Linearly lancing integrated pivot disposable

• US 20040225312A1
• Filed: 05/09/2003
• Published: 11/11/2004
• Est. Priority Date: 05/09/2003
• Status: Abandoned Application

• Current Assignee: Phoenix Bioscience, Inc.
• Original Assignee: Phoenix Bioscience, Inc.
• Inventors: Subramanian, Kumar, Orloff, Eugene
• Application Number:
  US10/435,409
• Publication Number:
  US 20040225312A1
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150503 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15142 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

A sample retrieval device for collecting fluid from skin. The sample retrieval device has a lancing device and an analytic device integrated into a single body, the analytic device residing in a sample retrieval portion of the body. The body is also equipped with a signal pathway and an engagement portion. The lancing device and the fluid inlet in the sample retrieval portion are positioned in the body so that the fluid released by the lancing device is taken up into the fluid inlet by having the body direct the lancing device and the sample retrieval portion to the fluid released from the skin by pivoting.

Claims

1. A device for obtaining fluid samples, the device comprising:

a body;

a lancing device at a first end of the body;

a sample retrieval portion adjacent a second end of the body and laterally offset with respect to the lancing device;

a signal pathway defined within the body and located between the first end and the sample retrieval portion; and

an engagement portion defined within the body for engaging a transport instrument.

2. A device in accordance with claim 1 where the fluid sample is blood.

3. A device in accordance with claim 1 where the fluid sample is interstitial fluid.

4. A device in accordance with claim 1 where the lancing device is a needle.

5. A device in accordance with claim 1 where the lancing device is fabricated from metal.

6. A device in accordance with claim 1 where the lancing device is fabricated from plastic.

7. A device in accordance with claim 1 where the analytic device is fabricated from plastic, glass, silicon, or any combination of the three.

8. A device in accordance with claim 1 where the body is fabricated from plastic.

9. A device in accordance with claim 1 wherein the sample retrieval portion comprises a slot for receiving an analytic device and tabs for holding the analytic device.

10. A device in accordance with claim 1 wherein the sample retrieval portion makes a fluid seal with an analytic device.

11. A device in accordance with claim 1 wherein the sample retrieval portion contains a fluid inlet.

12. A device in accordance with claim 1 where the signal pathway is a pair of electrodes.

13. A device in accordance with claim 1 where the signal pathway is optical.

14. A device in accordance with claim 1 wherein the engagement portion comprises a slot defined within the body at a side opposite the signal pathway.

15. A device in accordance with claim 1 wherein the engagement portion comprises a pivot point.

16. A device in accordance with claim 1 wherein the device is disposable.

17. A device in accordance with claim 1 further comprising a twist-off cap over the lancing device.

18. A device in accordance with claim 1 wherein the linear distance from a pivot point of the device to a fluid inlet of an analytic device in the sample retrieval portion of the device exceeds the linear distance from the pivot point of the device to the tip of the lancing device.

21. A system in accordance with claim 14 where the fluid sample is interstitial fluid.

19. A system for analyzing fluid samples, the system comprising:

an analytical instrument;

a transport instrument coupled to the analytical instrument; and

a device for obtaining fluid samples, the device comprising;

a body;

a lancing device at a first end of the body;

a sample retrieval portion adjacent a second end of the body and laterally offset with respect to the lancing device;

a signal pathway defined within the body and located between the first end and the sample retrieval portion, the signal pathway being located adjacent the analytical instrument; and

an engagement portion defined within the body for engaging the transport instrument.

20. A system in accordance with claim 19 where the fluid sample is blood.

22. A system in accordance with claim 19 where the lancing device is a needle.

23. A system in accordance with claim 19 wherein the sample retrieval portion comprises a slot for receiving an analytic device and tabs for holding the analytic device.

24. A system in accordance with claim 19 wherein the sample retrieval portion makes a fluid seal with an analytic device.

25. A system in accordance with claim 19 wherein the sample retrieval portion contains a fluid inlet.

26. A system in accordance with claim 19 where the signal pathway is a pair of electrodes.

27. A system in accordance with claim 19 where the signal pathway is optical.

28. A system in accordance with claim 19 wherein the engagement portion comprises a slot defined within the body at a side opposite the signal pathway.

29. A system in accordance with claim 19 wherein the body pivots in relation to the transport instrument

30. A system in accordance with claim 19 wherein the body is contained within an instrument housing and spring loaded within.

31. A system in accordance with claim 19 wherein the body is contained within an instrument housing driven by an electromechanical device within.

32. A system in accordance with claim 19 wherein the body is contained within an instrument housing and is both spring loaded and pivoted electromechanically within.

33. A system in accordance with claim 19 having a pivot point mated to a pivot receptacle whereby the body moves relative to the transport instrument with the pivot point and receptacle positioned opposite each other on the body and transport instrument.

34. A system in accordance with claim 19 wherein the device is disposable.

35. A system in accordance with claim 19 further comprising a twist-off cap over the lancing device.

36. A system in accordance with claim 19 wherein the linear distance from a pivot point of the device to a fluid inlet of an analytic device in the sample retrieval portion of the device exceeds the linear distance from the pivot point of the device to the tip of the lancing device.

37. A method of obtaining a fluid sample, the method comprising:

providing a sample retrieval device comprising a lancing device and sample retrieval portion;

engaging the lancing device with a subject at a sample retrieval location by moving the sample retrieval device along a linear axis defined by the lancing device;

retracting the lancing device from the subject by moving the sample retrieval device along the linear axis; and

pivoting the sample retrieval device such that sample retrieval portion is adjacent the sample retrieval location thereby allowing fluid to enter the sample retrieval portion.

38. A method in accordance with claim 37 wherein the linear distance from a pivot point of the device to a fluid inlet of an analytic device in the sample retrieval portion of the device exceeds the linear distance from the pivot point of the device to the tip of the lancing device.

39. A method of analyzing a fluid sample, the method comprising:

providing a sample retrieval device comprising a lancing device and sample retrieval portion;

engaging the lancing device with a subject at a sample retrieval location by moving the sample retrieval device along a linear axis defined by the lancing device;

retracting the lancing device from the subject by moving the sample retrieval device along the linear axis;

pivoting the sample retrieval device such that the sample retrieval portion is adjacent the sample retrieval location thereby allowing fluid to enter the sample retrieval portion;

analyzing a fluid sample at the sample retrieval location with an analytical instrument.

40. A method in accordance with claim 39 wherein the linear distance from a pivot point of the device to a fluid inlet of an analytic device in the sample retrieval portion of the device exceeds the linear distance from the pivot point of the device to the tip of the lancing device.

41. A method of collecting and analyzing fluids from skin, the method comprising:

positioning on the skin of a subject an instrument housing containing a removable, integrated lancing and analytic device for collecting fluid from the subject, the device comprising;

a body;

a lance at a first end of the body;

a sample retrieval portion adjacent a second end of the body and laterally offset with respect to the lance;

a signal pathway defined within the body and located between the first end and the sample retrieval portion; and

an engagement portion defined within the body for engaging a transport instrument within the instrument housing;

penetrating the lance into the subject by moving the lancing device along a linear axis defined by the lancing device;

retracting the lance from the subject to release fluid by moving the lancing device along the linear axis; and

pivoting the integrated lancing and analytic device so that the sample retrieval portion is adjacent the location on the subject penetrated by the lance; and

analyzing fluid that enters the sample retrieval portion through an inlet.

42. A method in accordance with claim 41 wherein the linear distance from a pivot point of the device to a fluid inlet of an analytic device in the sample retrieval portion of the device exceeds the linear distance from the pivot point of the device to the tip of the lancing device.

43. A method in accordance with claim 41 wherein the sample retrieval portion comprises a slot for receiving an analytic device and tabs for holding the analytic device.

44. A method in accordance with claim 41 wherein the sample retrieval portion makes a fluid seal with an analytic device.

45. A method in accordance with claim 41 wherein the sample retrieval portion contains a fluid inlet.

46. A method in accordance with claim 41 where the signal pathway is a pair of electrodes.

47. A method in accordance with claim 41 where the signal pathway is optical.

48. A method in accordance with claim 41 wherein the engagement portion comprises a slot defined within the body at a side opposite the signal pathway.

49. A method in accordance with claim 41 wherein the body is spring loaded within the instrument housing.

50. A method in accordance with claim 41 wherein the body is driven by an electromechanical device within the instrument housing.

51. A method in accordance with claim 41 wherein the body is both spring loaded and pivoted electromechanically within the instrument housing.

52. A method in accordance with claim 41 having a pivot point mated to a pivot receptacle whereby the body moves relative to the transport instrument with the pivot point and receptacle positioned opposite each other on the body and transport instrument.

53. A method in accordance with claim 41 wherein the fluid is analyzed optically.

54. A method in accordance with claim 41 wherein the fluid is analyzed electrochemically.

55. A method in accordance with claim 41 wherein the fluid is analyzed using fluorescence.

56. A method in accordance with claim 41 wherein the fluid is analyzed using chemiluminescence.

57. A method in accordance with claim 41 wherein the fluid is analyzed for glucose.

58. A method in accordance with claim 41 wherein the fluid is analyzed coulometrically.