An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

The present disclosure is directed to wearable or insertable devices that allow for ongoing sampling and analysis of biomarkers and self-cleaning. In various embodiments, an apparatus may include a base (102) defining at least one reservoir (104), and at least one microneedle (106, 306, 406, 506, 606, 706, 806, 906) extending from the base. The at least one microneedle may define an inner lumen (409, 509, 609, 709, 809, 909) that fluidly couples the at least one reservoir with tissue of the patient. A mechanically responsive material (670, 770, 870) on an inner surface of the at least one microneedle defining the inner lumen may be reactive to various stimuli to undergo various mechanical responses, such as one mechanical response that purges fluid from the inner lumen of the at least one microneedle and another mechanical response that draws fluid into the inner lumen of the at least one microneedle.

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.

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.

Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices. Methods include placing a cuff on a digit of a subject, inflating the cuff, and obtaining a small volume blood sample. Methods may further include warming a digit; lancing a digit; pulsing the cuff; and providing a signal indicating the end of the sample collection time period. Kits may include a device, a sample collection vessel, and may include a disposable for use in sample collection. These methods, devices, systems and kits for obtaining blood samples may be used to easily, reliably, and consistently obtain blood samples from subjects.

A system for increasing blood flow through a user's limb during a blood collection procedure includes an inflatable cuff that is worm around the user's limb. A pump and a deflation valve are in fluid communication with the inflatable cuff. A heating element and a temperature sensor are attached to the inflatable cuff. The system also includes a motion sensor. A controller is in communication with the pump, the deflation valve, the heating element and the temperature and motion sensors and detects a blood pressure or blood flow of the user, controls inflation and deflation of the inflatable cuff and controls energization of the heating element based on data from the motion sensor and the temperature sensor.

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

Methods and apparatus for blood sampling from skin capillaries are provided. Blood extraction is improved by applying gradient pressure in a proximal to distal direction of an extremity. Blood is extracted and sampled from the skin capillaries with a blood sampling mechanism of at least a lancet and testing kit.

The present disclosure relates generally to devices, systems, and methods for diagnosis and treatment via laser-treated skin and, more particularly, to devices, systems, and methods for inducing leakage or rupture of one or more blood vessels comprising the dermis for various diagnostic and therapeutic applications. Other aspects of the present disclosure can include methods for detecting one or more target analytes in a dermis of a subject, methods for facilitating skin-to-blood delivery of agent in a subject, and methods for collecting a fluid sample from the dermis of a subject.

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.