Integrated Needle and Test Strip Assembly and Method of Use

• US 20130172780A1
• Filed: 04/20/2012
• Published: 07/04/2013
• Est. Priority Date: 01/03/2012
• Status: Active Grant

• Current Assignee: Charleston Area Medical Center, Inc.
• Original Assignee: Charleston Area Medical Center, Inc.
• Inventors: Kuenstner, J. Todd
• Granted Patent: US 9,451,914 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

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.

Claims

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.

2. The needle assembly of claim 1, further comprising

a fluid filter permeable to gas but not fluids disposed between the sensor strip and the user deployment cover.

3. The needle assembly of claim 1, wherein the analyte reaction assembly comprises:

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.

4. The needle assembly of claim 1, wherein the user deployment cover comprises at least one transparent region.

5. The needle assembly of claim 1, wherein the user deployment cover comprises markings which direct a user to apply pressure to a region of the needle assembly.

6. The needle assembly of claim 1, wherein the needle guide further comprises an adhesive layer adjacent the needle to impede horizontal and vertical movement of the needle assembly during use.

7. The needle assembly of claim 6, further comprising:

a protective needle cover removably disposed over the needle guide adhesive layer, the protective needle cover maintaining a sterile environment for the needle, reaction region of the analyte reaction assembly, sensor strip and needle guide.

8. The needle assembly of claim 1, wherein the needle guide has a thickness that affects the depth of penetration of the needle during use.

9. The needle assembly of claim 1, wherein the sample comprises blood or dermal interstitial fluid.

10. The needle assembly of claim 1, wherein the needle is about 0.2 mm to 1.0 mm in length and about 25 gauge to 35 gauge in diameter.

11. The needle assembly of claim 1, wherein the volume of the sample is about 0.3 microliters to about 30 microliters.

12. The needle assembly of claim 1, wherein the analyte in the sample is at least one of glucose, lactate, fructosamine, glutamine, 3-hydroxybutyric acid, acetyl choline, amylase, bilirubin, alanine transaminase, aspartate transaminase, alkaline phosphatase, luteinizing hormone, chorionic gonadotropin, creatine kinase, creatinine, hemoglobin, myoglobin, albumin, troponin, cholesterol, a coagulate, C-reactive protein, proBNP, uric acid, pyruvate, a hormone, a sugar, a ketone, peroxide, prostate-specific antigen, prothrombin, fibrinogen, thromboplastin, thyroid stimulating hormone, an antibiotic, a drug, a bacterium and a virus.

13. The needle assembly of claim 1, wherein a reaction reagent in the sensor strip is at least one of glucose oxidase and glucose dehydrogenase.

14. The needle assembly of claim 1, wherein a reaction reagent in the sensor strip is carinactivase-1 and calcium ions.

15. The needle assembly of claim 14, wherein the reaction reagent in the sensor strip further includes an indicator.

16. The needle assembly of claim 15, wherein the indicator in the sensor strip is at least one of a peptidylarginine p-nitroanilide or peptidyl-7-amido-4-methylcoumarin.

17. The needle assembly of claim 3, wherein the insulating substrate includes a void passing therethrough and wherein the sensor strip is disposed in the void.

18. An integrated needle and test strip assembly, 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 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.

20. The method of claim 18, further comprising removing a protective needle cover from the integrated needle and test strip assembly before pressing the distal end of the needle into the skin of the patient.

19. A method of using an integrated needle and test strip assembly, comprising:

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.