Integrated needle and test strip with aspiration apparatus and method of use
First Claim
1. A needle assembly for aspiration of a sample, comprising:
- a needle having an upper flange, a distal end, a central hollow-bore extending through at least a portion of the needle, and at least one transverse hollow-bore in fluid communication with the central bore;
a differential pressure chamber having at least one port in fluid communication with the central hollow-bore of the needle;
a needle guide having at least one port for passage of the needle, wherein the needle guide has an adhesive thereon and adjacent to the needle to impede horizontal and vertical movement of the needle during use;
a sensor strip containing at least one reaction reagent for determining a concentration of at least one analyte in the sample, the sensor strip disposed between the differential pressure chamber and the needle guide, the sensor strip having at least one port for passage of the upper flange of the needle;
a fluid filter permeable to gas but not fluids disposed between the sensor strip and the differential pressure chamber; and
an analyte reaction assembly disposed between the fluid filter and the needle guide and configured to contain the sensor strip within a reaction region, the analyte reaction assembly comprising;
an insulating substrate having an electrical terminal at a first end;
a first conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip;
a second conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip; and
an insulating layer disposed on the insulating substrate, first conductor, and second conductor.
1 Assignment
0 Petitions
Accused Products
Abstract
Methods and systems to collect a sample of bodily fluid from a patient using an integrated needle and test strip assembly are provided. In this novel assembly, the test strip and needle form one unit that captures the sample of blood or interstitial fluid from the patient once the apparatus is pressed to the skin. The hollow aspiration needle includes more than one opening at a distal end, each opening coming into contact with the bodily fluid when disposed within a cutaneous or subcutaneous layer of the patient'"'"'s skin. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for linking to many commercially available test strip meters to provide readout of the analyte concentration. The sample may be captured by capillary flow, by an integrated aspirator, or by a differential vacuum device resident on the test strip meter.
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Citations
16 Claims
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1. A needle assembly for aspiration of a sample, comprising:
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a needle having an upper flange, a distal end, a central hollow-bore extending through at least a portion of the needle, and at least one transverse hollow-bore in fluid communication with the central bore; a differential pressure chamber having at least one port in fluid communication with the central hollow-bore of the needle; a needle guide having at least one port for passage of the needle, wherein the needle guide has an adhesive thereon and adjacent to the needle to impede horizontal and vertical movement of the needle during use; a sensor strip containing at least one reaction reagent for determining a concentration of at least one analyte in the sample, the sensor strip disposed between the differential pressure chamber and the needle guide, the sensor strip having at least one port for passage of the upper flange of the needle; a fluid filter permeable to gas but not fluids disposed between the sensor strip and the differential pressure chamber; and an analyte reaction assembly disposed between the fluid filter and the needle guide and configured to contain the sensor strip within a reaction region, the analyte reaction assembly comprising; an insulating substrate having an electrical terminal at a first end; a first conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip; a second conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip; and an insulating layer disposed on the insulating substrate, first conductor, and second conductor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A needle assembly for aspiration of a sample, comprising:
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a needle having an upper flange, a distal end, a central hollow-bore extending through at least a portion of the needle, and at least one transverse hollow-bore in fluid communication with the central bore; a conduit to connect to a differential pressure device, the conduit in fluid communication with the needle; a needle guide having at least one port for passage of the needle, wherein the needle guide has an adhesive thereon and adjacent to the needle to impede horizontal and vertical movement of the needle during use; a sensor strip containing at least one reaction reagent for determining a concentration of at least one analyte in the sample, the sensor strip having at least one port for passage of the upper flange of the needle; a fluid filter permeable to gas but not fluids, the fluid filter adjacent to the sensor strip; and an analyte reaction assembly disposed between the fluid filter and the needle guide and configured to contain the sensor strip within a reaction region, the analyte reaction assembly comprising; an insulating substrate having an electrical terminal at a first end; a first conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip; a second conductor disposed on the insulating substrate extending from the electrical terminal to the sensor strip; and an insulating layer disposed on the insulating substrate, first conductor, and second conductor. - View Dependent Claims (16)
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Specification