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Here is an updated scenario taken from the 2013 patent
Example 1 Method of Treatment of Skin by Disruption and Formation of Void Spaces
A method according to the present invention for effecting treatment of the skin on a human scalp is performed as follows. A male subject with early stage pattern hair loss is seated in a stationary examination chair. A clinician unseals a kit comprising a handpiece and a set of four containers. A first container comprises 1 mL of a composition comprising lithium gluconate. A second container comprises 5 mL of a composition comprising lithium gluconate. A third container comprises 1 mL of a composition comprising particles of lithium chloride. A fourth container comprises 5 mL of a composition comprising particles of lithium chloride.
The clinician first links the handpiece to a fractional laser generator, and then powers on the handpiece using a manual control. After a few moments, wireless communication is established between the handpiece and a computer onto which software for controlling the handpiece has previously been loaded.
The clinician asseses the scalp of the subject, and upon determination that the subject has a relatively minor degree of hair loss, selects the container comprising 1 mL of a composition comprising 8% lithium gluconate and the container comprising 1 mL of a composition comprising particles of lithium chloride. The handpiece includes two chambers for accommodating containers, and the clinician loads a container into each of the two chambers.
The handpiece is positioned about 5 cm above the surface of an area of the subject's scalp that is selected for treatment because of significantly thinning hair at that location. Using another manual control, the clinician activates a treatment protocol for disruption, formation of void spaces, and application of physiologically active composition to selected the target area. The generator activates a CO2 laser on the handpiece, and in accordance with the software protocol, the computer configures the laser so that it applies an ablative fractional pattern at 10,600 nm onto the target area. This pattern is sufficient to remove substantially all of the stratum corneum and epidermis from the portion of the target area onto which the laser is directed. The clinician moves the handpiece over the surface of the skin until an area measuring about 5 cm by 5 cm is treated. At the same time that the laser is being used to remove the stratum corneum and epidermis from the treatment area, the software protocol also directs the computer to configure the laser so that it intermittently forms a fractional ablative pattern that is effective to form void spaces in the dermis tissue at the treatment area. The void spaces are oriented at a substantially perpendicular angle relative to the surface of the skin, and extend to a depth of about 1 mm from the surface of the exposed dermis. Thus, translation of the handpiece over the surface of the skin is effective both to remove the stratum corneum and epidermis and to form void spaces by removal of dermis tissue during such translation.
The software-directed computer than commands the handpiece to deactivate the laser and a sequence begins for the application of physiologically active composition from the containers onto the injured target area. The clinician positions the handpiece about 5 cm above the surface of the injured skin, and begins translation of the handpiece over the surface of skin as the applicators are activated and begin applying physiologically active composition to the skin by spraying. The physiologically active composition is a mixture of the composition from the first container and the composition from the second container. The handpiece includes a mixing apparatus that combines the contents of the first container with the contents of the second container prior to activation of the applicator. By moving the handpiece over the injured target area, the clinician coats the exposed dermis with the mixed composition until the combined contents of the first and second containers are exhausted. When this occurs, the clinician deactivates the handpiece.
The clinician then applies a topical anaesthetic spray comprising 10% benzocaine to the injured target area. Next, a wand capable of generating ultrasonic vibration is placed in contact with the injured skin and activated. The clinician performs several passes of the wand over the entire surface of the injured target area in order to encourage penetration of the applied lithium chloride particles into the void spaces.
The preceding process is optionally performed iteratively with respect to additional target areas. Optionally, each target area is subject to injury by the fractional laser before any target area is contacted with physiologically active composition or subjected to ultrasonic vibration. Thus, the stratum corneum and epidermis may be removed and the void spaces may be formed with respect to all target areas prior to the application of any physiologically active composition or ultrasonic vibration, followed by the application of composition and ultrasonic vibration to all target areas. After ultrasonic vibration, the clinician may apply additional topical anaesthetic, antimicrobial compositions, bandaging, or any combination thereof, which marks the end of the treatment session for the subject.
Example 1 Method of Treatment of Skin by Disruption and Formation of Void Spaces
A method according to the present invention for effecting treatment of the skin on a human scalp is performed as follows. A male subject with early stage pattern hair loss is seated in a stationary examination chair. A clinician unseals a kit comprising a handpiece and a set of four containers. A first container comprises 1 mL of a composition comprising lithium gluconate. A second container comprises 5 mL of a composition comprising lithium gluconate. A third container comprises 1 mL of a composition comprising particles of lithium chloride. A fourth container comprises 5 mL of a composition comprising particles of lithium chloride.
The clinician first links the handpiece to a fractional laser generator, and then powers on the handpiece using a manual control. After a few moments, wireless communication is established between the handpiece and a computer onto which software for controlling the handpiece has previously been loaded.
The clinician asseses the scalp of the subject, and upon determination that the subject has a relatively minor degree of hair loss, selects the container comprising 1 mL of a composition comprising 8% lithium gluconate and the container comprising 1 mL of a composition comprising particles of lithium chloride. The handpiece includes two chambers for accommodating containers, and the clinician loads a container into each of the two chambers.
The handpiece is positioned about 5 cm above the surface of an area of the subject's scalp that is selected for treatment because of significantly thinning hair at that location. Using another manual control, the clinician activates a treatment protocol for disruption, formation of void spaces, and application of physiologically active composition to selected the target area. The generator activates a CO2 laser on the handpiece, and in accordance with the software protocol, the computer configures the laser so that it applies an ablative fractional pattern at 10,600 nm onto the target area. This pattern is sufficient to remove substantially all of the stratum corneum and epidermis from the portion of the target area onto which the laser is directed. The clinician moves the handpiece over the surface of the skin until an area measuring about 5 cm by 5 cm is treated. At the same time that the laser is being used to remove the stratum corneum and epidermis from the treatment area, the software protocol also directs the computer to configure the laser so that it intermittently forms a fractional ablative pattern that is effective to form void spaces in the dermis tissue at the treatment area. The void spaces are oriented at a substantially perpendicular angle relative to the surface of the skin, and extend to a depth of about 1 mm from the surface of the exposed dermis. Thus, translation of the handpiece over the surface of the skin is effective both to remove the stratum corneum and epidermis and to form void spaces by removal of dermis tissue during such translation.
The software-directed computer than commands the handpiece to deactivate the laser and a sequence begins for the application of physiologically active composition from the containers onto the injured target area. The clinician positions the handpiece about 5 cm above the surface of the injured skin, and begins translation of the handpiece over the surface of skin as the applicators are activated and begin applying physiologically active composition to the skin by spraying. The physiologically active composition is a mixture of the composition from the first container and the composition from the second container. The handpiece includes a mixing apparatus that combines the contents of the first container with the contents of the second container prior to activation of the applicator. By moving the handpiece over the injured target area, the clinician coats the exposed dermis with the mixed composition until the combined contents of the first and second containers are exhausted. When this occurs, the clinician deactivates the handpiece.
The clinician then applies a topical anaesthetic spray comprising 10% benzocaine to the injured target area. Next, a wand capable of generating ultrasonic vibration is placed in contact with the injured skin and activated. The clinician performs several passes of the wand over the entire surface of the injured target area in order to encourage penetration of the applied lithium chloride particles into the void spaces.
The preceding process is optionally performed iteratively with respect to additional target areas. Optionally, each target area is subject to injury by the fractional laser before any target area is contacted with physiologically active composition or subjected to ultrasonic vibration. Thus, the stratum corneum and epidermis may be removed and the void spaces may be formed with respect to all target areas prior to the application of any physiologically active composition or ultrasonic vibration, followed by the application of composition and ultrasonic vibration to all target areas. After ultrasonic vibration, the clinician may apply additional topical anaesthetic, antimicrobial compositions, bandaging, or any combination thereof, which marks the end of the treatment session for the subject.
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