WO2021230852A1 - Surveillance de l'activation des cellules souches - Google Patents

Surveillance de l'activation des cellules souches Download PDF

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Publication number
WO2021230852A1
WO2021230852A1 PCT/US2020/032309 US2020032309W WO2021230852A1 WO 2021230852 A1 WO2021230852 A1 WO 2021230852A1 US 2020032309 W US2020032309 W US 2020032309W WO 2021230852 A1 WO2021230852 A1 WO 2021230852A1
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WO
WIPO (PCT)
Prior art keywords
skin
patient
energy
property
delivery
Prior art date
Application number
PCT/US2020/032309
Other languages
English (en)
Inventor
Beth MCDOUGALL
Original Assignee
Clear LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Clear LLC filed Critical Clear LLC
Priority to PCT/US2020/032309 priority Critical patent/WO2021230852A1/fr
Publication of WO2021230852A1 publication Critical patent/WO2021230852A1/fr

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/443—Evaluating skin constituents, e.g. elastin, melanin, water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/326—Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00026—Conductivity or impedance, e.g. of tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—Light
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • 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
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • 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
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0034—Skin treatment
    • 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
    • A61N5/067—Radiation therapy using light using laser light

Definitions

  • the field of the invention is monitoring activation of stem cells.
  • Stem cell activation usually involves using an energy source, for example, laser or plasma.
  • Ex vivo activation is where blood is removed from the body, plasma fraction is extracted from the blood, and then the dormant stem cells in the plasma fraction are activated.
  • an energy source for example, laser or plasma.
  • Ex vivo activation is where blood is removed from the body, plasma fraction is extracted from the blood, and then the dormant stem cells in the plasma fraction are activated.
  • United States Patent Publication US20180280509A1 by Schena teaches treating blood with non-thermal plasma generated at atmospheric pressure and room temperature in vitro, where 8 J/cm 2 is determine to be an energy threshold for cell damage. However, it does not teach how much energy is required to sufficiently activate stem cells.
  • United States Patents US9,999,785 and US10,202,598 to Todd Ovokaitys teach using a laser beam to activate autologous or exogenous stem cells, but does not teach how much energy should be used.
  • VSELs very small embryonic-like stem cells
  • a protocol developed for activating other types of stem cells would not be suitable for activation of VSELs.
  • the inventive subject matter provides apparatus, systems and methods in which activation of VSELs or other stem cells is monitored and customized based on a patient’s skin condition.
  • Preferred methods of monitoring stem cell activation measure one or more skin conditions before delivering energy to the patient’s skin.
  • Different types of energy contemplated herein include light (including laser), heat, electric field, plasma radiation, acoustic waves (including ultrasound), and electromagnetic field (e.g., nuclear magnetic resonance (NMR)).
  • the amount of energy given can be calculated based on empirical correlations between a condition of the skin and the amount of energy required to sufficiently activate stem cells (including very small embryonic-like stem cells (VSELs)) without damaging the stem cells or skin tissue.
  • the calculation can also adjust for a variety of skin conditions, including coloration, skin texture, thickness, and pigmentation, etc.
  • the condition of the skin can be measured in any suitable manner, but preferably noninvasively, for example, by a wearable skin monitor, a light sensor, etc.
  • a light sensor can measure energy reflected from the skin and compare against a reference surface.
  • Color coded discs can be used to determine suitable energy levels.
  • Infrared (IR) or multi-channel light emitters can be used to determine absorption rate.
  • the skin conditions are continuously or periodically monitored during the treatment, to detect any changes in the skin conditions. These conditions include moisture, permeability, temperature, blood circulation in skin tissue, skin conductivity, cutaneous blood pressure, nerve activity in the skin (e.g., discharge rate, a nerve conductivity), and skin metabolism/metabolites, etc.
  • the conditions of the skin can be measured in any suitable manner, but preferably noninvasively, for example, by a wearable skin monitor, an electrode contact with the skin, an electronic skin patch, or a chemical sensor measuring skin metabolites.
  • IR blood flow or temperature change via LED color reference can be used to monitor skin conditions.
  • the patient’s skin is treated with a moisture soaking solution with 4-5% saline, about 95% water, and about 0.2 to 1 % carboxymethylcellulose to produce a wet skin prune effect, which is a desired outcome.
  • This treatment will increase the skin’s permeability which will facilitate energy absorption and penetration.
  • Treatment is paused or terminated when the skin property reaches a predetermined threshold value. For example, the treatment is terminated or paused when temperature of the treated skin reaches 45 °C, so that the skin is not overheated or burned. The treatment is resumed when the temperature of the treated skin drops below 40 °C. Treatment is terminated when the desired amount of energy is delivered.
  • the patient’s skin is stimulated (e.g., with massage and/or heat) before treatment to increase blood flow to the skin tissue, and thus the number of stem cells in the local area.
  • skin can be bleached with a chemical to increase the amount of light that can penetrate the skin and reach the stem cells in the blood vessels.
  • microporation in the skin e.g., using microneedles
  • Menthol can be used as a vasodilator.
  • Topical organic Methyl salicylate or Methyl-Salicylate-Oil-of-Wintergreen-Wintergreen-Oil can also be used.
  • the methods of monitoring stem cell activation include noninvasive characterization of a biomolecule of the human body.
  • the biomolecule is a biomarker of stem cell activation, or a biomarker of skin damage (e.g., reactive oxygen species).
  • Such noninvasive characterization can be performed using a Fourier-Transform Infrared Spectroscopy (FTIR) or Nuclear Magnetic Resonance (NMR).
  • FTIR Fourier-Transform Infrared Spectroscopy
  • NMR Nuclear Magnetic Resonance
  • the biomolecule is in a body fluid, for example, blood, saliva or tear fluid.
  • Alternate methodologies include using a dual channel asymmetrical laser to determine skin response adjacent to treatment location to analyze combined energy adsorption.
  • Fig. l is a flowchart showing steps of monitoring stem cell activation in a patient, according to one embodiment of the inventive subject matter.
  • FIG. 2 is a flowchart showing steps of monitoring stem cell activation in a patient, according to another embodiment of the inventive subject matter.
  • inventive subject matter provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
  • Coupled to is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms “coupled to” and “coupled with” are used synonymously.
  • Fig. 1 is a flowchart 100 showing steps of monitoring stem cell activation in a patient.
  • a first skin property of the patent is changed by stimulation (e.g., with massage and/or heat) before treatment to increase blood flow to the skin tissue, and thus the number of stem cells in the local area.
  • a first skin property can be changed by bleaching with a chemical to increase the amount of light that can penetrate the skin and reach the stem cells in the blood vessels.
  • a first skin property can be changed by microporation in the skin (e.g., using microneedles) to increase the light that can travel through the skin.
  • a first skin property can be changed by topically applying menthol as a vasodilator, or organic Methyl salicylate, or Methyl-Salicylate-Oil-of-Wintergreen-Wintergreen-Oil.
  • a first skin property of the patient is measured, preferably using a non-invasive method, for example, by characterizing light reflection from the patient's skin.
  • a non-invasive method for example, by characterizing light reflection from the patient's skin.
  • one or more of the following skin properties can be measured: skin coloration, skin texture, thickness, and pigmentation.
  • Step (120) the amount of energy (including energy intensity and duration) to be delivered to the patient is calculated based on the first skin property measured in step 110.
  • the amount of energy given can be calculated based on empirical correlations between a skin property and the amount of energy required to sufficiently activate stem cells without damaging the stem cells or the skin tissue.
  • the calculation can also adjust for a variety of skin conditions that may change the absorption rate of skin, including coloration, skin texture, thickness, pigmentation, scaring, etc. It is contemplated that a skin type that has a high absorption rate (e.g., light skin color, thin skin) is given less energy with lower intensity than a skin type that has a low absorption rate (e.g., dark skin color, thick skin).
  • Step (130) energy is delivered to the patient through the skin based on the calculation in step 120, including the intensity of the energy, the duration of energy delivery, and the total amount of energy to be delivered.
  • Different types of energy contemplated herein include light (including infrared and laser), heat, electric field, plasma radiation, acoustic waves (including ultrasound), and electromagnetic field (e.g., nuclear magnetic resonance (NMR)).
  • the duration of energy delivery is between 30 minutes and an hour. More preferably, energy is delivered in multiple sets (e.g., 3 to 5 sets), with each set between 5 to 15 minutes, having 30 seconds to 1 minute break between each set.
  • the second skin property is monitored, preferably continuously, during energy delivery.
  • the second skin property to be monitored can be one or more of the following: moisture, permeability, temperature, blood circulation in skin tissue, skin conductivity, cutaneous blood pressure, skin metabolism, and a nerve activity of the patient’s body.
  • the nerve activity can be neuron discharge rate or a nerve conductivity monitored by a nerve conduction velocity (NCV) test, to assess any nerve damage and dysfunction caused by the energy delivery.
  • the data related to the nerve activity can be transmitted to a processor, and the energy delivery can be adjusted accordingly, including decreasing or increasing the energy intensity, or pausing energy delivery.
  • energy delivery is adjusted in real-time based on a change in the second skin property.
  • “real-time” means energy delivery can be adjusted continuously (e.g., at least once every second) during the energy delivery, as the second skin property is continuously measured.
  • Step (132) energy delivery is paused when the second skin property reaches a predetermined threshold value.
  • the treatment is paused when the temperature of the skin area receiving energy reaches 45 °C, so that the skin is not overheated or burned.
  • the treatment is paused when the neuron discharging rate or nerve conduction velocity of the skin area is increased or decreased by 10%.
  • Step (133) energy delivery is resumed, when the second skin property reaches a predetermined threshold value.
  • a predetermined threshold value For example, the treatment is resumed when the temperature drops below 40 °C, or when neuron discharging rate or the nerve conduction velocity returns to baseline level before the treatment.
  • Step (140) treatment is terminated when the amount of energy is delivered, or when a second skin property fails to return to a predetermined level. For example, if neuron discharging rate or the nerve conduction velocity fails to returns to baseline level within 5 minutes after pausing energy delivery, the treatment is terminated.
  • Step 2 the first skin property is continuously or periodically measured during energy delivery.
  • Step (232) energy delivery (intensity or the amount) is adjusted in real-time based on a change in the first skin property.
  • “real-time” means energy delivery can be adjusted continuously (e.g., at least once every second) during the energy delivery, as the first skin property is continuously measured.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Dermatology (AREA)
  • Cell Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Activation de l'activation des cellules souches surveillée et personnalisée sur la base de l'état cutané des patients, comprenant la coloration, la texture, l'épaisseur, et la pigmentation de la peau. Les propriétés de la peau sont surveillées en continu durant l'activation des cellules souches, comprenant l'humidité, la perméabilité, la température, la circulation du sang, la conductivité, la pression artérielle, et le métabolisme. L'énergie utilisée dans l'activation des cellules souches peut être ajustée en temps réel sur la base des changements au niveau de l'état ou des propriétés de la peau du patient. La surveillance de l'activation des cellules souches peut également comprendre la mesure d'une molécule qui est associée à l'activation des cellules souches, aux lésions cutanées, ou à la génération d'espèces réactives de l'oxygène.
PCT/US2020/032309 2020-05-11 2020-05-11 Surveillance de l'activation des cellules souches WO2021230852A1 (fr)

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PCT/US2020/032309 WO2021230852A1 (fr) 2020-05-11 2020-05-11 Surveillance de l'activation des cellules souches

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000333907A (ja) * 1999-05-31 2000-12-05 Japan Science & Technology Corp 皮膚の活性酸素の測定方法
JP2012100599A (ja) * 2010-11-11 2012-05-31 Yohei Tanaka 幹細胞活性化装置
US8996090B2 (en) * 2002-06-03 2015-03-31 Exostat Medical, Inc. Noninvasive detection of a physiologic parameter within a body tissue of a patient
US20190078073A1 (en) * 2001-11-01 2019-03-14 Pthera LLC Enhanced Stem Cell Therapy and Stem Cell Production Through the Administration of Low Level Light Energy
US20200139160A1 (en) * 2017-07-04 2020-05-07 B.R.H. Medical Ltd. Internal Organ, Injury and Pain Treatment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000333907A (ja) * 1999-05-31 2000-12-05 Japan Science & Technology Corp 皮膚の活性酸素の測定方法
US20190078073A1 (en) * 2001-11-01 2019-03-14 Pthera LLC Enhanced Stem Cell Therapy and Stem Cell Production Through the Administration of Low Level Light Energy
US8996090B2 (en) * 2002-06-03 2015-03-31 Exostat Medical, Inc. Noninvasive detection of a physiologic parameter within a body tissue of a patient
JP2012100599A (ja) * 2010-11-11 2012-05-31 Yohei Tanaka 幹細胞活性化装置
US20200139160A1 (en) * 2017-07-04 2020-05-07 B.R.H. Medical Ltd. Internal Organ, Injury and Pain Treatment

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