摘要:
Methods of fabricating devices for collecting a sample of physiological and for measuring a characteristic, e.g ., an analyte concentration, of the sampled physiological sample. The 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. The fabrication methods provide various or forming the test strip and the skin-piercing element.
摘要:
A system employing an integrated analyte test strip including a biosensor and lancet is disclosed. The integration of lancet and the sensor elements eliminates the need to align the sensor to the biologic fluid sample after a lancet and lancing device are used in combination to pierce the skin. The system preferably includes a device comprising two body portions that slide relative to each other to both cock and fire a test strip at a target site. Meter reading and test strip disposal may be accomplished by removing the device from the target site. The device preferably employs a magazine loaded with test strips, with one strip being taken from the magazine each time the device is actuated. It preferably also includes a magazine in a cap to store spent test strips for disposal. The device may be turned on an off simply by removal and return of the cap.
摘要:
The present invention provides continuous strips of testers in an individually-sealed water-impermeable packaging which maintains the testers in a sterile condition until used. The subject testers include a test strip sensor integrated with a microneedle for accessing and collecting a sample of physiological fluid and for measuring a chemical characteristic, such as target analyte concentration, of the sampled fluid. The present invention further provides cassettes of the subject strips for removable engagement with a meter for individually dispensing the testers and for facilitating the analysis of the sampled fluid. Also provided by the present invention are systems which include the subject strips and cassettes and such a meter. Methods of using the strips and cassettes are also provided, along with kits for practicing the subject methods.
摘要:
A micro-needle (80) is provided which is particularly useful for the minimally invasive sampling of a biological fluid and/or the minimally invasive delivery of a drug or other formulation across the skin. The micro-needle (80) has a structure having a base (70) at a proximal end and a vertex (60) at a distal end (58), and an open lumen (55) extending there through and through which fluid may be transferred. The structure defines a structural axis (65) that intersects the lumenal axis (56) defined by the open lumen (55). The point of intersection (90) between these axes is at a point below the vertex (60) of the micro-needle (80) to provide a sharp apex (60) at the distal end (58) of the micro-needle (80) and defines the general configuration of the distal end (58) of the micro-needle (80), which may be selected or customized depending on the intended use of the microneedle (80). The micro-needle (80) may be integral with a measurement device for measuring the concentration of a constituent within sampled biological fluid and/or with a fluid reservoir for containing a fluid to be delivered, and may also be used in conjunction with a remote control means. Methods of making and using the micro-needle (80) of the present invention as well as kits comprising one or more of the micro-needles (80) are also provided.
摘要:
A system employing an integrated analyte test strip including a biosensor and lancet is disclosed. The integration of lancet and the sensor elements eliminates the need to align the sensor to the biologic fluid sample after a lancet and lancing device are used in combination to pierce the skin. The system preferably includes a device comprising two body portions that slide relative to each other to both cock and fire a test strip at a target site. Meter reading and test strip disposal may be accomplished by removing the device from the target site. The device preferably employs a magazine loaded with test strips, with one strip being taken from the magazine each time the device is actuated. It preferably also includes a magazine in a cap to store spent test strips for disposal. The device may be turned on an off simply by removal and return of the cap.
摘要:
The present invention provides continuous strips of testers in an individually-sealed water-impermeable packaging which maintains the testers in a sterile condition until used. The subject testers include a test strip sensor integrated with a microneedle for accessing and collecting a sample of physiological fluid and for measuring a chemical characteristic, such as target analyte concentration, of the sampled fluid. The present invention further provides cassettes of the subject strips for removable engagement with a meter for individually dispensing the testers and for facilitating the analysis of the sampled fluid. Also provided by the present invention are systems which include the subject strips and cassettes and such a meter. Methods of using the strips and cassettes are also provided, along with kits for practicing the subject methods.
摘要:
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 (2) which includes a biosensor and at least one skin-piercing element (6) which is a planar extension of a portion of the biosensor. At least one fluid pathway (108,128) 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 (22,86) upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter (40) for making analyte concentration measurements. Methods for using the devices and systems are also provided.
摘要:
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 (2) which includes a biosensor and at least one skin-piercing element (6) which is a planar extension of a portion of the biosensor. At least one fluid pathway (108,128) 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 (22,86) upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter (40) for making analyte concentration measurements. Methods for using the devices and systems are also provided.