A booty for an infant that heats the heel of the infant while preventing potential bruising, infection or cartilage damage caused by frequent heel sticks from blood tests being taken at the heel of the infant. The booty has a flexible body with a closure opening to allow the booty to be placed on the foot of the infant. The booty also has a closure device to adjust the size of the closure opening and further secure the booty to the foot of the infant. A warming device is included to heat the heel of the infant. The booty includes an attachment device to securely attach the warming device to the booty.

Transdermal sampling and analysis device, method and system are provided for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples. The transdermal sampling and analysis device, method and system may cause disruption to the skin cells to create capillary-like channels from which biological samples may flow to the transdermal sampling and analysis device. The transdermal sampling and analysis device, method and system may collect the biological samples in a reservoir where the biological sample may chemically react with a biologically reactive element. A sensor may convert the produced electrons (ions) into measured electrical signals. The converted signals may be measured and the levels of an analyte may be determined based on the measured signals.

Methods for obtaining a sample from a subject include providing a sample collection room within a retail store or physician's office; and obtaining a sample. Methods for analyzing a sample include providing a sample collection room within a retail store or physician's office; obtaining a sample; and analyzing it. A waiting room; a bathroom; and a pass-through from bathroom to sample collection room may be provided. Sample collection rooms may include a warming table; a warming plate; a finger warmer; a fingertip warmer; an air-warmer; a reclining chair; a calming feature; and adjustable lighting. Samples may be analyzed at the collection location or sent to elsewhere for analysis. Sample collection rooms may house a sample analysis device or system. Samples may be small, e.g., a finger-stick, and may be analyzed in a short period of time, e.g., in less than five hours, or less than four hours.

A blood circulation enhancement bracelet improves the efficacy and ease of blood draws. A polypropylene bracelet with an adhesive closure bears a placard on one side and a sodium acetate heating pack on the opposite side. The placard bears a soothing aesthetic side which may distract and comfort the patient. The heat pack, when activated, may be placed against the inside of the patient's arm, and more particularly inside of the elbow joint. Warmth applied to the inside of the arm assists in dilating the veins in this area, making it easier for a medical professional to find and access the veins. In this way, multiple painful attempts to draw from the veins may be avoided.

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.

The invention relates to analyte monitoring/drug (pharmaceutical agent) delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The electronics portion includes a processor and associated circuitry (e.g., memory, supporting electronics and the like), a motor or the like, a sensor, a power supply (e.g., battery) and optionally an interface. In general, the processor controls the operation of the device and is data communication with the actuator, motor, sensor and interface. The invention provides for autonomous operation, that is, without intervention of the user. The invention can optionally provide for calibration without intervention of the user. The invention can also provide for semi-continuous monitoring for day and night time. The invention can provide for up to four, or more, weeks of operation. The invention can provide for a device that is relative small in size, and therefore unobtrusive. The invention can also provide for device with remote control and interactive electronics. The invention may be also used for the delivery of various pharmaceutical agents including high potency drugs to minimize patient intervention and minimize discomfort.

Devices are provided to automatically access blood from beneath or within skin. These devices include an injector configured to drive a needle into the skin and subsequently to retract the needle from the skin. These devices additionally include a seal to which suction is applied. To drive the needle into the skin, the needle is first driven through the seal, creating at least one hole in the seal. The suction applied to the seal acts to draw blood from the puncture formed in the skin by the needle, through the at least one hole in the seal, and to a sensor, blood storage element, or other payload. These devices can be wearable and configured to automatically access blood from skin, for example, to access blood from the skin at one or more points in time while a wearer of a device is sleeping.

The invention relates to analyte monitoring/drug delivery device. The invention is suited for monitoring various blood constituents such as glucose. The device has a housing that at least partially encloses a plurality of microneedles disposed on a carrier and an electronics portion. Each microneedle is in fluid communication with a corresponding microchannel. Each microneedle is individually addressable. That is, each microneedle can be extended and retracted individually via an actuator. The invention can optionally provide for calibration without intervention of the user and can also provide for semi-continuous monitoring for day and night time. The invention can provide up to four, or more, weeks of operation. The invention can provide for a device that is relatively small in size, and therefore unobtrusive. The invention can also provide for device with remote control and interactive electronics. The invention may be also used for the delivery of various pharmaceutical agents.

A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.