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WO2021178628A1 - Appareil de lecture audible de la température destiné à être utilisé avec un système de traitement photo-thermique ciblé, et procédés associés - Google Patents

Appareil de lecture audible de la température destiné à être utilisé avec un système de traitement photo-thermique ciblé, et procédés associés Download PDF

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Publication number
WO2021178628A1
WO2021178628A1 PCT/US2021/020811 US2021020811W WO2021178628A1 WO 2021178628 A1 WO2021178628 A1 WO 2021178628A1 US 2021020811 W US2021020811 W US 2021020811W WO 2021178628 A1 WO2021178628 A1 WO 2021178628A1
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Prior art keywords
treatment
pet
audio output
energy source
energy
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PCT/US2021/020811
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English (en)
Inventor
Henrik Hofvander
Michael John Estes
Aubrey Jean ECK
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Accure Acne Llc
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Publication of WO2021178628A1 publication Critical patent/WO2021178628A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0616—Skin treatment other than tanning
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    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/067—Radiation therapy using light using laser light
    • A—HUMAN NECESSITIES
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
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    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
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    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
    • A61B2017/00123—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation and automatic shutdown
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    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
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    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00017—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids with gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
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    • A61B2018/00577—Ablation
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    • A61B2018/0066—Sensing and controlling the application of energy without feedback, i.e. open loop control
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    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00672—Sensing and controlling the application of energy using a threshold value lower
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    • A61B2018/00696—Controlled or regulated parameters
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    • A61B2018/00708—Power or energy switching the power on or off
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • A—HUMAN NECESSITIES
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    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods

Definitions

  • the present invention relates to energy-based treatments and, more specifically, systems and methods for improving the safety and efficacy of an energy- based dermatological treatment.
  • Sebaceous glands and other chromophores embedded in a medium such as the dermis can be thermally damaged as part of a therapeutic dermatological procedure by heating the chromophore with a targeted light source, such as a laser.
  • a targeted light source such as a laser.
  • the application of enough thermal energy to damage the chromophore can also be detrimentally damaging to the surrounding dermis and the overlying epidermis, thus leading to epidermis and dermis damage as well as pain to the patient.
  • Previous approaches to prevent epidermis and dermis damage, as well as patient pain include: [0005] 1. Cooling the epidermis, then applying the photo-thermal treatment; and
  • Cool the epidermis also condition (i.e., preheat) the epidermis and dermis in a preheating protocol, then apply photo-thermal treatment in a distinct treatment protocol.
  • the preheating protocol and the treatment protocol are performed by the same laser, although the two protocols involve different laser settings and application protocols, thus leading to further complexity in the treatment protocol and equipment.
  • measuring the temperature of the skin surface during the treatment provides valuable information that can be used to adjust the treatment protocol and/or equipment settings in real time.
  • Such temperature- based treatment protocol adjustments can be made by a practitioner, as an example, every few seconds over an hour-long procedure.
  • temperature measurements must be visually confirmed by the practitioner, for instance, by viewing a display or a stripchart, forcing the practitioner to take their eyes away from the treatment location.
  • Such shifting in visual attention of the practitioner can lead to errors in the treatment protocol and, in worst case, injury to the patient under treatment.
  • a method for operating a light source within a photo-thermal targeted treatment system for targeting a chromophore embedded within a medium includes: 1) administering at least one laser pulse from the light source at a first parameter setting to a first treatment location; 2) measuring a peak epidermal temperature (PET) at the first treatment location, following administration of the at least one laser pulse; 3) providing an audio output of the PET so measured; and 4) according to the audio output of the PET, determining whether to adjust the light source from the first parameter setting.
  • PET peak epidermal temperature
  • FIG. 1 shows an exemplary photo-thermal targeted treatment system for targeting a target, wherein the target includes specific chromophores embedded in a medium, and heating the target to a sufficiently high temperature so as to damage the target without damaging the surrounding medium.
  • the system can be used, for example, for photo-thermal ablation of sebaceous glands in a targeted fashion, where sebum is the chromophore embedded within the sebaceous gland, while sparing the epidermis and dermis surrounding the target sebaceous glands.
  • FIG. 2 is a flow diagram illustrating an exemplary method for operating a light source within a photo-thermal targeted treatment system
  • spatially relative terms such as “beneath,” “below,” “lower,” “under,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” or “under” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary terms “below” and “under” can encompass both an orientation of above and below.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • a layer when referred to as being "between” two layers, it can be the only layer between the two layers, or one or more intervening layers may also be present.
  • Embodiments of the invention are described herein with reference to cross-section illustrations that are schematic illustrations of idealized embodiments (and intermediate structures) of the invention. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and/or tolerances, are to be expected. Thus, embodiments of the invention should not be construed as limited to the particular shapes of regions illustrated herein but are to include deviations in shapes that result, for example, from manufacturing. Accordingly, the regions illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the actual shape of a region of a device and are not intended to limit the scope of the invention.
  • PET peak epidermal temperature
  • the embodiment described in the present disclosure includes an audible readout of PET via an earpiece, one or more headphones, or a speaker such that the practitioner can utilize the PET information in making adjustments to the treatment protocol and treatment system settings (e.g., light source parameter settings) while keeping the practitioner free to keep his/her eyes at the treatment location.
  • the audible readout can also be made through a speaker, for patient comfort it can be preferred that the audible readouts are just heard by the practitioner.
  • the operating thermal range is generally bound on the upper end at the epidermis and dermis damage threshold temperature of approximately 55°C, and at the lower end by the temperature required to bring the sebaceous gland to its damange threshold temperature of approximately 55°C.
  • the operating temperature range for acne treatment expressed in terminal skin surface temperature is approx. 40°C to 55°C, as an example. At skin surface temperaturess below 40°C, it has been determined that there is no damage to the sebaceous gland. When the skin surface temperature is between 40°C and 55°C, there are varying degrees of sebaceous gland damage, with no epidermal damage. Above 55°C, there is epidermal damage in addition to damage to the sebaceous gland.
  • the treatment system such as the light source parameter settings
  • FIG. 1 shows an exemplary photo-thermal targeted treatment system for targeting a target, wherein the target includes specific chromophores embedded in a medium, and heating the target to a sufficiently high temperature so as to damage the target without damaging the surrounding medium.
  • the system can be used, for example, for photo-thermal ablation of sebaceous glands in a targeted fashion, where sebum is the chromophore embedded within the sebaceous gland, while sparing the epidermis and dermis surrounding the target sebaceous glands.
  • a photo-thermal targeted treatment system 100 includes a cooling unit 110 and a photo-treatment unit 120.
  • Cooling unit 110 provides a cooling mechanism for a cooling effect to a treatment area, namely the outer skin layer overlying the target sebaceous gland. The cooling effect may be accomplished by contacting the skin with a cold solid medium to conduct heat away from the treatment area or by direct air cooling to convect heat away from the treatment area.
  • Cooling unit 110 is connected with a controller 122 within phototreatment unit 120. It is noted that, while controller 122 is shown to be contained within photo-treatment unit 120 in FIG. 1, it is possible for the controller to be located outside of both cooling unit 110 and photo treatment unit 122, or even within cooling unit 110.
  • Controller 122 further controls other components within photo treatment unit 120, such as a laser 124, a display 126, a temperature monitoring unit, a foot switch 130, a door interlock 132, and an emergency on/off switch.
  • Laser 124 provides the laser power for the photo-treatment protocol, and controller 122 regulates the specific settings for the laser, such as the output power and pulse time settings.
  • Laser 124 can be a single laser or a combination of two or more lasers. If more than one laser is used, the laser outputs are combined optically to function as one more powerful laser.
  • Display 126 can include information such as the operating conditions of cooling unit 110, laser 124, and other system status.
  • Temperature monitoring unit 128 is used to monitor the temperature of the skin surface in the treatment area, for example, and the measured skin surface temperature at the treatment area is used by controller 122 to adjust the photo-treatment protocol. Controller 122 also interfaces with footswitch 130 for remotely turning on or off laser 124 and/or cooling unit 110. Additionally, door interlock 132 can be used as an additional safety measure such that, when the door to the treatment room is ajar, door interlock 132 detects the condition and instructs controller 122 to not allow photo-treatment unit 120, or at least laser 124, to operate. Furthermore, emergency on/off switch 134 can be provided to quickly shut down photo-thermal targeted treatment system 100 in case of an emergency.
  • photo-thermal targeted treatment system 100 further includes a scanner 140, which is the portion of the device handheld by the user in applying the treatment protocol to the subject.
  • Scanner 140 can be formed, for example, in a gun-like or stick-like shape for ease of handling by the user.
  • Scanner 140 is connected with cooling unit 110 via a cooling connection 142, such that the cooling protocol can be applied using scanner 140.
  • the output from laser 124 is connected with scanner 140 via an optical fiber delivery 144, such that the photo-treatment protocol can be applied using scanner 140.
  • Scanner 140 is connected via a temperature connection 146 to temperature monitoring unit 128, so as to feedback the skin temperature at the treatment area, for example, to controller 122.
  • photo-treatment unit 120 further includes an audio out circuitry 150 for providing an audio output, such as a PET reading as recorded at temperature monitoring unit 128.
  • Audio out circuitry 150 provides a signal to, for example, an ear piece 152 through a wired or wireless connection such that the practitioner using the system can listen to the audio output.
  • Ear piece 152 can be replaced, for instance, by a speaker system or other audio communication means.
  • Audio out circuitry can also convey other information such as the status of the photo-treatment unit, any emergency warnings, or other messages to be conveyed to the user of photo-thermal targeted treatment system 100.
  • the ear piece 152, speaker, headphone, or other audio output device may include user input components such as volume controls, repeat message control, or a microphone that can be used to provide user input to the audio out circuitry 150 and/or the controller 122.
  • FIG. 2 is a flow diagram illustrating an exemplary method for operating a light source within a photo-thermal targeted treatment system.
  • a process 200 begins with a start step 212 to initialize the treatment protocol.
  • a laser pulse is applied to the treatment area according to the treatment protocol in a step 214.
  • the treatment protocol may determine particular characteristics of the laser pulse, such as power, pulse width, and duration.
  • the real-time skin surface temperature (i.e., PET) at the treatment area is measured in a step 216.
  • An audible PET reading is output to the practitioner in a step 218.
  • the audible reading may be a vocalization of a number by a pre-recorded or digital voice, and the temperature measurement may be read out in a selected temperature unit scale (e.g., Celcius, Fahrenheit, or Kelvin).
  • warning signals such as beeps, melodic tones, or other audio signals can be used to represent warnings, system status, or other important notifications.
  • the practitioner determines, in a decision 220, whether the PET is too high (i.e., whether the measured PET is close to the damage threshold for the epidermis and/dermis at the treatment area, or wether the PET is within a therapeutic temperature range).
  • the process returns to step 214 to apply another laser pulse to the treatment area.
  • the second (or subsequent) laser pulse may be applied using the same or different settings as used during application of the first laser pulse. In some embodiments, the second laser pulse is adjusted based on the PET measurement or based on the audio output of the PET measurement. If the answer to decision 220 is YES, the PET is too high (or is indicated as being within the therapeutic temperature range) and approaching the damage threshold for the treatment area, then the practitioner stops the treatment in a step 222, and the process is ended in an end step 224.
  • the treatment method may be stopped at step 222 if the user notices damage or abnormal skin reactions.
  • a second decision step (not shown) may be included where, from a NO answer at decision 220, the process asks whether a user has observed any concerning skin abnormalities in response to the laser treatment. If the answer is YES, the process may proceed to finish step 222; if the answer is NO the process may proceed to step 214 where additional treatment pulses are determined and applied as normal.
  • the audible PET measurement readout feature of the system 100 allows the user to constantly observe and evaluate the appearance of skin within the treatment area without requiring the user to look away during the treatment to obtain information relevant to the treatment.
  • the treatment process may take advantage of the user’s improved attention to skin appearance by providing an additional safety check that takes into account the user’s professional assessment of the skin based on constant observation. For example, during the treatment process, the user may notice a small blister forming on the patient’s skin and would be able to quickly assess and halt treatment as needed using the second decision block.
  • the constant treatment area observation facilitated by audio readouts can be accommodated in the treatment process to advantageously provide an extra layer of user input for improved patient safety.
  • the user may select a second treatment area different from the first treatment area and may repeat the process 200 again from the beginning on a new area of skin.
  • the second treatment area may be selected such that bounds of the first and second treatment areas do not overlap, but no untreated areas are left in between, so that the patient’s skin is evenly treated.
  • the audible readout feature included in the system 100 allows for the user to keep eyes on the patient at all times so as to facilitate this precise alignment between treatment areas.
  • a method for operating an energy-based treatment system for dermatological procedures includes: 1) administering at least one energy pulse at a first parameter setting to a first treatment location; 2) measuring a peak epidermal temperature (PET) at the first treatment location, following administration of the at least energy pulse; 3) providing an audio output of the PET so measured; and 4) according to the audio output of the PET, determining whether to adjust the energy source from the first parameter setting.
  • PET peak epidermal temperature
  • the audio output can also be used for additional functionality to perform tasks that would otherwise force the practitioner to take his/her eyes off of the treatment area.
  • the system can be set to issue audible warning messages (e.g., "PET is approaching the preset threshold level"), error messages (e.g., "Something has gone wrong - system is shutting down”), and timing notifications (e.g., "Treatment time thus far - 30 minutes”).
  • audible warning messages e.g., "PET is approaching the preset threshold level”
  • error messages e.g., "Something has gone wrong - system is shutting down”
  • timing notifications e.g., "Treatment time thus far - 30 minutes”

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Abstract

L'invention concerne un procédé de fonctionnement d'une source d'énergie à l'intérieur d'un système de traitement à base d'énergie pour des procédures dermatologiques. Le procédé comprend : 1) administrer au moins une première impulsion d'énergie provenant de la source d'énergie à un premier réglage de paramètre à un premier emplacement de traitement ; 2) mesurer une température épidermique de pic (PET) au niveau du premier emplacement de traitement, suite à l'administration de ladite au moins une impulsion d'énergie ; 3) fournir une sortie audio de la PET ainsi mesurée ; et 4) en fonction de la sortie audio du PET, déterminer s'il faut ajuster la source d'énergie à partir du premier réglage de paramètre.
PCT/US2021/020811 2020-03-04 2021-03-04 Appareil de lecture audible de la température destiné à être utilisé avec un système de traitement photo-thermique ciblé, et procédés associés WO2021178628A1 (fr)

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US62/984,938 2020-03-04

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Citations (6)

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WO2004098710A1 (fr) * 2003-05-05 2004-11-18 Håkan Lagergren Ab Appareil laser pour traitement thermique
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