摘要:
The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., to the skin and/or from the skin. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, for example, using pain scales such as the Wong-Baker FACES Pain Scale. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.
摘要:
A lancing device and lancet are provided with depth-control, lancet ejection, and/or guidance mechanisms. The depth-control mechanism includes a dial rotationally mounted at a distal end of the housing of the lancing device, the dial being coupled to a linkage whereby rotation of the dial imparts translational movement to a stop surface of the linkage to limit the stroke of the lancet and thereby control lancing penetration depth. The ejection mechanism includes an ejector that is advanced into contact with a transversely flared flange of the lancet to discharge the lancet from the lancing device. The guidance mechanism includes an inner guidance housing for restricting out-of-axis movement of a lancet carrier.
摘要:
The invention is directed to an integrated device for sampling and testing an analyte. The device generally comprises a housing, a lancing device for sampling an analyte, a test strip for substantially capturing at least a portion of the analyte, and a display unit for displaying a result corresponding to the captured portion of the analyte. The invention is further directed to methods for sampling and testing. For example, one method comprises performing a single operation to sample an analyte, to capture the sampled analyte, to perform testing on the sampled analyte, and to display a result corresponding to the performed test. A method such as this can be carried out using an integrated sampling and testing device of the invention, for example, by placing the device the device on a test site of a subject, such as a patient, and performing the single operation to obtain a test result. The invention has particular application in the sampling and testing of analytes in blood, such as the blood of a diabetic patient.
摘要:
Systems and methods for delivering and/or receiving a substance or substances, such as blood, from subjects. In one embodiment, devices and methods for receiving blood from a subject employ devices including a substance transfer component (such as one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, for example, using pain scales such as the WONG BAKER FACES Pain Scale. The device may be self-contained, applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may be processed to determine the blood and/or an analyte within the blood using sensors or agents in the device or an external apparatus. Other aspects of the present invention are directed at other devices for receiving bodily fluids kits involving such devices, methods of making such devices, methods of using such devices, and the like.
摘要:
A biological fluid collection device that is adapted to receive a multi-component blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to separate the plasma portion from the cellular portion. After separation, the biological fluid collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid collection device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with an anticoagulant. The biological fluid collection device is engageable with a testing device for closed transfer of a portion of the plasma portion from the biological fluid collection device to the testing device. The testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.
摘要:
A bodily fluid sampling device is operable to breach the skin surface and allow bodily fluid to emerge from the breach location. The bodily fluid sampling device further evaluates the amount of bodily fluid emerged from breach location and determines whether the amount is sufficient or insufficient for a particular purpose, such as sampling and testing. The determination is accomplished automatically without moving the device. The user may also intervene to perform a variety of tasks following the determination of the amount of bodily fluid.
摘要:
The medical puncturing device (10) includes a housing (12) having a proximal end (18) and a distal end (16) and a skin puncturing assembly (14) within the housing. The skin puncturing assembly includes a movable carrier (50) and a skin puncturing element (52). The skin puncturing element is adapted to puncture the skin of a patient. The carrier is movable from a retracted position wherein a distal tip of the skin puncturing element is disposed within the housing, to a puncturing position wherein the distal tip is exposed to puncture the skin of the patient. The carrier is moved from the retracted position to the puncturing position upon radial deformation of the housing. An internal guide (42) may be provided within the housing for guiding the movement of the carrier from the retracted position to the puncturing position.
摘要:
A meter system for analyzing body fluids includes a supply magazine for storing a stack of test elements, a meter for analyzing fluid samples, and a transport system for transporting test elements from the supply magazine to the meter. The test element in one embodiment includes a lancet integrated test element that has a lancet coupled to a test strip. The transport system is configured to minimize damage to the test element. In one form, the transport system includes a shuttle that slides the top-most test element from the stack onto a connection portion of the meter. In another form, the transport system includes a drum that rotates to transport test elements from the supply magazine to a testing position and, once used, to a waste magazine for disposal. In a further form, the transport system includes a disc that rotates to transport the test elements.
摘要:
A bodily fluid sampling device is operable to lance with a precise depth and express fluid from both fingertip and alternate sites. In one form, the device is operable to adjust the penetration depth of the lancet into the skin. The bodily fluid sampling device includes a lancet adapted to form an incision in skin. A skin contacting member has an orifice through which the lancet extends when lancing the skin. The orifice has a first opening size that is sized to flatten the skin around the lancet during lancing. The orifice has a second opening size that is larger than the first opening size after the incision is formed to express fluid from the incision.
摘要:
An integrated lancing test strip includes a pair of blade members that each have a lancing tip that are configured to lance skin. A pair of spacer members connect the blade members together such that the blade members define an internal capillary. A test strip is positioned along the internal capillary, and the test strip is configured to test analyte levels in the bodily fluid. During use, the lancing tips form one or more incisions in the skin. The fluid from the incisions is drawn via capillary action through the internal capillary and onto the test strip.