Abstract: A system, method, and device for non-invasive body fluid sampling is provided. According to one embodiment of the present invention, the system includes a controller that controls the generation of ultrasound; an ultrasonic applicator that applies the ultrasound to an area of biological membrane; a receiver that contacts the area of biological membrane and receives body fluid through and out of the area of biological membrane; and a meter that interacts with the receiver and detects the presence of at least one analyte in the body fluid in the receiver. The receiver may include a membrane and a medium, such as a hydrogel, a fluid, or a liquid, that is contained in the membrane.

Abstract: The invention provides a convenient and non-invasive means to prepare cells, tissues, and organs for electrical transmission and reception. In an embodiment of the invention, a control method comprises the use of at least one skin electrode, as a reference electrode, and an electrical sensor to measure periodically or continuously the skin's electrical conductance at the site of preparation. The dynamic change in the conductance through the skin is measured while the ultrasound is applied. Signal processing is performed on the measurement and the level of skin impedance change is controlled by performing a mathematical analysis and using the results of such analysis to control the application of ultrasonic energy. A desired level of skin impedance can be set at a predetermined value or based on a chosen level of skin integrity, subject's sensation of discomfort, or duration of the ultrasound application.

Abstract: The invention provides a convenient and non-invasive means to prepare cells, tissues, and organs for electrical transmission and reception. In an embodiment of the invention, a control method comprises the use of at least one skin electrode, as a reference electrode, and an electrical sensor to measure periodically or continuously the skin's electrical conductance at the site of preparation. The dynamic change in the conductance through the skin is measured while the ultrasound is applied. Signal processing is performed on the measurement and the level of skin impedance change is controlled by performing a mathematical analysis and using the results of such analysis to control the application of ultrasonic energy. A desired level of skin impedance can be set at a predetermined value or based on a chosen level of skin integrity, subject's sensation of discomfort, or duration of the ultrasound application.

Abstract: According to the present invention, a method for enhancing transdermal transport is disclosed. The method includes the steps of increasing a permeability of an area of a membrane with a permeabilizing device. The membrane may be, inter alia, biologic skin or synthetic skin. The permeabilizing device may be an ultrasound-producing device. A substance is transported into and through the area of the membrane. The substance may be a drug, a vaccine, or a component of interstitial fluid.

Abstract: According to the present invention, a method for enhancing transdermal transport is disclosed. The method includes the steps of increasing a permeability of an area of a membrane with a permeabilizing device. The membrane may be, inter alia, biologic skin or synthetic skin. The permeabilizing device may be an ultrasound-producing device. A substance is transported into and through the area of the membrane. The substance may be a drug, a vaccine, or a component of interstitial fluid.

Abstract: The present invention is directed to apparatus and methods for producing homogenous cavitation. An ultrasound souce comprising an ultrasound transmitting element having an axis and a cross-section along the axis is disclosed The ultrasound transmitting element also has a first axial end and a second axial end operable to produce ultrasonic waves. The cross-section has an area having a maximum value at the first axial end and a minimum value at the second axial end. A method for producing homogenous cavitation at an area of skin comprises creating a volume of fluid having a uniformly dispersed concentration of cavitation nuclei adjacent the area of skin. Ultrasound is then applied to the volume of fluid and causes cavitation at the cavitation nuclei.

Abstract: The present invention is directed to apparatus and methods for producing homogenous cavitation. An ultrasound souce comprising an ultrasound transmitting element having an axis and a cross-section along the axis is disclosed The ultrasound transmitting element also has a first axial end and a second axial end operable to produce ultrasonic waves. The cross-section has an area having a maximum value at the first axial end and a minimum value at the second axial end. A method for producing homogenous cavitation at an area of skin comprises creating a volume of fluid having a uniformly dispersed concentration of cavitation nuclei adjacent the area of skin. Ultrasound is then applied to the volume of fluid and causes cavitation at the cavitation nuclei.

Abstract: A portable ultrasonic scalpel/cautery device is disclosed. According to one embodiment of the present invention, the ultrasonic surgical instrument includes a low voltage battery-powered ultrasonic generator and a handheld ultrasonic surgical instrument. The battery-powered ultrasonic generator generates an ultrasonic signal having a frequency of about 55 kHz.

Abstract: Methods and devices for application of ultrasound to a small area of skin for enhancing transdermal transport. An ultrasound beam having a first focal diameter is channelled into a beam having a second, smaller diameter without substantial loss of energy. Higher energy ultrasound can be used while causing less pain. Alternatively, ultrasound energy is applied through a vibrating element positioned just contacting, above or extending into the skin. Use of the element facilitates extraction of analyte and may enhance drug delivery. A two step noninvasive method involves application of ultrasound to increase skin permeability and removal of ultrasound followed by transdermal transport that can be further enhanced using a physical enhancer.

Abstract: Methods and devices for application of ultrasound to a small area of skin for enhancing transdermal transport. An ultrasound beam having a first focal diameter is channelled into a beam having a second, smaller diameter without substantial loss of energy. Higher energy ultrasound can be used while causing less pain. Alternatively, ultrasound energy is applied through a vibrating element positioned just contacting, above or extending into the skin. Use of the element facilitates extraction of analyte and may enhance drug delivery. A two step noninvasive method involves application of ultrasound to increase skin permeability and removal of ultrasound followed by transdermal transport that can be further enhanced using a physical enhancer.

Abstract: Methods for enhanced transdermal transport wherein the application of ultrasound is required only once for repeated or sustained transdermal extraction or delivery, over a period of time, rather than prior to each extraction or delivery. The method is applicable to analyte extraction, as well as for drug delivery. The method involves the initial application of an amount of low frequency ultrasound effective to permeabilize the skin or membrane followed by analyte extraction or drug delivery over a period of time. The initial application of ultrasound is effective to permeabilize the skin or membrane for at least about 30 minutes, preferably at least one to two hours, and more preferably up to four to ten hours. The ultrasound is preferably low frequency ultrasound, less than 2.5 MHz, more preferably less than 1 MHz.