The invention relates to portable electro-mechanical devices for medical and/or cosmetic use. More specifically, the invention relates to systems and methods for use in enhancing medicament and/or cosmetic formula benefits with carbon dioxide for delivery to a user.
Health of skin has commonly been associated with proteins related to skin structure and cell adhesion, skin surface lipids, and intercellular lipid components in the stratum corneum such as ceramides, free fatty acids, and cholesterol, and natural moisturizing factor (NMF), which is composed of amino acids and organic acids, which are critical to improving/maintaining the physiological functions of the skin. Environmental factors such as ultraviolet light, climate—especially humidity, and changes in health status and aging can cause changes in the amount and composition of the functional molecules in the skin. These changes may include inflammation, cracking, scaling, increases in lines, dryness, loss of tone, etc. Therefore, if a mechanism that regulates the structure and function of skin, and the factors that affect this mechanism can be controlled, then stability and improvement to the health of the skin may be realized.
A number of procedures exist for treatment of the skin, including for medical and cosmetic purposes. Medications or beauty formulas are topically spread on the skin, as a cream, lotion, jelly, etc., to address directly one or more conditions. These medications and/or beauty formulas may deliver hydration, luminosity, improvement to fine lines, skin tone, firmness, damage repair, etc. Additionally, naturally occurring carbon dioxide springs have been used in the past to improve and address these health conditions.
Further, topically delivered carbon dioxide acts in a different manner than in subdermal applications. For example, carbon dioxide rich water bathing has been shown to enhance collateral blood flow in animal models. In humans, published studies comparing carbon dioxide rich water to non-carbon dioxide rich water showed that the partial pressure of oxygen (i.e., oxygenation) of tissues increased about 10% with carbon dioxide enrichment and resulted in a dramatic increase in vasodilation. These experiments, whether with animal or human subjects, utilized warm water containing the carbon dioxide. The control group using non-carbon dioxide rich water at elevated temperatures (i.e., warm water) did not show the same benefits.
No previous developments have contemplated the direct combination of carbon dioxide treatments with topical substances including beauty and health treatments.
The invention includes portable systems and methods for combining topical substance treatments with carbon dioxide treatments to compound benefits of each treatment. The invention includes devices that enhance and condition (i.e., infuse, mix, etc.) using carbon dioxide from a tank reservoir with topical substances thus adjusting/controlling the temperature to a desired level. The invention provides new systems that are easy to operate and deliver the mixture to clients' skin for treatment. The invention delivers topical substances compounded with carbon dioxide to affected skin sites.
The invention provides many additional benefits not realized by existing systems. The systems and methods of the invention provide the enhanced topical substance (i.e., the carbon dioxide with the topical substance), which thermally shocks the skin, lowers the pH of the topical substance, increases the viscosity of the topical substance, provides improved topical infusion due to application of the enhanced topical substances, and provides improved topical infusion and skin treatment through physical vibration of the dispenser. Further, the devices include ergonomically designed and manufactured actuation systems, including electro-mechanical valves and dispensers.
The invention systems include a device and a container. The invention devices include a base and a hand-held dispenser. The base holds a carbon dioxide tank reservoir and valving to turn on/off the flow of gas. When turned on, the carbon dioxide flows via tubing into a hand-held dispenser. In other embodiments, placing a carbon dioxide reservoir in the hand-held dispenser may be contemplated as an all-in-one device. The dispensers and/or bases may include a thermal regulation flow path that allows heat transfer sufficient to regulate the target temperature of the carbon dioxide, and subsequently the temperature of the delivered enhanced topical substances. The device includes processors, displays and the mechanisms to dispense the topical substance for application. The mechanisms to dispense the enhanced topical substances are in the hand-held dispenser and include a container for topical substance storage and dispensing. The containers include mixing chambers for mixing prior to dispensing the enhanced topical substances. The hand-held dispensers may also be configured to spray carbon dioxide sequential to application of the topical substances to be incorporated on the treated skin.
When activated, the carbon dioxide gas flows into the hand-held dispensers. A target temperature of the gas is determined, and the carbon dioxide gas from the reservoirs are heated to the target temperature along the flow path to a mixing chamber for the gas and the topical substance. The gas then flows into the mixing chamber at the end of the flow path to be mixed with the to be dispensed topical substance. The mixing chambers are near the dispenser tip that presses and/or is applied to the skin for topical application of the enhanced topical substances. Application to the skin may include direct flow onto the skin and/or spraying onto the skin.
The invention provides simultaneous and/or sequential delivery of a topical substance with carbon dioxide to an affected area while controlling temperature and flow rate of each of the topical substance and carbon dioxide. For example, the topical substance and carbon dioxide are mixed in one embodiment. In other embodiments, the carbon dioxide may be applied before the application of the topical substance, thus the topical substance is enhanced by pre-treatment of a clients' skin. For example, with regard to the temperature, the systems are configured to determine existing temperature, including ambient environment temperatures and temperatures of the carbon dioxide in the reservoirs, and flow rates at which the carbon dioxide is currently moving or will move through its flow path. The systems may then determine a target temperature for the carbon dioxide prior to its mixture with the topical substances. Based on this target temperature, existing temperatures, and flow rate, the system may determine how to raise the temperature of the carbon dioxide from the reservoir to the target temperature, by the time the carbon dioxide is mixed with the topical substance. The systems heat the carbon dioxide along the flow paths via heat exchanger. The heat exchangers generally use the ambient heat to raise the temperature of the carbon dioxide from the reservoirs, which are generally maintained at about −79° C.—in a liquid storage form to approximately ambient temperature. The heat exchangers have a fan which passes ambient air over the flow path. The flow paths can be aluminum or another material capable of ambient heat transfer to the carbon dioxide. The fan speed is regulated to raise the temperature of the liquid carbon dioxide to the target temperature. In some embodiments, the heating may include methods of heating which will result in a-carbon dioxide temperature at the target temperature. For example, direct heating elements in a secondary chamber and/or heating along the flow path of the carbon dioxide, recovery of waste heat of the devices, other conventional heating methods, or a combination of these heating methods.
The systems of the invention include a container, which contains the topical substance. The container includes a dispensing mechanism, which cooperates with an actuating mechanism. In one embodiment, the actuating mechanism is a stepper motor that regulates the speed of the dispensing mechanism. For example, the dispensing mechanism can be a plunger which, when actuated, pushes the topical substance out of the container. In other embodiments, mechanisms, including manual mechanisms (e.g., pump, crankset, etc.), capable of controlling the flow of the topical substance out of the container, such as, hydraulic motors, etc. may be used as the actuating mechanism. The containers may be single refillable cylinder cartridges or single-use cylinder cartridges for predetermined topical substances. Further, the cartridges may include various shapes and sizes for application. In some embodiments, the cartridges dispense enough topical substance to meet the requirements of a single treatment.
The invention provides a measured delivery of the topical substance and carbon dioxide mixture to an affected area. For example, the systems can be configured to dispense the enhanced topical substances over any time duration. Time settings as low as one second to a high setting of a continuous dispensing may be used. The dispense time determines a metered volume of enhanced topical substance which is applied. Further, the volume of enhanced topical substance may also be controlled by flow rates of the topical substance and determined by dimensions of the container, e.g., length and diameter. The amount of the applied enhanced topical substance optimizes treatment to the affected areas. Clinicians and/or cosmetologists can also use an illumination source on the tip of the hand-held dispensers to illuminate the treatment areas for accurate delivery of the enhanced topical substance.
The systems of the invention include a mixing cavity for combining topical substance and carbon dioxide to create the enhanced topical substance, and a dispenser tip which applies the enhanced topical substance. In the systems, the mixing cavities and dispenser tips may be integrated into the containers to provide optimal dispenser types for different topical substances. For example, the dispenser tips may be abrasive, i.e., include exfoliants, to provide physical abrasion for cleanser topical substances, and the dispenser tip may be smooth for burn cream topical substances to prevent harm to burned skin. Further, the mixing cavities may be larger or smaller based on optimal application volumes. For example, users of steroid creams may not want to apply large volumes of the topical substance, and thus the mixing cavity may be smaller, such as between 1 and 2 ml.
The systems of the invention include hand-held dispensers for capture of containers of topical substances by connecting the containers to the dispensers. The hand-held dispensers are connected to the bases to receive the carbon dioxide from the reservoirs in the bases. The hand-held dispensers include an actuating mechanism, heat exchanger, and a display for presenting information associated with the application of the topical substances and carbon dioxide to a patient. The displays may present system status information; advertisements for other topical substances; carbon dioxide reservoir levels; topical substance information; application duration, time of use, volume, etc. In some embodiments of the invention, various portions of the container/cartridge may be incorporated into the hand-held dispenser. For example, the dispenser tips and mixing cavities may be integrated into the hand-held dispensers and topical substances may flow from the containers to the mixing cavities. In other embodiments, the containers are refillable in the hand-held dispensers to allow full integration of the containers, dispenser tips, and mixing cavities to the hand-held dispensers.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
The portable electro-mechanical devices of the invention provide applications of topical substances infused/enhanced with carbon dioxide, to affected patient skin for treatment.
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The invention includes many features that ensure its ease of use and facilitate human factors. As shown in
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Clinicians and/or cosmetologists can use the invention in a number of different treatment environments, including medical treatments, veterinary treatments, and aesthetic treatments. Different system configurations provide different options, depending upon the treatment environment. For example, treatment times in the medical environment differ from treatment times in the aesthetic environment. The system 100 is configured for the desired environment and topical substance.
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Clinicians and other users provide topical substances for patient treatment areas using hand-held dispenser 103 shown in
The display 125 may be used to present any information related to the application of the topical substance to a patient, or information related to the system 100 itself as described in examples shown in
The hand-held dispenser 103 fits ambidextrously and comfortably into a user's hand and, because the invention includes a closed flow architecture, the wands are omni-directional, allowing clinicians to treat lesions in any direction or orientation. As shown in
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An external, low voltage power supply (reference numeral 590 shown in
Internal to the base unit 101, the system 100 includes a carbon dioxide source and a flow path from the carbon dioxide source to the hand-held dispenser 103. The carbon dioxide tank 105 has been developed to be durable, convenient to use, shippable, and provides an interface that is manufactured in high volume and for proven reliability. The carbon dioxide tank 105 stores a volume of liquid carbon dioxide for shipping and storage. The carbon dioxide source tank 105 is housed inside the rear of the base unit 101 and connects to the flow path through a pin valve (not shown separately), installed in the carbon dioxide source tank 105, that seals the carbon dioxide source tank 105 during shipping and storage. An adaptor connector engages and opens the pin valve in the carbon dioxide source tank 105 when the lock handle is actuated. The adapter connector works in tandem with a burst disk (not shown separately) on the pin valve of the carbon dioxide source tank 105 that controls overpressure, providing additional safety measures. The carbon dioxide source tank 105 interfaces with a main carbon dioxide supply valve via a thread and O-ring combination (not shown separately). When base unit 101, the top of the tank 105 protrudes only minimally above the handle 107 of the base unit 101 to both mechanically protect the tank 105 and to limit the torque a user can apply when threading the tank 105 to the main carbon dioxide supply valve. An adapter connector controlled by lever 113 is part of the flow path and engages at a neck of the tank 105 to deliver the carbon dioxide to the rest of the flow path. When activated, the lever 113 opens the pin valve in the tank 105.
A user does not need any special tools to exchange carbon dioxide tank 105. The mating threads of the carbon dioxide tank 105 pin valve thread with the mating threads of the base unit 101, and the combination assembly can be quickly changed out when the carbon dioxide is depleted. A solenoid valve between the main flow path and carbon dioxide tank 105 is normally closed, which prevents the carbon dioxide from dispensing until the clinician and/or cosmetologist initiates treatment.
To open the carbon dioxide tank 105 to allow the flow of carbon dioxide through the flow path, a user engages lever 113, which in turn pushes an adaptor connector (e.g., a post) in the pin valve assembly that opens the carbon dioxide tank 105 pin valve. Once a user engages the lever 113, the carbon dioxide from the tank 105 begins to flow through the flow path to the solenoid valve. The specifically designed high pressure electro-mechanical solenoid valve provides treatment time control. The solenoid valve receives the carbon dioxide in the flow path for release when triggered.
The solenoid valve is triggered by the activator button 131 to allow carbon dioxide to flow for a predetermined time. Users can determine and predetermined times based on the clinical environment, patient needs, and topical substance.
The solenoid valve operates consistently and effectively at the pressures exerted by the carbon dioxide. The valve seal (not shown separately) is designed and manufactured to avoid swelling and failure when exposed to the liquid carbon dioxide. That is, the valve seal maintains its original geometry when exposed to the liquid carbon dioxide. While components of any valve (body, bonnet, stem, stem seals, ball, seats, etc.) will contract and expand at different rates because of different material composition or the amount of time exposed to the carbon dioxide, the solenoid valve provides a positive seal that inhibits carbon dioxide flow when the valve is closed.
Once the carbon dioxide flows through the solenoid valve, the carbon dioxide leaves the base unit 101 and moves through the flow path to the hand-held dispenser 103 of the system 100. Once the carbon dioxide travels in the hand-held dispenser 103, a heat exchanger (not shown separately) is used along the flow path to raise the temperature of the carbon dioxide to a target temperature. The system 100 may regulate the temperature by determining an ambient temperature used to raise the temperature of the carbon dioxide from around −79° C. to ambient temperature, and use the heat exchanger fan 127 to raise the carbon dioxide temperature from the reservoir tank 107 before mixing in the cartridge 200.
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The management server 601 may retrieve from a topical substance storage medium 611, information associated with topical substances use and other information about the system. For example, a user may scan or provide the system with a cartridge which includes a topical substance which also has an RFID tag. The scan of the RFID tag provides all information needed by the unit for a treatment, e.g., treatment times, use of vibration, etc. This input may occur either through user input of the name, reading of a RFID as an identifier 225 incorporated with the cartridge 200, or through another scanning and/or receipt of a tagged identifier 225 on cartridge 200 (e.g., as a QR code or with an NFC tag respectively). The system 100 may then be correctly configured to apply a topical substance. Further examples may include the management system 601 tracking a tagged serial number of a topical substance cartridge 200, which shows the cartridge 200 was used a month ago.
Further, the server 601 may retrieve from a customer storage medium 613, information relating to treatments conducted. As previously stated, users may have different subscription levels which limit features of the base unit 101 and hand-held dispenser 103. Finally, the server 601 may track uses for billing purposes, and charge users per use.
Additionally, the server 601 may provide advertisements to be presented on display 125, as shown in
The invention provides improvements in operation over existing topical treatment systems in both usability of the device and reliability of the system. For example, the base unit 101 and hand-held dispenser 103 ship separated from carbon dioxide tank 105. When setting up and configuring the system 100, the user (i.e., clinician and/or cosmetologist) places the carbon dioxide tank 105 in the rear of the base unit 101. The user threads the carbon dioxide tank 105 into place until its rotation stops. Once the carbon dioxide tank 105 is in place, the user raises the tank lever 113 to activate the adapter connector mechanism and enable the flow of carbon dioxide.
The lever 113 action opens the carbon dioxide tank 105 pin valve (not shown separately) and pressurizes the carbon dioxide flow path. The user then connects the system power supply (not shown separately). Once power is applied to the system, the user checks the carbon dioxide level by actuating the trigger button to determine the volume of carbon dioxide remaining in the tank 105. Further, the system 100 may include an internal memory to track the usage of the carbon dioxide and show an approximate amount of carbon dioxide remaining in the carbon dioxide tank 105. Finally, the user loads a cartridge with a topical substance for mixing with the carbon dioxide. The user slides the cartridge 200, wing tip 223 first, into contact with the mating portions of the hand-held dispenser 103 including the carbon dioxide flow connector 121 and actuation mechanism connector 123.
When the user is ready to begin a treatment, the user connects the system 100 to external power supply (not shown separately). The user activates the system by either actuating the activator button 131 or using the controls on display 125 or face plate 109. Then, the user may then actuate the activator button 131 to treat the patient as needed. However, the system 100 may also include a pre-determined treatment time based on the topical substance to prevent use of expired or other time limitations. As the activator button 131 is pressed, the carbon dioxide and topical substance from the cartridge 200 are mixed in the mixing cavity 205 of the cartridge and may simultaneously be pressed or applied to an affected area of the patient's skin.
In other embodiments, once the user presses the treatment activator button 131 on the hand-held dispenser 103, the system 100 will deliver the infused topical substance to the treatment area for a selected treatment time. For example, a user may pause the treatment to provide timed breaks between application to either let the affected skin rest or for cleansing between applications.
The invention addresses design and ease of use difficulties of many previously available topical substance application systems. The invention provides an economical and easy to use platform when performing a large number of topical treatments.
This application claims the benefit of U.S. Provisional Application No. 62/986,092 filed on Mar. 6, 2020.
Number | Date | Country | |
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62986092 | Mar 2020 | US |