Patent Application
20220273963
The present disclosure relates generally to aesthetic treatment systems, and more particularly, to multifunction aesthetic treatment systems.
Lasers have been applied to medical procedures since they became commercially available in the 1970's. Generally, aesthetic lasers are used for invasive, minimally invasive and non-invasive aesthetic procedures such as, for example, skin treatment and body sculpting. However, with a wide range of wavelengths and power levels, more than 50 different treatment protocols are common. Conventionally, a single laser system is packaged into a single medical device. Thus, conventionally, aesthetic practitioners may require many laser aesthetic treatment systems to perform various procedures. For example, some doctors may require 4, 5, 6, 7, 15, or more laser aesthetic systems to perform procedures requiring different treatment protocols such as, for example, skin ablation/peeling, wrinkle reduction, hyper pigmentation, rosacea, acne, mole removal, skin toning, vein treatments, body sculpting, hair removal, tattoo removal, etc.
Conventional aesthetic laser systems have low efficiency, requiring large power supplies and cooling systems. For example, some conventional laser aesthetic systems incorporate large flash lamp pumped lasers often weighing more than 100 lbs. Diode pumped solid state lasers are more efficient and somewhat smaller, but are expensive and have maintenance issues. Direct Diode lasers offer efficiency and potential low cost, but the need for high amperage power, cooling, and poor beam quality has limited their application.
In one embodiment, a multifunctional aesthetic system is provided. The system includes a housing. The system also includes an electromagnetic array situated in the housing and having one or more electromagnetic radiation (EMR) source(s), each EMR source configured to generate an EMR beam having a wavelength different than that of an EMR beam generated by another, if any, of the EMR sources. The system also includes a controller in electronic communication with the array to operate one or more of the EMR sources to direct the EMR beam to a treatment area. The system also includes one or more sensors in electronic communication with the controller for providing feedback to the controller based on defined parameters to allow the controller to adjust at least one operating condition of the multifunctional system in response to the feedback.
In some embodiments, the housing is designed to be portable. In some embodiments, the one or more EMR sources are modularly replaceable within the array to provide customization of, or a combination of wavelengths generated by the one or more EMR sources. In some embodiments, each of the one or more EMR sources is configured to generate an EMR beam having one of an infrared wavelength, a visible light wavelength, or an ultraviolet wavelength. In some embodiments, the controller is configured to operate two or more EMR sources simultaneously, sequentially, or in an alternating pattern to emit the EMR beams from two or more EMR sources. In some embodiments, the controller is configured adjust the at least one operating condition. In some embodiments, the controller is configured to adjust at least one of a flow rate of a cooling airflow impinging on the treatment area, a temperature of the cooling airflow impinging on the treatment area, a spacing between the treatment area and an apparatus directing the cooling airflow onto the treatment area, a power of the EMR beam, a scanning speed of the EMR beam relative to the treatment area, or combinations thereof. In some embodiments, the one or more sensors includes a temperature sensor, the feedback including temperature data indicating a temperature of the skin (or the treatment surface) in the treatment area or the temperature of the skin (or the treatment surface) near the treatment area, wherein the at least one adjusted operating condition is an emitted EMR beam power. In some embodiments, the sensor includes a temperature sensor, the feedback including temperature data indicating a temperature of the treatment area or the temperature near the treatment area, wherein the at least one adjusted operating condition is a flow rate of a cooling airflow directed onto the treatment area. In some embodiments, the sensor includes a temperature sensor, the feedback including temperature data indicating a temperature of the treatment area, wherein the at least one adjusted operating condition is a spacing between the treatment area and an apparatus directing a cooling airflow onto the treatment area. In some embodiments, the sensor is configured to provide the feedback without contacting the treatment area. In some embodiments, the sensor includes a proximity sensor, the feedback including the distance the head is from the treatment area, wherein the adjusted operating condition is the spacing between the treatment area and the head. In some embodiments, the temperature of the skin is used to calculate the temperature of the subcutaneous region by using models which include information such as the heat flux through the skin.
In some embodiments, the system also includes an EMR pathway directing the EMR to the treatment area. In some embodiments, the pathway also includes two or more optically separated output fibers to permit simultaneous or sequential illumination of a target area by two or more different wavelengths. In some embodiments, the system also includes a device optically engaged with the pathway for modifying the EMR beam received from the pathway to direct the EMR beam onto the treatment area. In some embodiments, the device also includes an optical element for expanding the EMR beam to direct the EMR beam onto an expanded treatment area. In some embodiments, the device also includes a Fresnel or similar lens for focusing the expanded beam to prevent or minimize expansion of the EMR beam in a subsurface treatment region below the treatment area. In some embodiments, the device also includes a beam splitter optically engaged between the pathway and the device for generating a plurality of output beams, wherein the plurality of output beams are emitted by the device to impinge on the treatment area separately and to completely, partially, or to not overlap at a predetermined distance below the treatment area to treat a subsurface treatment region. In some embodiments, the device is optically engaged with a plurality of optically separate portions of the EMR pathway for generating a plurality of output beams, wherein the plurality of output beams are emitted by the device to impinge on the treatment area separately or to partially or completely overlap at a predetermined distance below the treatment area to treat a subsurface treatment region. In some embodiments, the array also includes at least two of the EMR sources each configured to generate an EMR beam having a same wavelength for being directed to the device by the optically separate portions of the pathway. In some embodiments, the device is engaged with one or more sensors for providing feedback associated with the treatment area. In some embodiments, the device is configured to direct a cooling airflow onto the treatment area without disrupting the EMR beam. In some embodiments, the device is configured to direct the EMR beam onto the treatment area, direct the cooling airflow onto the treatment area, and provide the sensor feedback associated with the treatment area without contacting the treatment area. In some embodiments, the system also includes an apparatus engaged at a first end with the housing and engaged at a second end with the device to position the device to direct the EMR beam onto the treatment area. In some embodiments, the apparatus also includes an articulable arm to position the device. In some embodiments, the apparatus is configured to receive a signal from the controller to instruct a movement of the apparatus to position the device with respect to the treatment area. In some embodiments, the apparatus is configured to receive the signal from the controller responsive to feedback received at the controller from the one or more sensors, wherein the sensor may include a position sensor, the feedback including position data indicating a position of the device relative to the treatment area, wherein the at least one adjusted operating condition is a position of the device. In some embodiments, the system also includes a chiller for chilling at least one of the EMR sources or a cooling airflow during operation. In some embodiments, the system also includes a second chiller for chilling another of the at least one of the EMR sources or the cooling airflow during operation.
In another embodiment, a method for aesthetic treatment using a multifunctional system is provided. The method includes operating, by a controller in electronic communication with an electromagnetic array situated in a housing, two or more electromagnetic radiation (EMR) sources of the array to direct an EMR beam generated by each EMR source to a treatment area, each EMR source configured to generate an EMR beam having a wavelength different than that of an EMR beam generated by another of the EMR sources. The method also includes providing, by one or more sensors in electronic communication with the controller, feedback to the controller based on defined parameters. The method may also include adjusting, by the controller, at least one operating condition of the multifunctional system in response to the feedback.
In some embodiments, each EMR source is configured to generate an EMR beam having one of an infrared wavelength, a visible light wavelength, or an ultraviolet wavelength. In some embodiments, the step of operating further comprises operating the two or more EMR sources simultaneously, sequentially, or in an alternating pattern to emit the EMR beams from the two or more EMR sources. In some embodiments, the step of adjusting further comprises maintaining the treatment area at a therapeutically acceptable temperature. In some embodiments, maintaining the treatment area at a therapeutically acceptable temperature includes adjusting at least one of a flow rate of a cooling airflow impinging on the treatment area, a temperature of the cooling airflow impinging on the treatment area, a spacing between the treatment area and a cooling apparatus directing the cooling airflow onto the treatment area, a power of the EMR beam, a scanning speed of the EMR beam relative to the treatment area, or combinations thereof.
In some embodiments, the method also includes directing the EMR beam along an EMR pathway onto the treatment area. In some embodiments, the method also includes modifying the EMR beam in a device optically engaged with the pathway to direct the EMR beam onto the treatment area. In some embodiments, the step of modifying also includes expanding, by an optical element of the device, the EMR beam to direct the EMR beam onto an expanded treatment area. In some embodiments, the step of modifying also includes focusing, by a Fresnel or similar lens, the expanded beam to prevent or minimize expansion of the EMR beam in a subsurface treatment region below the treatment area. In some embodiments, the step of modifying also includes splitting, by a beam splitter optically engaged between the pathway and the device, the EMR beam to generate a plurality of output beams. In some embodiments, the step of modifying also includes emitting, by the device, the plurality of output beams to impinge on the treatment area separately and to overlap at a predetermined distance below the treatment area to treat a subsurface treatment region. In some embodiments, the step of modifying also includes optically engaging the device with a plurality of optically separate portions of the EMR pathway to generate a plurality of output beams. In some embodiments, the step of modifying also includes emitting, by the device, the plurality of output beams to impinge on the treatment area separately and to overlap at a predetermined distance below the treatment area to treat a subsurface treatment region.
In some embodiments, the method also includes directing, to the device by the optically separate portions of the pathway, at least two EMR beams having a same wavelength, wherein the array includes at least two EMR sources each configured to generate EMR beams having a same wavelength. In some embodiments, the method also includes directing, via the device, a cooling airflow onto the treatment area without disrupting the EMR beam. In some embodiments, the steps of directing, by the device, the EMR beam onto the treatment area, directing, via the device, the cooling airflow onto the treatment area, and providing, by the one or more sensors, feedback to the controller are performed without contacting the device or the sensor with the treatment area. In some embodiments, the step of adjusting also includes controlling, by the controller, a movement of an apparatus engaged with the housing to position the EMR beam with respect to the treatment area. In some embodiments, the step of adjusting also includes moving the apparatus in response to the feedback to reposition EMR beam.
In accordance with example embodiments of the present invention, a method for providing an aesthetic treatment is provided. The method includes providing a plurality of markings to identify boundaries of a treatment area, registering, by an aesthetic treatment device, the plurality of markings to map the treatment area, the aesthetic treatment device having a source for directing an electromagnetic radiation (EMR) beam, and activating the source to generate the EMR beam at the mapped treatment area.
In accordance with aspects of the present invention, the aesthetic treatment device further includes a housing, a treatment arm, with two ends, connected to the housing at one end, a treatment head connected to the treatment arm at the other end, a controller, a system for directing the EMR beam to the treatment head, and a user interface for allowing a user to input data. The treatment head may not contact a surface of the treatment area during delivery of the EMR. The treatment head can include a lens that converts the EMR beam into a rectangular shape with a length and a width. The aesthetic treatment device can further include a system for providing air to the treatment head for delivery to the treatment area. The treatment zone can have a length and a width, with the length being approximately a whole number multiple of the length of the EMR beam and the width being approximately a whole number multiple of the width of the EMR beam.
In accordance with aspects of the present invention, the treatment area is a rectangular shape. The treatment area is set by moving the treatment head to a first corner of the treatment area and registering the first corner, moving the treatment head to a second corner of the treatment area and registering the second corner, moving the treatment head to a third corner of the treatment area and registering the third corner, and moving the treatment head to a fourth corner of the treatment area and registering the fourth corner. The method can further include aligning an alignment light of the aesthetic treatment device with one of the plurality of markings to initiate the registering of the treatment area. The method can further include moving the treatment head in response to an input into at least one of a joystick and the user interface.
In accordance with example embodiments of the present invention, a multifunctional aesthetic system for causing thermal apoptosis in subcutaneous fatty tissues is provided. The system includes an electromagnetic radiation (EMR) source to generate an energy beam and an energy delivery device for directing the energy beam over a first treatment zone in a treatment area while moving the electromagnetic radiation (EMR) source within the treatment zone at a rate that allows subcutaneous tissue to reach a target temperature range. The energy delivery device continues the application of the energy beam to the first treatment zone while keeping the subcutaneous tissue within the target temperature range and the energy delivery device discontinues the application of the energy beam to any of the subcutaneous tissue in the first treatment zone that have been in the target temperature range for a target treatment period of time.
In accordance with aspects of the present invention, the target temperature range of the of the subcutaneous tissue is 42° C.-51° C. The application of the energy beam can be applied to an area that is smaller than the area of the first treatment zone. The energy delivery device can apply less of energy after the subcutaneous tissue has reached the target temperature range than the application of the energy applied prior to the subcutaneous tissue reaching the target temperature range. The application of energy to the first treatment zone can be stopped when the temperature of the treatment zone surface is higher than a maximum surface temperature and the application of energy to the first treatment zone can be restarted when the temperature of the treatment zone surface is lower than the maximum surface temperature. The energy delivery device can apply the application of the energy beam and cooling air to the first treatment area while moving the electromagnetic radiation (EMR) source within the first treatment area to raise a temperature of the subcutaneous tissue to the target temperature range and the energy delivery device can stop the application of the energy beam to the first treatment area while maintaining the cooling air while moving the electromagnetic radiation (EMR) source within the first treatment area.
In accordance with example embodiments of the present invention, an aesthetic apparatus is provided. The aesthetic apparatus device includes an electromagnetic radiation (EMR) source configured to generate an EMR beam, a device for directing the EMR beam and an airflow to a treatment area, a lens for collimating the EMR beam, and a refractive diffuser for transforming the collimated EMR beam into a square EMR beam and produce a uniform energy distribute for uniform tissue heating.
In accordance with aspects of the present invention, the apparatus further includes an air system having a source of air and a cooling system for directing a volume of air at a target velocity sufficiently enough to provide impingement cooling on a tissue surface from the source of air to a treatment area. The apparatus can further include a sensor array having at least one of a skin temperature sensor, an air-cooling temperature sensor, air flow sensor, laser power sensor, a location sensor, and a proximity sensor. The energy delivery device can further include a blocking filter to filter light that reaches the proximity sensor increase accuracy of laser detection for proximity of the apparatus to a surface of the skin.
Illustrative, non-limiting example embodiments will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings.
Various exemplary embodiments will be described more fully hereinafter with reference to the accompanying drawings, in which some example embodiments are shown. The present disclosure may, however, be embodied in many different forms and should not be construed as limited to the example embodiments set forth herein. Rather, these example embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present disclosure to those skilled in the art. In the drawings, the sizes and relative sizes of layers and regions may be exaggerated for clarity. Like numerals refer to like elements throughout.
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 disclosure belongs. For example, when an element is referred to as being “operatively engaged” with another element, the two elements are engaged in a manner that allows electrical and/or optical communication from one to the other.
Embodiments of the present disclosure generally provide multifunction aesthetic systems. In particular, in some embodiments, the systems of the present disclosure can include one or more electromagnetic radiation (EMR) sources and optionally a beam combiner for combining electromagnetic radiation beams emitted by two sources. In this manner, in some embodiments, the multifunction aesthetic system can emit multiple wavelengths of electromagnetic radiation through a single output device. In some embodiments, the multiple wavelengths can be emitted simultaneously, in alternating pulses, and/or sequentially to permit multiple treatments to be performed by the same multifunction aesthetic system. In some embodiments, the multiple treatments can be performed sequentially, simultaneously, or in alternating fashion.
As used herein, EMR can refer to electromagnetic radiation having any desired wavelength. In particular, EMR generated and/or emitted by embodiments of the present disclosure can be any suitable wavelength, including, for example, visible light, ultraviolet radiation, x-ray radiation, infrared radiation, microwave radiation, radio waves, or combinations thereof.
Referring now to
In some embodiments, the system 10 can include a user interface 101 electronically connected to the housing 100 for receiving a user input. The user interface 101 can include, for example, an electronic display, a touch-screen monitor, a keyboard, a mouse, any other device or devices capable of receiving input from a user, or combinations thereof. The user input can include, for example, patient data such as height, weight, skin type, age, etc. as well as procedural parameters such as desired beam power, procedure type, wavelength or wavelengths to be applied, pulse duration, treatment duration, beam pattern, treatment area temperature limit, etc.
In some embodiments, the system 10 can also include a computing device 107 for receiving and storing the user input from the user interface 101, for storing and executing appropriate procedure protocols according to the user input, for providing control instruction to various components of the system 10 and receiving feedback from the various components of the system 10. The computing device 107 can be any suitable computing device such as, for example, a laptop, a desktop, a server, a smartphone, a tablet, a personal data assistant, or any other suitable computing device having a memory 109 and a processor 111. The memory 109, in some embodiments, can be any suitable memory 109 for storing electronic data, including the user input data and operational data associated with one or more components of the system 10. The memory 109 can include, for example, random access memory (RAM), flash memory, solid state memory, a hard disk, a non-transitory computer readable medium, any other form of electronic memory, or combinations thereof. The processor 111, in some embodiments, can be any processor suitable for receiving user input from the user interface 101, generating commands for operation of one or more system 10 components, executing any software stored in the memory 109, or combinations thereof. The processor, in some embodiments, can include one or more of a microprocessors, an integrated circuit, an application specific integrated circuit, a microcontroller, a field programmable gate array, any other suitable processing device, or combinations thereof.
As shown in
In some embodiments, each laser source 203 can be configured to emit EMR at a particular wavelength. For example, in some embodiments, each laser source 203 can emit EMR at a wavelength between about 200 nm to about 4500 nm. However, it will be apparent in view of this disclosure that each laser source 203 can emit EMR at any desired wavelength in accordance with various embodiments. Furthermore, it will be apparent in view of this disclosure that, in addition to laser sources 203, any other source of electromagnetic radiation having any wavelength can be used in accordance with various embodiments. For example, in some embodiments, EMR sources of the system 200 can emit electromagnetic radiation having any suitable wavelength, including, for example, visible light, ultraviolet radiation, x-ray radiation, infrared radiation, microwave radiation, or radio waves. Thus, because each laser source 203 can be configured to emit a different particular wavelength, just one system 10 can produce EMR beams at wavelengths or combinations of wavelengths required for any one of a plurality of procedures having disparate treatment protocol requirements. Accordingly, in some embodiments, the system can include laser sources 203 emitting wavelengths suitable for performing one or more procedures including, for example, but not limited to, fat reduction, body skin tightening, facial skin tightening, skin resurfacing, skin remodeling, vein reduction or removal, facial pigment removal or reduction, hair removal, acne treatment, scar reduction and removal, psoriasis treatment, stretch mark removal, nail fungus treatment, leukoderma treatment, tattoo removal, or combinations thereof.
Some aesthetic procedures may only require a single wavelength. For example, for some fat reduction procedures, a laser source 203 can be provided which is capable of emitting EMR at a wavelength of about 1064 nm (e.g., about 400 nm to about 3000 nm or about 900 nm to about 1100 nm) can be selected for hyperthermia or apoptosis of fat tissue because it exhibits good transmission through the skin, epidermis, and dermis and deposits energy within the fat cells. On the other hand, skin tightening generally requires other wavelengths that exhibit higher absorption in the epidermis and dermis, where the collagen resides. Thus, for example, a wavelength of about 1320 nm (e.g., about 400 nm to about 3000 nm or about 1300 nm to about 1500 nm) can be used for some body skin tightening procedures. These EMR beam wavelengths deposit more energy to the collagen, creating apoptosis or necrosis and eventually skin tightening from new collagen regrowth.
In other examples, such as for some facial pigment reduction or removal procedures and some vein reduction or removal procedures, for example, a laser source capable of emitting EMR at about 532 nm (e.g., about 500 nm to about 650 nm) can be provided.
Additionally, some aesthetic procedures or combinations of procedures may require two or more wavelengths. For example, to combine the fat reduction and body skin tightening procedures discussed above, a first laser source 203 capable of emitting EMR at 1064 nm and a second laser source 203 capable of emitting EMR at 1320 nm can be provided. In another example, for some facial skin tightening procedures, for example, a first laser source 203 capable of emitting EMR at about 1320 nm (e.g., 400 nm to about 3000 nm or about 1300 nm to about 1500 nm) and a second laser source 203 capable of emitting EMR at about 1470 nm (e.g., 400 nm to about 3000 nm or about 1300 nm to about 1500 nm) can be provided.
To provide additional functionality and facilitate ease of maintenance, in some embodiments, the one or more laser sources 203 can be removably mounted to the mount 201 to permit modular replacement of the laser sources 203. Thus, in such modular configurations, individual laser sources 203 can be replaced, for example, to provide additional or different wavelengths or wavelength combinations as needed for particular procedures. However, it will be apparent in view of this disclosure that, in some embodiments, the one or more laser sources 203 can be permanently attached to the mount 201.
The one or more laser sources 203, in some embodiments, can include one or more fiber coupled lasers. For example, in accordance with various embodiments, the laser sources 203 can include one or more fiber coupled diode lasers and/or flashlamp or diode pumped lasers such as Er:YAG, Er,Cr:YSGG, Nd:YAG, Nd:glass; Er:glass, or any other suitable fiber coupled EMR source. In some embodiments, fiber coupled laser sources 203 can be rated as continuous wave (CW) devices operating at 50 W, 100 W, etc. Such CW devices can be operated in a gated mode where the pulse energy is equal to the pulse duration times the power. Therefore, a 100 W diode laser gated to operate for 5 milliseconds will have pulse energy of 500 mJ. In cases where more pulse energy is required but, for example, power supply or cooling capacity limits the average power, fiber coupled laser sources 203 can be configured as a quasi-CW device. Such quasi-CW devices can produce higher power pulses for the same average power draw by operating at a lower pulse frequency rate. In some embodiments, a quasi-CW device can produce pulses having up to 10 times the average power draw. Thus, for example, a 1000 W/100 W quasi-CW diode would be capable of pulsed operation at 5 milliseconds with 5 Joules per pulse, but limited to one tenth the pulse frequency of a CW laser.
In some embodiments, at least one of the laser sources 203 can include a fiber coupled diode laser. Such laser systems can advantageously operate at efficiencies exceeding 50%, are relatively small in size, draw relatively low power, and exhibit wide wavelength diversity. Fiber coupled diode lasers can, for example, be driven by less than 2.0 volts DC to produce an output of 10 kW or more. Furthermore, such laser sources 203 can be small and lightweight, with the module weighing about 500 grams per 1 kW. In one embodiment, at least one of the laser sources 203 can be a 75 W fiber coupled diode having a size of about 8×4×3 cm (less than 100 cm3). In some embodiments, such laser sources 203 can be used to perform an aesthetic procedure while drawing less than 100 Watts of power. Such low power draw can, in some embodiments, reduce the amount of cooling required, permitting smaller, quieter, more efficient cooling systems.
The compliance voltage for nearly all diodes of interest is slightly less than 2.0 VDC. Packaging and differing bias voltage configurations can be applied to result in a common higher voltage which then allows a lower drive current. For example, a typical 50 W diode driven at 2.0 VDC can require a minimum threshold current of 8 amps to 12 amps and can require more than 60 to 70 amps to produce a desired power level. Such high current necessitates heavy gauge wiring such as #6- or #8-gauge wires to avoid voltage drop, preserve system reliability, and minimize Joule heating. To reduce the required current supply and wiring size, in some embodiments, the diode of each fiber coupled diode laser source 203 can be configured to operate with a common compliance voltage such as, for example, 20 VDC or 25 VDC, with a drive current controlled to match the laser selected and the required output power. By increasing the common compliance voltage to 20 or 25 VDC, the maximum drive current required to operate each laser source 203 can be limited to about 10 amps or less for most aesthetic procedures. By reducing required current, smaller gauge wiring can be used to improve reliability. In some embodiments, such an approach permits use of a single power supply to drive the one or the more than one laser sources 203 by manifolding the power supply into connections with the one or more than one EMR sources. Thus, for example, in embodiments where only one laser is operated at a time, then the system 10 may be provided with only one power supply.
Typical diode packaging employs semiconductor bars with compliance voltages near 2.0 VDC, where threshold currents are in the 8 to 12 amperage range. To reach significant power levels, such diodes can operate as high as 70 amps. The associated problem with these voltage drops and joule heating (I2*R) adds to reliability concerns. However, partial diode bars (i.e., diode bars having a shorter length than a standard 2.0 VDC diode bar) typically require less current proportional to the bar fraction. Thus, by using partial diode bars connected in series, delivering lower current but at a higher voltage for activating each of the partial diodes, required current can be reduced while power is maintained.
In some embodiments, at least one of the laser sources 203 can include a flashlamp or diode pumped laser. For example, many aesthetic skin treatments require application of EMR having a wavelength near 3000 nm, such as, for example, wavelengths greater than 2500 nm. Such wavelengths are typically produced by flashlamp or diode pumped solid state laser devices such as Er:YAG, which produces EMR having a wavelength of about 2940 nm or Er:YSGG, which produces EMR having a wavelength of about 2790 nm. However, although shown and described herein with reference to fiber coupled diode lasers and flashlamp or diode pumped lasers, it will be apparent in view of this disclosure that any suitable type of EMR source capable of being coupled to a fiber optic output cable can be used in accordance with various embodiments. In some embodiments, laser sources 203 including the flashlamp or diode pumped solid state laser devices can also be configured to operate at the common compliance voltage as explained above with reference to the fiber coupled diode lasers. Thus, the system 10, in some embodiments, can use the common power source as discussed above with reference to the fiber coupled diode lasers.
Still referring to
In some embodiments, the fiber optic relay cables 205 can be mated to the laser sources 203 by a fiber optic connector such as, for example, a SMA 905 connector or any other suitable connector. For each of the fiber optic relay cables, the fiber core diameter can be driven by the coupling efficiency of the diode driver and the required power. For example, in CW operation, in one embodiment, for near infrared wavelength ranges, the core diameter can be determined by an energy density limit in the cable of about 1.4 MW/cm2 to provide a reliable relay. This reliability limit on the fiber predicts that a 100-micron core diameter can handle up to 85 W and a 400 micron core diameter can be used up to 1300 W. Shorter wavelengths typically scale to lower power limits. Additionally, for pulsed operation where the pulse duration is less than one (1) microsecond (1×10−6 seconds), fiber damage is not thermal but caused by dielectric breakdown and occurs at lower levels proportional to the pulse duration. That is, although average power is low enough to prevent overheating of the fiber, the power delivered during a pulse duration of less than one (1) microsecond can cause breakdown of the dielectric materials of the fiber. More generally, by selecting the proper fiber core diameter and connectors capable of handling maximum expected power loadings, safe and reliable routing of the EMR power generated by the laser sources 203 is possible.
Still referring to
For example, free space combiners can be packaged with mirrors and gratings to fold separate beams into one fiber. Butt-coupled fiber combiners can mate smaller core fibers into a larger core output cable. For butt-coupled fiber combiners, the smaller fibers are stripped to their cladding and packaged as close to each other as possible, for example, in a circular footprint. The polished fiber ends can be mated (butt-coupled) to a larger fiber core with a diameter greater than the multiple fiber footprint. Tapered fibers can be used to reduce the core diameter of the combined fibers. That is, tapered fibers can be stretched such that the diameter of each tapered fiber is reduced to permit a higher packaging density for fiber coupling. Fiber fusing can be used to mate multiple fibers together by stripping the fibers and bundling them into a close-packed cross-section. The fibers can then be heated and melted to fuse into a single output fiber. Bundled fiber cables can also be used to route multiple sources into one output path. Bundled fibers, in general, can be larger diameter fiber cables formed from many small, individual fibers closely packed within the cable. In embodiments where there is only one laser source 203, common output cable 209 may be a continuation or extension of relay cable 205 if there is no need for beam combiner 207.
Additionally, as shown in
In such embodiments, because only the laser sources 203 producing the desired wavelengths are activated at any time, the beam combiner 207 can be a passive device, rather than an active fiber switch. Having a passive device also helps in defining the power limits for the fibers, where the limit in watts for the fibers can be matched to the highest power laser source 203 available where only a single laser source 203 is active at a time, rather than a sum from each laser source 203. To the extent that multiple laser sources 203 are activated simultaneously, the power limit of the combined fibers must be equivalent to at least the sum of the power required to operate each active laser source 203. Alternatively, in some embodiments, the beam combiner 207 can also include one or more fiber switches to selectively output particular wavelengths.
The beam combiner 207 can then output the combined beam to a common output cable 209 coupled to the beam combiner 207 for transmitting or relaying the EMR (also referred to as “treatment energy” or “beam”) combined in the beam combiner 207. Advantageously, the common output cable 209 can permit the different beams produced by the laser sources 203 to be emitted through a single optical device. In particular, by combining or directing the beams in the beam combiner 207 to the common output cable 209, a single optical device of the system 10 can emit beams of different wavelengths simultaneously, sequentially, or in an alternating pulsed pattern. Thus, advantageously, in some embodiments, two or more treatment procedures can be performed simultaneously, contemporaneously, or immediately sequentially to improve patient outcomes and to reduce the number of patient follow up procedures.
In some embodiments, the fiber optic output cable 209 can be, but is not limited to, substantially similar to fiber optic relay cables 205. In some embodiments where there is only one laser source and beam combiner 207 is not needed, output cable 209 can be the same cable as relay cable 205. More generally, the fiber optic output cable 209 can be any fiber optic cable capable of transmitting the combined beam emitted by the beam combiner 207 to a fiber optic output. In accordance with various embodiments, the output cable 209 can be formed as a single fiber, can be formed as a plurality of smaller, bundled fibers, or can be formed as two or more closely packed individual fibers for separately transmitting two or more distinct beams having different wavelengths.
More generally, although the relay cables 205 and the output cable 209 are shown herein as being fiber optic cables, it will be apparent in view of this disclosure that any optical pathway capable of directing or transmitting EMR from one or more EMR sources to the beam combiner 207 and from the beam combiner 207 to the treatment area can be used in accordance with various embodiments. For example, in some embodiments, the pathways can be constructed of a series of mirrors for directing the EMR beams.
For example, as shown in
In some embodiments, the fiber optic output cable 209 can also include a fitting 211 positioned at one end thereof for engagement with a device such as a hand piece, robotic head, or other emitter.
As shown in
The power and control electronics 400 can also include a controller 403, powered by the AC electrical power (e.g., 220 VAC), in electronic communication with the computing device 107 to command one or more additional components of the system 400 to perform one or more directed operations to execute an aesthetic procedure.
The power and control electronics 400 can also include a low voltage ADC 405 for converting AC power from the power box 401 into high or low voltage DC power for operating one or more additional components of the power and control electronics 400. The low voltage ADC 405 can include any suitable ADC, including, for example, a direct conversion ADC, successive approximation ADC, ramp compare ADC, Wilkinson ADC, integrating ADC, delta encoded ADC, pipelined ADC, sigma delta ADC, time interleaved ADC, intermediate FM stage ADC, any other suitable ADC, or combinations thereof.
The system can also include a high voltage ADC 407 for converting AC power from the power box 401 into high or low voltage DC power for operating one or more additional components of the power and control electronics 400. The high voltage ADC 407 can include any suitable ADC, including, for example, a direct conversion ADC, successive approximation ADC, ramp compare ADC, Wilkinson ADC, integrating ADC, delta encoded ADC, pipelined ADC, sigma delta ADC, time interleaved ADC, intermediate FM stage ADC, any other suitable ADC, or combinations thereof.
The power and control electronics 400 can also include a plurality of diode drivers 409 for delivering drive current to the one or more laser sources 203. The diode drivers 409, in some embodiments, can, for example, be semiconductor devices configured to pass a current through a junction region between an n-type semiconductor and a p-type semiconductor. In such configurations, electrons produced by the n-type semiconductor in the presence of a current source such as DC power supply 407 can result in production of photons upon encountering holes of the p-type semiconductor. The photons can oscillate within the junction region, resulting in an optical gain in the junction region. When the current delivered to the semiconductor device exceeds a threshold current, the optical gain can exceed a threshold intensity, causing the photons to exit the junction region as a beam of laser light. In general, after reaching the threshold current, the laser output increases in power density (intensity) linearly in proportion to an increase in the input current. Furthermore, in some embodiments, the diode drivers 409 can also include regulators for controlling current input and one or more protective features such as, for example reverse current blocking and electrical spike suppression features.
In some embodiments, a single DC power supply 407 or 405 can be used for multiple diode drivers if the required compliance voltage for each driver 409/laser source 203 pair is the same and within the limits of the chosen diode driver. Sufficient current capability of the DC power supply 407 or 405 to operate the number of simultaneously driven driver 409/laser source 203 pairs is required. Advantageously, no special switching is required between the DC power supply 407 or 405 and the driver 409 or driver 409 and laser source 203. The DC power supply 407 or 405, in some embodiments, can be parallel connected to each driver 409. This presents an option for multiplexing the main power supply to the multiple laser sources 203.
In such embodiments, each of the diode drivers 409, when activated, can directly drive a single laser source 203 to produce a beam having a particular wavelength as discussed above with reference to
Referring again to
Such heat is typically dissipated by one or more of forced air (e.g., fan) cooling, thermoelectric cooling, flowing coolant directly through the electromagnetic array 200, or a cooling plate. While some cooling systems have drawbacks, baseplate cooling to cold plate is efficient, safe, quiet, and compact. Large cold plates can accommodate multiple EMR source heads and drive electronics. In some embodiments, several cold plates can be connected in series to the master circulating chiller. In some embodiments, one or more additional master circulating chillers can be provided as required to accommodate different cooling temperature requirements.
As shown in
Referring now to
As shown in
In some embodiments, the air or gas can be driven through the heat exchanger 503 by a pump 507. The pump 507, in some embodiments, can be any suitable device capable of driving the gas through the heat exchanger 503 and onward to a jet impingement nozzle (not shown). In some embodiments, in order to maintain a therapeutically acceptable temperature at the treatment area (e.g., a patient's skin), the pump 507 can be in electronic communication with the controller 403 to receive instructions from the controller for adjusting a flow rate of the cooling air or gas responsive to feedback from one or more temperature sensors monitoring the treatment area.
The cooling system 500, in some embodiments, can route the coolant from the coolant outlet 503b of the heat exchanger 503 or directly from outlet 501a of a refrigeration unit to a first coolant port 201a of a mount 201 as described above with reference to
Referring again to
Referring again to
In order to provide desired coverage of an area to be treated and permit proper positioning of the device 950, the positioning apparatus 900 can be provided with any number of degrees of freedom for movement of the device 950. For example, in some cases a treatment process can employ only one DOF and move the device 950 back and forth over the treatment area. As shown in
Referring now to
Such positioning apparatus 900 can be important in various procedures such as, for example, in the case of subcutaneous fat reduction, where deposition of heat into the subcutaneous fat requires reaching and maintaining a therapeutically acceptable temperature range such as, for example, about 40° C. to about 48° C. over a period of time. In particular, in some embodiments, lower temperatures have no fat reduction benefit and higher temperatures can cause severe necrosis, cell damage, and scarring. Conventional devices modulate or cycle the power off and on to maintain this temperature range. However, the low thermal conductivity of fat makes EMR source on/off cycle times compatible with a scanning or moving the device during treatment to cover larger treatment areas and to avoid overheating of the treated tissue. Thus, the positioning apparatus 900 can be programmed to control the device 950 to follow the targeted patient's body shape and match the treatment zone desired. In such embodiments, the heat energy delivered, the treatment area, the dwell time for energy on and the heat source return time to maintain the target temperature are factors that can be used to determine the overall treatment protocol. Patient information, sensors, and feedback can also all be used to maintain a uniform heating over the entire treatment site by scanning the energy delivery module in such a fashion as to cover the entire site. However, it will be apparent in view of this disclosure that, in some embodiments, the system 10 may not include a positioning apparatus 900 and that the device 950 can instead be connected to the housing by the fiber output 209 and/or a cooling air source for manual operation and positioning. It will still further be apparent in view of this disclosure that, in some embodiments, the system 10 may include both a device 950 for use with the positioning apparatus 900 and a manually operated and positioned device 950 for use as required by a particular procedure. For example, the manually operated and positioned device 950 can be used where desired.
Furthermore, sensors 1000 and corresponding sensor feedback can be monitored in real time by the computing device 107 to permit the computing device 107 to reactively instruct (e.g., via controller 403) the positioning apparatus 900 to reposition the device 950. For example, in some embodiments, if the sensors 1000 detect that skin temperature is too high, the computing system 107 can instruct the positioning apparatus 900 to move the device 950 to a new location and/or to scan faster during treatment to reduce dwell time in one area and prevent overheating. In some embodiments, the if the sensors 1000 detect that skin temperature is too low, the computing system 107 can instruct the positioning apparatus 900 to increase a distance or spacing between the device 950 and the target surface to reduce the effects of cooling air flowing through the device 950. Still further, sensors 1000 can be included to detect a position of the device 950 relative to the surface to be treated. In such embodiments, the positioning apparatus 900 can responsively adjust a position or orientation of the device 950 relative to the surface to be treated according to the sensor 1000 feedback. For example, in some embodiments, the positioning apparatus 900 can maintain a prescribed separation height between the device 950 and the surface to be treated.
Numerical simulation modeling for an EMR source in the near-infrared where transmission to the subcutaneous fat is achieved shows that for 1.5 watts per centimeter squared over a 2×2 inch area, the adipose tissue at 12 mm depth reaches 47° C. within 50 seconds. This sample model also included controlled cooling of the skin at 30° C. Simulations show that, without cooling the skin surface would reach an unacceptable temperature of more than 57° C. In this case, the model also shows how the adipose tissue's temperature will decay with time. This model indicates that the patient can be treated in one zone for 50 seconds, after which the robotic control moves the energy source to the next zone for another 50 seconds. This can be repeated to multiple zones, only requiring return to the initial zone before its temperature falls too far below the target temperature range of 40 to 52° C. for efficient hyperthermia apoptosis. Additional modeling studies show that the second treatment duration requires less time to reach the 52° C. temperature and that the reduction in required reheat time is asymptotic. In some instances, as the treatment head is scanning around the pattern loop, it will scan at a particular power level until the tissue reaches the target temperature (52° C.) it can then decrease power until it reaches a plateau in which the decay matches the power level, and the power may not need to be decreased further once plateaued.
In some embodiments of the present invention, the control system can monitor a temperature of the treatment area and then skin within the proximity of the treatment area and can shut down the EMR delivery when the temperature of the skin or treatment area gets too high. For example, when a temperature of an area is outside a predetermined temperature range, the controller can initiate an OFF portion of the duty cycle to allow that area to cool. While in the OFF portion of the duty cycle the affected area can cool naturally or a cooling airflow can be applied by the system to the area. In some embodiments, the skin can be cooled by scanning for a brief time with the EMR delivery shut down while applying cooling air until skin temperature is reduced to the desired level. In some embodiments, instead of remaining at a first treatment location waiting for the skin or treatment area temperature to return to an acceptable range or level, the laser head can be moved to a second treatment location, during the OFF portion of the duty cycle, to begin treatment of the second treatment location, thereby reducing the overall procedure time.
It is important to note that this model is an example based on defined tissue characteristics. However, dwell times and reheat cycles may need to be adjusted on a case by case basis based on, for example, patient skin type, patient characteristics, wavelength, cooling characteristics, etc. Additionally, it will be apparent in view of this disclosure that the treatment does not need to target 52° C. and can instead target a lower temperature within a procedure-specific range. For example, the treatment can be successful with lower target temperatures, such as 44° C. In each case, the patient type and treatment time can be adjusted to a range of target temperatures. Additionally, it will be apparent in view of this disclosure that, in some embodiments, the temperature can be permitted to fall below the minimum effective temperature of 40° C. for short periods of time with reheating applied to raise the temperature back into the hyperthermia apoptosis targeted range. The application of computer control with the appropriate input parameters allows an efficient and optimized treatment protocol.
In some embodiments, a pattern may be scanned in which the energy source returns to the initial treatment site in a time equal to the expected decay time of the temperature. Since reheating to the target temperature requires less time on the second pass, the energy source may be moved at a faster rate on the second pass over tissues. Energy source scanning patterns may be optimized for treatment of a maximum area in a minimum time and will depend upon patient anatomy and tissue parameters. Scan rates and treatment patterns may be modified in real time based upon measured skin temperatures and heat flux and predicted subcutaneous tissue temperature. Energy source power may be modulated during movement of the energy source to further optimize treatment.
Referring to
For example, the cross-sectional area of the laser beam can be 4.3 cm by 4.3 cm or about 18.5 cm2, and this square cross section can be scanned in a 4×2 pattern, or an area that is 4×4.3 cm by 2×4.3 cm for a total area of tissue in the scan region of 148 cm2. Continuing the example, in some embodiments, the beam can be scanned over the two rows of tissue and may be turned off during the transitions between rows. As the beam is repeatedly scanned over the region, the fraction of time that a given 18.5 cm2 of tissue is in the beam is 18.5/148=1/8=0.125. Given a laser power during the initial scan of 150 Watts, the instantaneous power density is equal to 150/18.5=8.1 Watts/cm2. The average laser power density delivered to any tissue during the initial scan over the target tissue region is then equal to 8.1/8 Watts/cm2=1.01 Watts/cm2. Increasing the laser power from a therapeutic level of 1.01 Watts/cm2 for a stationary beam to 1.01/0.125=8.1 Watts/cm2 for the moving beam keeps the average power in any part of the scanned region at 1.01 Watts/cm2. In this example, any given tissue within the treatment area is in the 8.1 Watt/cm2 laser beam for 12.5% of the time, and out of the beam for 87.5% of the time (i.e., a 12.5% duty cycle). During the time that the tissue is out of the beam its temperature drops but remains in the therapeutic range. The laser is always ON in this embodiment, and the desired duty cycle can be achieved by scanning the beam at a particular rate and/or pattern. The average power density never exceeds a critical safety value of about 1.5 Watts/cm2. In some embodiments, a critical safety value is more than 5 W/cm2.
In some embodiments, a pattern 1804 can be created to create a rectangular treatment zone 1800 or treatment area, as depicted in
Continuing with
To ensure apoptosis of all tissue in the target region, the tissue must be held in the target temperature range for a time adequate to denature its cells. It has been determined that an exposure time of 15 minutes is adequate to cause apoptosis in tissue that is held in the target range of 40° C.-52° C. Since heat is retained in the target region, the average power needed to keep the temperature in the target range decreases with time. In some embodiments, a decrease in average power may be achieved by making reductions in the laser power density over the treatment duration. For example, tissue modelling has shown that about 50 scans of the tissue region of
In some embodiments, it may be possible to raise the temperature of the target tissue (for example, the fat layer for fat reduction procedures) higher than the range of 42° C.-51° C. For some patients, this range is selected in order to keep the skin temperature less than 40-43° C., the temperature where some patients feel pain. In some embodiments, it is possible to raise the temperature of the target tissue to a higher temperature of about 50° C. or about 55° C. without causing pain for the patient. This higher temperature may be used when the heat transfer from the treatment tissue to the skin is low and/or in conjunction with more aggressive skin cooling. If these higher temperatures are used, the treatment time may be reduced from 15 min to about 10 min or to about 5 min.
In some embodiments, a 150 W laser may be used to generate the laser beam (or EMR beam). In this embodiment, the laser can be used to heat the treatment zone 1800 to a temperature where the patient's skin is within an acceptable range. The laser may then be shut off for a period of time, for example, about 5 seconds, about 10 seconds, about 15 seconds, or whatever length of time is necessary to allow to prevent the temperature of the skin from going above an acceptable level while maintaining the temperature of the subcutaneous treatment area at an acceptable level. In some further embodiments, the laser can be moved to a new treatment area while the user/physician is waiting for the first treatment area to cool. In embodiments such as this, the higher laser power will heat the subcutaneous tissue faster than a lower power laser and the time that the laser is off or moved to another treatment area will allow the surface tissue to cool while maintaining a high temperature in the treatment area.
In some embodiments, a treatment zone, treatment area, or target tissue region can be created, in part, by using a template. For example, a template as shown in
In some embodiments, the template can be provided to assist in creating identifiable markings that are readable as inputs by the system for alignment of the treatment head, arm, etc. of the treatment device. The markings can be used to indicate where the boundaries of the treatment area should be and the treatment device can create a treatment pattern based on those boundaries. In some embodiments, with a template in place, the physician can place markings as indicated by the template on the patient's body. For example, using a template 2610, 2620, or 2630 as shown in
Referring now to
At step 1904, an energy source power density that keeps the treatment average power density below a predetermined safe level and keeps the tissue in a therapeutic temperate range is selected. The energy source power density can be set to a level that keeps the power density averaged over the entire treatment time less than a critical value. The options for the energy source power density can be recommended by the system based on the inputs from step 1902. In some embodiments, a higher laser power density can be used during a procedure because the laser beam is always moving, such that each tissue may see a lower amount of energy. For example, application of a 150-watt laser over a 4.3×4.3 cm area would be 8.1 W/cm2 which may be too high if stationary. However, by scanning over a 8.6×17.2 cm area, the average power is 1 W/cm2 and with efficient skin cooling appropriate in maintaining comfortable and safe skin temperature but reaching the target high fat temperatures. These values can be adjusted for equivalent average power density.
The inputs in steps 1902 and 1904 can be either entered by the user or stored or calculated by the treatment system. For example, the physician can use a system 2000 or similar to provide the inputs used to determine the laser scan pattern and scan speed. The system can also be used to provide feedback to the user, for example, laser power and temperature measurements can be shown on the display as the robot arm scans the laser head.
At step 1906, the energy source is moved over the first treatment area in the scan pattern and treatment begins as the energy source scans. For example, the energy source can be moved over treatment zone 1800 of
At step 1908, the system can check to determine whether a total treatment time has been reached. The total treatment time can be based on predetermined values 15-25 minutes, 20 minutes on average, or it could be based on feedback received form the device. The higher fat temperatures can be more effective and a treatment for 20 minutes approaches an asymptotic level. In some embodiments, the energy can be gradually reduced to maintain the target temperature throughout the total treatment time. The operator can select lower levels and also has the option of manually selected quick cools where the laser is off but cooling on for short cycles. If the total treatment time has been reached, then the process 1900 will advance to step 1910.
At step 1910, when the total treatment time has been achieved the energy source is turned OFF and the treatment is complete. In some embodiments, once the treatment is completed in a first area, the energy source can be moved to a next treatment area. If the total treatment time has not been reached, then the process 1900 will advance to step 1912. At step 1912, the energy source returns to step 1902 and continues to scan over the tissue in the prescribed pattern. In some embodiments, the controller can automatically adjust the energy being applied by the laser beam based on a combination of power being applied, time spent, movement speed of the treatment head, etc. In some embodiments, the user can also manually intervene to provide adjustment to the energy levels. For example, the user can turn off the laser beam while applying cooling if patient is in discomfort.
In some embodiments the energy source can be a laser beam having a cross sectional area. In some embodiments the laser power density can be in the range of 5 Watts/cm2 to 10 Watts/cm2. In some embodiments, the total area of the treated region is in the range of 20 cm2 to 200 cm2. The laser power density averaged over the entire treatment region can be held less than a critical value. In some embodiments the critical averaged laser power density can be 1.5 Watts/cm2.
Referring back to
Additionally, although shown in
Referring now to
To that end, the device 1700 can include a housing 1701 having a surface 1703 to be directed at a treatment area. In order to retain an appropriate shape for airflow control and withstand stresses and forces associated with operation, the housing 1701, in some embodiments, can be constructed of any suitable material such as metals, plastics, transparent plastics, glass, polycarbonates, polymers, sapphire, any other suitable material, or combinations thereof. To the extent that it is desirable to permit the EMR to be transmitted through the housing 1701 to be directed to the treatment area, it may be advantageous to form at least a portion of the housing 1701, in particular at least a portion of the surface 1703, from an optically transparent material. In some embodiments, the entire housing 1701 can be optically transparent. As shown in
To facilitate transmission of the EMR beam therethrough, the housing 1701 can also include an EMR port 1707 for engagement with the fiber output 209 to direct the EMR beam through the housing 1701, including the surface 1703, and onto the treatment area. In accordance with various embodiments, the EMR port 1707 can include any fitting capable of engaging the fiber output 209, such as, for example, a Luer slip, a Luer lock, a fitting, a fiber coupler, or any other suitable fitting. More generally, the EMR port 1707 can include any configuration suitable for directing an EMR beam generated by the fiber output 209 through the housing and toward the treatment area.
In some embodiments, the device 1700 can include beam shaping optics (not shown) for producing a particular beam shape. For example, as shown in
The device 1700, as shown in
The airflow received into the housing 1701 via the cold air port 1709 can be directed through the surface 1703 toward the treatment area for direct air cooling of the treatment area. In particular, the surface 1703 can include a plurality of openings 1705 formed in the surface 1703 for directing airflow onto the treatment area. In some embodiments, the openings 1705 can be positioned to direct the airflow onto the treatment area at temperatures, flow rates, and exit flow velocities suitable to maintain the treatment area at a therapeutically acceptable temperature range while avoiding interference with the EMR being directed at the treatment area. To that end, openings 1705 coincident with or within close proximity to a portion of the surface 1703 through which the EMR is transmitted (EMR transmission region) can be formed from optically transparent material. To the extent that other openings 1705 are not aligned with the EMR transmission region, those openings may not need to be transparent.
In some embodiments, the plurality of openings 1705 can be arranged in a pattern that can provide substantially uniform cooling over at least the treatment area illuminated by the EMR. In some embodiments, the substantially uniform cooling can extend over an area larger than the treatment area. In such embodiments, pre and post cooling to the treatment area is permitted as the device 1700 is moved from one treatment area to another by the positioning apparatus 900, whether manually or by automated control by the controller 403 as programmed to deliver the appropriate energy to maintain the target temperature range for a procedure.
In order to promote a uniform flow and maintain a desired cooling rate, during use, the openings 1705 can be spaced apart from the target surface to maintain the substantially uniform cooling and to promote efficient jet impingement cooling. For example, in some embodiments, the spacing between the exit plane of the openings 1705 and the target surface can be maintained between zero (0) inches to more than an inch. In some embodiments, the spacing can be about 0.5 inches. More generally, any spacing between the openings 1705 and the target surface can be used so long as substantially uniform cooling can be provided to the treatment area to maintain a therapeutically acceptable temperature range. In general, in jet impingement cooling or impingement cooling, cold or chilled high velocity air can be used to establish a very thin boundary layer that efficiently extracts heat from the treatment surface or skin. In other words, the target velocity can be high enough for impingement cooling on the tissue surface where a thin boundary layer establishes heat extraction that can be 3-4 times greater than that from forced convection. This enables the device 950 to apply a higher laser power. The high velocity air can be provided by forcing a large volume of air through a plurality of openings (e.g., openings 1705) within the treatment head of the device. For example, the velocity range can be greater than 50 m/s. In order to ensure that impingement cooling is happening, the proper air velocity and the proper distance of device 950 above the treatment surface must be chosen and maintained.
The spacing and positioning of the device 1700 can generally be maintained by adjustment of the positioning apparatus 900 as described above with reference to
Although shown in
In particular, the spacing can be maintained by providing program instructions for the computing device 107 and the controller 403 for operating the positioning apparatus 900 responsive to real time feedback from one or more position sensors 1711 mounted to the housing 1701 and directed toward the treatment area. The position sensors 1711 can be configured to detect one or more of a distance between the device 1700 and the target area, an orientation of the device 1700 relative to the target area, and a position of the device 1700 on the target area. The position sensors 1711 can generally be any suitable sensor for providing non-contact detection of a position of the device 1700 relative to the target area. For example, as shown in
In order to aid in meeting procedure requirements, in some embodiments, the device 1700 can include one or more temperature sensors 1713 to provide real time monitoring of a temperature of the treatment area. In particular, as shown in
While
Referring now to
The device 1500 is configured to direct the beams emitted from the output cables 1501a, 1501b at an angle such that the beams impinge separately on a surface to be illuminated S and overlap beneath the surface S in a subsurface tissue to be treated T. Such embodiments can generally provide a lower power density at the point of impingement on the surface S and a higher power density in the overlap region in the tissue T. In particular, power density in the overlap region will scale proportionally with the number of EMR output cables 1501a, 1501b, the power of each EMR beam, and the beam size of each beam in the overlap region. Accordingly, it will be apparent in view of this disclosure that any number of output cables producing any number of EMR beams can be used in accordance with various embodiments as desired to provide a desired power density at the surface S and in the overlap region of the tissue T. For example, in some embodiments, four beams can be provided wherein two pair of opposing beams can be configured in a square arrangement to emit beams at the slant angle to project a rectangular pattern onto the surface S and into the tissue T. In some embodiments, to overlap two more EMR beams from opposing but orthogonal locations, each beam footprint can be rectangular to create a similar projected beam footprint on the treatment plane. More generally, the beam shape of each EMR beam, in some embodiments, can, for example, be diverging, collimated, converging circular, square, rectangular, any other suitable shape, or combinations thereof.
Such a configuration is advantageous because, during, for example, a procedure for hyperthermia of adipose tissue to create apoptosis, the objective is to reach temperatures in the fat (adipose) tissue roughly from 40° C. to 52° C. During this process where the fat tissue is positioned beneath the skin and epidermis by approximately 2.8 mm, the skin, including the active nerve endings therein, can reach temperatures that feel warm or even hot to the patient. Although cold air or cryogenic cooling is typically provided, higher EMR power densities may nevertheless raise skin temperature to an uncomfortable temperature. In such cases, splitting the EMR power into two or more beams impinging separately on the surface of the skin can reduce local skin heating. On the other hand, the sum power of all overlapping beams is concentrated where the EMR beams overlap. Because maximum power is achieved in the overlap region, higher temperatures can be achieved in the overlap region for more efficient apoptosis. Conversely, the lower power density on the skin, epidermis, and dermis will result in lower temperatures in those regions. In some embodiments, such lower power density can reduce skin cooling requirements for maintaining patient comfort and safety during the treatment.
Additionally, by setting or adjusting beam impingement angle of the beams emitted by the output cables 1501a, 1501b, a depth of tissue treatment can be controlled. In particular, by decreasing the angle of the multiple beams relative to vertical, the overlap region can be formed deeper into the tissue and/or extend deeper into the tissue. Advantageously, by overlapping the beams deeper in the tissue T, more tissue T can be treated during a procedure. Additionally, deeper treatment areas can target different, deeper tissues T than single beam systems or systems having a shallow overlap region. Thus, particular selection or adjustment of slant incident angles, including, for example, from about three (3) degrees to about 75 degrees, can provide high EMR power targeted at a desired depth in the desired tissue T without overheating the impingement surface S.
Referring now to
For applications where the target tissue T is beneath a surface S to be illuminated (e.g., where apoptosis of adipose tissue is desired), a beam expander 1601 alone would cause the beam power to be most diffuse in the target tissue T. Such a configuration makes heat management of the illuminated skin more difficult because the skin surface S is exposed to more concentrated beam power and thus heats up more quickly than the target tissue T. Therefore, in some embodiments, the device 1600 can also include a Fresnel objective lens 1603 for refocusing the expanded beam. As shown in
Referring again to
To the extent that patient temperature data is required, in some embodiments, to maintain a therapeutically acceptable temperature range, a subcutaneous temperature prediction sensor 1000 can be provided. Some rely on blackbody radiation signals in the microwave region. Others employ temperature sensors, in combination with estimated skin and tissue thermal conductivity, to predict the core temperature. Some devices have attached heated sensors to the skin with temperature sensors to predict core temperatures. Other approaches have monitored the skin surface temperature and the energy input.
Invasive temperature measurements are possible but not preferred due to the associated risks, and desire for a fully non-invasive hyperthermia treatment. Elaborate instruments such as MRI (Magnetic Resonance Imaging) or advance ultrasonic devices are capable of these measurements but involve expensive and large devices which are also not readily used during many treatments.
Referring to
The sensor 1000 can then continuously monitor temperature and heat flux of the patient during treatment and feed that data back to the computing device 107 for processing. The temperature and heat flux data can be synthesized in an algorithm with user input data such as patient skin type, age, size, body fat percentage, etc. to estimate a temperature of the target subcutaneous fat. The computer system 107 can then adjust one or more operating parameters such as pulse length, EMR source activation, EMR source power, treatment duration, cooling airflow, scanning speed of the positioning apparatus, etc. to manage the temperature in response to the sensor 1000 feedback. Although shown as including both a temperature sensor 1001 and a heat flux sensor 1003, it will be apparent in view of this disclosure that, in some embodiments, the sensors 1000 may include only a temperature sensor 1001 or only a heat flux sensor 1003.
In some embodiments, the continuous temperature monitoring can begin with a numerical finite element simulation of fat region heating under EMR illumination to predict temperature over time and EMR source modulation. In particular, EMR source heating is applied in time dependent modulation and diminishes with depth of penetration. As the procedure progresses, skin temperature and skin heat flux are measured for the patient using the temperature sensor 1001 and the heat flux sensor 1003. Then, the temperature and heat flux data, the patient's unique data, and the finite element model are entered and combined in an overall algorithm to control the radiation input actively and maintain fat temperature in the effective range.
The measured parameters of a patient's skin temperature and skin heat flux in cooled regions can be measured several ways. Skin surface temperature can be made by a non-contact optical pyrometer recording in the radiated region, or a thermistor or thermocouple package. Temperature will be monitored before, during, and after EMR source irradiation. The rate of change of the skin temperature is monitored in the algorithm. The skin heat flux is derived in a non-contact method using the surface temperature measurement in combination with actively monitored cooling flow rate. When the two measurements are included in a heat transfer algorithm, calculation of skin heat flux is possible. Alternatively, a surface heat flux sensor can provide heat flux data.
Patient data used in this algorithm includes skin type and pigment, gender, age, size, weight, body mass index, and possible pretreatment history and skin distinctions. When available, more detailed tissue data can be entered. Tissue profiling collected from MRI's or ultrasonic devices can also provide accurate parameters to be incorporated into the tissue model. Other technologies such as non-invasive body core temperature measurement instruments that use black body radiation in the microwave region can be applied. Patient factors such as skin pigment characterization are important to estimate the anticipated EMR transmission and absorption values.
The algorithm is used to control the EMR energy delivered to a treatment area, known as fluence, in watts per square centimeter, as well as the exposure durations. The hyperthermia adipose reduction in some embodiments is done with on-off modulations and possible movement of beam location, which returns to reheat a region to maintain effective temperature range. The skin cooling is expected to be controlled based on skin surface temperature feedback for comfort level (e.g., 30° C.) and maximum safe temperature (e.g., 43° C.). The entire treatment period can last from several minutes to more than 30 minutes.
Referring now to
The diode driver 1201, in some embodiments, can be substantially similar to the diode drivers 409 discussed above in connection with
The switching device 1203 can be placed on ‘high side’ of the diode driver and the relays can be selected one at a time to drive a particular laser source 203. The relays must be capable of handling the current driven to the selected laser source 203. The relays or SSRs can be used as a safety interlock (emergency power cut) for the laser sources 203 as well. However, in the configuration of
When deciding between SSR and mechanical relays, SSRs tend to be faster, more reliable, and don't typically require electrically isolated control lines. However, isolated input SSRs allow the use of a single driver for several diodes with less concern for ground loop issues. In addition, in the event of a failure, an isolated SSR input will provide a buffer for the sensitive control circuitry.
Referring now to
Device 950, sometimes referred to as the treatment head, as used in some embodiments, is shown in
Referring to
In some embodiments, diffuser 2202 can be used to convert the columnar EMR beam from a cylinder to a square beam. The resulting beam can be square, a diverging square, a converging square, a rectangle, a diverging rectangle, or a converging rectangle. In some embodiments, refractive diffuser optical element or an etched micro lenses and prisms can be used to create the beam pattern. In some embodiments, diffuser 2202 can be an engineered diffuser which employs refraction with micro arrays of lenses and prisms to produce the desired EMR beam shape. The diffuser 2202 can convert the beam into a uniform beam that provides a uniform treatment within the cross-section side dimension of the beam. These engineered diffusers are wavelength independent, have a high efficiency, and can produce a ‘top hat’ beam with uniform power density. A ‘top hat’ beam is an EMR beam has a near-uniform fluence (energy density) across the entire beam. In some embodiments, the resulting beam is a 20° diverging square beam, meaning that all four sides of the beam increase at an angle of 10°. In further embodiments, the beam measures 4.3 cm×4.3 cm when it is emitted from device 950.
In some embodiments, the device 950 can include a blocking filter (not depicted) to filter out light that is reflected from sources that are not meant for interpretation. For example, the blocking filter can be used to increase the accuracy of a proximity sensor which relies on time of flight measurement to establish a distance between the device 950 and a surface of the skin. In this example, the blocking filter will filter which light reaches the proximity sensor. In some embodiments, the blocking filter can also protect one or more sensors against dust. The device 950 can also include a plurality of other sensors or a sensor array having a plurality of sensors. For example, the device 950 can include a sensor array having at least one of a skin temperature sensor, an air-cooling temperature sensor, air flow sensor, laser power sensor, a location sensor, and a proximity sensor. Also shown in circuit board 2111 can have two skin temperature sensors, 2203. After EMR beam passes through diffuser 2202, it passes through window 2113 having one or more openings 2105.
Referring to
Referring to
Referring to
Connector 2502 can be used to connect device 950 to positioning apparatus 900. In some embodiments, beam 2200 can be centered in the treatment head. In some embodiments, the beam 2200 can be coaxial with the chilled air flow so that the part of the treatment zone that is receiving the beam 2200 is cooled. As discussed herein, chilled air flow can be provided to cool any combination of the device 950 and the skin of a patient, however, chilled airflow is not intended to be limited to any temperature of air. For example, the chilled airflow is not limited to air that is refrigerated but can include any combination of airflows, air velocities, air volumes, and air temperatures, that can provide cooling. In some embodiments, the device 950 can include one or more air cooling temperature sensor proximal to the airflow exiting the device 950. Other types of air sensors can also be used to monitor the airflow from the device 950. For example, the device 950 can include any combination of air flow sensor, air flow rate sensor, air velocity sensor, etc.
Referring to
In some embodiments, in operation, the system 2000 can be designed to generate a square or rectangular EMR beam, which may be preferred to a round or rounded EMR beam. As a square or rectangular beam moves across the treatment surface, all of the treatment surface that is within the beam will receive approximately the same amount of energy as the beam has a constant length and width. If a round or rounded beam is used, the part of the treatment zone that lies in the axis or diameter of the beam (parallel to the direction of travel) will receive the maximum energy and the part of the treatment zone that lies at the edge of the EMR beam (at the ends of a diameter perpendicular to the direction of travel) will receive minimal energy.
In some embodiments, window 2113 can measure approximately 2.5 in×2.5 in and can have nine holes, each approximately 0.090 in in diameter spaced approximately 0.8 inches apart. The window 2113 can include any number of holes of any combination of dimensions to provide a high-volume airflow therethrough for cooling. For example, by supplying an air flow of 7 to 8 cubic feet per minute (CFM) (200 liters per minute (LPM) to device 950, the chilled air jet impingement output has a velocity of more than 60 meters per second. This configuration produces a cooling area of almost 3 in. by 3 in. to efficiently cool the treatment surface. As discussed herein, air is a useful cooling fluid as it does not interfere with the EMR delivery.
In some embodiments, device 950 also includes one or more indicators. The indicators can alert a user whenever EMR is being emitted. For example, the one or more indicators can be lasers or LEDs that light up when the EMR is being emitted. This alerts the patient and user/physician that the treatment is ongoing even if the EMR beam itself is not visible. In some embodiments, the one or more indicators can include an alignment light to assist a user with the alignment the aesthetic treatment device, for example, when registering or mapping one of the plurality of markings to initiate the registering of the treatment area.
In some embodiments, a computer control system or computing device (107 in
In some embodiments, the user/physician can input the treatment area into the control system. This can be accomplished by moving the treatment head to one corner of the treatment area and giving an indication to the control system by pressing a button or box on the user interface. In some embodiments, the device 950 is manually moved by the user/physician having a joystick in communication with the control system or by using arrow buttons or the like on the touch screen. The user/physician then indicates the other corners of the treatment area to the control system in the same fashion. While the treatment area may be any shape, at least three corners must be indicated. At this point, the user/physician may activate the system by pressing a start button or box on the user interface. As the treatment uses EMR such as laser, the system may require the user/physician acknowledge that everyone in the treatment room has proper eye protection. In some embodiments, the user/physician can use a template as discussed in greater detail herein to assist in marking the treatment area.
Once started, the control system can generate one or more treatment zones in the treatment area. The control system can move the robotic arm and device 950 to a position over the first treatment zone, and in some embodiments, start the cooling air flow and the EMR. While in operation, the proximity sensors can send information to the control unit to ensure that the face of device 950 stays within the proper distance away from the treatment surface. In some embodiments, the face of device is kept approximately 0.7+/−0.25 inches from the treatment surface. This distance is chosen to ensure that the air-cooling system works properly and the EMR beam is of the proper size and to ensure that the size of the beam will track within the treatment are according to a designated pattern (e.g., as shown in
While the EMR beam is active, a number of safety systems may be active. As discussed above, the proximity sensors maintain the device 950 a proper distance away from the treatment surface. Temperature sensors measure the surface temperature of the treatment area to ensure that the surface does not get above a specified temperature. The control system may use the surface temperature to calculate a subcutaneous treatment zone temperature. In some embodiments, an air temperature sensor may measure the temperature of the chilled air to ensure that it is within a proper range. The EMR system may have a sensor to detect the power of the EMR to ensure that it is within a specified range. There may be temperature sensors on the EMR generators and/or power supplies to ensure that they do not overheat. If any of the measured values are outside of a specified zone, the control system may notify the physician/user, may stop the EMR delivery, may change operational aspects of the system to correct the deviation, or may cease operation of the device. For example, in some embodiments, if the surface temperature of the treatment area gets too high, they system may turn the laser off, may move the laser to another treatment zone, may increase the rate of cooling, and/or may reduce the power of the EMR that is being delivered. In some embodiments, the application of energy to the treatment zone can be restarted when the temperature of the treatment zone surface is lower than the maximum surface temperature.
In some embodiments, the treatment zone can be a rectangle that has a length that is an approximate multiple of the length of the EMR beam and a width that is an approximate multiple of the width of the EMR beam. The multiple can be a whole or other number. In some embodiments, the treatment zone is four times the length and two times the width of the EMR beam. After starting the system, the device 950 is moved to the first treatment zone and the treatment begins. The control system moves the EMR beam in a predetermined pattern and at a predetermined rate in the treatment zone. In some embodiments, one complete scan (path over the entire treatment zone) is about 5 seconds or about 10 seconds. Once the treatment time is complete, the control system moves device 950 to the next treatment zone or, if the entire treatment area has been treated, the EMR is shut off and the device 950 is returned to the home position. The treatment time can be set as a fixed number of minutes, can be set as a number of minutes during which the treatment area or subcutaneous treatment zone is within the specified treatment temperature, or as a set number of scans over the treatment zone. In some embodiments, to speed up the overall treatment time, the control system may move device 950 to a subsequent treatment zone if the first treatment zone get too hot (rather than just shutting off the EMR).
In some embodiments, device 950 can have a visible laser, a LED or other indicator that provides a light source that acts as an aligning beam. When the device 950 is active, the aligning beam can generate a pattern that matches the treatment zone. In some embodiments, the generated pattern can be generated such that the beam will cover an entire area of the treatment area as it moved without having any overlap in previously treated areas, for example, as shown by the pattern in
Referring to
In operation, to perform a treatment, a patient, positioned on a treatment platform, is placed near the treatment system as described herein. When a system, for example, system 2000 in
The templates can be placed in different orientations for different procedures and for different patients. For example, for some patients who are being treated for belly fat, the template can be placed in a direction perpendicular to the longitudinal axis of the patient. For some patients, such as some women, the end of the template furthest away from the belly button will be 10° to 20° below the perpendicular axis. While some of the embodiments herein have been described for treatment of belly fat, the apparatus and systems described herein can be used for flank, leg, arm, back, or other fat.
Referring to
While some embodiments show the use of a template, in other embodiments the physician may draw the boundaries of the treatment area onto the skin of the patient with or without the use of a template. For example, the physician can create a customized template by using a marking device (dark ink, ultraviolet reflective ink, etc.) or other indicator that the system can see, the treatment head 950 can include sensors that recognize the markings and thus register or mark the treatment area by following the drawn pattern. In some embodiments, the physician can also create a custom template without using any markings. For example, with the assistance of a visible alignment light, the physician can more the treatment head to a location and click a button or other register a location with the device. This can be repeated until sufficient points have been registered to create a treatment area, for example, there or more registered points.
In some embodiments described above, lowering the EMR beam power during a treatment can help maintain the temperature of the skin at an acceptable level while the temperature of the subcutaneous treatment area can be raised to a therapeutically acceptable temperature. In other embodiments, the temperature of the skin can be kept at an acceptable level by implementing a cool down cycle intermittently during the treatment. For example, in a fat reduction treatment, applicants have found that the EMR beam can be kept at a power level of 150 W for the entire treatment as long as there are a number of cooling cycles. In some embodiments, the cooling cycle can run for 10 seconds and can include running the cooling air flow in the absence of the EMR beam while the treatment head continues to scan or move through the treatment area. In an example embodiment, a fat reduction treatment can include (i) scanning the treatment area with an EMR power level of 150 W for six minutes; (ii) running a cool down cycle for 10 seconds; (iii) scanning the treatment area for one minute at an EMR power level of 150 W; and (iv) repeating steps (ii) and (iii) until the subcutaneous tissue has been in the therapeutic temperature range for the target time period. By using this process, is has been determined that the deep fat tissue is maintained at a higher temperature while the skin and epidermis are both maintained at a sufficiently low level. This increased the effectiveness of the procedure while maintaining or even reducing the treatment time.
In one embodiment, it may be desirable to perform subcutaneous fat reduction and skin tightening simultaneously. However, as shown in the human tissue profile of
In such an embodiment, the controller 403 of the power and control electronics 400 of the multifunction aesthetic system 10 described herein can activate a first driver 409/laser source 203 pair to produce an EMR beam having a wavelength suitable for subcutaneous fat reduction while simultaneously activating a second driver 409/laser source 203 pair to produce an EMR beam having a wavelength suitable for skin tightening. In some embodiments, such a procedure can also be used in conjunction with other fat reduction techniques such as procedures using RF (radio frequency), MW (microwave), ultrasonic, or cryo (cold therapy) fat reduction methods.
In a further example, in some embodiments, the methods described above can be used to activate driver 409/laser source 203 pairs for emitting wavelengths suitable for performing any other procedure or combination of procedures including, for example, but not limited to, fat reduction, body skin tightening, facial skin tightening, skin resurfacing, skin remodeling, vein reduction or removal, facial pigment removal or reduction, hair removal, acne treatment, scar reduction and removal, psoriasis treatment, stretch mark removal, nail fungus treatment, leukoderma treatment, tattoo removal, or combinations thereof as discussed above.
In an example operation, a device 10 as shown in
Once the physician/user is certain that all parameters are set, the treatment begins. During treatment, proximity sensors 2501 on device 950 send data to device 107 so that positioning apparatus 900 keeps device 950 the proper distance from the treatment area. For some procedures, this will be between 0.5 and 1.0 inch, preferably 0.75 inches.
For treatments such as fat reduction or skin tightening, device 107 divides the treatment area into smaller treatment regions like shown in
The pressure/volume of air and the distance of device 950 from the skin can be controlled so that impingement cooling is affected. As the air does not interfere with the EMR, multiple openings can be provided both within and outside the area of the EMR beam. As the beam moves through the path shown in
In some embodiments, the systems and devices of the present disclosure can be used for causing thermal apoptosis in subcutaneous fatty tissues. The process can include moving a subcutaneous energy delivery device to a first treatment zone in a treatment area, applying energy to the first zone while moving the energy delivery device within the treatment zone at a rate that allows the subcutaneous tissue to reach a target temperature range, continuing the application of energy to the treatment zone while keeping the subcutaneous tissue within the target temperature range, the treatment zone having a treatment zone surface, and discontinuing the application of energy to any of the tissue in the first treatment zone that have been in the target temperature range for a target treatment time.
In some embodiments, less energy can be delivered on a scan as compared to a prior scan. The process can also include discontinuing the application of energy to any of the tissue in the first treatment zone when the temperature of the treatment zone surface. The target temperature range during the process can be 42° C.-51° C. and the energy can be applied to an area that is smaller than the area of the treatment zone. In some embodiments, the energy delivery device can complete a scan by applying energy to the entire area of the treatment zone. Multiple scans may be needed to raise the temperature of the subcutaneous tissue to the target temperature range. In some instances, less energy can be delivered by the energy delivery device after the subcutaneous tissue has reached the target temperature range than prior to the subcutaneous tissue has reached the target temperature range. The energy delivery device can also include a temperature sensor for sensing the temperature of the treatment zone surface. In some embodiments, the application of energy to the treatment zone can be stopped when the temperature of the treatment zone surface is higher than a maximum surface temperature. The application of energy to the treatment zone can be restarted when the temperature of the treatment zone surface is lower than the maximum surface temperature. The maximum surface temperature is 42° C. and the temperature of the subcutaneous tissue can be calculated from the temperature of the treatment surface temperature.
In some embodiments, the systems and devices of the present disclosure can be used for causing thermal apoptosis in subcutaneous fatty tissues. The process can include (i) moving a subcutaneous energy delivery device to a treatment area, (ii) applying energy and cooling air to the treatment area while moving the energy delivery device within the treatment area to raise the temperature of the subcutaneous fatty tissue to a therapeutically acceptable range, (iii) stopping the application of energy to the treatment area while maintaining the application of cooling air while moving the energy delivery device within the treatment area, and (iv) applying energy and cooling air to the treatment area while moving the energy delivery device within the treatment area. The temperature of the fatty tissue can be maintained in the therapeutically acceptable range during the treatment. The fatty tissue is maintained above 42° C. and the application of energy can be stopped for 5 to 15 seconds. The can also include repeating steps (iii) and (iv) until the fatty tissue has been maintained within the therapeutically acceptable range for a predetermined period of time.
While the present disclosure has been described with reference to certain embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt to a particular situation, indication, material and composition of matter, process step or steps, without departing from the spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the claims appended hereto.
As utilized herein, the terms “comprises” and “comprising” are intended to be construed as being inclusive, not exclusive. As utilized herein, the terms “exemplary,” “example,” and “illustrative,” are intended to mean “serving as an example, instance, or illustration” and should not be construed as indicating, or not indicating, a preferred or advantageous configuration relative to other configurations. As utilized herein, the terms “about,” “generally,” and “approximately” are intended to cover variations that may existing in the upper and lower limits of the ranges of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms “about,” “generally,” and “approximately” mean at, or plus 10 percent or less, or minus 10 percent or less. In one non-limiting example, the terms “about,” “generally,” and “approximately” mean sufficiently close to be deemed by one of skill in the art in the relevant field to be included. As utilized herein, the term “substantially” refers to the complete or nearly complete extend or degree of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. For example, an object that is “substantially” circular would mean that the object is either completely a circle to mathematically determinable limits, or nearly a circle as would be recognized or understood by one of skill in the art. The exact allowable degree of deviation from absolute completeness may in some instances depend on the specific context. However, in general, the nearness of completion will be so as to have the same overall result as if absolute and total completion were achieved or obtained. The use of “substantially” is equally applicable when utilized in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art.
Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present invention. Details of the structure may vary substantially without departing from the spirit of the present invention, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present invention be limited only to the extent required by the appended claims and the applicable rules of law.
It is also to be understood that the following claims are to cover all generic and specific features of the invention described herein, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
This application is a continuation-in-part of U.S. application Ser. No. 17/017,179, filed Sep. 10, 2020, which is a continuation of U.S. application Ser. No. 15/820,737, filed Nov. 22, 2017, now U.S. Pat. No. 10,994,151, which claims the benefit of and priority to U.S. Provisional Application No. 62/601,674, filed Mar. 28, 2017, U.S. Provisional Application No. 62/497,535, filed Nov. 22, 2016, U.S. Provisional Application No. 62/497,534, filed Nov. 22, 2016, U.S. Provisional Application No. 62/497,520, filed Nov. 22, 2016, and U.S. Provisional Application No. 62/497,503, filed Nov. 22, 2016, all of which are incorporated herein by reference. This application is a continuation of U.S. application Ser. No. 16/900,388, filed Jun. 12, 2020, which claims the benefit of and priority to U.S. Provisional Application No. 62/861,293, filed Jun. 13, 2019, all of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62601674 | Mar 2017 | US | |
| 62497535 | Nov 2016 | US | |
| 62497534 | Nov 2016 | US | |
| 62497520 | Nov 2016 | US | |
| 62497503 | Nov 2016 | US | |
| 62861293 | Jun 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15820737 | Nov 2017 | US |
| Child | 17017179 | US | |
| Parent | 16900388 | Jun 2020 | US |
| Child | 15820737 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17017179 | Sep 2020 | US |
| Child | 17744416 | US |
