Dosimetric determination of zones within the treatment area using real-time surface temperature mapping and associated methods

Abstract

An energy-based dermatological treatment system includes a temperature sensor for obtaining a first temperature measurement associated with a first treatment area. The system also includes a processing module for receiving the first temperature measurement and generating a temperature map based on the first temperature measurement. The system further includes a control module for setting parameters of a first treatment pulse based on the first temperature map and an energy source configured to deliver the first treatment pulse to the first treatment area. In one embodiment, the first temperature sensor is a non-contact temperature sensor. In another embodiment, a second temperature measurement of a second treatment area generates an updated temperature map based on the first and second temperature measurements. Parameters of a second treatment pulse are set according to the updated temperature map, and the second treatment pulse is delivered to the second treatment area.

Description

Technical Field

[0001] The present invention relates to energy-based treatments and, more particularly, to systems and methods for determining and adjusting the dosimetry of laser pulses based on skin temperature maps that can be generated and updated in real time to provide measured and estimated temperature data for the treatment area. Background Art

[0002] Sebaceous glands and other chromophores embedded in a medium such as the dermis can be treated using thermal injury by heating the chromophores with a directed light source (e.g., a laser). However, applying thermal energy sufficient to injure the chromophores may also result in unintended injury to the surrounding dermis and overlying epidermis, leading to epidermal and dermal damage and potential pain for the patient during treatment. Summary of the Invention

[0003] The following presents a simplified summary of one or more aspects to provide a basic understanding of such aspects. This summary is not an extensive overview of all aspects considered and is not intended to identify key or critical elements of all aspects nor to delineate the scope of any or all aspects. Its purpose is to present some concepts of one or more aspects in a simplified form as a prelude to the more detailed description below.

[0004] In one embodiment, an energy-based dermatological treatment system includes: a temperature sensor for obtaining a first temperature measurement associated with a first treatment area; and a processing module for receiving the first temperature measurement and generating a temperature map based on the first temperature measurement. The system further includes: a control module for setting parameters of a first treatment pulse based on the temperature map; and an energy source for delivering the first treatment pulse to the first treatment area. In one embodiment, the parameters include at least one of pulse intensity and pulse duration. In one embodiment, the temperature sensor is a non-contact temperature sensor. In another embodiment, the non-contact temperature sensor includes an infrared sensor. In yet another embodiment, the energy source transmits the first treatment pulse to the first treatment area, then takes a second temperature measurement of the first treatment area to generate a second temperature map, and the control module is further configured to set at least one parameter of the second treatment pulse based on the second temperature map. In some embodiments, the system further includes a cooling unit for convectively transferring heat from the first treatment area. The control module is operably coupled to the cooling unit and is further configured to set operating parameters of the cooling unit based on the temperature map.

[0005] In another embodiment, a method of operating an energy-based dermatological treatment system including an energy source for delivering therapeutic pulses is disclosed. The method includes: selecting a first treatment area; obtaining a first temperature measurement associated with the first treatment area; and generating a temperature map of the first treatment area based on the first temperature measurement. The method further includes: setting parameters for a first treatment pulse based on the temperature map; and delivering the first treatment pulse to the first treatment area. In embodiments, the parameters include at least one of pulse intensity and pulse duration. In another embodiment, the method further includes: defining lower and / or upper thresholds for the parameters; and generating an alarm when the parameters are set below the lower threshold or above the upper threshold. In yet another embodiment, the method includes: obtaining a second temperature measurement associated with the first treatment area; generating an updated temperature map of the first treatment area based on the first and second temperature measurements; adjusting parameters of a second treatment pulse based on the updated temperature map; and delivering the second treatment pulse to the first treatment area. In embodiments, the second temperature measurement is performed on a second treatment area, which may be adjacent to the first treatment area. The first and second treatment pulses may be delivered sequentially or substantially simultaneously. In embodiments, the method further comprises cooling the first and / or second treatment zone prior to and / or during delivery of the first and / or second treatment pulses.

[0006] In another embodiment, a method for operating an energy-based dermatological treatment system is disclosed. The energy-based dermatological treatment system includes an energy source for delivering treatment pulses. The method includes: selecting a first treatment area; delivering a first treatment pulse to the first treatment area; obtaining a first temperature measurement associated with the first treatment area; generating a temperature map of the first treatment area based on the first temperature measurement; and setting parameters for a second treatment pulse based on the temperature map. In an embodiment, the method further includes cooling the first treatment area before delivering the first treatment pulse. In another embodiment, the method further includes delivering the second treatment pulse to the first treatment area, or alternatively, to a second treatment area. The second treatment area may be adjacent to the first treatment area. In yet another embodiment, the second treatment area is also cooled before and / or during delivery of the second treatment pulse. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The drawings illustrate only some embodiments and therefore should not be considered limiting in scope.

[0008] Figure 1 A block diagram illustrating an energy-based photoelectric therapy system providing real-time skin temperature mapping and dosimetry feedback and adjustment capabilities is shown in accordance with an embodiment.

[0009] Figure 2A and 2B Examples of simultaneous and sequential laser pulse application protocols and associated temperature map generation procedures according to embodiments are described, respectively.

[0010] Figure 3 Movement of a photoelectric therapy system to different areas of a patient's skin and generation of updated skin temperature maps according to an embodiment are described.

[0011] Figure 4 A block diagram illustrating an energy-based photoelectric therapy system including cooling and other functionality, providing real-time dosimetry feedback, map generation and adjustment capabilities according to an embodiment is shown.

[0012] Figure 5A and 5B A process flow diagram is shown describing a method of operating a phototherapy system to obtain skin temperature measurements and generate a skin temperature map according to an embodiment.

[0013] Figure 6 A partial cross-sectional view illustrating a portion of a scanner apparatus suitable for use with a phototherapy system according to an embodiment.

[0014] Figure 7 is a diagram illustrating a field of view (FoV) of a thermal sensor according to an embodiment.

[0015] Figure 8 is a front view of a reference surface for use with a photoelectric therapy system according to an embodiment.

[0016] Figure 9 is an isometric view of a reference surface as viewed diagonally from the bottom, according to an embodiment.

[0017] Figure 10 is a process flow diagram illustrating an exemplary non-contact method of sensing the temperature of the skin surface according to an embodiment. DETAILED DESCRIPTION

[0018] The present invention is described more fully below with reference to the accompanying drawings, in which embodiments of the invention are shown. However, the invention can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will convey the scope of the invention to those skilled in the art. In the figures, the sizes and relative sizes of layers and regions may be exaggerated for clarity. Like numbers refer to like elements throughout.

[0019] It should be understood that although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another region, layer, or section. Thus, a first element, component, region, layer, or section discussed below could be referred to as a second element, component, region, layer, or section without departing from the teachings of the present invention.

[0020] Spatially relative terms such as "below," "beneath," "under," "above," "upper," and the like may be used herein to describe the relationship of one element or feature to another element or feature, as illustrated in the figures. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were turned over, an element described as being "below," "beneath," or "beneath" other elements or features would be oriented "above" the other elements or features. Thus, the exemplary terms "below" and "beneath" can encompass both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein should be interpreted accordingly. Additionally, it should be understood that when a layer is referred to as being "between" two layers, it can be the only layer between the two layers or one or more intervening layers may also be present.

[0021] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. As used herein, the singular forms "a / an" and "the" are intended to also include the plural forms, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises and / or comprising" when used in this specification specify the presence of stated features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. As used herein, the term "and / or" includes any one and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0022] It should be understood that when an element or layer is referred to as being “on,” “connected to,” “coupled to,” or “adjacent to” another element or layer, it may be directly on, directly connected to, coupled to, or adjacent to the other element or layer, or there may be intervening elements or layers. In contrast, when an element is referred to as being “directly on,” “directly connected to,” “directly coupled to,” or “immediately adjacent to” another element or layer, there are no intervening elements or layers. Similarly, when light is received or provided “from” an element, it may be received or provided directly from that element or from an intervening element. On the other hand, when light is received or provided “directly from” an element, there are no intervening elements.

[0023] Embodiments of the present invention are described herein with reference to cross-sectional illustrations, which are schematic illustrations of idealized embodiments (and intermediate structures) of the present invention. Thus, variations from the illustrated shapes as a result, for example, of manufacturing techniques and / or tolerances, are to be expected. Thus, embodiments of the present invention should not be construed as limited to the particular shapes of regions illustrated herein, but are to include deviations in shapes that result, for example, from manufacturing. Thus, the regions illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the actual shape of a region of a device and are not intended to limit the scope of the present invention.

[0024] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It should be further understood that terms (such as those defined in commonly used dictionaries) should be interpreted as having a meaning consistent with their meaning in the context of the relevant art and / or this specification, and should not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0025] In laser treatment of acne, the operating thermal range is typically limited at the upper end to the epidermal and dermal damage threshold temperature of approximately 55°C and at the lower end by the temperature required to bring the sebaceous glands to their therapeutic damage threshold temperature of approximately 55°C. Based on clinical data, as an example, the operating temperature range for acne treatment, expressed in terms of terminal skin surface temperature, is approximately 40°C to 55°C. At skin surface temperatures below 40°C, it has been determined that the sebaceous glands are not damaged and, therefore, are ineffective. When the skin surface temperature is between 40°C and 55°C, there is varying degrees of sebaceous gland damage without damage to the epidermis. At skin surface temperatures above 55°C, in addition to effective therapeutic damage to the sebaceous glands, damage to the dermis and epidermis occurs.

[0026] The requirements for successful photothermal targeted treatment of specific chromophores with minimal patient discomfort include: 1) sparing the epidermis, i.e., ensuring that the peak temperature at the skin surface is less than approximately 55°C; 2) sparing the dermis, i.e., avoiding overheating of the dermis by balancing the average power of the treatment pulses with heat removal by the cooling system; and 3) selectively heating the target chromophore, e.g., a peak temperature greater than 55°C for sebaceous gland treatment. The embodiments described herein achieve the same results as existing systems with a much simpler system and protocol.

[0027] Tissue parameters (e.g., thickness of the epidermis and dermis) vary between individuals based on factors such as age and gender, as well as between different skin locations. For example, even for the same individual, the forehead has different tissue properties than the back, necessitating different treatment parameter settings for different treatment locations. Considering such variations in tissue properties when determining a specific treatment protocol is important for laser-based treatments (e.g., acne treatment). Additionally, due to manufacturing variability and operating conditions, there may be variations in, for example, the exact laser power, spot size, and cooling capacity between specific laser systems.

[0028] Clinical data also indicate that terminal skin surface temperature is strongly dependent on tissue parameters at the specific treatment area of a specific individual. While existing treatment protocols have been of the "one treatment fits all" type based approach, innovative analytical protocols can be incorporated into treatment methods to directly determine individually tailored treatment parameters, extrapolating from measurements of terminal skin temperature at lower laser powers and / or terminal skin surface temperatures achieved during previous treatments to avoid epidermal damage while effectively causing sebaceous gland damage. In this way, treatment protocols can be customized for a specific treatment area of a specific individual and also mitigate treatment variations that can be caused by variations in the laser power output of a specific machine and variations in treatment conditions (e.g., ambient humidity and temperature).

[0029] This analysis protocol can be performed using, for example, a scanner that can be built into a scanner held by a medical professional to apply treatment to a patient (e.g., see the Figure 1 and 4 Temperature measurement can be performed by incorporating temperature measurements into a commercial, off-the-shelf, low-cost IR camera in a temperature measurement device (e.g., a temperature measurement device 146) or by using a separate, commercial off-the-shelf single-pixel or multi-pixel thermal measurement device. The predictive process can be performed at a highly localized level, allowing adjustments to the treatment protocol in real time or before treatment begins, even for each individual zone in the treatment area. In this way, a treatment protocol can be tailored to deliver the necessary therapeutic laser power while maintaining temperatures below the epidermal and dermal damage thresholds.

[0030] While there is no good way to directly measure the temperature of the sebaceous glands targeted by a treatment protocol, the skin surface temperature in the immediate area of the gland can be used as an indicator of sebaceous gland temperature. A correlation model that provides a correspondence between sebaceous gland temperature and skin surface temperature can then be used to tailor the actual treatment protocol using the skin surface temperature measurements to effectively target sebaceous gland damage while remaining below the damage threshold of the epidermis and dermis. The correlation model can be developed using, for example, analytical heat transfer models or by using clinical data (e.g., via biopsies) that correlates skin surface temperature with sebaceous gland damage given an application-specific treatment protocol.

[0031] A skin temperature map can be generated based on measured skin temperature. This skin temperature map can be particularly beneficial when using a treatment system and protocol that delivers more than one laser pulse to a patient's skin in response to a single operator-provided input (e.g., a single "trigger" of a treatment device). The use of skin temperature maps and associated models to tailor laser pulses for specific skin zones within a treatment area is described in detail below.

[0032] Figure 1 A block diagram illustrating an energy-based phototherapy system providing real-time dosimetry feedback and adjustment capabilities according to an embodiment is shown. It should be noted that the terms "phototherapy," "photothermal therapy," and "energy-based dermatological therapy" are used interchangeably throughout this disclosure, and all of these terms refer to the controlled delivery of energy (e.g., laser pulses) for treating dermatological conditions.

[0033] like Figure 1 , system 100 includes a phototherapy unit 110, which in turn includes a controller 120 for controlling a laser 122. Laser power output from laser 122 is transmitted via an optical fiber 124 to a scanner 130. Scanner 130 is, for example, a handheld device for applying the laser power output to a treatment site. The phototherapy unit further includes a temperature monitoring unit 142 connected to scanner 130 via a temperature connection 144. For example, a temperature measurement device 146 (e.g., a thermistor, infrared camera, or other temperature sensing device) is attached to or integrated into scanner 130 to provide real-time temperature measurement of the skin surface temperature at the treatment site. The temperature information measured by temperature measurement device 146 can be transmitted to temperature monitoring unit 142 via temperature connection 144. Controller 120 can then transmit the temperature information to a real-time temperature display 150, where the temperature information can be viewed by a user of system 100.

[0034] Alternatively or additionally, the temperature measured by the temperature measurement device 146 may be transmitted to the controller 120, where a skin temperature map is generated based on actual temperature measurements taken at known locations within the treatment area. Thermodynamic equations and / or empirical data may be used to roughly estimate the skin temperature in portions of the treatment area that are not directly measured by the temperature measurement device 146 when generating the skin temperature map. In some embodiments, to reduce reliance on estimates, equations, and empirical data, skin temperature may be measured in several locations throughout the treatment area. For example, temperature measurements may be taken in areas that will receive direct laser pulses from the phototherapy system. In other embodiments, temperature measurements may be taken incrementally in a grid or other patterned arrangement. In yet another embodiment, the temperature measurement device 146 may include an array of sensors, such as an array of infrared sensors, and thus be able to simultaneously obtain temperature readings over a large area of the treatment area (rather than at a single point). More skin temperature measurements may improve the accuracy of the generated skin temperature map.

[0035] Skin temperature mapping may be particularly beneficial for treatment systems and protocols in which multiple laser pulses are generated in response to a single operator input (eg, a single trigger pull). Figure 2A and 2B Two examples of this protocol are described. First, refer to Figure 2A , showing treatment area 200. Treatment area 200 represents an area that can be treated using a phototherapy system (e.g., phototherapy system 100) without repositioning the system. When the system is oriented toward the patient's skin, treatment area 200 overlies the area of the patient's skin to be treated. While treatment area 200 is shown as a square, depending on the specific configuration of the laser source and / or shielding within the phototherapy system, the area may be oval, circular, rectangular, or any other regular or irregular shape.

[0036] Within treatment area 200 are zones 202-208. Each of zones 202-208 represents a portion of the treatment area that may be affected by a single laser pulse from the phototherapy system. In some embodiments, laser pulses directed at two or more of zones 202-208 may be emitted substantially simultaneously by the phototherapy system in response to a single input from an operator. Although four square zones are shown, there may be more or fewer zones of any shape within treatment area 200, depending on the configuration of the associated phototherapy system. Zones 202-208 may be substantially adjacent to one another, such that there are no gaps and no overlapping areas between zones 202-208. In some embodiments, the size of each of zones 202-208 may be approximately 5 mm x 5 mm; however, other sizes and grid arrangements (e.g., 1 x 1, 2 x 1, 3 x 3, 3 x 4) are possible.

[0037] As discussed above, skin temperature can vary even across a relatively small treatment area 200, which in some embodiments may be approximately 1 cm x 1 cm in size. Because the dermis and epidermis are very sensitive to laser pulses used to treat nearby sebaceous glands, it is desirable to project only the amount of energy needed to therapeutically heat the sebaceous glands within each of zones 202-208 to a threshold terminal temperature (e.g., 55° C.) without heating the dermis and epidermis beyond the threshold terminal temperature. Tuning the laser pulses emitted by the phototherapy system on a per-zone basis can help reduce unwanted damage and discomfort to the patient. The cooling system can also be calibrated to deliver cool air onto the skin surface to remove heat.

[0038] The amount of adjustment required for the laser pulse dose for each zone can be determined using the skin temperature map discussed above. In some embodiments, the skin temperature map may indicate that the skin temperature associated with zone 202 is lower than the skin temperature associated with zone 204. Therefore, to achieve the same threshold terminal temperature for zones 202 and 204, the laser pulse dose delivered to zone 202 may be higher than the laser pulse dose delivered to zone 204. For example, the laser pulse delivered to zone 202 may be at 100% intensity, while the laser pulse delivered to zone 204 may be at 97% intensity. As another example, the intensity and pulse duration of subsequent laser pulses delivered to zone 202 may be rapidly adjusted based on the measured skin temperature associated with zone 204. Subsequent laser pulses may be delivered nearly simultaneously or very close in time and distance, such as in a time-sequential manner. Similar adjustments may be made for zones 206 and 208 based on the skin temperature map in conjunction with a correlation model that correlates skin surface temperature with the sebaceous gland, dermis, and / or epidermal temperature of a given skin region. The correlation model may take into account the location of the treatment area on the body, as well as the patient's age and gender.

[0039] refer to Figure 2B , illustrating a second example treatment protocol in which laser pulses are delivered to each zone in a time-sequential manner. Treatment area 210 includes zones 212-218. Although four square zones are shown, more or fewer zones of any shape may exist within treatment area 210, depending on the configuration of the associated photoelectric therapy system. Zones 212-218 may be substantially adjacent to one another, such that there are no gaps and no overlapping areas between zones 212-218. Zones 212-218 may be approximately 5 mm by 5 mm in size; however, as discussed above with respect to zones 202-208, other sizes and configurations are possible without departing from the scope of this disclosure.

[0040] exist Figure 2BIn some embodiments, each zone 212-218 within the treatment area 200 receives a laser pulse at a unique time and each time a sequential laser pulse is directed to a unique zone within the treatment area 210. Figure 2A The laser pulse dose associated with each of the zones 212 to 218 can be customized based on the skin temperature map and the associated model using a protocol. The photoelectric therapy system can automatically adjust the intensity and / or duration of the laser pulses delivered to each of the zones 212 to 218. The laser pulses in a time-sequential configuration can be spaced apart for a time ranging from approximately 1 millisecond to approximately 1 second.

[0041] In some embodiments, additional intermediate treatment temperature measurements are obtained for updating the skin temperature map substantially in real time throughout the photoelectric treatment. The intermediate treatment temperature measurements may be taken at one or more of the same locations as the original temperature measurements and / or may be taken at other specific locations (e.g., near the zone that will receive the subsequent laser pulse dose). Updating the skin temperature map substantially in real time using these additional intermediate treatment temperature measurements can improve the accuracy of the skin temperature map by taking into account heat transferred to or from the skin during the previous portion of the treatment. For example, when the first laser pulse is delivered to zone 212, thermal energy may be dissipated into adjacent zones 214, 216, thereby increasing the skin temperature in those zones. If this thermal crosstalk is not accounted for when adjusting the subsequent laser pulse doses, the laser pulses delivered to zones 214, 216 based solely on the initial skin temperature map may be too high and may result in a terminal skin temperature that is above the target temperature, thereby reducing the safety margin, damaging the dermis and epidermis, and / or causing pain to the patient.

[0042] In addition to adjusting the laser pulse dose, the treatment order of the zones 212 to 218 can be adjusted so that as much space as possible is provided between one laser pulse and the subsequent laser pulse. Figure 2B In the present invention, it may be beneficial to deliver sequential laser pulses to zone 212, zone 218, zone 214, zone 216, and so on. The treatment order and / or arrangement of the multiple zones may be manually determined by an operator or may be automatically suggested or selected by a processor module that may be local to the phototherapy system or remotely coupled to the phototherapy system. The processor may also take into account the area of the body being treated and / or the age and sex of the patient when recommending a particular treatment protocol.

[0043] Another variable that can be adjusted in a sequential treatment protocol is the time between laser pulses. Increasing the time between pulses can allow the skin to dissipate more heat and cool to a temperature closer to the original skin temperature. However, over time, heat can also spread further into other treatment areas. Inter-treatment temperature measurements and real-time skin temperature mapping can help track temperature changes over time and provide information about when the next area within treatment area 200 is ready to receive a laser pulse.

[0044] Other variables can also cause skin temperature to vary. For example, a skin cooling process (e.g., blowing cool air onto the surface of the skin) can be implemented during a treatment protocol to convectively transfer heat away from the skin and prevent overheating of the epidermis and dermis. Variations in air flow patterns, air temperature, humidity, and other cooling variables can cause uneven heat removal from the skin, thereby leaving warmer and cooler spots within the treatment area. As discussed above, failure to account for warm areas can lead to damage to surrounding tissue due to overheating. Failure to account for cooler areas can reduce the efficacy of phototherapy if the underlying sebaceous glands are not heated to a threshold terminal temperature. Therefore, it is beneficial to identify substantially real-time skin temperature using a skin temperature map that is continuously updated as additional measurements are collected to accurately represent skin temperature. Adjustments to increase or decrease laser pulse dose based on the real-time skin temperature map can be made manually by the operator and / or can be automatically suggested or selected by the phototherapy system.

[0045] Regarding Figure 2A Concurrent treatment protocols described and about Figure 2B As with the sequential treatment protocols described, the photoelectric treatment system can be repositioned over a different portion of the patient's skin to continue treatment over a larger portion of the patient's skin than is accessible by treatment area 200 . Figure 3 , shows an example of a phototherapy device moved to a second position to the right of a previously treated area 200. Depending on the distance between the first treatment area 200 and the second treatment area 200', thermal crosstalk may occur between one or more previously treated zones 202-208 and one or more of the zones 202'-210' yet to be treated. Therefore, continuing real-time skin temperature measurement and skin temperature mapping over an area larger than the immediate treatment area may be beneficial to account for previous thermal changes in the nearby skin that may affect subsequent stages of treatment. When an updated and expanded skin temperature map is generated and the data is available for determining the next set of laser pulses for zones 202'-210' (either simultaneously or sequentially), the operator may receive a prompt from the phototherapy system indicating that the treatment protocol for treatment area 200' is ready. In other embodiments, the operator may receive a prompt indicating that treatment area 200' overlaps with a previously treated area 200 and that the phototherapy system position should be adjusted to prevent overtreatment of the overlapping area.

[0046] A trigger pull by the operator may initiate treatment, including multiple laser pulses delivered to one or more of zones 202'-210', as described above with respect to Figure 2A and 2B Discussion. Because of the ever-changing nature of skin temperature during a phototherapy session, it may be beneficial to deliver laser pulses as quickly as possible after the real-time skin temperature map is updated and the pulse dose is determined. For example, it may be desirable to deliver a laser pulse within 10 milliseconds of determining the dose for a selected area.

[0047] Figure 4 Shown is a block diagram of an energy-based photoelectric therapy system including cooling and other functionality, providing real-time dosimetry feedback, real-time skin temperature measurement and mapping, and adjustment capabilities according to an embodiment.

[0048] System 400 includes Figure 1 Components of system 100 include a laser 122, an optical fiber 124 that transmits the laser power output to a scanner 130, a temperature monitoring unit 142, a temperature connection 144, a temperature measurement device 146 attached to or integrated into the scanner 130, and a real-time temperature display 150. Phototherapy unit 410, which contains several of these components, also includes a controller 420 configured to control the operation of the laser 122, the temperature monitoring unit 142, the real-time temperature display 150, a foot switch 440, an optional door interlock 442, and an emergency on / off switch 444. System 400 also includes additional components (required and optional) including a cooling unit 430 and a cooling connection 432. Figure 1 and 4 Additional examples and experimental results related to the system are described in U.S. Provisional Patent Application No. 62 / 824,995, filed on March 27, 2019.

[0049] Figure 5A and 5B A flow chart illustrating a method of operating an energy-based dermatological treatment system incorporating real-time measurement and mapping of skin surface temperature is shown. Figure 5A According to an embodiment, the treatment method 500 uses an energy source (e.g., a laser) (e.g., Figure 1 and 4 Energy-based photoelectric therapy system (energy source shown in ).

[0050] like Figure 5A, treatment method 500 begins by measuring the skin surface temperature at a first treatment area in step 502. The temperature measurement of step 502 may include, for example, taking sequential temperature measurements at multiple points within the first treatment area or taking simultaneous temperature measurements within an area, such as using an array sensor or an infrared camera. Next, in step 504, a temperature map of the first treatment area is generated based on the measured skin surface temperature from step 502. In an embodiment, the temperature map is generated to indicate the skin surface temperature over the first treatment area in substantially real time, incorporating the most recently measured skin surface temperature measurements.

[0051] Next, in step 506, the temperature map is used to set parameters of the energy source. The parameters may include, for example, the intensity or duration of one or more of the energies (e.g., laser pulses) to be delivered by the energy source to the first treatment area. As an example, if the first treatment area has been treated with a cooling unit (e.g., Figure 4 If the cooling unit 430 in the first treatment area is sufficiently cooled, the patient being treated may be able to tolerate higher energy laser pulses at the first treatment area.

[0052] Optionally, the treatment method 500 may include step 508 to calculate and display a recommended dosage (i.e., settings for energy source parameters) to a user of the treatment system. Assuming an experienced user experiences the various setting options and pain thresholds of the patient being treated, the user may choose to make further adjustments to the treatment protocol, such as increasing the cooling provided by the cooling unit or terminating treatment.

[0053] Next, treatment method 500 proceeds to step 510 to deliver a treatment pulse (or pulses) to the first treatment area with the energy source parameters adjusted. Next, a decision 512 is made as to whether to continue treatment. Decision 512 may be based on, for example, the patient's response to the treatment pulses delivered in step 510, visual observation of the condition of the skin surface at the first treatment area, or another skin surface temperature measurement. If the answer to decision 512 is yes, treatment method 500 returns to step 502 to obtain another set of skin surface temperatures and update the temperature map. In additional iterations of treatment method 500, steps may be performed again at the first treatment area or at another treatment area (adjacent to or remote from the first treatment area). If the answer to decision 512 is no, treatment ends in termination step 520.

[0054] Now refer to Figure 5B , illustrating alternative treatment methods according to embodiments. Figure 5B, treatment method 550 begins by delivering one or more treatment pulses to a first treatment area at an initial setting of an energy source in step 552. For example, the initial setting of the energy source may be intentionally set below a known injury threshold of the dermis and epidermis, or much lower than an energy setting known to cause pain in a patient.

[0055] In step 554, the skin surface temperature at at least one location within the first treatment area is measured, and then, in step 556, a temperature map of the first treatment area is generated based on the measured skin surface temperature. Figure 5A As described, the temperature map can be generated substantially in real time using the last known skin surface temperature information of the first treatment area.

[0056] Based on the temperature map, a recommended dose for one or more additional treatment pulses is generated in step 558. The recommended dose may include, for example, various parameter settings of the energy source (e.g., laser treatment pulse intensity, pulse duration, duty cycle, etc.) or temperature settings that can be translated by the system controller into specific parameter settings for the energy source. Optionally, in step 560, the recommended dose is displayed for review by the user.

[0057] Next, in step 562, a determination is made as to whether the initial laser settings for the first set of treatment pulses are too high or too low. This determination may be made by a user of the treatment system based on the recommended dose display in step 560, the patient's response to the delivery of the initial treatment pulses, a visual inspection of the first treatment area, or other factors. Alternatively, determination 562 may be made automatically by the treatment system based on preset lower and / or upper thresholds for measured skin temperature and / or energy source parameter settings. For example, the treatment system may include preset thresholds so that the user cannot accidentally deliver laser pulses having an energy above a known pain tolerance. Optionally, the treatment system may include an override sequence to enable setting the energy source parameters above or below preset system thresholds to provide the user with additional flexibility in customizing the treatment protocol.

[0058] If the determination 562 concludes that the initial parameter settings of the energy source are too high or too low, then a determination 564 is made as to whether to adjust the parameter settings (e.g., the power setting of the laser). If the determination 564 further concludes that adjustment of the energy source parameter settings (e.g., the laser power) is required, then in step 566, the necessary adjustment is made. Next, a determination 568 is made as to whether to continue treatment. If the determination 568 concludes that additional treatment is necessary, then the treatment method 550 returns to step 552. If no further treatment is deemed necessary, then the treatment method 550 ends in a termination step 570. If the determination 562 concludes that the initial parameter settings are sufficient, or if the determination 564 concludes that no parameter adjustment is required, then the treatment process 550 also continues to the determination 568. After returning to step 552, the treatment method 550 may be repeated for the first treatment area or applied to a second treatment area adjacent to or remote from the first treatment area.

[0059] Figure 5A and 5B The process described in is an example of a process control that combines the process of measuring skin surface temperature and generating a skin temperature map in real time with a control strategy based on, for example, the relationship between laser power and skin surface temperature, with optional control actions to increase or decrease laser power (or other parameter settings of the energy source). In addition, if a cooling mechanism (e.g. Figure 4 If a cooling unit 430 in FIG. 1 is provided in an energy-based treatment system, one or more parameters of the cooling unit (e.g., air flow rate and air temperature) may also be adjusted based on the measured or estimated (based on a temperature map) skin surface temperature. Adjustments to the energy source and / or cooling unit parameters may be performed manually by the user or by a controller unit (e.g., Figure 1 Controller 120 or Figure 4 420 in the figure). Furthermore, adjustments to the energy source and / or cooling unit can be repeated and performed continuously during the treatment protocol so that the desired skin surface temperature is maintained regardless of variations in treatment site characteristics, energy source output, and cooling unit output. Furthermore, it should be noted that temperature map generation can be performed before or after the initial treatment pulse is applied.

[0060] The mapping and related models described above increase the effectiveness and safety of treatments when they make predictions based on accurate skin surface temperature measurements. Various non-contact methods exist for measuring skin surface temperature, for example, during dermatological procedures. Devices such as infrared (IR) cameras, pyrometers, bolometers, and dual-wavelength sensors can provide readings of skin surface temperature. However, for procedures such as photothermal targeted therapy, which causes thermal damage to subcutaneous sebaceous glands, accurate, calibrated readings of skin surface temperature can prevent damage to the epidermis and dermis in and around the treatment area.

[0061] The system and associated methods described in U.S. Provisional Patent Application No. 62 / 804,719 and PCT Patent Application No. PCT / US20 / 12473 (both of which are incorporated herein by reference in their entirety) provide a fast, inexpensive, and compact system and method to significantly improve the accuracy of non-contact temperature measurement. This accurate, real-time temperature measurement encompassing the treatment area enables new energy-based treatment systems that allow real-time, instant adjustments to treatment dosimetry that were not possible before. Additionally, a visual display of the real-time temperature measurement (e.g., Figure 1 A real-time temperature display 150 (e.g., 150 or 4) provides feedback to the user of the system, which can be used when the user controls the energy output of the photoelectric treatment system, the output of the cooling system, or both, resulting in increased user satisfaction, enhanced safety, and improved efficacy. The measurement system can further transmit real-time temperature measurement data corresponding to multiple points within the treatment area to a processing module, which can be local or remote to the treatment system, for generating a real-time skin temperature map. An accurate measurement system in combination with the processing module can calculate or otherwise define a safe operating range for the parameters of the light and cooling sources that will achieve a desired skin surface temperature. The desired skin surface temperature can be selected so that undesirable thermal damage at the location to be treated is avoided while still being effective.

[0062] Figure 6 A side view illustrating a portion of a scanner apparatus suitable for use with photothermal therapy system 100, according to an embodiment. Scanner 600 includes an optical fiber 602 for transmitting a laser beam 604 along a laser beam path 610 from a base station (not shown) toward a treatment tip 620, which is placed in contact with the treatment site. Scanner 600 may optionally include optical components at treatment tip 620 for shaping the beam projected onto the skin.

[0063] The treatment tip 620 serves as a visual guide for the user to position the scanner 600 at the desired treatment location. To allow for non-contact temperature measurement, an IR camera 630 is attached to the scanner 600 and pointed downwardly at the treatment tip 620, such that the IR camera 630 can detect the temperature of the treatment location along the optical path 635. In an embodiment, the IR camera 630 has a fast time response between consecutive surface temperature measurements, for example, less than 40 milliseconds. Additionally, Figure 6 , the scanner 600 includes a cooling air duct 640. As an example, an air hose (not shown) can be attached to the cooling air duct 640 via a threaded opening 642. Alternative configurations of the scanner device may include one or more scanning optical components configured to redirect the laser beam path 610 and / or the optical path 635 in one or two dimensions to provide additional degrees of freedom for laser pulse delivery and IR temperature measurement.

[0064] Figure 7 The field of view (FoV) of an IR camera 630 is illustrated, looking toward the treatment tip 620. According to an embodiment, the IR camera's FoV 710 is represented by an ellipse. Visible within FoV 710 are the treatment tip 620 and a reference surface 730 attached to the inner surface of the scanner 600. Thus, the IR camera 630 can simultaneously measure the temperature of the skin within the treatment area and the reference surface 730.

[0065] Further details of the reference surface according to the embodiment are given in Figure 8 and 9 According to an embodiment, as viewed diagonally from the bottom, Figure 8 is the front view of the reference surface, and Figure 9 is an isometric view of the reference surface. Figure 8 and 9 , the front surface of the reference surface 800 includes a texture 810 that directs reflections and stray light from any surface (except the reference surface itself) away from the FoV 710. In an exemplary embodiment, the reference surface 800 also includes an inner surface (e.g., a scanner 600) by which the reference surface 800 can be attached. Figure 6 One or more mounting holes (not shown) are provided on the IR camera (shown in FIG). Alternatively, the reference surface 800 is captively attached or otherwise mounted to an appropriate location within the IR camera's Field of View (FOV). In an embodiment, the reference surface is characterized by a reference emissivity value approximately equal to the measured emissivity value of the measured skin surface. In another example, the surface coating on the reference surface exhibits light scattering properties that are approximately Lambertian rather than specular. Further details regarding the configuration of the reference surface are described in U.S. Patent Application No. 16 / 734,280, filed on January 3, 2020.

[0066] Figure 10 FIG. 1 is a flow chart illustrating an exemplary non-contact method of sensing the temperature of the skin surface according to an embodiment. Figure 10 As shown in FIG, process 1000 begins with a start step 1010, in which a temperature sensing protocol is activated. Next, in step 1020, an IR camera in the setup is activated, e.g. Figure 6 Next, in step 1022, the IR camera measures the skin surface temperature and the reference surface temperature. Some IR cameras have an internal self-correction / calibration / shutter mechanism. One such self-correction is the so-called "flat field correction," which ensures that every pixel in the camera measures the same temperature of a constant temperature surface. Figure 10The method described in

[1024] uses a reference surface provided external to the IR camera. In parallel, in step 1024, a temperature reading of the reference surface is obtained using a contact sensor within the reference surface. In step 1026, the reference surface temperature obtained by the IR camera in step 1022 is compared with the reference surface temperature reading obtained in step 1024 using the contact sensor within the reference surface. In step 1028, an offset (if any) is calculated between the temperature measured in step 1022 and the reading obtained in step 1024. In step 1030, the offset calculated in 1028 is used to correct the skin surface temperature measurement taken by the IR camera. Process 1000 ends in end step 1040.

[0067] In other words, by comparing the temperature of a reference surface (measured by a non-contact sensor) with a known, highly accurate contact measurement of the same reference surface, an offset is calculated, which is used to correct the temperature reading of the skin surface. Thus, the accuracy of the non-contact measurement is greatly improved, regardless of the specific treatment protocol, skin cooling program, or patient parameters (e.g., age, gender, specific treatment location). It should be noted that the contact temperature measurement performed in step 1024 of process 1000 need not occur with every non-contact temperature measurement performed in 1022. For example, after the offset has been calculated once, steps 1024, 1026, 1028, and 1030 can be performed periodically to correct for potential calibration errors. This non-contact temperature measurement method is particularly relevant for temperature mapping, because by using, for example, an infrared camera with many pixels, the accuracy of temperature mapping can be improved relative to contact temperature measurements.

[0068] The foregoing is illustrative of the present invention and should not be construed as limiting thereof. Although a few exemplary embodiments of the present invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention.

[0069] Thus, many different embodiments are derived from the above description and figures. It should be understood that literally describing and illustrating every combination and subcombination of these embodiments would be unduly repetitive and obfuscating. Therefore, this specification (including the figures) should be construed to constitute a complete written description of all combinations and subcombinations of the embodiments described herein, as well as the manner and process of making and using them, and should support claims for any such combination or subcombination.

[0070] For example, consider embodiments such as:

[0071] 1. An energy-based dermatological treatment system comprising:

[0072] a temperature sensor configured to obtain a first temperature measurement associated with a first treatment area;

[0073] a processing module configured to receive the first temperature measurement and generate a temperature map based on the first temperature measurement;

[0074] an energy source configured to transmit a first treatment pulse to the first treatment area; and

[0075] A control module is configured to set at least one parameter of the first therapy pulse based on a first temperature map, wherein the first temperature sensor is a non-contact temperature sensor.

[0076] 2. A system according to claim 1, wherein the non-contact temperature sensor comprises an infrared temperature sensor.

[0077] 3. A system according to claim 1, wherein the at least one parameter includes at least one selected from the group consisting of pulse intensity and pulse duration.

[0078] 4. A system according to claim 1, wherein the temperature sensor is further configured to obtain a second temperature measurement associated with a second treatment area, wherein the processing module is configured to generate an updated temperature map based on the first and second temperature measurements, and wherein the energy source is further configured to emit a second treatment pulse to the second treatment area.

[0079] 5. The system of clause 4, wherein the control module is configured to set at least one parameter of the second therapy pulse based on the updated temperature map.

[0080] 6. The system of claim 4, wherein the control module is configured to set at least one parameter of the first and second therapy pulses based on the first and second temperature measurements.

[0081] 7. The system of claim 1 , further comprising a cooling unit configured to convectively transfer heat from the first treatment area.

[0082] 8. The system of clause 7, wherein the control module is operably coupled to the cooling unit, and wherein the control module is configured to adjust at least one operating parameter of the cooling unit based on the temperature map.

[0083] 9. A method of operating an energy-based dermatological treatment system, comprising:

[0084] targeting the energy-based dermatological treatment system at a first zone of a first treatment area;

[0085] obtaining a first temperature measurement associated with the first zone of the first treatment area;

[0086] generating a temperature map of the first treatment area based at least in part on the first temperature measurement;

[0087] setting at least one parameter of a first therapy pulse based on the temperature map; and

[0088] The first treatment pulses are selectively transmitted from an energy source to the first zone of the first treatment area.

[0089] 10. The method of clause 9, further comprising obtaining a second temperature measurement associated with a second treatment area.

[0090] 11. The method of clause 9, further comprising generating a first updated temperature map of the first treatment area based at least in part on the first and second temperature measurements.

[0091] 12. A method according to clause 11, wherein setting the at least one parameter of the first therapy pulse is based on the first updated temperature map.

[0092] 13. A method according to item 12, wherein the at least one parameter comprises one selected from the group consisting of pulse intensity and pulse duration.

[0093] 14. The method of claim 12, further comprising selectively emitting a second treatment pulse from the energy source to the second treatment area.

[0094] 15. A method according to item 14, wherein the first and second treatment pulses are emitted sequentially.

[0095] 16. A method according to item 15, wherein the first and second treatment pulses have the same parameters and are emitted substantially simultaneously.

[0096] 17. The method according to claim 9, further comprising:

[0097] targeting the energy-based dermatological treatment system at a third treatment area;

[0098] obtaining a third temperature measurement associated with the third treatment area;

[0099] generating second updated temperature maps for the first and second treatment zones based at least in part on the first, second, and third temperature measurements;

[0100] setting at least one parameter of a third therapy pulse based on the second updated temperature map; and

[0101] The third treatment pulses are selectively transmitted from the energy source to the third treatment zone.

[0102] 18. The method of claim 17, further comprising generating an alarm when the second treatment area overlaps with the first treatment area.

[0103] 19. The method of clause 17, further comprising generating an alarm when the at least one parameter of the third therapy pulse is set to a value below an effective therapy value.

[0104] 20. The method of clause 9, further comprising cooling at least the first treatment area with a cooling unit configured to convectively transfer heat away from the first treatment area.

[0105] 21. The method of clause 9, wherein obtaining the first temperature measurement comprises measuring the first zone within the first treatment area using a non-contact temperature sensor.

[0106] 22. The method of clause 21, wherein the non-contact temperature sensor comprises an infrared sensor.

[0107] 23. An energy-based dermatological treatment system comprising:

[0108] an energy source configured to emit a first treatment pulse to a first treatment area;

[0109] a temperature sensor configured to obtain a first temperature measurement associated with the first treatment area;

[0110] a processing module configured to receive the first temperature measurement and generate a temperature map of the first treatment area based on the first temperature measurement;

[0111] a control module configured to adjust at least one parameter of a second therapy pulse to be emitted by the energy source based on the first temperature map,

[0112] The first temperature sensor is a non-contact temperature sensor.

[0113] 24. The system of claim 23, wherein the control module is further configured to direct the energy source to emit the second treatment pulse toward the first treatment area.

[0114] 25. The system of claim 24, wherein the control module is further configured to redirect the energy source to emit the second treatment pulse to a second treatment area.

[0115] 26. A method of operating an energy-based dermatological treatment system, comprising:

[0116] targeting the energy-based dermatological treatment system at a first treatment area;

[0117] selectively transmitting a first treatment pulse from an energy source to the first treatment area;

[0118] obtaining a first temperature measurement associated with the first treatment area;

[0119] generating a temperature map of the first measurement region based at least in part on the first temperature measurement; and

[0120] At least one parameter of a second therapy pulse to be emitted by the energy source is adjusted based on the temperature map.

[0121] 27. The method of claim 26, further comprising selectively emitting the second treatment pulse from the energy source to the first treatment area.

[0122] 28. The method according to claim 26, further comprising

[0123] targeting the energy-based dermatological treatment system at a second treatment area; and

[0124] The second treatment pulses are selectively transmitted from the energy source to the second treatment area.

[0125] Therefore, although the present disclosure has been provided in accordance with the illustrated embodiments, it will be readily appreciated by those skilled in the art that variations in the embodiments are possible and that those variations are within the scope of the present disclosure. Therefore, many modifications may be made by those skilled in the art without departing from the scope of the appended claims.

Claims

1. An energy-based dermatological treatment system comprising: a temperature sensor for obtaining a first temperature measurement associated with a first treatment area; a processing module for receiving the first temperature measurement and generating a temperature map based on the first temperature measurement; a control module for setting parameters of a first therapy pulse based on the temperature map; and an energy source for delivering the first treatment pulse to the first treatment area, wherein the temperature sensor is a non-contact temperature sensor, wherein the temperature sensor is further configured to obtain a second temperature measurement associated with a second treatment area, wherein the processing module is further configured to generate an updated temperature map based on the first and second temperature measurements, wherein the control module is further configured to set parameters of a second therapy pulse based on the updated temperature map, wherein the energy source is further configured to deliver the second treatment pulse to the second treatment area, and The second treatment area includes a plurality of zones, and the second treatment pulses are delivered to the plurality of zones in a time sequential manner.

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