Integrated lancing and analytic device

• US 6,783,502 B2
• Filed: 04/24/2002
• Issued: 08/31/2004
• Est. Priority Date: 04/26/2001
• Status: Expired due to Fees

• Current Assignee: Phoenix Bioscience, Inc.
• Original Assignee: Phoenix Bioscience, Inc.
• Inventors: Subramanian, Kumar, Orloff, Eugene L. Y.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/131,973
• Publication Number:
  US 20020177761A1
• Time in Patent Office: 860 Days
• Field of Search: 600/309, 600/310, 600/341, 600/345, 600/347, 600/573, 600/576, 600/583, 600/584, 294/28, 264/239, 264/328.1
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

This invention provides for an integrated device having a lance and analytic device in a single disposable unit where the lance releases fluid from skin and the analytic device collects and analyzes the fluid without the user removing an instrument housing which holds the disposable unit. In addition to the device, this invention provides for methods of using and manufacturing the device.

Claims

1. An integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body wherein:

i. the lance has a tapered skin penetrating portion extendible from the body so that it penetrates the skin to release fluid when the body of the device is held to the skin;

ii. the analytic device comprises an inlet, an analytic region having capillary dimensions, an outlet and a signal pathway wherein the analytic region is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside said signal not visible to a user; and

iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet by having the device body direct the lance and the analytic device to the fluid released from the skin.

2. A device of claim 1 wherein the device body creates a fluid seal with the analytic device.

3. A device of claim 1 wherein the lance is a needle.

4. A device of claim 1 wherein the analytic device holds 50-300 nanoliters of fluid.

5. A device of claim 1 wherein the signal pathway is a pair of electrodes.

6. A device of claim 1 wherein the signal pathway transmits an optical signal.

7. A device of claim 1 wherein the fluid is blood.

8. A device of claim 1 wherein the fluid is interstitial fluid.

9. A device of claim 1 wherein the analytic device is held rigidly in the device body.

10. A device of claim 1 where in the lance is rigidly fixed to the device body.

11. A device of claim 1 wherein the lance is extendible by its being moveably positioned along a pathway within the device body.

12. A device of claim 1 wherein the lance is spring loaded in the device body.

13. A device of claim 1 wherein the analytic device is moveably positioned within a pathway within the device body to extend to the fluid released on skin.

14. A device of claim 1 wherein the analytic device is spring loaded within the device body.

15. A device of claim 1 wherein the lance penetrates less than 2 mm into the skin.

16. An instrument system comprising an instrument housing containing an integrated lancing and analytic device for collecting fluid from skin said instrument housing fitted to removably house the device said device having a lance and an analytic device integrated into a single device body wherein:

i. the lance has a tapered skin penetrating portion which extends from the body so that it penetrates the skin and retracts to release fluid from the skin when the instrument housing is held to the skin;

ii. the analytic device that comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside said signal not visible to a user; and

iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet without removing the instrument housing from the skin.

17. A system of claim 16 wherein the analytic device holds 50-300 nanoliters of fluid.

18. A system of claim 16 wherein the signal pathway is a pair of electrodes.

19. A system of claim 16 wherein the signal pathway transmits an optical signal.

20. A system of claim 16 wherein the lance is a needle.

21. A system of claim 16 wherein the lance is a hypodermic syringe.

22. A system of claim 16 wherein the lance has a fluid channel.

23. A system of claim 16 wherein the lance is rigidly fixed in the device body.

24. A system of claim 16 wherein the lance is spring loaded in the device body.

25. A system of claim 16 wherein the lance is spring loaded in the instrument housing.

26. A system of claim 16 wherein the lance is driven by an electromechanical device in the instrument housing.

27. A system of claim 16 wherein the analytic device is spring loaded in the device body.

28. A system of claim 16 wherein the analytic device is spring loaded in the instrument housing.

29. A system of claim 16 wherein the analytic device is driven by an electromechanical device in the instrument housing.

30. A system of claim 16 wherein the device body pivots in relation to the instrument housing.

31. A system of claim 16 wherein the analytic device is rigidly fixed to the device body.

32. A system of claim 16 having a pivot point mated to a pivot receptacle whereby the device body moves relative to the instrument housing with the pivot point and receptacle positioned opposite each other on the device body and housing.

33. A method of collecting and analyzing fluids from skin said method comprising the steps of:

a) positioning on the skin of an animal an instrument housing containing a removable, integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body wherein;

i. the lance comprises a tapered skin penetrating portion which extends from the body so that it penetrates and releases fluid from the skin when the body of the device is held to the skin;

ii. the analytic device comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside where the signal is not visible to the user; and

iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet by directing the lance and the analytic device to the fluid without removing the instrument housing from the skin;

b) penetrating the lance into the skin to release fluid; and

c) positioning the analytic device to the location on the skin penetrated by the lance; and

d) analyzing the fluid that enters the analytic device through the inlet.

34. A method of claim 33 wherein the analytic device is held rigidly in the device body.

35. A method of claim 33 wherein the lance can move within the device body.

36. A method of claim 33 wherein the analytic device can move within the device body to extend to the fluid on the skin.

37. A method of claim 33 wherein the lance is held rigidly in the device body at an angle with respect to the analytic device.

38. A method of claim 33 wherein the lance is reinserted into the skin while positioning the analytic device on the skin.

39. A method of claim 33 wherein the device body is pivoted to position the lance and analytic device on the skin.

40. A method of claim 33 wherein the lance and analytic device move within the device body for positioning on the skin.

41. A method of claim 33 wherein the fluid is analyzed optically.

42. A method of claim 33 wherein the fluid is analyzed electrochemically.

43. A method of claim 33 wherein the fluid is analyzed using fluorescence.

44. A method of claim 33 wherein the fluid is analyzed using chemiluminescence.

45. A method of claim 33 wherein the fluid is analyzed for glucose.

46. A process for manufacturing an integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body said process comprising attaching a lance and analytic device to a device body wherein the lance and inlet of the analytic device are positioned in the device body so that fluid released by the lance is taken up into the inlet without having to remove the device from the skin, by directing the lance and the analytic device to the same position on the skin,

wherein the lance has a tapered, skin-penetrating portion configured to extend from the body so that it penetrates and releases fluid from the skin when the body of the device is held to the skin;

and,

wherein the analytic device comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside.

47. A process of claim 46 wherein the device body is fabricated using plastic injection molding.

48. A process of claim 46 wherein the analytic device is fabricated from silicon.

49. A process of claim 46 wherein the analytic device is fabricated from a combination of silicon with plastic or glass.

50. A process of claim 46 wherein the lance is fabricated from metal.

51. A process of claim 46 wherein the lance is fabricated from silicon.

52. A process of claim 46 wherein the lance is fabricated from plastic.