Patent Grant
11896841
The present invention relates to photo-thermal targeted treatment and, more specifically, systems and methods for photo-induced thermal treatment targeting specific chromophores, or targets containing specific chromophores, embedded in a medium.
Targets, such as chromophores and objects that contain chromophores, that are embedded in a medium can be thermally damaged by heating the target with a light source, such as a laser. For example, sebaceous glands that contain sebum that are embedded in the dermis can be thermally damaged by heating the sebum with a laser, until the sebum itself, or the sebaceous gland containing the sebum, is damaged. However, the application of enough thermal energy to damage the target can also be damaging to the surrounding dermis and the overlying epidermis, thus leading to epidermis and dermis damage as well as pain to the patient.
Previous approaches to prevent epidermis and dermis damage, as well as patient pain, include:
In accordance with the embodiments described herein, a photo-thermal targeted treatment system for damaging a target embedded in a medium includes a controller and a photo-thermal treatment unit including a light source. The controller is configured for administering a treatment protocol and the treatment protocol is administered using the light source at a preset power setting and a preset pulse timing setting.
In another embodiment, the treatment protocol includes a pre-conditioning procedure for preheating the medium and the target and a photo-thermal treatment procedure. The pre-conditioning procedure and the photo-thermal treatment procedure are both administered using the light source, without changing the preset power setting and the preset pulse timing setting between the pre-conditioning procedure and the photo-thermal treatment procedure. In a further embodiment, the pre-conditioning procedure takes a longer duration of time than the photo-thermal procedure.
In still another embodiment, the system includes a cooling unit, and the treatment protocol further includes a cooling procedure prior to and during the treatment protocol. In yet another embodiment, for both the pre-conditioning procedure and the photo-thermal treatment procedure, the light source is set to emit a series of light pulses at a preset power level, preset pulse length, and preset pulse interval.
In yet another embodiment, the pre-conditioning procedure and the photo-thermal treatment procedure include the application of the light pulses in a scanned fashion over a preset area. In an exemplary embodiment, the preset area is a 2-by-2 matrix of 5 millimeter-by-5 millimeter treatment blocks.
In a further embodiment, during the pre-conditioning procedure and the photo-thermal treatment procedure, the temperature in the medium is less than a threshold for denaturation and damage of the medium, and the target is heated to a temperature greater than a damage threshold for the target. In an exemplary embodiment, the temperature of the medium (e.g., epidermis) is less than 55° C., and the target is heated to a temperature greater than 55° C. In another embodiment, the temperature of the medium is adjusted according to the location of the treatment area on the patient.
In another embodiment, a method for using a photo-thermal targeted treatment system for damaging a target embedded in a medium is disclosed. The system includes a light source. The method includes defining a set of parameters for a series of light pulses to be generated by the light source, the set of parameters including a preset power level, preset pulse length, a preset pulse interval, and a number of light pulses. The method also includes generating the series of light pulses, in accordance with the set of parameters as defined, and administering the series of light pulses to the medium.
In yet another embodiment, the method further includes cooling the medium while administering the treatment protocol. Further, in another embodiment, applying the series of light pulses includes defining the preset area as a matrix of treatment blocks of 2-by-1 and larger. In an exemplary embodiment, applying the series of light pulses includes defining the preset area as a 2-by-2 matrix of 5 millimeter by 5 millimeter treatment blocks.
In a further embodiment, administering the series of light pulses includes applying the series of light pulses such that a temperature of the medium is less than a threshold for denaturation and damage of the medium, and the target is heated to a temperature greater than a damage threshold for the target. In an exemplary embodiment, administering the series of light pulses includes raising a temperature of the medium (e.g., epidermis) to less than 55° C., while heating the target to a temperature greater than 55° C.
In accordance with the embodiments described herein, a method for automatically initiating a treatment protocol using a photo-thermal targeted treatment system is described. The method includes administering a cooling mechanism at the treatment location, monitoring a skin surface temperature at the treatment location, and when the skin surface temperature reaches a preset threshold, automatically initiating the treatment protocol.
In a further embodiment, the treatment protocol is initiated without any manual input by a user.
In accordance with another embodiment, a method for automatically terminating a treatment protocol using a photo-thermal targeted treatment system is described. The method includes, during administration of the treatment protocol at a treatment area, monitoring a skin surface temperature at the treatment location, and when the skin surface temperature reaches a preset threshold, automatically terminating the treatment protocol.
In accordance with a further embodiment, the treatment protocol is terminated without any manual input by a user.
Additional modifications and various to the contemplated embodiments are described hereinafter.
Embodiments of the present invention are described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, 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 fully convey the scope of the invention to those skilled in the art. In the drawings, the size and relative sizes of layers and regions may be exaggerated for clarity. Like numbers refer to like elements throughout.
It will 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 termed a second element, component, region, layer or section without departing from the teachings of the present invention.
Spatially relative terms, such as “beneath,” “below,” “lower,” “under,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will 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 is turned over, elements described as “below” or “beneath” or “under” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary terms “below” and “under” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. In addition, it will also 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.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will 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 preclude 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 and all combinations of one or more of the associated listed items, and may be abbreviated as “/”.
It will 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 can be directly on, connected, coupled, or adjacent to the other element or layer, or intervening elements or layers may be present. 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 present. Likewise, when light is received or provided “from” one element, it can 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” one element, there are no intervening elements present.
Embodiments of the invention are described herein with reference to cross-section illustrations that are schematic illustrations of idealized embodiments (and intermediate structures) of the invention. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, embodiments of the 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. Accordingly, 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 invention.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and/or the present specification and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Still referring to
Controller 122 further controls other components within photo-treatment unit 120, such as a laser 124, a display 126, a temperature monitoring unit 128, a foot switch 130, a door interlock 132, and an emergency on/off switch. Laser 124 provides the laser power for the photo-treatment protocol, and controller 122 regulates the specific settings for the laser, such as the output power and pulse time settings. Laser 124 can be a single laser or a combination of two or more lasers. If there more than one laser is used, the laser outputs are combined optically to function as one more powerful laser. Display 126 can include information such as the operating conditions of cooling unit 110, laser 124, and other system status. Temperature monitoring unit 128 is used to monitor the temperature of the skin surface in the treatment area, for example, and the measured skin surface temperature at the treatment area is used by controller 122 to adjust the photo-treatment protocol. Controller 122 also interfaces with footswitch 130 for remotely turning on or off laser 124 and/or cooling unit 110. Additionally, door interlock 132 can be used as an additional safety measure such that, when the door to the treatment room is ajar, door interlock 132 detects the condition and instructs controller 122 to not allow photo-treatment unit 120, or at least laser 124, to operate. Furthermore, emergency on/off switch 134 can be provided to quickly shut down photo-thermal targeted treatment system 100 in case of an emergency. In another modification, additional photodiodes or other sensors can be added to monitor the power level of the energy emitted from laser 124.
Continuing to refer to
In the exemplary embodiment illustrated in
In an exemplary method in accordance with an embodiment, a cooling protocol is applied to the overall treatment area. The cooling protocol can include, for example, the application of a cold airstream across the treatment area for a prescribed time period, such as 10 seconds. Following cooling, the cooling mechanism (e.g., cold airstream) remains active and a photo-treatment protocol is applied to the treatment area. In one embodiment, pulses of a square, “flat-top” beam is used in combination with a scanner apparatus to sequentially apply a laser pulse to segments within the treatment area. In accordance with an embodiment, the photo-treatment protocol includes the application of a set number of light pulses onto each of the segments in the treatment area, with the laser pulses being sequentially applied to the different segments. In another embodiment, the laser pulses are applied to the segments in a random order.
In an exemplary usage scenario, the full treatment area overlying the sebaceous glands to be treated is cooled. A virtual grid configuration is overlaid over the treatment area as shown in
In an exemplary method in accordance with an embodiment, a cooling protocol is applied to the overall treatment area (i.e., blocks 310, 312, 324, and 326) in grid configuration 300. The cooling protocol can include, for example, the application of a cold airstream across the treatment area for a prescribed time period, such as 10 seconds. Following cooling, the cooling mechanism (e.g., cold airstream) remains active and a pre-conditioning and photo-treatment protocol is applied to the treatment area. In one embodiment, pulses of a square, “flat-top” beam is used in combination with a scanner apparatus to sequentially apply a laser pulse to blocks 310, 312, 324, and 326. In accordance with an embodiment, the integrated pre-conditioning/photo-treatment protocol includes the application of a set number of light pulses onto each of the blocks in the treatment area, with the blocks being pulsed sequentially. In another embodiment, the blocks are pulsed in a random order.
An example of a set of pulses suitable for a treatment protocol or an integrated pre-conditioning/photo-treatment protocol is illustrated in
The beam size is 4.9 mm square, in an embodiment. The exact beam size can be adjusted, using for example collimation optics, depending on the size of the treatment area, power profile of the laser, the location of the treatment area of the body, and other factors. Furthermore, the average laser power per area should be in balance with the heat extraction achieved by the cooling system. The resulting changes in the measured skin surface temperature are shown in a graph 500, where a peak 522 corresponds to the application light pulse 422 as shown in
The pulse duration should be short enough to enable a rapid rise in the temperature at the target, e.g., the sebaceous gland, as long pulse durations can allow diffusion to soften the temperature peak. It is recognized that there are a variety of other pulse trains that will achieve the same average energy deposited in the skin tissue, while still maintaining short pulse durations. In example shown in
Continuing to refer to
It is also noted that the number of light pulses applied for pre-conditioning purposes is slightly larger than the number of light pulses that effect the photo-treatment. This characteristic is reversed from existing photo-thermal targeted treatment systems in that existing systems have tried to minimize the amount of time taken for pre-conditioning due to the difficulties in balancing the cooling and pre-conditioning effects for pain management during the treatment. The system and methods as described herein eliminate the concern of minimizing the pre-conditioning time, as the same light pulse settings for pre-conditioning are used for the photo-treatment.
The successful photo-thermal treatment of specific targets with decreased patient discomfort may include: 1) Epidermis sparing, namely the peak temperature value at the epidermis is less than around 55° C.; 2) Dermis sparing, namely avoiding overheating the dermis by balancing the average power of the treatment pulses with the heat extraction of the cooling system; and 3) Selective heating of the target target, such as a peak temperature greater than 55° C. for sebaceous gland treatment. Additionally, during the cooling phase, over-cooling the treatment area should be avoided, in order to prevent cold damage (e.g., frostbite) to the epidermis.
It is noted that the number of pulses applied during the photo-thermal treatment protocol can be in a range between 2 pulses and up to approximately 100 pulses depending on such variables as effectiveness of the cooling, laser power, pulse width, and pulse frequency.
Alternatively, a raster scanning process can be used to scan a continuous wave laser beam across the treatment area, rather than applying a laser pulse to a particular block, then moving the laser to another block for application of another laser pulse. In this case with raster scanning, the temperature rise in the target, e.g., the sebaceous gland, can be calculated as a convolution of the size of the sebaceous gland and the speed of the beam.
It is known in the literature that tissue parameters, such as the thickness of the epidermis and dermis, vary among individuals, according to factors such as age, gender, ethnicity, pH, oil content, and hydration as well as between different skin locations. For example, the forehead has different tissue properties than the back, even for the same individual, thus necessitating different treatment parameter settings for the different treatment locations. While existing treatment protocols have been based on a “one treatment fits all” type of an approach, such variations in tissue properties in determining the specific treatment protocol can significantly influence the effectiveness of the laser-based treatment of acne. Additionally, there may be variations in, for instance, the exact laser power, spot size, and cooling capacity between specific laser systems due to manufacturing variability and operating conditions. Mitigating treatment variations that can be caused by variations in the laser power output of a specific machine, as well as variations in treatment conditions, such as ambient humidity and temperature, helps to achieve more uniform treatment results. In other words, reducing variability during photo-thermal treatments enhances safety and increases efficacy.
In one aspect, any variation in the skin surface temperature at the start of a photo-thermal treatment protocol affects the thermal transfer of the laser pulse energy to the target. For instance, in
For existing photo-thermal treatment systems, this variation in the skin surface temperature at the start of the photo-thermal treatment protocol is inevitable, as the cooling procedure includes the application of a cooling means (e.g., cold air or a chilled surface) for a preset amount of time. As an example, the user is directed by the photo-thermal treatment system to apply a stream of cold air onto the treatment area for a certain number of seconds, then the user is prompted to initiate the photo-thermal treatment protocol including the application of the laser pulses. However, this process does not consider the potential variations in the photo-thermal treatment system performance as well as the thermal coefficients of the skin surface in the treatment area, thus inevitably leading to variability in the treatment efficacy.
In an embodiment, a method for performing a treatment includes monitoring the skin surface temperature during the cooling and automatically triggering the pre-conditioning and photo-thermal treatment protocol when a threshold skin surface temperature is reached, and without user intervention.
This cooling monitoring and automatic treatment protocol triggering can be performed by incorporating temperature measurements using, for example, a commercial, off-the-shelf, low-cost sensor that can be built into the scanner (e.g., see temperature sensor 206 of
Turning to
If the answer to decision 716 is YES, then automatic treatment initiation process 700 proceeds to automatically initiate the treatment protocol, without intervention from the user, in a step 718. The automatic treatment initiation process is ended in a step 720.
Optionally, for safety reasons and control purposes, the current skin surface temperature can be compared to stored thresholds value adapted to different control parameters. The monitoring of the skin surface temperature at the treatment area can be continued throughout the treatment protocol as well as after the conclusion of the laser pulse application such that, if the cooling mechanism is continued to be applied to the treatment area, the cooling mechanism application can be stopped once the measured epidermis temperature has reached, for instance, the room temperature or another preset post-treatment temperature setting.
An optional, additional process of automatically terminating the treatment protocol without human intervention is illustrated in
Continuing to refer to
Still referring to
The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this 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. For example, lasers with other wavelengths, such as around 1210 nm, can be used. An important aspect of the embodiments described herein is the increased safety for the patient by making the treatment protocol initiation and/or termination automatic such that potential tissue damage due to operator error is reduced.
Accordingly, many different embodiments stem from the above description and the drawings. It will be understood that it would be unduly repetitious and obfuscating to literally describe and illustrate every combination and subcombination of these embodiments. As such, the present specification, including the drawings, shall be construed to constitute a complete written description of all combinations and subcombinations of the embodiments described herein, and of the manner and process of making and using them, and shall support claims to any such combination or subcombination.
The present disclosure includes the following clauses, which are part of the present disclosure.
Clause 1. A photo-thermal targeted treatment system for damaging a target embedded in a medium, the system including a controller; and a photo-thermal treatment unit including a light source, wherein the controller is configured for administering a treatment protocol, and wherein the treatment protocol is administered using the light source at a preset power setting and a preset pulse timing setting.
Clause 2. The system of Clause 1, wherein the treatment protocol includes a pre-conditioning procedure for preheating the medium, and a photo-thermal treatment procedure, wherein the pre-conditioning procedure and the photo-thermal treatment procedure are both administered using the light source, without changing the preset power setting and the preset pulse timing setting between the pre-conditioning procedure and the photo-thermal treatment procedure, and wherein the pre-conditioning procedure takes a longer duration of time than the photo-thermal procedure.
Clause 3. The system of Clause 2, further including a cooling unit, wherein the treatment protocol further includes a cooling procedure for cooling the medium while administering the treatment protocol.
Clause 4. The system of Clause 3, wherein, for both the pre-conditioning procedure and the photo-thermal treatment procedure, the light source is set to emit a series of light pulses at a preset power level, preset pulse length, and preset pulse interval.
Clause 5. The system of Clause 4, wherein the preset power level is in a range of 10 watts to 50 watts per pulse.
Clause 6. The system of Clause 4, wherein the preset pulse length is in a range of 25 milliseconds to 200 milliseconds per pulse.
Clause 7. The system of Clause 4, wherein the preset pulse interval is in a range of 0.5 seconds to 2.5 seconds.
Clause 8. The system of Clause 4, wherein the pre-conditioning procedure and the photo-thermal treatment procedure include application of the light pulses in a scanned fashion over a preset area.
Clause 9. The system of Clause 8, wherein the preset area is a matrix of treatment blocks of 2-by-1 and larger.
Clause 10. The system of Clause 8, wherein the preset area is a 2-by-2 matrix of 5 millimeter-by-5 millimeter treatment blocks.
Clause 11. The system of Clause 4, wherein, during the pre-conditioning procedure and the photo-thermal treatment procedure, a temperature of the medium is less than a damage threshold for the medium, and the target is heated to a temperature greater than a damage threshold for the target.
Clause 12. The system of Clause 11, wherein, during the pre-conditioning procedure and the photo-thermal treatment procedure, a temperature of the medium is less than 55° C., and the target is heated to a temperature greater than 55° C.
Clause 13. The system of Clause 11, further including a temperature monitor for measuring a temperature of the medium as the series of light pulses are being applied to the medium.
Clause 14. A method for using a photo-thermal targeted treatment system for damaging a target embedded in a medium, the system including a light source, the method including: 1) defining a set of parameters for a series of light pulses to be generated by the light source, the set of parameters including a preset power level, preset pulse length, a preset pulse interval, and a number of light pulses; 2) generating the series of light pulses, in accordance with the set of parameters as defined; and 3) administering the series of light pulses to the medium.
Clause 15. The method of Clause 14, further including, before administering the series of light pulses to the medium, cooling the medium for cooling the medium before and while administering the series of light pulses.
Clause 16. The method of Clause 15, wherein applying the series of light pulses includes defining the preset area as a matrix of treatment blocks of 2-by-1 and larger.
Clause 17. The method of Clause 16, wherein applying the series of light pulses includes defining the preset area as a 2-by-2 matrix of 5 millimeter-by-5 millimeter treatment blocks.
Clause 18. The method of Clause 14, wherein administering the series of light pulses includes applying the series of light pulses such that a temperature of the medium is less than a damage threshold for the medium, and the target is heated to a temperature greater than a damage threshold for the target.
Clause 19. The method of Clause 14, wherein administering the series of light pulses includes raising a temperature of the medium to less than 55° C., while heating the target to a temperature greater than 55° C.
Clause 20. The method of Clause 14, further including monitoring a temperature of the medium as the series of light pulses are administered to the medium.
Clause 21. A method for automatically initiating a treatment protocol using a photo-thermal targeted treatment system, the method including administering a cooling mechanism at a treatment location; monitoring a skin surface temperature at the treatment location; and when the skin surface temperature reaches a preset threshold, automatically initiating the treatment protocol.
Clause 22. The method of Clause 21, wherein automatically initiating the treatment protocol is performed without any manual input by a user.
Clause 23. A method for automatically terminating a treatment protocol using a photo-thermal targeted treatment system, the method including, during administration of the treatment protocol at a treatment area, monitoring a skin surface temperature at the treatment location, and when the skin surface temperature reaches a preset threshold, automatically terminating the treatment protocol.
Clause 24. The method of Clause 23, wherein automatically terminating the treatment protocol is performed without any manual input by a user.
In the specification, there have been disclosed embodiments of the invention and, although specific terms are employed, they are used in a generic and descriptive sense only and not for purposes of limitation. Although a few exemplary embodiments of this 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. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. Therefore, it is to be understood that the foregoing is illustrative of embodiments of the present invention and is not to be construed as limited to the specific embodiments disclosed, and that modifications to the disclosed embodiments, as well as other embodiments, are intended to be included within the scope of the appended claims. The invention is defined solely by the following claims, and the full scope of the equivalents thereof.
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| WO2019/234507 | 12/12/2019 | WO | A |
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