Integrated Needle and Test Strip Assembly and Method of Use
First Claim
1. A needle assembly for collection 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 needle guide having at least one port for passage of the needle;
a user deployment cover;
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 user deployment cover and the needle guide, the sensor strip having at least one port for passage of the upper flange of the needle; and
an analyte reaction assembly disposed between the user deployment cover and the needle guide and configured to contain the sensor strip within a reaction region.
1 Assignment
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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. 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 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 sample may flow through the needle onto a test region by capillary action and/or the positive pressure of the bodily fluid (e.g. blood or interstitial fluid) relative to the external environment. The disclosed test strip includes at least one reaction site for testing analyte concentrations and a means for interfacing with many commercially available test strip meters to provide readout of the analyte concentration.
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Citations
20 Claims
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1. A needle assembly for collection 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 needle guide having at least one port for passage of the needle; a user deployment cover; 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 user deployment cover and the needle guide, the sensor strip having at least one port for passage of the upper flange of the needle; and an analyte reaction assembly disposed between the user deployment cover and the needle guide and configured to contain the sensor strip within a reaction region. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An integrated needle and test strip assembly, 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 near the distal end in fluid communication with the central bore; and a test strip containing at least one sensor region, wherein the sensor region contains at least one reaction reagent for determining a concentration of at least one analyte in the sample, the sensor region in fluid communication with the upper flange of the needle. - View Dependent Claims (20)
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19. A method of using an integrated needle and test strip assembly, comprising:
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pressing the distal end and at least one transverse bore of 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 near the distal end in fluid communication with the central bore into skin of a patient; and holding the needle in place until a sample is drawn through the needle into a test strip in fluid communication with the needle, the test strip containing at least one reaction reagent for determining a concentration of at least one analyte in the sample.
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Specification