3140results about "Blood sampling devices" patented technology

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical / reflectance testing measuring device, or a visual inspection.

A device for use with a penetrating member driver to penetrate tissue is provided. A plurality of penetrating members are coupled to a single cartridge and are operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of analyte sensors are coupled to the single cartridge and are positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

An integrated lancing and measurement device is provided comprising a sensor designed to determine the amount and / or concentration of analyte in a biological fluid having a volume of less than about 1 μL. A piercing member is adapted to pierce and retract from a site on the patient to cause the fluid to flow therefrom, and the sensor is positioned adjacent to the site on the patient so as to receive the fluid flowing from the site to generate an electrical signal indicative of the concentration of the analyte in the fluid. The sensor is comprised of a working electrode comprising an analyte-responsive enzyme and a redox mediator, and a counter electrode. An analyte monitor is operatively connected to the sensor and adapted to measure the signal generated by the sensor. Also provided are analyte measuring methods that optionally employ the integrated lancing and measurement device.

The method comprises providing a lancing device comprising a penetrating member (68) driver having a position sensor (74) and a processor (60) that can determine the relative position and velocity of the penetrating member (18, 72) based on measuring relative position of the penetrating member with respect to time; providing a predetermined velocity control trajectory based on a model of the driver (68) and a model of tissue to be contacted. Furthermore, a feedforward control is able to maintain penetrating member velocity along the trajectory.

Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,(b) forming a seal between said blood collection device and said surface of the skin,(c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood,(d) triggering a lancing assembly and causing a lancet to penetrate said skin,(e) retracting said lancet,(f) withdrawing blood toward and onto a fluid collector, and(g) releasing the vacuum.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a housing having a sealable chamber located therein and a sealable opening in fluid communication with said sealable chamber,(b) a power source,(c) a vacuum pump operably connected to said power source, said vacuum pump in communication with said sealable chamber,(d) a lancing assembly positioned within said housing, said lancing assembly capable of moving a lancet towards said sealable opening, and(e) a fluid collector positioned in said sealable chamber, said fluid collector in fluid communication with said sealable opening.

Provided is an analyte monitoring device having a housing, the device comprising: a plurality of needles, each having a tip, a retracted position, a position wherein the tip is extended from the housing a distance adapted to pierce skin; an electrically or spring powered needle pushing apparatus movable to separately engage each of the needles to move each from the retracted position to the extended position; an energy source located within the housing; a plurality of analysis sites comprising an analysis preparation, each adapted to receive liquid from the needles to wet the analysis preparation; one or more light sources adapted to direct light at the analysis sites; one or more light detectors adapted to receive light from the analysis sites; and a processor.

An assembly to be detachably mounted on a body fluid monitoring system is provided. The assembly has a lancet and a device for collecting and detecting a body fluid. The lancet has a puncture needle. In this assembly, the puncture needle is maintained in sterilized conditions until its use, and the sterilization can be conducted with no adverse effects on the detection device. A readily sterilizable lancet unit and a body fluid-collecting and detecting unit adapted for use in such an assembly as well as a body fluid-monitoring system including such an assembly are also provided. The assembly comprises a first housing having a sleeve which movably accommodates the lancet in its interior, and a second housing having the body fluid detection device. The first housing and the second housing share an opening. The lancet is sterilized before the assembly. The body fluid-collecting and detecting section has a body fluid guide on the periphery of the inlet.

An apparatus for detection and quantitation of an electrochemically-detect- able analyte, such as glucose, in blood or interstitial fluid includes a meter unit, a lancet and an electrochemical sensor. Of these components, the meter is preferably reusable, while the lancet and the electrochemical sensor are preferably incorporated in assemblies intended for single-use. The meter unit has a housing, within which a lancet is engaged with a mechanism for moving then lancet; a connector disposed within the housing for engaging an electrochemical sensor specific for the analyte and transmitting a signal indicative of the amount of analyte, and a display operatively-associated with a connector for displaying the amount of the analyte to user. The electrochemical sensor is adapted for detection of a particular analyte. In addition, the electrochemical sensor has an absorptive member for uptake of a sample of blood or interstitial fluid. In one version, the lancet moves from a initial position to a piercing position in which skin of the user is pierced and optionally back to a retracted position. The electrochemical sensor is disposed such that the absorptive member takes up a sample from the pierced skin of the user when it is pierced by the lancet without movement of the apparatus. In an alternative version, the lancet is a hollow cannula through which blood or interstitial fluid is transported from the puncture site to an absorbent portion of the electrochemical sensor. In either version, the apparatus provides single-step operation in which sample acquisition and analysis occur as a result of the single action of pressing the apparatus against the users skin.

A glucose sensor in the form of a skin patch 2 has a microneedle 4 which painlessly penetrates the skin to draw out interstitial fluid. The interstitial fluid passes to a common entrance port 7. A series of microchannels 8 is provided on the skin patch. The fluid drawn onto the patch is selectively switched between a number of microchannels 8 by means of electro-osmotic pumps 10 and hydrophobic gates 12. Each microchannel 8 has an electrochemical detector 11 for sensing gluocse concentration. Also disclosed is a monlithic device with an integrated lance 83.

Disclosed herein are systems and methods for a continuous analyte sensor, such as a continuous glucose sensor. One such system utilizes first and second working electrodes to measure analyte or non-analyte related signal, both of which electrode include an interference domain.

Systems and methods are provided for sensing analyte (e.g., glucose) and / or dispensing therapeutic fluid (e.g., insulin). The systems and methods are based on transporting the therapeutic fluid through a cannula at least a portion of which is permeable to molecule of the analyte. Sensing and detection of the concentration level of the analyte can be carried out by optical sensing, electrochemical sensing, acoustical sensing etc. Sensing and dispensing can be carried out by sensing and dispensing device operating in either closed or semi-closed loop.

A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid.

Abstract of Disclosure Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. At least one fluid pathway resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter for making analyte concentration measurements. Methods for using the devices and systems are also provided.

A system for extracting a bodily fluid sample (e.g., an interstitial fluid [ISF] sample) and monitoring an analyte therein includes a disposable cartridge and a local controller module. The disposable cartridge includes a sampling module adapted to extract a bodily fluid sample and an analysis module adapted to measure an analyte (e.g., glucose) in the bodily fluid sample. The local controller module is in electronic communication with the disposable cartridge and is adapted to receive and store measurement data from the analysis module. An ISF extraction device includes a penetration member configured for penetrating and residing in a target site of a user's skin layer and, subsequently, extracting an ISF sample therefrom. The device also includes a pressure ring(s) adapted for applying pressure to the user's skin layer in the vicinity of the target site. The device is configured such that the pressure ring(s) is capable of applying pressure in an oscillating manner whereby an ISF glucose lag of the ISF sample extracted by the penetration member is mitigated. A method for extracting ISF includes providing an ISF fluid extraction device with a penetration member and a pressure ring(s). Next, a user's skin layer is contacted by the pressure ring(s) and penetrated by the penetration member. An ISF sample is then extracted from the user's skin layer while pressure is being applied in an oscillating manner by the pressure ring(s). The oscillating pressure mitigates an ISF glucose lag of the extracted ISF sample extracted.

An automatic skin puncturing system that was operable with one hand for allowing individuals with the use of only a single hand to take the blood samples needed to monitor their blood glucose levels. The automatic skin puncturing system includes a housing assembly, a power connecting jack, a battery holder, an indexable, motor driven turntable, an index switch, a reed switch, a lancet lifting assembly, a disposable lancet carousel cartridge, and an electronic, micro-processor controlled circuit.

A device and method for measuring clotting times in a fluid, typically blood, within a microchannel, with the onset of clotting being determined by measurement of the rate of change, or the value, of capacitance or impedance between two electrodes situated on either side of the microchannel. The device includes an upper support member and a lower support member with a microchannel formed therein. The device also includes electrodes situated along the length of the microchannel.

An interstitial fluid (ISF) extraction device includes a penetration member configured for penetrating a target site of a user's skin layer and, subsequently, residing in the user's skin layer and extracting an ISF sample therefrom and at least three concentrically-arranged pressure rings, each adapted for applying pressure to the user's skin layer in the vicinity of the target site while the penetration member is residing in the user's skin layer. In addition, the ISF extraction device is configured such that (i) the pressure rings apply pressure in an oscillating manner with asymmetric deployment and retraction cycles and (ii) only one of the at least three concentrically-arranged pressure rings is deployed at a time, thereby mitigating an ISF glucose lag of the ISF sample extracted by the penetration member.

A region of skin, other than the fingertips, is stimulated. After stimulation, an opening is created in the skin (e.g., by lancing the skin) to cause a flow of body fluid from the region. At least a portion of this body fluid is transported to a testing device where the concentration of analyte (e.g., glucose) in the body fluid is then determined. It is found that the stimulation of the skin provides results that are generally closer to the results of measurements from the fingertips, the traditional site for obtaining body fluid for analyte testing.

An analyte test device is constructed as an integrated, single-use, disposable cartridge which can be releasably installed into a compatible analyte test monitor. In use, the device can be used in conjunction with the monitor to lance the skin of a patient to create a blood sample, express the blood sample from the wound site using vacuum forces and calculate the concentration of a particular analyte in the expressed blood sample. In one embodiment, the device includes a base which includes a top surface and a bottom surface. The base is also shaped to define an aperture which extends transversely through its top and bottom surfaces. An electrochemical test sensor is affixed to the base in such a manner so that a vacuum path is at least partially defined between the base and the test sensor, the vacuum path being in fluid communication with the aperture. A cover is affixed to the top surface of the base over the aperture, the cover comprising a flexible dome-shaped member and a lancet coupled to the member, the lancet being orientated such that its longitudinal axis extends at an approximate right angle relative to the longitudinal axis of the test sensor. The bottom surface of the base is shaped to include a skin receiving surface which at least partially defines the aperture in the base, the skin receiving surface having a steep inward contour to distend the skin of the patient when pressed thereagainst.

A method of measuring an analyte concentration in body fluid in an animal body having skin and subcutaneous soft tissue that includes body fluid. The method comprises, introducing a portion of an analyte-measuring device into the subcutaneous soft tissue. The analyte-measuring device includes an analyte sensing element, having a sharpened distal end to facilitate introduction into the animal body. Additionally the sensing element has an indicating electrode that is adapted to be activated by electric power and to form a raw analyte measurement, when it is activated and in contact with the body fluid, in less than two minutes. The sensing device further has a reference electrode and an electric power and display device that is adapted to mate to the analyte-sensing element. The power and display device activates the analyte-sensing element by applying electric power to it. The analyte-sensing element is introduced into the animal body and is activated by the electric power and display device, thereby causing the analyte-sensing element to form a raw analyte measurement. The power and display device forms and displays a second analyte measurement that is related to the raw analyte measurement, within two minutes of the analyte sensing element being introduced into the body.

Microneedle devices and methods of manufacturing the microneedle devices. The microneedle devices include microneedles protruding from a substrate, with the microneedles piercing a cover placed over the substrate surface from which the microneedles protrude. The cover and the microneedle substrate together define a capillary volume in fluid communication with the base of each microneedle. One manner of using microneedle arrays of the present invention is in methods involving the penetration of skin to deliver medicaments or other substances and / or extract blood or tissue. Manufacturing methods may include simultaneous application of pressure and ultrasonic energy when piercing the cover with the microneedles.

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

Simple microneedle devices for delivery of drugs across or into biological tissue are provided, which permit drug delivery at clinically relevant rates across or into skin or other tissue barriers, with minimal or no damage, pain, or irritation to the tissue. The devices include a substrate to which a plurality of hollow microneedles are attached or integrated, and at least one reservoir, containing the drug, selectably in communication with the microneedles, wherein the volume or amount of drug to be delivered can be selectively altered. The reservoir can be formed of a deformable, preferably elastic, material. The device typically includes a means, such as a plunger, for compressing the reservoir to drive the drug from the reservoir through the microneedles. In one embodiment, the reservoir is a syringe or pump connected to the substrate.

A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

A device is provided for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may include a plurality of penetrating members each at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from openings on the cartridge to penetrate tissue. The device may also include a plurality of analyte detecting members and a plurality of chambers. Each chamber may be associated with one of the cavities, the chambers positioned along an outer periphery of the cartridge, wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of chambers. In one embodiment, the device may also include a fluid spreader positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members.

A method of measuring an analyte concentration in body fluid. The method includes the use of an analyte measuring device that has an analyte sensing element with a sharpened distal end and further has an indicating electrode covered by an absorbent layer. Also, an electric power, data processing and display device is adapted to mate to and activate the analyte sensing element by applying electric power to it and adapted to receive the raw analyte measurement and to compute and display a refined analyte measurement from the raw analyte measurement. The analyte sensing element is introduced into the animal body, thereby placing the absorbent layer into contact with the body fluid. The absorbent layer becomes saturated with body fluid and the analyte sensing element is removed from the body and is activated to form a raw analyte measurement. Which is used to form and display a refined analyte measurement.