a mounting head 40. As shown in FIGS. Having the mounting head 40 allows the main body 100 to be mounted on a movable stand 80 shown in FIG. 4 so that the user can easily move the main body 100 to the appropriate treatment position. Stand 80 includes a base 81 and a vertical post 82. The base 81 may further include a plurality of wheels 87 at the bottom to allow the user to horizontally move the illumination device to the appropriate position. The wheels 87 may include locks to prevent further horizontal movement of the stand 80 once properly positioned. Vertical struts 82 may also be attached to base 81 at pivot points 83. The pivot point 83 allows the vertical support 82 to rotate, thereby widening the range of position adjustment of the irradiation device. Vertical post 82 includes at its upper end a connecting arm 85 that can serve as a mounting structure for body 100. Connecting arm 85 includes a hinge point 86 to allow body 100 to move vertically relative to stand 80 . Vertical strut 82 may also be configured as a telescoping structure to allow a user to change the height of vertical strut 82. This increases the range of movement of the main body 100 in the vertical direction, allowing the user to position the main body 100 at low-lying treatment sites such as the patient's legs and feet. Stand 80 may include stabilizing arms 84. After positioning stand 80 and body 100, stabilizing arm 84 may be attached to body 100 to prevent unwanted movement of body 100 during treatment. Further, as shown in FIG. 4, a control device and power source 90 are mounted on the stand 80 to power the body 100 and allow a user to control the body 100 for therapeutic purposes. Alternatively, the control device and power source 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.

Also, at least one control device (also referred to as a control unit) is connected to the panel to adjust the power supply so that the plurality of lights achieves the uniformity and intensity required for the desired treatment. In at least one embodiment, the controller may also control the output of heat source 160, as described in more detail below. In at least one embodiment, at least one dynamic process is controlled, e.g., one or more light sources, one or more heat sources, and/or one or more air sources (such as fans). Multiple control devices may be provided to control the outputs in any combination. For example, a plurality of control devices may be provided separately or in an integrated manner to respectively control the output of the plurality of LED arrays 60 and the output of the heat source 160. In at least one embodiment, by way of example, a first controller may control both a light source and a heat source, and a second controller may control an air source.

The control device may be realized as hardware, software, or a combination thereof, such as a combination of a storage device that stores a computer program and a processor that executes the program. Alternatively, uniformity and efficiency may be further improved by providing each panel with a dedicated controller that adjusts the power delivered to one LED array in any given panel to perform a specific calibration with the illumination device. . For example, according to Lambert's law of cosines, 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. Thus, a light beam directed in front of a curved surface (eg, a patient's head) will reach that area approximately perpendicularly, resulting in an absorbance of 100%. However, the light rays that reach the side edges of the curved surface arrive approximately parallel to each other. According to Lambert's cosine law, the intensity and absorption of light approach zero at the side edges, making treatment at that area ineffective. Thus, a "fall off" in exposure dose tends to occur at the edges of the curved surface. Also, the longer the distance between the light source and a point on the surface, the greater the "drop".

The shape of the irradiator that conforms to the curved surface (eg, a U-shape designed to "wrap" the curve of the surface) helps reduce this effect and increases 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 of the treatment area is illuminated from all angles. In order to increase the uniformity of exposure of the treatment area while keeping the irradiation device to a practical size, multiple LED arrays 60 are individually arranged so that the intensity of the light emitted by a particular diode is increased to compensate for the dip phenomenon. It may be configured as follows.

An example of multiple LED arrays 60 that can be individually configured is shown in FIG. Here, the plurality of LED arrays 60 are divided into three regions, which are "addressable strings" (multiple LEDs connected in a string, each LED can be individually controlled). It's okay. Regions 1, 3 and 5 correspond to addressable string configurations, which may be included in wide panels 10a, 10c and 10e. Regions 2, 4 and 6, on the other hand, correspond to addressable string configurations, which may be included in narrow panels 10b and 10d. The current to each region is adjusted to adjust the intensity of 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 with 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 overall intensity of the light emitted from the end increases, and the drop phenomenon can be reduced. Alternatively, the illumination device may be configured to individually adjust each diode in a given LED array 60 to provide even greater calibration effects (ie, allow for fine tuning).

Additionally, multiple LED arrays 60 may be individually configured to emit more intense light only to the desired areas using pre-programmed settings or multiple sensors that detect the curvature of the surface to be treated. good. 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 may also be used to Or, it may be used to configure multiple LED arrays 60 to emit weak light to desired areas. Specifically, in at least one embodiment, at least one sensor detects the orientation of at least one panel and provides detection information to a controller. The plurality of sensors may include one or more encoders, such as one or more angular encoders, located at one or more locations on the panel. In at least one embodiment, the at least one sensor is a microswitch configured to sense the position of the at least one panel. In some embodiments, the plurality of sensors may include encoders, microswitches, or a combination thereof. The sensor is configured to communicate with the controller and provide the controller with information regarding the orientation of the panel, such as the angle at which the panel is positioned. Then, the control device controls the intensity of the light according to the detection result. In at least one embodiment, the plurality of sensors provide information to the controller such that the controller can determine whether the shape of the illumination device is one of a plurality of predetermined configurations. be done. For example, the controller may store information regarding one or more preset structures (eg, curved illuminators, flat illuminators, etc.) in memory.

When the controller receives information transmitted from the plurality of sensors, the controller compares the sensed information with the preset structures and determines a match between the sensed information and the one or more preset structures. It's okay. Further, the controller may store a protocol for changing the intensity that is executed when it is determined that the sensed information matches one or more preset structures. For example, if the illumination device is detected to be a curved illumination device, the controller implements a light intensity output that correlates with a preset protocol for curved illumination devices. The controller may further compare the current strength and the strength associated with the particular structure and determine whether the strength should be adjusted. As a result, the output and/or light intensity can be increased only in specific diodes as needed, and the uniformity of exposure can be efficiently improved. In at least one embodiment, a plurality of structures may be presented to the clinician or practitioner on a touch screen, for example, and a preset structure may be selected that corresponds to the physical placement of the delivery device in the clinical environment. good.

Additionally, the multiple addressable strings of LED array 60 may include varying numbers of individual diodes attached to particular areas. For example, for wide panels 10a, 10c and 10e, 12 diodes are installed in each area 1, 9 diodes are installed in each area 3, 41 diodes are installed in area 5, and wide panels 10a, 10c and 10e may each include a total of 83 individual diodes. For narrow panels 10b and 10d, 8 diodes are installed in each area 2, 9 diodes are installed in each area 4, and 23 diodes are installed in area 6, and each of narrow panels 10b and 10d is may include 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, wide panels 10a, 10c and 10e may each include a total of between about 80 and about 350 diodes. Similarly, narrow panels 10b and 10d may each include a total of between about 50 and about 250 diodes. By varying the placement of diodes in each of the addressable strings of LED array 60, the power and/or intensity of light emitted from any given array may be better controlled and fine-tuned.

Additionally, individually adjusting the power supplied to multiple LED arrays 60 may also help reduce or eliminate optical dead space that may otherwise occur at multiple hinge points. can. Specifically, near the ends of the array closest to the nested hinges, the power and/or emission intensity may be increased to compensate for the lack of light emitted from the points of contact between the panels. The narrow panels 10b, 10d are also preferably operated at higher power levels and/or higher luminous intensity than the wider panels 10a, 10c, 10e to provide additional fill-in light. Additionally, individual power adjustments may help compensate for manufacturing tolerances in each diode. Finally, because each array is individually configurable to meet the lighting needs of a particular application, each array 60 can be fine-tuned to easily position the panels for use in other applications. .

The irradiation device may further include a timer that can indicate to the user the appropriate length of exposure time for a particular treatment. The delivery device may also be programmed with pre-stored light dose parameters to allow the user to select the type of treatment desired. Pre-stored parameters may include, for example, pre-stored settings for exposure time, light intensity and output wavelength. Based on the treatment selected, the delivery device is automatically configured to provide the appropriate power to provide the correct light dose and uniformity required for the treatment. Alternatively, the irradiation device can be equipped with a sensor that detects the size of the treatment area located in front of the irradiation device. These sensors then determine accurate light dose parameters based on the sensed treatment area. The delivery device may also further include an actuator and be programmed to move automatically depending on the selected treatment. After a treatment is selected, the actuator may automatically position the irradiation device into the appropriate configuration without the user manually moving the system. Further, the sensor may detect an adjustment position of the irradiation device that is manually set by the user. The detected position of the irradiation device may then be used to indicate the intended treatment site. Accurate light dose parameters for a particular treatment area may then be provided based on the detection position set by the user.

With the irradiation device of the present disclosure, there are an infinite number of configurations that can be adapted to the treatment target area. These structures vary from planar emitters (as shown in FIGS. 1B and 2B) to approximately U-shaped structures (as shown in FIGS. 1A and 2A). The adjustable irradiation device can also be used to create a smaller U It may be configured to form a letter-shaped structure. In this manner, adjustable radiation devices allow additional treatment of other areas of the patient's body. That is, an adjustable illumination device can not only effectively deliver uniform intensity light to traditionally targeted surfaces such as the face and scalp, but also to other parts of the patient's body, particularly the arms and It can also be easily constructed as a device for treating areas with small curved surfaces, such as legs. Furthermore, the adjustable illumination device can also be easily positioned to deliver a uniform intensity of light to larger treatment areas, such as the back or chest.

As mentioned above, the narrow panels 10b, 10d are sized such that they function as "lighting hinges." Therefore, when the wide panels 10a, 10c, 10e are shaped into a desired shape, "bending" conventionally occurs substantially at the hinges themselves, but in this irradiation device, "bending" occurs at the narrow panels 10b, 10d. In this way, instead of the "bent" part that does not light up in conventional irradiation devices, this irradiation device has a "bent" part that is configured to also emit light, thereby providing the necessary fill-in light. Optical dead space can be reduced without requiring large differences in the power supply between the light sources of each panel to provide the optical dead space. The effect of this configuration can best be understood by comparing FIGS. 7 and 8. Figure 7 shows the uniformity of light from a conventional illumination device, measured at a distance of 2 inches using a cosine-sensitive detector that mimics the response of the patient's skin to the incident light described above. be. The total light dose, expressed in units of J/cm ² , was measured over time (in seconds) based on the irradiance (W/cm ² ). The illustrated treatment target region is the patient's head, with height as the y-axis and rotation angle from the center of the radial plane as the x-axis. As can be understood from FIG. 7, the light dose is as high as about 10 J/cm ² at the center of the face near the patient's nose (for example, region A). At this point, the patient is closest to the centermost panel and facing approximately vertically. The total light dose decreases as you move away from the center of the face, and the cosine "dip" phenomenon and optical dead space become more visible. For example, the light dose is reduced by about 20% in the patient's cheek area (e.g., area B) and by about 80% towards the outer borders of the patient's face, such as the ears and forehead (e.g., area E). do. Therefore, as shown in Figure 7, a conventional adjustable illumination device using panels of the same size operating at the same power level requires particularly high light uniformity, as it results in fields of varying light uniformity. It is undesirable and ineffective for treatment.

Although the particular embodiments described above are directed to illumination devices that include multiple panels, other embodiments may include arcuate illumination devices that do not have individual linear panels. For example, in at least one embodiment, the illumination device may be comprised of at least one curved member. Further, the arch-shaped irradiation device may be configured such that the plurality of substantially curved portions extend from a substantially flat portion provided therebetween. The patient's face may be placed facing a substantially flat area so that the patient's head is surrounded by the irradiation device from at least three sides. 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.

On the other hand, FIG. 8 illustrates the light uniformity produced by embodiments of the present disclosure. The treatment target site is the same as the site measured in FIG. However, compared to Figure 7, the uniformity of the light output produced by this illumination device is significantly higher across the patient's face, from the light output measured at the center of the patient's face to the edges of the patient's face. There is little or no variation in the measured light output. For example, as shown in FIG. The amount is approximately 10 J/cm ² (for example, region A'). Furthermore, the reduction in total light dose at the outermost borders of the patient's face is minimal (eg, region B'). In one embodiment, the measured power over the entire effective emission area (over the total effective emission area) is greater than or equal to 60% of the maximum measured value (over the entire effective emission area) measured by the cosine sensitive detector at any working distance. More preferably, the measured power of the entire light emitting area is greater than or equal to 70% of the maximum measured value at a distance of 2 inches to 4 inches. More preferably, the measured power of the entire light emitting area is greater than or equal to 80% of the maximum measured value at a distance of 2 inches to 4 inches.

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

Basically, 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 inhibit dispersion of the ALA mixture. The mixture may be applied by the technique disclosed in U.S. patent application Ser. good. After the first application of the ALA mixture has dried, one or more successive applications may be performed in a similar manner. Approximately 10-20% ALA solution is administered. Formation of photosensitive porphyrins and photosensitization of the treated lesions occurs after 30 minutes to 18 hours. Exposure to direct sunlight or other bright light sources during this time should be minimized. Between 30 minutes and 18 hours after administration of ALA, the lesion is irradiated with an adjustable irradiation device according to the present disclosure. The irradiation device irradiates the lesion with uniform blue light for a predetermined period of time. In a preferred treatment, the visible light has a nominal wavelength of 417 nm.

Such embodiments thus provide a method for photodynamic diagnosis or treatment of contoured surfaces of a patient, comprising: providing the adjustable illumination device as described above; positioning the patient relative to the illumination device; A method is provided that includes irradiating a patient with light for diagnosis or treatment. Light may be applied to a patient to treat actinic keratosis, acne, photodamaged skin, cancer, warts, psoriasis, or other skin conditions. Such methods may also be used for hair removal and cancer diagnosis and treatment.

One of the parameters that needs to be controlled to deliver an accurate therapeutic light dose is the exposure time, since total light dose (J/cm ² ) = irradiance (W/cm ² ) x time (seconds). . This may be achieved by the timer mentioned above. This timer can appropriately control the power supplied to the plurality of LED arrays 60, and the timer is configurable by the physician. The data indicates that 10 J/ ^cm2 delivered from a light source at an irradiance density of 10 mW/cm2 or an irradiance density of about 9.3 to about 10.7 mW/ ^cm2 is applied to the desired treatment area (e.g. face, scalp, extremities) ^. demonstrated to produce clinically acceptable results. According to the above equation, this light dose requires an exposure time of 1000 seconds (16 minutes and 40 seconds). Additionally, due to the individually controllable nature of the adjustable irradiation device, patients may be treated using the irradiation device at a higher power to reduce the time required for effective treatment. . For example, an adjustable irradiation device may emit light with an exposure time of 500 seconds (8 minutes 20 seconds), an irradiance density of 20 mW/ ^cm2 , and a clinically acceptable light dose of 10 J/ ^cm2 . Good too. Alternatively, the adjustable irradiation device may be operated at a higher power range during the exposure time, for example 30 mW/ ^cm2 , resulting in a light dose of 10 J/ ^cm2 . Selective light doses may also be implemented by additionally or alternatively varying the irradiance density during the treatment period. In at least one embodiment, the controlled parameter is the temperature at which the irradiation device is heated, as described below.

According to one embodiment, a treatment method includes warming up an irradiation device to emit heat from the irradiation device and exposing skin of a patient to the irradiation device. Heat promotes the conversion of ALA to porphyrins (eg, photosensitive porphyrins or protoporphyrins). The relationship between temperature exposure and ALA conversion is nonlinear, and the enzymatic pathways involved in conversion are highly sensitive to temperature. In at least one embodiment, increasing the temperature by about 2° C., for example, can approximately double the rate of production of protoporphyrin IX (PpIX). In at least one embodiment, the thermal output of the irradiation device can be increased, for example, by about 2 degrees Celsius, so that the effect can be achieved about 20 minutes after treatment. This is comparable to the effect achieved with a course of treatment of 1 to 3 hours without increasing the temperature.

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 an illumination device. Such methods may include activating both the plurality of LEDs 60 and the heating element simultaneously so that both light and heat are applied during the treatment period. The method may also further include activating the plurality of LEDs 60 after heater heating (eg, 5 minutes of prewarming). For a treatment period of about 20 minutes, the total allowable light dose delivered to the patient may be about 10-20 J/cm ² . The treatment period in one exemplary embodiment may be about 10 minutes to about 1 hour. The total allowable light dose in one exemplary embodiment may be about 10-40 J/cm ² . In at least one embodiment, the treatment duration may be greater than 1 hour or less than 10 minutes, and the total allowable light dose may be less than 10 J/cm ² or greater than 40 J/cm ² , depending on the clinical situation.

In at least one embodiment, multiple LEDs 60 and heating elements 160 may be activated sequentially rather than simultaneously. For example, ALA may be applied first. The heating element can then be activated to apply heat to the patient's skin during a first treatment period for the heat soak, which may be, for example, 20-30 minutes. It has been found that the surface temperature of the face stabilizes in about 5 minutes. The first treatment period can be followed by a second treatment period, eg, about 8-15 minutes of light application. 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 skin disease in a patient. The treatment period in one exemplary embodiment may be about 10 minutes to about 1 hour. The total allowable light dose in one exemplary embodiment may be about 10-40 J/cm ² . In at least one embodiment, the treatment duration may be greater than 1 hour or less than 10 minutes, and the total allowable light dose may be less than 10 J/cm ² or greater than 40 J/cm ² , depending on the clinical situation.

In at least one embodiment, the treatment method also 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. It further includes. The volume may be a cubic or other shaped control volume that at least partially corresponds to the portion of the patient's skin that is exposed to the irradiation device.

9A and 9B illustrate an apparatus according to an embodiment of the present disclosure. The device is, for example, an irradiation device that includes the specific components shown in FIGS. 2A-2B. The illumination device includes a frame 150 to which panels 10a-10e are mounted. 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, and at least a portion may be placed behind panel 10c. The heat source 160 may include a plurality of curved ends 162, 164 that protrude beyond the plurality of panels, such that at least a portion of the heat source is directly exposed to the patient unobstructed by the plurality of panels. Good too. 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 form a partially enclosed space for bathing a portion of the patient (eg, the patient's head) in warm air. It becomes a hot air tank that can

In at least one embodiment, heat source 160 may be comprised of a frame-mounted resistive tape heater. In at least one embodiment, the heat source 160 includes a plurality of heaters including at least one selected from the group including infrared LEDs, electrical resistance cartridge heaters, PTC (positive temperature coefficient) heaters, or infrared quartz heaters as described above. It may be composed of. In at least one embodiment, the infrared quartz heater is highly responsive and outputs sufficient heat. The infrared quartz heater can also 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.

Heat source 160 may include at least one control unit, such as controller 77, for targeted therapy heat output. The control unit may be a control device realized as hardware, software, or a combination thereof, such as a combination of a storage device that stores a computer program and a processor that executes the program. In at least one embodiment, the heat source 160 is controlled by a PID controller that provides monitoring and over-temperature/over-temperature control. In some embodiments, the controller 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 with a software framework driver programmed to control the input set point temperature to a specified tolerance based on feedback from a reference and reference thermistor 170, discussed below. . 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, eg, 40°C ± 2°C.

FIG. 9C shows an irradiation device according to one embodiment. In at least one embodiment, the illumination device further includes one or more thermistors. The thermistor may be integrated with the irradiation device or provided as part of a kit containing 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 located at or near the heat source 160. In at least one embodiment, the thermistor 170 may be located as part of the heat source 160 near the top of the panel 10c. The temperature measured by the reference and reference thermistor 170 may be compared to the temperature measured at the patient's exposed skin by a temperature probe, such as a contact thermocouple, placed on the patient's forehead, for example. In some embodiments, one or more thermocouples may be used to determine the relationship between skin temperature (thermocouple temperature) and the temperature sensed by thermistor 170 (control temperature or thermistor temperature). .

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

In at least one embodiment, heat source 160 may be used in conjunction with fan 70. For example, fan 70 may be operated to circulate cooling air within the system. Additionally, cold or room temperature air traveling along the path indicated by arrow "C" in FIG. 9C may be directed to a heat exchanger within heat source 160. A heat exchanger heats cold air. The heated air moving along the path indicated by arrow "H" in FIG. 9C may be blown at a slow flow rate. In at least one embodiment, fan 70 is controlled by a controller to provide an air speed of approximately 3 to 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 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 controller may control the output of one or more fans 70, for example, by varying the revolutions per minute (RPM) of the fans 70. Heated air may be blown onto the patient's face by fan 70, for example from above and below heat source 160. This air flow forms, for example, a warm air bath or pocket that substantially surrounds the patient's skin so as to envelop the patient's face with warm air. The thermodynamic behavior of the system allows control such that the temperature of the patient's skin (as measured by a contact thermocouple) and the temperature measured by the thermistor differ by, for example, within about 15°C. In at least one embodiment, the surface of the patient's skin (eg, facial skin) reaches a stable temperature within 5 minutes of heat radiation from heat source 160.

By controlling the thermodynamic transfer behavior, the blown air and heat output from the heat source can be tailored to the desired skin heating effect. In at least one embodiment, a desired increase in skin temperature (eg, 2° C.) can be achieved by determining the temperature increase of the air and the corresponding time. That is, the controller may be programmed to determine the temperature increase and time required to heat the patient's skin to a desired temperature. Additionally, in at least one embodiment, the controller may also make such determinations for air velocity and/or volumetric flow. Such determinations by the controller may be made with reference to one or more maps stored in the controller's memory. For example, one such map is a map that relates the temperature of thermistor 170 to an increase in skin temperature. Another map is a map that relates thermistor temperature to air velocity and air volumetric flow rate. The air velocity and volumetric flow rate themselves vary based at least in part on the configuration of the heat source 160 and, more specifically, the configuration and geometry 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 one or more maps to provide accurate control of skin temperature. The system may include multiple sensors for sensing temperature at multiple locations, and the controller uses the aforementioned map containing data from these sensors to control the heat source 160 at one or more locations. may be referred to. Furthermore, information from the temperature/heat map may be taken into consideration to control the heating of the skin at multiple points in accordance with the treatment plan. In one embodiment, such a map can be used to obtain a desired skin temperature without, for example, placing one or more temperature sensors on the skin to directly measure skin temperature.

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, heat source 160 may radiate heat toward a treatment target, eg, a target within a 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, temperature may be sensed at a location 3 inches from the center panel 10c where the predetermined treatment target is located at the center of the cubic volume 172. FIG. 9E shows a cubic volume 172 where 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 heat source 160 and irradiation device.

Figure 10 shows a volume (a particular three-dimensional space) in which nodes 1-12 are defined, where node 10 is the center node of the volume and node 12 is the node outside the volume (e.g., at a distance from the volume). ) is a node. To create a temperature map, temperature can be measured at any or all multiple nodes. In at least one embodiment, recording of data may occur every minute or at different predetermined time intervals. In at least one embodiment, cubic volume 172 is provided as a measurement framework. Measurements of temperature (and distance measurements from one or more panels 10) may be made at one or more nodes and compared to the temperature measured at the thermistor 170, for example. In this way, the positioning of the patient relative to the irradiation device may be controlled to ensure that the total allowable light dose is achieved.

11A-11B illustrate temperature maps according to one embodiment. FIG. 11A shows a temperature map of the patient's skin before heating. Average skin temperature before heating was 93.6°F. In at least one embodiment, after 5 minutes of prewarming of heat source 160, the patient can be exposed to light from light source 60 and heat from heat source 160 for about 10 minutes. FIG. 11B shows a temperature map after 5 minutes of prewarming of heat source 160 and 10 minutes of heat soaking. The average skin temperature after the warm-up time and 10 minute heat soak was 102°F. In at least one embodiment, forced convection may be selected and used because it is less unstable and provides less variation in temperature across the heated target. Additionally, in at least one embodiment, indirect heating may be used so that the patient's skin is not in direct contact with the heat source 160. Rather, the heat is radiated at a distance from the patient's skin, and the controller receives a comparison of the temperature measurements taken at the thermistor 170 with the temperature measurements taken at the nodes of the reference volume 172. Based on this, a radiation pattern proposal is determined.

In at least one embodiment, the controller may receive temperature feedback from thermistor 170 to turn 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 skin temperature and provide sensed skin temperature data to the controller. Input from the non-contact IR sensor may be shown on one or more maps stored in the controller as further data indicative of skin temperature. In at least one embodiment, during an initial warm-up period (e.g., 5 minutes), heat source 160 begins warm-up, but the system is not in a steady state that can be controlled to deliver the desired output. It is in a transient state. A non-contact IR sensor may be used to detect the patient's skin temperature and allow the detection results to be compared to skin temperature values for multiple patients. Such skin temperature data may be data 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 heat source 160 to more efficiently promote warming of the patient's skin. Alternatively, if the patient's skin temperature is equal to or higher than the average skin temperature, the heating process may be continued without increasing the speed.

In at least one embodiment, the skin or tissue temperature was approximately 40.3-42.6°C at high, with an average skin temperature of 41.3°C. Thermal tests were performed at 10 mW/cm ² and 20 mW/cm ² with light only, heat only, or both light and heat. Thermal testing showed that the light itself did not appear to affect the patient's facial skin temperature when heat was applied.

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

Figures 13A-13D show temperature data with no heat applied. Specifically, FIG. 13A shows a temperature map of the patient's skin or tissue without application of heat. Figure 13B shows the temperature map after phototherapy. FIG. 13C shows temperature data (thermocouple and thermistor data) at the central node 10. FIG. 13D shows a plot 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 a predetermined amount of time may elapse between when the light source is first activated and when the patient's skin temperature is measured. . For example, 5 minutes may elapse between the time the light source is first activated and the patient's skin temperature is measured, after which the patient may receive an additional 10 minutes of light-only therapy.

14A-14D illustrate node-based temperature data according to one embodiment. Specifically, FIGS. 14A-14D show data for an embodiment in which the 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 temperature data including thermocouple temperature (skin temperature) and thermistor temperature (control temperature) data at node 10 when the irradiance density is 20 mW/cm ² . FIG. 14D shows a plot of temperature data over time during a 10 minute heat soak at a position 3 inches from the front panel (eg, panel 10c) with a control temperature setting of 57°C.

Further advantages and modifications will readily occur to those skilled in the art. Therefore, the invention is not limited to the specific details or representative apparatus and methods shown and described herein. Accordingly, 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.

1 to 6 Regions 1 to 12 Nodes 10a to 10e Panel 23 Tab 40 Mounting head 50 Hinge 51 Flange 53 Bolt 60 LED array 70 Fan 77 Control device 80 Stand 81 Base 82 Vertical column 83 Pivot point 84 Stabilizing arm 85 Connection arm 86 Hinge Point 87 Wheels 90 Control device and power source 100 Main body 150 Frame 160 Heat source 162 End section 164 End section 170 Reference/comparison thermistor 172 Cubic volume

Claims (14)

a plurality of panels including five panels, the plurality of panels being pivotally connected laterally to adjacent panels, the plurality of panels being configured to be arranged in a bent or flattened configuration upon rotation; , with multiple panels,
a plurality of light sources each attached to one of the plurality of panels and configured to irradiate a surface with uniform intensity of visible light;
The plurality of panels include at least one panel that is narrower in the width direction than at least one other panel of the plurality of panels and disposed between two adjacent panels, The panels provide fill-in light from between the two adjacent panels to reduce optical dead space when the plurality of panels are in the bent configuration in which the panels are pivoted to wrap around the patient. a plurality of panels configured to
a heat source configured to radiate heat toward the patient between panels located on the outer side in the width direction among the plurality of panels;
An irradiation device for photodynamically diagnosing or treating a patient's surface, comprising: 2. The irradiation device of claim 1, further comprising a controller programmed to control operation of the heat source such that the temperature of the surface increases by 2[deg.]C. 2. The irradiation device of claim 1, wherein the heat source comprises an infrared heater with a quartz emitter. The irradiation device according to claim 1, wherein the plurality of light sources are light emitting diodes. The irradiation device according to claim 1, wherein the plurality of light sources are configured to emit light with a wavelength of 400 nm to 430 nm. The irradiation device according to claim 5, wherein the plurality of light sources are configured to emit light with a wavelength of 417 nm. The plurality of light sources include 80 to 350 individual light emitting diodes provided in at least a first panel of the plurality of panels, and 50 to 350 individual light emitting diodes provided in at least a second panel of the plurality of panels. 5. Illumination device according to claim 4, comprising: 250 individual light emitting diodes. 2. The irradiation device of claim 1, further comprising at least one thermistor configured to sense the temperature of the heat source. 2. The power supplied to light sources located at the periphery of individual panels of said plurality of panels is greater than the power supplied to light sources located at a central region of each individual panel of said plurality of panels. The irradiation device described. 3. The irradiation device of claim 2, wherein the controller is configured to adjust the total light dose based on the selected treatment site. The irradiation device according to claim 2, wherein the control device is configured to cause the irradiation device to emit a certain amount of light based on a selected treatment period. a plurality of panels including five panels, the plurality of panels being pivotally connected laterally to adjacent panels, the plurality of panels being configured to be arranged in a bent or flattened configuration upon rotation; , with multiple panels,
a plurality of light sources each attached to one of the plurality of panels and configured to irradiate a surface with visible light;
The plurality of panels include at least one panel that is narrower in the width direction than at least one other panel of the plurality of panels and disposed between two adjacent panels, The panels provide fill-in light from between the two adjacent panels to reduce optical dead space when the plurality of panels are in the bent configuration in which the panels are pivoted to wrap around the patient. a plurality of panels configured to
at least one sensor configured to detect an orientation of at least one of the plurality of panels;
An irradiation device for photodynamically diagnosing or treating a patient's surface, comprising: a heat source configured to radiate heat to the surface;
a controller programmed to adjust at least one of a light output of at least one of the plurality of light sources and a thermal output of the heat source based on the detected orientation;
The irradiation device according to claim 12, further comprising: 13. The illumination device of claim 12, further comprising a controller programmed to control the output of at least one of the plurality of light sources based on at least the orientation and skin temperature detected by the sensor.

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