Apparatus and methods for a single, handheld device that provides for both insertion of a catheter and collection of a fluid. Some embodiments further include a needle that assists in the insertion of the catheter into a blood vessel, and which includes a retraction feature that protects the user from an accidental needle stick when the device is ready for disposal. Still further embodiments include a protective cover that prevents a user from accidentally being stuck by a second needle used for the introduction of the patient's blood into a collection device.

A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

A blood draw device including an introducer and an actuator. The introducer has a proximal end portion, a distal end portion, and an inner volume, and includes a top surface having a first portion of a first length and a second portion of a second length. The first portion may have a smooth surface along the first length and the second portion has a plurality of ridges along the second length. The actuator includes an exterior portion positioned above the top surface and an interior portion positioned within the inner volume, wherein the exterior portion of the actuator includes an engagement member and a downwardly-extending tab projecting below the engagement member such that the downwardly-extending tab of the actuator may contact at least the plurality of ridges of the second portion of the introducer to provide at least one of tactile and audible feedback to a user.

A dermal patch for collecting a physiological sample includes a housing with a collection chamber, a sample channel and a pin within a receptacle of the housing. The sample channel is configured to direct a physiological sample drawn from a subject to the collection chamber. The pin is removably positioned within the receptacle and is configured to move from an undeployed position to a deployed position. The pin is configured to seal the receptacle when in the undeployed position and is further configured to facilitate generation of negative pressure in the sample channel when the pin is moved from the undeployed to the deployed position.

Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a certain volume of sample from a source of bodily fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample to the patient. The analyte monitoring system can include an automated blood withdrawal system that is configured to withdraw blood from the patient's vasculature at low pressure and/or withdrawal rates so as to reduce or prevent contamination of the withdrawn fluid from the infusion fluids.

A method of assembling a lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is disclosed. The method includes forming a plurality of lancet structures in a lancet sheet. The lancet sheet has a removable ledge for releasing the lancet structures. The removable ledge of the lancet sheet is flexed for releasing the lancet structures from the removable ledge.

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

A lancet device generally includes a housing having opposing lateral sides extending between a forward end and a rearward end, and a shield coaxially and movably associated with the housing. The housing includes a plurality of longitudinal ribs extending along a portion of at least one of the opposing lateral sides. The plurality of longitudinal ribs form a finger grip on at least one of, and typically both of the opposing lateral sides. The shield is generally movable from a first position in which the shield extends outwardly from the forward end of the housing to a second position in which the shield is at least partially moved within the housing, based on axial pressure applied by the user against the finger grip formed by the longitudinal ribs.

A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has sequestration portion that can be vented or evacuated. The fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to the sequestration portion and a second state in which (1) the initial volume is sequestered in the sequestration portion, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow through at least a portion of the fluid control device and into the fluid collection device. The fluid control device can transition automatically or in response to an actuation of a portion of the fluid control device after the sequestration portion receives the initial volume.

A kind of safety lancing device has a front cap and lancet holder with feature: the front cap and lancet holder are connected in insert-plug type, and the front cap is equipped with connecting block at connection end and the lancet holder is equipped with slot at connection end. And the slot includes slideable slot and deadlock slot. The slideable slot is located in front of deadlock slot. The latch is set at the flexible arm end of ejection pin and the latch is equipped with bayonet at the front end and equipped with latch hook at rear end; the width of slideable slot and deadlock slot is larger than that of latch; the slideable slot is equipped with a blocking shoulder at rear end and the deadlock slot is equipped with latching shoulder at front end.